In October 2012, over 600 people were sickened by a meningitis outbreak that ultimately killed 39. The epidemic spread across 28 states and was linked to a contaminated strand of methylprednisolone acetate, a steroid that is injected into the spine to treat back pain and inflammation. The contamination was traced back to the New England Compound Center (NECC) in Framingham, Mass.
On January 4, 2013, Massachusetts Governor Deval Patrick proposed new rules with the intent of preventing another such outbreak.
At the heart of this case were the practices of NECC, a compounding pharmacy, recently shut down by the Food and Drug Administration after an investigation uncovered extensive contamination and a long history of questionable practices.
So how did this lapse in regulation occur?
The Massachusetts proposals are specifically targeted at compounding pharmacies. These are facilities that mix their own drug preparations supposedly for individual patients with very specific needs. It could be very expensive for a drug manufacturer to create an entire line of a drug for very few people, and thus, compounding pharmacies have taken on the role of creating small-batch medications.
Sometimes compounding merely requires repackaging a drug in a smaller dosage or removing an item from the original product to which a patient may be allergic. In other cases, the compounder could distribute discontinued or generally unavailable products. Sometimes, these facilities combine medications in order to increase compliance.
These compounding pharmacies are not uncommon, though they are certainly not intended to operate as large-scale drug manufacturers. Compounding pharmacies exist in large pharmacy centers (such as NECC), in nearly all hospitals in the United States, an estimated 75 percent of small independent drugstores and in many drugstore chains. According to the International Academy of Compounding Pharmacists, between 1 and 3 percent of prescriptions dispensed in the U.S. are compounded.
Apparently, however, the NECC began to act more like a manufacturer, which explains how it was able to distribute more than 14,000 dosages of the back pain medication that did so much harm. State legislation covers pharmacies, while federal government rules apply to manufacturers. In the case of the NECC, it was operating under the name of a pharmacy while distributing, on a national level, large amounts of drugs mixed on site, as a manufacturer would.
Stopping a Future Outbreak
In the wake of the meningitis outbreak, the Commissioner of the FDA was called before the Senate Committee on Health, Education, Labor and Pensions to make a statement on the issue. The FDA spoke in support of the existence of compounding pharmacies, though stressed that there must be strict enforcement of the rules. Similarly, the FDA issued a policy paper entitled, "The Special Risks of Pharmacy Compounding," alerting consumers to be more proactive in asking questions of a pharmacist or doctor.
Gov. Patrick's proposed legislation would establish strict licensing requirements for compounding sterile drugs (which would have been covered in the NECC case) and to let the state assess fines against pharmacies that break the rules (as opposed to relying on national oversight to catch any violations).
However, as noted by Daniel Carpenter of Harvard University in the New York Times, all states must adopt these new rules or else compounding pharmacies will simply move from state-to-state to avoid stricter rules.
Goodnough, A. and Grady, D. (January 4, 2013). "Massachusetts plans stricter control of compounding pharmacies." The New York Times. Retrieved from http://www.nytimes.com/2013/01/05/us/massachusetts-plans-stricter-control-of-compounding-pharmacies.html?_r=0.
Hamburg, M. (November 15, 2012). "Pharmacy compounding: Implications of the 2012 meningitis outbreak." Statement before the Senate Committee on Health, Education, Labor and Pensions. Retrieved from http://www.fda.gov/NewsEvents/Testimony/ucm327667.htm.
International Academy of Compounding Pharmacists. (2012). "What is compounding?" International Academy of Compounding Pharmacists. Retrieved from http://www.iacprx.org/displaycommon.cfm?an=1&subarticlenbr=1.
U.S. Food and Drug Administration. (December 3, 2012). "The special risks of pharmacy compounding." FDA.gov. Retrieved from http://www.fda.gov/forconsumers/consumerupdates/ucm107836.htm.
Wilson, Jacque. (October 11, 2012). "Meningitis outbreak: What is a compounding pharmacy?" CNN.com. Retrieved from http://www.cnn.com/2012/10/11/health/compounding-pharmacies-explainer/index.html.