In 2014, Canada enacted Vanessa’s Law to protect Canadians from dangerous drugs. It obliges hospitals to report serious adverse effects or face condemnation of institutional directors. While the profession of pharmacovigilance specialist existed before the law was introduced, it has seen a resurgence of interest.
For Denis Lebel, pharmacist and deputy head of the pharmacy department at Sainte-Justine Hospital and responsible for pharmacovigilance, it is a specialization for the future. All hospitals in Quebec will want to recruit such a specialist, named “pharmacovigilance coordinator” in his department.
Generally, such a person is employed to manage side effects and to study and prevent the risks associated with a drug. What are its side effects and its reactions with other substances? “A drug never behaves like a clinical trial,” says Denis Lebel.
Depending on the workplace, this professional may have different responsibilities. Those who work in industries or firms specializing in quality control and pharmacovigilance can study the safety (toxicity) of a drug before it enters the market or after an incident.
Pharmacovigilance done upstream helps prevent the risk of dangerous side effects for patients: tolerance to a drug and its interaction with other substances are studied. The specialist must also help laboratories adapt the product to standards.
At the hospital
As Denis Lebel explains, the work expected at Sainte-Justine Hospital, for example, is rather done downstream. The pharmacovigilance coordinator has to monitor the side effects identified in national databases and communicate them to the hospital departments.
When an incident occurs, the clinical team manages the situation with the patient and the specialist has to declare it to Health Canada, especially if it is “serious”, as required by Vanessa’s Law. A review of the literature and databases will then be carried out to determine the causes of such an adverse effect based on the patient’s context, other substances ingested, etc.
His mandate is also to create a “safety net” to identify unreported cases. In effect, he performs the task of practitioners whose daily priority is the patient in front of them. “But the administrative tasks and declarations can be forgotten,” continues Denis Lebel.
While it is essential to monitor adverse side effects better, the pharmacovigilance specialist must constantly interact with clinical staff. So it is a central role!