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NEW YORK's BENZODIAZEPINE TRIPLICATE Rx REGS ACCUSED OF OBSTRUCTING LEGITIMATE PRESCRIBING AT NIDA MEETING; WHITE HOUSE IS DEVELOPING POSITION ON SUCH SYSTEMS

Executive Summary

New York State's benzodiazepine triplicate prescription requirement has resulted in a reduction in "legitimate prescribing" without affecting street use, Carl Salzman, MD, director of psychopharmacology at the Massachusetts Mental Health Center, maintained in a presentation at a May 30-June 1 National Institute of Drug Abuse conference on drug diversion control systems. "The new [New York State] regulations are clearly having an impact on benzodiazepine prescribing, and at least the data we have so far would suggest that it is a bad impact," Salzman asserted. "What is actually happening," he suggested, "is that legitimate prescribing is decreasing and being replaced by more toxic drugs, and that the regulations have not in fact affected the street use." NIDA sponsored the conference as part of its assessment of the impact of policies aimed at prescription drug diversion control, undertaken at the request of the White House Office of Drug Control Policy. While the conference's scope was broad, much of the actual discussion focused on triplicate prescription programs, particularly for benzodiazepines. Salzman was one of several practitioners participating in the NIDA conference who criticized the New York law for obstructing legitimate benzodiazepine prescribing. David Greenblatt, MD, professor of psychiatry at Tufts-New England Medical Center, declared that the "consequence of unilaterally imposed, invasive regulation of benzodiazepine prescriptions, as has happened in New York State, has the clear and unequivocal effect..... of depriving the availability of the drug to those who need it." The concept of prescription drug diversion control systems like the New York state model, which is the first to go after benzodiazepines, is getting increased attention due to interest in such programs from the Drug Enforcement Agency and Congress. House Ways & Means/Health Subcommittee Chairman Stark (D-Calif.) is developing a federal legislative proposal to require electronic tracing of prescriptions for controlled substances. Last year, Stark introduced a bill that would have required triplicate prescriptions nationwide for controlled drugs. Stark characterized that legislation as a bill that would help "millions" of elderly and poor people "unnecessarily addicted" to controlled substances and that could save the federal government "more than $ 1 bil." Commenting on presentations on New York's experience, White House Office of National Drug Control Policy Deputy Director for Demand Reduction Herbert Kleber, MD, noted that "clearly costs to the state went down; when you take in all the [benzodiazepine] substitutes, drug costs still went down, but not as great perhaps as the state was estimating." He observed that use of "alternative medications clearly went up, [but] the consequences of that are still unclear." Kleber said the Administration plans to develop its position on programs such as multiple copy prescriptions in the next "month or so." Both HHS and the Justice Department have been asked to prepare "position papers" within the next month. New York Division of Public Health Protection Director John Eadie told the conference that apparent trends of savings and decreased prescribing of benzodiazepines seen in the state's Medicaid program are also reflected in the Empire Blue Cross/Blue Shield program and the state's Elderly Pharmaceutical Insurance Coverage program, which aids low-income elderly. A recent Department of Health memo concluded that the benzodiazepine triplicate reg saved New York Medicaid a net $ 25 mil. in 1990, even accounting for a partial substitution of other anxiolytic and hypnotic drugs ("The Pink Sheet" June 3, T&G-6). In the aggregate statewide, for every decrease of 100 benzodiazepine prescriptions in 1989 compared to 1988 levels, there was an increase of only 20 scripts for other anxiolytic/hypnotic products such as buspirone, chloral hydrate and meprobamate, Eadie reported. For 1990 versus 1988, there was an increase of only 10 anxiolytic/hypnotic drugs per decline of 100 benzodiazepine prescriptions. In the Empire program, "even in 1989, there were only 11 new prescriptions for all of those drugs together compared to 100 decreasing benzodiazepine prescriptions," Eadie said. In the EPIC program, Eadie reported, the number of enrollees receiving a benzodiazepine prescription during a quarter of the year followed a "gradual decline" from 21% in the second quarter of 1988 to 11.7% in the fourth quarter of 1990. He suggested that this trend likely reflects "physicians exercising caution, intelligently reducing prescribing in some of these patients and gradually withdrawing [benzodiazepine therapy]. Secondly, we think that it indicates an improvement in practices as it relates to the treatment of the elderly." Eadie asserted that "certainly, the 21% [benzodiazepine use] finding in an ambulatory population..... was very much of considerable concern." Eadie reported that there has been an "even sharper drop off" in the number of benzodiazepine prescriptions per EPIC patient using that category of product, from 5.2 scripts per patient in 1988 to 2.5 in 1990. In addition, the doses per prescription has decreased. These findings may be "consistent" with "appropriate intermittent prescribing" of benzodiazepines. The issue of intermittent prescribing gained the attention of conference participants following a presentation that as many as one-quarter of patients treated with benzodiazepines take the drugs on an uninterrupted basis for more than a year. Eadie informed the conference that New York officials are tracking 18,000 EPIC enrollees who received benzodiazepine prescriptions in 1988. Their prescription patterns will be followed through 1990, and a subset will then be analyzed more in- depth. Michael Weintraub, MD, associate professor of the University of Rochester's Department of Community and Preventive Medicine, presented data showing that the number of hip fractures in New York state declined in 1989, due possibly to reduced use of benzodiazepines. Weintraub noted that hospital admissions of individuals over age 55 due to hip fracture increased to 11,859 in 1988, but dropped to 11,408 in 1989. He presented the data as the "first cut" of research under way by him and Rochester colleagues on a possible link between hip fractures and decreased use of benzodiazapine drugs. Weintraub acknowledged that the data does not yet show a clear-cut improvement in health care outcomes from the triplicate prescription rule. Weintraub's message to the conference was that overall, "there's no doubt" that "some of the process goals of the program have been met -- there's been quite a marked decrease in benzodiazapine prescribing, there have been some financial savings." But he urged policymakers to "realize that we have a lot of unanswered questions, particularly about the health and clinical outcomes" of the triplicate rule. University of New Mexico Department of Psychiatry Professor Eberhard Uhlenhuth, MD, commented that New York's benzodiazepine rule was, if not the reason for the conference, responsible for much of the "heat" surrounding it. Uhlenhuth remarked that there were "assertions but no systematic information presented" at the conference about the impact of multiple copy programs, and further suggested a need to clarify whether the programs' goals are to prevent diversion and fraud or reduce undesirable medical use. Brandeis University Bigel Institute for Health Policy Deputy Director Jeffrey Prottas, PhD, similarly noted that while 10 or so states have multiple copy programs for Schedule II controlled substances, only New York has expanded its program to include benzodiazepines, but benzodiazepines have tended to "overwhelm" discussions of multiple copy issues. The Bigel Institute was asked by NIDA to assess the published and unpublished research literature on multiple copy programs. Prottas concluded that most of the studies currently available "have many weaknesses." These include little attention to separating the programs' impact from other trends, "little or no systematic effort" to examine the "social calculus" of trade-offs between decreased diversion and restraints on prescribing; adapting data gathered for other purposes for use in analyzing multiple copy programs, and focus so far on only preliminary assessments of the programs' operational performance.
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