Health plans that limit drug converge may encourage consumers to obtain medicines illegally, according to pharmacy experts. Marv Shepherd, director of the Center for Pharmacoeconomic Studies at the University of Texas College of Pharmacy and others noted at the Partnership for Safe Medicines Interchange in October in Washington that an increase in narrow health plan formularies that carry only one or two drugs per class or category will boost purchases of substandard, counterfeit and diverted prescription medicines through illicit operators. Patients accustomed to treatment with a certain drug may seek out other sources of supply if a streamlined plan fails to provide coverage for that medicine, explained Bryan Liang, anesthesiologist and law professor at the University of California San Diego.
Reimbursement is a main factor in encouraging booth prescribers and patients to seek less costly medicines through websites that appear legitimate but often are not. The spread of counterfeit versions of the oncology drug Avastin two years ago was prompted by a change in Medicare Part B reimbursement for drugs that made oncologists eager to obtain less costly medicines. The demand for lower-priced drugs also prompted Maine to enact a law legalizing the import of drugs from Canada and other English-speaking countries. Backers of the law “brainwashed everyone” into believing that medicines ordered online would actually come from legitimate operators in those countries, explained Maine pharmacist Amelia Arnold at the Safe Medicines Interchange. But rogue websites go to great lengths to appear legitimate, observed Gg Levine of the National Association of Boards of Pharmacy.
To counter these trends, the Department of Justice is bringing felony charges and winning jail sentences for operators importing misbranded drugs. FDA’s Office of Criminal Investigations is working with counterparts in some 20 countries to provide a better understanding of the dangers of these drugs. Similarly, the Center for Drug Evaluation and Research (CDER) is collaborating with international organizations to combat the spread of substandard and falsified medical products, noted Ilisa Bernstein, deputy director of CDER’s Office of Compliance. FDA aims to improve surveillance to better detect counterfeit products, expand laboratory capacity and detection tools, and support a “rapid response” effort to remove fraudulent products from the market.