Innovations in Healthcare

I recently visited my parents in my ancestral home of Wisconsin. As parents of a certain age, they inexplicably are genetically predisposed to owning a minivan. Another quirk of their DNA is that they must own a new minivan. No sooner has the last wisp of new-car smell osmosed from the burled walnut interior than they are trading up to the newest, tricked-out minivan. Perhaps more puzzling is the manner of pride they display in their minivan.

Now, my dad, as if not readily apparent, is not cool. And to see him folded into the driver’s seat, his furry-ear-to-furry-ear grin signaling a self-satisfaction customarily reserved for his grandchildren, painstakingly recounting glory-day stories and 4:30 p.m. dinner buffets, further solidifies his place in the Annals of Uncool.

When I’m home, they tend to employ my chauffeur services (most likely in retribution for my peri-pubescent years), and on the first day back home, I stopped their newest ride near the back door of the house, foot idling on the brake while this exchange occurred: “That’s a fascinating story about how much more challenging the world was when you were my age, Dad. You are a true American hero. Would you like to get out here or in the garage?”

“Here,” he replied.

“OK, then get out,” I countered.

“I can’t,” he responded knowingly.

“Why not?” I queried, the patience seeping from my voice.

“Because the door’s not open,” he answered, seemingly mocking me.

“Then open it,” I replied, silently recounting the evidence for his institutionalization.

“I can’t,” he responded.

“Why not?” I replied again, this time calculating the likelihood that I was adopted.

“Because it’s locked,” came his retort.

“Then unlock it,” I answered, reconfirming my decision to move away for college.

“I can’t,” he replied, ostensibly encouraging parenticide.

“Why not?” I queried, strongly contemplating parenticide.

“Because you haven’t put the car in park,” he responded triumphantly.

A System So Safe

As a safety feature, the minivan needed to be in park before you could open the door to exit. I’ve never heard of anyone actually falling out of a moving car, but recollecting high school, I can fathom the right mix, type, and number of teenagers where possibility would meet inevitability. But, apparently, enough people are falling out of moving vehicles that car engineers have built a system that is so safe, this can’t happen. So no matter how hard someone tries, it just isn’t possible to fall out of a moving car (believe me, toward the end of a week of my father’s car stories, my mind had worked every possible angle).

Likewise, newer vehicles employ occupant-sensitive sensors that detect the weight, size, and position of the passenger to determine if the airbag should deploy. Rather than depending on the driver to turn the passenger-side airbag on or off, the car does it for you: heavy enough to trigger the sensor, and the airbag will deploy; too light, and the car assumes you are a child and doesn’t deploy. It’s a system that is so safe because it doesn’t depend on the operator to get it right.

Ditto motion sensors that detect objects behind the car while reversing (avoiding accidental back-overs), antilock brakes (to maintain control during panicked braking), traction control (improves stability during acceleration), electronic stability control (foils spinouts), tire-pressure-monitoring systems (avoids blowouts), daytime running lights (ensures others see you), rollover airbags (they stay inflated to keep you in the car), lane-departure warning (alerts you if you stray from your lane), and doors that automatically lock after the car starts (again, falling out of cars).

For all the negative press of late, car manufacturers understand safety.

A System Not So Safe

Contrast this to healthcare, in which 10% of patients will suffer a serious, preventable, adverse event during their hospital stay.¹ Read that sentence again. That’s 10%; that’s preventable; that’s a number that has largely remained unchanged in the past decade. If 1 in 10 drivers suffered a serious adverse preventable auto accident, Congress would do nothing but hold automotive safety hearings.

In medicine, we still largely employ unsafe systems in which even the best doctors can, and do, hurt patients. Sure, we have made strides in this arena (oxygen tubing that only works if hooked up properly, smart pumps that avert IV dosing errors, CO₂ monitors to detect proper endotracheal tube placement), but remarkably, in this era of patient safety, we still utilize systems that largely depend on the heroism of the individual.

As physicians, we are famously autonomous and value our professional independence, even to the degree that it might harm patients. We generally eschew standardization, believing that each patient is inherently different. In fact, the thrill of the improvisational theater that follows every patient’s chief compliant is one of the great satisfiers in medicine. We love that feeling that comes from sleuthing each case, deftly enacting a plan of action to shepherd the patient to health.

To suggest following protocols, guidelines, and checklists is derisively dismissed as “cookbook medicine.” To work in teams in which certain tasks are delegated to others is seen as weakness—we don’t need a system that utilizes a pharmacist; rather, we should know the doses of all medicines, their interactions, and the effect of renal and liver impairment on their clearance. To suggest otherwise is an insult to our Oslerian roots. To examine our errors, our system breakdowns, our patient harms is anathema to our practice, an admission of failure.

The result is that most of us continue to toil in systems that have become exponentially unsafe as healthcare has become more complex. Today, we still have a system that will more or less allow us to kill a patient by doing nothing more than forgetting the letter “g.” I can go to my hospital today and intend to write “4 grams of magnesium sulfate (MgSO4)” and inadvertently forget the “g” in “Mg.” This could result in an order for a lethal dose of morphine sulfate (MSO4). It’s that easy to hurt a patient. Now, you might say that would never happen, because the pharmacy would catch it. And this is likely. But is it guaranteed? Can you 100% ensure it wouldn’t happen? Consider that nearly 20% of medication doses administered in a hospital are done so incorrectly.² Nearly 1 in 5. This is the type of system we are employing to stop this lethal overdose. Is this system, which depends on another human to prevent an error, foolproof, or just a snare waiting to prove you the fool?

This represents our opportunity. As hospitalists, the hospital is our tapestry, our system of care, our responsibility. Few others are as well-positioned to ensure that the systems that envelop our patients are highly functional, reliable, and safe. This will take work—work that will feel burdensome, underappreciated, undercompensated. And, fully recognizing that none of us went into medicine to become systems engineers, this will be hard.

However, if not us, who? Who will ensure that our fathers, our mothers, our children will be as safe in the hospital as they are on the drive to the hospital? TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Global health leaders join the World Health Organization to announce accelerated efforts to improve patient safety. World Health Organization website. Available at: www.who.int/mediacentre/news/releases/2004/pr74/en/. Accessed Feb. 14, 2011.
2. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162(16):1897-1903.

I recently visited my parents in my ancestral home of Wisconsin. As parents of a certain age, they inexplicably are genetically predisposed to owning a minivan. Another quirk of their DNA is that they must own a new minivan. No sooner has the last wisp of new-car smell osmosed from the burled walnut interior than they are trading up to the newest, tricked-out minivan. Perhaps more puzzling is the manner of pride they display in their minivan.

Now, my dad, as if not readily apparent, is not cool. And to see him folded into the driver’s seat, his furry-ear-to-furry-ear grin signaling a self-satisfaction customarily reserved for his grandchildren, painstakingly recounting glory-day stories and 4:30 p.m. dinner buffets, further solidifies his place in the Annals of Uncool.

When I’m home, they tend to employ my chauffeur services (most likely in retribution for my peri-pubescent years), and on the first day back home, I stopped their newest ride near the back door of the house, foot idling on the brake while this exchange occurred: “That’s a fascinating story about how much more challenging the world was when you were my age, Dad. You are a true American hero. Would you like to get out here or in the garage?”

“Here,” he replied.

“OK, then get out,” I countered.

“I can’t,” he responded knowingly.

“Why not?” I queried, the patience seeping from my voice.

“Because the door’s not open,” he answered, seemingly mocking me.

“Then open it,” I replied, silently recounting the evidence for his institutionalization.

“I can’t,” he responded.

“Why not?” I replied again, this time calculating the likelihood that I was adopted.

“Because it’s locked,” came his retort.

“Then unlock it,” I answered, reconfirming my decision to move away for college.

“I can’t,” he replied, ostensibly encouraging parenticide.

“Why not?” I queried, strongly contemplating parenticide.

“Because you haven’t put the car in park,” he responded triumphantly.

A System So Safe

As a safety feature, the minivan needed to be in park before you could open the door to exit. I’ve never heard of anyone actually falling out of a moving car, but recollecting high school, I can fathom the right mix, type, and number of teenagers where possibility would meet inevitability. But, apparently, enough people are falling out of moving vehicles that car engineers have built a system that is so safe, this can’t happen. So no matter how hard someone tries, it just isn’t possible to fall out of a moving car (believe me, toward the end of a week of my father’s car stories, my mind had worked every possible angle).

Likewise, newer vehicles employ occupant-sensitive sensors that detect the weight, size, and position of the passenger to determine if the airbag should deploy. Rather than depending on the driver to turn the passenger-side airbag on or off, the car does it for you: heavy enough to trigger the sensor, and the airbag will deploy; too light, and the car assumes you are a child and doesn’t deploy. It’s a system that is so safe because it doesn’t depend on the operator to get it right.

Ditto motion sensors that detect objects behind the car while reversing (avoiding accidental back-overs), antilock brakes (to maintain control during panicked braking), traction control (improves stability during acceleration), electronic stability control (foils spinouts), tire-pressure-monitoring systems (avoids blowouts), daytime running lights (ensures others see you), rollover airbags (they stay inflated to keep you in the car), lane-departure warning (alerts you if you stray from your lane), and doors that automatically lock after the car starts (again, falling out of cars).

For all the negative press of late, car manufacturers understand safety.

A System Not So Safe

Contrast this to healthcare, in which 10% of patients will suffer a serious, preventable, adverse event during their hospital stay.¹ Read that sentence again. That’s 10%; that’s preventable; that’s a number that has largely remained unchanged in the past decade. If 1 in 10 drivers suffered a serious adverse preventable auto accident, Congress would do nothing but hold automotive safety hearings.

In medicine, we still largely employ unsafe systems in which even the best doctors can, and do, hurt patients. Sure, we have made strides in this arena (oxygen tubing that only works if hooked up properly, smart pumps that avert IV dosing errors, CO₂ monitors to detect proper endotracheal tube placement), but remarkably, in this era of patient safety, we still utilize systems that largely depend on the heroism of the individual.

As physicians, we are famously autonomous and value our professional independence, even to the degree that it might harm patients. We generally eschew standardization, believing that each patient is inherently different. In fact, the thrill of the improvisational theater that follows every patient’s chief compliant is one of the great satisfiers in medicine. We love that feeling that comes from sleuthing each case, deftly enacting a plan of action to shepherd the patient to health.

To suggest following protocols, guidelines, and checklists is derisively dismissed as “cookbook medicine.” To work in teams in which certain tasks are delegated to others is seen as weakness—we don’t need a system that utilizes a pharmacist; rather, we should know the doses of all medicines, their interactions, and the effect of renal and liver impairment on their clearance. To suggest otherwise is an insult to our Oslerian roots. To examine our errors, our system breakdowns, our patient harms is anathema to our practice, an admission of failure.

The result is that most of us continue to toil in systems that have become exponentially unsafe as healthcare has become more complex. Today, we still have a system that will more or less allow us to kill a patient by doing nothing more than forgetting the letter “g.” I can go to my hospital today and intend to write “4 grams of magnesium sulfate (MgSO4)” and inadvertently forget the “g” in “Mg.” This could result in an order for a lethal dose of morphine sulfate (MSO4). It’s that easy to hurt a patient. Now, you might say that would never happen, because the pharmacy would catch it. And this is likely. But is it guaranteed? Can you 100% ensure it wouldn’t happen? Consider that nearly 20% of medication doses administered in a hospital are done so incorrectly.² Nearly 1 in 5. This is the type of system we are employing to stop this lethal overdose. Is this system, which depends on another human to prevent an error, foolproof, or just a snare waiting to prove you the fool?

This represents our opportunity. As hospitalists, the hospital is our tapestry, our system of care, our responsibility. Few others are as well-positioned to ensure that the systems that envelop our patients are highly functional, reliable, and safe. This will take work—work that will feel burdensome, underappreciated, undercompensated. And, fully recognizing that none of us went into medicine to become systems engineers, this will be hard.

However, if not us, who? Who will ensure that our fathers, our mothers, our children will be as safe in the hospital as they are on the drive to the hospital? TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Global health leaders join the World Health Organization to announce accelerated efforts to improve patient safety. World Health Organization website. Available at: www.who.int/mediacentre/news/releases/2004/pr74/en/. Accessed Feb. 14, 2011.
2. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162(16):1897-1903.

I recently visited my parents in my ancestral home of Wisconsin. As parents of a certain age, they inexplicably are genetically predisposed to owning a minivan. Another quirk of their DNA is that they must own a new minivan. No sooner has the last wisp of new-car smell osmosed from the burled walnut interior than they are trading up to the newest, tricked-out minivan. Perhaps more puzzling is the manner of pride they display in their minivan.

Now, my dad, as if not readily apparent, is not cool. And to see him folded into the driver’s seat, his furry-ear-to-furry-ear grin signaling a self-satisfaction customarily reserved for his grandchildren, painstakingly recounting glory-day stories and 4:30 p.m. dinner buffets, further solidifies his place in the Annals of Uncool.

When I’m home, they tend to employ my chauffeur services (most likely in retribution for my peri-pubescent years), and on the first day back home, I stopped their newest ride near the back door of the house, foot idling on the brake while this exchange occurred: “That’s a fascinating story about how much more challenging the world was when you were my age, Dad. You are a true American hero. Would you like to get out here or in the garage?”

“Here,” he replied.

“OK, then get out,” I countered.

“I can’t,” he responded knowingly.

“Why not?” I queried, the patience seeping from my voice.

“Because the door’s not open,” he answered, seemingly mocking me.

“Then open it,” I replied, silently recounting the evidence for his institutionalization.

“I can’t,” he responded.

“Why not?” I replied again, this time calculating the likelihood that I was adopted.

“Because it’s locked,” came his retort.

“Then unlock it,” I answered, reconfirming my decision to move away for college.

“I can’t,” he replied, ostensibly encouraging parenticide.

“Why not?” I queried, strongly contemplating parenticide.

“Because you haven’t put the car in park,” he responded triumphantly.

A System So Safe

As a safety feature, the minivan needed to be in park before you could open the door to exit. I’ve never heard of anyone actually falling out of a moving car, but recollecting high school, I can fathom the right mix, type, and number of teenagers where possibility would meet inevitability. But, apparently, enough people are falling out of moving vehicles that car engineers have built a system that is so safe, this can’t happen. So no matter how hard someone tries, it just isn’t possible to fall out of a moving car (believe me, toward the end of a week of my father’s car stories, my mind had worked every possible angle).

Likewise, newer vehicles employ occupant-sensitive sensors that detect the weight, size, and position of the passenger to determine if the airbag should deploy. Rather than depending on the driver to turn the passenger-side airbag on or off, the car does it for you: heavy enough to trigger the sensor, and the airbag will deploy; too light, and the car assumes you are a child and doesn’t deploy. It’s a system that is so safe because it doesn’t depend on the operator to get it right.

Ditto motion sensors that detect objects behind the car while reversing (avoiding accidental back-overs), antilock brakes (to maintain control during panicked braking), traction control (improves stability during acceleration), electronic stability control (foils spinouts), tire-pressure-monitoring systems (avoids blowouts), daytime running lights (ensures others see you), rollover airbags (they stay inflated to keep you in the car), lane-departure warning (alerts you if you stray from your lane), and doors that automatically lock after the car starts (again, falling out of cars).

For all the negative press of late, car manufacturers understand safety.

A System Not So Safe

Contrast this to healthcare, in which 10% of patients will suffer a serious, preventable, adverse event during their hospital stay.¹ Read that sentence again. That’s 10%; that’s preventable; that’s a number that has largely remained unchanged in the past decade. If 1 in 10 drivers suffered a serious adverse preventable auto accident, Congress would do nothing but hold automotive safety hearings.

In medicine, we still largely employ unsafe systems in which even the best doctors can, and do, hurt patients. Sure, we have made strides in this arena (oxygen tubing that only works if hooked up properly, smart pumps that avert IV dosing errors, CO₂ monitors to detect proper endotracheal tube placement), but remarkably, in this era of patient safety, we still utilize systems that largely depend on the heroism of the individual.

As physicians, we are famously autonomous and value our professional independence, even to the degree that it might harm patients. We generally eschew standardization, believing that each patient is inherently different. In fact, the thrill of the improvisational theater that follows every patient’s chief compliant is one of the great satisfiers in medicine. We love that feeling that comes from sleuthing each case, deftly enacting a plan of action to shepherd the patient to health.

To suggest following protocols, guidelines, and checklists is derisively dismissed as “cookbook medicine.” To work in teams in which certain tasks are delegated to others is seen as weakness—we don’t need a system that utilizes a pharmacist; rather, we should know the doses of all medicines, their interactions, and the effect of renal and liver impairment on their clearance. To suggest otherwise is an insult to our Oslerian roots. To examine our errors, our system breakdowns, our patient harms is anathema to our practice, an admission of failure.

The result is that most of us continue to toil in systems that have become exponentially unsafe as healthcare has become more complex. Today, we still have a system that will more or less allow us to kill a patient by doing nothing more than forgetting the letter “g.” I can go to my hospital today and intend to write “4 grams of magnesium sulfate (MgSO4)” and inadvertently forget the “g” in “Mg.” This could result in an order for a lethal dose of morphine sulfate (MSO4). It’s that easy to hurt a patient. Now, you might say that would never happen, because the pharmacy would catch it. And this is likely. But is it guaranteed? Can you 100% ensure it wouldn’t happen? Consider that nearly 20% of medication doses administered in a hospital are done so incorrectly.² Nearly 1 in 5. This is the type of system we are employing to stop this lethal overdose. Is this system, which depends on another human to prevent an error, foolproof, or just a snare waiting to prove you the fool?

This represents our opportunity. As hospitalists, the hospital is our tapestry, our system of care, our responsibility. Few others are as well-positioned to ensure that the systems that envelop our patients are highly functional, reliable, and safe. This will take work—work that will feel burdensome, underappreciated, undercompensated. And, fully recognizing that none of us went into medicine to become systems engineers, this will be hard.

However, if not us, who? Who will ensure that our fathers, our mothers, our children will be as safe in the hospital as they are on the drive to the hospital? TH

Dr. Glasheen is associate professor of medicine at the University of Colorado Denver, where he serves as director of the Hospital Medicine Program and the Hospitalist Training Program, and as associate program director of the Internal Medicine Residency Program.

References

1. Global health leaders join the World Health Organization to announce accelerated efforts to improve patient safety. World Health Organization website. Available at: www.who.int/mediacentre/news/releases/2004/pr74/en/. Accessed Feb. 14, 2011.
2. Barker KN, Flynn EA, Pepper GA, Bates DW, Mikeal RL. Medication errors observed in 36 health care facilities. Arch Intern Med. 2002;162(16):1897-1903.

Which patients are you most likely to see again? It’s a particularly vexing question for hospitalists amid the heightened focus on lowering hospital readmissions, and one that several recent studies have sought to address.

One Journal of Hospital Medicine analysis of more than 10,300 admissions found that unplanned rehospitalizations within 30 days of discharge were far more likely for African-American patients and those on high-risk medications like narcotics and corticosteroids.¹ Patients with such chronic conditions as cancer, renal failure, and congestive heart failure also were at increased risk.

A second, smaller study of 142 inpatients who had been hospitalized within the preceding six months found that chronic disease, depression, and being underweight or obese all predicted a higher risk of another readmission within the next six months.²

And a third report in the Journal of Urban Health examined more than 36,000 Medicare patients admitted to urban public hospitals to assess which were most likely to return within the following year. Chronic medical conditions, substance abuse, and homelessness all contributed to increased odds.³

Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different. Inherent in that assumption is: more difficult to manage or sicker or more complicated.—Lakshmi Halasyamani, MD, SFHM, SHM board member, vice president for medical affairs, Saint Joseph Mercy Health System, Ann Arbor, Mich.

Most efforts aimed at reducing rehospitalizations, such as SHM’s Project BOOST, include a risk assessment that can point to potential trouble spots for individual patients. For certain populations, research has highlighted socioeconomic and racial disparities in access to healthcare that likely lead to unnecessary hospitalizations. But it’s one thing to identify the factors associated with higher rates, and quite another to actively manage them, especially when many crop up well beyond a hospital’s walls. Anxiety over these contributing factors is steadily building in anticipation of Medicare penalties for excessively high readmission rates set to begin in 2012.

“Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different,” says Lakshmi Halasyamani, MD, SFHM, SHM board member and vice president for medical affairs at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Inherent in that assumption is: more difficult to manage or sicker or more complicated.”

Stephen Jencks, MD, MPH, an independent healthcare safety and quality consultant based in Baltimore, says he’s heard the same complaint for three decades. “It’s what we call the 'Lake Wobegon effect': All of our patients are sicker than average.

“I think it’s just a really poor way to go about what is a very human sort of question,” he adds. “If Mrs. Jones is back in the hospital because she didn’t understand the discharge instructions, the question is not ‘Does my population have more literacy problems than somebody else’s population of patients?’ The question is ‘What can we do for Mrs. Jones so she can understand this stuff?’ ” (For help communicating with patients, check out SHM's on-demand webinar, "Implementing Teach Back as a System-Wide Patient Communication Strategy.")

Healthcare experts say it’s not difficult to find challenges unique to particular urban areas or populations. Florida Hospital Association President Bruce Rueben, MBA, says many Floridians speak English as a second language, making clear communication critical. The state also has one of the highest percentages of elderly residents and is in a funding crisis that has required providers to do more with less. But instead of worrying about exceptions or anomalies, Rueben says, focusing on the best overall readmission-reducing approaches will help ensure that all patients are being treated and discharged effectively.

What about dealing with specific conditions? Paul McGann, MD, deputy chief medical officer at the Centers for Medicare & Medicaid Services (CMS), says good evidence exists for the effectiveness of interventions aimed at diseases ranging from congestive heart failure and cancer to chronic obstructive lung disease, ulcers, and stroke. But data from Medicare’s Care Transitions Program, he says, suggest that even if all hospitals pursued the dozens of disease-specific interventions collectively implemented by the program’s participants, they still wouldn’t address more than about half of the causes of readmission. Based on that finding, he says, project leaders have insisted on an all-cause focus.

Dr. Halasyamani says it’s only natural to sometimes focus on the exception rather than the rule. “And we’ve all had those experiences where, boy, you feel like you’ve done everything you can and the patient still comes back,” she says. “But having said that, we also have opportunities where we haven’t done everything that we can and the patient comes back. So I think we need to focus on that first, rather than say, ‘Well, this isn’t fixable based on all of the patient-level issues.’”

Rachel George, MD, MBA, FHM, regional medical director and vice president of operations for West Cogent Healthcare Inc., says it all comes down to perspective. “Instead of looking at what’s the percentage that we can’t deal with,” she says, “let’s look at the patient population that we can affect.”

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

2. Mudge AM, Kasper KM, Clair, A, et al. Recurrent readmissions in medical patients: a prospective study. J Hosp Med. 2011;6(2):61-67.

3. Raven, MC, Billings, JC, Goldfrank LR, Manheimer ED, Gourevitch MN. Medicaid patients at high risk for frequent hospital admission: real-time identification and remediable risks. J Urb Health. 2009;86(2):230-241.

Which patients are you most likely to see again? It’s a particularly vexing question for hospitalists amid the heightened focus on lowering hospital readmissions, and one that several recent studies have sought to address.

One Journal of Hospital Medicine analysis of more than 10,300 admissions found that unplanned rehospitalizations within 30 days of discharge were far more likely for African-American patients and those on high-risk medications like narcotics and corticosteroids.¹ Patients with such chronic conditions as cancer, renal failure, and congestive heart failure also were at increased risk.

A second, smaller study of 142 inpatients who had been hospitalized within the preceding six months found that chronic disease, depression, and being underweight or obese all predicted a higher risk of another readmission within the next six months.²

And a third report in the Journal of Urban Health examined more than 36,000 Medicare patients admitted to urban public hospitals to assess which were most likely to return within the following year. Chronic medical conditions, substance abuse, and homelessness all contributed to increased odds.³

Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different. Inherent in that assumption is: more difficult to manage or sicker or more complicated.—Lakshmi Halasyamani, MD, SFHM, SHM board member, vice president for medical affairs, Saint Joseph Mercy Health System, Ann Arbor, Mich.

Most efforts aimed at reducing rehospitalizations, such as SHM’s Project BOOST, include a risk assessment that can point to potential trouble spots for individual patients. For certain populations, research has highlighted socioeconomic and racial disparities in access to healthcare that likely lead to unnecessary hospitalizations. But it’s one thing to identify the factors associated with higher rates, and quite another to actively manage them, especially when many crop up well beyond a hospital’s walls. Anxiety over these contributing factors is steadily building in anticipation of Medicare penalties for excessively high readmission rates set to begin in 2012.

“Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different,” says Lakshmi Halasyamani, MD, SFHM, SHM board member and vice president for medical affairs at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Inherent in that assumption is: more difficult to manage or sicker or more complicated.”

Stephen Jencks, MD, MPH, an independent healthcare safety and quality consultant based in Baltimore, says he’s heard the same complaint for three decades. “It’s what we call the 'Lake Wobegon effect': All of our patients are sicker than average.

“I think it’s just a really poor way to go about what is a very human sort of question,” he adds. “If Mrs. Jones is back in the hospital because she didn’t understand the discharge instructions, the question is not ‘Does my population have more literacy problems than somebody else’s population of patients?’ The question is ‘What can we do for Mrs. Jones so she can understand this stuff?’ ” (For help communicating with patients, check out SHM's on-demand webinar, "Implementing Teach Back as a System-Wide Patient Communication Strategy.")

Healthcare experts say it’s not difficult to find challenges unique to particular urban areas or populations. Florida Hospital Association President Bruce Rueben, MBA, says many Floridians speak English as a second language, making clear communication critical. The state also has one of the highest percentages of elderly residents and is in a funding crisis that has required providers to do more with less. But instead of worrying about exceptions or anomalies, Rueben says, focusing on the best overall readmission-reducing approaches will help ensure that all patients are being treated and discharged effectively.

What about dealing with specific conditions? Paul McGann, MD, deputy chief medical officer at the Centers for Medicare & Medicaid Services (CMS), says good evidence exists for the effectiveness of interventions aimed at diseases ranging from congestive heart failure and cancer to chronic obstructive lung disease, ulcers, and stroke. But data from Medicare’s Care Transitions Program, he says, suggest that even if all hospitals pursued the dozens of disease-specific interventions collectively implemented by the program’s participants, they still wouldn’t address more than about half of the causes of readmission. Based on that finding, he says, project leaders have insisted on an all-cause focus.

Dr. Halasyamani says it’s only natural to sometimes focus on the exception rather than the rule. “And we’ve all had those experiences where, boy, you feel like you’ve done everything you can and the patient still comes back,” she says. “But having said that, we also have opportunities where we haven’t done everything that we can and the patient comes back. So I think we need to focus on that first, rather than say, ‘Well, this isn’t fixable based on all of the patient-level issues.’”

Rachel George, MD, MBA, FHM, regional medical director and vice president of operations for West Cogent Healthcare Inc., says it all comes down to perspective. “Instead of looking at what’s the percentage that we can’t deal with,” she says, “let’s look at the patient population that we can affect.”

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

2. Mudge AM, Kasper KM, Clair, A, et al. Recurrent readmissions in medical patients: a prospective study. J Hosp Med. 2011;6(2):61-67.

3. Raven, MC, Billings, JC, Goldfrank LR, Manheimer ED, Gourevitch MN. Medicaid patients at high risk for frequent hospital admission: real-time identification and remediable risks. J Urb Health. 2009;86(2):230-241.

Which patients are you most likely to see again? It’s a particularly vexing question for hospitalists amid the heightened focus on lowering hospital readmissions, and one that several recent studies have sought to address.

One Journal of Hospital Medicine analysis of more than 10,300 admissions found that unplanned rehospitalizations within 30 days of discharge were far more likely for African-American patients and those on high-risk medications like narcotics and corticosteroids.¹ Patients with such chronic conditions as cancer, renal failure, and congestive heart failure also were at increased risk.

A second, smaller study of 142 inpatients who had been hospitalized within the preceding six months found that chronic disease, depression, and being underweight or obese all predicted a higher risk of another readmission within the next six months.²

And a third report in the Journal of Urban Health examined more than 36,000 Medicare patients admitted to urban public hospitals to assess which were most likely to return within the following year. Chronic medical conditions, substance abuse, and homelessness all contributed to increased odds.³

Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different. Inherent in that assumption is: more difficult to manage or sicker or more complicated.—Lakshmi Halasyamani, MD, SFHM, SHM board member, vice president for medical affairs, Saint Joseph Mercy Health System, Ann Arbor, Mich.

Most efforts aimed at reducing rehospitalizations, such as SHM’s Project BOOST, include a risk assessment that can point to potential trouble spots for individual patients. For certain populations, research has highlighted socioeconomic and racial disparities in access to healthcare that likely lead to unnecessary hospitalizations. But it’s one thing to identify the factors associated with higher rates, and quite another to actively manage them, especially when many crop up well beyond a hospital’s walls. Anxiety over these contributing factors is steadily building in anticipation of Medicare penalties for excessively high readmission rates set to begin in 2012.

“Whenever there is a program that has financial incentives, people always get concerned that they have patients who are somehow different,” says Lakshmi Halasyamani, MD, SFHM, SHM board member and vice president for medical affairs at Saint Joseph Mercy Health System in Ann Arbor, Mich. “Inherent in that assumption is: more difficult to manage or sicker or more complicated.”

Stephen Jencks, MD, MPH, an independent healthcare safety and quality consultant based in Baltimore, says he’s heard the same complaint for three decades. “It’s what we call the 'Lake Wobegon effect': All of our patients are sicker than average.

“I think it’s just a really poor way to go about what is a very human sort of question,” he adds. “If Mrs. Jones is back in the hospital because she didn’t understand the discharge instructions, the question is not ‘Does my population have more literacy problems than somebody else’s population of patients?’ The question is ‘What can we do for Mrs. Jones so she can understand this stuff?’ ” (For help communicating with patients, check out SHM's on-demand webinar, "Implementing Teach Back as a System-Wide Patient Communication Strategy.")

Healthcare experts say it’s not difficult to find challenges unique to particular urban areas or populations. Florida Hospital Association President Bruce Rueben, MBA, says many Floridians speak English as a second language, making clear communication critical. The state also has one of the highest percentages of elderly residents and is in a funding crisis that has required providers to do more with less. But instead of worrying about exceptions or anomalies, Rueben says, focusing on the best overall readmission-reducing approaches will help ensure that all patients are being treated and discharged effectively.

What about dealing with specific conditions? Paul McGann, MD, deputy chief medical officer at the Centers for Medicare & Medicaid Services (CMS), says good evidence exists for the effectiveness of interventions aimed at diseases ranging from congestive heart failure and cancer to chronic obstructive lung disease, ulcers, and stroke. But data from Medicare’s Care Transitions Program, he says, suggest that even if all hospitals pursued the dozens of disease-specific interventions collectively implemented by the program’s participants, they still wouldn’t address more than about half of the causes of readmission. Based on that finding, he says, project leaders have insisted on an all-cause focus.

Dr. Halasyamani says it’s only natural to sometimes focus on the exception rather than the rule. “And we’ve all had those experiences where, boy, you feel like you’ve done everything you can and the patient still comes back,” she says. “But having said that, we also have opportunities where we haven’t done everything that we can and the patient comes back. So I think we need to focus on that first, rather than say, ‘Well, this isn’t fixable based on all of the patient-level issues.’”

Rachel George, MD, MBA, FHM, regional medical director and vice president of operations for West Cogent Healthcare Inc., says it all comes down to perspective. “Instead of looking at what’s the percentage that we can’t deal with,” she says, “let’s look at the patient population that we can affect.”

Bryn Nelson is a freelance medical writer based in Seattle.

References

1. Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

2. Mudge AM, Kasper KM, Clair, A, et al. Recurrent readmissions in medical patients: a prospective study. J Hosp Med. 2011;6(2):61-67.

3. Raven, MC, Billings, JC, Goldfrank LR, Manheimer ED, Gourevitch MN. Medicaid patients at high risk for frequent hospital admission: real-time identification and remediable risks. J Urb Health. 2009;86(2):230-241.

Infection-prevention leaders and state hospital association representatives participated in regional meetings sponsored across the country during the summer of 2009 by the U.S. Department of Health and Human Services (HHS) and suggested ways that the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN)—a leading federal system for tracking healthcare-associated infections (HAIs)—could be made easier for hospitals. Participants recommended steps to reduce data-collection burdens and to increase usefulness for hospital infection prevention and quality-improvement (QI) programs.

HHS convened the regional meetings to get stakeholders’ input into HHS’ Action Plan to Prevent Healthcare-Associated Infections (www.hhs.gov/ophs/initiatives/hai/index.html), as well as to hear about their experiences with the network. The action plan is a blueprint for HAI prevention and sets specific targets for monitoring and preventing HAIs nationally. Leaders from various HHS agencies, including the Agency for Healthcare Research and Quality (AHRQ), CDC, Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), and the Office of Public Health and Science joined me in discussing participants’ concerns at these meetings.

HHS uses NHSN data to help monitor progress toward the action plan goals. Twenty-eight states require hospitals to report HAIs publicly; most use the NHSN (www.cdc.gov/nhsn). Hospital enrollment in the NHSN has increased dramatically, to more than 2,700 hospitals in mid-2010 from 300 in 2005.

Daniel Pollock, MD, the surveillance branch chief for CDC’s Division of Healthcare Quality Promotion, and I reported on CDC’s efforts to update the NHSN and improve its ease of use. Simplifying and streamlining the system, and assuring sufficient technical capacity and user support, are top priorities. For example:

• CDC has instituted changes in data collection requirements for healthcare-associated urinary tract infections into the NHSN application;
• More NHSN staff were hired to perform comprehensive assessments and upgrades of the system’s technical infrastructure and usability, and to provide additional user support for enrollment and training;
• NHSN will begin migrating this fall to a new system of authenticating users; and
• NHSN Web pages are being redesigned to speed response times during peak use.

Dr. Pollock emphasized that the CDC is committed to accelerating the transition from manual to electronic case detection and reporting for the NHSN, and leveraging advances in health information technology as a primary strategy for enhancing the NHSN. As part of that effort, NHSN now is accepting electronic infection records submitted by hospitals that use commercial infection control surveillance systems.

The CDC continues to work closely with AHRQ, CMS, and the Office of the National Coordinator for Health Information Technology to coordinate integration efforts of federal information systems that provide HAI data. That is part of our commitment here in Washington to support hospitals’ efforts to reduce and eliminate HAIs, and to make healthcare safer for patients and families.

Don Wright, MD, MPH,

deputy assistant secretary for healthcare quality,

U.S. Department of Health and Human Services

Infection-prevention leaders and state hospital association representatives participated in regional meetings sponsored across the country during the summer of 2009 by the U.S. Department of Health and Human Services (HHS) and suggested ways that the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN)—a leading federal system for tracking healthcare-associated infections (HAIs)—could be made easier for hospitals. Participants recommended steps to reduce data-collection burdens and to increase usefulness for hospital infection prevention and quality-improvement (QI) programs.

HHS convened the regional meetings to get stakeholders’ input into HHS’ Action Plan to Prevent Healthcare-Associated Infections (www.hhs.gov/ophs/initiatives/hai/index.html), as well as to hear about their experiences with the network. The action plan is a blueprint for HAI prevention and sets specific targets for monitoring and preventing HAIs nationally. Leaders from various HHS agencies, including the Agency for Healthcare Research and Quality (AHRQ), CDC, Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), and the Office of Public Health and Science joined me in discussing participants’ concerns at these meetings.

HHS uses NHSN data to help monitor progress toward the action plan goals. Twenty-eight states require hospitals to report HAIs publicly; most use the NHSN (www.cdc.gov/nhsn). Hospital enrollment in the NHSN has increased dramatically, to more than 2,700 hospitals in mid-2010 from 300 in 2005.

Daniel Pollock, MD, the surveillance branch chief for CDC’s Division of Healthcare Quality Promotion, and I reported on CDC’s efforts to update the NHSN and improve its ease of use. Simplifying and streamlining the system, and assuring sufficient technical capacity and user support, are top priorities. For example:

• CDC has instituted changes in data collection requirements for healthcare-associated urinary tract infections into the NHSN application;
• More NHSN staff were hired to perform comprehensive assessments and upgrades of the system’s technical infrastructure and usability, and to provide additional user support for enrollment and training;
• NHSN will begin migrating this fall to a new system of authenticating users; and
• NHSN Web pages are being redesigned to speed response times during peak use.

Dr. Pollock emphasized that the CDC is committed to accelerating the transition from manual to electronic case detection and reporting for the NHSN, and leveraging advances in health information technology as a primary strategy for enhancing the NHSN. As part of that effort, NHSN now is accepting electronic infection records submitted by hospitals that use commercial infection control surveillance systems.

The CDC continues to work closely with AHRQ, CMS, and the Office of the National Coordinator for Health Information Technology to coordinate integration efforts of federal information systems that provide HAI data. That is part of our commitment here in Washington to support hospitals’ efforts to reduce and eliminate HAIs, and to make healthcare safer for patients and families.

Don Wright, MD, MPH,

deputy assistant secretary for healthcare quality,

U.S. Department of Health and Human Services

Infection-prevention leaders and state hospital association representatives participated in regional meetings sponsored across the country during the summer of 2009 by the U.S. Department of Health and Human Services (HHS) and suggested ways that the Centers for Disease Control and Prevention’s (CDC) National Healthcare Safety Network (NHSN)—a leading federal system for tracking healthcare-associated infections (HAIs)—could be made easier for hospitals. Participants recommended steps to reduce data-collection burdens and to increase usefulness for hospital infection prevention and quality-improvement (QI) programs.

HHS convened the regional meetings to get stakeholders’ input into HHS’ Action Plan to Prevent Healthcare-Associated Infections (www.hhs.gov/ophs/initiatives/hai/index.html), as well as to hear about their experiences with the network. The action plan is a blueprint for HAI prevention and sets specific targets for monitoring and preventing HAIs nationally. Leaders from various HHS agencies, including the Agency for Healthcare Research and Quality (AHRQ), CDC, Centers for Medicare and Medicaid Services (CMS), the National Institutes of Health (NIH), and the Office of Public Health and Science joined me in discussing participants’ concerns at these meetings.

HHS uses NHSN data to help monitor progress toward the action plan goals. Twenty-eight states require hospitals to report HAIs publicly; most use the NHSN (www.cdc.gov/nhsn). Hospital enrollment in the NHSN has increased dramatically, to more than 2,700 hospitals in mid-2010 from 300 in 2005.

Daniel Pollock, MD, the surveillance branch chief for CDC’s Division of Healthcare Quality Promotion, and I reported on CDC’s efforts to update the NHSN and improve its ease of use. Simplifying and streamlining the system, and assuring sufficient technical capacity and user support, are top priorities. For example:

• CDC has instituted changes in data collection requirements for healthcare-associated urinary tract infections into the NHSN application;
• More NHSN staff were hired to perform comprehensive assessments and upgrades of the system’s technical infrastructure and usability, and to provide additional user support for enrollment and training;
• NHSN will begin migrating this fall to a new system of authenticating users; and
• NHSN Web pages are being redesigned to speed response times during peak use.

Dr. Pollock emphasized that the CDC is committed to accelerating the transition from manual to electronic case detection and reporting for the NHSN, and leveraging advances in health information technology as a primary strategy for enhancing the NHSN. As part of that effort, NHSN now is accepting electronic infection records submitted by hospitals that use commercial infection control surveillance systems.

The CDC continues to work closely with AHRQ, CMS, and the Office of the National Coordinator for Health Information Technology to coordinate integration efforts of federal information systems that provide HAI data. That is part of our commitment here in Washington to support hospitals’ efforts to reduce and eliminate HAIs, and to make healthcare safer for patients and families.

Don Wright, MD, MPH,

deputy assistant secretary for healthcare quality,

U.S. Department of Health and Human Services

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

New Generics

• Atomoxetine capsules (Strattera)¹
• Clonidine transdermal system USP (catapres-TTS)²
• Enoxaparin sodium injection (Lovenox)³
• Naratriptan hydrochloride 2.5-mg tablets (Amerge)⁴

New Drugs, Devices, Indications, and Dosage Forms

• A combination tablet containing both aliskiren and amlodipine (Tekamlo) has been approved by the FDA for the treatment of hypertension (HTN).⁵ Four strengths for once-daily dosing are available.
• Antihemophilic factor VIII (recombinant) injection (Xyntha) for treatment of hemophilia A has been approved by the FDA in a pre-filled, dual-chamber syringe for intravenous (IV) infusion following reconstitution of the freeze-dried powder with 0.9% sodium chloride diluent (both supplied in the dosage form).⁶ The first dose will be available in the 3,000 international units strength (4 mL). Other dosages will be available in 2011.
• Bimatoprost ophthalmic solution 0.01% (Lumigan) has been approved by the FDA as a first-line treatment for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension.⁷
• Buprenorphine/naloxone sublingual film (Suboxone sublingual) has been approved by the FDA for the treatment of opioid dependence.⁸
• Coagulation factor VIIa room temperature stable (recombinant) (NovoSeven RT) has been approved by the FDA in an 8-mg vial.⁹ This larger size allows rapid initiation and administration of this product for patients who need a larger dose. Additionally, this product is approved for an extended shelf life, for all vial sizes, to 36 months at room temperature.
• Donepezil 21-mg tablets (Aricept) have been approved by the FDA for the treatment of moderate to severe Alzheimer’s disease.¹⁰
• Glycopyrrolate cherry-flavored oral solution (Cuvposa) has been approved by the FDA as an orphan drug for treating chronic severe drooling in patients ages 3 to 16 with neurological conditions such as cerebral palsy.¹¹
• Immune globulin subcutaneous (human) 20% liquid (Hizentra) has been approved by the FDA for a 24-month shelf life at room temperature when protected from light.¹²
• Miconazole 50-mg buccal tablets (Oravig) have been approved by the FDA to topically treat oropharyngeal candidiasis in patients 16 and older.¹³
• Niacin extended release/simvastatin tablets (Simcor) have been approved by the FDA in two new dosage strengths: 500 mg/40 mg and 1000 mg/40 mg.¹⁴
• Olmesartan medoxomil, amlodipine besylate, and hydrochlorothiazide tablets (HCTZ) (Tribenzor) have been approved by the FDA in a single tablet to treat hypertension (not initial therapy).¹⁵ This combination should not be used in patients with a creatinine clearance <30 mL/minute, or in patients with renal artery stenosis.
• STX-100 has received orphan drug status for treating idiopathic pulmonary fibrosis (IPF) for which there currently are no FDA-approved treatments.¹⁶ STX-100 is a humanized, monoclonal antibody that targets integrin vb6, which exhibited major antifibrotic activity in preclinical animal models of the lung and other organs. The FDA previously granted orphan drug designation for STX-100 for chronic allograft nephropathy. A Phase 2 trial in IPF is planned for 2011.
• Docetaxel injection concentrate (Taxotere) has been approved by the FDA in a one-vial system, which eliminates the dilution step.¹⁷
• Valganciclovir injection (Valcyte) is FDA-approved for an increased therapy length (200 days) in adult renal transplant patients at high risk of developing cytomegalovirus disease (CMV).¹⁸ This extends the length of therapy from 100 days.

Safety, Warnings, and Label Changes

• Carbidopa/levodopa and entacapone tablets (Stalevo) are undergoing a safety review in relation to a possible increased cardiovascular event risk, including myocardial infarction, stroke, and cardiovascular death, compared with patients only taking carbidopa/levodopa.¹⁹ An FDA meta-analysis of 15 clinical trials found a small increased risk of cardiovascular events. However, this meta-analysis was not specifically designed to assess cardiovascular safety, and most patients had pre-existing cardiovascular disease risk factors, so even small differences in the level of these risks could significantly affect the study outcomes. Additionally, most negative cardiovascular events occurred in a single trial. The FDA recommends regular evaluation of patients’ cardiovascular status.
• Tigecycline IV injection (Tygacil) has undergone a label change in its “Warnings” and “Precautions” in relation to an increased mortality risk.²⁰ A pooled analysis compared tigecycline use to other similar antibacterials for managing different serious infections. Patients who had a greater increased risk of death were those with hospital-acquired pneumonia, ventilator-associated pneumonia, complicated skin and skin structure infections, diabetic foot infections, and complicated intra-abdominal infections.

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Actavis receives FDA approval of atomoxetine HCI capsules. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/199692.php. Accessed Sept. 2, 2010.
2. Mylan receives approval for generic version of Catapres-TTS. Mylan Inc. website. Available at: http://investor.mylan.com/releasedetail.cfm?ReleaseID=489338. Accessed July 20, 2010.
3. Riley K. FDA approves first generic enoxaparin sodium injection. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm. Accessed Sept. 13, 2010.
4. First-time generic approvals August 2010. Formulary website. Available at: http://formularyjournal.modernmedicine.com/formulary/Modern+Medicine+Now/First-time-generic-approvals-Aug.-2010/ArticleStandard/Article/detail/683182?contextCategoryId=44276. Accessed Sept. 7, 2010.
5. Novartis receives FDA approval of Tekamlo, a single-pill combination of aliskiren and amlodipine to treat high blood pressure. Novartis Pharmaceuticals Corporation website. Available at: http://www.pharma.us.novartis.com/info/newsroom/press-release.jsp?PRID=2286. Accessed Sept. 13, 2010.
6. Xyntha prefilled dual-chamber syringe approved for hemophilia A treatment. Monthly Prescribing Reference website. Available at: http://www.empr.com/xyntha-pre-filled-dual-chamber-syringe-approved-for-hemophilia-a-treatment/article/176666/. Accessed Aug.18, 2010.
7. Allergan, Inc. receives FDA approval for Lumigan 0.01% as first-line therapy indicated for the reduction of elevated intraocular pressure in glaucoma patients. MarketWatch website. Available at: http://www.marketwatch.com/story/allergan-inc-receives-fda-approval-for-lumiganr-001-as-first-line-therapy-indicated-for-the-reduction-of-elevated-intraocular-pressure-in-glaucoma-patients-2010-08-31?reflink=MW_news_stmp. Accessed Sept. 2, 2010.
8. MonoSol Rx announces Reckitt Benckiser FDA approval of Suboxone sublingual film for treatment of opioid dependence. PR Newswire website. Available at: http://www.prnewswire.com/news-releases/monosol-rx-announces-reckitt-benckiser-fda-approval-of-suboxone-sublingual-film-for-treatment-of-opioid-dependence-101874388.html. Accessed Sept. 14, 2010.
9. NovoSeven RT 8mg vial approved for hemophilia A or B. Monthly Prescribing Reference website. Available at: http://www.empr.com/novoseven-rt-8mg-vial-approved-for-hemophilia-a-or-b/printarticle/176743/. Accessed Sept. 13, 2010.
10. Eisai announces U.S. FDA approval for new higher dose Aricept 23 mg tablet for the treatment of moderate-to-severe Alzheimer’s disease. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/196410.php. Accessed Sept. 13, 2010.
11. Cuvposa approved for chronic severe drooling associated with neurologic conditions. Monthly Prescribing Reference website. Available at: http://www.empr.com/cuvposa-approved-for-chronic-severe-drooling-associated-with-neurologic-conditions/article/175824/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 2, 2010.
12. Shelf life of Hizentra extended from 18 to 24 months. Monthly Prescribing Reference website. Available at: http://www.empr.com/shelf-life-of-hizentra-extended-from-18-to-24-months/article/177068/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Aug. 23, 2010.
13. Oravig available for oropharyngeal candidiasis. Monthly Prescribing Reference website. Available at: http://www.empr.com/oravig-available-for-oropharyngeal-candidiasis/article/177492/. Accessed Sept. 13, 2010.
14. Additional dosage strengths of Simcor approved. Monthly Prescribing Reference website. Available at: http://www.empr.com/additional-dosage-strengths-of-simcor-approved/article/175825/?DCMP=EMC-MPR_WeeklyNewsbrief. Accessed Sept. 13, 2010.
15. Tribenzor 20/5/12.5mg. Monthly Prescribing Reference website. Available at: http://www.empr.com/tribenzor-205125mg/drugproduct/129/. Accessed Sept. 13, 2010.
16. Stromedix receives FDA orphan drug designation for STX-100 for the treatment of idiopathic pulmonary fibrosis. Stromedix website. Available at: http://www.stromedix.com/Stromedix_STX-100_Orphan_Drug_IPF.pdf. Accessed Sept. 13, 2010.
17. Dane L. Sanofi-Aventis garners FDA approval for one-vial formulation of Taxotere. FirstWord website. Available at: http://www.firstwordplus.com/Fws.do?articleid=E0B4E517F06C4A9E94DC88EADBA079A8. Accessed Sept. 13, 2010.
18. FDA approves longer use of Valcyte for adult kidney transplant patients at high risk of developing cytomegalovirus (CMV) disease. Genentech website. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=12907. Accessed Sept. 13, 2010.
19. FDA drug safety communication: ongoing safety review of Stalevo and possible increased cardiovascular risk. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm223060.htm. Accessed Sept. 13, 2010.
20. FDA drug safety communication: increased risk of death with Tygacil (tigecycline) compared to other antibiotics used to treat similar infections. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm224370.htm. Accessed Sept. 13, 2010.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

From the outset, HM has been about efficiency. And there was nothing wrong with that, for value is quality divided by cost. But in our story, we found that mere efficiency was not enough: The lowering of the denominator (cost) had to be met with an escalation of the numerator (quality) to ensure value.

And see us as being born in the right place at the right time. For with the national focus turning to the need for quality and patient safety, hospital medicine was in the right place and the right time to heed the call to action: appropriately stepping up to enact efforts to make the slope of the line (on a chart of quality vs. cost) “STEEEPER” … finding systems innovations to make care Safe, Timely, Efficient, Effective, Equitable, and Patient-centered.

Of course, the story continued with the Affordable Care Act and healthcare reform, greatly accelerating our evolution as change agents. And now we find ourselves fully invested in a “change the system” mentality, perfectly positioned to meaningfully change healthcare for millions of people. But threats loom—specifically, the “R” in the STEEEPER mnemonic: the risks to quality in the face of healthcare reform.

So in the next chapter of our story, I present to you our challenge: how to overcome the threats to quality in the context of healthcare reform. The first three are presented here; in subsequent articles, I will address the remainder. Overcoming all threats will hinge on mastering the four truisms of cultural change:

1. Systems drive function;
2. Every system is perfectly designed to produce the outcomes that it does;
3. This is not an issue of people needing to try harder; and
4. The “no blame” culture begins with a paradigm shift from the “person at fault” to the “system at fault.”

Threat 1: Failure to Fund Quality

SHM elected to merge its annual State of Hospital Medicine survey with the MGMA. Though not without risk, this has resulted in the anticipated benefits. The MGMA collaboration brings greater leverage in working with the C-suite, which is pre-programmed to react to MGMA surveys. From the most recent MGMA survey comes good news: The financial compensation for hospitalists has increased. A sobering insight, however, is that this increase in compensation has been met with a corresponding increase in work intensity—RVUs. Further, the link between RVUs and compensation appears to be tightening, quantifying what has long been of concern: The time devoted to the nonclinical “value added” duties of the hospitalist is shrinking.

The threat to the culture of quality is captured in the single question: How many RVUs is a quality-improvement (QI) project worth? I’m not sure we have that answer. But without an answer, it is difficult to believe that meaningful QI can be expected without time to do so. And again, as the gap between compensation and RVUs narrows, one is left wondering if there will soon be a day where there is no value-added time remaining to perform QI at all.

Fortunately, the Affordable Care Act might provide some movement in the right direction via value-based purchasing. Linking quality outcomes to financial reimbursement is a big step forward in the hospitalist’s quest to leverage the C-suite in trading RVUs for devoted QI time. Although we still are left asking the question of how many RVUs a QI project is worth, value-based purchasing at least sets the stage for the conversation. But in the interim, it is still upon hospitalists to design these QI projects, and to learn the skills necessary to see the design to its fruition.

Threat 2: Quality Stops at Core Measures

It is hard to argue that fulfilling “core measures” is a bad thing. Nonetheless, the core measures were not meant to be quality; instead, they were meant as surrogate measures of quality. The presumption of the core-measures initiative is that the system would exist without direct attention to the core measures, operating as it ordinarily would with generic attention to meeting all standards of quality for all diseases. And at some point in time, the core measures would be assessed to give an overall assessment of the system’s quality.

What has evolved, however, is a concerted attention to meeting the core measures, with little regard to the overall culture of quality.

Let’s say you were tasked with improving the public school system in your state. As a measure of the improvement, you choose five of the 1,000 schools as “core measure” schools. The state board of education is told that the performance of these five sample schools will be assessed at the end of the year, and financial support for the system as a whole will hinge on their performance. The intended result is that attention would be paid to improving the performance of every school in the system, and this improvement would be reflected in the performance of the five sample schools. The board of education could take the route of improving all schools, but the more pragmatic route would be to funnel all resources into these five schools, to the detriment of resources for the other 995 schools. The performance of the core measure schools would dramatically improve, and funding would be secured. But ask yourself: Did the performance of the school system as a whole actually improve?

Such is the risk of the core measures in healthcare. The original intent of the core measures was to instill a culture of QI for all points of care. And this has been a valuable contribution to changing the consciousness of the healthcare system. The presumption was that the core measures would be “seeds,” and that by emphasizing these select measures, the QI culture eventually would spread to all aspects of patient care. But this plan hinged on the presumption that that there is an unlimited amount of mental energy and resources to be devoted to all tasks within healthcare. The reality is that there is a fixed amount of intellectual energy and resources to be devoted to the various aspects of healthcare. One wonders if the overemphasis on meeting the core measures might actually have taken the wind out of the sails for QI in other non-core-measure patient care.

The implications are twofold. By definition, a core measure has to be applicable to all healthcare systems, and with a fixed amount of mental energy and resources, there is a real risk that what portion is reserved for QI finds its way only to the core indicators, especially if they are overemphasized in the system. The second implication is captured in our experience with time to antibiotics. With meeting the core indicator as the priority, many systems instituted the “work-around”: Give antibiotics to every patient presenting to the ED, and you will be sure to have met the four-hour window in the core indicator. The result was an exponential increase in inappropriate antibiotic administration and radiographic tests, all because meeting the indicator became more important than the overall goal.

As stewards of the hospital system, it is upon us to ensure that the original intent of core measures remains secure: The core measures seed a culture of quality, but do not become ends in and of themselves. QI apart from the core measures must remain an equal priority, and it is the hospitalist who will be central in ensuring this comes to fruition.

Threat 3: Misplaced Incentives

There is an interesting anecdote in Steven Levitt and Stephen Dubner’s book Freakonomics.¹ The story begins with a daycare center struggling with a problem: Some parents are showing up late to pick up their children at the end of the day, and this is costing the center in the way of overtime charges for the staff. To solve the problem, the center elects to institute a financial disincentive: Those showing up late to pick up their children will pay a modest financial penalty.

Fast-forward to months after the policy was put in place. The result? An exponential increase in the number of parents showing up late to pick up their children.

How do you explain worsening performance in spite of a financial disincentive? The answer resides in understanding human behavior. According to the authors, there are three primary motivations in life: financial, social, and moral. As ugly as it sounds, the decisions people make in life are driven by one of these three motivations. There is nothing wrong with providing incentives for behavior; incentives work.

But the danger arises when incentives are mismatched to behaviors. For example, if a financial outcome is the goal, then financial incentives make sense. If a social outcome (people should play better as a team) is the goal, the social incentives make sense (public recognition). But when the incentives get misaligned with their respective goals, trouble results.

What went wrong with the daycare’s plan is simple—most of the parents were motivated to pick up their children on time out of moral (“I gave my word”) or social (“I don’t want to be talked about by other parents”) incentives. But once a financial incentive was offered, the daycare center had essentially given the parents a way out in absolving their social and moral obligations. The parents had essentially cost-adjusted their behavior.

If you think this couldn’t happen to the healthcare system, let me ask you this. As a hospitalist, I see all of my patients early in the morning, because I see it as part of my obligation to the hospital team to discharge patients by 11 a.m. (social motivation).

But what if the CEO released this directive: “You will see all of your patients early in the morning, or you will take a $1,000 a year pay cut.” Is it possible that I might cost-adjust the $1,000 in exchange for sleeping in a little later and not having to deal with the morning traffic? I don’t know.

When it comes to financial incentives, there is a valley in the U-shaped curve. When the financial incentive is trivial, it is disregarded and the social/moral motivations of behavior persist (the kids are picked up on time; I persist in seeing patients early in the morning). When the financial incentive is huge, the financial incentive trumps all social/moral motivations, ensuring compliance with the goal behavior (every kid is picked up on time to avoid a penalty; I see all patients early in the day to avoid a larger penalty).

But in between is the risk zone: When the person feels they are paying an appropriate penance for not complying with the goal behavior, the financial disincentive absolves any social/moral guilt.

Healthcare reform is about incentives—and there is nothing wrong with that. But as the stewards of the inpatient healthcare system, it is upon us as hospitalists to ensure that the incentives remain matched to their intended goals, and that the untoward consequences of the incentives do not adversely affect the quality and safety of a patient’s care.

It is safe to say that the Affordable Care Act of 2010 moves us closer to a true environment of quality and patient safety. But it is equally safe to say that meaningful change will require more than what the law can provide. As stewards of the inpatient system, we have a responsibility to ensure that the healthcare system, particularly in how it responds to incentives, evolves to remain patient-centered, effective, and safe.

The next chapter in our story—the hospitalists’ story—will be one of accountability and responsibility. While there are things the government can do, the majority of what needs to be done will come directly from us. TH

Dr. Wiese is president of SHM.

Reference

1. Levitt SD, Dubner SJ. Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. New York City: William Morrow; 2005.

In the past three years, SHM has brought in-depth quality-improvement (QI) programs to nearly every state in the country.

Between its three major mentored implementation projects—Project BOOST (Better Outcomes for Older Adults through Safe Transitions), Glycemic Control Mentored Implemen-tation, and the Venous Thromboembolism (VTE) Collaborative—SHM has worked with more than 100 hospitals across the country and in Canada. SHM is expanding these three programs to additional hospitals and actively developing other QI initiatives.

“SHM’s quality-improvement programs focus on real change, and they have made a substantial impact,” says Joe Miller, SHM’s senior vice president and chief solutions officer. “Hospitalists using SHM’s quality-improvement methods have impacted the care of tens of thousands of hospitalized patients.”

SHM’s programs all use a mix of in-depth mentoring led by national experts and specially designed resource toolkits that enable hospitalists to lead major initiatives within their hospitals. The programs also facilitate “peer learning,” allowing hospitalists to learn from one another.

Project BOOST, which is designed to reduce unplanned readmissions to the hospital, has received national attention. In early 2010, SHM teamed with Blue Cross/Blue Shield of Michigan and the University of Michigan to bring the program to more than a dozen hospitals in that state. SHM also announced a new collaboration with the California HealthCare Foundation to implement Project BOOST in more than 20 hospitals in California.

“Healthcare reform is creating a new focus on quality improvement,” Miller says. “SHM is bringing a multidisciplinary approach to transforming inpatient care to hospitals across the country.” TH

Chapter Updates

Milwaukee/SE Wisconsin

The Milwaukee/SE Wisconsin chapter held a meeting June 10 at Bacchus Restaurant in Milwaukee, at which congratulations were doled out to chapter member Eric Siegal, MD, SFHM, on his election to SHM’s board of directors. As chair of SHM’s Public Policy Committee, Dr. Siegal advocates for such issues as the Physician Quality Reporting Initiative (PQRI).

The chapter also acknowledged Dr. Len Scarpinato of St. Luke’s Hospital, who achieved Senior Fellow in Hospital Medicine (SFHM) designation and was honored at HM10 in April in Washington, D.C. As the regional director of Cogent Healthcare in southeast Wisconsin, Dr. Scarpinato has been instrumental in bringing hospitalists together to network and exchange innovative ideas.

Chapter member Jeanette Kalupa, DNP, ACNP-BC, APNP, of St. Luke’s was mentioned in the opening presentation at HM10 for her work as co-chair of the Nonphysician Providers Committee. Despite a busy HM10 schedule, Drs. Don Lee, Wes Lafferty, Scarpinato, Betty Tucker, and Peter Quandt took time out for a White House tour.

Greater Baltimore Area

The Greater Baltimore Area chapter of SHM met June 16 at Linwood’s Restaurant in Owings Mills, Md. Dr. Suzanne Mitchell spoke on “Relating to the Patient.” The meeting, sponsored by Merck, attracted 50 hospitalists and guests from 10 HM groups.

Los Angeles

The latest Los Angeles chapter meeting was held July 29. The featured speaker was Darrell Harrington, MD, associate medical director for Graduate Medical Education and chief of the division of general internal medicine at Harbor-UCLA Medical Center. Dr. Harrington delivered a presentation about maximizing DVT and PE quality measures. The chapter’s next meeting will be held in the fall.

Fellow in Hospital Medicine Spotlight

James C. Pile, MD, FACP, SFHM

Dr. Pile is an associate professor of medicine, interim director of hospital medicine, and associate program director of the internal residency program at the MetroHealth Campus of Case Western Reserve University in Cleveland. As a 10-year SHM member, he has been heavily involved in the growth of the Journal of Hospital Medicine, for which he is now deputy editor. He is an active member of the Annual Meeting and Education committees, and is former physician editor of The Hospitalist.

Undergraduate: Kings College in Briarcliff Manor, N.Y.

Medical school: Ohio State University College of Medicine, Columbus.

Internship and residency: University Hospitals of Cleveland.

Fellowship: Infectious Disease, National Naval Medicine Center, Bethesda, Md.

Notable: Prior to working as a hospitalist, Dr. Pile served as a battalion surgeon with Marine infantry on the front lines of the first Gulf War. He also worked as a general practitioner and infectious-disease specialist. His current interests lie in medical education, anti-microbial stewardship, and perioperative medicine.

Quotable: “I continue to see hospital medicine being front and center in patient safety in this country. … That is our whole reason for being, essentially. I anticipate us continuing to grow and develop into the real national leaders in quality improvement in the inpatient setting.”

FYI: Dr. Pile is an avid cyclist. He recently completed a one-day, 200-mile ride, and during his time in medical school, he biked from Seattle to New York City. He loves traveling and spending time with his wife and two daughters.

— Sarah Gelotte

SHAPE the Landscape of Academic Hospital Medicine: Participate in the Academic Hospitalist Survey

The recently released State of Hospital Medicine: 2010 Report Based on 2009 Data provides an unprecedented look at the factors shaping the specialty. However, for academic hospitalists, the picture can be very different. That is why SHM and the Medical Group Management Association (MGMA) are embarking on their first joint survey of academic hospitalists.

Academic HM groups—including groups at community-based teaching hospitals—can participate in the survey now through Nov. 5 by logging on to www6.mgma.com, or by contacting MGMA’s Survey Operations Department at 877-275-6462, Ext. 1895.

“Academic hospitalists and executive leaders at academic institutions need to know how they stack up against their peers in the field,” says Leslie Flores, SHM’s senior advisor for practice management. “Participating in this survey is the first step in providing an in-depth resource that identifies the major trends in academic hospital medicine.”

Like the new State of Hospital Medicine report, the academic report will provide data on hospitalist compensation and productivity, staffing information, and financial support. It also will examine the organizational structure of academic hospitalist practices and how academic hospitalists allocate their time between clinical, research, and teaching responsibilities. The new report also will feature information about medical-school and research funding.

MGMA will publish its standard academic survey results early next spring. Hospitalist-specific data will also be published in the 2011 State of Hospital Medicine report, to be released next summer.

In the past three years, SHM has brought in-depth quality-improvement (QI) programs to nearly every state in the country.

Between its three major mentored implementation projects—Project BOOST (Better Outcomes for Older Adults through Safe Transitions), Glycemic Control Mentored Implemen-tation, and the Venous Thromboembolism (VTE) Collaborative—SHM has worked with more than 100 hospitals across the country and in Canada. SHM is expanding these three programs to additional hospitals and actively developing other QI initiatives.

“SHM’s quality-improvement programs focus on real change, and they have made a substantial impact,” says Joe Miller, SHM’s senior vice president and chief solutions officer. “Hospitalists using SHM’s quality-improvement methods have impacted the care of tens of thousands of hospitalized patients.”

SHM’s programs all use a mix of in-depth mentoring led by national experts and specially designed resource toolkits that enable hospitalists to lead major initiatives within their hospitals. The programs also facilitate “peer learning,” allowing hospitalists to learn from one another.

Project BOOST, which is designed to reduce unplanned readmissions to the hospital, has received national attention. In early 2010, SHM teamed with Blue Cross/Blue Shield of Michigan and the University of Michigan to bring the program to more than a dozen hospitals in that state. SHM also announced a new collaboration with the California HealthCare Foundation to implement Project BOOST in more than 20 hospitals in California.

“Healthcare reform is creating a new focus on quality improvement,” Miller says. “SHM is bringing a multidisciplinary approach to transforming inpatient care to hospitals across the country.” TH

Chapter Updates

Milwaukee/SE Wisconsin

The Milwaukee/SE Wisconsin chapter held a meeting June 10 at Bacchus Restaurant in Milwaukee, at which congratulations were doled out to chapter member Eric Siegal, MD, SFHM, on his election to SHM’s board of directors. As chair of SHM’s Public Policy Committee, Dr. Siegal advocates for such issues as the Physician Quality Reporting Initiative (PQRI).

The chapter also acknowledged Dr. Len Scarpinato of St. Luke’s Hospital, who achieved Senior Fellow in Hospital Medicine (SFHM) designation and was honored at HM10 in April in Washington, D.C. As the regional director of Cogent Healthcare in southeast Wisconsin, Dr. Scarpinato has been instrumental in bringing hospitalists together to network and exchange innovative ideas.

Chapter member Jeanette Kalupa, DNP, ACNP-BC, APNP, of St. Luke’s was mentioned in the opening presentation at HM10 for her work as co-chair of the Nonphysician Providers Committee. Despite a busy HM10 schedule, Drs. Don Lee, Wes Lafferty, Scarpinato, Betty Tucker, and Peter Quandt took time out for a White House tour.

Greater Baltimore Area

The Greater Baltimore Area chapter of SHM met June 16 at Linwood’s Restaurant in Owings Mills, Md. Dr. Suzanne Mitchell spoke on “Relating to the Patient.” The meeting, sponsored by Merck, attracted 50 hospitalists and guests from 10 HM groups.

Los Angeles

The latest Los Angeles chapter meeting was held July 29. The featured speaker was Darrell Harrington, MD, associate medical director for Graduate Medical Education and chief of the division of general internal medicine at Harbor-UCLA Medical Center. Dr. Harrington delivered a presentation about maximizing DVT and PE quality measures. The chapter’s next meeting will be held in the fall.

Fellow in Hospital Medicine Spotlight

James C. Pile, MD, FACP, SFHM

Dr. Pile is an associate professor of medicine, interim director of hospital medicine, and associate program director of the internal residency program at the MetroHealth Campus of Case Western Reserve University in Cleveland. As a 10-year SHM member, he has been heavily involved in the growth of the Journal of Hospital Medicine, for which he is now deputy editor. He is an active member of the Annual Meeting and Education committees, and is former physician editor of The Hospitalist.

Undergraduate: Kings College in Briarcliff Manor, N.Y.

Medical school: Ohio State University College of Medicine, Columbus.

Internship and residency: University Hospitals of Cleveland.

Fellowship: Infectious Disease, National Naval Medicine Center, Bethesda, Md.

Notable: Prior to working as a hospitalist, Dr. Pile served as a battalion surgeon with Marine infantry on the front lines of the first Gulf War. He also worked as a general practitioner and infectious-disease specialist. His current interests lie in medical education, anti-microbial stewardship, and perioperative medicine.

Quotable: “I continue to see hospital medicine being front and center in patient safety in this country. … That is our whole reason for being, essentially. I anticipate us continuing to grow and develop into the real national leaders in quality improvement in the inpatient setting.”

FYI: Dr. Pile is an avid cyclist. He recently completed a one-day, 200-mile ride, and during his time in medical school, he biked from Seattle to New York City. He loves traveling and spending time with his wife and two daughters.

— Sarah Gelotte

SHAPE the Landscape of Academic Hospital Medicine: Participate in the Academic Hospitalist Survey

The recently released State of Hospital Medicine: 2010 Report Based on 2009 Data provides an unprecedented look at the factors shaping the specialty. However, for academic hospitalists, the picture can be very different. That is why SHM and the Medical Group Management Association (MGMA) are embarking on their first joint survey of academic hospitalists.

Academic HM groups—including groups at community-based teaching hospitals—can participate in the survey now through Nov. 5 by logging on to www6.mgma.com, or by contacting MGMA’s Survey Operations Department at 877-275-6462, Ext. 1895.

“Academic hospitalists and executive leaders at academic institutions need to know how they stack up against their peers in the field,” says Leslie Flores, SHM’s senior advisor for practice management. “Participating in this survey is the first step in providing an in-depth resource that identifies the major trends in academic hospital medicine.”

Like the new State of Hospital Medicine report, the academic report will provide data on hospitalist compensation and productivity, staffing information, and financial support. It also will examine the organizational structure of academic hospitalist practices and how academic hospitalists allocate their time between clinical, research, and teaching responsibilities. The new report also will feature information about medical-school and research funding.

MGMA will publish its standard academic survey results early next spring. Hospitalist-specific data will also be published in the 2011 State of Hospital Medicine report, to be released next summer.

In the past three years, SHM has brought in-depth quality-improvement (QI) programs to nearly every state in the country.

Between its three major mentored implementation projects—Project BOOST (Better Outcomes for Older Adults through Safe Transitions), Glycemic Control Mentored Implemen-tation, and the Venous Thromboembolism (VTE) Collaborative—SHM has worked with more than 100 hospitals across the country and in Canada. SHM is expanding these three programs to additional hospitals and actively developing other QI initiatives.

“SHM’s quality-improvement programs focus on real change, and they have made a substantial impact,” says Joe Miller, SHM’s senior vice president and chief solutions officer. “Hospitalists using SHM’s quality-improvement methods have impacted the care of tens of thousands of hospitalized patients.”

SHM’s programs all use a mix of in-depth mentoring led by national experts and specially designed resource toolkits that enable hospitalists to lead major initiatives within their hospitals. The programs also facilitate “peer learning,” allowing hospitalists to learn from one another.

Project BOOST, which is designed to reduce unplanned readmissions to the hospital, has received national attention. In early 2010, SHM teamed with Blue Cross/Blue Shield of Michigan and the University of Michigan to bring the program to more than a dozen hospitals in that state. SHM also announced a new collaboration with the California HealthCare Foundation to implement Project BOOST in more than 20 hospitals in California.

“Healthcare reform is creating a new focus on quality improvement,” Miller says. “SHM is bringing a multidisciplinary approach to transforming inpatient care to hospitals across the country.” TH

Chapter Updates

Milwaukee/SE Wisconsin

The Milwaukee/SE Wisconsin chapter held a meeting June 10 at Bacchus Restaurant in Milwaukee, at which congratulations were doled out to chapter member Eric Siegal, MD, SFHM, on his election to SHM’s board of directors. As chair of SHM’s Public Policy Committee, Dr. Siegal advocates for such issues as the Physician Quality Reporting Initiative (PQRI).

The chapter also acknowledged Dr. Len Scarpinato of St. Luke’s Hospital, who achieved Senior Fellow in Hospital Medicine (SFHM) designation and was honored at HM10 in April in Washington, D.C. As the regional director of Cogent Healthcare in southeast Wisconsin, Dr. Scarpinato has been instrumental in bringing hospitalists together to network and exchange innovative ideas.

Chapter member Jeanette Kalupa, DNP, ACNP-BC, APNP, of St. Luke’s was mentioned in the opening presentation at HM10 for her work as co-chair of the Nonphysician Providers Committee. Despite a busy HM10 schedule, Drs. Don Lee, Wes Lafferty, Scarpinato, Betty Tucker, and Peter Quandt took time out for a White House tour.

Greater Baltimore Area

The Greater Baltimore Area chapter of SHM met June 16 at Linwood’s Restaurant in Owings Mills, Md. Dr. Suzanne Mitchell spoke on “Relating to the Patient.” The meeting, sponsored by Merck, attracted 50 hospitalists and guests from 10 HM groups.

Los Angeles

The latest Los Angeles chapter meeting was held July 29. The featured speaker was Darrell Harrington, MD, associate medical director for Graduate Medical Education and chief of the division of general internal medicine at Harbor-UCLA Medical Center. Dr. Harrington delivered a presentation about maximizing DVT and PE quality measures. The chapter’s next meeting will be held in the fall.

Fellow in Hospital Medicine Spotlight

James C. Pile, MD, FACP, SFHM

Dr. Pile is an associate professor of medicine, interim director of hospital medicine, and associate program director of the internal residency program at the MetroHealth Campus of Case Western Reserve University in Cleveland. As a 10-year SHM member, he has been heavily involved in the growth of the Journal of Hospital Medicine, for which he is now deputy editor. He is an active member of the Annual Meeting and Education committees, and is former physician editor of The Hospitalist.

Undergraduate: Kings College in Briarcliff Manor, N.Y.

Medical school: Ohio State University College of Medicine, Columbus.

Internship and residency: University Hospitals of Cleveland.

Fellowship: Infectious Disease, National Naval Medicine Center, Bethesda, Md.

Notable: Prior to working as a hospitalist, Dr. Pile served as a battalion surgeon with Marine infantry on the front lines of the first Gulf War. He also worked as a general practitioner and infectious-disease specialist. His current interests lie in medical education, anti-microbial stewardship, and perioperative medicine.

Quotable: “I continue to see hospital medicine being front and center in patient safety in this country. … That is our whole reason for being, essentially. I anticipate us continuing to grow and develop into the real national leaders in quality improvement in the inpatient setting.”

FYI: Dr. Pile is an avid cyclist. He recently completed a one-day, 200-mile ride, and during his time in medical school, he biked from Seattle to New York City. He loves traveling and spending time with his wife and two daughters.

— Sarah Gelotte

SHAPE the Landscape of Academic Hospital Medicine: Participate in the Academic Hospitalist Survey

The recently released State of Hospital Medicine: 2010 Report Based on 2009 Data provides an unprecedented look at the factors shaping the specialty. However, for academic hospitalists, the picture can be very different. That is why SHM and the Medical Group Management Association (MGMA) are embarking on their first joint survey of academic hospitalists.

Academic HM groups—including groups at community-based teaching hospitals—can participate in the survey now through Nov. 5 by logging on to www6.mgma.com, or by contacting MGMA’s Survey Operations Department at 877-275-6462, Ext. 1895.

“Academic hospitalists and executive leaders at academic institutions need to know how they stack up against their peers in the field,” says Leslie Flores, SHM’s senior advisor for practice management. “Participating in this survey is the first step in providing an in-depth resource that identifies the major trends in academic hospital medicine.”

Like the new State of Hospital Medicine report, the academic report will provide data on hospitalist compensation and productivity, staffing information, and financial support. It also will examine the organizational structure of academic hospitalist practices and how academic hospitalists allocate their time between clinical, research, and teaching responsibilities. The new report also will feature information about medical-school and research funding.

MGMA will publish its standard academic survey results early next spring. Hospitalist-specific data will also be published in the 2011 State of Hospital Medicine report, to be released next summer.

New Generics

• Anastrazole tablets (generic Arimidex)¹
• Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²
• Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³
• Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴
• Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵
• Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶
• Tacrolimus 5-mg capsules (generic Prograf)⁷
• Trandolapril/verapamil tablets (generic Tarka)⁸
• Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹
• Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

• The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.
• Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.
• Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³
• Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.
• Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.
• HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.
• Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

• HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.
• Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

• Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.²¹

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.
2. Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.
3. APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.
4. Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.
5. Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.
6. Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.
7. Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.
8. Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.
9. Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.
10. Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.
11. Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.
12. Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.
13. Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.
14. FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.
15. Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.
16. FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.
17. Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.
18. Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.
19. Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.
20. Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.
21. Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.
22. New Jersey State Board of Pharmacy News, April 2010;24:2-3.

New Generics

• Anastrazole tablets (generic Arimidex)¹
• Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²
• Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³
• Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴
• Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵
• Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶
• Tacrolimus 5-mg capsules (generic Prograf)⁷
• Trandolapril/verapamil tablets (generic Tarka)⁸
• Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹
• Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

• The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.
• Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.
• Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³
• Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.
• Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.
• HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.
• Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

• HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.
• Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

• Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.²¹

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.
2. Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.
3. APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.
4. Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.
5. Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.
6. Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.
7. Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.
8. Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.
9. Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.
10. Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.
11. Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.
12. Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.
13. Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.
14. FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.
15. Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.
16. FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.
17. Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.
18. Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.
19. Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.
20. Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.
21. Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.
22. New Jersey State Board of Pharmacy News, April 2010;24:2-3.

New Generics

• Anastrazole tablets (generic Arimidex)¹
• Azelastine hydrochloride ophthalmic solution 0.05% (generic Optivar)²
• Aztreonam for injection in single-dose vials of 1 g/20 mL and 2 g/30 mL (generic Azactam)³
• Bupropion hydrochloride extended-release 150-mg tablets (generic Zyban)⁴
• Meropenem injection, USP, IV, 500-mg and 1-g vials (generic Merrem IV)⁵
• Levetiracetam injection in 100 mg/1 mL and 500 mg/5 mL single-use vials (generic Keppra injection)⁶
• Tacrolimus 5-mg capsules (generic Prograf)⁷
• Trandolapril/verapamil tablets (generic Tarka)⁸
• Valacyclovir hydrochloride tablets, USP (generic Valtrex)⁹
• Venlafaxine extended-release capsules (generic Effexor XR)¹⁰

New Drugs, Indications, Approval Recommendations

• The Alair Bronchial Thermoplasty System is the first device to be FDA-approved for treating severe and persistent asthma.¹¹ It is to be used by adults who are still symptomatic despite treatment with high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). Radiofrequency signals are converted into heat that warms the lining of targeted airways via bronchoscope. There are a number of contraindications and warnings for this device. Treatment is delivered using a standard bronchoscope under moderate sedation.
• Buprenorphine Transdermal System (Butrans) is FDA-approved to treat moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.¹² It is a Schedule III controlled substance and will be available in early 2011 in 5 mcg/hour, 10 mcg/hour, and 20 mcg/hour dosage strengths. Patches continuously release the drug over seven days.
• Denosumab injection (Prolia) has been approved by the FDA for treating postmenopausal women with osteoporosis at high risk for fractures.¹³
• Fingolimod (FTY720), an oral sphingosine 1-phosphate receptor (S1PR) modulator and disease-modifying treatment for relapsing-remitting multiple sclerosis (RRMS), has received a positive review by an FDA Advisory Committee.¹⁴ The committee voted 25-0, stating that in clinical trials to date that FTY720 has demonstrated substantial evidence of effectiveness in patients with RRMS, reducing the frequency of clinical exacerbations. This agent works by retaining lymphocytes in the lymph nodes, preventing them from entering the central nervous system to cause damage. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.
• Ketorolac tromethamine intranasal (Sprix) is FDA-approved for treating acute moderate to moderately severe pain requiring opioid-level analgesia for up to five days.¹⁵ Even though it is administered intranasally, gastrointestinal hemorrhage, bleeding, and cardiovascular risks are included in the labeling as adverse events.
• HCV Rapid Antibody Test (OraQuick) has been approved by the FDA for use in patients 15 and older to identify hepatitis C virus (HCV) antibodies.¹⁶ Available as a test strip, it identifies HCV antibodies within 20 minutes, which allows patients to more quickly present for evaluation and treatment.
• Lopinavir/ritonavir (Kaletra) has been approved by the FDA for once-daily dosing for treatment-experienced HIV patients.¹⁷ The agent had been approved for once-daily treatment for therapy-naive patients.

Pipeline

• HPV vaccine (Gardasil) is being evaluated by the FDA in order to potentially expand its indication to include women 27 to 45 years old.¹⁸ A decision is expected by the end of the year.
• Roflumilast is a phosphodiesterase 4 (PDE4) enzyme inhibitor that targets underlying inflammation in COPD patients.¹⁹ The FDA has issued a complete response letter for Roflumilast, which was filed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. No new clinical trials have been requested.

Product Discontinuation

• Estradiol vaginal tablets 10 mcg (Vagifem) will replace estradiol vaginal tablets 25 mcg to treat the symptoms of atrophic vaginitis due to menopause.²⁰ Sales of the 25-mcg formulation were discontinued July 31.

Medication Safety

GlaxoSmithKline has received reports of dispensing errors related to rosiglitazone (Avandia), glimepiride (Amaryl), rosiglitazone/metformin (Avandamet), candesartan (Atacand), and warfarin (Coumadin). In some instances, the patient received the wrong medication (one severe case led to impaired mental status). Errors likely occurred due to illegible written prescriptions and/or incorrectly interpreted, labeled, and filled prescriptions. Some of these products have similar dosage strengths and also look alike, leading to the errors.²¹

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Teva gets FDA approval for generic cancer drug. Forbes.com website. Available at: http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-teva-pharmaceutical-industries-fda_7726375.html. Accessed June 29, 2010.
2. Sun Pharma bags FDA approval for generic Optivar. Pharmaceutical Business Review website. Available at: http://regulatoryaffairs.pharmaceutical-business-review.com/news/sun_pharma_bags_fda_approval_for_generic_optivar_100622/. Accessed June 25, 2010.
3. APP Pharmaceuticals Inc receives FDA approval for generic Aztreonam for injection, USP. TradingMarkets.com website. Available at: http://www.tradingmarkets.com/news/stock-alert/appx_apcvz_app-pharmaceuticals-inc-receives-fda-approval-for-generic-aztreonam-for-injection-usp-995249.html. Accessed June 24, 2010.
4. Mylan gets FDA approval for generic Zyban. Forbes.com website. Available at: http://www.forbes.com/feeds/prnewswire/2010/05/04/prnewswire201005040700PR_NEWS_USPR_____NE98210.html. Accessed June 25, 2010.
5. Hospira receives FDA approval for Meropenem for injection, USP (I.V.) Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192733.php. Accessed June 24, 2010.
6. Sun Pharma announces USFDA approval for generic Keppra injection. Medical News Today website. Available at: http://www.medicalnewstoday.com/articles/192275.php. Accessed June 24, 2010.
7. Watson’s generic Prograf 5 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1443895. Accessed July 7, 2010.
8. Glenmark arm gets US FDA nod for Tarka generic; stk up. Money Control website. Available at: http://www.moneycontrol.com/news/buzzing-stocks/glenmark-gets-us-fda-nod-for-tarka-generic-stk-up_460856.html. Accessed June 25, 2010.
9. Watson’s generic Valtrex 500 mg and 1000 mg receives FDA approval. Watson website. Available at: http://ir.watson.com/phoenix.zhtml?c=65778&p=irol-newsArticle&ID=1430538&highlight=. Accessed June 25, 2010.
10. Walsh S. FDA approves first generic Effexor extended release capsules to treat major depressive disorder. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217624.htm Accessed June 29, 2010.
11. Waknine Y. FDA approves first non-drug treatment for severe, persistent asthma. Medscape website. Available at: www.medscape.com/viewarticle/720922. Accessed June 30, 2010.
12. Butrans transdermal system approved for chronic pain. Monthly Prescribing Reference website. Available at: www.empr.com/butrans-transdermal-system-approved-for-chronic-pain/article/173803/. Accessed July 7, 2010.
13. Amgen’s Prolia garners FDA approval. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=BDE45B4D9F3F4C4A9326074859FF661F&logRowId=366890. Accessed June 30, 2010.
14. FDA advisory committee unanimously recommends approval of Novartis investigational treatment FTY720 to treat relapsing remitting MS. Novartis Pharmaceuticals Corporation website. Available at: www.pharma.us.novartis.com/newsroom/press-release.jsp?PRID=2284. Accessed June 29, 2010.
15. Roxro announces FDA approval of Sprix. Sprix website. Available at: www.sprix.com/docs/SPRIX-approval-press-release.pdf. Accessed June 29, 2010.
16. FDA approves rapid test for antibodies to hepatitis C virus. U.S. Food and Drug Administration website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm217318. Accessed July 7, 2010.
17. Abbott receives FDA approval for once-daily dosing of Kaletra (lopinavir/ritonavir) for treatment-experienced patients. Abbott website. Available at: www.abbott.com/global/url/pressRelease/en_US/60.5:5/Press_Release_0849.htm. Accessed June 30, 2010.
18. Dane L. FDA extends review of Merck & Co.’s Gardasil for use in older women. FirstWord website. Available at: www.firstwordplus.com/Fws.do?articleid=2843FE3BFE2B44C5B463DBA787F213ED&logRowId=369474. Accessed July 7, 2010.
19. Forest Laboratories and Nycomed receive complete response letter for Roflumilast. Forest Laboratories website. Available at: www.frx.com/news/PressRelease.aspx?ID=1428047. Accessed July 25, 2010.
20. Vagifem 10 mcg to replace Vagifem 25 mcg formulation for atrophic vaginitis due to menopause. Novo Nordisk website. Available at: http://press.novonordisk-us.com/index.php?s=43&item=252. Accessed June 29, 2010.
21. Dear Pharmacist Letter, June 2010. Important Drug Warnings: Medication Dispensing Errors; GlaxoSmithKline.
22. New Jersey State Board of Pharmacy News, April 2010;24:2-3.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

More than 400 people attended the Pediatric Hospital Medicine annual conference July 22-25 in Minneapolis. The annual meeting is the premier networking and educational event for pediatric hospitalists and is sponsored by the American Academy of Pediatrics (AAP), SHM, and the Academic Pediatric Association (APA).

Innovation and improvement were popular topics throughout the conference. Keynote speaker George Buckley, CEO of manufacturing and technology conglomerate 3M, spoke about inspiring innovation, and a large percentage of the sessions and posters had quality-improvement (QI) themes. Experts from Cincinnati Children’s Hospital, led by Steve Muething, MD, assistant vice president of patient safety, and Shannon Phillips, MD, MPH, Cleveland Clinic’s patient safety officer, guided several popular sessions on QI.

A major innovation announced at the conference was the planned launch of a journal of pediatric hospital medicine, which will be sponsored by the AAP. (Update 09.14.2010--The journal has yet to officially announce an editor).

Research presentations have continued to increase in this young field, and the meeting was full of poster and platform presentations in the areas of clinical research, QI, educational research, and health services research. Vineeta Mittal, MD, of the University of Texas Southwestern and Children’s Medical Center in Dallas presented research on family-centered rounds, which was recently published in Pediatrics and picked up by the National Association of Children’s Hospitals (NACHRI) for dissemination.¹ Patrick Brady, MD, of Cincinnati Children’s Hospital presented his research on short- versus long-course IV therapy for pediatric urinary tract infections, also published in Pediatrics.²

Other buzzed-about sessions included Vanderbilt University pediatric hospitalist Dr. Paul Hain’s ambitious attempt to create a PHM performance dashboard, and a case of “situational” epilepsy presented by Dr. Lisa Zaoutis of CHOP.

As in years past, the hottest ticket was for the luncheon presentation of the “Top Articles in Pediatric Hospital Medicine,” paneled this year by Drs. John Pope, Kris Rehm, and Brian Alverson. Raj Srivastava, MD, of Primary Children’s Medical Center in Salt Lake City and chairperson of the Pediatric Research in Inpatient Settings network, announced that the network had been awarded major grant funding.

Dan Rauch, MD, chair of the AAP’s Section on Hospital Medicine, dropped the biggest bombshell of all: He announced that the American Board of Pediatrics will support the development of pediatric HM as a full-fledged subspecialty in the near future. TH

Dr. Ralston is associate professor of pediatrics and chief of the division of inpatient pediatrics at the University of Texas Health Science Center in San Antonio, and medical director of inpatient services at Christus Santa Rosa Children’s Hospital.

References

1. Mittal VS, Sigrest T, Ottolini MC, et al. Family-centered rounds on pediatric wards: a PRIS network survey of U.S. and Canadian hospitalists. Pediatrics. 2010;126(1):37-43.
2. Brady PW, Conway PH, Goudie A. Length of intravenous antibiotic therapy and treatment failure in infants with urinary track infections. Pediatrics. 2010;126(2):196-203.

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

As the field of HM continues to mature, branch out, and is called upon to lead in the care of a larger cross-section of hospitalized patients, it is only natural that this includes the critically ill patient. Hospitalists already care for—and are the attending of record for—this patient population in most U.S. hospitals. It is my position that a technically proficient hospitalist service, which is facility-exclusive and offers 24/7 coverage, is able to offer the same quality of care as an intensivist group. An important feature of this model is the inclusion and “buy in” from community pulmonologists in order to provide backup and consultative assistance when warranted.

Our program at Westside Regional Medical Center in Plantation, Fla., has made great strides as we continue to integrate this model in the hospital. We are actively tracking ICU length of stay and throughput, incidence of ventilator-associated pneumonia (VAP), central-line infection rates, and ICU mortality.

I believe that a clinically competent and aggressive HM service is able to drive down costs and generate revenue by establishing clinically beneficial quality-improvement (QI) protocols; drive down ICU length of stay; provide effective and timely procedural services; and incur a lower cost burden (i.e., hospitalists cost less than intensivists). And I believe all of these benefits are available without sacrificing quality or patient care.

Leadership from medical staff and administration is imperative to establish the appropriate vision and drive toward hospitalist/intensivist implementation. Finding the right supporting physicians who bring excitement and energy is equally as important. Establishing expectations for skill sets, as well as the opportunity and mechanism by which these skill sets might be acquired and refined, is a must. The following technical skills should be required of hospitalist/intensivists:

• Ultrasound-guided central line insertion;
• PICC line insertion;
• Endotracheal intubation;
• Advanced airway management;
• Thoracostomy tube insertion;
• Arterial-line insertion;
• Transvenous pacing wire insertion;
• Lumbar puncture;
• Thoracentesis; and
• Paracentesis.

An important starting point is the identification of skill sets for each hospitalist. Once this information is ascertained, the next step is to understand what the credentialing requirements for the individual procedures are. This usually consists of a certain number of “logged” cases, which must be put forward for review by the medical staff leadership. Most physicians completing residency are required to keep a procedural log where cases are documented. Any deficiencies within the log can be supplemented by establishing a practice log where proctored cases are documented until the recommended number of cases are completed and put forward for credentialing.

Obtaining buy-in from the medical staff is important. They can serve as allies in many areas, specifically as proctors in the credentialing process. The key to successful interface is in awakening them to the beneficial impact a service such as this can have on patients and on the lifestyle of providers.

As an example, before our group started the hybrid model at Westside, the nursing staff would call anesthesia to evaluate patients for endotracheal intubation. This system took anesthesia away from its OR cases, causing delays and frustration. After a conversation, the anesthesia director realized the benefits that would come with assisting the hospitalists in becoming more proficient with intubations. This same scenario has been true in our experience with ED physicians, cardiothoracic surgeons (chest tubes), and so on.

Other resources for hospitalists include the National Procedure Institute, which offers CME credit and certification toward “Hospitalist Procedures.” Additionally, difficult airway or advanced airway courses provide certification.

Hospitalists have long been called on to provide emergency services for unstable patients via rapid response or codes. In many facilities hospitalists serve as the lead physicians in the management of critically ill patients. Our hospitalist model serves as a great launching pad for the development and evolution of this new breed of physician.

There exists no clinical evidence to assert inferiority between the care provided by an in-house, 24/7 hospitalist group with assistance from pulmonary medicine versus an intensivist group. It is my belief that if the appropriate infrastructure, fostered skill sets, pulmonologist partnership, and QI protocols are implemented, there will be no measurable difference in scope of care or outcomes.

The inpatient management of critically ill and unstable patients continues to be a significant and important subgroup of hospital patient populations. As patients continue to live longer with debilitating chronic diseases, the fallout from decompensation can be devastating. Many facilities have hospitalists leading the charge in the care of these patients. It is undeniable that the next evolution in HM will require a more proactive inpatient physician, with both the clinical and technical acumen to manage all patients across the hospital spectrum.

Ulises A. Perez, MD,

medical director, hospitalist division,

Westside Regional Medical Center, Plantation, Fla.,

Kendall Regional Medical Center, Miami

New Generics

• Desloratadine tablets (generic Clarinex)¹
• Didanosine delayed-release capsules (Generic Videx EC)²

New Indications, Dosage Forms, and Recommendations

• Ganciclovir ophthalmic gel 0.15% (Zirgan) has been approved by the FDA for treating acute herpetic keratitis.³ The recommended dose is one drop in the affected eye five times daily until the ulcer heals, then one drop three times daily for seven more days. The most common side effects in clinical trials were blurred vision, eye irritation, punctate keratitis, and conjunctival hyperemia. It will be available in a 5-g tube.
• Immune globulin intravenous 10% liquid (human) (Privigen) has received an updated approval from the FDA, which allows for room temperature storage throughout its entire 36-month shelf life.⁴ The agent is used to treat patients with primary immunodeficiency disorders.
• Miconazole buccal tablets (Oravig) have been approved by the FDA for treating oropharyngeal candidiasis in adults and children 16 years of age and older. It is the first, and currently the only local, buccal prescription formulation of miconazole.⁵ The buccal tablet was developed to adhere to the gum. It should not be crushed, chewed, or swallowed. The most common adverse effects in clinical trials were diarrhea, nausea, headache, dysgeusia, upper abdominal pain, and vomiting. It is recommended to monitor patients with a history of hypersensitivity to azoles, as there is no information regarding cross-reactivity between miconazole and other azole agents.
• A supplemental new drug application (sNDA) has been submitted to the FDA for naltrexone extended-release injectable suspension (Vivitrol) for treating opioid dependence.⁶ It is administered as a once-monthly intramuscular injection and currently is approved by the FDA for treating alcohol dependence.
• Oxycodone controlled-release (OxyContin) has been approved by the FDA in a new, abuse-deterrent formulation.⁷
• Pancrelipase delayed-release capsules (Pancreaze) joins Creon (Abbott Labs) and Zenpep (Eurand) as the third pancreatic enzyme product (PEP) to be approved by the FDA for treating exocrine pancreatic insufficiency.⁸
• Pramipexole extended-release tablets (Mirapex ER) have been approved by the FDA as a once-daily treatment for the signs and symptoms of idiopathic Parkinson’s disease (early and late).⁹
• The active ingredient in the vaccine Diamyd, rhGAD65, has received orphan drug status for treating Type 1 diabetes mellitus (T1DM) with residual beta cell function.^10,11 This agent is in Phase 3 clinical trials and is being investigated to determine whether it can stop or slow the autoimmune destruction of insulin-producing beta cell function. The DiaPrevent study is enrolling patients. In Phase 2 studies, the agent preserved remaining beta cell function in adolescents and children recently diagnosed with T1DM.
• Warfarin genetic diagnostic: Machaon Diagnostics has received FDA approval for an array-based diagnostic technology that detects genetic variation and could aid in determining an accurate initial warfarin dose.¹² At least 40% of Americans have at least one genetic variation involved in warfarin metabolism, which can cause a more than fivefold disparity in the weekly warfarin dose. This test can be used to more accurately determine dosing for warfarin-treated patients.

Pipeline

• The NDA for DM-1796 (gabapentin extended-release tablet) has been submitted to the FDA for treatment of postherpetic neuralgia.¹³ It is a once-daily, extended-release formulation of gabapentin.
• The “quad” combination of elvitegravir, cobicistat (formerly GS 9350), emtricitabine, and tenofovir disoproxil fumarate in a fixed-dose single tablet is currently in Phase 3 clinical trials for treatment of HIV.¹⁴
• FTY720 is an investigational oral immune modulator agent for treating relapsing-remitting multiple sclerosis (RR-MS).¹⁵ The NDA for this agent was submitted in December 2009; the FDA granted it a priority review in February. Two-year data from the FREEDOMS trial showed that FTY720 reduced annual relapse rates by 62%, compared with treatment-naive patients. For patients that had received prior treatments, the annual relapse rate was reduced by 44%. At two years, FTY720 delayed disability progression by 30% for patients treated with 0.5 mg, compared with placebo. The serious infection rate was comparable in the different “immune modulator” treatment groups.

Product Removal

Inhalers containing ozone-depleting chlorofluorocarbons (CFCs) are continuing to be phased out.¹⁶ These agents are used to treat asthma and COPD, and alternate products that do not contain CFCs are available. Some pharmacies might be depleting stock after the “last-sale date.” The affected products and their phase-out dates are:

• Tilade (nedocromil): June 14, 2010;
• Alupent (metaproterenol): June 14, 2010;
• Aerobid (flunisolide): June 30, 2010;
• Azmacort (triamcinolone): Dec. 31, 2010;
• Intal (cromolyn): Dec. 31, 2010;
• Combivent (albuterol/ipratropium): December 31, 2013; and
• Maxair (pirbuterol) autohaler: December 31, 2013. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Food and Drug Administration website. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=078357&TABLE1=OB_Rx. Accessed April 27, 2010.
2. Mylan announces approval under PEPFAR for generic version of Videx EC HIV treatment. Medical News Today website. Available at: www.medicalnewstoday.com/articles/186273.php. Accessed April 27, 2010.
3. Sirion Therapeutics announces availability of Zirgan (ganciclovir ophthalmic gel) 0.15% for ocular herpes. PR Newswire website. Available at: www.prnewswire.com/news-releases/sirion-therapeutics-announces-availability-of-zirgantm-ganciclovir-ophthalmic-gel-015-for-ocular-herpes-92084614.html. Accessed April 27, 2010.
4. CSL Behring receives FDA approval to extend shelf life for Privigen from 24 to 36 months. CSL Behring website. Available at: www.cslbehring-us.com/s1/cs/enus/1154272074489/news/1255923905944/prdetail.htm. Accessed April 27, 2010.
5. FDA approves Oravig (miconazole) buccal tablets for treatment of oropharyngeal candidiasis. PAR Pharmaceuticals website. Available at: investors.parpharm.com/phoenix.zhtml?c=81806&p=irol-newsArticle&ID=1413993&highlight=. Accessed April 27, 2010.
6. Alkermes submits supplemental new drug application for Vivitrol for the treatment of opioid dependence. Medical News Today website. Available at: www.medicalnewstoday.com/articles/185456.php. Accessed April 27, 2010.
7. FDA approves reformulated oxycontin. Contract Pharma website. www.contractpharma.com/news/2010/04/07/fda_approves_reformulated_oxycontin. Accessed April 27, 2010.
8. Gansz Bobo E. FDA approves pancreatic enzyme product, Pancreaze. FDA website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208135.htm. Accessed April 27, 2010.
9. Once-daily Mirapex ER now approved by FDA for both early and advanced Parkinson’s disease. Medical News Today website. Available at: www.medicalnewstoday.com/printerfriendlynews.php?newsid=183272. Accessed April 27, 2010.
10. DiaPrevent diabetes research. DiaPrevent website. Available at: www.diaprevent.diamyd.com/. Accessed April 27, 2010.
11. Diamyd granted orphan drug designation in the US. Diamyd website. Available at: www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=479460. Accessed April 27, 2010.
12. Same-day genetic testing service available for safer warfarin dosing. Monthly Prescribing Reference website. Available at: www.empr.com/same-day-genetic-testing-service-available-for-safer-warfarin-dosing/article/167586/. Accessed April 27, 2010.
13. NDA submitted for DM-1796 for postherpetic neuralgia (PHN). Monthly Prescribing Reference website. Available at: www.empr.com/nda-submitted-for-dm-1796-for-postherpetic-neuralgia-phn/article/167056/. Accessed April 26, 2010.
14. Gilead initiates Phase III clinical program evaluating single-table, once-daily “quad” regimen for HIV. Gilead website. Available at: www.gilead.com/pr_1411934. Accessed April 27, 2010.
15. Novartis investigational multiple sclerosis therapy Gilenia (FTY720) shown to reduce relapse rates regardless of treatment history. Drugs.com website. Available at: www.drugs.com/clinical_trials/novartis-investigational-multiple-sclerosis-therapy-gilenia-fty720-shown-reduce-relapse-rates-9139.html. Accessed April 27, 2010.
16. Inhalers containing CFCs being eliminated. Pharamacist eLink website. Available at: www.pharmacistelink.com/index.php/Drugs-and-Treatment/Inhalers-containing-CFC-s-being-eliminated.html. Accessed April 27, 2010.

New Generics

• Desloratadine tablets (generic Clarinex)¹
• Didanosine delayed-release capsules (Generic Videx EC)²

New Indications, Dosage Forms, and Recommendations

• Ganciclovir ophthalmic gel 0.15% (Zirgan) has been approved by the FDA for treating acute herpetic keratitis.³ The recommended dose is one drop in the affected eye five times daily until the ulcer heals, then one drop three times daily for seven more days. The most common side effects in clinical trials were blurred vision, eye irritation, punctate keratitis, and conjunctival hyperemia. It will be available in a 5-g tube.
• Immune globulin intravenous 10% liquid (human) (Privigen) has received an updated approval from the FDA, which allows for room temperature storage throughout its entire 36-month shelf life.⁴ The agent is used to treat patients with primary immunodeficiency disorders.
• Miconazole buccal tablets (Oravig) have been approved by the FDA for treating oropharyngeal candidiasis in adults and children 16 years of age and older. It is the first, and currently the only local, buccal prescription formulation of miconazole.⁵ The buccal tablet was developed to adhere to the gum. It should not be crushed, chewed, or swallowed. The most common adverse effects in clinical trials were diarrhea, nausea, headache, dysgeusia, upper abdominal pain, and vomiting. It is recommended to monitor patients with a history of hypersensitivity to azoles, as there is no information regarding cross-reactivity between miconazole and other azole agents.
• A supplemental new drug application (sNDA) has been submitted to the FDA for naltrexone extended-release injectable suspension (Vivitrol) for treating opioid dependence.⁶ It is administered as a once-monthly intramuscular injection and currently is approved by the FDA for treating alcohol dependence.
• Oxycodone controlled-release (OxyContin) has been approved by the FDA in a new, abuse-deterrent formulation.⁷
• Pancrelipase delayed-release capsules (Pancreaze) joins Creon (Abbott Labs) and Zenpep (Eurand) as the third pancreatic enzyme product (PEP) to be approved by the FDA for treating exocrine pancreatic insufficiency.⁸
• Pramipexole extended-release tablets (Mirapex ER) have been approved by the FDA as a once-daily treatment for the signs and symptoms of idiopathic Parkinson’s disease (early and late).⁹
• The active ingredient in the vaccine Diamyd, rhGAD65, has received orphan drug status for treating Type 1 diabetes mellitus (T1DM) with residual beta cell function.^10,11 This agent is in Phase 3 clinical trials and is being investigated to determine whether it can stop or slow the autoimmune destruction of insulin-producing beta cell function. The DiaPrevent study is enrolling patients. In Phase 2 studies, the agent preserved remaining beta cell function in adolescents and children recently diagnosed with T1DM.
• Warfarin genetic diagnostic: Machaon Diagnostics has received FDA approval for an array-based diagnostic technology that detects genetic variation and could aid in determining an accurate initial warfarin dose.¹² At least 40% of Americans have at least one genetic variation involved in warfarin metabolism, which can cause a more than fivefold disparity in the weekly warfarin dose. This test can be used to more accurately determine dosing for warfarin-treated patients.

Pipeline

• The NDA for DM-1796 (gabapentin extended-release tablet) has been submitted to the FDA for treatment of postherpetic neuralgia.¹³ It is a once-daily, extended-release formulation of gabapentin.
• The “quad” combination of elvitegravir, cobicistat (formerly GS 9350), emtricitabine, and tenofovir disoproxil fumarate in a fixed-dose single tablet is currently in Phase 3 clinical trials for treatment of HIV.¹⁴
• FTY720 is an investigational oral immune modulator agent for treating relapsing-remitting multiple sclerosis (RR-MS).¹⁵ The NDA for this agent was submitted in December 2009; the FDA granted it a priority review in February. Two-year data from the FREEDOMS trial showed that FTY720 reduced annual relapse rates by 62%, compared with treatment-naive patients. For patients that had received prior treatments, the annual relapse rate was reduced by 44%. At two years, FTY720 delayed disability progression by 30% for patients treated with 0.5 mg, compared with placebo. The serious infection rate was comparable in the different “immune modulator” treatment groups.

Product Removal

Inhalers containing ozone-depleting chlorofluorocarbons (CFCs) are continuing to be phased out.¹⁶ These agents are used to treat asthma and COPD, and alternate products that do not contain CFCs are available. Some pharmacies might be depleting stock after the “last-sale date.” The affected products and their phase-out dates are:

• Tilade (nedocromil): June 14, 2010;
• Alupent (metaproterenol): June 14, 2010;
• Aerobid (flunisolide): June 30, 2010;
• Azmacort (triamcinolone): Dec. 31, 2010;
• Intal (cromolyn): Dec. 31, 2010;
• Combivent (albuterol/ipratropium): December 31, 2013; and
• Maxair (pirbuterol) autohaler: December 31, 2013. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Food and Drug Administration website. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=078357&TABLE1=OB_Rx. Accessed April 27, 2010.
2. Mylan announces approval under PEPFAR for generic version of Videx EC HIV treatment. Medical News Today website. Available at: www.medicalnewstoday.com/articles/186273.php. Accessed April 27, 2010.
3. Sirion Therapeutics announces availability of Zirgan (ganciclovir ophthalmic gel) 0.15% for ocular herpes. PR Newswire website. Available at: www.prnewswire.com/news-releases/sirion-therapeutics-announces-availability-of-zirgantm-ganciclovir-ophthalmic-gel-015-for-ocular-herpes-92084614.html. Accessed April 27, 2010.
4. CSL Behring receives FDA approval to extend shelf life for Privigen from 24 to 36 months. CSL Behring website. Available at: www.cslbehring-us.com/s1/cs/enus/1154272074489/news/1255923905944/prdetail.htm. Accessed April 27, 2010.
5. FDA approves Oravig (miconazole) buccal tablets for treatment of oropharyngeal candidiasis. PAR Pharmaceuticals website. Available at: investors.parpharm.com/phoenix.zhtml?c=81806&p=irol-newsArticle&ID=1413993&highlight=. Accessed April 27, 2010.
6. Alkermes submits supplemental new drug application for Vivitrol for the treatment of opioid dependence. Medical News Today website. Available at: www.medicalnewstoday.com/articles/185456.php. Accessed April 27, 2010.
7. FDA approves reformulated oxycontin. Contract Pharma website. www.contractpharma.com/news/2010/04/07/fda_approves_reformulated_oxycontin. Accessed April 27, 2010.
8. Gansz Bobo E. FDA approves pancreatic enzyme product, Pancreaze. FDA website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208135.htm. Accessed April 27, 2010.
9. Once-daily Mirapex ER now approved by FDA for both early and advanced Parkinson’s disease. Medical News Today website. Available at: www.medicalnewstoday.com/printerfriendlynews.php?newsid=183272. Accessed April 27, 2010.
10. DiaPrevent diabetes research. DiaPrevent website. Available at: www.diaprevent.diamyd.com/. Accessed April 27, 2010.
11. Diamyd granted orphan drug designation in the US. Diamyd website. Available at: www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=479460. Accessed April 27, 2010.
12. Same-day genetic testing service available for safer warfarin dosing. Monthly Prescribing Reference website. Available at: www.empr.com/same-day-genetic-testing-service-available-for-safer-warfarin-dosing/article/167586/. Accessed April 27, 2010.
13. NDA submitted for DM-1796 for postherpetic neuralgia (PHN). Monthly Prescribing Reference website. Available at: www.empr.com/nda-submitted-for-dm-1796-for-postherpetic-neuralgia-phn/article/167056/. Accessed April 26, 2010.
14. Gilead initiates Phase III clinical program evaluating single-table, once-daily “quad” regimen for HIV. Gilead website. Available at: www.gilead.com/pr_1411934. Accessed April 27, 2010.
15. Novartis investigational multiple sclerosis therapy Gilenia (FTY720) shown to reduce relapse rates regardless of treatment history. Drugs.com website. Available at: www.drugs.com/clinical_trials/novartis-investigational-multiple-sclerosis-therapy-gilenia-fty720-shown-reduce-relapse-rates-9139.html. Accessed April 27, 2010.
16. Inhalers containing CFCs being eliminated. Pharamacist eLink website. Available at: www.pharmacistelink.com/index.php/Drugs-and-Treatment/Inhalers-containing-CFC-s-being-eliminated.html. Accessed April 27, 2010.

New Generics

• Desloratadine tablets (generic Clarinex)¹
• Didanosine delayed-release capsules (Generic Videx EC)²

New Indications, Dosage Forms, and Recommendations

• Ganciclovir ophthalmic gel 0.15% (Zirgan) has been approved by the FDA for treating acute herpetic keratitis.³ The recommended dose is one drop in the affected eye five times daily until the ulcer heals, then one drop three times daily for seven more days. The most common side effects in clinical trials were blurred vision, eye irritation, punctate keratitis, and conjunctival hyperemia. It will be available in a 5-g tube.
• Immune globulin intravenous 10% liquid (human) (Privigen) has received an updated approval from the FDA, which allows for room temperature storage throughout its entire 36-month shelf life.⁴ The agent is used to treat patients with primary immunodeficiency disorders.
• Miconazole buccal tablets (Oravig) have been approved by the FDA for treating oropharyngeal candidiasis in adults and children 16 years of age and older. It is the first, and currently the only local, buccal prescription formulation of miconazole.⁵ The buccal tablet was developed to adhere to the gum. It should not be crushed, chewed, or swallowed. The most common adverse effects in clinical trials were diarrhea, nausea, headache, dysgeusia, upper abdominal pain, and vomiting. It is recommended to monitor patients with a history of hypersensitivity to azoles, as there is no information regarding cross-reactivity between miconazole and other azole agents.
• A supplemental new drug application (sNDA) has been submitted to the FDA for naltrexone extended-release injectable suspension (Vivitrol) for treating opioid dependence.⁶ It is administered as a once-monthly intramuscular injection and currently is approved by the FDA for treating alcohol dependence.
• Oxycodone controlled-release (OxyContin) has been approved by the FDA in a new, abuse-deterrent formulation.⁷
• Pancrelipase delayed-release capsules (Pancreaze) joins Creon (Abbott Labs) and Zenpep (Eurand) as the third pancreatic enzyme product (PEP) to be approved by the FDA for treating exocrine pancreatic insufficiency.⁸
• Pramipexole extended-release tablets (Mirapex ER) have been approved by the FDA as a once-daily treatment for the signs and symptoms of idiopathic Parkinson’s disease (early and late).⁹
• The active ingredient in the vaccine Diamyd, rhGAD65, has received orphan drug status for treating Type 1 diabetes mellitus (T1DM) with residual beta cell function.^10,11 This agent is in Phase 3 clinical trials and is being investigated to determine whether it can stop or slow the autoimmune destruction of insulin-producing beta cell function. The DiaPrevent study is enrolling patients. In Phase 2 studies, the agent preserved remaining beta cell function in adolescents and children recently diagnosed with T1DM.
• Warfarin genetic diagnostic: Machaon Diagnostics has received FDA approval for an array-based diagnostic technology that detects genetic variation and could aid in determining an accurate initial warfarin dose.¹² At least 40% of Americans have at least one genetic variation involved in warfarin metabolism, which can cause a more than fivefold disparity in the weekly warfarin dose. This test can be used to more accurately determine dosing for warfarin-treated patients.

Pipeline

• The NDA for DM-1796 (gabapentin extended-release tablet) has been submitted to the FDA for treatment of postherpetic neuralgia.¹³ It is a once-daily, extended-release formulation of gabapentin.
• The “quad” combination of elvitegravir, cobicistat (formerly GS 9350), emtricitabine, and tenofovir disoproxil fumarate in a fixed-dose single tablet is currently in Phase 3 clinical trials for treatment of HIV.¹⁴
• FTY720 is an investigational oral immune modulator agent for treating relapsing-remitting multiple sclerosis (RR-MS).¹⁵ The NDA for this agent was submitted in December 2009; the FDA granted it a priority review in February. Two-year data from the FREEDOMS trial showed that FTY720 reduced annual relapse rates by 62%, compared with treatment-naive patients. For patients that had received prior treatments, the annual relapse rate was reduced by 44%. At two years, FTY720 delayed disability progression by 30% for patients treated with 0.5 mg, compared with placebo. The serious infection rate was comparable in the different “immune modulator” treatment groups.

Product Removal

Inhalers containing ozone-depleting chlorofluorocarbons (CFCs) are continuing to be phased out.¹⁶ These agents are used to treat asthma and COPD, and alternate products that do not contain CFCs are available. Some pharmacies might be depleting stock after the “last-sale date.” The affected products and their phase-out dates are:

• Tilade (nedocromil): June 14, 2010;
• Alupent (metaproterenol): June 14, 2010;
• Aerobid (flunisolide): June 30, 2010;
• Azmacort (triamcinolone): Dec. 31, 2010;
• Intal (cromolyn): Dec. 31, 2010;
• Combivent (albuterol/ipratropium): December 31, 2013; and
• Maxair (pirbuterol) autohaler: December 31, 2013. TH

Michele B. Kaufman, PharmD, BSc, RPh, is a freelance medical writer based in New York City and a clinical pharmacist at New York Downtown Hospital.

References

1. Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Food and Drug Administration website. Available at: www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=078357&TABLE1=OB_Rx. Accessed April 27, 2010.
2. Mylan announces approval under PEPFAR for generic version of Videx EC HIV treatment. Medical News Today website. Available at: www.medicalnewstoday.com/articles/186273.php. Accessed April 27, 2010.
3. Sirion Therapeutics announces availability of Zirgan (ganciclovir ophthalmic gel) 0.15% for ocular herpes. PR Newswire website. Available at: www.prnewswire.com/news-releases/sirion-therapeutics-announces-availability-of-zirgantm-ganciclovir-ophthalmic-gel-015-for-ocular-herpes-92084614.html. Accessed April 27, 2010.
4. CSL Behring receives FDA approval to extend shelf life for Privigen from 24 to 36 months. CSL Behring website. Available at: www.cslbehring-us.com/s1/cs/enus/1154272074489/news/1255923905944/prdetail.htm. Accessed April 27, 2010.
5. FDA approves Oravig (miconazole) buccal tablets for treatment of oropharyngeal candidiasis. PAR Pharmaceuticals website. Available at: investors.parpharm.com/phoenix.zhtml?c=81806&p=irol-newsArticle&ID=1413993&highlight=. Accessed April 27, 2010.
6. Alkermes submits supplemental new drug application for Vivitrol for the treatment of opioid dependence. Medical News Today website. Available at: www.medicalnewstoday.com/articles/185456.php. Accessed April 27, 2010.
7. FDA approves reformulated oxycontin. Contract Pharma website. www.contractpharma.com/news/2010/04/07/fda_approves_reformulated_oxycontin. Accessed April 27, 2010.
8. Gansz Bobo E. FDA approves pancreatic enzyme product, Pancreaze. FDA website. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm208135.htm. Accessed April 27, 2010.
9. Once-daily Mirapex ER now approved by FDA for both early and advanced Parkinson’s disease. Medical News Today website. Available at: www.medicalnewstoday.com/printerfriendlynews.php?newsid=183272. Accessed April 27, 2010.
10. DiaPrevent diabetes research. DiaPrevent website. Available at: www.diaprevent.diamyd.com/. Accessed April 27, 2010.
11. Diamyd granted orphan drug designation in the US. Diamyd website. Available at: www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=479460. Accessed April 27, 2010.
12. Same-day genetic testing service available for safer warfarin dosing. Monthly Prescribing Reference website. Available at: www.empr.com/same-day-genetic-testing-service-available-for-safer-warfarin-dosing/article/167586/. Accessed April 27, 2010.
13. NDA submitted for DM-1796 for postherpetic neuralgia (PHN). Monthly Prescribing Reference website. Available at: www.empr.com/nda-submitted-for-dm-1796-for-postherpetic-neuralgia-phn/article/167056/. Accessed April 26, 2010.
14. Gilead initiates Phase III clinical program evaluating single-table, once-daily “quad” regimen for HIV. Gilead website. Available at: www.gilead.com/pr_1411934. Accessed April 27, 2010.
15. Novartis investigational multiple sclerosis therapy Gilenia (FTY720) shown to reduce relapse rates regardless of treatment history. Drugs.com website. Available at: www.drugs.com/clinical_trials/novartis-investigational-multiple-sclerosis-therapy-gilenia-fty720-shown-reduce-relapse-rates-9139.html. Accessed April 27, 2010.
16. Inhalers containing CFCs being eliminated. Pharamacist eLink website. Available at: www.pharmacistelink.com/index.php/Drugs-and-Treatment/Inhalers-containing-CFC-s-being-eliminated.html. Accessed April 27, 2010.