Brian Bandell
Senior Reporter- South Florida Business JournalEmail | LinkedIn | Twitter Consumers often assume drugs are manufactured with the utmost care before injecting them into their veins or dropping them into their eyes, but Florida pharmacy inspectors have found that’s not always the case.
Since October 2012, 11 South Florida pharmacies have had their licenses revoked, relinquished or permanently suspended as compounders by the state Board of Pharmacy because of violations that directly impacted product safety. The violations come at a time when
hospitals and other health care providers are increasingly turning to pharmacies to compound sterile drugs because of a nationwide drug shortage, which is the subject of a recent
Business Journal’s feature story.
A survey released in January by the Florida Board of Pharmacy found that 946 pharmacies licensed by the state, or 12 percent, perform compounding of sterile products, such as injectables, eye drops and inhalants. Of those, 301 are located outside Florida but are licensed to ship drugs into the state. The survey found 57 Florida-based pharmacies that ship compounded sterile drugs to other states. While most of the sterile compounders made the drugs only for specific patient prescription orders, 348 admitted to producing the drugs in bulk.
The
Food and Drug Administration regulates drug manufacturers but not compounding pharmacies, who make generic versions of the same products. Compounding intravenous drugs has been the subject of national controversy since 2012 when pain shots made at the New England Compounding Center in Massachusetts caused at least 751 meningitis infections, leading to deaths in 20 states, including three in Florida, according to the
U.S. Centers for Disease Control. Florida regulators revoked NECC's license.
The Board of Pharmacy’s actions haven’t been limited to out-of-state pharmacies. Here are some snapshots from the 11 South Florida pharmacies that regulators cracked down on:
Pharmacy Care, Wilton Manors, emergency suspension:
- Sterile drugs weren’t tested for microbiological contamination.
- Drugs were given beyond-use-dates of six months to a year without the required sterility testing to confirm their safety.
- Failed to have a buffer room, where sterile compounding can take place with lower risk of contamination.
- Compounding workers wore street shoes in the drug making area and left dirty shoe prints.
- Didn’t have an ante room, where workers clean themselves before transitioning between dirty and clean areas.
- Poor record keeping and tracking the source of raw materials that were used in drugs, which would make responding to a material recall extremely difficult.
Mednx Rx Pharmacy, Deerfield Beach, emergency suspension:
- Produced and dispensed oxycondone, a controlled substance painkiller, with pharmacy manager working only one day a week and continued doing so after the pharmacy manager resigned.
- Left doors open despite strict security requirements for working with controlled substances.
- Previously placed on probation for improper dispensing of oxydocone.
NW Pharmacy, Miami, emergency suspension:
- Medications were mixed in the same room construction was taking place.
- The sterility of its production of injectable drugs and eye drops was in doubt as staff repeatedly exposed them to non-sterile surfaces, even bare hands.
- Failing to test injectable medication for harmful bacteria.
- Labeling medication with “beyond-use-dates” that were too long.
People’s Choice Pharmacy, Tamarac, relinquished license:
- No compounding documentation for human chorionic gonadotropin (HCG), which treats infertility in women and for men increases sperm count and enhances athletic performance.
- One patient name was not listed.
- Testosterone and HCG were given one year beyond their use dates without sterility testing to ensure their quality.
- Questionable prescriptions for large quantities of oxycodone were filled without obtaining a customer's driver's license.
- Some prescription orders weren’t signed by physicians.
- Sterile compounding rooms failed certification.
- Refrigerator had no thermometer and massive ice buildup.
- No hair covers for workers.
- Unlicensed personnel performed pharmacy duties.
- Failed to test for airborne or surface contaminants.
SCI Medical Supply, Miami, license revoked:
- Animal feces on the work counters.
Yun Phrma Inc., Miami, relinquished license
- Facilities not clean and safe.
- Operating without pharmacy manager for more than a year.
- Unauthorized personnel in prescription area removed drugs that had labels from other pharmacies.
AJ Cargo Express, Miami, relinquished license:
- Medication from pharmacy found in owner’s office with no expiration date or lot number.
- No anti-fraud policy for controlled medications.
- Didn’t keep a daily log of transactions.
Rejuvi Pharmaceuticals, Boca Raton, license suspended and permanently barred from sterile compounding:
- Unclean conditions such as powder residue all over room.
- Dirty water left in sink.
- Dead bugs and rodent fecal matter in prescription department.
- Shipped medications with wrong expiration dates.
- Compounding without pharmacist on site.
Izz and Sons, Miami, relinquished license:
- Acted as a wholesaler by shipping drugs without a prescription, which isn’t allowed under its community pharmacy license.
SDU, aka DBA Veterinarians Prescription., Boca Raton, relinquished license:
- Failed to sterilize eye drop medications compounded for canines.
- Listed unreasonable beyond-use dates on drugs.
- No buffer or ante rooms to separate clean areas from dirty areas.
- Poor record keeping, such as not listing ingredients and quantities.
Las Mercedes Drug Store, Miami, relinquished license:
- Faulty documentation, where the quantity of drugs received didn’t match the quantity of drugs delivered to patients.
Most pharmacies in Florida perform non-sterile drug compounding, which has fewer safety requirements because the products are less vulnerable to contamination.
The Florida Department of Health pharmacy investigators started receiving training to supervise sterile compounding in March 2013. The Florida Board of Pharmacy has given pharmacies until March 1 to obtain a special permit for compounding for the first time and recent inspections are focused on ensuring the sterility of those medications and proper documentation, Executive Director
Mark Whitten said.
Boca Raton family practitioner Dr.
Kenneth Woliner said he’s received mailers from several compounding pharmacies with state discipline records offering to split fees with him if he refers them prescriptions, which is illegal. He developed a list of 10 quality pharmacies that he sends his patients to.
“There are rouge pharmacies that haven’t been shut down because enforcement is so bad,” Wiliner said. “It’s really hard to know if someone prepared a prescription that’s potent or not.”
To search for enforcement actions against Florida health care providers and pharmacies,
go here.
Brian Bandell covers banking, finance, health care and education. Get the latest banking industry news here.
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