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.”