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SILVER SPRING, MD. – Vicodin, Norco, and other hydrocodone combination products should be reclassified as schedule II drugs, because stricter controls on prescribing are needed to address the current epidemic of abuse, misuse, and diversion of these products in the United States, the majority of a Food and Drug Administration advisory panel has recommended.
At the end of a 2-day meeting on Jan. 25, the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 that these products should be rescheduled from schedule III under the Controlled Substances Act (CSA), to schedule II. Schedule III allows written or oral prescribing, and five refills within 6 months, while schedule II drugs require handwritten prescriptions and other restrictions. The meeting was held in response to a request from the U.S. Drug Enforcement Administration that these products be rescheduled because of evidence they are overprescribed, diverted, and abused.
Panelists said that based on the epidemiologic and pharmacologic data presented during the meeting – which they acknowledged had limitations and was somewhat confusing – the abuse potential and pharmacology of hydrocodone combination products were similar to those of oxycodone and other schedule II drugs.
Those voting in favor of rescheduling said that it would result in a net public health benefit by making these drugs less available for abuse and reducing the amount that ends up in medication cabinets and on the street. And they acknowledged that there is little concrete evidence that tighter regulation would reduce the widespread abuse, misuse, and diversion of these products. In addition, rescheduling is likely to have some negative consequences, panelists noted.
"While I don’t think reclassification is some panacea for the opiate use problem in this country, I think it’s an important step in getting physicians to rethink prescribing practices and to look at other approaches in pain management," said Mary Ellen Olbrisch, Ph.D., professor of psychiatry and surgery, Virginia Commonwealth University, Richmond. She added that other measures would be necessary to ensure access to patients with appropriate needs for these drugs, such as legislation in states allowing nonphysician providers to prescribe schedule II drugs.
"For me, the most persuasive argument was that rescheduling is a signal to the public [and] to the medical profession about the abuse potential, and it [corrects] the misperception that hydrocodone combination products are a safer option than class II [agents] when it comes to long-term risk of abuse," added Elaine Morrato, Dr.P.H., of the department of health systems, management and policy, Colorado School of Public Health, Aurora.
Dr. Peter Kaboli, of the department of internal medicine at the University of Iowa, and a hospitalist at the Iowa City Veterans Affairs Medical Center, said that when considering the CSA’s list of factors used to determine scheduling of drugs with abuse potential, "it seemed pretty clear to me that the preponderance of the evidence supported rescheduling." Those factors include the drug’s actual or relative potential for abuse; scientific evidence of its pharmacologic effect; history and current pattern of abuse; and the scope, duration, and significance of abuse.
"We are witnessing the unintended consequences of poorly controlled opioid prescribing now," with people dying and developing hyperalgesia, dependence, and addiction, said Dr. Lewis Nelson, professor of emergency medicine at New York University. While there will be unintended consequences of stricter regulation, these products have become an alternative to heroin, and rescheduling will likely reduce the supply on the street and have a net benefit, he said.
But panelists voting against rescheduling said there was no evidence that rescheduling would have an impact on abuse and diversion, and would likely result in an increase in the use of heroin and other illicit drugs, and problems with other schedule III drugs. They were also concerned about the negative consequences of rescheduling on the treatment of pain, with the increased burden and reduced access to effective pain medications for patients in pain, particularly those in rural areas or those who have difficulty getting to a doctor for a prescription renewal.
Voting no, Dr. John Mendelson, senior scientist in the Addiction and Pharmacology Research Laboratory at St. Luke’s Hospital, San Francisco, said, "The net result will be increased prescribing of other [schedule II] drugs, which may have greater abuse liability and actually fuel rather than reduce an epidemic in progress." Another likely outcome is an increase in illicit opiate use and the abrupt withdrawal of medication for some patients who need it, he added, referring to public testimony at the meeting about people whose suicides were directly related to abrupt withdrawal from a hydrocodone product.
Winifred A. Landis, R.Ph., a pharmacist in Lafayette, Ind., said that the recommendation for rescheduling was "a knee jerk reaction" and that when prescribed and used appropriately, hydrocodone combination products should remain as schedule III drugs. "Those who are addiction-seeking will find other medications that are available, whether it’s clonazepam, alprazolam, or hydrocodone, and at the same time we’re going to reduce access for those who really need the medication for pain."
Almost all (99%) of hydrocodone used in the world is in the United States, where hydrocodone combination products are the most widely prescribed products: In 2011, there were about 131 million prescriptions for the combination hydrocodone analgesic products, for 47 million people, compared with 34.6 million for oxycodone combination drugs prescribed for 15.1 million patients, according to national prescription data cited by the FDA. About 40% of the hydrocodone combination analgesics are prescribed by primary care practitioners.
Because of indiscriminate prescribing, rogue pain clinics, leftovers in medication cabinets, and other sources, "there’s so much hydrocodone on the street it’s getting into the wrong hands," Joseph Rannazzisi, the deputy assistant administrator in the Drug Enforcement Administration’s office of diversion control, said at the meeting. He described these drugs as a gateway drug to harder drugs for teenagers, who tend to combine it with benzodiazepines and muscle relaxants.
The FDA’s analysis of the national data indicates that hydrocodone products are widely abused. High school students are more likely to abuse hydrocodone products than oxycodone products, because there are so many more hydrocodone prescriptions and wider availability of leftover drugs in homes. However, hydrocodone combination products have lower abuse ratios than oxycodone combination products, according to the FDA reviewers, who acknowledged that calculating accurate abuse ratios is complicated
Panelists strongly recommended close study of the impact of the scheduling change on prescribing practices, abuse, and diversion. There should be a transition period in the rescheduling process so patients with appropriate needs for the drug and prescribers can adjust to the tighter regulations and avoid losing access to the drug abruptly.
Currently, there are 81 products that contain up to 10 mg of hydrocodone per dosage unit with acetaminophen or ibuprofen, and 12 cough suppressant products that contain up to 10 mg of hydrocodone per dosage unit, with chlorpheniramine, homatropine, or pseudoephedrine, according to the FDA. Hydrocodone alone is a schedule II drug, but there is no single-ingredient hydrocodone product available. In December another FDA advisory panel voted against approval of an extended-release, single-ingredient hydrocodone formulation, largely because of what they considered an enormous potential for abuse once it became available.
Parents and other family members of people who had committed suicide or died of overdoses related to hydrocodone products also testified at the meeting, including several who had testified a month earlier at the meeting on the extended-release hydrocodone product, calling for tighter controls on the drug.
Dr. Olbrisch, Dr. Morrato, Dr. Kaboli, Dr. Nelson, Dr. Mendelson, and Ms. Landis are committee members. The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. While a panelist may be given a waiver, none were granted at this meeting.
SILVER SPRING, MD. – Vicodin, Norco, and other hydrocodone combination products should be reclassified as schedule II drugs, because stricter controls on prescribing are needed to address the current epidemic of abuse, misuse, and diversion of these products in the United States, the majority of a Food and Drug Administration advisory panel has recommended.
At the end of a 2-day meeting on Jan. 25, the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 that these products should be rescheduled from schedule III under the Controlled Substances Act (CSA), to schedule II. Schedule III allows written or oral prescribing, and five refills within 6 months, while schedule II drugs require handwritten prescriptions and other restrictions. The meeting was held in response to a request from the U.S. Drug Enforcement Administration that these products be rescheduled because of evidence they are overprescribed, diverted, and abused.
Panelists said that based on the epidemiologic and pharmacologic data presented during the meeting – which they acknowledged had limitations and was somewhat confusing – the abuse potential and pharmacology of hydrocodone combination products were similar to those of oxycodone and other schedule II drugs.
Those voting in favor of rescheduling said that it would result in a net public health benefit by making these drugs less available for abuse and reducing the amount that ends up in medication cabinets and on the street. And they acknowledged that there is little concrete evidence that tighter regulation would reduce the widespread abuse, misuse, and diversion of these products. In addition, rescheduling is likely to have some negative consequences, panelists noted.
"While I don’t think reclassification is some panacea for the opiate use problem in this country, I think it’s an important step in getting physicians to rethink prescribing practices and to look at other approaches in pain management," said Mary Ellen Olbrisch, Ph.D., professor of psychiatry and surgery, Virginia Commonwealth University, Richmond. She added that other measures would be necessary to ensure access to patients with appropriate needs for these drugs, such as legislation in states allowing nonphysician providers to prescribe schedule II drugs.
"For me, the most persuasive argument was that rescheduling is a signal to the public [and] to the medical profession about the abuse potential, and it [corrects] the misperception that hydrocodone combination products are a safer option than class II [agents] when it comes to long-term risk of abuse," added Elaine Morrato, Dr.P.H., of the department of health systems, management and policy, Colorado School of Public Health, Aurora.
Dr. Peter Kaboli, of the department of internal medicine at the University of Iowa, and a hospitalist at the Iowa City Veterans Affairs Medical Center, said that when considering the CSA’s list of factors used to determine scheduling of drugs with abuse potential, "it seemed pretty clear to me that the preponderance of the evidence supported rescheduling." Those factors include the drug’s actual or relative potential for abuse; scientific evidence of its pharmacologic effect; history and current pattern of abuse; and the scope, duration, and significance of abuse.
"We are witnessing the unintended consequences of poorly controlled opioid prescribing now," with people dying and developing hyperalgesia, dependence, and addiction, said Dr. Lewis Nelson, professor of emergency medicine at New York University. While there will be unintended consequences of stricter regulation, these products have become an alternative to heroin, and rescheduling will likely reduce the supply on the street and have a net benefit, he said.
But panelists voting against rescheduling said there was no evidence that rescheduling would have an impact on abuse and diversion, and would likely result in an increase in the use of heroin and other illicit drugs, and problems with other schedule III drugs. They were also concerned about the negative consequences of rescheduling on the treatment of pain, with the increased burden and reduced access to effective pain medications for patients in pain, particularly those in rural areas or those who have difficulty getting to a doctor for a prescription renewal.
Voting no, Dr. John Mendelson, senior scientist in the Addiction and Pharmacology Research Laboratory at St. Luke’s Hospital, San Francisco, said, "The net result will be increased prescribing of other [schedule II] drugs, which may have greater abuse liability and actually fuel rather than reduce an epidemic in progress." Another likely outcome is an increase in illicit opiate use and the abrupt withdrawal of medication for some patients who need it, he added, referring to public testimony at the meeting about people whose suicides were directly related to abrupt withdrawal from a hydrocodone product.
Winifred A. Landis, R.Ph., a pharmacist in Lafayette, Ind., said that the recommendation for rescheduling was "a knee jerk reaction" and that when prescribed and used appropriately, hydrocodone combination products should remain as schedule III drugs. "Those who are addiction-seeking will find other medications that are available, whether it’s clonazepam, alprazolam, or hydrocodone, and at the same time we’re going to reduce access for those who really need the medication for pain."
Almost all (99%) of hydrocodone used in the world is in the United States, where hydrocodone combination products are the most widely prescribed products: In 2011, there were about 131 million prescriptions for the combination hydrocodone analgesic products, for 47 million people, compared with 34.6 million for oxycodone combination drugs prescribed for 15.1 million patients, according to national prescription data cited by the FDA. About 40% of the hydrocodone combination analgesics are prescribed by primary care practitioners.
Because of indiscriminate prescribing, rogue pain clinics, leftovers in medication cabinets, and other sources, "there’s so much hydrocodone on the street it’s getting into the wrong hands," Joseph Rannazzisi, the deputy assistant administrator in the Drug Enforcement Administration’s office of diversion control, said at the meeting. He described these drugs as a gateway drug to harder drugs for teenagers, who tend to combine it with benzodiazepines and muscle relaxants.
The FDA’s analysis of the national data indicates that hydrocodone products are widely abused. High school students are more likely to abuse hydrocodone products than oxycodone products, because there are so many more hydrocodone prescriptions and wider availability of leftover drugs in homes. However, hydrocodone combination products have lower abuse ratios than oxycodone combination products, according to the FDA reviewers, who acknowledged that calculating accurate abuse ratios is complicated
Panelists strongly recommended close study of the impact of the scheduling change on prescribing practices, abuse, and diversion. There should be a transition period in the rescheduling process so patients with appropriate needs for the drug and prescribers can adjust to the tighter regulations and avoid losing access to the drug abruptly.
Currently, there are 81 products that contain up to 10 mg of hydrocodone per dosage unit with acetaminophen or ibuprofen, and 12 cough suppressant products that contain up to 10 mg of hydrocodone per dosage unit, with chlorpheniramine, homatropine, or pseudoephedrine, according to the FDA. Hydrocodone alone is a schedule II drug, but there is no single-ingredient hydrocodone product available. In December another FDA advisory panel voted against approval of an extended-release, single-ingredient hydrocodone formulation, largely because of what they considered an enormous potential for abuse once it became available.
Parents and other family members of people who had committed suicide or died of overdoses related to hydrocodone products also testified at the meeting, including several who had testified a month earlier at the meeting on the extended-release hydrocodone product, calling for tighter controls on the drug.
Dr. Olbrisch, Dr. Morrato, Dr. Kaboli, Dr. Nelson, Dr. Mendelson, and Ms. Landis are committee members. The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. While a panelist may be given a waiver, none were granted at this meeting.
SILVER SPRING, MD. – Vicodin, Norco, and other hydrocodone combination products should be reclassified as schedule II drugs, because stricter controls on prescribing are needed to address the current epidemic of abuse, misuse, and diversion of these products in the United States, the majority of a Food and Drug Administration advisory panel has recommended.
At the end of a 2-day meeting on Jan. 25, the FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 that these products should be rescheduled from schedule III under the Controlled Substances Act (CSA), to schedule II. Schedule III allows written or oral prescribing, and five refills within 6 months, while schedule II drugs require handwritten prescriptions and other restrictions. The meeting was held in response to a request from the U.S. Drug Enforcement Administration that these products be rescheduled because of evidence they are overprescribed, diverted, and abused.
Panelists said that based on the epidemiologic and pharmacologic data presented during the meeting – which they acknowledged had limitations and was somewhat confusing – the abuse potential and pharmacology of hydrocodone combination products were similar to those of oxycodone and other schedule II drugs.
Those voting in favor of rescheduling said that it would result in a net public health benefit by making these drugs less available for abuse and reducing the amount that ends up in medication cabinets and on the street. And they acknowledged that there is little concrete evidence that tighter regulation would reduce the widespread abuse, misuse, and diversion of these products. In addition, rescheduling is likely to have some negative consequences, panelists noted.
"While I don’t think reclassification is some panacea for the opiate use problem in this country, I think it’s an important step in getting physicians to rethink prescribing practices and to look at other approaches in pain management," said Mary Ellen Olbrisch, Ph.D., professor of psychiatry and surgery, Virginia Commonwealth University, Richmond. She added that other measures would be necessary to ensure access to patients with appropriate needs for these drugs, such as legislation in states allowing nonphysician providers to prescribe schedule II drugs.
"For me, the most persuasive argument was that rescheduling is a signal to the public [and] to the medical profession about the abuse potential, and it [corrects] the misperception that hydrocodone combination products are a safer option than class II [agents] when it comes to long-term risk of abuse," added Elaine Morrato, Dr.P.H., of the department of health systems, management and policy, Colorado School of Public Health, Aurora.
Dr. Peter Kaboli, of the department of internal medicine at the University of Iowa, and a hospitalist at the Iowa City Veterans Affairs Medical Center, said that when considering the CSA’s list of factors used to determine scheduling of drugs with abuse potential, "it seemed pretty clear to me that the preponderance of the evidence supported rescheduling." Those factors include the drug’s actual or relative potential for abuse; scientific evidence of its pharmacologic effect; history and current pattern of abuse; and the scope, duration, and significance of abuse.
"We are witnessing the unintended consequences of poorly controlled opioid prescribing now," with people dying and developing hyperalgesia, dependence, and addiction, said Dr. Lewis Nelson, professor of emergency medicine at New York University. While there will be unintended consequences of stricter regulation, these products have become an alternative to heroin, and rescheduling will likely reduce the supply on the street and have a net benefit, he said.
But panelists voting against rescheduling said there was no evidence that rescheduling would have an impact on abuse and diversion, and would likely result in an increase in the use of heroin and other illicit drugs, and problems with other schedule III drugs. They were also concerned about the negative consequences of rescheduling on the treatment of pain, with the increased burden and reduced access to effective pain medications for patients in pain, particularly those in rural areas or those who have difficulty getting to a doctor for a prescription renewal.
Voting no, Dr. John Mendelson, senior scientist in the Addiction and Pharmacology Research Laboratory at St. Luke’s Hospital, San Francisco, said, "The net result will be increased prescribing of other [schedule II] drugs, which may have greater abuse liability and actually fuel rather than reduce an epidemic in progress." Another likely outcome is an increase in illicit opiate use and the abrupt withdrawal of medication for some patients who need it, he added, referring to public testimony at the meeting about people whose suicides were directly related to abrupt withdrawal from a hydrocodone product.
Winifred A. Landis, R.Ph., a pharmacist in Lafayette, Ind., said that the recommendation for rescheduling was "a knee jerk reaction" and that when prescribed and used appropriately, hydrocodone combination products should remain as schedule III drugs. "Those who are addiction-seeking will find other medications that are available, whether it’s clonazepam, alprazolam, or hydrocodone, and at the same time we’re going to reduce access for those who really need the medication for pain."
Almost all (99%) of hydrocodone used in the world is in the United States, where hydrocodone combination products are the most widely prescribed products: In 2011, there were about 131 million prescriptions for the combination hydrocodone analgesic products, for 47 million people, compared with 34.6 million for oxycodone combination drugs prescribed for 15.1 million patients, according to national prescription data cited by the FDA. About 40% of the hydrocodone combination analgesics are prescribed by primary care practitioners.
Because of indiscriminate prescribing, rogue pain clinics, leftovers in medication cabinets, and other sources, "there’s so much hydrocodone on the street it’s getting into the wrong hands," Joseph Rannazzisi, the deputy assistant administrator in the Drug Enforcement Administration’s office of diversion control, said at the meeting. He described these drugs as a gateway drug to harder drugs for teenagers, who tend to combine it with benzodiazepines and muscle relaxants.
The FDA’s analysis of the national data indicates that hydrocodone products are widely abused. High school students are more likely to abuse hydrocodone products than oxycodone products, because there are so many more hydrocodone prescriptions and wider availability of leftover drugs in homes. However, hydrocodone combination products have lower abuse ratios than oxycodone combination products, according to the FDA reviewers, who acknowledged that calculating accurate abuse ratios is complicated
Panelists strongly recommended close study of the impact of the scheduling change on prescribing practices, abuse, and diversion. There should be a transition period in the rescheduling process so patients with appropriate needs for the drug and prescribers can adjust to the tighter regulations and avoid losing access to the drug abruptly.
Currently, there are 81 products that contain up to 10 mg of hydrocodone per dosage unit with acetaminophen or ibuprofen, and 12 cough suppressant products that contain up to 10 mg of hydrocodone per dosage unit, with chlorpheniramine, homatropine, or pseudoephedrine, according to the FDA. Hydrocodone alone is a schedule II drug, but there is no single-ingredient hydrocodone product available. In December another FDA advisory panel voted against approval of an extended-release, single-ingredient hydrocodone formulation, largely because of what they considered an enormous potential for abuse once it became available.
Parents and other family members of people who had committed suicide or died of overdoses related to hydrocodone products also testified at the meeting, including several who had testified a month earlier at the meeting on the extended-release hydrocodone product, calling for tighter controls on the drug.
Dr. Olbrisch, Dr. Morrato, Dr. Kaboli, Dr. Nelson, Dr. Mendelson, and Ms. Landis are committee members. The FDA usually follows the recommendations of its advisory panels, which are not binding. Panelists have been cleared of potential conflicts of interest related to the topic of the meeting. While a panelist may be given a waiver, none were granted at this meeting.
AT A MEETING OF THE FDA'S DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
