2009 – New Year, New President, New Packaging?
(Article courtesy Pharmaceutical & Medical Packaging News)
President-elect Barack Obama will expect manufacturers to take immediate action to protect the drug supply chain, or else face regulation. This prediction comes from two members of the Partnership for Safe Medicine’s board of directors, Marvin D. Shepherd, Ph.D., and Bryan A. Liang, M.D., Ph.D., J.D. Shepherd is president, Partnership for Safe Medicines, as well as director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas-Austin. Liang is vice president, Partnership for Safe Medicines. He is also executive director, Institute of Health Law Studies, California Western School of Law; and co-director, San Diego Center for Patient Safety at the University of California, San Diego School of Medicine. The Partnership for Safe Medicines is a coalition of more than 50 organizations and individuals dedicated to protecting consumers from counterfeit medicines.
“As president, Obama won’t have the patience that President Bush had waiting for industry,” explains Liang. “The onus will be on industry, and the message will be, ‘If you don’t do it, we will make you do it.’ ”
Shepherd believes that Obama will see to it that FDA mandates both serialization and authentication. “A layered approach will be favored, and companies will get to choose what technologies are employed. But the number of layers to be used may be dictated.”
Photo Above: New laws may prevent consumers from buying “fake” drugs. A layered approach (multiple anti-counterfeiting levels) protects the public and is an excellent loss prevention tool.
Efforts to increase supply-chain safety could go further than Obama and vice-president-elect Joe Biden had originally foreseen. On the Obama-Biden Web site, www.change.gov, the team suggests that “allowing the importation of safe medicines from other developed countries” is one way the United States can reduce healthcare costs. However, Obama is reevaluating his long-standing support of drug importation programs in light of tainted medicines and other goods made in other countries, according to the Partnership for Safe Medicines. “People may be backing away from reimportation after safety concerns arose from China,” says Liang. “Expect to see a greater regulatory role, similar to what Obama is supporting in the Food Safety Bill.”
Shepherd expects that unit-of-use packaging will be favored for safety reasons. The ideal scenario would be “a bottle or blister package from the manufacturer with 30- or 60-day supplies and security devices for the pharmacist and for the patient each to use. The security code could be linked somehow with the product’s expiration date. If pharmacists aren’t counting pills, they will have time to verify each package.”
Such changes demand collaboration among manufacturers and their packaging partners, distributors, and pharmacists, says Shepherd. “We need a coordinated, voluntary effort. Without it, the government will step in with dictates.”
