QUEBEC CITY, Que. — New antimicrobial regulations could be published this year changing the way medications for livestock are bought and sold.
No products will be prohibited and officials at Health Canada’s veterinary drugs directorate have promised a smooth transition to the new system.
“Our role in ensuring stewardship of antimicrobials is to make sure the products on the market are safe and effective and high quality,” said Mary Jane Ireland, director-general of the directorate. She described the rule changes at the animal nutrition conference of Canada held May 10-11 in Quebec City.
The first round of regulations and policy changes was enacted last year and Ireland said the final regulations are expected sometime in 2017.
The six major changes are as follows:
- Increase oversight on the importation of veterinary drugs for own-use on farm. This will be prohibited with the exception of certain products. No products that are medically important to humans or prescription drugs will be allowed.
- More oversight on the importation of active pharmaceutical ingredients to ensure these products are of the highest quality and produced with good manufacturing practices, as well as require persons who import, fabricate, package, label or test veterinary APIs (active Pharmaceutical Ingredients) to do so in accordance with an establishment licence.
- Mandatory reporting of sales and imports is coming because there is poor understanding of what is sold in Canada. Manufacturers will report on an annual basis on the total quantity sold and which species it was intended for. This covers imports of drugs and APIs.
- Access to low risk veterinary products will be allowed.
- The interim notification pilot program has been in place since 2012 to allow sales of products like vitamins, minerals or Chinese medicines. It has allowed about 600 oral and topical products to enter Canada for pets and horses. It will be expanded to food producing animals and allows products like calcium boluses to prevent milk fever.
- Growth promotion claims from medically important antimicrobials will be removed. Health Canada has not approved one of these since 2004 and there is no modern data that says they work. About 64 products are implicated. Regulators do not want to take them off the market but need to find other ways to de-scribe them.
- Increase veterinary oversight and prescriptions for all antimicrobials sold. This includes over-the-counter and medicated feed products. Provinces and territories may make additional rules about who can sell veterinary drugs.
“The bottom line for in-feed medications containing medically important antimicrobials is that we want you to have a prescription and provide vets notice before you receive it,” Ireland said.
“We want to make sure you have the same tools available to you to mix, blend, refer or reference.”
The same products will still be included in the Canadian Medicating Ingredients Brochure.
The changes are partly motivated by the growing problem of antimicrobial resistance around the world. More drugs are less effective in preventing and controlling infection.
Antimicrobial resistance is often blamed on the widespread use of treatments for livestock. Antimicrobials can include anti-virals, antibiotics, anti-fungals and anti-parasitics.
“There is no doubt antimicrobial use in animals is only one part of a very complex issue. In Canada, we estimate 70 percent of all medically important antimicrobial drugs are sold for use in food producing animals,” Ireland said.
That number sounds surprising but it is important to remember how many animals exist as well as their size.
Health Canada estimates more than 20,000 hospital patients in Canada develop infections that are resistant to antimicrobials resulting in more than $250 million in direct medical costs every year.
Globally, the use of antimicrobials in food-producing animals is estimated at 63,000 tonnes in 2010 and it is expected to grow to more than 100,000 tonnes by 2030.
Canada estimates about 1.6 million kilograms of antimicrobials were distributed for animal use in 2013.
Health Canada reports infections caused by antimicrobial-resistant bacteria cause at least two million illnesses and at least 23,000 deaths annually in the United States.
In Europe, about 25,000 patients die each year from drug-resistant bacterial infections.
The full comments on the changes may be viewed at: bit.ly/ 2dTh2MO.