Regulatory Focus™ > News Articles > Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

Posted 07 May 2015 | By Michael Mezher 

Critics Call for Canada to Bolster New Drug Safety Law, Clarify Reporting Requirements

A critic of Canada's Protecting Canadians from Unsafe Drugs Act—commonly known as Vanessa's Law—argues that without improvements to the country's adverse drug reaction (ADR) reporting systems, the law will fail to meet its goal of improving drug safety.

Background

Vanessa's Law came into effect on 6 November 2014, after years of campaigning for stricter drug monitoring mechanisms by Conservative Member of Parliament Terence Young. The law was named for Young's daughter, who died of a heart attack at age 15 while taking the drug Prepulsid, which was later pulled from the market in both the US  and Canada after hundreds of patients died of serious cardiac events.

Vanessa's Law amended Canada's Food and Drugs Act to require mandatory adverse drug reaction (ADR) reporting by healthcare providers. The law also encourages companies to more clearly label their products with health risk information.

In addition, the law substantially increased the penalties makers of unsafe products are subject to—from $5,000 to $5 million (CAD). Courts also have the option to increase penalties if violations are caused intentionally.

Reporting Issues

While Vanessa's Law requires healthcare providers to report documented ADRs, most ADRs go undocumented by healthcare providers.

In a commentary published in the Canadian Medical Association Journal, Dr. Corinne Hohl claims that the law "does not require health care providers to document serious adverse drug reactions, but mandates that health care institutions report all documented serious reactions." This, Hohl argues, leads to significant underreporting.

Hohl cites one study that looked at emergency room visits at a tertiary care facility in Canada. According to the study, 5% of all emergency room visits were a result of adverse drug reactions; however, only 37% of those visits required the patient to be admitted. According to Hohl, only those 37% would be required to be reported under Vanessa's Law.

Hohl also points to other studies which indicate similarly low levels of ADR reporting in Canada. Part of the issue, Hohl posits, is that ADR reporting systems "are poorly fitted to clinical practice, time consuming to complete and not integrated into clinical processes."

Usefulness for Clinicians

Another issue observed by Hohl is that there are no current means of obtaining "meaningful patient-level data to inform care" through ADR reporting systems. Hohl envisions a system by which alerts could be pushed to healthcare providers reporting ADRs, notifying them of any contraindicated drugs that could pose harm to their patient.

Hohl says that existing reporting requirements are ambiguous and create confusion for healthcare practitioners, who may fail to report serious ADRs out of uncertainty.

Proposed Changes

For Vanessa's Law to improve patient safety, Hohl argues that "a new framework for documenting and reporting [ADRs] must be developed."

This framework, Hohl contends, must take into account the healthcare practitioners who will be creating the reports by making ADR reports "simple and quick to complete, and support clinical decisions at the point of care."

 

Canadian Medical Association Journal


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe