REBECCA S BUSCHThe World Health Organization (WHO) estimates that 1% to 10% of drugs sold world-wide are counterfeit. I think we all assume those counterfeit drugs enter the market through unscrupulous individuals and organized crime. A very valid assumption, but not necessarily always the case. Even the pharmaceutical giants can make mistakes, as evidenced in these headlines.
Jury Rules Against Baxter In Contaminated Heparin Case
Counterfeit Drugs Are a Problem
What were the problems? Well, as this is a blog, not a lengthy expose, I will sum it up as a lack of compliance and regulation issues. In the GlaxoSmithKline case the company failed to enforce proper manufacturing standards. In the Baxter case a Chinese supplier supplied a raw ingredient that was almost identical to the active ingredient in Heparin resulting in an inferior product that allegedly has caused more than 80 people to die as a result of severe allergic reactions.
My point is not to wag my finger at pharmaceutical companies, but to ask the companies the following questions in regards to drug safety: 1) What measures do they have in place to ensure the integrity of the supply chain and prevent counterfeit drugs? This is especially relevant as nearly 80% of the ingredients used in the manufacturing of drugs are supplied by countries with less reliable regulatory processes than the United States. 2) Are the appropriate compliance measures in place for manufacturing and distribution, with strict adherence policies and consequences? 3) Are proper tracking measures in place, such as the use of pedigree papers in all sales and returns? 4) Is there an efficient consumer alert protocol in place for tainted drugs? 5) Is there an alert system in place to notify the FDA when problems are detected? And finally, 6) Is the consumer’s safety paramount above reputation and profit?
Ensuring Drug Safety
I will admit Baxter reacted responsibly by issuing numerous nationwide recalls for the contaminated Heparin. Furthermore, in response to the Heparin contamination issue, Baxter has posted on their website that they have ‘made significant changes to its supply chain, streamlining processes and introducing additional safeguards to reduce the risk of adulteration’. That said, as recently as January 2011 Baxter received a letter of warning, unrelated to Heparin, from the FDA reporting a “significant violation of current good manufacturing practice” in their Jayuya, Puerto Rico facility. It would appear compliance is an ongoing problem.
Fortunately, overall, the $825 billion pharmaceutical industry is taking drug safety seriously by investing millions of dollars in ensuring their products reach consumers safely. They get it. Their reputation, integrity and ability to continue to operate depend on it – as does our health.
Thanks for reading!
Healthcare Advocate
Rebecca Busch