Health Canada Consumer Information Study Report to Health Canada

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

Date: 2001-10-12

Contact:Policy Bureau Enquiries

---

September 2001

COMPAS Inc.

Multi-Audience Research

Ottawa, Toronto and Winnipeg

www.compas.ca

---

Executive Summary

Health Canada commissioned COMPAS to conduct a series of 16 focus groups with members of the public to evaluate consumer information (section III of a document entitled "Product Monograph" [PM]) that the Department is developing for use with Canadians. Groups were conducted between August 28^th and September 6^th in six locations, in both official languages, and with various segments of the population, including current users and non-users of information on medications, seniors, youth, new Canadians and Aboriginal Canadians.

Attitudes and Behaviour Regarding Consumer Information

· Participants were asked whether they currently look for or read information on drugs or pharmaceutical products, either for themselves or on behalf of someone else. This was said to include information such as when to use such products, how to use them safely, and their side effects. The large majority said that they look for or read this type of information. Many said they use such information whenever they can get it because they want to know what they are taking and how it is likely to affect them.

· When asked when or how often they use consumer drug information, many people simply noted that they do so each time they receive a prescription drug from their pharmacist. However, a number of other circumstances were identified as times when people are most likely to look for or use such consumer information:

- When a new drug is prescribed.

- When they are taking more than one drug.

- When responsible for giving medication to other people (children, seniors, other family members) or in work situations (e.g. teachers).

- To help them better understand medications that are used for chronic conditions, particularly those prescribed for long-term use, either for themselves or others.

- When they need to check out the ingredients if they or a child or other family member is allergic to something.

- When the potential risk is higher (e.g. heart disease compared to the flu).

- When something important is covered in the media.

· When asked where they get such information, most said that they receive it from their pharmacist when filling a prescription. By a wide margin, this was the most common source of information, particularly for people who were less inclined to search for consumer information. It was often noted by some people that they have good relationships with their pharmacists and tend to rely on them to ensure that they have the information they need.

· As well, numerous people rely more on verbal than written information. This was particularly true of non-users and others who tend to pay attention to information given to them, but not to look for or search out this type of information. Verbal information comes most often from the attending physician or the pharmacist.

· In addition to pharmacists and physicians, a number of other sources were cited:

- The Internet. This included a combination of using search engines and returning to health-related sites that have been book marked.

- Health magazines.

- Health-related associations.

- Natural food stores.

- Pamphlets.

- Product inserts.

- Newspapers, including news coverage, health columns or sections.

· Most participants identified drug companies as the producers of much of the written consumer information that they receive. This appeared to be particularly the case for information handed out by pharmacists, and less so for information obtained through the Internet, magazines or other sources. Universities (Berkley, Harvard), health associations, hospitals, physicians, pharmacy companies and associations, and individual authors were also cited as producers of information. Virtually no one mentioned information from the federal or provincial governments.

· Most participants view the existing consumer information that they obtain to be user friendly. They indicated that it is usually relatively easy to find and understand the information they need. Such information was generally seen to be readily available and typically written in layperson's language (though not always).

· Despite the overall favourable assessment of consumer information that is currently available, several concerns were raised. Many identified small print as a problem with much of the written material. As well, some have found the text to be too dense, with long paragraphs, few or no graphics and little of interest to draw them in. Medical terminology and complicated language were also a negative factor in some of the information that people have received.

· There was a virtual consensus that this type of information is extremely important. It was seen to be a "matter of life and death" by some participants. People want and need to know what will happen to them as a result of taking medication, with respect to the desired outcome as well as potential undesirable consequences such as side effects. Consumers need information in order to take the medication properly, thereby increasing its chances of success.

· Participants who do not use consumer drug information (principally, but not only, in non-user groups) pointed to a number of things to explain their non-use. This includes perceptions that they are healthy and don't need such information. Some said they were already familiar with the medications relevant to them and did not need any additional information. Several noted that they trust their doctors to give them the correct drug and to tell them all they need to know about it.

Desired Content and Presentation of Consumer Information

· Participants were told that Health Canada was developing consumer information that would be given to Canadians and were asked to identify the type of information that would be most important to them. There was tremendous consistency with respect to the type of information that people felt should be included. The same issues or topics were repeatedly identified by participants across the different locations and target audiences. This included both the main categories of information, as well as many of the content items that would be addressed in each section. This included:

- How best to use the medication: Here, the focus was on "how-to" instructions to maximize the effectiveness of the medication and ensure that it is properly used to minimize potential negative consequences

- Possible side effects: Participants wanted to know what the potential side effects are, and how they might be recognized, avoided and addressed.

- The purpose of the medication: Many wanted to know what the medication is used for, what it is intended to do.

- List of ingredients: While this type of information was of no value to some people, it was essential to others (due to allergies).

- Clear naming: Many wanted the brand name and the generic name clearly identified. Others wanted all of the scientific names, as well as the brand names of similar medications that are produced by other pharmaceutical companies. A few wanted the name accompanied by phonetic spelling.

- Contact information on where to go for additional information.

- Dosage information, things like the right amount of medication to take, and the number and strength of the tablets in the bottle.

· Not only were participants highly consistent in their identification of the type of information that should be included in the patient information section of the PM, there was also considerable consistency in the way in which the information should be presented. There was a widespread sense that the information should be:

- Clear and easy to understand.

- Easy to scan.

- Use of point form and bullets.

- Use a big enough font to make it easy to read.

- Use of bolding, underlining and other highlights.

- Use of pictograms or icons.

- Use of colour.

- Attractive format to make it visually interesting.

Also suggested was having a standard format so that people know where to look for specific information (i.e. for all medications).

· Invariably, people wanted the information to be short and to the point. Many wanted it to be one page, two at the most. Only a small number felt it could be longer than this, although some acknowledged that for certain medications this might be needed.

· There was strong support for Health Canada's involvement in the development and approval of consumer information that would be given to Canadians about medications and other pharmaceutical products. There was a general consensus that this was very important and beneficial to Canadians. When asked to explain why, participants pointed to a number of factors:

- Assurances of quality control (i.e. the information is accurate, no important information is missing, etc.).

- The provision of standardized information (i.e. everyone receives the same information).

- Assurances of objective information. People expressed greater confidence in consumer drug information if it were reviewed and approved by Health Canada. As noted, people felt that most of the written information they now receive is produced by drug companies; as such, it is not seen to be entirely objective (some even felt that this was a conflict of interest). ("Drug firms will tell you what they want you to know"; "The alternative is leaving this up to the drug companies").

- Increased trust in the information, related to the previous point, since the information would be approved by Health Canada.

- Ensuring the availability and distribution of this type of information. It would no longer be made available to Canadians on an ad hoc basis, but rather would be consistently provided each time someone filled a prescription.

- Providing information for future reference (i.e. standardized information that could be retained by people, for each medication used, for reference when needed).

Reaction to Draft Consumer Information

· Participants were given one of two consumer information sections of the product monographs prepared by Heath Canada (for Statin or Amoxicillin). People were told to assume that a pharmacist would give them this leaflet when they fill a prescription for the medication. The overwhelming majority of participants reacted favourably to the material. In general, they found the documents to be comprehensive, well written, straightforward and clear. People felt that the consumer information did a good job of providing them with the information they needed in a concise and easy to understand manner. Participants routinely noted that the documents contained the same information that they themselves had previously identified for inclusion in this type of consumer document.

· Participants' written evaluations of the consumer information were highly consistent with the verbal feedback they provided. When asked to rate the document on a 5-point scale (very favourable to very unfavourable), well over three-quarters indicated that they had a favourable impression of it (almost evenly divided between very and somewhat favourable). Almost all the rest were neutral, while only a handful had an unfavourable impression of the leaflets (7 of 155 participants).

· Some participants found the documents to be too long and wordy. This was particularly true of non-users (who place less value on this type of information) and Francophone participants (because the French-language versions were in fact longer). When asked for specific areas that could be cut, however, few could identify "unnecessary information". Generally, most people wanted the information to be retained but to be streamlined, with repetition removed.

· In terms of the layout of the leaflets, there was a general consensus that the information was well presented and easy to follow. People routinely noted that the document was easy to scan, enabling readers to search for and locate the information that was most interesting or useful to them. Participants commented positively on the use of headings (clear and bolded), point form/bullets, different fonts, lists, highlighting, and text blocks. The main layout issue to receive criticism was the ordering of the information. However, most people appeared to find the documents well ordered. A few suggested other ways in which the information could be ordered.

· In terms of areas of potential confusion, participants identified relatively few words or sections that they found to be confusing or hard to understand. As noted, one of the strengths of the documents was that they were widely seen to be clear and relatively easy to understand. That said, a number of areas of confusion were identified, including specific medical terms in the two documents.

· Participants were asked whether there was information in the documents that was not important to them and could be cut. They were also asked whether there was any other information that they would like to see added. With few exceptions, the answer to both questions was no. While a few people did identify things that could be cut - particularly Non-Medicinal Ingredients - others disagreed, noting that this information was very important to retain. In terms of information to be added, once again participants were generally unable to identify anything. Suggestions that were identified are included in the report.

· The vast majority of participants said they would read the consumer information, either for this or another medication, if a pharmacist handed it to them when filling a prescription. Relatively few said they would not do this. Moreover, most people said they would read all of the information, although some said they would be more likely to scan it and pick out information that was most interesting or important to them. People who were less likely to read the information were non-users.

Comprehension Evaluation

· Participants were asked to complete a questionnaire near the end of the groups to evaluate their level of comprehension of the information in the patient information. This comprehension evaluation should be seen as a very rough or approximate measure to gauge people's level of understanding. Since people had relatively little time to complete the questionnaire, the results need to be interpreted cautiously. The findings indicate quite clearly that, with few exceptions, people did understand the information contained in the documents. The vast majority of "errors" were as a result of sloppiness, a lack of time, or differing interpretations as to the meaning of the questions. Participants' verbal feedback and a review of their completed questionnaires identify no deficiencies in the documents themselves. There was a consensus that it was easy to locate the information they were asked for.

Related Issues

· Most participants felt that physicians should be involved in the distribution of this information. Some wanted the information to be handed out by doctors when they give prescriptions to their patients. It was often noted that the attending physician generally knows the patient and his or her health better than any others, and that this is obviously relevant to the proper and effective use of medications. Many of the questions in the Advice Before Using This Medication section deal with issues best known by and discussed with the doctor. It was felt that the physician could best highlight and clarify important issues related to the medication and its use by the patient, and discuss alternative treatments/medications. And, the best time to do that would be when the prescription is being given to patients, and before it is filled (before people have to pay money for the prescription).

· When asked to choose directly between their doctor or pharmacist in terms of who should hand out the patient information, more identified the latter. However, many did prefer that doctors be the distributors of the information. As well, some noted that while they would prefer that their doctor hand out and discuss this information, this was less practical due to the time constraints on doctors.

· A broad range of suggestions relative to this initiative were identified by participants. These are presented in the body of the report.

The full report is available, in English only, upon request.