Vanessa was the fifteen-year-old daughter of the then Conservative Member of Parliament Terence Young. Vanessa suffered a stomach ailment and was prescribed medication as a result. Soon after beginning the medication, Vanessa sadly died of a heart attack. The drug she had been prescribed was later found to be unsafe and was pulled from the market. Mr. Young thereafter pushed for more stringent legislation to protect Canadians from unsafe drugs and for a better drug-monitoring system.
The result was the Protecting Canadians from Unsafe Drugs Actpassed in November of 2014. It has become known as Vanessa’s Law. It amended the Food and Drugs Actby adding the obligation that prescribed health care institutions (hospitals) were to report any negative experiences with therapeutic medications and medical devices.
A serious adverse drug reaction (SADR) is defined under the legislation as:
noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
A medical device incident (MDI) is defined under the legislation as:
n incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.
Amendments to the Regulations made under the Food and Drugs Act and Vanessa’s Law are now passed and will come into force on December 16th, 2019. They seek to better outline the scope of the reporting obligation. They will impact virtually all hospitals in Canada.
According to the amendments, the required report must be submitted in writing within thirty days of the reporting incident and must include:
Hospitals are exempted from the reporting requirements where:
Practicing up-to-date compliance with the law is the best way to avoid litigation in the future. To ensure compliance with all applicable health care regulations and legislation, it's best to reach out to an experienced health care lawyer who is up to date on all applicable laws and amendments.
At Wise Health Law,we are passionate about helping healthcare organizations, regulated health professionals, and regulated health professional associations understand and protect their legal rights. We follow developments in the law and are consistently at the forefront of change and innovation. Contact us online, or at 416-915-4234 for a consultation.
The Chief Medical Officer of Health for Ontario has issued an updated Directive #2 (dated May 26, 2020) for Regulated Health Professionals in the province.
Pursuant to the updated Directive #2, all deferred non-essential and elective services by health care providers may be gradually restarted – subject to the rest of the requirements set out in the Directive.
The updated Directive #2 does not provide particularly detailed guidance to health professionals on how to proceed, likely because it applies to such a broad spectrum of health care and health professionals. It does, however, provide some principles to assist health care providers in making decisions as we enter this transitional period.
In addition to the mask and hand sanitizer shortages, Ontario’s response to COVID-19 highlights the need for more frontline health care workers. Each regulated health profession’s college responded differently, and we have discussed some of those changes in other posts to keep you apprised.
Today, we focus on the College of Physicians and Surgeons of Ontario (CPSO), who set out to increase the number of available and licenced physicians out on the frontlines through certificates of registration that authorize supervised practice of short duration. The temporary licences authorize practice for 30 days.
Undoubtedly, COVID-19 has affected how health professionals practice. Pharmacists across the country are not only experiencing changes in how they practice (for example, accepting emailed prescriptions, where appropriate) but the scope of their practice as well. The latter change is not permanent, although the disruptions in practice may be felt long after the COVID-19 emergency subsides.
On March 19, 2020, Health Canada issued a short-term section 56(1) exemption under the Controlled Drugs and Substances Act (CDSA) that would authorize pharmacists to prescribe, sell, or provide controlled substances in limited circumstances, or transfer prescriptions for controlled substances (the CDSA Exemption).