Accurate, up-to-date information is essential for making informed treatment decisions. Although the majority of information on drug efficacy and toxicity is collected during pre-approval clinical trials, toxicity data continues to emerge well after medications are approved. In fact, some estimates say that over half the drugs approved in Canada have serious side effects that are only detected after approval. Occasionally this may have dramatic consequences – as with the
anti-inflammatory drug Vioxx®, which was withdrawn from the market due to unacceptably high occurrences of heart attacks and strokes.

The process for tracking adverse drug events (ADEs) after drug approval is also known as Post Marketing Surveillance. In Canada it is termed a post-approval surveillance system or PASS. New information on post-approval ADEs is collected by the Canadian Adverse Drug Reaction Monitoring Report (CADRMP) – a program of the Marketed Health Products Directorate (MHPD) of Health Canada. Health professionals may report newly observed ADEs to CADRMP, but are not required to do so. Consumers themselves may report ADEs directly – however, very few are aware of this, and the existing system is difficult for non-medical professionals to use. Presently, only manufacturers are legally required to report new ADEs to CADRMP.

The current PASS is quite passive in nature and does not focus on consumers. For those living with HIV, the skill of prescribing HIV treatment lies in maximizing benefits and reducing the risks. Antiretrovirals (ARVs) though very effective at controlling HIV and the progression of the disease, are often at the price of toxicities and side effects. In order to make the most informed decisions when it comes to treatment, PHAs need accurate and complete up-to-date information about drug benefits and adverse effects - both short-term and long-term.