Why Support Approved Drugs?
by Tracey Runions, Canadian Animal Health Institute

Now that the holiday season has passed, can anyone tell me how many of the new gadgets advertised actually made our lives any easier? Now that we have our feet firmly planted back in reality, and are facing a new year, we’ll be ready to implement some new and not-so-new “improvements” to make life easier right? Maybe, but then again, maybe not!

It should come as no surprise, that the Canadian market for animal health products is unique in the developed world, and not with good reason. It’s becoming increasingly well known that we’re famous for the slowness of our licensing process and its consequence on fewer new products being available. Another dubious credit is our ingenuity to adapt to this shortfall. How so? First of all, there is the missed opportunity for producers and veterinarians, to access the newest, most targeted products available to our competitors abroad, to treat disease and maintain the health of our production animals. To adapt, we have more and more producers and veterinarians utilizing loopholes in antiquated federal legislation to by-pass the regulatory process and use product that has not been approved by Health Canada. Commodity organizations are beginning to realize the potential negative consequences in some of these practices, and their potential to compromise Quality Assurance Programs.

So, what’s the real story? For those not intimately familiar with the Canadian predicament, the short version is that the Veterinary Drugs Directorate - Health Canada’s agency charged with conducting the risk assessment on new animal drug submissions (or addition of new species or additional claims to already approved products) is averaging over 4 years behind in their review process. Thus, if I submit a product tomorrow that has been proven to control maggots on lambs following tail-docking, this product is approved in the U.S., Australia, and the EU, on average, Canadian veterinarians won’t even have the potential to prescribe this product until 2008 – at the earliest.
No one ever said that farmers or veterinarians weren’t innovative. So, over the years, both groups have developed tactics to obtain product that is not approved for animal use in Canada, and been applying it to their herds and flocks. A deadly mix for a PR disaster if the public were to find out? You decide.

The purpose of the following series of Q & As is to address some current practices, and their implications.

Can I import product for my “own-use”?
This is presently permitted under Health Canada policy. The policy contains a component that was intended for humans who are out of the countryand require medications. Patients are allowed to bring drugs into Canada upon their return from their trip abroad, as well as a 3-month supply, which should allow their primary physician to diagnose and prescribe a course of therapy. Certain producers have been known to apply this “loophole” to herds and flocks.

On the positive side of things, it applies to veterinary products listed on Schedule F Part 2 of the Act, which are non-prescription veterinary drugs, available over the counter. On the negative, there is the risk of the development of antimicrobial resistance, residue violations, and the potential of the negative public reaction to producers using product that is not licensed for use in food producing animals in Canada.

Health Canada recently has indicated that they will be taking steps to manage this loophole. Along with this comes the challenge of enforcement. Canada Pork has taken the lead of self-regulating this practice through their CQA Program. Effective October 1, 2003, any drug used on CQA recognized farms in Canada now require a license for food animal use in Canada. This includes medications acquired through the “own-use” provision, which may not be used on CQA recognized farms.

What is Compounding of veterinary products?
Compounding of product has been around as long as the practice of pharmacy. In theory, it is used to compound an unapproved product when there is no existing approved product to treat an individual. Compounding in its simplest form allows veterinarians or pharmacists to produce small amounts of unapproved drugs. It does not mean that drugs can be manufactured.

Today, however, compounding of veterinary product is becoming increasingly more complicated. The active pharmaceutical ingredient (API), the raw material that has pharmaceutical properties, can and are being purchased from offshore sources. APIs are then re-constituted in pharmacies, under veterinary prescription and in some veterinary clinics. The quality and efficacy of this product is unknown. What’s more, the necessary third-party risk assessment (presently done by the Veterinary Drugs Directorate, Health Canada) has not been conducted. Note as well, that Good Manufacturing Practices – required in the development and sale of all licensed veterinary drugs has not been carried out, raising further doubts about the quality, stability and efficacy of the end product.

Positive for the producer: compounded product is often an economical source of a drug. The negative: the product is often not what it’s said to be. Impurities may be attached to the API, the API may not be as potent as it was intended to be, the API may not even be the same pharmaceutical that it is claimed to be. The end-compounded product may be pharmacologically more or less potent than intended, leading to over or under-dosing of the treated animals.

What about using product that’s not labeled for use in sheep?
Commonly referred to as “off-label/extra-label” use, this is an everyday component of veterinary medicine. Veterinarians are able to prescribe products in animal medicine that have no animal claims (even human product), in higher doses or for longer durations than those recommended on the label, or to species other than those listed on the label. The application of product to species not listed on the label is particularly true in the case of the “minor” species, such as sheep.

This puts veterinarians and producers in a catch-22. When there is no existing labeled product for minor species veterinarians must prescribe “off/extra label”. However, if this practice is continued once a veterinary formulation is approved, they are inadvertently restricting future access to other veterinary approved drugs. Manufacturers will not invest in acquiring minor species or animal claims on product if the human or other species products are being used.

It should also be made clear, that veterinarians (and producers) are liable for prescribing “off/extra label”. It is like asking the drug to do something it was not tested to do. Important factors that must be taken into consideration are withdrawal periods, efficacy and animal safety.

What are the costs of bringing an animal medication to market?
Animal health products typically undergo 10 to 12 years of research & development, with food animal compounds reaching up to a $250 million investment. (It is estimated that 1 in 7,000 new entities initially tested actually make it to market.) This means, that pharmaceutical companies must recoup their R & D investment through product sales.

We must also remember that approved animal medications have met demanding Canadian standards assessing their risk to humans, animals, and the environment. This means that research has been conducted and is able to support the rigid approval requirements for safety, efficacy and manufacturing.

So what’s the “right thing to do”?
Ultimately, as consumers first, and food producers second, we should do our utmost to support licensed Canadian product. The public continues to demand more and more information about where their food and water is coming from. As producers, we need to provide quality product produced in a responsible manner. The easiest way to defend an industry in the face of crisis is to be aware of the different practices that are occurring, and to respond in a publicly acceptable manner.