Feature Compounding Pharmacies

Meningitis outbreak shines light on compounding pharmacies

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e7432 (Published 05 November 2012) Cite this as: BMJ 2012;345:e7432
  1. Allen F Shaughnessy1
  1. 1Tufts University School of Medicine, Boston, Massachusetts, USA
  1. Correspondence to: Allen.Shaughnessy{at}Tufts.edu

Compounding pharmacies are back in a big way, reports Allen F Shaughnessy, but deaths from a meningitis outbreak have raised questions about the practice and the laws that control it

The practice of pharmacy is not flashy. Pharmacists behind the bulwarks in chain pharmacies or isolated in hospital basements quietly and efficiently hew to their motto: providing the right medicine to the right patient at the right time. No television dramas showcase a quirky pharmacist producing and delivering life saving medications.

Similarly, life is prosaic in the Boston suburb of Framingham, Massachusetts, best known in medical circles as the site of an epidemiologic study now spanning 65 years. Framingham is also home to the now shuttered New England Compounding Center (NECC), suspected of mass producing a tainted methylprednisolone injectable used to treat hundreds of patients for back and joint problems in physicians’ offices across the country. Both the town and the practice of compounding pharmacy have been thrust into the spotlight. As of this writing, there have been 28 deaths and 377 people made ill by a fungal infection that plagues plants more than people.1

The tragedy has focused attention on pharmacy practice and has brought up questions about the safety of pharmaceuticals, the distinction between compounded and manufactured medicines, and the regulations in place that protect the public.

What is a compounding pharmacy?

Pharmaceutical compounding is the preparation of a specific medicine, based on a physician’s prescription, for a specific patient. To make the prescription, the pharmacist starts with raw chemicals and develops a finished product that is dispensed to a patient. The process of compounding may be as simple as adding a dose of a medicine to an intravenous solution or as complex as decocting a tincture from the dried leaves of a plant.

Pharmaceutical compounding was the main function of …

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