REP. STARK's CONTROLLED DRUG TRACEABILITY DRAFT BILL RELEASED NOV. 26; INTRODUCTION EXPECTED IN LATE JANUARY WITH REP. BREWSTER AS COSPONSOR
Rep. Stark (D-Calif.) plans to introduce his controlled drug accountability bill "in late January 1992," he said in a Nov. 26 speech on the House floor. Stark has released a bill draft for comment. Stark's "Prescription Accountability and Patient Care Improvement Act," would provide for electronic, computer tracing of prescription drugs prescribed and dispensed under Schedules II- V of the Controlled Substances Act. Stark will introduce his bill jointly with Rep. Brewster (D-Okla.). Stark emphasized that he is "not planning on introducing multiple-copy prescription legislation. Period." Such legislation is opposed by professional groups as imposing a paperwork burden on physicians and pharmacists. The California Democrat noted that his draft bill is based on Oklahoma's electronic "OSTAR" program, which is supported by the state's medical and pharmacy associations, "various patient organizations and several large pharmaceutical manufacturers." The draft requires HHS to make $ 20 mil. available "to at least 10 states" with "problems with illegal diversion or illegal prescribing of controlled substances," evidence of "inappropriate prescribing patterns," a high "number of residents addicted to controlled substances" and "undertreatment" of appropriate conditions with controlled substances. States with multiple-copy prescription programs would use the funds to aid "transition to electronic data transfer systems." In his statement, Stark said the funding would be "raised by reasonable fees imposed on pharmaceutical drug manufacturers." Within a year after receiving funding, the draft continues, states would set up computer software and hardware for pharmacies to record for each prescription of a Schedule II-V drug the physician's and pharmacist's DEA (Drug Enforcement Administration) numbers, the prescriber's practice specialty, the prescription drug's National Drug Code number, date dispensed, quantity dispensed and a "unique identifier number determined by the state." The draft requires states to maintain a central repository that is "a data processing system" capable of providing the "prescriber name or registration number," dispenser name or number, patient name or identification number and type of Schedule II-V drug, "frequency, quantity and location of dispensation." The information is required to be kept secure "against access by unauthorized persons." Stark said the "information will be managed and administered by a board composed of five health agency officials, the director of the designated state health agency, and four appointees," two with "health care and prescribing backgrounds and two with investigative backgrounds." Each state board will provide information to the state's narcotics control agency "only in those cases" in which "there is reasonable cause for further inquiry into the illegal diversion of, or the illegal prescribing of, controlled substances," the draft states. The bill's provisions for confidentiality include prison penalties of up to 20 years and "automatic fines of $ 250,000 for individuals and $ 500,000 for corporations" involved in unauthorized disclosure of information. In addition, he said, the "state is required to purge patient data from the central repository no later than two years after data is made available to the board, unless it is part of an active investigation or effort to facilitate substance abuse counseling." Brewster, a pharmacist, recently met with representatives of several major national pharmacy associations and drug manufacturers to reach a consensus on basic elements of a prescription accountability bill that would be acceptable to all parties.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth