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Health Canada's Approach to the Inclusion of Risk / Safety Information Communication (Section 2.21) in the Revised Consumer Advertising Guidelines for Marketed Health Products
(for nonprescription drugs including natural health products)
Prepared for the Invitational Roundtable of June 28, 2006
Hosted by
Office of Consumer and Public Involvement
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
1) Introduction
The proposed revised guidelines state that in order to make informed decisions about their health, consumers should be provided with fair and balanced information about the benefits and the risks associated with the use of the advertised product. This statement is compatible with Section 9(1) of the Food and Drugs Act which prohibits false, misleading or deceptive advertising of a drug. In proposing these revised guidelines, Health Canada has considered multiple factors such as the practices of other international regulatory agencies, the previous 1990 Consumer Drug Advertising Guidelines, the current environment, the Government of Canada Precautionary Approach, adverse reaction data, literature findings and survey results. The overall objective is to provide Canadians with fair and balanced information in order to help them make more informed decisions about their own health.
Section 2.21 (Appendix A) of the revised Consumer Advertising Guidelines requires that risk information, if applicable, be conveyed to consumers when advertising nonprescription drugs and natural health products. Following the February 2005 and April 2006 consultations on these guidelines, it became evident that consensus of opinion regarding the presentation of risk or safety information in advertising had not been reached. Some stakeholders believe that the labelling material already provides all the information about the risks associated with a product, that the inclusion of such information in advertising is not useful, and further that consumer education is not the purpose of advertising. Other stakeholders believe that to make an informed decision about their health, consumers should be provided with all the facts about the product, including a balanced message, prior to the purchase of a nonprescription product. They believe that omitting to do so could be misleading.
The purpose of the roundtable discussion on June 28, 2006 is to enhance the dialogue with stakeholders regarding communication of risk information in advertising. Stakeholders will have the additional opportunity to review and provide feedback on Section 2.21 to propose the most viable options whereby consumers have access to the information they need to make informed decisions and manufacturers can appropriately advertise their products. These discussions will help in determining whether the proposed measures are appropriate and if not, how can they be improved to achieve the objective of having better informed consumers without unduly infringing on manufacturers' ability to advertise their products.
Self medication is becoming an increasingly important area within healthcare. It moves patients towards greater independence and empowerment in making decisions about management of minor illnesses. Self medication also has potential advantages for healthcare systems as it facilitates better use of clinical skills, increases access to medication and may contribute to reducing prescribed drug costs associated with publicly funded health programmes. However, self medication is also associated with risks such as misdiagnosis, use of excessive drug dosage, prolonged duration of use, drug interactions and polypharmacy (Carmel 2001).1 Patients wish to have a greater role in their own treatment choices and in order for them to be able to make appropriate decisions about their own health, they must have access to all relevant information prior to the purchase of a product. Although nonprescription drugs and natural health products are generally safe they can cause problems in certain instances. For example, Vitamin A can have serious adverse effects at high dosages, including birth defects, and Ginkgo biloba can interact with blood-thinning prescription drugs.
Incorrect or inappropriate use may arise from a lack of information and knowledge on the part of the patient (Carmel 2001).1 Information demonstrating public ignorance of package inserts/product monographs while at the same time paying attention to product advertising highlights the appropriateness of providing balanced information about benefits and risks in advertising. Because advertising has an influence on consumer perception and behaviour, Section 2.21 of the revised Consumer Advertising Guidelines outlines to advertisers how they should provide balanced information to patients when advertising nonprescription drugs and natural health products to the general public.
Top of Page2) Section 9(1) of the Food and Drugs Act
2.1 Definition
Section 9(1) of the Food and Drugs Act has existed since 1953 and reads as follows: "No person shall label, package, treat, process, sell or advertise any drug in manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety"
2.2 Interpretation
The intent of Section 9(1) of the Food and Drugs Act is, in part, to protect consumers from being misled by or from being exposed to advertising material which could create an erroneous impression as to the merits or safety of an advertised product. The revised section 2.21 of the Consumer Advertising Guidelines supports the intent of Section 9(1) of the Act and explains what Health Canada considers to be acceptable practices and provides guidance to industry to facilitate compliance to the Act.
Section 9(1) is relevant, useful and reasonable. It is well written, clear and concise and the broad scope is accomplished with clear and simple language. It conveys the same information in a few words that foreign legislation has taken pages to express. However, enforcement actions under this section are not necessarily straight forward. Whether a product's label, package, or advertising is false is a relatively straight forward matter and can be easily proven. However, determining whether a product's label, package, or advertising is misleading, deceptive or likely to create an erroneous impression is a more complex process (Legislative Renewal, 2003)2. The revised Guidelines are intended to clarify Health Canada's interpretation of "misleading" or "deceptive" so as to reduce any disputes and complaints.
2.3 Clarification Regarding the Application of Section 2.21
The first part of the application subsection of Section 2.21 (Appendix A) requires that consumers are always advised to read the label, follow directions of use and be provided with an easily accessible source of additional information. This would apply to all nonprescription drugs including natural health product advertising material.
The second part of the application subsection of Section 2.21 requires that, when applicable or where appropriate, consumers are advised of the risks (side effects, drug interactions or contraindications) associated with the use of the product, and to consult a health professional for additional information or appropriate advice. This only applies to products for which risks and contraindications have been identified. As risks or contraindications are specific to each marketed health product, each advertisement will have to be designed to accommodate the particular product. Thus, sound scientific judgement will be required on a case-by-case basis, to determine the appropriate presentation of risk information that should be included in a given advertisement. When appropriate, a specific statement highlighting a specific risk followed by a general statement such as "See labelling for risk information" could be added. For example, if a product is known to be associated with a specific risk or contraindication that may be harmful to a targeted patient population, this information could be conveyed by stating "If you suffer from liver disease, this product can be harmful. See labelling or consult a health professional for additional information" or "This cold product contains a decongestant which is not suitable for people with high blood pressure. See labelling for risk information".
Thus, it is unlikely that this part of the requirement would apply to low risk health products such as toothpastes, sun screen lotions, antiperspirants or anti-dandruff shampoo. In most cases, risk information for nonprescription products will be limited, however in cases where risk information needs to be provided, advertisers could briefly and economically present such information in the interest of public health so as to avoid the inappropriate use of these products.
The third part of the application subsection of Section 2.21, applies to products/ingredients for which a safety advisory has been issued in Canada and the product labelling has not yet been updated with the new safety information. By directing consumers to the Health Canada Website, the market authorization holder's website or to a health professional, consumers would have better access to the most up-to-date information about the advertised product.
2.4 Precautionary Principle
In the interpretation and application of Section 9(1) of the Food and Drugs Act, Health Canada would apply precautionary principles. Governments can rarely act on the basis of full scientific certainty and cannot guarantee zero risk. Indeed, they are traditionally called upon to address new or emerging risks and potential opportunities, and to manage issues where there is significant scientific uncertainty. However, the need for decision making in the face of scientific uncertainty has grown both in scope and public visibility and this has led to a growing awareness of and emphasis on the application of precaution to decision making (Government of Canada, 2003).3
Canada has a long-standing history of applying precaution in areas of federal regulatory activities. While scientific information is still inconclusive, decisions have to be made to meet society's expectations about addressing the potential for risks. An understanding of the full potential of the products and processes arising from rapidly evolving science and technology is critical to shaping Canada's laws and regulations, as well as international agreements and guidelines.
The application of "the precautionary principle" recognizes that the absence of full scientific certainty shall not be used as a reason for postponing decisions where there is a risk of serious or irreversible harm. The application of precaution is distinctive within science-based risk management and is characterized by three basic tenets: the need for a decision, a risk of serious or irreversible harm and a lack of full scientific certainty. Given the distinctive circumstances associated with the application of precaution, notably the lack of full scientific certainty about a risk of serious or irreversible harm, guidance and assurance are required as to the conditions governing decision making.
2.5 Current Context and Environment
A consistent approach has generally been taken over the years in interpreting the application of Section 9(1). However, with several changes occurring over the years, it is deemed essential to adapt policies and guidelines on a regular basis to provide interpretations that are relevant and meaningful in the current context. New technologies, new products, increased use of advertising, evolved marketing techniques, increased involvement of consumers in decisions affecting their health, are all components of the current environment and thus there is a need to provide clear and up-to-date interpretations in order to take these factors into consideration.
The concept of "fair balance" in the presentation of therapeutic claims for health product advertising directed at health professionals already exists. Presenting unbalanced information about benefits and risks in advertisements directed to health professionals is considered an unacceptable practice as per the Code of Advertising Acceptance of the Pharmaceutical Advertising Advisory Board (PAAB). The PAAB applies its Code to all types of products being advertised (prescription, nonprescription, natural health product).
When risks associated with the use of nonprescription drugs and natural health products, have been identified, the communication of information about those risks is deemed an appropriate measure to ensure that consumers are provided with accurate, fair and balanced information about the benefits and risks associated with the use of marketed health products. This will allow more informed and sound decision making. Section 2.21 does not reinterpret the Act and Regulations in a new way, but rather provides more detailed guidance taking into account the changing environment and consumer needs. It is within the mandate of Health Canada to minimize health risk factors to Canadians and maximize the safety of health products through an appropriate regulatory system. It is deemed that Section 2.21 has a positive impact towards achieving that mandate. Since nonprescription products are readily available and can be purchased directly by consumers, providing risk information is in the public interest and is in accordance with the government's precautionary approach.
2.6 Omission of Information and Fair Balance Representation
Consumers demand that the products that they purchase are labelled, packaged, treated, processed, sold and advertised in a manner that is not false, misleading or deceptive. The requirements set out in Section 2.21 of the Guidelines respond to those requests. Nonprescription drugs and natural health products are not just commodity products, they may pose risks to the health of consumers and thus the public should be provided with a balanced representation of all the relevant information concerning the risks and benefits associated with the use of these health products. An advertisement that omits to include important facts and fails to present a fair and balanced picture is misleading. The concepts of "misleading by omission" and of "fair and balanced representations" were already captured in the 1990 Consumer Drug Advertising Guidelines. The following excerpts of the1990 Guidelines highlight these important elements:
- "Because drugs have both risks and benefits associated with their use, the Health Protection Branch considers them to be inherently different from other consumer products";
- "Promotional material associated with a drug should describe both the positive aspects and the adverse effects associated with the use of a particular drug so that the consumer can make an informed decision regarding the drug's use";
- Under "Misrepresentation":
"Drug advertising, by clearly describing the purpose of the drug, should indicate to the consumer that the product is a drug. The description of the product, its purpose, or its method of use in a way that implies some other status-most commonly food or cosmetic- is often misleading and can create an erroneous impression regarding the character, merit and safety of the preparation"; - Under "Comparisons":
"Comparisons may be misleading for several reasons: They exaggerate the importance of the alleged advantages of the product (e.g., speed of action, quantity of medicinal ingredient, or extent or duration of action). Failure to disclose the lack of real therapeutic advantage is often misleading and deceptive."
In the former excerpt, providing an unbalanced message between advantages of a relatively small clinical importance and real therapeutic benefits was deemed misleading. Such an interpretation supports the approach that Health Canada is currently proposing in terms of risk information (Section 2.21). These excerpts also convey the importance of including material facts and that omitting to do so would likely be considered misleading.
Section 2.21 of the revised Guidelines provides additional clarification to allow for the provision of fair and balanced messages and to avoid the dissemination of advertisements which would omit relevant information in a way that could cause the public to be misled on matters of significance such as health risks.
3) International Perspective
The review of the issue at the international level confirms that a number of countries (Australia, New Zealand, United Kingdom) have requirements for balanced advertising (outlining benefits and risks) which include more than the basic reference to "read the label / follow directions of use". Omission of information is also considered misleading in the United States.
3.1 United States
In the United States, preclearance of nonprescription drug advertising is not required. Claims made in advertisements for nonprescription drugs are regulated by the Federal Trade Commission (FTC). Under the Federal Trade Commission Act, advertising must be truthful and non-deceptive. Advertisers must have evidence to back up their claims and advertisements cannot be unfair. In determining whether an advertisement is misleading, several factors are considered, including the representations made and any material facts omitted. According to the FTC's Deception Policy Statement, an ad is deceptive if it contains a statement - or omits information - that:
- is likely to mislead consumers acting reasonably under the circumstances, to the consumers detriment, and
- is "material" - that is, important to a consumer's decision to buy or use the product. Examples of material claims are representations about a product's performance, features, safety, price, or effectiveness.
A finding of materiality is a finding that injury is likely to exist because of the representation, omission, sales practice, or marketing technique. Injury exists if consumers would have chosen differently but for the deception. If different choices are likely, the claim is material, and injury is likely as well.
US Officials also work in collaboration with the Consumer Healthcare Products Association when issues are related to nonprescription products. Members of this association must abide by a voluntary Code of Advertising Practices for Nonprescription Medicines which stipulates that advertising of a nonprescription medicine should urge consumers to read and follow label directions and should not be advertised in a manner which suggests that it will prevent or cure a serious disease which requires treatment by a licensed practitioner.
3.2 Australia
In Australia, preclearance of nonprescription medicinal product advertisements is mandatory, i.e. advertisements which appear in mainstream media, other than the internet must be approved for compliance with the Therapeutic Good Advertising Code (TGAC) prior to publication or broadcast. The approval function was delegated to the Australian Self-Medication Industry (ASMI) - for advertising of nonprescription medicines - and to the Complementary Healthcare Council (CHC) - for complementary healthcare products. The Code is a set of principles and guidelines that ensures socially responsible marketing and advertising of therapeutic goods in a way that will promote the appropriate use of these products. It sets out minimum requirements such as inclusion of statements to "Always read the label", "Use only as directed", "If symptoms persist, see your doctor/healthcare professional". It also contains requirements for specific classes of medicines (e.g. when advertising analgesics, the ad shall contain "Use only as directed. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist"). The Australian Self-Medication Industry Code of Practice also states that "Information and medical claims about non-prescription consumer healthcare products must be current, accurate, balanced and must not mislead".
One key element of the law in Australia is that due to statutory provisions on conduct that is misleading or deceptive or that is likely to mislead or deceive, advertisements must generally be balanced and moderate. The TGAC is regularly updated by a broad representational committee (Therapeutic Goods Advertising Code Council) which includes representatives from all peak stakeholder groups.
3.3 United Kingdom
In the United Kingdom, preclearance of consumer directed nonprescription medicine advertisements is mandatory (requires pre-publication approval) through the Proprietary Association of Great Britain (PAGB), the trade association which represents the manufacturers of nonprescription medicines. The PAGB Medicines Consumer Advertising Code, which covers the control of advertising of nonprescription medicines, states that advertising must carry an invitation to read the leaflet or label. It also states that information and claims about side effects must reflect available evidence.
The control of medicines advertising in the UK is based on a long established system of self-regulation supported by the statutory role of the Medicines and Healthcare Products Regulatory Agency (MHRA), acting on behalf of Health Ministers. On November 16, 2005, the MHRA published the Blue Guide "Advertising and Promotion of Medicines in the UK" which states that advertisements to the public should include a clear and legible invitation to read carefully the instructions on the leaflet contained within the package or on the label. It also states that advertising material should clearly indicate that the safe use of medicines depends on compliance with certain conditions (prior necessary medical diagnosis, continuous treatment required, etc.) and that care should be taken to ensure that vulnerable patient groups are not put at risk. All messages conveyed to the audience should support safe use of the products concerned. It also states that companies may include a website on disease-related information in advertising together with approved patient information leaflets.
3.4 New Zealand
In New Zealand, advertisements for nonprescription medicines need to be pre-vetted for compliance with legislative and industry code requirements regarding advertising based on agreement by the Advertising Standards Authority and the organisations which represent the media in which the advertisement are to be published. This system is known as the Therapeutic Advertising Pre-Vetting System (TAPS). Under this system, approval of advertisements is undertaken voluntarily, with mainstream media agreeing not to accept an advertisement for publication unless there is evidence that the advertisement has been pre-approved by TAPS. In December 2005, Medsafe published the "Guidelines for Advertising Over-the-Counter (OTC) Medicines Direct to the Consumer". These Guidelines are intended to provide advertisers with a practical interpretation of current Medicines legislation in New Zealand to ensure consumers are provided with a balanced presentation of the benefits and risks associated with all medicines. The Medicines Regulations 1984 require any advertisements for a medicine include consumer information about any appropriate precautions, contra-indications and adverse effects of that medicine. The new Guidelines clarify that ads must, where appropriate, "state information about precautions, contra-indications and adverse effects in a form that is both relevant to, and easily accessible and understood by the consumer" and "prominently direct the consumer to an easily accessible source of appropriate additional information". The Code also states that it is important and responsible to inform the consumer that there are risks to be considered, there is further information available and the use of the medicine should be discussed with an appropriate health professional.
Australia and New Zealand are currently working on the development of a joint regulatory scheme for the advertising of therapeutic products. The July 2005 draft Australia New Zealand Therapeutic Products Advertising Code states that if a product has known serious adverse effects or is contraindicated for a known group of people, an appropriate warning of those effects must be given in the advertisement. The development of common sense guidelines, with appropriate input by relevant expert committees, to provide parameters for the inclusion of warnings relating to the severity and the clinical importance of adverse effects and contraindications appropriate for a category of products (likely sedating anti-histamines, pseudoephedrine and non-steroidal anti-inflammatory drugs) is recommended during the implementation period.
3.5 European Union
The appropriate development of Community legislation has made it possible to gradually eliminate technical barriers to trade in pharmaceutical products within the EU. The single market in pharmaceutical products is now in the process of completion. Since November 2001, the technical requirements relating to the marketing authorisation, production, labelling, classification, distribution and advertising of medicinal products for human use have been grouped under the Community code relating to medicinal products for human use.
This code assembles, in a single instrument, all the provisions in force governing the placing on the market, production, labelling, classification, distribution and advertising of medicinal products for human use in the EU. The advertising part of the code states that all advertising to the general public of a medicinal product must be clearly identifiable as such and must include the following minimum information: name of the medicinal product, the information necessary for correct use of the medicinal product, and an express, legible invitation to read carefully the instructions the package leaflet. It also states that advertising must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, and shall not be misleading.
The Community Code relating to medicinal products for human use (Article 97 of the European Parliament and Council Directive 2001/83/EC) states that "Member States shall ensure that there are adequate and effective methods to monitor the advertising of medicinal products. Such methods, which may be based on a system of prior vetting, shall in any event include legal provisions under which persons or organizations regarded under national law as having a legitimate interest in prohibiting any advertisement inconsistent with this Title, may take legal action against such advertisement, or bring such advertisement before an administrative authority competent either to decide on complaints or to initiate appropriate legal proceedings".
4) Literature Review and Survey Results
4.1 Literature Review and Survey Results
This section examines the available information about self-reported adverse reactions (AR) associated with nonprescription and natural health product use, consumer perception and preferences regarding advertising of such products.
A review of hepatic adverse events associated with acetaminophen is also presented as an illustration of the serious risks and safety issues that the use of nonprescription drugs can pose.
In addition to survey reports and summaries, a search was performed for articles published between 1999 and March 2006 which could be relevant to advertising of these products. An automated literature search was carried out with five databases (Medline, PreMedline, CINAHL CAB Health/Global Health, AgeLine Current Contents and IPA), which were searched for the following keywords and subject headings when applicable as well as directly in titles and abstracts: "Non-prescription", "Over-the-counter (OTC)", "Natural", "Herbal" and "Dietary supplements"; "Advertising", "Publicity", "Magazine", "television", "dtc" and "direct to consumer".
The review is exploratory in nature and is not intended to be exhaustive due to constraint of time and resources. As a result, this section is an emerging and evolving exploration of the medical literature regarding the advertising of nonprescription and natural health products.
4.2 Reasons why various aspects of nonprescription products, including advertising, should be reviewed
Prescription drugs are increasingly being switched to nonprescription status, some in classes not previously eligible (eg, omeprazole, Sweden & simvastatin, UK) (Cohen 2005)4. Regulations regarding advertising for nonprescription products should be reviewed to be sure they reflect the information needs required by consumers to use these products appropriately and safely.
Because nonprescription drugs do not generate prescription records, it is difficult to conduct standard epidemiological follow-up studies through available data and this impedes the ability to establish safety profiles of these products (Bond 2003)5.
Self medication is also associated with risks such as misdiagnosis, use of excessive drug dosage, prolonged duration of use, drug interactions and polypharmacy (Carmel 2001).1
Various ethnic groups appear to be receiving different information, through advertising of health products (and other products and services that promote healthy or unhealthy lifestyles, for example, fresh vegetables and pharmaceuticals versus alcohol and high calory snack foods) which are differentially targeted to ethnic group-specific media (Omonuwa 20016, Duerksen 2005)7. Minority ethnic groups could be misinformed by absence of targeted information.
4.3 A case for targeted advertising regulations for specific products: acetaminophen
Nearly 50% of drug-induced acute liver failure and a high proportion of subsequent liver transplants are estimated to be attributable to acetaminophen (Lazerow 2005)8.
Two studies in the U.S. estimated that the unintentional acetaminophen overdose leading to acute liver failure was 48%, with intentional overdose at 44%, and of 458 deaths which occur each year from acetaminophen-associated overdoses 100 are unintentional (Larson 20059, Nourjah 2005)10. This suggests that many emergency room and hospital visits could be avoided if consumers had better information regarding the potential toxicity of acetaminophen.
Severe acetaminophen-induced hepatotoxicity cases mostly result from deliberate self-poisoning and form the major cause of acute liver failure hospital admissions and indication for emergency liver transplantation in the U.K. (Bernal 2003).11
In the U.S., acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/year) and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year (Lee 200412,, Nourjah 200510).
4.4 Evidence that consumers are getting incorrect messages from current lines of communications
An interview study conducted with 40 Australian parents of children younger than five years suggested that many held unsupported beliefs about the usefulness and safety of acetaminophen for their children (Allotey 2004).13
It has been shown that some adolescents are not aware of the adverse effects and underestimate the potential lethal effects of acetaminophen. The fact that this analgesic is easily accessible has been linked to higher frequencies of overdose (Van den Bulck, 2004)14. A strong and persistent relationship between higher levels of television viewing and frequent consumption of nonprescription analgesics in a sample of 2546 Flemish adolescents was found.
A study in which five clinical pharmacists evaluated print advertisements appearing in consumer periodicals indicated that nonprescription drug advertisements lack information necessary for consumers to make informed purchase decisions (Sansgiry 1999).15
4.5 Evidence that specific groups would ignore warnings in advertisements
An experimental study suggested that techniques which could be utilized by advertising regulatory agencies, such as highlighted warnings on printed advertisements, did not have a strong deterrent effect on the stated intentions of normal weight women, who were unsatisfied with their own body image, to use weight loss products (Whisenhunt 2003)16. The best intentions of advertisers and regulators will not reach all consumers who intend to use certain health products and stronger controls of such products may be needed for "at-risk" populations (e.g., women with high body dysphoria).
4.6 Canadians' experience of nonprescription drug use, results from population surveys: Evidence supporting the proposed "Section 2.21"
An estimated 58% of Canadians report taking a nonprescription product in the six months before the survey. One in five of these, or about 10% of Canadians, report having experienced a negative reaction or side effect from a nonprescription product (Decima 2005)17.
Only 30% of respondents were able to name the active ingredient in their preferred nonprescription headache medication. Another 30% were able to pick the name correctly from a list, leaving approximately 40% who were unaware of the ingredients. Only one third of nonprescription drug users report comparing the ingredients in medications they are taking simultaneously and even fewer (22%) report adding them up to establish maximum doses.17 One third of nonprescription product users reported taking their next dose earlier than directed. Sixteen to 18 % said they took more pills than recommended at one time and 15-17% exceeded daily doses. One quarter of the nonprescription respondents said they took four or more different medications in the month before the survey (Decima 2005, Ipsos-Reid 2006).17,18
A 2002 Canadian survey showed that 17% of non-prescription medication users claimed that they had experienced a negative reaction/side effect. While 43% claim to look at the dosage level on the package information when they take a non-prescription medication for the first time, only 27% do so for direction for usage and 25% for the possible side effects (Decima 2002).19
Other survey reports suggest that instead of relying on a single source of information, Canadians may use various sources of information pertaining to their health resources use. When asked about what type of information should be sought, about half of adults (49%) stated that information about possible side effects should be asked from a health care professional before taking nonprescription medication (Decima 2005, Leger Marketing 2004).17,20
Despite the fact that nearly all Canadians (91%) recognize pharmacists as a good information source only 38% of nonprescription product users got information from a pharmacist, while 52% cited the media and as many as 51% get this information from advertising.17 Comparable survey results were found in the Decima 2002.19 Also, the Internet has become the main source of health information for approximately three in 10 Canadians (IBM 2006).21
When specifically asked about drug and other health products' safety, 29% of Canadians reported that they turned to advertising on TV, newspapers and/or magazines as source of information (Decima 2006)22. This suggests that Canadians could benefit from obtaining general risk information about nonprescription products through advertisements along with other sources of information.
4.7 Natural health products use in Canada: Adverse events, risk perception, advertising and regulation
A survey conducted in 2000 Canadians (Ipsos-Reid, 2005)23 showed that 12% of those who use natural health products reported that they have experienced a related unwanted side effect or adverse reaction, 14% agree that natural health products are harmful to use and 20 to 23% think that natural health products are safe because they are made from natural ingredients. More Canadians (46%) agree that a lot of claims made by the manufacturers of natural health products are unproven (only 24% disagree), and almost a third of them (30%) agree that they do not understand the information on natural health product labels.
4.8 Summary of the review
Within the limitations of this review, a few key messages were reported by Canadians.
There is evidence of widespread reported use of nonprescription and natural health products by Canadians, of which a certain percentage reported an episode of adverse reaction which merits attention. Many Canadians show a limited knowledge of nonprescription and natural health products, do not read labels, and may not make use of the information contained in labels; this suggests that counting solely on the latter as a source of information may not be sufficient to mitigate the risk of adverse reactions or encourage appropriate use. Usage of concomitant drugs is not uncommon and may put consumers at (further) risk of undesirable drug interactions.
Canadians rely on various sources of knowledge for managing their health and consider advertising as an important source of information regarding the safety of the health products they elect to use.
5) Analysis of Adverse Reactions
5.1 Nonprescription products and suspected adverse reactions in the CADRIS database
Health Canada receives reports of adverse reactions (ARs) which are entered into the Canadian Adverse Drug Reaction Information System (CADRIS) database. Hundreds of reports relate to nonprescription drugs and natural health products. A snapshot of reports received for acetaminophen, St John's Wort (Hypericum perforatum) and pseudoephedrine is provided in Appendix B, as examples of information contained in CADRIS.
A total of 637 reports relating to acetaminophen were received by Health Canada between January 1, 2000 and January 31, 2006. More than half of these reports relate to acetaminophen-containing products that can be purchased without prescription. Liver and biliary system disorders are among the ARs signalled in 118 of the reports for acetaminophen. Close to 50 of these reports describe serious reactions (excluding cases of non-accidental overdoses and suicide attempts) in patients who had taken an acetaminophen-containing product available without prescription.
CADRIS contains many reports relating to other nonprescription drugs as well. Another example is pseudoephedrine. Between January 1, 2000 and January 31, 2006, Health Canada received 303 reports of adverse reactions suspected of being associated to pseudoephedrine; 298 of these relate to products available without prescription. Over half of these reports described a serious AR.
Health Canada also receives reports of ARs suspected of being associated to natural health products. As an example, 22 reports were received for St John's Wort (Hypericum perforatum) between January 1, 2000 and January 31, 2006, more than half of which were described as being serious.
The purpose of providing this information is to indicate that Health Canada has received numerous serious AR reports relating to nonprescription drugs and natural health products.
Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown. There is evidence of significant and widespread underreporting of adverse drug reactions to spontaneous reporting systems, including serious and fatal reactions. Some estimates approximated the level of underreporting to be in excess of 90% (Hazell 2006)24. Patients' nondisclosure of natural health product use to primary care physicians makes reporting ARs difficult for clinicians (Busse 2005)25. Therefore, figures provided in Appendix B should not be used as predictors of the incidence of ARs in the general population.
6) Consumer Information vs Advertising
6.1 The Need for Consumer Education
Health Canada recognizes the need to educate consumers and patients on their role in the safe use of drugs and other health products. To that end, Health Canada is developing an adverse reaction reporting education module as a guide for consumers and patients to report a suspected adverse reaction, or side effect, to drugs and other health products to their health care professional and/or Health Canada. Health Canada considers a multi strategy approach to giving consumers and patients drug risk/safety information to have the greatest impact on educating consumers on health product safety issues. Of particular interest, Health Canada communicates safety information surrounding health product therapy in the Canadian Adverse Reaction Newsletter (CARN) and in It's Your Health (IYH). The CARN has published 24 articles or other types of communications relating to nonprescription health products since 1991, half of which relate to natural health products. IYH has produced 8 publications relating to nonprescription health products. Some examples of these CARN and IYH publications are shown in Appendix C (Tables 5 and 6 respectively). Safety issues are also conveyed through Health Canada's advisories and communications to health professionals and the public, as well as those issued by manufacturers. Over a dozen of these communications have been issued since 1991 and subject matters range from product safety updates to stop-sale orders for both nonprescription drugs and natural health products (Appendix C, Table 7).
In 2003, Health Canada commissioned Decima Research to conduct a national survey of Canadians' opinions on the effectiveness of Health Canada's methods of communicating important health product safety information23. The Canadian general public opinion survey indicated that consumers look first to the government to ensure that drugs consumed by Canadians are safe. Patient groups and the public are looking for a Canadian source of drug information that is objective and sound and that provides unbiased information about the risks and benefits of drugs that they use. The product monograph is the obvious source for this information as it represents the conditions of marketing authorization for the product and it was to this end that Health Canada began the Product Monograph Project.
An analysis of Health Canada stakeholder recommendations and conclusions on enhancing health product safety surveillance and risk communications identified the importance of increasing awareness and educating consumers on health product safety information. An important aspect of communicating drug safety information is the shared responsibility model whereby all parties with a role in the communication of health product safety information share a responsibility to ensure the information reaches its intended audience in a timely fashion, that it is easy to access and understand, and that it is relevant to those who it is intended to inform.
Other initiatives such as the BeMedWise campaign, which is part of a North American campaign educating Canadians about proper nonprescription drug use ( 
http://www.bemedwise.ca) provides consumers with information on how to read drug labels and know their medicine - including its active ingredients and knowing the importance of taking the correct dosage at the right time. While this education tool is available to help Canadians use nonprescription medications safely, when in doubt, they should always seek the advice of a health professional.
Thus, the inclusion of risk information in advertising of nonprescription products (proposed Section 2.21 of the Guidelines) attempts to play a complementary role with other educational activities with respect to balanced representation of information. It reinforces the messaging to consumers that health products are not just like other common commodity products. Through advertising, consumers could be informed on where to access additional safety information.
6.2 Power of Advertising
Market research, research on consumer trends, thinking, and buying practices have developed into multi million dollar businesses creating a need for companies such as Ipsos-Reid and others, who provide companies with assistance in the development of their advertising campaigns and strategies. Ipsos Insight's Pharm Trends has been tracking healthcare consumers' behaviour trends since 1997 and provides a complete and up-to-date picture of the healthcare consumer's behaviour trends.
Ipsos-Reid Healthcare acknowledges that patients are becoming increasingly informed and aware of drug advertising, treatment options, and competing nonprescription products. The empowered health consumer is changing the landscape of the health industry for healthcare practitioners, employers and insurers. Understanding the influence and opinion of physicians and patients has never been more critical to achieving success in the health sector.
7. Conclusion
Health Canada's primary focus is always to serve the best interest of the public. The safe use of health products is a shared responsibility, including the regulator who reviews and monitors the health product, the manufacturer who makes the health product, the health professional who provides advice to the patient and the informed consumer who uses it. All health products have benefits and risks which the consumer must consider. Health Canada is taking appropriate steps to update the guidelines which will provide mechanisms to present fair and balanced information regarding the risks and benefits of nonprescription drugs and natural health products in advertising to consumers. It is expected that these measures will enable consumers to make more informed decisions about their health prior to the purchase of a product.
Nonetheless, Health Canada recognizes the competitive nature of the marketplace. Therefore, in order to ensure that the proposed measures are appropriate in providing consumers with balanced information without imposing undue impediments on the ability of manufacturers to advertise their products, stakeholders will have the opportunity, through the roundtable discussion on June 28, 2006, to review Section 2.21 to propose the most viable options whereby consumers have access to the information they should have to make informed decisions.
Top of PageAppendix A
Section 2.21: Risk/Safety Information Communication
Guideline
In order to make informed decisions about their health, consumers should be provided with fair and balanced information about the benefits and the risks associated with the use of the advertised product.
Application
Consumers should always be:
- Advised to read the label and follow directions of use for the advertised product.
- Provided with an easily accessible source of additional, appropriate information.
When applicable or where appropriate, consumers should be:
- Advised that the use of the advertised product may cause side effects or drug interactions and thus should be instructed to read the label for applicable risk information (where authorized product risk information exists) and to follow directions of use. Television and radio messages should also carry a verbal message to the effect that labels should be consulted to obtain risk information.
- Advised that the advertised product may not be suitable for everyone (e.g. where contraindications may apply to a certain population - such as patients with hypertension).
- Invited to discuss with a health professional for additional information and appropriate advice (e.g. in cases where a symptom may be a sign of a serious underlying condition).
Where a safety advisory related to the advertised product or ingredient has been issued and when the label information may not be up-to-date, consumers should be:
- Invited to consult Health Canada's Website to access new safety information about the advertised product or ingredient.
- Invited to contact a health professional for up-to-date information.
Technical requirements:
- Visual disclosures (supers) in broadcast advertisements shall always be of a size and shade and shall appear on the screen for duration sufficient for an average person to read and comprehend it.
- Disclosures in print advertisements shall always be in a type size and location sufficiently noticeable for an average person to read and comprehend it, in print that contrasts with the background against which it appears.
Example
Cold Product X (which contains Ingredient X which is contraindicated for patients with hypertension)
Acceptable Claim:
"Product X is suitable for adults over 18 years of age looking for relief of cough, cold and flu symptoms". Product X is not suitable for patients with high blood pressure and may cause side effects. Always read the label and follow directions of use. Additional information about the risks associated with this product may be obtained by calling 1- 800-xxx-xxxx or by consulting the Website xxxx. Talk to your doctor or pharmacist for further advice".
Unacceptable Claim:
"Product X is suitable for adults over 18 years of age looking for relief of cough, cold and flu symptoms".
Appendix B
Nonprescription Products and Suspected Adverse Reactions in the CADRIS Database
Health Canada receives reports of adverse reactions (ARs) which are entered into the Canadian Adverse Drug Reaction Information System (CADRIS) database. Hundreds of reports relate to nonprescription drugs and natural health products. A snapshot of reports received for acetaminophen, St Johns Wort (Hypericum perforatum) and pseudoephedrine is provided below, as examples of the information contained in CADRIS. These reports have not been analysed or assessed for causality. The purpose of providing this information is to indicate that Health Canada has received reports relating to nonprescription drugs and natural health products.
The following data was extracted from CADRIS; searches were performed on reports received by the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) between January 1, 2000 and January 31, 2006.
Acetaminophen
| Table 1: Number of reports received by CADRMP for acetaminophen, with a suspected or interacting role (between January 1, 2000 and January 31, 2006 | |
|---|---|
| Reports received (total number) | 637 |
| Reports concerning nonprescription products* (total number) | 380 |
CAVEAT: some reports may be duplicates, as initial, follow-up and duplicate (from various reporting sources) reports may have been provided to Health Canada. Reports have not been assessed or analyzed.
* Includes reports for all products containing acetaminophen, available without prescription, whether used under medical recommendation/supervision or not.
To provide an example of the types of reports received, a second CADRIS search was conducted for acetaminophen. This search listed all reports of suspected adverse reactions for acetaminophen for the following system organ class (SOC): liver and biliary system disorders. A summary of the information is provided below.
Acetaminophen and Liver and Biliary System Disorders
Liver and biliary system disorders are known to be potential ARs suspected of being associated to the use of acetaminophen. Table 2 presents reports of liver and biliary system disorders suspected of being associated with the use of acetaminophen between January 1, 2000 and January 31, 2006.
| Table 2: Number of reports received by CADRMP concerning acetaminophen for liver and biliary system disorders, by report type (between January 1, 2000 and January 31, 2006) | |
|---|---|
| Reports received (total number) | 118 |
| Reports concerning nonprescription products* (total number) | 99 |
| Reports concerning nonprescription products*, excluding reports of non-accidental overdosage and suicide attempts (total number) | 51 |
| Serious** reports concerning nonprescription products*, excluding reports of non-accidental overdosage and suicide attempts (total number) | 49 |
CAVEAT: some reports may be duplicates, as initial, follow-up and duplicate (from various reporting sources) reports can be provided to Health Canada. Reports have not been assessed or analyzed.
* Includes reports for all products containing acetaminophen, available without prescription, whether used under medical recommendation/supervision or not.
** A serious adverse reaction is one which requires inpatient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent one of these outcomes are also considered to be serious.
St John's Wort (Hypericum perforatum)
| Table 3: Number of reports received by CADRMP concerning St John's Wort (Hypericum perforatum) by report type (between January 1, 2000 and January 31, 2006) | |
|---|---|
| Reports received (total number) | 22 |
| Serious* reports (total number) | 13 |
CAVEAT: some reports may be duplicates, as initial, follow-up and duplicate (from various reporting sources) reports can be provided to Health Canada. Reports have not been assessed or analyzed.
* A serious adverse reaction is one which requires inpatient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent one of these outcomes are also considered to be serious.
Pseudoephedrine
| Table 4: Number of reports received by CADRMP concerning pseudoephedrine by report type (between January 1, 2000 and January 31, 2006) | |
|---|---|
| Reports received (total number) | 303 |
| Reports concerning nonprescription products* (total number) | 298 |
| Serious** reports concerning nonprescription products* (total number) | 153 |
CAVEAT: some reports may be duplicates, as initial, follow-up and duplicate (from various reporting sources) reports can be provided to Health Canada. Reports have not been assessed or analyzed.
* Includes reports for all products containing acetaminophen, available without prescription, whether used under medical recommendation/supervision or not.
** A serious adverse reaction is one which requires inpatient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening or results in death. Adverse reactions that require significant medical intervention to prevent ne of these outcomes are also considered to be serious.
Tables 1, 2, 3 and 4 demonstrate that Health Canada does receive reports of adverse reactions suspected of being associated with nonprescription drugs and natural health products.
CAVEAT: This summary is based on information from adverse event reports submitted by health professionals and lay persons either directly to Health Canada or via market authorization holders. Each report represents the suspicion, opinion or observation of the individual reporter. The Canadian Adverse Drug Reaction Monitoring Program is a spontaneous reporting system that is suitable to detect signals of potential health product safety issues during the post-market period. The data has been collected primarily by a spontaneous surveillance system in which adverse reactions to health products are reported on a voluntary basis. Under reporting of adverse reactions is seen with both voluntary and mandatory spontaneous surveillance systems. Accumulated case reports should not be used as a basis for determining the incidence of a reaction or estimating risk for a particular product as neither the total number of reactions occurring, nor the number of patients exposed to the health product is known. Because of the multiple factors that influence reporting, quantitative comparisons of health product safety cannot be made from the data. Some of these factors include the length of time a drug is marketed, the market share, size and sophistication of the sales force, publicity about an adverse reaction and regulatory actions. In some cases, the reported clinical data is incomplete and there is not certainty that these health products caused the reported reactions. A given reaction may be due to an underlying disease process or to another coincidental factor. This information is provided with the understanding that the data will be appropriately referenced and used in conjunction with this caveat statement. (12/2003)
Appendix C
Health Canada Risk Communications Concerning Nonprescription Products
Health Canada communicates safety information surrounding health product therapy in the Canadian Adverse Reaction Newsletter (CARN) and in It's Your Health (IYH). Some examples of nonprescription drug and natural health product-related CARN and IYH publications are shown in Tables 5 and 6, respectively. Safety issues are also conveyed through Health Canada's advisories and communications to health professionals and the public, as well as those issued by manufacturers (examples shown in Table 7).
| Table 5: Examples of articles, communiques, updates or case presentations relating to nonprescription health products, published in the Canadian Adverse Reaction Newsletter (CARN) from 1991 to 2006* | ||
|---|---|---|
| Example | Title of the publication | CARN Issue |
| 1 | Tenofovir (Viread) and NSAIDs: acute renal failure | April 2006; 16 (2) |
| 2 | Safe use of energy drinks | January 2006; 16 (1) |
| 3 | Black cohosh: international reports of liver toxicity | July 2005; 15 (3) |
| 4 | Ibuprofen: Stevens-Johnson syndrome | July 2005; 15 (3) |
| 5 | Products derived from bees: serious adverse reactions | April 2005; 15 (2) |
| 6 | Safe use of health products containing camphor and eucalyptus oils | January 2005; 15 (1) |
| 7 | Natural health products and adverse reactions | January 2004; 14 (1) |
| 8 | The safe use of products containing acetaminophen | April 2003; 13 (2) |
| 9 | Reports of convulsions with newer-generation antihistamines | January 2003; 13 (1) |
| 10 | RespirActin | January 2003; 13 (1) |
| 11 | Adverse reactions to natural health products | October 2002; 12 (4) |
| 12 | Kava | July 2002; 12 (3) |
| 13 | Oral sodium phosphates solutions: electrolyte disturbances | April 2002; 12 (2) |
| 14 | Ibuprofen pediatric oral liquid: gastrointestinal bleeding | January 2002; 12 (1) |
| 15 | Warfarin and glucosamine: interactions | April 2001; 11 (2) |
| 16 | Glucosamine sulfate: hyperglycemia | October 2000; 10 (4) |
| 17 | Potentially harmful drug interaction with St. John's wort and prescription drugs | July 2000; 10 (3) |
| 18 | Gingko biloba: bleeding disorders | January 2000; 10 (1) |
| 19 | Low-dose ASA and serious gastrointestinal bleeding | January 1999; 9 (1) |
| 20 | Nicotine patches and exercise | January 1996; 6 (1) |
| 21 | Drug names: confusion from two fronts | July 1995; 5 (3) |
| 22 | The safety of OTC antifungals: a topical issue | April 1995; 5 (2) |
| 23 | H-1 Antihistamines and cardiotoxic effects | November 1993; 3 (2) |
| 24 | Nicotine patches: update / inadvertent exposure | August 1993; 3 (1) |
* The CARN index is available at: http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/ar-ei_index-eng.php
| Table 6: Examples of IYH publications relating to nonprescription health products, published from 2001 to 2006* | ||
|---|---|---|
| Example | Title of the publication | Date |
| 1 | Caffeine | February 2006 |
| 2 | The Safety of Vitamin E Supplements | January 2006 |
| 3 | Safe Use of Energy Drinks | June 2005 |
| 4 | Safe Use of Health Products Containing Camphor and/or Eucalyptus Oils | October 2004 |
| 5 | Safe Use of Natural Health Products | January 2004 |
| 6 | Safe Use of Medicines | March 2003, updated May 2004 |
| 7 | Fluorides and Human Health | November 2002, updated September 2005 |
| 8 | Reye's Syndrome | 2002 |
* The list of IYH publications is available at: http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/alpha-eng.php.
| Table 7: Examples of Health Professional and Public Communications relating to nonprescription health products, posted on the Health Canada website from 1991 to 2006* | |||
|---|---|---|---|
| Example | Subject of communication | Type of communication | Date |
| 1 | Safety Information on Phosphates solution (oral sodium phosphates) and kidney impairment | HPC, PC | December, 2005 |
| 2 | Reports of renal impairment and nephrocalcinosis with Fleet Phospho-Soda (Sodium Phosphates Oral Solution) | HPC, PC | December, 2005 |
| 3 | Health Canada is advising Canadians about the safe use of products containing Acetaminophen | PC | February 13, 2003 |
| 4 | Health Canada issues a stop-sale order for all products containing kava | PC | August 21, 2002 |
| 5 | Health Canada is advising Canadians of incorrect information on new approved uses for Aspirin | PC | August 13, 2002 |
| 6 | Important Update Regarding Indications for Aspirin | HPC | August 8, 2002 |
| 7 | Important safety information for patients taking sodium phosphates oral solutions (Fleet, Phospho-soda and Phosphates Solution) | PC | April 4, 2002 |
| 8 | Important Safety Information Regarding Sodium Phosphates Oral Solution | HPC | March 18, 2002 |
| 9 | Important Safety Information Regarding Fleet Phospho-Soda (Sodium Phosphates Oral Solution) | HPC | March 15, 2002 |
| 10 | Health Canada is advising consumers not to use any products containing kava | PC | January 16, 2002 |
| 11 | Health Canada advising of possible interaction between warfarin and vaginal miconazole | PC | August 15, 2001 |
| 12 | Update on Drug Products Containing Phenylpropanolamine (PPA) | HPC, PC | June 2001 |
| 13 | Health Canada withdraws drug products containing phenylpropanolamine (PPA) from the market | PC | May 30, 2001 |
| 14 | Risk of Important Drug Interactions Between St.John's Wort and Prescription Drugs | HPC | April 6, 2000 |
* Indexes are available at: http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2006/index-eng.php
and http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2006/index-eng.php
HPC: Health Professional Communication
PC: Public Communication
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