by Written on behalf of Wise Health Law August 08, 2019 3 min read

Introduction

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.

Serious Adverse Drug Reactions

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.

Medical Device Incidents

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

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:

  1. the name and contact information of a representative of that hospital;
  2. a description of the Adverse Incident;
  3. the drug's brand name or common name, and its DIN; or
  4. the device's name or identifier, manufacturer and the lot or serial number;
  5. the age, sex, and medical condition(s) related to the incident, the names of any other products being used by the patient and the effects of the incident on the patient's health; and
  6. the patient's first use of the product, when the patient stopped using the product and the date of their recovery.

Exemptions

Hospitals are exempted from the reporting requirements where:

  1. where vaccines have been administered under a routine provincial immunization program;
  2. where the drugs or devices were used in clinical trials; and
  3. where drugs or devices that are authorized for sale as part of the Special Access Programme.

Further Guidance From Dedicated Health Law Lawyers

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.



Also in Blog

The Interaction between College Proceedings and Limitation Periods

by Rozmin Mediratta April 02, 2020 3 min read

Earlier this year, Wise Health Law succeeded on a motion for summary judgment in a dental malpractice case on the basis that the limitation period had expired before the Statement of Claim was issued. The (unreported) decision was delivered orally on the day of the motion. 

In part, the plaintiff argued that she did not discover her claim until the Royal College of Dental Surgeons of Ontario (the “RCDSO” or “College”) rendered its decision, as she did not know if the defendant was negligent when she complained to the RCDSO, but merely had a “suspicion”. 

Ontario Gives Statutory Tribunals Discretion to Conduct Proceedings Electronically Amid COVID-19

by Rozmin Mediratta March 30, 2020 2 min read

In the midst of COVID-19, the proceedings of many health colleges, and consequently of the health professionals they regulate, have been in limbo while everyone finds a way forward. 

On March 25, 2020, the Ontario government enacted the Hearings in Tribunal Proceedings (Temporary Measures) Act, 2020 (the “Act”) to help the process along.

The Act empowers statutory tribunals with more discretion over how proceedings before them are held.

Chiropractors: Considerations in Providing “Emergency Care”

by Valerie Wise March 25, 2020 2 min read

Effective 11:59 p.m. on March 24, 2020, the Ontario government ordered the closure of “non-essential” workplaces.  The list of “essential” workplaces included “health care professionals providing emergency care including dentists, optometrists and physiotherapists”.

The College of Chiropractors of Ontario (“CCO”) interprets this list as including chiropractors, and we agree.

So the question becomes – what is “emergency care”?