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October 11, 2012

Contaminated Steroid Injections Spotlight Role of Custom Drug Firms

by Vidushi Sinha

U.S health officials are still investigating an outbreak of a rare fungal meningitis that so far has killed at least 14 people and sickened more than 170 over the past two weeks. Investigators suspect the outbreak was caused by a batch of contaminated steroid injections given to more than 13000 people across the country to relieve chronic back or joint pain.  The shots, produced by a small Massachusetts drug company known as a "compounding pharmacy" have all been recalled, and the firm's operations halted.  But the outbreak has focused renewed attention on the expanding role of such pharmacies in the U.S. and other countries, and prompted calls for stricter regulation. 

Public health officials in the United States have moved quickly to contain the current outbreak.  Dr. John Lanza, a health officer in Florida, has been working to contact every patient known to have received a fungus-tainted steroid injection - since they are still at risk of contracting the infection.

“Fungal meningitis is a very severe situation, that's why we are making the extra efforts to try and find these people and warn them," said Lanza.

Besides alarming health officials, the outbreak has also highlighted gaps in the regulation of so-called "compounding pharmacies." These small businesses re-mix, customize and package prescription drug ingredients for specific clients. David Miller is executive Vice President of the International Academy of Compounding Pharmacists.

“You may be allergic to part of the ingredients from the manufacturer.  If you are an older patient and if you don’t have the liver and kidney function you had when you were younger you may not metabolize drugs the same way. So we have to take stronger medicines and reduce their strength," said Miller.

The remix might also be used to make a child's medication more palatable.  Miller, who is a pharmacist by training, says there are many ways in which dangerous contaminants can accidently be introduced while customizing a drug.

“Whenever you are doing sterile medicine it can be the person, it can be the environment and it can be the equipment that introduces a contaminant. For example if I did not wash my hands well enough, if I have skin exposure, if I have my hair exposed in other words am I bringing bacteria or contaminant in, the environment is very specific, the air is filtered, its decontaminated," he said.

It is not yet known how the the steroids produced at the Massachusetts pharmacy became contaminated with fungus.  But state regulatory authorities question whether the company might have taken on too large a role as a national drug supplier.  And many public health experts say federal regulators should oversee this and other compounding pharmacies.

Dr. Patrick Lukulay is with The United States Pharmacopeia, a scientific group that sets standards for medicines in the U.S.  He believes pharmacies around the world should be more strictly regulated.
 
I think the best approach is protecting the market in every country where the regulatory authorities in those markets have ultimate responsibilities - either in the field or in laboratories," said Lukulay.

In the United States, as in other countries, compounding pharmacies often step in to fill gaps in critical drug supplies, such as vaccines, and they are widely seen as an integral part of the pharmaceutical industry.  All the more reason - many health experts say - for them to be more strictly regulated.