Consultations

Proposed Amendments to Canada’s Food and Drug Regulations to Require the Reporting of Serious Adverse Drug Reactions by Hospitals

Due Date: August 22, 2018

Further to the publication in Canada Gazette, Part I, on June 16, 2018, of the proposed regulations to amend the Food and Drug Regulations to require hospitals to report serious adverse drug reactions (ADRs) ( http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/reg5-eng.html), the Canadian Society of Hospital Pharmacists (CSHP) urges all of its members to provide comments on the proposed regulations and the accompanying Regulatory Impact Analysis Statement. Under the proposed regulations, all hospitals will be required to report all serious ADRs to Health Canada in writing, within 30 days of when the incident was first documented within the hospital. This regulatory proposal supports authorities gained through the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law, http://www.laws-lois.justice.gc.ca/eng/AnnualStatutes/2014_24/FullText.html), in order to improve the quality and increase the quantity of serious ADR reports provided to Health Canada.


As you know, Health Canada has no jurisdiction over health care delivery, solely over health products. Therefore the proposed regulatory changes pertain to the reporting of serious adverse drug reactions (i.e., drug toxicity), not to the reporting of serious adverse events (i.e., patient safety incidents, near misses and hazards = medication errors). According to the Food and Drug Regulations, a serious adverse drug reaction means a 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.

In developing the proposed regulations, Health Canada has sought input since early 2015 from health care institutions, health care professionals, advocacy groups, provinces and territories, other stakeholders, and the public on the issue of mandatory reporting by health care institutions. CSHP provided feedback at each step of the way ( https://www.cshp.ca/adverse-drug-reactions).


In June 2017, Health Canada published a consultation paper to inform the design of the regulations. The following table compares the 2017 and 2018 proposals:


2017 Consultation Paper 2018 Proposed Regulations
Applicable health care institutions Hospitals that provide acute care services All hospitals regulated through provincial or territorial legislation, as well as to those operated by the federal government and that provide health services to persons who are in-patients
Types of reportable serious ADRs Serious, unexpected ADRs Example: bone marrow suppression induced by antineoplastic agents would not be reportable All documented serious ADRs Example: bone marrow suppression induced by antineoplastic agents would be reportable
Applicable therapeutic products

  • Pharmaceuticals (prescription and non-prescription)

  • Biologic drugs (that are not vaccines)

  • Radiopharmaceuticals

  • Disinfectants

  • Pharmaceuticals (prescription and non-prescription)

  • Biologic drugs (that are not vaccines)

  • Radiopharmaceuticals

  • Disinfectants
Required information

  • Minimum amount of required information:

    • name of the health care institution and the contact information of a representative of that institution

    • name or DIN of the drug that is suspected of causing the reaction

    • age and gender of patient

    • description of the serious unexpected ADR

  • Additional information required to be submitted, if information known:

    • therapy and reaction dates (dates the drug was started and stopped; and dates the ADR occurred and was resolved)

    • relevant tests/lab data

    • relevant medical history (concomitant disease states)

    • concomitant health products

    • patient outcome

  • Minimum amount of required information:

    • name of the hospital and contact information of a representative of that hospital

    • drug’s brand name, proper name or common name;

    • in the case of a drug imported under Division 10 of the Regulations (Access to Drugs in Exceptional Circumstances), the identifying code or number of the drug, if any is assigned in the country in which the drug was authorized for sale

    • DIN for the drug, if applicable

    • patient’s age and sex

    • description of the serious ADR

  • Additional information required to be submitted If in a hospital’s control:

    • date on which the patient first used the drug and, if applicable, date on which the patient stopped using the drug

    • date on which the serious ADR first occurred and, if applicable, date on which the patient’s health was restored to its state prior to the reaction

    • any medical condition of the patient that directly relates to the serious ADR

    • any concomitant therapeutic products used by the patient

    • result of the serious ADR on the patient’s health
Timeline for reporting Within 30 days of first documentation of the reaction Within 30 days after the day on which the serious ADR is first documented within the hospital

PLEASE PROVIDE YOUR COMMENTS ON THE PROPOSED REGULATIONS AND THE ACCOMPANYING REGULATORY IMPACT ANALYSIS STATEMENT TO BOTH:


  1. Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, at email LRM_MLR_consultations@hc-sc.gc.ca, citing the Canada Gazette, Part I, Volume 152, Number 24, June 16, 2018

    • The more feedback, the better!

  2. Cathy Lyder, Director, Members & Programs, CSHP at email clyder@cshp.pharmacy

    • Your perspective will strengthen CSHP’s collective response to Health Canada.



Project files


CSHP's response