Compounding pharmacies. We trust that medications for our families and our pets are made with the highest regard for purity and safety. But, several recent high profile cases have unnerved many people and created a negative spotlight for compounding pharmacies. So, can you trust the medications your veterinarian orders for your pet? From the very first time our ancient ancestors mixed certain tree barks with water to create a pain-deadening tea, the art and science of pharmacology have flourished. Through great civilizations like Rome, into the Middle Ages and straight through to modern times, the pharmacist (or “chemist”) has been an integral part of patient care in both human and veterinary practices.
Most people do not realize there are two types of pharmacies. Compounding pharmacies are those that actually make, mix or “compound” therapeutic medications “in-house” as compared to those that simply count and dispense prepared medications. This concept is not new…in fact, for most of this profession’s history, pharmacists used their knowledge of chemicals and base ingredients to create the appropriate drug ordered by the doctor. It has only been within the last 50 years that pharmacists have moved from being compounders of medicines to dispensers of pre-made drugs.
But even the modernization and convenience of prepared pharmaceutical drugs did not remove the need for many special or out of production drugs to be made on site. Some patients have allergies to ingredients in the medications. Others, especially children and veterinary patients, require unique flavorings to help disguise bitter drugs and improve compliance. And, as the age old joke describes, giving a pill to a cat can be a hair-raising experience! In fact, compounding pharmacies account for approximately 30 million prescriptions a year across the United States. From bio-identical hormones for human patients to tuna-flavored antibiotics for pets, compounding is an important part of the medical community.
Many veterinarians rely on compounding pharmacies to formulate patient friendly medications. A very common example is the use of a transdermal gel to deliver the drug, Tapazole® to cats with hyperthyroidism. Cats with this disease have a propensity for vomiting and diarrhea, so allowing the drug to be absorbed through the skin instead of fighting with a pill, lessens stress on the cat and on the owner! Beyond flavoring and transforming the medicine into a new form, some pharmacies can actually combine two medications into one single injection. This is helpful for patients, like our dogs and cats, who might be difficult to handle for multiple injections during a hospital stay.
What compounding pharmacies can’t do is avoid the drug approval process for a new drug or create a product similar to one already on the market. Some people feel the pharmacy in Florida that accidently created the lethal injection for a team of polo horses broke the law by compounding a product not approved for use in the US. However, with a veterinarian’s prescription, this is perfectly legal. Critics of these businesses maintain that the FDA doesn’t properly regulate compounded products or that these pharmacists are over-stepping their authority.
Despite media stories to the contrary, compounding pharmacies don’t operate outside the law. Rod Shafer, Executive Vice President of the International Academy of Compounding Pharmacists (IACP), says that compounding pharmacies are regulated just like your neighborhood drug store. First, state boards of pharmacy inspect the businesses and even test random batches of compounded drugs for problems. Many of these pharmacies will send samples to independent labs for verification. In addition to the states, the FDA oversees and regulates this industry insuring that no one is circumventing normal drug approval channels or providing unsafe, cheaper drug alternatives to the public. “Also, the IACP has implemented a Pharmacy Compounding Accreditation Board (PCAB) so that patients can trust and feel comfortable with the high quality standards that are in place,” says Shafer. Since its inception in 2004, about 50 of the more than 3500 individual compounding pharmacies have met the standards and 110 more have applied for accreditation. The PCAB is a voluntary process and pharmacies are not required to join.
Millions of household pets, horses and other animals owe their better quality of life to these pharmacists continuing to uphold a long-standing tradition. If you are concerned about your pet’s medication or a reaction to a drug, please communicate this to your veterinarian.