Danger Ahead: The Growing Safety Challenges

“THREAT,” “CRISIS,” “RISK” — these are some of the alarming adjectives used in our features for this safety-themed issue. With the number of counterfeit drug investigations having grown almost tenfold in the last five years, the number of prescription drug shortages nearly tripling from 2005 to 2010, and with recent indications that this threat is increasing rather than diminishing, keeping patients safe has never been more challenging.

The drug shortage crisis, referred to as a “tsunami of medical risk” in our feature article, has risen to an alarming level. While the causes of this crisis vary from manufacturing issues to economic factors, the impact is far-reaching.

Patients with curable conditions are at risk of not surviving due to difficult-to-access lifesaving medications, and many hospitals are forced to buy medicines from the socalled “gray market” where price-gouging is commonly practiced — sometimes up to 4,500 percent of the standard cost of drugs. The gray market also leaves patients and their healthcare providers vulnerable to compromised or counterfeit product because drugs are purchased outside authorized channels.

Counterfeit can mean many things from “fake,” to “substandard” or “gray,” but the deliberate misrepresentation of the safety and efficacy of a pharmaceutical product has a direct and potentially life-threatening consequence for patients, not to underscore the impact on public confidence. Though the FDA estimates that less than 1 percent of drugs on the U.S. market are counterfeit, that still amounts to as many as 40 million illicit products!

Our feature Counterfeit Drugs: A Growing Threat helps to define what counterfeit drugs are, the health risk they present, how they can infiltrate the supply chain and what is being done to stymie trafficking. It is truly alarming how sophisticated counterfeiters have become and how difficult it is to detect a fake.I would encourage all of our readers to become familiar with The Partnership for Safe Medicines (www.SafeMedicines.org) and to sign up for the organization’s weekly emails. This site has many resources for healthcare professionals, specifically for physicians, pharmacists and nurses.

Safety is certainly a broad topic, but the focus from all stakeholders on the key areas where they have influence will collectively reduce risk for those who are the most vulnerable. From my perspective as an authorized biopharmaceutical distributor, this threat has always been present, and my top priority has been making the channel secure — a “patients first” philosophy. Now celebrating 24 counterfeit-free years, FFF has put in place systems and services that validate our Guaranteed Channel Integrity, defined by our commitment to purchase only from manufacturers and ship only to healthcare providers. This commitment is evidenced by safety innovations such as our Verified Electronic Pedigree system to validate our safe channel — an industry first — and our Lot-Track service that provides accurate product lot tracking and recall notification within four hours to those affected.

Healthcare practitioners can have an impact on the counterfeit issue by simply refusing to purchase products outside of an authorized distribution channel, even in times of shortage, and by verifying the pedigree of products when they are received.

We hope you enjoy this issue of BioSupply Trends Quarterly, and as always, we welcome your feedback to help us bring the greatest value to you and your practice.

Helping Healthcare Care,

Patrick M. Schmidt

Publisher