Pharmacovigilance project celebrates success

The BC Centre for Excellence in HIV/AIDS (BC-CfE) has successfully completed a demonstration project that is helping B.C.’s health care system monitor side effects (adverse drug reactions) to antiretroviral medications.

Adverse drug reactions can gravely affect patients’ health and compromise treatment success. Although all drugs are tested for safety before they are approved for sale in Canada, pre-marketing clinical trials cannot study enough patients to be able to detect rare or delayed onset drug reactions, or reactions that predominantly affect special groups, such as women, seniors or specific ethnic groups. These types of adverse reactions may not be discovered until after a drug is marketed and widely used.

Ongoing surveillance of adverse drug reactions is required to detect unexpected toxicities as soon as possible, so that health care providers and patients can be warned of new safety concerns. This type of monitoring activity is conducted through pharmacovigilance programs which collect, evaluate and analyze reports of drug toxicity and use this information to understand and prevent drug-related problems. Health care professionals and patients themselves are the most important sources of information in identifying a drug’s potential toxicity.

Since its inception, the BC-CfE has been active in collecting and reporting antiretroviral treatment-related information and has published numerous scientific studies and issued public safety alerts. However, until recently, the BC-CfE lacked the resources to operate an ongoing adverse drug reaction reporting and monitoring program. Thanks, in part, to the generous support of the Canadian Patient Safety Institute, the BC-CfE was able to launch a pharmacovigilance program as a demonstration project in July 2008. The first HIVfocused reporting mechanism of its kind in B.C., the program provides an opportunity for all health care professionals and for patients themselves to submit reports of suspected adverse drug reactions to antiretroviral medications.

“Because the BC-CfE Drug Treatment Program provides all antiretroviral medications within B.C., we can estimate the proportion of people taking a drug or drug regimen who experience a particular adverse reaction,” explained Kathy Lepik, project coordinator. “The BC-CfE sets the HIV treatment guidelines for the province, so we will also be able to respond rapidly and translate reports of unexpected drug toxicities into safety alerts for health care providers and people living with HIV/AIDS.”

During the first nine months of pharmacovigilance program operation, approximately 5,000 people living with HIV/AIDS were treated with antiretroviral medications and the program received 435 reports of adverse drug effects via prescription forms and spontaneous reports. Approximately 80 per cent of these reports were submitted by physicians, and 20 per cent by pharmacists and nurses. Dr. Rolando Barrios, project leader, noted, “Reporting patterns to date have been consistent with the known adverse reaction profiles of the commonly used antiretroviral medications, which suggests that there are no identifiable biases in the reporting process. We are presently closely monitoring and investigating some potential safety concerns.”