Hydrocodone rescheduling: Intended and unintended consequences

Recently, the Food and Drug Administration announced that it will submit a formal recommendation to the Department of Health and Human Services to reclassify hydrocodone combination products as Schedule II.Efforts to reschedule hydrocodone date back several years and originate from the increase in overdose deaths attributed to hydrocodone as well as the drug’s relative overrepresentation in opioid abuse.

Hydrocodone has been the most prescribed drug in the United States for more than 5 years – more than medications for hypertension, diabetes, and infections, just to name a few. Studies of opioid abuse have found the majority of diverted opioids are obtained from a friend or relative who received the drug from a treating physician (as opposed to buying on the street or from a "pill mill"). Paradoxically, the FDA simultaneously approved Zohydro ER, a long-acting hydrocodone product, despite an 11-2 vote against approval in the FDA’s own advisory committee.

Our colleagues are understandably confused by these developments. Physicians and patients alike perceive that hydrocodone is weaker than other opioids, largely because it is not currently classified as Schedule II. In states with Prescription Monitoring Programs, this misperception is increased by the fact that hydrocodone prescriptions do not require a special prescription pad. Prescribers often are very surprised to discover that hydrocodone and morphine are 1:1 in opioid equianalgesic tables (Clin. J. Pain 19:286-97). While a change in the schedule classification for a drug has no bearing on its pharmacokinetics or safety profile, it will have the intended effect of decreasing the number of prescriptions written. It remains to be seen whether this change will limit access to opioids for patients with legitimate need for opioids, as is feared by many chronic pain patients and their advocates. On the other hand, there will be no perverse incentive to use a combination opioid, with consequent increased risk of hepatotoxicity from acetaminophen.

It is difficult to know precisely how this change will affect hospitalists.

In our community, a significant portion of hospitalists have chosen not to obtain the necessary prescription blanks for Schedule II drugs and prescribe exclusively hydrocodone products upon discharge. We suspect that hospitals will need to devote significant resources to early transition from parenteral to oral opioids, with subsequent transition away from opioids altogether as part of the discharge planning process. Additional time will need to be allotted for counseling patients and their families about the rationale and timing of these transitions. Furthermore, reclassifying hydrocodone will limit the number of refills permitted without a physician visit, which may lead to increased ED visits and duplicative testing, as well as patients who are dissatisfied with hospital care.

Chronic pain is a difficult and complex clinical problem. The evidence for long-term opioid therapy in chronic nonmalignant pain is weak, but for many patients opioid therapy is the only choice fully covered by insurance, or the only affordable choice for the uninsured/underinsured. Other modalities to be considered include but are not limited to adjuvant drugs (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and anticonvulsants), physical therapy, exercise, lifestyle modifications, massage, acupuncture, biofeedback, and counseling. Hospital systems will bear the consequences of this change, and may be well served by developing additional service lines for pain management. Though we cannot know the exact timing of the expected change, hospitalist groups should begin developing their approach immediately.

Dr. Fredholm and Dr. Bekanich are codirectors of Seton Palliative Care, part of the University of Texas Southwestern Residency Programs in Austin.

Recently, the Food and Drug Administration announced that it will submit a formal recommendation to the Department of Health and Human Services to reclassify hydrocodone combination products as Schedule II.Efforts to reschedule hydrocodone date back several years and originate from the increase in overdose deaths attributed to hydrocodone as well as the drug’s relative overrepresentation in opioid abuse.

Hydrocodone has been the most prescribed drug in the United States for more than 5 years – more than medications for hypertension, diabetes, and infections, just to name a few. Studies of opioid abuse have found the majority of diverted opioids are obtained from a friend or relative who received the drug from a treating physician (as opposed to buying on the street or from a "pill mill"). Paradoxically, the FDA simultaneously approved Zohydro ER, a long-acting hydrocodone product, despite an 11-2 vote against approval in the FDA’s own advisory committee.

Our colleagues are understandably confused by these developments. Physicians and patients alike perceive that hydrocodone is weaker than other opioids, largely because it is not currently classified as Schedule II. In states with Prescription Monitoring Programs, this misperception is increased by the fact that hydrocodone prescriptions do not require a special prescription pad. Prescribers often are very surprised to discover that hydrocodone and morphine are 1:1 in opioid equianalgesic tables (Clin. J. Pain 19:286-97). While a change in the schedule classification for a drug has no bearing on its pharmacokinetics or safety profile, it will have the intended effect of decreasing the number of prescriptions written. It remains to be seen whether this change will limit access to opioids for patients with legitimate need for opioids, as is feared by many chronic pain patients and their advocates. On the other hand, there will be no perverse incentive to use a combination opioid, with consequent increased risk of hepatotoxicity from acetaminophen.

It is difficult to know precisely how this change will affect hospitalists.

In our community, a significant portion of hospitalists have chosen not to obtain the necessary prescription blanks for Schedule II drugs and prescribe exclusively hydrocodone products upon discharge. We suspect that hospitals will need to devote significant resources to early transition from parenteral to oral opioids, with subsequent transition away from opioids altogether as part of the discharge planning process. Additional time will need to be allotted for counseling patients and their families about the rationale and timing of these transitions. Furthermore, reclassifying hydrocodone will limit the number of refills permitted without a physician visit, which may lead to increased ED visits and duplicative testing, as well as patients who are dissatisfied with hospital care.

Chronic pain is a difficult and complex clinical problem. The evidence for long-term opioid therapy in chronic nonmalignant pain is weak, but for many patients opioid therapy is the only choice fully covered by insurance, or the only affordable choice for the uninsured/underinsured. Other modalities to be considered include but are not limited to adjuvant drugs (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and anticonvulsants), physical therapy, exercise, lifestyle modifications, massage, acupuncture, biofeedback, and counseling. Hospital systems will bear the consequences of this change, and may be well served by developing additional service lines for pain management. Though we cannot know the exact timing of the expected change, hospitalist groups should begin developing their approach immediately.

Dr. Fredholm and Dr. Bekanich are codirectors of Seton Palliative Care, part of the University of Texas Southwestern Residency Programs in Austin.

Recently, the Food and Drug Administration announced that it will submit a formal recommendation to the Department of Health and Human Services to reclassify hydrocodone combination products as Schedule II.Efforts to reschedule hydrocodone date back several years and originate from the increase in overdose deaths attributed to hydrocodone as well as the drug’s relative overrepresentation in opioid abuse.

Hydrocodone has been the most prescribed drug in the United States for more than 5 years – more than medications for hypertension, diabetes, and infections, just to name a few. Studies of opioid abuse have found the majority of diverted opioids are obtained from a friend or relative who received the drug from a treating physician (as opposed to buying on the street or from a "pill mill"). Paradoxically, the FDA simultaneously approved Zohydro ER, a long-acting hydrocodone product, despite an 11-2 vote against approval in the FDA’s own advisory committee.

Our colleagues are understandably confused by these developments. Physicians and patients alike perceive that hydrocodone is weaker than other opioids, largely because it is not currently classified as Schedule II. In states with Prescription Monitoring Programs, this misperception is increased by the fact that hydrocodone prescriptions do not require a special prescription pad. Prescribers often are very surprised to discover that hydrocodone and morphine are 1:1 in opioid equianalgesic tables (Clin. J. Pain 19:286-97). While a change in the schedule classification for a drug has no bearing on its pharmacokinetics or safety profile, it will have the intended effect of decreasing the number of prescriptions written. It remains to be seen whether this change will limit access to opioids for patients with legitimate need for opioids, as is feared by many chronic pain patients and their advocates. On the other hand, there will be no perverse incentive to use a combination opioid, with consequent increased risk of hepatotoxicity from acetaminophen.

It is difficult to know precisely how this change will affect hospitalists.

In our community, a significant portion of hospitalists have chosen not to obtain the necessary prescription blanks for Schedule II drugs and prescribe exclusively hydrocodone products upon discharge. We suspect that hospitals will need to devote significant resources to early transition from parenteral to oral opioids, with subsequent transition away from opioids altogether as part of the discharge planning process. Additional time will need to be allotted for counseling patients and their families about the rationale and timing of these transitions. Furthermore, reclassifying hydrocodone will limit the number of refills permitted without a physician visit, which may lead to increased ED visits and duplicative testing, as well as patients who are dissatisfied with hospital care.

Chronic pain is a difficult and complex clinical problem. The evidence for long-term opioid therapy in chronic nonmalignant pain is weak, but for many patients opioid therapy is the only choice fully covered by insurance, or the only affordable choice for the uninsured/underinsured. Other modalities to be considered include but are not limited to adjuvant drugs (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and anticonvulsants), physical therapy, exercise, lifestyle modifications, massage, acupuncture, biofeedback, and counseling. Hospital systems will bear the consequences of this change, and may be well served by developing additional service lines for pain management. Though we cannot know the exact timing of the expected change, hospitalist groups should begin developing their approach immediately.

Dr. Fredholm and Dr. Bekanich are codirectors of Seton Palliative Care, part of the University of Texas Southwestern Residency Programs in Austin.