Repost: Compounding Basics for the for the Veterinarian by Dr. Kenton Morgan

 I know I have posted this paper before, but it is an amazing overview of compounding in the animal world.
To view this document, click here  Note, however, this paper contains no date and some of the information is outdated. For example, the information relating to pergolide has changed.  See blogpost here  Readers feel free to point out any other changes that may have occurred since this paper was published.

Confused About Compounding?--in the Vet World

May 10, 2012

Tips on avoiding illegal imposters of brand-name drugs.

From AQHA Corporate Partner Merial

Dr. April Knudson is an equine specialist with Merial Veterinary Services. She has a special interest in sport horse lameness and internal medicine. She holds a doctor of veterinary medicine from the University of California-Davis. Below, she answers a question about compounded equine drugs.

Q. Some of my friends at the barn were talking about compounded drugs and whether or not they are safe to use. What are they? Should I ever use them?

A. I’m glad you asked that question because the equine drug marketplace can be overwhelming. There are websites offering drugs for sale, products being sold at equine events around the country and opinions available from everyone who has ever owned a horse. It’s really important to sort through all of the information and consult with your veterinarian, if needed, before giving anything to your horse.

First, let’s clear up any confusion about what is meant by a “compounded drug.”

The American Association of Equine Practitioners defines a compounded drug as one that is created by manipulating an existing U.S. Food and Drug Administration-approved drug.¹ Examples include crushing a tablet to make a paste or gel or adding a flavor to a drug to make it more palatable.²

For a drug to be legally compounded:

• It must be compounded by a licensed veterinarian or pharmacist for a single horse to meet a specific need,²
• The horse owner must have a valid client-patient relationship with the prescribing veterinarian,²
• There must be no FDA-approved, commercially available drug that will appropriately treat the patient,¹ and
• The product must be made from an FDA-approved commercially available drug.¹

While the use of legally compounded drugs is recognized as an occasional necessity in equine health care, AAEP cautions veterinarians to “limit the use of compounded drugs to unique needs in specific patients.” Because of the time and financial investment required to bring a new equine drug to the marketplace, there are times when a legally compounded medication could be a veterinarian’s only option.

Unfortunately, some FDA-approved equine drugs are illegally manufactured, then advertised and/or sold to horse owners who are led to believe that they are the same as those legitimately on the market. These drugs have not been through the stringent FDA approval process, so they have not been demonstrated to be safe or effective for their intended use.³ Illegal manufacturers often make claims about how well the drugs work, but are not required to prove them. Consider these claims carefully and, if in doubt, ask the manufacturer for proof that the product works and that the manufacturer can back up its claims.

Guidance on Veterinary Compounding:

Veterinary Compounding 

2012 Editor’s Note: Veterinarians occasionally use compounded preparations to meet a specific patient’s medical need. The purpose of this content, created jointly by the Animal Health Institute (AHI), the American Veterinary Distributors Association (AVDA), and the American Veterinary Medical Association (AVMA), is to explain the Food and Drug Administration (FDA) requirements for compounding preparations for veterinary use and the distinction between drug products approved by the U.S. FDA and compounded preparations.

What is compounding?

Compounding that is consistent with the FDA Extralabel Drug Use regulations is the customized manipulation of an approved drug(s) by a veterinarian, or by a pharmacist upon the prescription of a veterinarian, to meet the needs of a particular patient. For example, mixing two injectable drugs is compounding. Preparing a paste or suspension from crushed tablets is another example of compounding. Likewise, adding flavoring to a drug is compounding. Be aware, however, that products are being promoted to veterinarians under the guise of compounding that do not fit this definition. According to the FDA, legal compounding is not the formulation of preparations from bulk or raw active ingredients. Compounding should not be used as a way of circumventing the drug approval process or producing a product so it can be sold for less cost than an FDA-approved drug.

Federal regulations to follow

The FDA regulations and Compliance Policy Guide 608.400 “Compounding of Drugs for Use in Animals” describe specific circumstances under which FDA will either permit compounding for use in animals or may exercise its enforcement discretion where: 

• A valid veterinarian-client-patient relationship exists.

• The health of an animal is threatened, or suffering or death may result from failure to treat.

• Compounding is performed by a licensed veterinarian or a licensed pharmacist on the order of a veterinarian within the scope of professional practice.

• There is no approved animal or human drug that, when used as labeled or in conformity with the extra-label drug use regulations, will, in the available dosage form and concentration, appropriately treat the condition diagnosed.

• Preparations are compounded from FDA-approved animal or human drugs. Nothing in the regulations permits compounding from bulk (raw pharmaceutical ingredient) drugs.

• Compounding from a human drug for use in food-producing animals is not permitted if an approved animal drug can be used for the compounding.

• For animals produced for human consumption, the veterinarian institutes procedures to assure the identity of treated animals, establishes a substantially extended withdrawal interval for the compounded preparation supported by appropriate scientific information, and ensures food safety. Compounding is not permitted if it results in violative food residue, or any residue that may present a risk to public health.

• No drug may be compounded for food animals from drugs listed on the prohibited list (go to www.fda.gov/AnimalVeterinary/ and enter “530.41” in the search engine).

• Veterinarians comply with all aspects of the federal extra-label drug use regulations including record-keeping and labeling requirements.

• Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product.

• The scale of compounding in advance of receiving prescriptions is limited and  commensurate with the established need for compounded products.

• All relevant state laws relating to the compounding of drugs for use in animals are followed.

Compounding from unapproved substances

Federal regulations describe specific circumstances under which veterinarians, or pharmacists upon veterinarians’ prescriptions, are legally permitted to compound drugs for extralabel use in animals. Under these regulations, compounding for non-food animals may only be performed using

Veterinary Drug Compounding-A Drug Sponsor's Perspective AAVPT Symposium

Powerpoint Presentation at the 14th Biennial Symposium May 16-17, 2005 Rockville, Md.  To view powerpoint, click here

In 2012, IACP Launched Veterinary Compounding Fact Sheet

As part of IACP’s continuous efforts to educate others about pharmacy compounding, the Academy has worked to develop a comprehensive Veterinary Compounding Fact Sheet. The objectives of the IACP’s Veterinary Compounding Fact Sheet are to:

1. Raise awareness of how licensed compounding pharmacists work with veterinarians to help provide a wider range of needed medications for animals.
2. Emphasize how pharmacy compounding plays a vital role in helping to improve medication compliance for animal patients which have very specific dosage, flavoring, strength and concentration requirements.
3. Clarify how pharmacy compounding is regulated by State Boards of Pharmacy and the United States Pharmacopeia (USP) standards employed in its operation as there has been considerable misinformation disseminated on this topic. 
4. Clarify the FDA’s role in ensuring that the Active Pharmaceutical Ingredients (API) used in compounding are safe and are manufactured by FDA-registered and inspected facilities, and that they are not “unapproved substances.”  To emphasize that there is no such thing as the often- quoted “FDA-approved pharmacy.”
5. Raise awareness of how pharmacy compounding has been a critical help to veterinarians and their owners/patients during the current medication shortages.
6. Introduce veterinarians to IACP’s Compounding Pharmacy Assessment Questionnaire (CPAQ™) and explain how this tool can help them select a pharmacy compounding practice.
7. Gather information from veterinarians on how compounding pharmacists can better serve their practices and their patients’ medication needs.

IACP shared this Veterinary Compounding Fact Sheet at the American Veterinary Medical Association’s (AVMA) Annual Convention Friday, August 3 – Saturday, August 4, 2012.  

Click here to view the Veterinary Compounding Fact Sheet.

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:

http://blogs.webmd.com/pet-tales/2012/10/the-compounding-pharmacy-problem-what-pet-owners-should-know.html

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.”

Adapted from: http://blogs.webmd.com/pet-tales/2012/08/pet-medications-6-tips-to-keep-pets-safe.html