Spotlight on Safety

IN OUR LAST edition of BioSupply Trends Quarterly, I reflected on the obsession with safety that our plasma manufacturing partners consistently convey. As a specialty distributor of these same fragile proteins, our “safety first” approach and unwavering commitment to channel integrity could also be characterized as obsessive. Yet, when dealing with blood products, manufacturing and supply chain vulnerabilities are matched only by those of the patients who are in need of the life-saving and livegiving benefits that only a blood transfusion or blood plasma product can provide. As so eloquently expressed in our feature, Good Blood, the merging of someone else’s life blood with your own is truly an act of faith, yet for those patients on the receiving end, there is rarely the luxury of choice. The real or perceived risks are generally trumped by the acute or chronic need.

You may recall the documentary that was released in the fall of 2010 titled Bad Blood, which recounted the circumstances that led to HIV contamination in the nation’s blood supply. Our article Good Blood revisits this dark period of history for the industry with what we hope you will find to be an unbiased, accurate review of the many factors — from diminished blood supplies and understaffed health agencies to the ignorance and fear that surrounded HIV and AIDS — that combined to create the perfect viral storm. True to the old adage that every cloud has a silver lining, the AIDS epidemic served as a catalyst for industry improvement and reform. That today, according to the U.S. Centers for Disease Control and Prevention, the U.S. blood supply is considered the safest in the world is an achievement born of a “liberal dose of literal blood, sweat and tears.”

Risk versus benefit is not an uncommon dilemma with regards to safety. Our article titled Risk Evaluation and Mitigation Strategies (REMS) gives an update on the FDA’s new strategy to ensure that the safety of certain drugs outweighs their risks, with a focus on the abuse of prescription medications. When evaluating the risk profile of a drug, the potential for abuse, misuse, overdose, addiction or teratogenicity (ability to cause birth defects) poses unique considerations requiring REMS.

Ultimately, we hope that those in positions of authority who influence our industry have patients’ best interests at heart. So our Industry Insight column titled A Fake and a Fraud that exposes a prominent clinical expert in fluid resuscitation therapy whose self-interest eclipsed his integrity is disheartening at best. And, in keeping with our theme of safety, our Myths and Facts: Skin Cancer feature is meant to help people understand the risks of sun exposure and how they can best protect themselves from this often-deadly disease.

We are keeping a close watch on healthcare reform, with two in-depth articles: New Transparency Reporting Guidelines Affecting Physicians and ACOs: Reducing Costs While Improving Care.

We hope you find this issue of BioSupply Trends Quarterly relevant and helpful as we all endeavor to serve patients in need of these essential biopharmaceutical products.

Helping Healthcare Care,

Patrick M. Schmidt

Publisher