After last years fungal meningitis outbreak that killed close to 60 people, 9 of who were Tennesseans, and injured hundreds more, the Food and Drug Administration (FDA) is cracking down on “compounding pharmacies” though a crash inspection program.
Compounding pharmacies are businesses managed by drug manufacturers, and this classification currently exempts them from many of the safety regulations, inspections, and oversight that private pharmacies must undergo.
The recent meningitis scare originated from a New England compounding center and has sparked federal action when it comes to monitoring these drug suppliers. But FDA officials are running into obstacles because of the exemptions that compounding pharmacies have.
“It may surprise some people to know that, even in light of the recent tragic events, some of the firms we inspect still challenge our authority to conduct full inspections of their facilities,” wrote FDA commissioner, Dr. Margaret A. Hamburg, in a blog this past April.
The tension between the FDA and compounding pharmacies has continued to grow as federal agents investigate steroid injection distribution around the country. And it’s a good thing they did.
Upon recent inspection of a Tennessee specialty pharmacy, federal officials discovered fungus and bacteria growth in two unopened vials of the steroid injection methylprednisolone acetate, a steroid used to treat inflammation, joint pain, and respiratory issues—the same steroid involved in last year’s deadly meningitis outbreak.
The guilty business, Main Street Family Pharmacy, is in the town of Newbern, and began being investigated in May after several patients reported skin abscesses after injecting the steroid.
In a statement to TIME: Health & Family, a spokesman for the pharmacy, Joe Grillo, said: “We continue to fully cooperate with state boards of health and pharmacies, the FDA and CDC to protect patients and resolve any lingering concerns.”
Prior investigations found various problems with the pharmacy, and the business was put on a three-year probation back in March. Reported issues included: 109 out-of-date or deteriorated medications on the shelves, an uncertified technician, unsafe drug manufacturing procedures, and other problems.
“The complex nature of supply chains makes the task of ensuring the safety and quality of the medicines remarkably challenging,” remarks Dr. Hamburg. “Moreover, as the Internet introduces more players into distribution channels, there are more opportunities for criminals to make money by producing or selling counterfeit and other substandard products.”
Our advice to Tennesseans in need of prescription drugs, but concerned about unsafe pharmaceutical practices, is to ask your doctor if the drug is compounded. If it is, then inquire about an FDA-approved alternative. If there is no alternative, ask where the drug was manufactured and check the FDA website for any safety alerts and warnings. And never purchase prescription drugs from a non-certified online pharmacy.
And of course, if you or a loved one experience suffering from a contaminated or expired drug, don’t hesitate to schedule a free consultation with our medical malpractice attorneys at Gilreath & Associates.