Canadians prescribe and take a lot of antibiotics and why not? They are safe. They are effective. They are inexpensive. All good? Not at all.
There is a complicated reason why sensible, well-meaning Canadians are making decisions that are harmful to themselves, their neighbours and their children – antibiotic resistance.
The more antibiotics we all take, the more likely that they won’t work for any of us. This makes for a very difficult problem. We need to use antibiotics very well as a group which is very different from how people generally think about things. Drugs are personal, given one prescription at a time by one doctor to one patient. People naturally do not fear antibiotic resistance, they fear personal illness and death.
There are, quite literally, hundreds of thousands of scientific papers describing antibiotic resistance. A search in Google Scholar for “antibiotic resistance” returns “about 1,000,000″ articles. There are also thousands of descriptions of antibiotic misuse in every conceivable area that they have been used. We have not been careful.
Pharmaceutical companies have stopped searching for and developing new antibiotics. There is very little incentive for many reasons:
- Antibiotics cure infections quickly. Small amounts are taken for a short time. Drugs taken for chronic conditions are taken continuously for long times making them much more profitable.
- Antibiotic resistance can occur quickly making the antibiotic ineffective. This is unpredictable.
- Antibiotics must be extremely safe because a large amount of antibiotics are taken for non-serious illness. For example, if one person in a million dies from liver toxicity from an antibiotic taken for sore throat the drug will be removed from the market. Several recent antibiotics have “died” after regulatory approval in recent times for this reason after hundreds of millions of dollars of development costs.
The antibiotics we have are being used poorly and resistance to them is increasing. There are almost no new ones being developed. Disaster is looming.
What is the Canadian response? Basically, there isn’t one. Certainly no concerted one. There is no federal leadership of any kind. There is no coordinated measurement of antibiotic resistance. There is no coordinated measurement of antibiotic use. No drug plan, provincial or third-party, regularly evaluates the appropriateness of the antibiotics they pay for. Physicians are not evaluated in their antibiotic knowledge or prescribing practices by anyone. Instruction in medical schools concerning antibiotics is very sparse.
Current drug regulations don’t work for antibiotics
Despite the very obvious differences, antibiotics are subject to the identical regulatory structures that govern cholesterol drugs, diabetes drugs, blood pressure drugs and erectile dysfunction drugs. The process works this way:
- A new drug must be approved by the Therapeutic Products Directorate (TPD) of Health Canada.
- Once approved (referred to as being given a “notice of compliance” with the Food and Drugs Act and Regulations) legal marketing, prescription, and dispensing can occur.
- Companies then lobby to get the new drug covered by provincial and large private drug plans (e.g. Blue Cross).
Each province and territory has their own drug plan and several large private plans provide coverage to private company employees, government employees, unions members and some individuals. A very large proportion (~90%) of drugs in Canada are payed for by these plans. It is at this level that control over drug use can be affected by regulation, education and monitoring but there is very little attention afforded to antibiotics because of their relatively small cost. Cardiac, gastrointestinal, cancer and neurologic / psychiatric drugs command all of the drug utilization attention. The individual provinces don’t have the economic interest or the infrastructure to develop antibiotic optimization strategies.
In 2005 the first ministers conference saw a plea for a national pharmacare plan endorsed by all premiers. It was widely discredited as a provincial grab for federal money as a response to pharmaceuticals being the most rapidly expanding sector of healthcare expenditure. It was scoffed at by the federal government and deemed to be “too expensive” for consideration. This despite overwhelming evidence that the buying power and reduced bureaucracy afforded by cooperation would result in significant savings.
What if it was limited to antibiotics?
The federal expense would not be prohibitive. Outpatient antimicrobials total less than a billion dollars annually. It could lay the groundwork for future expansion to other classes of drugs and most importantly it would distinguish antimicrobials as needing special regulatory attention.
A framework Australia’s Pharmaceutical Benefits Scheme is
Key Recommendations in the Executive Summary of the Report of the Advisory Committee on Animal Uses of Antimicrobials and Impact on Resistance and Human Health
- Make all antimicrobials used for disease treatment and control available by prescription only.
- Develop an extra-label use policy which ensures that this practice does not endanger human health. Such a policy should include the ability to prohibit the extra-label use of specific drugs of critical importance to human health.
- Evaluate, register and assign a DIN to all antimicrobials used in food animals, whether manufactured domestically or imported. This include antimicrobials imported in bulk Active Pharmaceutical Ingredients (APIs), which should be allowed into Canada only under permit. The intent of this recommendation is to stop the direct use of APIs in food animals.
- Stop the importation, sale and use of antimicrobials not evaluated and registered by Health Canada. The intent of this recommendation is to stop the “own use” loophole.
- Evaluate antimicrobials for growth promotion or feed efficiency using sound risk analysis principles and rapidly phase out antimicrobial claims not fulfilling the following criteria: demonstrably effective; involving products rarely, if ever used in human therapy; and not likely to impair the efficacy of any other prescribed antimicrobial for human infections through the development of resistant strains.
- In consultation with the provinces, other federal agencies and industry groups, design and implement an ongoing, permanent, national surveillance system for antimicrobial resistance arising from food-animal production. Surveillance should include indicator and pathogenic bacteria isolated from animals, foods and imported animal products.