FL Got Drugs Linked to New Outbreak

May 24, 2013

Florida is one of 13 states that received drugs from a compounding pharmacy linked to a new outbreak of illness, health officials said late Friday afternoon.  At least three facilities in Florida -- two in Melbourne and one in Chipley -- received the suspect drugs, Florida Department of Health said Friday evening.

The steroids in question are the same type that caused an outbreak last year that hurt 720 people and killed 48 -- including five in this state.

Federal health officials are asking all facilities that received steroids injection drugs from Main Street Family Pharmacy  in Newbern, Tenn., to quarantine those products immediately and contact patients who may have received them.

An Associated Press report, citing information from the Food and Drug Administration, says there have been seven adverse reactions so far, five in Illinois and two in North Carolina.

The first word of a potential problem from the Florida DOH arrived in e-mail just before 5 p.m. Friday. The agency said it is working with health care facilities that received products from the Tennessee company.

About 90 minutes later, DOH identified three recipients of the suspect drugs from Main Street Family Pharmacy as: Family Health Care of Chipley, The B.A.C.K. Center of Melbourne and Dr. Parvesh Bansal, also in Melbourne.

"DOH has notified each of these facilities and is currently working with them to notify patients who may  have been exposed," the agency said in its release.

Tennessee health officials said that Main Street has been cooperative, recalling all of its sterile products.  Those are liquids that are injected or infused into a sterile space, such as the blood stream, spine, joint or eye.

The timing of the alert could hardly be worse. It went out after many people had already left for a three-day holiday weekend.

Last year's outbreak, caused by contaminated steroid injections from the now-defunct New England Compounding Center in Massachusetts, triggered severe cases of fungal meningitis, as well strokes and other problems.

The patients in both outbreaks received injections of methylprednisolone acetate, according to the FDA. The drug is called MPA for short.

Five of the patients in the new outbreak,  who got the shots at a primary care clinic in Herrin, Ill.,  developed skin infections on the hips and buttocks, CDC reported.  At least one of two patients in North Carolina appears to have a fungal infection.

As Health News Florida reported in December, about half of Florida's 9,000 licensed pharmacies engage in compounding to some extent, and 950 of those are in the high-risk category because they make drugs that must be produced in ultra-clean facilities and  kept sterile.

One-third of the high-risk compounders licensed in Florida are based in other states, shipping their products to hospitals and clinics.

Compounding pharmacies tailor-make drugs for particular patients who can't take brand-name manufactured drugs, and must do so under  a doctor's prescription. However, as the Florida Board of Pharmacy has reported, many compounding pharmacies have become de facto manufacturers, producing drugs in bulk outside the regulatory reach of the FDA.

States are responsible for regulating pharmacies, but it has been difficult for them to ride  herd on compounders, particularly those that are based in other states.

--Health News Florida, www.HealthNewsFlorida.org, is published by WUSF Public Media. Editor Carol Gentry can be reached at 813-974-8629 (desk) or 727-410-3266 (cell) or by e-mail, cgentry@wusf.org.