Safe Medicine: A Shared Responsibility

AS A SPECIALTY distributor of fragile biologics and transport-sensitive vaccines, FFF Enterprises has always taken a “safety first” approach when it comes to business best practices. Our commitment to channel integrity is at the core of everything we do, which is why the annual safety-themed issue of BioSupply Trends Quarterly is always one of my personal favorites.

In this issue, we take a look at some of the unique 21st-century challenges facing stakeholders in the healthcare arena. In our article “Safety in Medicine: Ensuring the Integrity of Drugs,” we investigate current global efforts to stem the growth of counterfeit and adulterated drugs. Although improved safeguards are in place, in recent years, we’ve seen an uptick in supply chain safety risks and compromises, including the sale of contaminated products, a proliferation of fake online pharmacies promoting gray market pricing and hard-to-find drugs, and widespread distribution of counterfeits. Without a doubt, as the threats posed by a globalized marketplace and the complexity of the supply chain continue to grow, more needs to be done to protect the public.

Of course, our pharmaceutical supply chain is not the only widespread public health threat. Our food supply chain is also at risk, as outlined in our article “Foodborne Illness: A Continuing Threat to Public Health.” The Centers for Disease Control and Prevention states that while serious foodborne illnesses are rarer than ever in the developed world, mild cases are still extremely common, and the potential for deadly consequences remains a very real concern. Statistics show one in six Americans (48 million) will contract a foodborne illness this year alone, with 128,000 of those cases requiring hospitalization and roughly 3,000 of them resulting in fatalities. Not surprisingly, outside the developed world, statistics are grimmer. Responsibility for preventing the spread of foodborne illness lies with many stakeholders, including ranchers, farmers, distributors, grocers, restaurateurs and the general public. The role of healthcare providers is also significant, since most foodborne illness outbreaks are now required to be reported to public health authorities.

Another hot topic making headlines is the debate surrounding biosimilar legislation. Should biosimilars be substituted for biopharmaceuticals? What are the best ways to legislate them? What guidelines should be used when naming these products? We explore the issues surrounding these and other questions in our article “Biosimilars: The Race for Approval.” Of particular note is the fact that the U.S. Food and Drug Administration recently published its first edition of the Purple Book. As biosimilars are approved (the first of which was approved in March), they will be added to the Purple Book so healthcare professionals can view them.

Also in this issue, we tackle some of the safety, medical, ethical and legal ramifications linked to the headline-making “right-to-try” initiatives. Lawmakers in at least 20 states either have introduced or have indicated they will introduce right-to-try legislation in 2015. The resulting debate is a heated one: Proponents argue that federal regulations that violate constitutional liberties can never trump state laws, while critics say right-to-try laws are far more likely to harm patients than help.

As always, we hope you enjoy this issue of BioSupply Trends Quarterly and find it both relevant and helpful to your practice. We welcome your comments.

Helping Healthcare Care,

Patrick M. Schmidt

Publisher