A contaminated steroid medication was recalled on October 2012. By the end of the year, the medication was linked to a breakout of fungal meningitis that infected 372 people and killed 39. A terrible tragedy in itself, this incident leads to at least two broader consumer concerns regarding pharmaceuticals: where do drugs come from and who is responsible for ensuring their safety?
Drug Manufacturing Versus Drug Compounding
Drug making is broken down by law into two categories. The first is manufacturing, which encompasses drugs that are made in large quantities by pharmaceutical companies and are designed for mass consumption.
The second category is called compounding. Compounding is the process that involves altering in some fashion a manufactured drug for an explicit reason. It’s performed by licensed pharmacists when tailoring a prescription drug to the specific needs of a patient. Compounding normally is requested and directed by the prescribing physician, for a variety of reasons. For example, a patient might be allergic to a dye used in a manufactured drug and the pharmacist is instructed by the physician to remove the dye.
Compounding is not uncommon. Before pharmaceutical companies began making drugs in mass quantities – during the 1950s – this is the way all medications were manufactured. Pharmacists actually made the drugs for each prescription.
And while the compounding of drugs remained focused on individual needs and usage, there wasn’t any concern over the practice. However, some compounded drugs today are targeted to a much larger audience and produced on a much larger scale, thereby increasing the dangers.
Compounded Drugs Use for Large Numbers of Patients
The contaminated injectable steroid medication that led to the deaths of 39 people is one such example. The drug – produced by one single compounding center – was used by individuals in 19 states and 650 people in total were harmed by the drug. As of yet, no explanation has been found for why there was such a widespread distribution.
Even more worrisome is the fast-growing segment of compounded drugs called “bio-identicals,” which are anti-aging products. The makers of bio-identicals claim they are a “natural” solution that is safer than federally approved hormone-replacement medicines. But the Food and Drug Administration (FDA), disputes many of these claims.
Despite the FDA’s objections, these products are mass produced and shipped across the country to buyers, such as hospitals and clinics. The companies argue that they are not drug manufacturers and therefore are not subject to federal regulation. So far, they have prevailed in legal challenges.
Drug Regulatory Responsibilities May Now Overlap and Cause Problems
Which leads to the second consumer concern over drugs – who is responsible for ensuring their safety? The FDA is responsible for testing and approving manufactured drugs from pharmaceutical companies; those designed for mass consumption. State pharmaceutical boards, however, are responsible for oversight of drug compounding.
With drug compounding now targeting a much wider audience, the process for guaranteeing the safety of many medicines may fall through bureaucratic cracks. The lines between federal and state responsibilities are being blurred.
And, last fall, we saw that the consequences can be deadly.