Health Canada
Symbol of the Government of Canada

Common menu bar links

Drugs and Health Products

Health Professional Reporting of Adverse (Drug) Reactions

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

This audio-visual presentation is available in your choice of four formats:

  1. An HTML version showing the text of the slides and the narration.
  2. A narrated Microsoft PowerPoint slide show.
  3. A PDF version showing the text of the slides and the narration.
  4. A narrated Flash version of the slide show.

Slide 1

Health Professional Reporting of Adverse (Drug) Reactions

A Vital Link in the Patient Safety Chain

Educational Module for the Health Professional

Audio Script:

P1: (Health Canada representative):
Welcome, and thank you for joining us today to learn about an important aspect of patient safety: reporting of adverse reactions to drugs and other marketed health products. At the end of this presentation, you should be more knowledgeable about adverse reaction reporting. You should also become more motivated to, and better able to:

  • Describe an adverse reaction
  • Associate adverse reaction reporting with your current work practice
  • Describe the adverse reaction reporting process
  • Report an adverse reaction

Some physicians have discontinued or changed their patients' medication regime due to adverse reactions associated with a particular drug. While this information is very valuable to Health Canada, it is often not reported because the physician or any other member of the patient's health care team does not realize that the reaction should be reported, is unfamiliar with the reporting process or falsely believes that only proven adverse reactions should be reported.

With over 50% of newly approved therapeutic health products having serious side effects that are discovered only after the product is on the market, the need to report is critical. It has been estimated that for every adverse reaction that gets reported, up to 10 go unreported. It is for these reasons that there is a need to stimulate the reporting of adverse reactions by health professionals.

I invite you now to listen to a case presented by one of your colleagues to help explain the process and role of adverse reaction reporting towards improved patient safety.

Slide 2

Case Presentation

  • 32 year old male with depression
  • prescribed drug Sertraline 50 mg daily
  • presented with severe diarrhea, syncope
  • required hospitalization for rehydration

Audio Script:

P2: (health care professional)
A 32 year old male patient was diagnosed with depression a month & a half ago. He was started on Sertraline 50 mg daily. A week after starting therapy, he developed severe diarrhea. He lost consciousness, fell and was admitted to hospital for rehydration.

Slide 3

Case Presentation Cont'd

  • While hospitalized
    • taken off Sertraline
    • diarrhea stopped
      ...possible association?
  • Treatment
  • Public Health care

Audio Script:

P2: While in hospital, Sertraline was discontinued and the diarrhea resolved. He is coming to see me today to discuss restarting his Sertraline or some other treatment. I'm concerned that his severe diarrhea may be due to Sertraline: I don't want to restart the Sertraline.

P1: There are actually two problems here to deal with. First, what should be done for the patient and secondly how Health Canada is involved in the adverse reaction of this patient.

P2: This patient has not used any other antidepressant, so there are many other treatment choices available.

Slide 4

Case Presentation Cont'd

  • Suspected adverse reaction
    • report to Health Canada
  • Approaches to this case
    • treatment
    • health care

Audio Script:

P1: Even with going onto another antidepressant, it is important to report this suspected adverse reaction to Health Canada. From a Health Canada medical evaluator's point of view, they'd tell you how important it is for you to let Health Canada know about adverse reactions that you think your patients have experienced.

P2: This patient is not taking any other prescribed medications and is not regularly using any OTC or natural health product. He is a young healthy man, with an unremarkable recent annual health exam. There is no relevant past history of concern. This is his 1st presentation of depression and there are a variety of therapeutic choices available for the treatment of depression.

Slide 5

Could this be an ADR?

  • Harmful and unintended response
  • Undesirable patient effect
    • unintended effect
    • health product abuse
    • overdose
    • interaction e.g., drug-drug, drug-food
    • unusual lack of therapeutic efficacy

Audio Script:

P2: I suspect that the severe diarrhea that lead to my patient being hospitalized, has been an adverse reaction to his medication.

P1: Health Canada describes an adverse reaction as a harmful and unintended response to a health product. This includes any undesirable effect suspected to be associated with the use of a health product.

Examples of undesirable effects reportable to Health Canada include:

  • Any unintended effect
  • Health product abuse
  • overdose
  • Interaction (including drug-drug and drug-food interactions)
  • And any unusual lack of therapeutic efficacy

Slide 6

Health Canada Wants to Know

  • Suspected adverse reactions that are:
    • serious
    • unexpected
    • recently marketed (< 5 years)

Audio Script:

P2: I'm uncertain about reporting this reaction as I only suspect that the severe diarrhea might be due to the Sertraline.

P1: So even if you are just thinking this might be an adverse reaction, report it anyway. You are not saying that the drug caused the reaction - you are reporting the reaction. If you think the reaction might be from the drug and it's a bad or serious reaction, Health Canada wants to hear about it.

In addition to reporting serious reactions, Health Canada also wants to hear about any reaction that seems unexpected to you, that is, if it's not consistent with the product information or labelling regardless of severity; and they want to hear about any adverse reaction to a product that you believe has been available for less than 5 years.

Slide 7

Serious Adverse Reactions

  • Serious is defined by:
    • hospitalization (initial or prolonged)
    • congenital malformation
    • disability
    • required intervention to prevent damage/permanent impairment
    • life-threatening
    • death

Audio Script:

P2: What defines a 'serious' reaction that should be reported?

P1: Health Canada has definitions of what 'serious' entails, and therefore what it wants reported to them. For example: a serious effect would require hospitalization or prolong an existing hospital stay; it may have caused congenital malformation, persistent or significant disability or incapacity; have required an intervention to prevent damage or permanent impairment, was life-threatening or resulted in death.

Slide 8

Where to Start

  • Health Canada Adverse Reaction Reporting Form
    • CPS
    • Online
      Health Canada's MedEffect Web site
  • Fax or mail or phone Health Canada

Audio Script:

P2: The principle of reporting is clear. How would I actually go about it?

P1: This is what discourages a lot of health professionals from reporting: where to start. There are a number of ways to report. There is a written form in the back of the CPS to photocopy, fill in and send to Health Canada. The form is also available on line from the Health Canada Web site in a section called MedEffect. In addition to faxing or mailing in the form, a health professional can phone a toll free number and speak to someone who can take the information from the caller.

Slide 9

'Must Have' Entries

  • Identifiable patient
  • Description of the reaction
  • Suspected health product
  • Identifiable reporter

Audio Script:

P2: So here I have the form.

P1: There are 4 pieces of information that must be entered on the form; an identifiable patient in Section A: a description of the reaction in Section B; a suspect health product in Section C, and an identifiable reporter in Section D .

Information on the identity of the patient and the reporter of the adverse reaction is kept strictly confidential. Personal information will not be disclosed to anyone except Health Canada personnel who need the information to carry out responsibilities of their job. Any requests for disclosure of the personal information would be dealt with according to the federal Privacy Act.

Slide 10

Section A: Patient Information

  • Health professional to identify their patient
  • Follow-up purposes
  • Code recognizable to health professional only
    • no names

Audio Script:

P2: In section A "Patient Information" it says "Identifier". How should I identify my patient? And why is it necessary?

P1: The 'patient identifier' is strictly for the health professional to identify their patient in the event that follow-up is needed, in which case they would want to be able to identify their patient in some way. A code, recognizable to the patient's health professional only, is best put here - no names.

Slide 11

Required Information

Audio Script:

P2: For this patient I'd write:
Identifier - DEF22310.
Adverse Reaction - severe diarrhea with syncope requiring hospitalization

P1: The words used to describe the adverse reaction are very important here as this description will get a medical code so the information can be retrieved from the database as needed.

P2: Suspect drug - Sertraline 50 mg daily;
Reporter - Dr. A. Reaction, Suite 2A, Pine Way, Ottawa. 613 555-1212

Slide 12

Additional Information

Audio Script:

P2: So the 4 'must have' pieces of information have been given. There are other fields of the form still blank.

P1: The remaining fields when filled in add value to the report. They become indicators of causality to help Health Canada detect early warning signs.

Slide 13

Value Added

  • Date of reaction
    • 06/01/2005
  • Therapy dates
    • 29/12/2004 to 06/01/2005
  • Relevant tests/lab data
    • none
  • Other relevant history
    • na

Audio Script:

P2: Section A.2 "age at time of reaction" (32 years). Sex- "male". Date of reaction I will have to refer back to the patient's chart.

P1: Time-lines are very important to Health Canada - when the reaction took place, and when the patient started the drug. The physicians and scientists working at Health Canada look at these reports to decide whether the suspected drug is likely to have caused the reaction. Indications of a temporal relationship are important.

P2: Date of reaction.......on or about January 6, 2005. Therapy dates....started 29 Dec 2004 and discontinued 6 Jan 2005.

P1: The patient's health condition in the past, any relevant lab data, what happened when the patient stopped the drug, or if they started the drug again. All this information is very important to note.

P2: Relevant tests/lab data....none. Nothing to report as relevant history, other than the depression the patient is being treated for.

Slide 14

Value Added

  • Concomitant health products
    • no other drugs taken
  • Reaction abated after use stopped or dose reduced
    • yes
  • Reaction reappeared after reintroduction
    • na

Audio Script:

P1: If a patient was taking other drugs or health products during the time of the adverse reaction, these products should be listed in the section calling for concomitant drugs. It is also good to write ' no other drugs taken' rather than leaving this space blank.

P2: The form asks whether the reaction abated after use stopped or dose reduced. The severe diarrhea did resolve once he was admitted and the Sertraline was discontinued, so that would be a 'Yes'. Here I'm asked about the reaction reappearing after reintroduction. I do not plan to reintroduce this medication. Is Health Canada suggesting that I reintroduce the Sertraline for the purpose of this report?

P1: This information field does not imply that the patient should be put back on the drug just to see if the reaction reappears. However, if the patient ends up coming back to this drug some time soon, whether he again reacts with severe diarrhea or doesn't, would be useful information to tell Health Canada as follow-up information.

Slide 15

What does Health Canada do with the AR report form?

  • Reports Received
  • Initial Screening
  • Data Entry
    • Canadian Adverse Drug Reaction Information System
  • Report Assessment
    • (serious, medical terminology)
  • Detection of Signals

Audio Script:

P2: I will send the form to Health Canada. From what I understand, the report is then entered into a database.

P1: The adverse reaction report forms received are screened for the 4 minimum criteria mentioned earlier: an identifiable patient & reporter, a suspect drug and a reaction. When all 4 are present, the report is entered into the Canadian Adverse Drug Reaction Information System database.

The report is further assessed regarding the seriousness of the reaction, and a standard medical terminology is used to classify the reported information. Assigning standard medical terminology helps ensure that the same term is applied in similar situations reported.

Signals may be identified through the systematic review of adverse reaction reports plus any other additional information on product safety, and may be early indicators of a product-related issue. Detecting a safety signal triggers the need for Health Canada to investigate further a potential association between the product and the adverse reaction.

Medical evaluators use adverse reaction reports from the database (among other relevant sources of information) to determine if the suspect drug could have caused the reported reaction. Health professionals are encouraged to report their cases in as much detail as possible because it makes the information that much more valuable to the medical evaluators and Health Canada.

Slide 16

Products Reported on the AR Form

  • Prescription drugs
  • Non-prescription drugs
  • Natural health products
  • Radiopharmaceuticals
  • Biologics
    • blood products
    • biotech drugs
    • therapeutic and diagnostic vaccines

Audio Script:

P2: I am now comfortable reporting adverse reactions to prescription drugs, as with this report of the suspect drug Sertraline. Are adverse reactions for all health products reported using this same form?

P1: The type of health product to which this form would apply include:

  • prescription and non-prescription drugs
  • natural health products
  • radiopharmaceuticals, and
  • biologics, which could be blood products like albumin, immunoglobulins, solvent detergent treated plasma, clotting factors - both human and recombinant; biotech drugs, and therapeutic and diagnostic vaccines.

Slide 17

Products NOT Reported on this Form

Audio Script:

P2: How would I report an adverse reaction to vaccines?

P1: Preventative vaccines like the MMR are monitored by the Public Health Agency of Canada. For these vaccines, health professionals should report to their local public health department. You can complete a copy of the Adverse Events Following Immunization reporting form and mail or fax it to the address mentioned on the form, which is available on the Internet or in the appendices of the CPS.

An adverse reaction to a medical device gets reported to another part of Health Canada: the Health Products and Food Branch Inspectorate. You'll find this form by clicking on the 'Compliance and Enforcement' section on the left hand side on MedEffect's main page followed by the "topic" called "Problem Reporting".

Slide 18

When will Health Canada contact the Reporting Health Professional?

  • Acknowledgement letter
    • thank you
    • reference number

Audio Script:

P2: What follow-up on this report could I expect from Health Canada.

P1: After reporting this reaction, an acknowledgment letter is sent thanking the reporter for their report and a reference or tracking number is given should any follow-up information become available or be needed at a later date, e.g., a biopsy or autopsy report, or any other clarification where needed.

Slide 19

Where can I get the form?

  • Internet
  • CPS

Audio Script:

P1: As was mentioned earlier, the adverse reaction report form is available on the Internet from Health Canada's MedEffect Web site, or you can go to the back of the CPS and photocopy the form that's there.

Slide 20

To make a report

  • Online reporting
  • Paper copy report form
    • toll-free fax: 1-866-678-6789
    • mail (stamped envelope)
  • Toll-free phone
    • 1-866-234-2345

Audio Script:

P1: You can fill out and submit a report form online. Or you can fax the report form toll-free, or send it through the regular mail to your closest Regional Adverse Reaction Monitoring Office: the contact information is listed on the back of the report form.

Or, you can call the toll-free number on the form. Your call will automatically be routed to your local Regional Adverse Reaction Monitoring Office and you can report in person.

Slide 21

Reference Material

Audio Script:

P2: I now have a good understanding of the process and role of adverse reaction reporting and that the adverse reaction information health professionals send to Health Canada helps accumulate important safety information for assessing new or evolving patterns of risk.

P1: Let's now briefly look at some of Health Canada's adverse reaction informational resources. A number of reference documents to help you with the reporting process can be found in the MedEffect section of Health Canada's website. You can simply go to the web address posted on this slide, or do an internet search for MedEffect to find more information on the topics listed on the screen. Some of the features which may be most clinically relevant are the most recent advisories, warnings and recalls, and the quarterly Canadian Adverse Reaction Newsletter. If you'd like to receive the advisories and newsletter automatically via your email account, you can sign up to receive the MedEffect e- Notice.

Slide 22

Suspect an Adverse Reaction?

Please report it!

Audio Script:

P2: Given that a suspicion is quite possibly the best tool that a clinician has in identifying an adverse reaction, the next time you suspect your patient is presenting with an adverse reaction - please report it to Health Canada.

Slide 23

Thank You!

Audio Script:

P1: Thank you!