Law & Psychiatry
effort, has generated some impressive data documenting the effects of the state’s new regulations (9,10). Since January 1, 1989, benzodiazepines have been included in New York’s 13-year-old program that regulates prescription of certain drugs. Previously applied only to Schedule II drugs, which include many opiates, cocaine, and amphetamines, the program requires orders for regulated drugs to be written on state-supplied, triplicate prescription forms. A copy of each prescription is kept by the physician and the dispensing pharmacist. The third copy is sent by the pharmacist to the state Department of Health. Data generated from the prescription copies can be used to identify physicians who prescribe
large amounts of benzodiazepines, pharmacies that dispense them iilegally, and patients who collect multiple prescriptions from different physicians. In addition, the new rules limit prescriptions for benzodiazepines to a maximum 30-day supply, but allow prescriptions for a 90-day supply for patients with a small number of specified conditions, including panic disorder, attention-deficit hyperactivity disorder, convulsive disorders, narcolepsy, and severe pain associated with incurable conditions in elderly patients. No automatic refills are allowed. A physician must examine the patient before an initial prescription is made, but prescription renewals do not require reexamination. Nine states have triplicate prescription programs for Schedule II drugs(1 1), but New York is the first state to add benzodiazepines to its program. Thus the results ofits effort have been awaited with great interest. Data from the first year in which benzodiazepines were regulated reveal striking effrcts (8-10). Six months after the program began, the number of prescriptions for benzodiazepines paid for by Medicaid had fallen from an average of 389,250 per quarter to 173,000 per quarter, a drop of5 5 percent. The number of prescriptions for a group of heavy users of prescription mcdications ingeneral-acategory of persons suspected of benzodiazepine diversion and abuse-fell9S percent. Smaller but stillsubstantial decreases were seen in data from insurance programs covering state employees and elderly persons, groups in which abuse was thought to be less likely and misuse was more of a concern. Overall, the state saved $18 million in prescription costs under Medicaid and other publicly funded programs in the first year that benzodiazepines were included in the triplicate prescription program. An obvious concern of observers of the triplicate prescription program is that other drugs with the potential of being abused might be substituted for benzodiazepines. Although small compensatory increases in use of other anxiolytics and hypnotics were
January
Hospital
Controlling Prescription of Benzodiazepines Paul
S. Appelbaum,
M.D.
Benzodiazepines-including diazepam and triazolam-are among the most frequently prescribed drugs in the United States. They play important roles in the treatment of anxiety, insomnia, panic disorder, and epilepsy (1). Recently, however, the therapeutic virtues of benzodiazepines have been overshadowed in both the lay and the professional media by concerns about adverse effects that may accompany their use, including physical dependence, functional impairment, and behavioral abnormalities (2-4). States are now beginning to respond to these concerns with new statutes aimed at controlling and monitoring the prescription of benzodiazepines. Whether special procedures are needed to prevent abuse and misuse of benzodiazepines is a matter of some controversy. Reviews of epidemiologic data suggest that few patients who are prescribed benzodiazepines for legitimate indications become abusers of the drugs (5). In household surveys, most persons who report benzodiazepine use appear to have taken the medications appropriately (6). Only a select portion of the population, who may have some propensity to abuse substances in
Dr. Appelbaum is A. F. Zeleznik professor of psychiatry and director of the law and psychiatry program at the University of Massachusetts Medical School. Address correspondence to him at the De-
partment sity of School,
Worcester,
12
of Psychiatry, Massachusetts 55 Lake Avenue Massachusetts
UniverMedical North, 01655.
general, appears susceptible to abuse ofbenzodiazepines (7). However, these findings have done little to calm the fears of many public health officials. They point to the frequent practice of prescribing the medications for long periods, often for years, although studies have not been performed to demonstrate efficacy beyond several weeks; the association between use of benzodiazepines by elderly people and injuries, particularly those caused by falls; the use of the drugs in higher doses than prescribed, which may be precipitated by their disinhibiting effects; and the impairment of driving skills that may be caused by the drugs (8). Related to these concerns is a beliefthat states could save large amounts ofmoney ifunnecessary and fraudulent prescriptions for benzodiazepines could be eliminated. As a result, new laws intended to restrict use of benzodiazepines are now being proposed. New York, which has been the leader in this
1992
Vol.43
No.
1
and
Community
Psychiatry
found, they offset only a small amount of the drop in benzodiazepine prescriptions. Moreover, use of alcoholic beverages in the state continued a long-term decline. There is no proof, however, that persons who once used benzodiazepines did not increase their alcohol intake. New York also has data indicating that emergency room admissions involving benzodiazepine overdoses fell from 2,637 in 1988 to 1,617 in 1989, with no increase in admissions associated with overdoses of other medications that could be substituted for benzodiazepines. The price of illegally distributed benzodiazepines soared during this period, as diversion from legal sources presumably became more difficult. One milligram of alprazolam cost $1 .50 on the street before the program began; nine months later the asking price was $8. The apparent success of the New York program has stimulated interest in similar programs in other states. Indeed, a bill before Congress in 1 990 would have required all states to establish “accountable prescription” programs for all controlled substances (12). Although that effort failed, similar proposals, perhaps substituting computerized reporting by pharmacies for the clumsy triplicate prescriptions, are likely to surface in the future. Not everyone, however, is pleased with triplicate prescription proposals. A group of New York doctors tried to block implementation of the state’s plan by filing suit in the courts. They and other physician groups, including the American Psychiatric Association, fear that negative effects of the program, not easily measured in state data, may outweigh its benefits. One of their prime concerns is the threat to patients’ confidentiality. Although the confidentiality of information reported about prescriptions is protected bylaw, the data are available to a wide variety of local, state, and federal investigators. Patients with a legitimate need for benzodiazepines may be reluctant to accept them, worried that their treatment will become known to state authorities or even to parties who
Hospital
and
Community
Psychiatry
obtain unauthorized access to the system. Given the stigma attached to psychiatric treatment in our society, such concerns are understandable. More subtle effects are also feared. Physicians may avoid prescribing benzodiazepines, evei-n when mdicated, to avoid appearing in state records. They may fear that unusual, albeit legitimate, patterns of benzodiazepine prescription might make them targets for investigation or disciplinary action. Patients may misunderstand the reasons for the triplicate prescription system and decline benzodiazepines because ofan unrealistic fear of their side effects or their potential for addiction. The New York State data do not reveal what percentage of the decrease in the use of benzodiazepines might be accounted for by physicians’ or patients’ turning away from them even though they represented the treatment of choice for patients’ conditions. Professional associations and pharmaceutical manufacturers urge states to rely on educational programs to improve physicians’ prescribing practices or to try to track the distribution of controlled mcdications by means other than regulating prescriptions. Several states have created such programs to help control the prescription ofhighly addictive Schedule II drugs (13). In light of the New York experience, however, alternatives to prescription-based monitoring will not have an easy time attracting support. Although epidemiologic data suggest that benzodiazepine abuse is not a widespread problem, the easy availability of these drugs on the street is common knowledge. Most practitioners are aware of physicians in their community who will write prescriptions for benzodiazepines on request, even without examining patients. The clear implication of the dramatic fall in prescribing of benzodiazepines in New York is that many of the prescriptions written previously were inappropriate. This conclusion is further supported by the drop in benzodiazepine prescribing for the population covered by Medicaid, a group for whom confidentiality is not likely to be a major issue.
January
1992
Vol.43
No.
1
Unless the educational efforts promoted by professional associations and non-prescription-based tracking systems can be shown to be equally effective, it is probable that triplicate prescription programs similar to New York’s, or computerized equivalents ofsuch programs, will soon be introduced more widely.
References 1.
2.
3. 4.
5.
6.
7.
8.
9.
10.
11.
12.
Benzodiazepine Dependence, Toxicity, and Abuse: A Task Force Report of the American Psychiatric Association. Washington, DC, American Psychiatric Association, 1990 Clinthorne JK, Cisin IH, Baiter MB, et a!: Changes in popular attitudes and beIiefs about tranquilizers. Archives of General Psychiatry 43:527-532, 1986 Sweet dreams or nightmares? Newsweek,Aug 19, l99l,pp44-5l Ray WA, Griffin MR, Downey W: Benzodiazepines oflong and short elimination ha1f-1if and the risk ofhip fracture. JAMA 262:3303-3307, 1989 WoodsJH,KatzJL,WingerG: Use and abuse ofbenzodiazepines: issues relevant to prescribing. JAMA 260:3476-3480, 1988 Mellinger GD, BaIter MB, Manheimer DI, et a!: Psychic distress, life crisis, and use of psychotherapeutic medications: national household surveydata. Archives of General Psychiatry 35:1045-1052, 1978 Ciraulo DA, Sarid-Segal 0: Benzodiazepines: abuseliability, in Benzodiazepines in Clinical Practice: Risks and Benefits. Edited by Roy-Byrne PP, Cowley DS. Washington, DC, American Psychiatric Press, 1991 New York State’s Regulation Placing Benzodiazepines on Triplicate Prescriptions: The First Year, 1989. Albany, New York State Department of Health, May25, 1990 Benzodiazepines: prescribing declines under triplicate program. Epidemiology Note 4 (12). Albany, New York State Department of Health, Dec 1989 Benzodiazepines: additional effrcts of the triplicate program. Epidemiology Note 5(1). Albany, New York State Department of Health, Jan 1990 State multiple prescription programs. State Health Legislation Report (American Medical Association) 16 (3):35-39, Aug 1988 Prescription Accountability Act of 1990, HR 5530, 101st Congress, 2nd
Session, 13.
Multiple Washington, u&cturers
1990
Copy
Prescription Programs. DC, Pharmaceutical ManAssociation, Jan 1990
13
effort, has generated some impressive data documenting the effects of the state’s new regulations (9,10). Since January 1, 1989, benzodiazepines have been included in New York’s 13-year-old program that regulates prescription of certain drugs. Previously applied only to Schedule II drugs, which include many opiates, cocaine, and amphetamines, the program requires orders for regulated drugs to be written on state-supplied, triplicate prescription forms. A copy of each prescription is kept by the physician and the dispensing pharmacist. The third copy is sent by the pharmacist to the state Department of Health. Data generated from the prescription copies can be used to identify physicians who prescribe
large amounts of benzodiazepines, pharmacies that dispense them iilegally, and patients who collect multiple prescriptions from different physicians. In addition, the new rules limit prescriptions for benzodiazepines to a maximum 30-day supply, but allow prescriptions for a 90-day supply for patients with a small number of specified conditions, including panic disorder, attention-deficit hyperactivity disorder, convulsive disorders, narcolepsy, and severe pain associated with incurable conditions in elderly patients. No automatic refills are allowed. A physician must examine the patient before an initial prescription is made, but prescription renewals do not require reexamination. Nine states have triplicate prescription programs for Schedule II drugs(1 1), but New York is the first state to add benzodiazepines to its program. Thus the results ofits effort have been awaited with great interest. Data from the first year in which benzodiazepines were regulated reveal striking effrcts (8-10). Six months after the program began, the number of prescriptions for benzodiazepines paid for by Medicaid had fallen from an average of 389,250 per quarter to 173,000 per quarter, a drop of5 5 percent. The number of prescriptions for a group of heavy users of prescription mcdications ingeneral-acategory of persons suspected of benzodiazepine diversion and abuse-fell9S percent. Smaller but stillsubstantial decreases were seen in data from insurance programs covering state employees and elderly persons, groups in which abuse was thought to be less likely and misuse was more of a concern. Overall, the state saved $18 million in prescription costs under Medicaid and other publicly funded programs in the first year that benzodiazepines were included in the triplicate prescription program. An obvious concern of observers of the triplicate prescription program is that other drugs with the potential of being abused might be substituted for benzodiazepines. Although small compensatory increases in use of other anxiolytics and hypnotics were
January
Hospital
Controlling Prescription of Benzodiazepines Paul
S. Appelbaum,
M.D.
Benzodiazepines-including diazepam and triazolam-are among the most frequently prescribed drugs in the United States. They play important roles in the treatment of anxiety, insomnia, panic disorder, and epilepsy (1). Recently, however, the therapeutic virtues of benzodiazepines have been overshadowed in both the lay and the professional media by concerns about adverse effects that may accompany their use, including physical dependence, functional impairment, and behavioral abnormalities (2-4). States are now beginning to respond to these concerns with new statutes aimed at controlling and monitoring the prescription of benzodiazepines. Whether special procedures are needed to prevent abuse and misuse of benzodiazepines is a matter of some controversy. Reviews of epidemiologic data suggest that few patients who are prescribed benzodiazepines for legitimate indications become abusers of the drugs (5). In household surveys, most persons who report benzodiazepine use appear to have taken the medications appropriately (6). Only a select portion of the population, who may have some propensity to abuse substances in
Dr. Appelbaum is A. F. Zeleznik professor of psychiatry and director of the law and psychiatry program at the University of Massachusetts Medical School. Address correspondence to him at the De-
partment sity of School,
Worcester,
12
of Psychiatry, Massachusetts 55 Lake Avenue Massachusetts
UniverMedical North, 01655.
general, appears susceptible to abuse ofbenzodiazepines (7). However, these findings have done little to calm the fears of many public health officials. They point to the frequent practice of prescribing the medications for long periods, often for years, although studies have not been performed to demonstrate efficacy beyond several weeks; the association between use of benzodiazepines by elderly people and injuries, particularly those caused by falls; the use of the drugs in higher doses than prescribed, which may be precipitated by their disinhibiting effects; and the impairment of driving skills that may be caused by the drugs (8). Related to these concerns is a beliefthat states could save large amounts ofmoney ifunnecessary and fraudulent prescriptions for benzodiazepines could be eliminated. As a result, new laws intended to restrict use of benzodiazepines are now being proposed. New York, which has been the leader in this
1992
Vol.43
No.
1
and
Community
Psychiatry
found, they offset only a small amount of the drop in benzodiazepine prescriptions. Moreover, use of alcoholic beverages in the state continued a long-term decline. There is no proof, however, that persons who once used benzodiazepines did not increase their alcohol intake. New York also has data indicating that emergency room admissions involving benzodiazepine overdoses fell from 2,637 in 1988 to 1,617 in 1989, with no increase in admissions associated with overdoses of other medications that could be substituted for benzodiazepines. The price of illegally distributed benzodiazepines soared during this period, as diversion from legal sources presumably became more difficult. One milligram of alprazolam cost $1 .50 on the street before the program began; nine months later the asking price was $8. The apparent success of the New York program has stimulated interest in similar programs in other states. Indeed, a bill before Congress in 1 990 would have required all states to establish “accountable prescription” programs for all controlled substances (12). Although that effort failed, similar proposals, perhaps substituting computerized reporting by pharmacies for the clumsy triplicate prescriptions, are likely to surface in the future. Not everyone, however, is pleased with triplicate prescription proposals. A group of New York doctors tried to block implementation of the state’s plan by filing suit in the courts. They and other physician groups, including the American Psychiatric Association, fear that negative effects of the program, not easily measured in state data, may outweigh its benefits. One of their prime concerns is the threat to patients’ confidentiality. Although the confidentiality of information reported about prescriptions is protected bylaw, the data are available to a wide variety of local, state, and federal investigators. Patients with a legitimate need for benzodiazepines may be reluctant to accept them, worried that their treatment will become known to state authorities or even to parties who
Hospital
and
Community
Psychiatry
obtain unauthorized access to the system. Given the stigma attached to psychiatric treatment in our society, such concerns are understandable. More subtle effects are also feared. Physicians may avoid prescribing benzodiazepines, evei-n when mdicated, to avoid appearing in state records. They may fear that unusual, albeit legitimate, patterns of benzodiazepine prescription might make them targets for investigation or disciplinary action. Patients may misunderstand the reasons for the triplicate prescription system and decline benzodiazepines because ofan unrealistic fear of their side effects or their potential for addiction. The New York State data do not reveal what percentage of the decrease in the use of benzodiazepines might be accounted for by physicians’ or patients’ turning away from them even though they represented the treatment of choice for patients’ conditions. Professional associations and pharmaceutical manufacturers urge states to rely on educational programs to improve physicians’ prescribing practices or to try to track the distribution of controlled mcdications by means other than regulating prescriptions. Several states have created such programs to help control the prescription ofhighly addictive Schedule II drugs (13). In light of the New York experience, however, alternatives to prescription-based monitoring will not have an easy time attracting support. Although epidemiologic data suggest that benzodiazepine abuse is not a widespread problem, the easy availability of these drugs on the street is common knowledge. Most practitioners are aware of physicians in their community who will write prescriptions for benzodiazepines on request, even without examining patients. The clear implication of the dramatic fall in prescribing of benzodiazepines in New York is that many of the prescriptions written previously were inappropriate. This conclusion is further supported by the drop in benzodiazepine prescribing for the population covered by Medicaid, a group for whom confidentiality is not likely to be a major issue.
January
1992
Vol.43
No.
1
Unless the educational efforts promoted by professional associations and non-prescription-based tracking systems can be shown to be equally effective, it is probable that triplicate prescription programs similar to New York’s, or computerized equivalents ofsuch programs, will soon be introduced more widely.
References 1.
2.
3. 4.
5.
6.
7.
8.
9.
10.
11.
12.
Benzodiazepine Dependence, Toxicity, and Abuse: A Task Force Report of the American Psychiatric Association. Washington, DC, American Psychiatric Association, 1990 Clinthorne JK, Cisin IH, Baiter MB, et a!: Changes in popular attitudes and beIiefs about tranquilizers. Archives of General Psychiatry 43:527-532, 1986 Sweet dreams or nightmares? Newsweek,Aug 19, l99l,pp44-5l Ray WA, Griffin MR, Downey W: Benzodiazepines oflong and short elimination ha1f-1if and the risk ofhip fracture. JAMA 262:3303-3307, 1989 WoodsJH,KatzJL,WingerG: Use and abuse ofbenzodiazepines: issues relevant to prescribing. JAMA 260:3476-3480, 1988 Mellinger GD, BaIter MB, Manheimer DI, et a!: Psychic distress, life crisis, and use of psychotherapeutic medications: national household surveydata. Archives of General Psychiatry 35:1045-1052, 1978 Ciraulo DA, Sarid-Segal 0: Benzodiazepines: abuseliability, in Benzodiazepines in Clinical Practice: Risks and Benefits. Edited by Roy-Byrne PP, Cowley DS. Washington, DC, American Psychiatric Press, 1991 New York State’s Regulation Placing Benzodiazepines on Triplicate Prescriptions: The First Year, 1989. Albany, New York State Department of Health, May25, 1990 Benzodiazepines: prescribing declines under triplicate program. Epidemiology Note 4 (12). Albany, New York State Department of Health, Dec 1989 Benzodiazepines: additional effrcts of the triplicate program. Epidemiology Note 5(1). Albany, New York State Department of Health, Jan 1990 State multiple prescription programs. State Health Legislation Report (American Medical Association) 16 (3):35-39, Aug 1988 Prescription Accountability Act of 1990, HR 5530, 101st Congress, 2nd
Session, 13.
Multiple Washington, u&cturers
1990
Copy
Prescription Programs. DC, Pharmaceutical ManAssociation, Jan 1990
13
