As adulterated medications continue to pose a threat to the American health care system, the Partnership for Safe Medicines sponsored a Congressional hearing, last week, delving into the issues associated with unsafe and counterfeit pharmaceuticals. Using last year’s counterfeit Avastin scandal as an illustrative case study, the Partnership, with the support of Senator Michael Bennet, emphasized the need to safeguard the American drug supply and recommended the following two initiatives targeting both the pharmaceutical industry and bureaucratic regulators.
First, industry representatives are advocating the use of track and trace technologies that follow prescription medications throughout their life cycle – from sourcing, manufacturing, distribution and sale. While the idea has been endorsed, the technological development needed to effectively track prescription medications has been functionally blocked by the industry wide practice of tagging by lot rather than unit. Tracking individually, or by unit, follows the prescription through the distribution channels until it is received by a patient. Tracking drugs by lot, as some states have done, only allows regulators to track the product to a non-specific point such as distributor due to the wide range of units in a lot. Currently, there is no industry standard on how many units a lot contains, resulting in lots carrying anywhere between 1,000 to 100,000 individual doses. Tracking an individual drug by unit would be more effective in tracing products in case of misplacement, theft or diversions and would open doors to targeted drug recalls rather than mass recalls. Recent technologies, such as electronic labeling and smart phones, act as a great base for launching the initiative as they are both cost effective and practical steps in following drug flow.
Second, there needs to be uniformity across the industry, in both drug regulation and track and trace technology. As states slowly begin to adopt or change policies, the lack of uniform drug regulation or interoperability across the country causes confusion for the pharmaceutical industry. Several regulations would establish unlevel playing fields not just regionally, but also within the industry itself. To protect public health, federal regulations must establish universal safety standards at every stage of prescription manufacturing -from sourcing raw materials to tracking the sale of the final product. Without having the ability to follow medications across the entire supply pathway, serious concerns over the safety of the American pharmaceuticals go unaddressed. Having these standards will help in authenticating products through an ePedigree system which verifies the prior history of a drug at every transaction.
While the hearing recommended positive policy changes, the concerns of critics must be addressed in order for serious strides in tracing prescriptions to take place. Patient information security concerns usually rank as the most problematic when implementing monitoring programs. Between 2009 and 2010, over six million electronic health records were accessed without proper authorization, resulting in numerous security breaches for companies or groups using electronic databasesi. Without any assurances that Health Insurance Portability and Accountability Act (HIPPA) regulations on patient medical information will be upheld, moving to electronic monitoring programs would be difficult and equally irresponsible. Additionally, though the ePedigree system of verification before sale looks great on paper, the policy lacks the ability to regulate prescription repackaging. Often times prescription medicines are removed from their original containers and repackaged into new ones, opening up opportunities for active drug diversion or misplacement. This process eventually leaves an enormous technical loophole that is difficult to close with current policies.
Everyday Americans consume medications they assume to be safe when they may actually be harmful. Previous cases such as the Avastin scandal reminds policy makers of the serious and unseen risks associated with drugs that should be saving lives. The pharmaceutical industry, along with policy makers, must collaborate in order to protect the public from ineffective, adulterated and potentially poisonous medicine.