The October 2012 cases of meningitis caused by contaminated doses of a steroid compounded drug, highlight challenges for consumers regarding medications they’re prescribed.
In May of 2007, “FDA Consumer Health Information” produced an article entitled “The Special Risks of Pharmacy Compounding,” (http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107839.pdf).
That article advised consumers to ask questions in order to obtain information about medications prescribed to them, ask the doctor if there was an FDA approved drug that could be used instead of the compounded drug, and ask the pharmacist if they have experience compounding the drug. Today’s articles relating the story of meningitis in several states linked to a compounded steroid drug add another question you might ask which is whether the compounded drug is manufactured by bigger pharmaceutical companies or only smaller compounded drug companies.
Naturally, the “ask questions” advice doesn’t work if you’re unable to speak or you’re unaware of the drugs you’re being given. Hospitals also frequently use compounded drugs.
For consumer purposes, the question becomes, “Who knew?”
Compounded drugs have benign purposes such as including custom blends of drugs that omit ingredients that might create negative reactions in certain patients, or providing different forms of medication for those with trouble swallowing pills.
But in 2007 the FDA determined, “The emergence…of firms with pharmacy licenses making and distributing unapproved new drugs in a way that’s clearly outside the bounds of traditional pharmacy is of great concern to FDA,” (Special Risks of Pharmacy Compounding, FDA Consumer Health Information, May 31, 2007).
Compounded drugs are frequently cheaper, supporting their use and eligibility for coverage under prescription plans, including those for Medicare Part D. Compounded drugs produced by compounding pharmaceutical companies (rather than larger drug manufacturers) may be even cheaper which means that they’re not going away.
In 2003 only one percent of all prescriptions in the US were compounded drugs, according to the FDA. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm204237.htm. Today, the number of compounded drug prescriptions is said to be at about two to three percent based on statistics from the International Academy of Compounding Pharmacists.
While the FDA will likely be targeted for criticism, its own information describes the challenges with overseeing the customized compounded drugs. The FDA does not approve the drugs because of this complexity. It’s also important that the FDA only becomes involved in drug recalls after there are a certain number of horrific consequences that are reported.
However, it seems as if consumers should be entitled to the information in advance of receiving such a prescription or such a drug. That is not currently the case.
