The rare fungal meningitis outbreak in 11 states tied to a
compounding pharmacy in Massachusetts is spurring
calls for tighter federal regulations for the 3,000 outfits in the US. We asked
Zintro experts to explain how the outbreak will affect this industry.
Patrick Stone, an expert in biotechnology regulatory
compliance, says that compound pharmacies nationwide have enjoyed the
protection of their
states’ pharmacy board or have not engaged in interstate
distribution. Stone explains: “This means that compound pharmacies do not
have to operate under good manufacturing
procedures to compound their drug products. The FDA routinely inspects compound
pharmacies for verification that compounded drug products are for a specific
patient prescription and not a bulk manufacturing process,” he says. “Many
times, FDA auditors find that the inspected compounding pharmacy is
manufacturing bulk drug products, sometimes even sterile drug products, without
sterility controls in place.”
The New England Compounding Center
in Framingham, Mass.has been tied to more than 20 deaths and over 300 patients
have been affected following injections of steroids that the company
manufactured. “Between May 21 and September 24, 2012, patients in up to 17 US
states have possibly received injections of products from this company. This is
going beyond compounding pharmacy practice and into national distribution of a
drug product,” Stone cautions. “The FDA should have regulated this company under
strict drug manufacturing laws with the systems approach method of inspection.
Congress is now going to have to decide whether or not to provide FDA with
proper regulatory oversight of this type of drug
manufacturing operation. Only time will tell if FDA has to keep its hands
tied or if public safety measures will be put in place to keep this type of
outbreak from happening again.”
Dana Hadfield, an expert in
pharmacy management, says that it is important look at the motivations of
the compounding pharmacy in question. “It’s possible that this situation was
started by a pharmaceutical
company that did not want to make products with little profit because they
are off patent,” says Hadfield. “We now experience many drug shortages because
of this type of behavior. Unfortunately, this was a perfect storm type of
situation. The drug in question has unique chemical attributes as a suspension,
to be given intrathecally (into the spinal cord with no preservatives), and a
terrible error occurred somewhere in processing.”
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