With about 7,700 pharmacies in Florida, it remains a mystery as to how they compound drugs, even to state officials who should be monitoring them.
Last week, Florida regulators issued an emergency order requiring those pharmacies to complete a survey about exactly how they compound drugs and how much material is being produced.
The urgency follows the Massachusetts compounding pharmacy mistake that sickened 500 and killed 33 due to fungal meningitis.
Compounding is a practice that involves mixing raw ingredients to make medications, usually by a special order for a patient who cannot take a commercially available brand or to fill the shortfall of a drug.
Previously, the Florida Department of Health (DOH) issued a voluntary survey for pharmacists to complete, but Ocala.com reports 90 percent of pharmacists ignored it and did not provide any information on their compounding practices. Of the 2,078 pharmacies the state inspected, the DOH reports about 18 percent were compounding drugs.
With little oversight from the U.S. Food and Drug Administration (FDA), compounding pharmacies around the country have fallen under the radar of state scrutiny in most cases, even as they have taken on a larger role of supplying drugs that are in short supply and shipping them throughout the country.
Earlier this month in an emergency move, the Florida DOH suspended the license of Rejuvi Pharmaceuticals, a Boca Raton compounding pharmacy.
The DOH called the facility an, “immediate, serious danger” to the public and called conditions uncovered during a routine DOH inspection, “deplorable.”
Another compounding pharmacy in Ocala, Franck’s Pharmacy, announced in May it would stop producing sterile compounds after two incidents – in one, 3 cases of fungal eye infections were tracked to two ophthalmic products made by the Ocala pharmacy. Several bacterial and fungal contaminants were identified by the Centers for Disease Control and Prevention (CDC).
Back in 2009, Franck’s was the same pharmacy that erroneously mixed a veterinary nutritional supplement with more selenium that needed. Twenty-one polo horses died. The pharmacy remains opened making non-sterile and veterinary compounds.
The New England Compounding Center (NECC) a Massachusetts-based compounding pharmacy shipped lots of contaminated methylprednisolone acetate which has left 33 dead including three in Florida according to the CDC.
There are 24 cases of Floridians who have been sickened with fungal meningitis by the contaminated injections given for back pain. Most of the contaminated injectables were sent to Marion County and three medical facilities.
The mandatory Florida DOH survey is considered a first step to learn more about the industry.
Pharmacy board members tell the paper that it is likely that Florida pharmacists who compound medications will have to meet accreditation standards in the future. Currently, a licensed pharmacist in Florida does not have to have any accreditation to compound medications.