At any pharmacy you visit, you generally assume that the medications you are being given are safe – they have been measured out correctly, were already approved by the FDA, and are now going to help aid you in whatever illness you are currently dealing with.
At a Florida pharmacy, Franck’s Pharmacy in Ocala, this was unfortunately not the case. At the very core of Florida’s horse country sits the pharmacy that made an error of monumental proportions. A compounding lab that prepares medication for both human and veterinary patients, had received an order from one of the veterinarians of the polo ponies of the Venezuelan polo team, Lechuza Caracas. The order placed was apparently for an off-brand of Biodyl, a vitamin mixture that has not been approved in the United States by the FDA.
After mixing the drugs with too much of one of the ingredients, the 21 horses who were later administered the supplement died. Even though a toxicology test was sent out and the COO of Franck’s Pharmacy admitted to one of their staff incorrectly mixing the prescription, it does not change the fact that 21 polo horses tragically passed away from completely preventable circumstances.
Why Are Unapproved Drugs Illegal and What Are the Steps for Approving a Drug?
Though the polo team’s veterinarian should not have sent in this order in the first place considering its lack of FDA approval, the pharmacy’s mistake was in accepting the order in the first place and compounding it for the horses. According to federal laws, replicating unapproved drugs in the United States is illegal because they have either not been properly vetted to ensure their safety or they have been reviewed but were deemed potentially harmful.
If a person or animal is administered a drug that has not gone through the proper channels to be approved by the FDA, there are many risks that can pose a threat to their health. Without FDA approval:
- The ingredients, all active and inactive, have not been tested for safety and effectiveness. They have also not been tested to determine how all the ingredients interact when they are together in one formula.
- The prescription, ingredient, and other labels on the packaging have not been approved, edited, or reviewed by the FDA to determine whether they are complete and/or accurate.
- The process for manufacturing the drug is unknown, making it unclear how exactly the final product is created.
- Safety surveillance and thorough documentation during the manufacturing, packaging, and selling processes have not been performed, creating a giant question mark in regards to the safety concerns of how the drug comes to exist.
- The drug has not been researched/studied enough in order to collect sufficient evidence that it is effective in its intended use.
It is important to note that even though the FDA has approved a drug for safety, it does not mean that there may not be any significant side effects. FDA approval simply means that they have gone through the above steps to check that the drug is safely produced, is effective, and that the pros outweigh the cons.
It is imperative that you consult your physician before starting a prescription to make sure you are a good candidate and that the drug does not pose any health risks to you on the basis of your medical history.
For a free legal consultation , call (813) 259 0022
Negative Health Effects of a Pharmacy’s Errors
The poisoning incident with the polo horses was enough to land Franck’s Pharmacy in hot water, with them recently being slapped with a $2.5M verdict in the trial that ended in 2016. However, in addition to their veterinary failure, they also found themselves as the target of anger when 33 customers reported issues with their eyes after taking medication from the Ocala pharmacy. Though it has never officially been called an “investigation,” the FDA did trace back to Franck’s and conclude that the infections were due to a fungus.
The rare fungal infection only affected people who had recently undergone surgical procedures or injections for their eyes, and of the many who dealt with the aftermath of the Ocala pharmacy’s mistake, some experienced vision loss, and others required an additional operation to repair the damage.
The infections were due to a fungus that somehow got into the drugs as well as a dye that the CDC found to be defective. After Franck’s Pharmacy continued to compound and produce, warnings to avoid purchasing anything from the business were issued to the public by the CDC. The FDA even went as far as to try to prevent the pharmacy from ever compounding drugs again, but Franck’s sadly won their U.S. District Court Case and retained their right. Franck has made claims since in order to maintain their customer base, including that they are now taking additional safety precautions and have even hired new pharmacists to ensure accuracy in drug compounding and catch mistakes early, but the damage has already been done.
Call a Tampa Medical Malpractice Attorney for Help with Medication Mistakes
What do doctors, veterinarians, and pharmacists all have in common? They are experts in their field and professionals that the general public should be able to trust wholeheartedly. Unfortunately, this is not always the case, and sometimes your diagnosis or treatment plan may go awry. If you or a loved one have been negatively affected by a medication that was compounded incorrectly or mixed with ingredients not approved by the FDA, contact one of our Tampa-based medical malpractice lawyers today.
Call or text (813) 259 0022 or complete a Free Case Evaluation form