U.S. Meningitis Outbreak: Role of Compounding Pharmacies

U.S. health officials are currently battling a deadly form of meningitis. So far, more than three hundred people have been infected by the fungus and twenty three have died.  All the victims received contaminated steroids. The outbreak has been linked to contaminated bottles of medicinal steroids made by a specialty pharmacy in New England. The steroids were injected into thousands of patients. And there are concerns that some of the product may have ended up in Canada.  The outbreak raises serious questions about the safety of drugs manufactured by compounding pharmacies.

Here's what we know about the time line so far. On September 21st of this year, the Tennessee Department of Health notified the US Centers for Disease Control that a patient developed meningitis approximately nineteen days after receiving an injection into the epidural space in the back of a steroid called methylprednisolone. This occurred at a clinic in Tennessee.  The injection is a treatment for slipped discs and chronic back pain. The steroid came from specialty pharmacy called the New England Compounding Center. 

Four days later, the New England Compounding Center recalled three lots of the very same kind of steroid used on the Tennessee patient.  Three days after that, investigators identified a second case of meningitis outside the state of Tennessee, which alerted authorities that the problem of possible contaminated medication was on a much wider scale. Since then, the infection has been confirmed  in at least fifteen states.  In addition to meningitis, several patients suffered strokes believed to be due to the infection.  All told, as many as fourteen thousand people received potentially tainted steroids across two-dozen or so U.S. states.

On October 1st, the US Food and Drug Administration or FDA began inspecting the New England Compounding Center's facility.  That's when investigators identified particulate matter in an unopened vial of steroid. Two days later, the pharmacy voluntarily shut down operations and expanded its recall of steroids.  And the next day the FDA began testing samples from the pharmacy. On October 10th, NBC News- quoting the Centers for Disease Control - reported that two types of fungal infections had been identified:  Aspergillus and Exserohilum rostratum.  Last week, federal agents from the FDA raided the offices of the New England Compounding Center.  Since then, there have been calls for the US Justice Department to launch a criminal investigation unrelated to the steroid issue to determine whether the pharmacy violated federal laws designed to stem illegal activity in narcotic or controlled substances. 

As reported in the Boston Globe, earlier today, Massachusetts state officials said they found unclean conditions including dark specks of fungus in steroids. They added that a preliminary investigation found drugs had been shipped before tests results on their sterility had come back. Officials have charged that New England Compounding Pharmacy operated as a drug manufacturer by producing products for broad use as opposed to filling individual orders, which state officials say is all the Center's pharmacy permitted.  Massachusetts Gov. Deval Patrick said the state has moved to revoke the license of the New England Compounding Center and three pharmacists.

Pharmaceutical compounding means creating a customized pharmaceutical drug for a specific patient. That might mean combining two or more drugs that aren't usually put together, turning a pill into a drink to it can be more easily swallowed, and removing ingredients to which the patient is allergic.  Before mass production, compounding was common; today, far less so.  The meningitis story is hardly the first of its kind.

Last week, a blog on the NBC News web site noted that since 2004, the FDA has issued 49 warning letters to compounding pharmacies.  Since 1990, there have been twenty or so recalls, serious illnesses and deaths linked to faulty compounding practices across the U.S.  NBC News says during the past twenty years, the FDA has logged at least two hundred adverse events at seventy-one compounding pharmacies.  And last week, the US-based Institute for Safe Medicine Practices compiled a large list of instances of contaminated drugs that affected the health of thousands of patients. 

Though unlikely, it's not one hundred percent certain Canada will be spared any cases. I have been advised that there is apparently some question that injectable steroid made by the New England Compounding Center may have been imported into Canada.  As well, it is not entirely clear that Health Canada would necessarily stop a shipment from crossing the border into Canada.  In other words, it could have been imported into Canada and administered here.  That's why front line health care workers here are being asked to look for possible cases of meningitis in patients who may have received injections of the steroid methylprednisolone after May 21st, 2012.  The steroid may have been injected into the back or into a joint such as the knee.

There have been calls that compounding pharmacies in the US and here submit to the same scrutiny as any drug maker.  Those making the call say compounded products need to meet standards for quality and safety as mass-produced pharmaceuticals.  They feel that compounding pharmacists need to disclose what products they are making and to report illnesses and deaths suspected of being caused by their products. 

These standards exist in documents like the USP797 guidelines from U.S. Pharmaceopeial Convention, a non-profit organization that recommends standards for drug safety.  The big thing compounding pharmacies need to do is compound their products under strict sterile technique so that drugs don't get contaminated as happened in this case.  I don't want to see compounding pharmacies disappear, but this is really serious.  The lawsuits have already begun in the U.S. and by the time they've played out, New England Compounding Center and compound pharmacies may be historical footnotes.

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