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New drug regulations require adjustment

Vet Advice with Dr. Ron Clarke

No issue over the past 15 years occupied more space in agriculture, veterinary or public health-related press than antimicrobial resistance (AMR). No single topic appears more often on conference and seminar agendas than topics addressing the use, abuse and prudent use of antimicrobials in humans and animals. Petitions, a plethora of committees of every description, and scientific debate has done little to lessen the stain of agriculture’s influence on antimicrobial resistance, or initiate concrete steps to fix it — until recently.

World Antibiotic Awareness Week began Monday, November 13. The United Nations, through its Food and Agriculture Organization (FAO), the World Health Organization (WHO) and the World Organization for Animal Health (OIE), summoned all those responsible to take steps toward prudent use of antibiotics. The emergence of bacterial resistance is a troubling issue tied to the use of antimicrobials in both animals and humans. The issue is complex and global in nature. Answers are hard to find.

No subject touches modern livestock production more fully than antimicrobial use in animal-based food production and the relationship it has to AMR (antimicrobial-resistance) in humans. The assignment of cause for the growing dilemma of highly resistant, life-threatening bacterial infections on hospital wards stimulates arduous debate and finger pointing over the judicious use of antimicrobials. Agriculture must approach the future with the responsibility to be actively engaged in finding answers or stand suspect and untrustworthy. Regulatory changes, now underway in both the U.S. and Canada, will affect producers, veterinarians, and businesses in the business of selling antimicrobials.

“Antibiotic resistance is a global crisis that we cannot ignore,” said Tedros Adhanom Ghebreyesus, director-general of WHO. “If we don’t tackle this threat with strong, co-ordinated action, antimicrobial resistance will take us back to a time when people feared common infections and risked their lives from minor surgery.” Animal diseases are becoming harder, and sometimes impossible, to treat as antibiotics become less effective. The WHO has gone as far as recommending the elimination of antibiotic use in animal agriculture. As implausible as this might seem, we must remember that WHO called for the reduction of feed-grade antibiotics for growth promotion, which the animal health industry readily adopted. Also on the table: the elimination of antibiotics for disease prevention, unless a veterinarian has diagnosed a disease condition within a herd or flock. With WHO’s recommendations comes rising pressure for food companies to develop “antibiotic-free” policies. In Europe, companies like Domino’s Pizza Group U.K. have committed to phasing out the routine use of antibiotics in beef, pork and poultry.

The federal government has proposed new rules for veterinary drugs used in livestock. In that agriculture uses an estimated 80 per cent of antimicrobials produced, Health Canada has clearly taken the stand that overuse and misuse of antimicrobials in animals is a contributing factor to the development and spread of AMR in humans. Health Canada says the decreasing effectiveness of antimicrobials is having a significant impact on the government’s ability to protect Canadians from infectious diseases. In their view, current regulations do not provide the necessary regulatory oversight to mitigate risk.

Both Canada and the U.S. have been criticized for lagging behind Europe in regulations governing prudent use of antimicrobials. North American agriculture is under pressure to enact major changes. Significant trade sanctions lie at the crux of inattention.

Health Canada updated the framework for veterinary-use antimicrobials by publishing regulatory changes to the Food and Drug Regulations in the Canada Gazette, Part II on May 17, 2017. These changes aim to increase oversight of antimicrobials available for use in animals. In particular, Health Canada addressed gaps in the regulations identified as issues multiple times over the last decade:

  • Active pharmaceutical ingredients (API) for veterinary use.
  • Personal importation of certain drugs for food-producing animals (Own Use Imports).
  • Reporting antimicrobial sales information (surveillance).
  • Use of veterinary health products (VHP) — low-risk drugs used to maintain or promote the health and welfare of companion and food-producing animals. VHPs contain ingredients like vitamins, minerals and traditional medicines.

In addition, Health Canada has implemented microbiological safety requirements for assessing new veterinary antimicrobial drug submissions for use in food-producing animals. They have also categorized antimicrobials into four categories based on their importance in human medicine to help prioritize risk management options, and added warnings on certain medically important antimicrobials in Categories I, II, and III. Steps have been taken to increase surveillance activity and enhance communication on prudent use of antimicrobials with a wide network of stakeholders including: provincial and territorial authorities, international counterparts, veterinarians, industry, food animal producers, associations, other animal health stakeholders, other federal departments and agencies.

Many producers do not understand the implication of changes coming forward in 2018 in the form of regulations. By default, everyone handling antimicrobials will assume ownership of a major international crisis. There will be a need to understand the issues and a need to correct any deficiencies in your health practices.

Practices associated with how antimicrobials are purchased and used will change, and there will be costs tied to these changes. Key among them will be the need to develop a veterinary client-patient relationship with a veterinary practitioner who will facilitate the maintenance of appropriate animal care practices and issue prescriptions for the purchase of antimicrobials. Registered pharmacists may be a part of the equation. The loss of API and own use permit privileges (as they existed) will affect some production units.

If industry and government don’t carry out this transition cleanly and smoothly, the outcome could range from trade sanctions to erosion of consumer confidence. Whether we like it or not, animal agriculture must play a part in tackling antibiotic resistance. It is essential that the public and consumers understand we are there and doing the right thing.

— Dr. Ron Clarke prepares this column on behalf of the Western Canadian Association of Bovine Practitioners. Suggestions for future articles can be sent to Canadian Cattlemen or to the WCABP.

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