Information about medicines is required as part of the consultation so that consumers can make informed decisions about their treatment. Written information, especially manufacturers' consumer product information (CPI), is an important adjunct to good verbal communication. Doctors have extra responsibilities when prescribing for unapproved indications.
General practitioners are usually the first entry point to medical care and most prescribing takes place in general practice. Over 60% of all consultations can result in the prescribing of one or more drugs.4 Adequate information enables consumers to make better decisions about treatment. Informed consumers may be willing to accept or continue treatment despite minor or transitory adverse effects.
Informed decision making
During consultations, consumers wish to discuss their condition. They want to know:
- its cause and possible course
- the options for treatment and non treatment
- the possible outcomes
Available treatments, their suitability and effectiveness, risks, and how to use them correctly should be discussed.
Consumers wish to understand what the medicine is expected to do. Is it expected to cure the condition or is it being offered for symptom relief? They need to be aware of known possible adverse effects and to have clear and precise information about how to respond to them. If relevant, dosage regimens should be negotiated. For many people, taking medicines at the right time, in the right amount and in accordance with other instructions requires adjustments in their lives which are not always easy to make or remember. Information about storage and disposal of medicines is also needed.
Costs may influence consumers' decisions in seeking, choosing and complying with treatment. While doctors may not wish, or be able, to keep up with the details of costs, charges and concessions, they should be able to discuss the cost of treatment in general terms. For instance, while an out of pocket cost difference between a generic and brand name drug may not seem significant to the doctor, it may influence a patient's choice.
When generic prescribing will result in an unfamiliar medicine being dispensed to the consumer, early advice and reassurance about this change will help the consumer to adjust.
Information provision is a complex process. Health professionals and consumers both need resources and skills to achieve a satisfactory outcome.
Real or perceived differences between doctor and patient in knowledge, education, status, class, gender, ethnicity and culturally derived ideas about power, autonomy, respect and deference often lead to passivity in patients. Particular communication difficulties including language, sight, hearing or intellectual impairment are further factors which can impair effective communication.
Prescribers can genuinely believe that they have given sufficient information, or that information about adverse effects will lead consumers to noncompliance or to imagining symptoms. Conversely, patients often leave consultations dissatisfied with the information they have received. This can result in doubts about how to take medicines, what to do about forgotten doses and which subsequent events justify contacting the doctor again.5
The cultural diversity and individual differences within our society ensure that each consultation will vary with different amounts of information being wanted, communicated and understood.
Communication techniques such as simple and direct language, concrete and specific information, reflecting back, inviting patients to repeat back their understanding of information and giving reassurance that it is all right to ask questions will encourage more active participation. An interpreter service (which may be provided over the telephone) should be used whenever language differences interfere with communication.*
* For interpreting assistance, telephone the Translating and Interpreting Service on 131 450.
The Consumers' Health Forum recommends that advocates should be used when the consumer's comprehension is judged to be limited through intellectual or mental impairment. When the consumer requests the use of interpreters or advocates, they should be used.
New developments in written information
Different forms of written information have become increasingly available in the past few years. They include printouts from pharmacies and books for consumers.
Written patient information (consumer product information CPI) is now required by legislation.6 From January 1993, manufacturers' applications for marketing new drugs or changes to existing drugs must include a draft CPI. Written information must be provided for all drugs by the year 2002.
The availability of CPI will go a long way to fulfilling the consumer need for information. Consumer groups require CPI to satisfy a number of criteria. It should be:
- written in a way that can be understood by consumers
- accessible, with its availability not at the discretion of doctors or pharmacists
- action oriented so that if consumers experience any of the listed possible adverse effects or other adverse
- events, or need further clarification, they are encouraged to contact their doctor or pharmacist.
CPI should motivate consumers to want to know more about the medicines they are taking.
For the prescriber, the CPI may become an important resource and backup to their verbal counselling.
Prescribing outside approved indications
The increased availability of CPI will heighten consumer awareness of drugs prescribed for unapproved indications. This decision must be justifiable in the eyes of prescribers and able to withstand public scrutiny. Professional organisations will need to guide their members on this issue.
The consumer movement views prescribing outside approved indications as 'experimental'. The obligation for the prescriber to provide complete information in order to obtain the patient's valid informed consent is even greater when the information is not in the public domain. Consumers need to be advised about:
- the status of the drug
- the approved uses
- the reason the proposed use has not been approved (if known)
- the reason the unapproved use is proposed
- the evidence for and against the proposed use
- additional adverse effects associated with the unapproved use.
Prescribers should advise the consumer to report adverse events. Adequate records should be kept so that problems can be reported to the Adverse Drug Reactions Advisory Committee. This is one area where 'defensive' medicine may be appropriate and in the best interests of the patient and the doctor.
Consumer rights and responsibilities
The consumer movement has recognised that the right to information goes hand in hand with certain responsibilities for consumers. The Consumers' Health Forum and the health consumer network have been advocating that consumers assist prescribers by being clear about symptoms and knowing the medicines they are taking, including over the counter and 'alternative' preparations. They have also advised about preparing patient held medication record cards and storing and disposing of drugs.
Effective provision and receipt of information about medicines require health professionals to be up to date. They must have the necessary skills to communicate important and relevant information to patients so that it is understood, absorbed and integrated into the consumer's understanding and view of their health and treatment.
A resource which will increasingly become available is CPI. If the CPI is readable and understandable, it will be a useful resource for both consumers and health professionals.
Discrepancies between indications in the CPI and the doctor's stated purpose for prescribing the medicine will create pressures on manufacturers, government and professional organisations to resolve the difference.
The consumer movement is keen to raise awareness among the public of the benefits and risks of medicines and gain a better appreciation of the role of medicines in health. Given the heterogeneity of Australian consumers, their needs and wants are many and complex. Consumers, in taking responsibility for clearly identifying what they want to know about medicines, may help their doctors meet their needs for a more productive and satisfying consulting relationship.
(See also Dental implications)
- National Health and Medical Research Council. General guidelines for medical practitioners on providing information to patients. Canberra: National Health and Medical Research Council, 1993.
- Baume P. A question of balance: report on the future of drug evaluation in Australia. Canberra: Australian Government Publishing Service, 1991.
- Consumers' Health Forum of Australia. Legal recognition and protection of the rights of health consumers. Canberra: Consumers' Health Forum of Australia, 1990.
- Bridges Webb C, Britt H, Miles DA, Neary S, Charles J, Traynor V. Morbidity and treatment in general practice in Australia 1990-1991. Med J Aust 1992;157(Suppl)1S-56S.
- Ley P. Satisfaction, compliance and communication. Br J Clin Psychol 1982;21:241-54. 6 . Therapeutic Goods Regulations. Schedule 12, Patient Information Documents. Canberra, 1992:69-71.