Pharmacovigilance, at first blush, sounds like the title of a blood-curdling Michael Crichton thriller.
In fact, it is the "science of collecting, monitoring, researching, assessing and evaluating information on the adverse effects of medicines after they are marketed, in order to identify new information about the hazards associated with medicines and to prevent harm to patients."
This definition is from a new report commissioned by the Health Council of Canada entitled Keeping an Eye on Prescription Drugs, Keeping Canadians Safe.
The report, prepared by York University researchers Mary Wiktorowicz and Joel Lexchin, notes that while pharmacovigilance is an evolving science, it is essential to a safe and effective delivery of health care in our drug-saturated culture.
Canadians gobble down about $25-billion a year in legal pharmaceuticals. But, under the current system, testing for safety and effectiveness takes place almost exclusively before medications are approved. These tests are usually carefully crafted company-sponsored clinical trials with select patients using the drug in optimal conditions. Often only a specific surrogate end point is measured: for example, does a drug lower low-density lipoprotein (so-called bad cholesterol), as opposed to measuring a clinical end point, such as does it prevent death from heart disease.
In the real world, the situation is different. A broader range of patients will be prescribed a new drug; they won't always follow the instructions to the letter; they will add the new product to their current pharmacopia, raising the distinct possibility of unforeseen interactions; and they tend to consume drugs for much longer than test patients. Not to mention that, in the real world, millions of people may take a medication, which can expose rare side effects that are not obvious in clinical trials involving hundreds or thousands.
Yet, under the current regulatory regime, there are "few regulatory obligations once a product reaches the market," in the words of Health Canada itself.
What we have instead of sound regulation is a patchwork of monitoring programs for specific drugs and conditions and a lot of wishful thinking.
As the Health Council report notes, most people naively assume that if a drug is approved it is perfectly safe. Yet a lot of Canadians are exposed to unsafe drugs, or take prescription drugs (and non-prescription drugs including so-called complementary therapies) in a manner that makes them unsafe.
In the real world, adverse drug reactions are a big killer. As many as 12,000 Canadians a year die of adverse drug reactions - more than 30 a day, according to the Canadian Adverse Events Study.
In fairness, one must note that this does not necessarily mean drugs are bad or dangerous. Every drug has side effects; every drug that has the potential to do good has equal or greater potential to do harm. Prescribing can be a balancing act.
That is why we owe it to ourselves to be vigilant - pharmacovigilant - to at least avoid the avoidable harms.
Post-market surveillance should be an integral part of the approval process. But Health Canada does not have the tools or the powers it needs to do the job.
Under the Food and Drugs Act, Health Canada cannot order post-market studies, it cannot demand label changes and it does not have the power to monitor patient registries (in which patients with specific conditions are tracked for research purposes). It can withdraw a drug but it rarely exercises this power; even Vioxx, one of the most spectacular drug failures in history (in economic terms anyhow), was withdrawn voluntarily.
In Canada, there is no national system of surveillance, only a voluntary reporting database that is grossly underused. In 2008, there were only 16,272 reports of adverse drug reactions entered in the Canada Vigilance registry. Only one in five doctors ever report an adverse drug reaction.
Studies show that voluntary systems capture 1 to 10 per cent of actual adverse drug reactions. If we believe in patient safety, that's not good enough.
So what needs to be done?
First and foremost, give Health Canada some legislative authority so it can be active, not merely reactive, in ensuring drug safety. Bill C-51 was a good start: The legislation, which died when Parliament was prorogued, introduced the concept of progressive licensing - granting a licence with conditions, such as post-marketing surveillance.
Health Canada also needs to communicate in the communications age. Currently, drug safety issues are communicated principally through so-called "Dear Doctor" letters, a highly ineffective method. For example, after it was revealed that the antipsychotic drugs Zyprexa and Risperdal could cause dangerous adverse reactions in seniors, three "Dear Doctor" letters went out but prescriptions actually increased sharply in this age group.
Patients and families (and to a large extent doctors themselves) should not have to rely on media reports and Internet sleuthing to learn about potential problems with prescription drugs, as is the case now.
The situation is not entirely dire. The Drug Safety and Effectiveness Network - funded by Health Canada - does a lot of great research work. But there is still not enough formal monitoring.
If Health Canada is going to practise pharmacovigilance, it needs not only a change of culture but the resources to do so. Currently, it has 827 staff and a budget of $74.6-million for drug approvals; it has 213 staff and a budget of $23.6-million for monitoring safety.
Those figures tell a tale of misplaced priorities.
Sure, there is a longing for new, more effective drug treatments. But promise is not enough.
You need to deliver on promises in the real world without doing more harm than good. And consumers need to be fully informed of benefits and risks.
Only then can drugs truly be considered effective.