Adverse Reaction Reporting – Public Safety Requires Your Compliance

On August 19th, 2009, Health Canada released the Adverse Reaction Reporting Guidance Document which supersedes the 1996 regulations for Adverse Reaction Reporting. This guidance document provides market authorization holder (MAHs) with assistance on how to comply with the Food and Drugs Act, the Food and Drug Regulations, and the Natural Health Products Regulations with respect to reporting adverse reactions (ARs) to marketed health products (MHPs). Every MAH should have a system in place for reporting ARs to the Marketed Health Product Directorate (MHPD),

ARs for marketed health products within the scope of this guidance document are to be reported to the Canada Vigilance AR Monitoring Program of the Marketed Health Products Directorate (MHPD) of Health Canada. The preferred format for reports is the use of this form from the Council for International Organizations of Medical Sciences (CIOMS). Health Canada also provides a voluntary reporting form for use by consumers and health care professionals which can be viewed here. These regulations in this document apply to the following MHPs:

• prescription and non prescription pharmaceutical drugs

• biologics (excluding blood and blood components and preventative immunization vaccines)

• radiopharmaceutical drugs

• natural health products

There are two types of reports required in the reporting of adverse reactions: Case Reports and Annual or Interim Summary Reports. Two types of ARs require case reports in addition to the Annual or Interim Summary Reports, with some variance on what type of reporting is required between domestic and foreign reactions as follows:

*Licensees must not submit these, but must keep them on file in case a safety concern arises

Case Reports

ARs requiring case reports must be dealt with immediately as the report is due within 15 days of the day you become aware of the reaction. It is essential that your employees are fully trained on how to recognize these serious reactions, obtain the necessary information, and communicate and/or submit it in a timely manner. Health Canada defines serious and serious unexpected reactions as follows:

Serious adverse reaction: “a noxious and unintended response to a natural health product that occurs at any dose and that requires in-patient hospitalization or prolongation of existing hospitalization, that causes congenital malformation, that result in persistent or significant disability or incapacity, that is life-threatening or that results in death.

”Serious unexpected adverse reaction: “a serious adverse reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the natural health product.” i

If a licensee is unable to acquire all the necessary information for the case report within those 15 days they may submit a preliminary report containing the following minimum information:

• an identifiable reporter

• an identifiable patient

• a suspect product

• an adverse reactionii

Licensees are required to provide a follow-up report as soon as the information becomes available to them so that it can be added to Health Canada’s database. The key data elements are outlined on pages 19-22 of the Adverse Reaction Reporting Guidance Document.

Annual and Interim Summary Reports

Summary reports must be kept for all ARs, and must be prepared and submitted annually for all domestic ARs as well as foreign ARs requiring a case report. Summary reports must contain a concise and critical analysis of each reaction, therefore it is essential that complete and accurate information is gathered from the consumer or person reporting the reaction and that each report is analysed on an ongoing basis.

The minister may request the submission of annual and interim summary for any NHP if there is a reason to believe the NHP is no longer safe when used as recommended. The MAH will then have 30 days to submit the requested reports for the evaluation of the product’s safety, therefore it is essential that all reports be complete and kept on file for the required 25 years.

FDA Regulations

The U.S. Food and Drug Administration (FDA) put its current regulations regarding the reporting of ARs into effect in 2007. The reporting requirements are almost identical to those in Canada, and make use of MedWatch, their equivalent to Canada’s MedEffect, for voluntary reporting. Mandatory reports are submitted to the FDA using this form. An important terminology difference that should be noted is that in the U.S., ARs are referred to as “Adverse Events” whereas in Canada “adverse event” is defined differently and is not subject to the reporting regulations discussed in this article.

Are Your Procedures Adequate?

Whether you have a method in place for ARs to be reported to you directly or if they are handled through a contractual arrangement with a third party, the regulatory reporting is ultimately your responsibility. This makes it crucial to ensure that all individuals who may be on the receiving end of an AR report from a consumer or health professional are adequately trained and familiar with regulatory requirements. They must know how to advise the person who suffered the AR, what information to gather, and most importantly they must communicate this information in a timely manner due to regulatory requirements.

Furthermore, there are many parties involved in the manufacturing, packing, marketing, and distribution of MHPs and both Canada and the U.S. have regulations outlining which party is responsible for AR reporting and record keeping. It is important to know where the responsibility falls and to ensure that AR reports are being handled consistently.

How dicentra Can Help

dicentra’s team of professionals can assist you to ensure an adequate system is in place for the reporting of ARs related to your products. Whether your needs are information, training, advice, or a third-party arrangement for handling the reporting of ARs, please contact us for more information.

Erin Riggs, B.A.

dicentra, Inc.

erin@dicentra.ca

416.361.3400 ext.232

iGuidance Document for Industry – Reporting Adverse Reactions to Marketed Health Products, Health Canada 2009, p. 10

iiGuidance Document for Industry – Reporting Adverse Reactions to Marketed Health Products, Health Canada 2009, p. 231