Monday, October 15, 2012

What Pet Owners Should Know About the Compounding Pharmacy Problem


The questions on dogs and cats blog author has done a great job of putting together some information on compounding for pet owners.  This information can be found at 
http://questionsondogsandcats.blogspot.com/2012/10/pet-prescriptions-and-pharmacies.html

Ann Hohenhaus, a practicing veterinary internal medicine specialist offers these tips for helping you understand:
The Compounding Pharmacy Problem: What Pet
Owners Should Know
By Ann Hohenhaus, DVM, DACVIM
A rare form of human meningitis has recently been in the news. The outbreak, believed to stem from fungal contamination of a medication compounded to treat back pain, has resulted in several fatalities. The manufacturer of the implicated medication is not a big pharma or an overseas company; the medication was produced by a compounding pharmacy in Massachusetts. The Food and Drug administration has identified fungal organisms in a sealed vial of methylprednisone acetate produced by the compounding pharmacy.
Pets not affected
This outbreak is unusual since the fungi involved, aspergillus and exserohilum, live in soil and water. Exactly how they came to contaminate the medication is under intense investigation. Since veterinarians don’t treat back pain in dogs and cats with steroids like methlyprednisone acetate injected around the spinal cord, there are no reports of fungal meningitis in pets, but veterinarians do use compounded medications, and understanding their role in managing disease in your pet is important.
Compounding defined
Compounding is the alteration of the original drug dosage form for the purposes of ease of administration or because the original dosage form is unsuitable for the purpose intended. Translated for the pet owner, compounding is flavoring a medication to hide the bad taste, dissolving pills into a liquid to facilitate administration, or putting multiple medications into one capsule to help a pet owner comply with a multidrug treatment protocol. Without a good compounding pharmacy, my job would be impossible.
Compounding dangers
Compounding is not regulated by the FDA because it is a process initiated by prescription and on a case-by-case basis. In veterinary medicine, compounding rules have been stretched in an attempt to create cheaper medications. Some compounding pharmacies offer expensive medications at unbelievably low prices. I suspect these cheaper products are being produced by what is known as bulk compounding from raw materials. Just last week, I had to advise a pet owner against using the compounding pharmacy’s cheaper “house” brand of an expensive medication. That medication is not currently available as a less expensive generic. Although I am sympathetic to the financial burden of treating a pet with cancer, my overriding concern is for the patient and the efficacy and safety of the prescribed treatments. Prescribing an approved medication provides some assurance of efficacy and safety for my patients.
Medication safety
Listen to your veterinarian. If they believe a particular medication is better, ask why. If they are concerned about the safety and efficacy of a compounded medication, I recommend trying to make the standard formulation work for your pet.
Learn more about safely medicating your pet here:
Pet Medications: 6 Tips to Keep Pets Safe (a summary)
All of us want to give the best and safest medications to our pets. Here are my tips to make sure your pet gets the medications he needs.
1. Approved is easy
Some of the work of selecting safe medications for your pet has already been done for you. The United States Food and Drug Administration (FDA) approves medications for use in pets by a similar process used for human drugs. Animal vaccines receive approval from the United States Department of Agriculture and treatments to prevent ectoparasites, also known as flea and tick preventatives, by the Environmental Protection Agency. Approved medications help you ensure you are administering drugs that have met standards for both safety and efficacy.
2. Don’t play veterinarian and give your own medications to your pet.
Certain human medications can be lethal to pets. For example, acetaminophen (a common brand is Tylenol) in cats, ibuprofen (a common brand is Advil) in dogs. The leading phone call to animal poison control experts is about accidental or owner administered human medications.
3. Human pharmacies
Like nearly all veterinarians, I too prescribe human medications for my patients. I do this for convenience when the pet owner is far from The Animal Medical Center (in NYC) or because there is not a veterinary-approved version of the drug. Human medications are most often a solution for dogs over 40 or 50 pounds, since tablet and pill sizes are too big for cats and little dogs. So if it is Saturday night and your veterinarian tells you to come to the clinic to pick up medication, it is because nothing but a doggie drug or kitty capsule will do.

4. Legal drugs

The law requires all veterinarians to prescribe medications only in the context of a valid veterinarian-client-patient relationship. Translated from the legalese, the statement means I have to examine your pet in order to prescribe a medication. This is all about safety –Fluffy’s safety. Although you are sure she has the same skin condition as last year, I need to be sure you are correct in order to prescribe the medication with the best chance of fixing the problem with the least risk of an adverse reaction.
5. Custom compounding
Veterinarians rely on compounding pharmacies to convert pills and tablets into chicken-flavored liquids, to place multiple medications into a single capsule to simplify medicating the pet with bear trap-like jaws, or to scale down a large tablet for a tiny terrier. Regulations govern compounding like they do for any prescription. Prescriptions for compounded medications can only be written on a case-by-case basis and must be made specifically for an individual pet. Compounded medications may mean the difference between therapeutic success and failure, but because compounded products are not regulated, products may be of variable quality as demonstrated in a recent scientific study of compounded trilostane. Using a pharmacy certified by the Pharmacy Compounding Accreditation Board assures you of a compounding pharmacy that adheres to established principles, policies and standards.

6. Internet pharmacies
The challenge in using an internet pharmacy is finding the right one. Although the prices offered by electronic drug stores are attractive, high-quality service may be lacking. Red flags in online reviews include companies who fill email boxes with spam, distribute counterfeit products, or never ship product at all. I spoke with the CEO of PetCare Rx, Jonathan Shapiro, about how his company ensures the quality of medications they ship. “PetCare Rx purchases product directly from the manufacturer or veterinary purchasing groups to protect our customers from counterfeit products. Consumers should look for an internet pharmacy accredited by the Veterinary Verified Internet Pharmacy Practice Sites (Vet-VIPPS). This accreditation ensures the pharmacy complies with regulations and laws governing pharmacy practice.”

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