Concern over drug recall
TALLAHASSEE – When considering the complexities of the human body it’s not unreasonable to think that if each person’s body is different then their responses to the medicine they take should be too.
Yet it is often the case that medicines manufactured on an industrial scale, and often work safely and effectively, just won’t in all instances or immune systems. For high-quality, compound pharmacists that presents something of a niche: making products commercially available in forms and strengths they wouldn’t be, otherwise.
“Say your cat needs to be prescribed a pill because it has anxiety, and is urinating all over your house because you brought another cat in,” said Jennifer Bridges, head compound pharmacist at Sunshine Wellness Center in Brooksville. “Well, the vet wants to give that cat a pill, but cats are finicky and don’t like pills, so you can have that pill changed to a liquid or a cream, and apply it on its ear: the cat thinks it’s getting a massage, and the owner is happy, and the cat is happy.”
But industry trends like the kind seen over the last seven months have given some cause to worry, Bridges said. Clearly something went wrong Wednesday when Main Street Family Pharmacy, of Newbern, Tenn., which distributed potentially contaminated products linked to Florida cases involving adverse reactions to steroid injections, was mandated to sign a voluntary agreement with the Department of Health restricting its practice in the state.
Although the DOH calls that agreement “voluntary,” that mandate is enforceable by law, and should the company violate the terms and not cease compounding, dispensing, and shipping sterile medications to Florida residents, the pharmacy risks emergency suspension of its license to practice pharmacy in the state.
“My worry – and it’s a valid worry – is that some people are going to be worried about compounding because of the issues that are coming around now,” Bridges said. “I think compounding does have a place, and if ever you need a compounded product, my only advice is you do your homework, because just because it’s the cheapest doesn’t mean it’s the best.”
The compounded product, methylprednisolone acetate, or MPA, has not resulted in any known reported cases of meningitis or life-threatening infections, according to DOH, and all of Florida’s currently identified adverse reaction cases are associated with skin abscesses following intra-muscular injections of MPA. The pharmacy’s invoice records, which were obtained by the Food and Drug Administration and Centers for Disease Control and Prevention, show that the compounded MPA product was produced by an outside manufacturer, and an epidemiological investigation is under way.
“My understanding is you can bulk lots, or many different injectables at one time – that’s not anything we do here, and it’s definitely putting a mark on compounding pharmacies, and it’s a very bad mark that I don’t think is usual or customary for compounding pharmacies,” Bridges said. “Many compounding pharmacies don’t do sterile techniques because they’re not set up to do that, and if you are you have to make sure you have all the equipment and testing necessary, make sure every lot you have is sterile – whether that’s sending every lot out and ensuring it’s sterile, because they actually have companies that test to make sure there’s no bacteria.”
“If you mess those things up, very, very bad things happen because you’re injecting them.”
Whether or not any of the compounding pharmacies in and surrounding Hernando County have dispensed the contaminated injectables is not obvious. Although the DOH’s Central Pharmacy is a communications resource of the pharmaceutical system, and broadcasts product information for State Emergency Management and Public Health issues like pharmacy dispensing during emergency orders, that office said Wednesday it does not have access to data to confirm where, if at all, any such compounding pharmacies are located other than the three it is presently aware of.
The Tennessee pharmacy is the only entity that tracks where products go, not the Florida Department of Health, they said.
“Currently DOH is aware of three Florida facilities that were in receipt of MPA products from the Main Street Family Pharmacy, none of which are in Hernando County,” said Public Information Specialist Erica Chicola. “These facilities are Family Health Care of Chipley in Washington County, and Dr. Parvesh Bansal and the Back Center of Melbourne in Brevard County. This is an ongoing epidemiological investigation and DOH will continue to provide updates as needed.”
Joe Grillo, of Nicolazzo & Associates Inc., a strategic communications crisis management firm for Main Street Pharmacy, said the company is not releasing where contaminated drugs may have been dispensed.
“Since this matter surfaced, Main Street Family Pharmacy has done everything in its power to ensure that all potentially affected compounded medicines are recalled and no longer used by consumers or health care providers,” reads a statement provided by Main Street Family Pharmacy. “In addition to the recall, our efforts have also included comprehensive, aggressive outreach to everyone who could be affected. We continue to fully cooperate with state boards of pharmacies, the FDA and (Center for Disease Control and Prevention) to protect patients and resolve any lingering concerns.”
Pill shortages have brought customers to compounding pharmacies, Bridges said, but the fact that compounding pharmacies are marketing a lower price for medications that, by trade, should be more expensive, should also raise a red flag to patients about the quality of that medication.
“I do believe that shortages are an issue, and if people need their medicine they’ll do anything to get it,” Bridges said. “If cost is a factor, not knowing that all compounding pharmacies aren’t the same, patients may think it’s like going to Walgreens and viewing a difference in price between two manufactured products, but it’s not the same as two different prices from a compounded pharmacy: you’re dealing with two completely different products there.”
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