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Drugs and Health Products

Reporting of Adverse Reactions for Naturopathic Doctors

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Slide 1:

Title

Reporting of Adverse Reactions for Naturopathic for Naturopathic Doctors

Narration

Welcome, and thank you for taking the time to learn about an important aspect of public health and patient safety: your role in reporting adverse reactions to drugs, natural health products, and other marketed health products to Health Canada. The reporting of adverse reactions helps Health Canada identify potential product safety issues which can then investigate, and as a result allow patients, clients and health professionals to have access to the most recent safety information so they can make informed choices when they buy and use natural health products.

Slide 2:

Title

Learning Objectives

Narration

When you have completed this module you should be able to:

  • Recognize the importance of reporting adverse reactions
  • Be able to describe an adverse reaction
  • Apply adverse reaction reporting in your current practice, and
  • Be able to report an adverse reaction
  • Know how to use Health Canada's adverse reaction resources

Slide 3:

Title

Why report adverse reactions?

Narration

Over fifty percent of newly-approved health products have serious side effects that are discovered only after the product comes on the market. Clinical trials identify most common serious side effects and the drug can be labeled as per its known safety profile before it is released to market- but once the drug is available, the individuals using the health product may be different that those subjects in a clinical trial. With such a high rate of serious adverse reactions appearing after the health product is on the market, it is critical that Health Canada, as the federal regulator of health products, receives reports of adverse reactions and interactions to monitor the safety profile of the health product.

Yet, it has been estimated that for every adverse reaction that gets reported, up to 10 go unreported.

Health practitioners often discontinue or change a patient's treatment protocol because of an adverse reaction, or because an interaction has occurred, possibly between drugs, natural health products, or something in the patient's diet. While that addresses the immediate problem with the patient's care, it's important to take the additional step: reporting the adverse reaction to Health Canada.

Slide 4:

Title

Why should Naturopathic Doctors report Adverse Reactions?

Narration

Under the Food and Drugs Act, manufacturers of drugs and natural health products must send reports of adverse reactions related to their products to Health Canada. Currently, there are no regulatory requirements for health practitioners to report adverse reactions. But there are ethical considerations, as suggested by the Canadian Association of Naturopathic Doctors in their "Guide to the Ethical Conduct of Naturopathic Doctors."

The first principle of Naturopathic medicine, primum non nocere insists that the Naturopathic Doctor "endeavours to first, do no harm; to provide the most effective health care available with the least risk to his/her patients at all times."

And, as a responsibility to society - the Naturopathic doctor "will strive to improve the standards of medical care and promote health and safety for the individual, the public and the global community. "

Not only are there ethical considerations to reporting, but you, as Naturopathic doctors are a valuable resource to Health Canada in the safety monitoring of marketed health products-through the detection of adverse reactions, and interactions between drugs, natural health products and foods.

Slide 5:

Title

Why you are important

Narration

Let's take a closer look at why you are important in the safety monitoring of marketed health products.

In practice, you often see patients who are on multiple products. Many patients do not tell their physicians if they are using a natural health product along with their other medications. So you may see a more complete picture of a patients health product use.

Patient visits tend to be long and detailed giving your patients the time they need to talk to you about their health.

Your in-depth patient history can provide information which may help you recognize an adverse reaction or interaction the patient has or may experience, including where a patient's diet may play a role.

As a Naturopathic Doctor you have an extensive knowledge of natural health product lines. But do you know the regulatory history of natural health products and how health product regulation introduced in 2004 impacts the safe use of natural health products on the market today? The next few slides will briefly touch upon some of the important changes that have occurred in the way natural health products are regulated in Canada.

Slide 6:

Title

Before 2004: Regulation of health products in Canada

Narration

Before 2004, there were two categories under which most natural health products were regulated: as foods, or as drugs. There was no separate regulatory definition of what constituted a natural health product. That meant that some of those products were considered to be foods, while others were regulated as drugs. According to the Food and Drugs Act,

A Food is defined as a substance that is "manufactured, sold or represented for use as food or drink for human beings". Generally, foods must be safe for consumption, be labeled for nutritional value, and cannot make health claims.

A Drug, on the other hand, is defined as a substance that is "manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms" OR "restore, correct or modify organic functions in human beings or animals". As drugs make health claims, they must be labeled with conditions for use including indications, contra-indications, dose, duration of use, cautions and warnings.

Most foods are not required to go through an evaluation process before they are placed on the market, while drugs must be evaluated for safety and efficacy, and must comply with Good Manufacturing Processes to assure quality.

Slide 7:

Title

Natural Health Products

Narration

On January 1st, 2004, we saw the introduction of the Natural Health Product Regulations.

Look at the definition of a natural health product: it looks almost identical to the definition we saw earlier for drugs.

To be considered a natural health product, a product must contain substances listed in a chart called "Schedule 1".

A simplified version of this schedule is shown on the bottom of the screen. Certain words are highlighted in red for quick reference. The definition of a natural health product also includes homeopathic and traditional medicines.

Like drugs, natural health products can make health claims, and so they must also be properly identified and labelled with conditions of use. Having monographs and adequate labelling allows for options to deal with any new safety concerns that may arise.

Slide 8:

Title

Addressing New Safety Concerns: the Options

Narration

When new safety concerns are identified about a drug, there are options to address the issue.

Because drugs are therapeutic health products, they must be labeled as to their safety profile before they are released to market. If a new safety concern comes to light once a drug is already being used, Health Canada and the manufacturer can make changes to the product label and in the product monograph.

These changes may include:

  • A change in indications
  • Addition of contraindications (such as health conditions, or interactions)
  • A different, or maximum dose
  • A variation in duration of use
  • Addition of cautions and warnings

Before 2004, when some natural health products were considered to be foods, these options were not available, so in some cases, a market withdrawal became the only option to address a safety concern.

In extreme cases, a product may be removed from the market.

When any changes are made about the conditions of use for a product, or if a product is withdrawn altogether, this information is conveyed to Canadians, both to Health Professionals and the Public, through communications such as advisories, and other resource materials.

Slide 9:

Title

Case Presentation

Narration

Let's use a clinical case study to explore how a naturopath, like you, might recognize and follow through on reporting an adverse reaction.

A 27-year-old female patient described her symptoms of Irritable Bowel Syndrome (IBS), with alternating constipation and diarrhea. As well, she was experiencing anxiety and depression. After working with this patient's diet to address the IBS, a Chinese diagnosis of liver chi stagnation with shen disturbance was made for her anxiety and depression. The patient then started on the traditional Chinese herbal formula- Tian Wang Bu Xin Dan (Celestial Emperor Nourish Heart pills) at a dose of 3 tablets TID, and was scheduled for a follow-up in one month. About two weeks after starting therapy, she had an episode of severe abdominal pain radiating to her right shoulder. Alarmed at the severity of the pain, she visited the hospital's Emergency department, where her liver enzymes were tested and found to be elevated. An ultrasound showed non-obstructing mobile gallstones. She returned home, but the next day she was admitted to hospital for three days following a further increase in her liver enzymes.

Slide 10:

Title

Case Presentation cont'd

Narration

While hospitalized, the patient discontinued the herbal formula and her enzymes began to decrease, returning to normal within a week. The question now is whether she should restart the Celestial Emperor Nourish Heart pills or some other therapy, given the possibility that her liver enzyme increase could be associated with the herbal formula.

There are two issues to think about here. First, what should be done for the patient who has experienced the potential adverse reaction? And second, since Health Canada monitors marketed health product safety data through adverse reaction reports (among other resources), should this situation be reported?

Slide 11:

Title

Case Presentation cont'd

Narration

The answer is "YES." Treatment of the patient is a priority. But in addition, this suspected adverse reaction should be reported as soon as possible. Heath Canada's evaluators consider reports like this to be important information for assessing the ongoing safety of marketed health products.

Here are the details you would consider in deciding how to address this particular case.

This patient was not taking any other medications. She smokes cigarettes, but is otherwise a young healthy woman. Her recent annual health exam showed no problems. There is no past history and this is her first presentation of depression and anxiety.

Given that this patients treatment has not been approached using other Naturopathic modalities than nutrition, there are a variety of other treatment choices available.

Slide 12:

Title

Why this could be an adverse reaction...

Narration

In thinking about whether to report this case, you would ask: could the liver enzyme increases have been an adverse reaction to the Chinese herbal formula?

Health Canada describes an adverse reaction as a harmful and unintended response to a health product. In other words, an adverse reaction is any undesirable effect that you even suspect is associated with a health product.

Undesirable patient effects that should be reported include:

  • any unintended effect
  • health product abuse
  • overdose, associated with therapeutic use
  • Interactions, including drug-with-natural health product and natural health product-with-food interactions
  • And, any unusual lack of therapeutic efficacy

Slide 13:

Title

Health Canada wants to know

Narration

Sometimes you may feel uncertain about whether to report suspected adverse reactions. In this case presentation, for example, there might have been just a suspicion that the Chinese herbal formula caused the liver enzyme increases to the extent that the patient needed to be hospitalized. You may also have a suspicion that it could have been the quality of the product the patient used that led to the outcome. For example, perhaps the product was contaminated.

Health Canada does not expect you to know what caused the outcome. You should just report the incident. Your report would not be taken to mean that the herbal formula definitely caused the reaction. It would be seen simply as a report that a reaction had happened. However, if you suspect that the quality of the product was responsible for the adverse reaction in this case, (for example, you think that it may be a faulty or contaminated batch) you could also indicate that in your report, and Health Canada would follow up on that too.

Health Canada asks you to report all suspected adverse reactions, especially the reactions that:

  • are serious, whether expected or not
  • are unexpected, regardless of their severity
  • involve recently marketed products, which means less than five years, regardless of their nature or severity
  • involve unauthorized products, that is, they have not been evaluated by Health Canada and therefore do not display a Drug Identification Number, a Natural Product Number, or a Drug Identification Number-Homeopathic Medicine on the label

Let's take a closer look at what each one of these means

Slide 14:

Title

Serious Adverse Reactions

Narration

Serious adverse reactions are the most important to report, and they should be reported as soon as possible, because their outcomes are the most severe.

By law, manufacturers of health products must report these reactions to Health Canada within 15 days of becoming aware of them.

A serious reaction could:

  • Result in hospitalization (or prolong an existing hospital stay);
  • Cause a congenital malformation;
  • Result in persistent or significant disability or incapacity;
  • Require intervention to prevent damage or permanent impairment;
  • Be life-threatening
  • Result in death; or
  • Be considered otherwise medically significant (such as convulsions, or a serious allergic reaction);

Slide 15:

Title

Also very important

Narration

Also very important to report are unexpected reactions, that is, ones not consistent with the product information or labeling, regardless of severity. These include adverse reactions that are new, or rare (for example, according to the Council for International Organization of Medical Sciences, this means a reaction occuring in between 1 in 1000 to 1 in 10 000 individuals), that were not identified during clinical trials. Similarly, it is important to report all reactions related to products about which safety information is less known, either through a long history of use or by clinical trials.

Adverse reactions involving recently-marketed products are important as well. Why? Because new reactions most often appear within these first five years.

Also, it is important to report adverse reactions involving products which have not been evaluated and authorized for sale by Health Canada. If a product is authorized, it would display a drug identification number (for products regulated as drugs), a natural product number (for natural health products), or a drug identification number- homeopathic medicine (for homeopathic medicines).

While descriptions of reportable adverse reactions such as serious, unexpected and recently marketed seem clear, in practice, some adverse reactions you come across may not fit perfectly into these categories. The thing to keep in mind is this: if you feel, clinically, that a medically significant reaction has happened, but you're not sure if the product is new or if the reaction is unexpected, report it anyway.

Slide 16:

Title

Where to Start

Narration

Now you know why to report and what to report. Here's how to report.

Start by filling in Health Canada's Adverse Reaction report form. There are a number of places to find the form. There is a copy in the back of the CPS that you can photocopy and fill in.

The form is also available online from Health Canada's website, in the MedEffect section. You can complete the form online and print it out, or print the form out and fill it in by hand. When Health Canada finalizes its Adverse Reaction Web Reporting Form for electronic submission, you will be able to submit your completed online form over the internet. Check back later to the MedEffect site to see when this will become active.

Another source to get a report form is to contact a Regional Adverse Reaction Centre to request some copies (their contact information will follow later in this presentation). In any case, you should mail or fax the completed form to your regional Health Canada adverse reaction centre.

If you prefer, you can phone a toll-free number to connect you with a regional adverse reaction centre and speak to someone who can take the information directly from you.

Slide 17:

Title

'Must Have' Entries

Narration

There are four minimum criteria that must be completed on the report form, in order for it to processed;

  • an identifiable patient in Section A
  • a description of the reaction in Section B
  • the suspected product or products involved, in Section C
  • and an identifiable reporter in Section D.

Information in sections A and D, about the identities of the patient and the reporter, is kept confidential. It is only viewed by Health Canada personnel who need it to carry out the responsibilities of their jobs. Any requests for disclosure of personal information would be dealt with according to the provisions of the Access to Information and Privacy Act.

Slide 18:

Title

Patient Information

Narration

In section A, "Patient Information," the form asks you to provide a patient "Identifier". The 'patient identifier' is there strictly for your own reference. It lets you, the reporter, be able to identify your patient if follow-up is needed. In such a case, you'd want to be able to distinguish who your patient actually is. In this space therefore, it's best to use a code that you, the reporter, will recognize later. For reasons of confidentiality, do not provide personal information, such as the patient's name, initials, birthdate or social insurance number for example.

Slide 19:

Title

Required Information

Narration

This slide shows the four minimum (or screening) criteria Health Canada requires in every report, using the example of the case we looked at earlier in this presentation. However, the more details you provide will help with the assessment of the report. We will discuss the information which adds additional value, in a moment.

In Section A, an Identifier (our example uses numbers and letters) has been filled in, along with her age, height and weight.

In Section B, the Adverse Reaction has been described for our case: abdominal pain, liver enzyme increase requiring hospitalization. The words you use to describe the adverse reaction are very important, as this description will get standard medical terminology so the information can be retrieved from Health Canada's database. You would also check the 'hospitalized' box, and insert the date of the reaction and the date of your report.

In section C, the suspected health product (in this case, Tian Wang Bu Xin Dan - Celestial Emperor Nourish Heart pills) has been filled in. You should include the manufacturer's name, although our example doesn't show one. For products which contain several ingredients (for example, a multivitamin), it is preferable to include a list of the ingredients, or a copy of the label along with the report form. The dose, frequency, and therapy dates have also been completed.
And finally, In Section D, Reporter Information, you would give your name, address and phone number, occupation, and indicate whether you area a health professional, as you are the reporter. It is important to note that this section asks for the reporter's name, which won't necessarily be the name of the prescriber or the patient's health.

Slide 20:

Title

Concerns about liability?

Narration

In many cases, the reporter is also the prescriber, and the question has often been raised, "If I am identified in an adverse reaction report, or if I report an adverse reaction a patient has had because of my treatment protocol, am I putting myself at risk for legal action?"

To date, Health Canada has never pursued litigation towards any health professional involved in adverse reaction reports. It is understood that adverse reactions reports are received in good faith - that is, to enhance our knowledge about the safety of a product.

Slide 21:

Title

Value Added

Narration

Let's get back to the report form for our case. So far, we've filled out only the minimum (or screening) criteria. But there is other information you should include too, details that give additional quality criteria, that is, information that adds real value to the report. They may be indicators of causality that help Health Canada detect early warning signs.

What other information should you add to your report?

Time-lines are very important, specifically the date the reaction took place, and the date the patient started the natural health product or drug. The evaluators working at Health Canada, consisting of Epidemiologists, Medical Doctors, Naturopathic Doctors, Nurses, Pharmacists, Toxicologists and other scientists, consider this information when evaluating the link between the product and the reaction.

As well, information about the patient's health condition in the past, any relevant lab data, a description of what happened when the patient stopped the natural health product, or what happened if they started using it again are all important for assessing whether there is a cause-and-effect relationship.

In the field requesting Relevant tests/lab data, for our case study, you'd give any baseline lab values, the AST/ALT values for the days your patient was admitted to hospital, and any follow up results which may be relevant. If you have the actual lab reports, you could submit copies of them as well. In the Relevant history field you would describe the patient as a social smoker (about one pack a week) and also note the dietary changes that were made to address her symptoms of IBS.

Slide 22:

Title

Value Added

Narration

The form asks whether the reaction abated after use of the product was stopped or if the dose was reduced. Given that the liver enzymes returned to normal once our example patient was admitted to hospital and the herbal formula was discontinued, you'd simply check-off the 'Yes' box in this case.

The field that asks about the reaction reappearing after reintroduction does not imply that the patient should be put back on the product just to see if the reaction reappears. However, if the patient ends up coming back to this herbal formula at some time soon, whether she again reacts with increased liver enzymes, or doesn't, would be useful information. For our example case, as there is no intention at this time to reintroduce the herbal formula, you'd check off the 'doesn't apply' box.

If your patient was taking other drugs or health products during the time of the adverse reaction, these products should be listed in the section for concomitant drugs. It's a good idea to indicate 'no other products taken' if this was the case, rather than leaving this space blank.

Slide 23:

Title

Products Reported on the AR Form

Narration

The adverse reaction report form we've just reviewed is used for some products, but not for others.

Look over the list of health product types this form is used for. Do any of these surprise you?

Any thoughts on which products would not be reported with this form?

Slide 24:

Title

Products NOT Reported on this Form

Narration

Adverse reactions to some health products are not reported on this form. Did you come up with some of these?

Preventative vaccines like the MMR. For these vaccines, health professionals report to local, provincial and/or territorial public health authorities about events they feel are associated, because of their timing, with a vaccination. These authorities, along with manufacturers, forward all such reports for aggregation on a national level to the Public Health Agency of Canada. This form is available online or in the appendices of the CPS.

Adverse reactions to medical devices get reported to another part of Health Canada: the Health Products and Food Branch Inspectorate. There is a specific form for reporting medical device problems.

Both of these forms can be found along with the adverse reaction report form we've just seen, in the MedEffect section of the Health Canada Website. The weblink will be shown again at the end of the presentation.

Slide 25:

Title

Will Health Canada contact the Reporting Practitioner?

Narration

You may be wondering, will you hear back from Health Canada after you report an adverse reaction? The answer is yes!

When Health Canada receives your report about a reaction, your Regional Adverse Reaction Centre will send you a letter thanking you for your report and giving a reference or tracking number. This tracking number would be used if follow-up information becomes available or if more information is needed at a later date, for example, if there was a biopsy or autopsy report, or for other clarification.

Health Canada may contact you to request further information, or, should you have obtained information which may be relevant to the assessment of the case, you may forward it to a regional centre, referencing the tracking number assigned to your report.

Slide 26:

Title

What does Health Canada do with the AR report form?

Narration

Now that you've done your part by sending in an adverse reaction report, what does Health Canada do with it, and with others they receive?

Adverse reaction reports are first screened for the four minimum criteria mentioned earlier: an identifiable patient, a reporter, a suspect drug, and a reaction. The report is entered into the database of the Canadian Adverse Reaction Monitoring Program.

The report is assessed as to 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 when similar situations are reported.

Product-related safety issues could show up through Health Canada's review of adverse reaction reports, as well as through other information on product safety. A potential product-related issue is called a 'Signal'. At this point, it is considered only to be a preliminary indication. Detecting a safety signal triggers the market authorization holder and/or Health Canada and/or other interested scientists and academics to investigate a potential association between the product and the adverse reaction further. As a health professional, your ability to add clinical details is important, because it makes the information that much more valuable to the evaluators and Health Canada.

Evaluators assess adverse reaction reports from the database, along with other relevant sources of information, as part of the overall safety assessment of a product to determine if there are problems that would require action. For example, changes in the conditions of use (as we saw earlier) such as a change in indications, addition of contraindications, a change in dose, or addition of cautions and warnings. These actions are communicated to both Health Professionals and the Public, through communications such as advisories, and other resource materials.

Slide 27:

Title

A reminder: here's where you get the form

Narration

Just a reminder: the adverse reaction report form is available on the Internet from the Health Canada website, in the MedEffect section; you can find it at the back of the CPS and photocopy it; or request copied from you regional adverse reaction centre

Slide 28:

Title

What do I do with the form?

Narration

You can fax the report form toll-free, or send it through the regular mail with a stamp, to your closest Regional or National Adverse Reporting Centre. The contact information for these centres is given 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 or National Adverse Reporting Centre, and you can report in person.

The form is available online on the Health Canada Website in the MedEffect section. You can fill it out online and print it, or print a copy and complete it by hand. Once electronic submission becomes functional, you will be able to submit your report electronically if you prefer.

Slide 29:

Title

Reference Material

Narration

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 right hand side of 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.

The links to the advisories, the newsletter, and the sign up for the MedEffect e-Notice bring you directly to the information.

Another useful feature is the online search capability of the Adverse Reaction Database to see what's been reported. The database search function has a few more steps. Let's take a quick look how to get there.

Slide 30:

Title

Reference Material

Narration

While we describe the links, think about a product for which there may be reports of adverse reactions. This could include a pharmaceutical or natural health product.

From the MedEffect homepage, click on "Search the adverse reaction database'
This will bring you to the Adverse reaction database welcome page. This page describes the two ways you can retrieve data: either by searching online, or by downloading ACSII files.
Scroll to the bottom, and click the link to bring you to the next page.

This page talks briefly about the adverse reaction database and lists some caveats about interpreting the data you receive. For example, it's important to know that the information here is raw data, that is, there is no analysis of causality. The information is exactly what reporters have provided, with personal information removed. All of the caveats are explained before you begin a search.

Once you get to the bottom on the page, select the link on the left to confirm that you have read and understood the preceding statement, to continue to the search.

And here you are! When you report an adverse reaction, this collection of data is what you're going to be contributing to!

We've now come to the end of our presentation. At this point, we hope that you will be better able to recognize the importance of reporting adverse reactions and apply adverse reaction reporting in your current practice. This includes describing and reporting adverse reactions, and knowing how to use some of Health Canada's adverse reaction informational resources.

On a final note, did you think about a product you'd like to look up in the online database? If so, to get you started, click on the hyperlink at the bottom of the page, and welcome to MedEffect!