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Executive Summary

Legislation introduced by Rep. Stark (D-Calif.) to require prescription forms that will create a paper trail to prescribers of controlled substances will reduce unnecessary prescribing and adverse effects of controlled substances, Health Research Group Director Sidney Wolfe, MD, contended Sept. 14. In written testimony prepared for Rep. Waxman's (D-Calif.) House Health Subcommittee hearing on Medicaid budget initiatives, Wolfe maintained that Stark's legislation would extend nationwide the benefits of reduced prescribing seen under New York State's triplicate prescription requirements, enacted in 1988. The number of benzodiazepine Rxs filled under New York's Medicaid program decreased 59.3% from 1.6 mil. prescriptions in 1988 to 630,000 in 1989, Wolfe asserted, adding that, as a result, the state program saved $11.2 mil. in 1989 just on prescriptions for benzodiazepines. * A package of three bills (HR 5529-5531) was introduced by Rep. Stark earlier this year to ensure that prescriptions for controlled substances can be traced to prescribers. Waxman placed the legislation on the hearing agenda for consideration as an approach for reducing Medicaid expenditures by eliminating unnecessary prescriptions ("The Pink Sheet" Sept. 10, p. 5). Multiple prescription laws are currently in effect in nine states: New York, California, Texas, Indiana, Hawaii, Michigan, Illinois, Rhode Island and Idaho. Prescriptions for Schedule II drugs decreased by 56% in Rhode Island and by 69% in Texas in the years since those states enacted similar laws. The Drug Enforcement Agency, which supports the Stark legislation, states that such laws generally reduce the number of prescription drugs for controlled drugs by 50%. The Pharmaceutical Manufacturers Association and the American Medical Association oppose the legislation. In a position paper, PMA contended that Stark's legislation is "unsound and unneeded." Programs to eliminate "diversion and abuse of prescription drugs must have the parallel goal of not obstructing their legitimate medical use," the paper states. "The Stark legislation is not narrowly drawn to target episodes of misuse, abuse or diversion; the medications are the target." Furthermore, PMA maintained, the proposal duplicates existing tracking systems," such as DEA's ARCOS system, AMA's PADS system, Medicaid's MMIS system and the Drug Abuse Warning Network. The "increased administrative costs" incurred by the Stark legislation are not accounted for in "estimates of alleged cost savings." AMA board member Lonnie Bristow, MD, maintained that multiple prescription programs "are expensive" and can cost more than $1 per prescription. They also create paperwork that "can easily result in backlogs of data," Bristow testified. For example, California estimated in 1985 "that at most 50% of the data received on prescription forms were actually entered into the system." Bristow acknowledged that such programs can lead to reductions in the prescribing of controlled substances, probably because they "intimidate prescribers." However, he maintained, evidence of decreased prescribing of controlled drugs is "not accompanied by a reduction in abuse." * A coalition of patient groups issued a statement in opposition to the Stark bills on Sept. 13, claiming the legislation would have a "chilling effect" on prescribing of controlled drugs. "The measure is intended to supplement the war on drugs and reduce Medicaid fraud, but members of the healthcare community believe it is misguided and would hamper the treatment of cancer pain, narcolepsy, anxiety disorders, epilepsy and other serious medical conditions," the statement said. Led by the Wisconsin Cancer Pain Initiative, the coalition includes the American Narcolepsy Association, the New York Alliance for Patient Welfare and the Epilepsy Institute. The Wisconsin Cancer Pain Initiative is a voluntary organization of health care professionals. It was established in the mid-1980s as a World Health Organization demonstration project. WCPI wrote to Stark Aug. 30 detailing its opposition to the bill.



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