Reporting Harm Caused by Medicines
FACTS TO ACT ON FROM WOMEN AND HEALTH PROTECTION
Written by Colleen Fuller and Diane Saibil in collaboration with Women
and Health Protection
People use medicines to treat a range of conditions, from minor ailments to life-threatening illnesses, as well as to prevent the onset or worsening of medical conditions. All medicines have a variety of effects, some beneficial, some neutral, and some that are harmful. These effects may occur in all, most, or only a few people. Most of what we hear and read about medicinal drugs are messages from the drug manufacturers that focus on benefits. The harmful or unexpected effects receive less attention and are called ‘adverse drug reactions’ or ‘side effects’. This language makes the downside of medications seem less important.
Women use medications more frequently than men and it is usually a woman who is responsible for a family’s purchase and use of medicines. This fact sheet explains why it is essential for women to report all cases of known or suspected harm from medicines. It also provides the information you need to file a report.
Why report harm caused by medicines?
Before a new medicine can be sold or used in Canada, it must be approved by Health Canada. To get approval, the manufacturer must submit for review all knowledge of the drug, including individual reports of unexpected harm and the results of clinical trials. The process is primarily designed to find out if a drug is safe and effective in treating or preventing a specific medical condition. Health Canada also collects and tabulates all reported harm associated with the drug. The Health Canada reviewer then makes a judgement about whether the anticipated benefit of the medicine outweighs any risk of harm that it might cause.
Unfortunately, this process is far from perfect and must be seen only as a starting point in assuring that a drug is safe. Although clinical trials are designed to determine the safety and effectiveness of new medicines, the number and types of people in these trials is often limited and the testing period may be quite short. As a result, the trials may not give information about the effects of the medication when it is used for a long time or in a more diverse population. Therefore, it is extremely important to continue monitoring the effects of medicines after they have been approved. Only with time and with broader use can unexpected effects be detected.
There have been far too many cases of medications that have caused serious harm, including long-term illnesses or disability and sometimes death, after they were approved for use. Examples include the pregnancy drug DES that was given to millions of women worldwide until it was found to cause serious harm to the children of women who took it; hormone replacement therapy, also used by millions of women worldwide before it was found to increase the risk of breast cancer and cardiovascular disease; and more recently; the pain relief drug Vioxx, also used by millions, withdrawn from the market because it was found to increase the risk of cardiovascular disease in users.
Effective, government-sponsored post-approval surveillance could detect these harmful effects and lead to better prescribing practices by health professionals. However, the Canadian system for monitoring approved medications has relied on voluntary reporting of harm or suspected harm. This may change in the near future if reports by doctors become mandatory, but the system will only work effectively if both physicians and consumers report their experiences.
What should be reported?
When a person experiences serious harm while on medication, it is not necessary to determine whether or not the medication was the cause of the harmful effect. Harm should be reported if the person believes an adverse reaction is linked to the medication – evidence is not required. Harm or unexpected effects should also be reported even if you think that what you are experiencing is common knowledge, because it is important for regulators to know how frequently an effect occurs.
Health Canada Definitions
Health Canada defines harm caused by medicines as follows:
Adverse drug reaction : a noxious and unintended response to a drug, which occurs at doses normally used or tested for the diagnosis, treatment or prevention of a disease or the modification of an organic function.
Serious adverse drug reaction : a noxious and unintended response to a drug that occurs at any dose and that requires in-patient hospitalisation or prolongation of existing hospitalisation, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death.
Serious unexpected adverse drug reaction : a serious adverse drug reaction that is not identified in nature, severity or frequency in the risk information set out on the label of the drug.
An adverse drug event means any adverse occurrence in a person to whom a drug is administered. The event may be caused by the administration of the drug (a medication error) or by the drug itself (an adverse drug reaction).
In plain language, an adverse drug reaction (ADR) is any harmful effect that occurs where it is suspected that a medication is the cause, whether the effect is serious or not and whether the effect is expected or not.
How does Health Canada monitor harm caused by medicines?
Health Canada is responsible for monitoring the safety and effectiveness of medicines and for providing information to consumers about drugs approved for the Canadian market. The Canadian Adverse Drug Reaction Monitoring Programme (CADRMP) is the Health Canada program that collects and analyses what they term ‘adverse drug reaction reports’. CADRMP maintains a computerized database – the Canadian Adverse Drug Reaction Information System (CADRIS) – with information about all reported ‘adverse drug reactions’. There are three sources for this information: health professionals, manufacturers and consumers.
Doctors, pharmacists and other health professionals report harmful effects on a voluntary basis, although reporting by doctors may become mandatory in the near future. The law requires manufacturers to submit reports of serious harm. However, most manufacturers will only report if the case is considered ‘reportable’ (that is, the report is considered relevant by a medical professional in the industry).
Most experts estimate that, overall, only between 1% and 5% of harmful effects are reported to Health Canada. Therefore, reporting to a health professional or a manufacturer does not ensure that a consumer’s concerns get to Health Canada and does not provide Health Canada with enough data to effectively detect and monitor harmful and unexpected effects of medications.
Even if it becomes mandatory for doctors to report cases of suspected harm, they are unlikely to report everything that a consumer might think of as harm caused by a medication. As well, the person experiencing the harm is likely to provide a different perspective from that conveyed in a doctor’s report. Fortunately, Canada is one of a growing number of countries that permit consumers to report harmful effects directly to government.
How to report
If you suspect that you, or someone you know, has experienced a harmful effect while taking a medication, you can report it on the CADRMP website, or by telephone, fax, mail or e-mail. Health Canada requires that a report from a consumer identify:
- the person reporting (It is possible to report on behalf of another person, for example, a child or parent),
- the person who has experienced the harm (even if not precisely identified by name and date of birth),
- the name of the medicine that is suspected to be the cause, and
- a description of the reaction the person has had.
It is important to also include information about the age and sex of the person who experienced a harmful effect, as medicines are known to have differing effects depending on age and sex. Information that could identify individuals is protected under Canada’s privacy laws.
To report directly to Health Canada
on-line, go to www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.pdf,
by telephone , call 1-866-234-2345,
by fax , dial 1-866-678-6789.
Toll free telephone calls are routed to one of five regional centres or the National Adverse Reaction Centre. You can also contact these centres directly as follows:
British Columbia Regional AR Centre
Tel: (604) 806-8625 Fax: (604) 806-8262
Ontario Regional AR Centre (London)
Tel: (519) 663-8801 Fax: (519) 663-2968
Atlantic Regional AR Centre
Tel: (902) 473-7171 Fax: (902) 473-8612
Saskatchewan Regional AR Centre
Tel: (306) 966-6329 Fax: (306) 966-2286
Québec Regional AR Centre
Tel: (514) 338-2961 Fax: (514) 338-3670
All other provinces and territories
National AR Centre
Tel: (613) 957-0337 Fax: (613) 957-0335
To report adverse incidents associated with medical devices, contact the medical devices hotline at 1-800-267-9675.
There are a number of ways Canadian women can stay informed about the safety of medicines and medical devices and share information with others.
- The Marketed Health Products Directorate (MHPD) within Health Canada publishes the Canadian Adverse Reaction Newsletter available by subscription (free of charge) to all Canadians by regular mail or by e-mail. Three Health Canada directorates (MHPD, the Therapeutic Products Directorate and the Biologic and Genetic Therapies Directorate) post safety alerts, public health advisories, press releases and other notices for both consumers and health professionals.
- PharmaWatch, a national non-profit consumer advocacy group based in British Columbia, monitors adverse drug reaction (ADR) reports on behalf of consumers and provides information about the ADR profiles of prescription drugs. Consumers can report ADRs to PharmaWatch directly by phone at 1-866-234-3411 (toll free in British Columbia only) or 1-604-687-6729 (for the rest of Canada). Reporting and information are also available on-line at www.pharmawatch.net.
- A number of policy and research-oriented women’s health organisations provide information related to medical safety issues that pertain specifically to women. These include Women & Health Protection ( www.whp-apsf.ca/en), the Canadian Women’s Health Network (www.cwhn.ca), the Yukon Women’s Directorate (www.womensdirectorate.gov.yk.ca), Women’s Health Clinic in Winnipeg (www.womenshealthclinic.org), the Vancouver Women’s Health Collective (www.womenshealthcollective.ca), and la Fédération du Québec pour le planning des naissances (www.fqpn.qc.ca ).
- There are a number of non-governmental consumers’ groups working in this area. A dvocacy-oriented groups include: The Society for Diabetic Rights (www.geocities.com/beefandporkinsulin), The Benzodiazepine Awareness Network (www.benzo.org.uk), and D.E.S. Action Canada (www.web.ca/~desact). Some groups, such as Breast Cancer Action Montreal (www.bcam.qc.ca/bcamhome.htm), are involved specifically in women’s health issues. A growing number of groups are taking advantage of the Internet to connect consumers with similar concerns. The Depo Provera Users’ Group (http://groups.msn.com/DepoProveraUsers/yourwebpage.msnw) is an example of an Internet-based group. Keep in mind that some groups are more informed and/or independent of commercial ties than others. It’s just as important to make informed choices about consumer groups as it is about prescription drugs. If you are uncertain about any particular group, contact PharmaWatch, Women and Health Protection or the Canadian Women’s Health Network.
For more information...
For background information about reporting harm caused by medicines, including the rationale for reporting by consumers, see Post-Market Surveillance of Therapeutic Drugs in Canada and Women and Adverse Drug Reactions, Reporting in the Canadian Context. Both documents can be found at www.whp-apsf.ca.
Copyright ©2006-2010 Women and Health Protection