Florida drugstores resist drug paper trail system
exemption from legislation requiring a strict paper-based pedigree
for drugs throughout the supply chain, on the grounds that it is
too expensive to comply.
Walgreen and CVS, with the backing of the Florida Retail Federation, say that the cost of maintaining the exhaustive paper trail demanded by the Prescription Drug Safety Act of 2003, which is due to come into full effect in July 2006, is prohibitive and no longer necessary now that regulators are keeping closer tabs on wholesalers, according to local news reports. The law was passed in the wake of a number of reports of counterfeit drugs reaching the market.
The act requires a detailed accounting of prescription medication, in the form of drug pedigree papers, from manufacturer to pharmacy, guaranteeing its authenticity and safety. It also requires prospective wholesalers to provide detailed information, including criminal background checks, to the state. Stiffer penalties for those who knowingly sold fake medication are also part of the new law.
The drugstores say that initial expectations that technologies such as radiofrequency identification (RFID) would make compliance easier have proved unfounded, because the cost of the technology has not fallen as far as hoped.
The Act has already resulted in a one-third reduction in the number of pharmaceutical wholesalers in Florida to 966 from over 1,400, according to a report in the Tampa-based St Petersburg Times newspaper.
The retailers are receiving short shrift from Florida's Attorney General Charlie Crist and officials at the state's drug control office, who believe it is essential to have the system in place at the retail level. Pharmacies are another entry point for fake drugs, they claim.
Currently 31 of the most-often counterfeited drugs sold in Florida are tracked all the way from manufacturer to pharmacy. The law requires that all drugs be tracked starting July 1, 2006.
