Consumer Medicine Information conundrums

People have a right to receive accurate and up-to-date information about their medicines from their health professionals. Providing written and verbal medicine information can improve consumers' use of medicines, but it can also have a negative impact. Consumer Medicine Information is standardised written information about prescription and pharmacist-only medicines in Australia. It is a tool which can be used by health professionals during their consultations to explain about the treatment they are recommending, including its harms and benefits. If used effectively and appropriately, Consumer Medicine Information could become an important vehicle in ensuring the quality use of medicines. Although some consumers are receiving Consumer Medicine Information from their health professionals, the documents are generally underutilised.

There have been increasing demands for information about medicines from consumers who consider written information to be useful^1,2 and have been in favour of receiving it.^3,4 In Australia consumer organisations drove the development of Consumer Medicine Information (CMI) which is now available for all prescription medicines. Some consumers prefer to receive this information from their doctors⁵ while others prefer pharmacists,^3,5 however many health professionals have been doubtful about the value of CMI.

Research shows that there is limited interaction between consumers and health professionals when written medicine information is provided.^2,5 This is unfortunate because, when received with verbal advice, written information has many positive impacts on consumers,⁶ including improved adherence to therapy.^7,8,9 Medicines information specifically written for consumers should therefore have an important role in consultations and support the quality use of medicines.

It is a legal requirement that CMI is available for all prescription (S4 and S8) and pharmacist-only (S3) medicines, and that it is consistent with the approved product information. The content of a CMI is defined by legislation and includes headings such as how to take your medicines, side effects and a description of the product. Australian CMIs are unique because they were developed to enable consumers to easily locate the information they need and the current design and content have been tested to ensure this.

The name 'Consumer Medicine Information' is intended to show clearly that the information is about medicines. It is therefore a concern that the consumer section of the Pharmaceutical Benefits Scheme website (PBS Online) uses the term 'Consumer fact sheet' to describe CMIs. Pharmaceutical industry, health professional and consumer organisations have been battling to increase consumer awareness of 'CMIs'. The use of an additional term that does not specifically refer to medicines may create confusion.

Health professionals have a duty of care to provide information, whether verbal, written or both, to ensure that consumers can use their medicines correctly and safely. While they are not legally obliged to provide CMI with every medicine prescribed or supplied, Box 1 shows how CMI can be used with consumers.¹⁰

In 2003, and as part of the Medicines Information for Consumers program, community pharmacists in Australia began to receive financial incentives for distributing CMI.¹¹ Participating pharmacists therefore have an obligation to provide CMI following the guidelines of the Pharmaceutical Society of Australia.¹²

The vast majority of CMIs are distributed from health professionals' computers. Currently more than 1200 (about 88% of all CMIs) are available electronically. The websites of pharmaceutical companies and health professional and consumer organisations are increasingly including CMIs (Box 2).

Anecdotally, very few Australian consumers are receiving CMI with their prescription medicines. Moreover, when CMI is given, it tends not to be discussed as part of the consultation. Those consumers who are aware of CMI, who receive it from pharmacists and who read it,^5,11 do not know how it differs from other forms of written information.¹³

In a survey of 226 consumers in community pharmacies in metropolitan Sydney, 58% reported receiving CMI on the day of the interview, and 82% said that they had received CMI in the past.⁵ Their main reasons for reading CMI were to gain knowledge about their medicines, and concerns about adverse effects. The most commonly cited impact of reading the CMI was being informed, followed by being more confident about the medicine and its importance. Fear of experiencing adverse effects made 11 consumers (5%) stop taking their medicine. A further 20 reported having concerns, the majority of whom contacted their health professional. Only two of the 20 ceased taking their medicine, and three reported changing it.⁵

The Medicines Information for Consumers program was evaluated in 2003 and 2004.¹¹ The first survey of 200 consumers showed that 94% had received a computer-generated CMI from their pharmacist on at least one occasion. Two later telephone surveys of 1000 consumers indicated that 24% and 29% of the respondents had remembered receiving a computer-generated CMI from their pharmacist, sometime in the past. Some reported that the CMI caused them to be anxious about their medicines.

There is contradictory evidence regarding the impact of written medicine information on the adverse effects experienced by consumers who read the information. Some studies show a direct relationship between fear of adverse effects and stopping medicines after reading written information.^14,15 Other studies have shown no relationship.^7,16,17 The reluctance of some health professionals to provide CMI to consumers for fear that the information can lead to perceived or actual experience of adverse effects and consequent non-adherence to therapy may not be fully justified. However, the negative impact is real and this is why it is preferable to discuss CMI with the consumer rather than just handing it out.

Although there is some discrepancy between the actual research and the anecdotal evidence, there is confusion among consumers about what a CMI leaflet is and what it contains. CMI is not meant to be a stand-alone document, but an important tool that should be part of the interaction between health professionals and consumers. Health professionals have the responsibility to ensure that consumers understand the information in the CMI and know what action to take should they experience adverse effects.

Consumers want to receive information from their health professionals, some from their doctors⁵ and others from their pharmacists.^3,5 It is therefore in the best interests of consumers if health professionals are aware of CMI and how to use it.

The first guidelines for health professionals were published in 1995.¹⁸ They contained recommendations on the provision of CMIs, their use in counselling about the treatment and the action to be taken in special circumstances, such as emergencies. The guidelines suggested that health professionals provide CMIs to non-English speaking people, but take reasonable steps to ensure that they understand the information content, such as seeking assistance from a family member, friend or interpreter who can read and translate the CMI for the consumer.

Pharmacy and nursing specific guidelines have since been developed to encourage the use of CMIs by these professionals. There is also a guide for consumers and health professionals which provides information about CMIs, how they can improve health care and how they can be used.¹⁰

Despite all this activity, there is limited knowledge among health professionals of what CMIs are (with the exception of pharmacists who are paid a fee to distribute them) and how they can be used for the benefit of consumers. Pharmacists and doctors may feel that they are too busy to include CMI in their consultations or they may not provide it because they are uncertain what to do with it.

In using CMI with consumers (Box 1), it is important that health professionals are familiar with its structure and content.¹⁰ It is also important to note that while areas within a CMI can be highlighted for increased consumer attention, no sections of a CMI should be deleted or crossed out as this de-emphasising of information might increase the health professional's liability should any problems occur.¹²

Health professionals can increase consumer awareness of CMI by encouraging their patients to ask for CMI for their current and new medicines.

Consumers have a right to receive information about the medicines they are taking. Although some consumers are receiving CMI, there is a need to increase its provision. The challenge for all health professionals is to integrate the CMI into their consultations. Consumers, too, should be made aware of CMI and that they can ask for a CMI about their medicine.

There is also a need to evaluate CMI receipt and use by consumers, and to assess the impact of CMI on the healthcare system. There is an expectation that CMI will promote the quality use of medicines, but there is no evidence currently available to confirm this.

Acknowledgement: The author thanks the following for their time and valuable contributions to this manuscript: Diana Aspinall, Trish Dunning, Mary Emanuel, Deborah Monk, Susan Parker, David Pearson, Sylvia Roins, Gillian Shenfield and David Sless.

Conflict of interest: none declared