Consumer product information affects us all

A new experience awaits health professionals in 1996. In July, we will be part of the first National Medicines Week. Between 7 and 13 July, patients will be encouraged to ask about consumer product information (CPI). Are you ready?

Most health professionals may not be familiar with the Baume report.¹ However, the effects of the Government's decision to implement this report in full will soon be felt around Australia. Recommendation 50 required patient information to be provided for all new drugs. All existing products must also have CPI by the year 2002. Although the intention was that the Therapeutic Goods Administration (TGA) would evaluate CPI, it was unable to scrutinise every document. There was a concern that unevaluated CPI would not meet consumers' needs. It could have become a collection of dreary documents designed to limit product liability rather than to help patients. A coalition of interests from the pharmaceutical industry, health professionals and consumer organisations has been working hard with the Department of Health and Family Services to try to ensure that CPI will be useful.²

For CPI to be successful, people must be able to understand the information. It has to be easy to read. In addition to using simple terms, this also requires clearly legible typefaces. As CPI only needs to be produced in English, its usefulness to many patients will be limited. While it is surprising that other languages were not initially considered, this problem is being addressed. However, a solution is unlikely to be in place before July.

When should CPI be given? The 'General guidelines for health professionals on consumer product information'³ propose that CPI should be given

• when a drug is first provided (including starter packs)
• the dose form has been changed
• regular reinforcement of information is needed e.g. warnings about the teratogenicity of retinoids
• the patient is on long-term therapy (giving CPI every 6 months is suggested)
• the CPI has been significantly revised.

Although the penalties for not supplying CPI have been removed from the TGA regulations, the General Guidelines clearly imply that CPI should be provided or offered every time a medicine is prescribed, dispensed or administered. The Guidelines say that a record should be kept each time a patient accepts or rejects CPI. Some of these Guidelines may seem rather daunting, but organisations representing health professionals have the opportunity to adapt them so that they are workable in different situations.

Who gives the CPI to the patient? Although the legal responsibility rests with the pharmaceutical companies, CPI will usually be provided by a doctor or pharmacist. Logically, the prescribing doctor should give CPI, but, at first, pharmacists will be doing most of the delivery. When both professions can provide CPI, there will be a need to agree who says what to avoid confusing the patient. Will there be a requirement for the diagnosis to be written on all prescriptions or perhaps a box to tick when the medical practitioner has given the CPI?

Good practice should already involve informing patients about their medication. CPI should be seen as part of that interaction, not a substitute. One could predict how a court would react to a defence that the adverse effects of a drug were not discussed because the patient was given CPI.

Legal liability is an increasing concern for health professionals. At present, we do not know what will happen if a patient comes to harm because of CPI. There have already been examples of depressed patients not taking their drugs because they have read about the possible adverse effects of antidepressants. Drugs with several indications also cause problems, particularly if some of the indications are not approved. CPI must be based on the product information approved by the TGA. It cannot include alternative, but professionally legitimate, uses of a drug e.g. the use of certain anticonvulsants in mood disorders. Medical practitioners will therefore have to be familiar with the CPI of the drugs they prescribe. This will avoid inadvertently giving the patient advice which may conflict with the CPI. If inconsistencies exist, or if the drug is being prescribed for an unapproved indication, the patient will require a more detailed explanation.

There are other problems with CPI, many of which are discussed by the authors of papers in this issue. However, there is great potential for CPI to improve the use of medicines in Australia. The probability is that CPI will be evolutionary rather than revolutionary. If good quality CPI can be consistently produced and improved, it may become a well accepted part of the dialogue between health professionals and their patients. There is everything to be gained from improved communication.

i . industry view

Pat R. Clear, Chief Executive Officer, Australian Pharmaceutical Manufacturers Association, Sydney

The introduction of consumer product information
The requirement to provide consumer product information (CPI) for prescription pharmaceutical products was introduced following recommendations in the Baume report on drug evaluation in Australia. From 1 January 1993, all new prescription products, including changes to existing products, were required to have CPI. The requirement was introduced through Therapeutic Goods Regulation 9A and the content of CPI is described in Schedule 12 of the Regulations.

At a meeting convened by the Pharmaceutical Health And Rational use of Medicines (PHARM) Committee in April 1994, considerable concern was expressed by doctors and pharmacists about CPI. They were concerned about the responsibility they believed would be placed on them to provide CPI each time a prescription product was administered or dispensed to a patient, and the penalties associated with not doing so. As a result, in November 1994, Regulation 9A was amended to state clearly that it is the sponsor's (i.e. the pharmaceutical company's) responsibility to supply CPI.

On 4 July 1995, the requirement for CPI was extended to require CPI for all new Schedule 3 (pharmacist only) medicines.

By January 2002, all prescription and Schedule 3 products will have CPI.

Usability guidelines
With funding from the Department of Health and Family Services Pharmaceutical Education Program, the Communication Research Institute of Australia (CRIA) has developed usability guidelines for the writers of CPI. The guidelines describe how to communicate information about medicines effectively in CPI and a method for testing CPI with consumers.

The Australian Pharmaceutical Manufacturers Association (APMA) has established CPI consistency working groups. This should encourage consistency between CPI for products in the same therapeutic class and minimise the potential for confusion if a consumer's therapy is changed to a different product for the same condition. 'Core' CPI documents, on which individual product CPI may be based, have been developed for antianginal products, antidepressants, drugs to treat hypercholesterolaemia and drugs to treat hyperacidity, reflux and ulcers. Working groups are currently developing core CPI for tetracyclines, penicillins, cephalosporins and topical corticosteroids, with further groups planned in other therapeutic classes.

Quality assurance
A CPI Content/Quality Assurance Reference Group (QARG) has been established under the auspices of the Australian Pharmaceutical Advisory Council (APAC). The Reference Group includes representatives of consumers, doctors, nurses, pharmacists, clinical pharmacologists, CRIA and industry. Its main role is to promote high quality, useful CPI and to oversee the work of the CPI consistency working groups. The Reference Group considers matters related to content and quality of CPI. *

General guidelines for health professionals
'General guidelines for health professionals on consumer product information' have been developed by a working group of APAC. The Guidelines suggest how frequently CPI should be provided in the community and practical ways to provide CPI in situations other than following a consultation in a surgery. The General Guidelines are intended to form a basis for more detailed specific guidelines to be developed by different health professions or institutions.+

Distribution
Until recently, CPI was distributed either as package inserts or as leaflets mailed directly to health professionals. In August 1995, electronic distribution of CPI through community pharmacy commenced. Electronic distribution of CPI has a number of advantages over both package inserts and leaflets. These include ease of storage and speed of updating the CPI.

Community pharmacy has been the initial focus for electronic distribution of CPI due to a high level of computerisation. As doctors increase their use of computers, they will also be able to generate CPI.

Supporting the quality use of medicines
The APMA strongly supports the role of doctors and pharmacists in providing information to consumers about their medicines. The Australian pharmaceutical industry has taken the lead in the development and delivery of CPI which is an important way to improve the quality use of medicines in Australia.

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* It may be contacted through the Chairperson, Ms Deborah Monk,
c/- APMA, tel. (02) 9922 2699, fax (02) 9959 4860.

+ Copies can be obtained from the APAC secretariat, tel. (06) 289 7491.

ii. consumer view

Sarah Fogg, Australian Pensioners' & Superannuants' Federation, Sydney

Consumer product information (CPI) has the potential to make a significant contribution to the wise and proper use of medicines in Australia.

Consumer groups see CPI as offering many practical advantages. Consumers, particularly older people, are often well aware that they cannot remember everything they have been told about a particular medicine. Therefore, they value written information that backs up what they were told during the consultation.

Often, many factors conspire to make communication during consultations less than ideal. For example, older people often perceive their doctors to be very busy, and not altogether encouraging of questions. While CPI cannot and should not replace the discussion between consumers and their medical practitioners, it provides a means of reminding people what their doctor said. The CPI can be referred to later if an unanticipated situation arises e.g. if a dose is forgotten. CPI will really come into its own when the consumer is at home deciding how to take the medicine, when they do not have a helpful doctor or pharmacist at their side.

Most importantly, CPI contains practical advice about the relative significance of possible adverse effects. Often, consumers are unsure if an effect should merely be reported to the doctor at the next scheduled visit, warrants an unscheduled visit or phone call, or needs immediate action. To discuss all the possibilities in a single consultation is difficult, if not impossible.

Consumers have difficulties when different health professionals give apparently conflicting advice about a particular treatment. CPI offers a form of standard information which will be the same whether it is obtained from a general practitioner, a specialist or a pharmacist.

While there are certainly individual and cultural differences about the amount of information people want, doctors commonly underestimate how much information consumers want or have understood. (The opposite occurs too, with consumers underestimating what their doctors need to be told.)

Some professionals are concerned that, when faced with CPI and a list of unpleasant adverse effects, consumers will be less likely to take their treatment. However, there is some evidence to suggest that, while consumers may find that detailed information about possible negative outcomes increases their anxiety at the time of the treatment decision, once the decision is made they value having been given the information. Subsequently, they are more likely to complete the agreed treatment.

Older people often report a feeling of having been let down by their doctors if they suffer unpleasant or serious adverse effects which they had not been warned about. The feeling and damage to the relationship caused by being let down can be even stronger than the memory of the adverse effects. Warnings about possible adverse effects make them easier to deal with if they do occur.

CPI is clearly not going to solve every problem or information need. A significant proportion of the population does not read well, or does not read English. Methods of enabling these groups to have access to the information they need and want is a challenge yet to be properly tackled. However, consumer groups have been impressed with and are glad to have been involved in the efforts to ensure that CPI is well written and designed, properly tested and evaluated.

The distribution of CPI is in its early days. Consumers will be relying on medical practitioners to tell them about the existence of CPI and to give it to them or remind them to ask the pharmacist for it. If CPI is to work, it must reach the consumer!

iii. pharmacist view

Simon Appel, Executive Pharmacist, Pharmacy Guild of Australia, Canberra

The 'introduction' of consumer product information (CPI) with community pharmacy as the initial provider of the information represents an important advance in the role of the pharmacist. In combination with the introduction of brand substitution, the provision of CPI places responsibility on the pharmacist to perform a new and complex role.

Pharmacists operate in a highly regulated environment, with their obligations clearly defined. We are entering a new professional era where the obligations of the pharmacist are grey rather than black and white. The demands from a better informed consumer are increasing recognition of 'duty of care' in a less rigid, but expanding, operational environment.

Eventual introduction of electronic CPI in community pharmacy on a large scale will depend on agreement being reached on a number of points. Pharmacists will need to be adequately reimbursed for the considerable expense in receiving and supplying CPI. Current printers, for example, are unable to perform a CPI print-out (often comprising several A4 pages) in a reasonable time. The costs for consumables such as paper, and dispensary re-fitting are also likely to be substantial. The greatest cost will be associated with the pharmacist's time in counselling 'in concert' with a CPI document.

The practicality of some current CPI documents is in doubt. Consumer surveys will be required to modify CPI documents into a more 'user-friendly' format.

While these issues are being addressed currently, pressure on the pharmacist to undertake expenditure in advance of a negotiated agreement is unrealistic and unfair.

At the same time, the medical profession is being charged with the obligation to 'inform' the patient more comprehensively on diagnosis and treatment options.

The medical and pharmacy professions will need to work more closely in the interests of the quality use of medicines and improved health outcomes. CPI has the potential to enhance our relationship, or to damage the trust and independence so necessary in today's health environment.

In the short term, community pharmacy offers an accessible and convenient source for supplying CPI to the patient. There are many compelling reasons for this to proceed, but we are now entering a development phase in medication information that requires trust, confidence and improved communication between prescriber and dispenser.

The debate covering implementation of CPI has often reached destructive proportions. There has been confusion surrounding the concepts of 'informed consent' and 'duty of care' and some arguments have been mischievous at best.

Although beneficial outcomes from better medication management have been identified, the process of a pharmacist providing unilateral advice on a prescribed medicine, without an understanding by the prescriber of the advice being given, can lead to a real breakdown in doctor/pharmacist relationships. This does not benefit patients.

The Pharmacy Guild of Australia is concerned to ensure closer co-operation and understanding between doctors and pharmacists with respect to CPI. We encourage regular communication between the professions. A joint project conducted in Cranbourne, Victoria by the Royal Australian College of General Practitioners and the Pharmaceutical Society of Australia has highlighted the real benefits possible when good communication is established.

CPI represents an opportunity and a threat to both pharmacists and doctors and it is most important that the two professions work together at the practitioner level.

iv. medical practitioner view

Peter Joseph, Australian Medical Association (South Australian Branch), Adelaide

Consumer product information (CPI) is a challenge to current medical practice which doctors must meet. In most countries which have enacted similar legislation, the legal requirement is satisfied by package inserts. Many patients either ignore these, or, if they read them without the advice of a 'learned intermediary', may be so upset that they refuse to take the medication.

In Australia, the patient will be given the written information by a health professional. At the moment, pharmacy is the only profession with the cohesion and computer capacity to discharge the sponsors' legal obligation to supply CPI. (The 'sponsor' is the pharmaceutical company.)

Medical training stresses the need for patient education. The provision of limited information within the constrained time of a consultation has always been undesirable professionally. Now it is also unsafe legally.

The Rogers v Whitaker decision (see 'Common law duties of prescribers' Aust Prescr 1996;19:18-20) involved the level of information patients must be provided with in order to be able to give informed consent. It applies equally to medical and surgical management. Even relatively remote risks of following medical advice may need to be disclosed to discharge legal liability. Patients may forget what they were told, so the National Health and Medical Research Council guidelines on informed consent include reference to written as well as verbal information.

The current plan for distribution of CPI is at the point of dispensing - the pharmacy. The pharmacists had already recognised the need to re-establish their professional relevance by providing professional advice when dispensing. Their professional bodies have recognised the value of CPI in expanding both the professional role and the financial and commercial interests of pharmacy. Pharmacists and medical practitioners share the health budget, which is not expanding, so how will the distribution of CPI be funded?

The challenge to doctors is not merely that their patients' Medicare rebates for medical services may be reduced. More significantly, their professionalism has been subject to external review, found wanting, and their responsibility for education handed to the dispensing, rather than the diagnostic and treating, profession. CPI presents medical practitioners with a golden opportunity to resume their proper role. It encompasses both the informed consent and written information now required when prescribing. This is clearly the doctor's duty and the duty can be discharged by providing the CPI and discussing it with the patient.

If CPI is provided by pharmacists, new and complex professional and personal relationships need to be established. The pharmacist's role in providing advice is unquestioned. Pharmacists have always acted as one point of entry into the health care system, and, using their knowledge and experience, have advised on over-the-counter remedies and provided advice on when and how to take medication, drug interactions and adverse effects. They are also an important safety net for prescribers.

If doctors do not provide CPI, inter professional conflict will escalate. The pharmacist's advice to the patient may reflect concern at both proper and improper prescribing practices and cause significant loss of confidence in the practitioner by the patient, whether this is warranted or not. Attempts to resolve these conflicts before they become widespread have resulted in discussions between the professions, and pharmacy and medical boards in some States

Some medications are prescribed for unapproved but quite legitimate indications. Pharmacists may assume that the medication is being taken for a particular purpose and cause concern by presuming that the indication is one for which the medication is normally prescribed.

Pharmacists believe that to provide appropriate CPI they require the diagnosis. While privacy is the patient's right and the doctor's duty, the patient can provide the pharmacist with that information, or can allow the doctor to do so. Nevertheless, the provision of CPI by a pharmacist does not absolve the doctor of the legal responsibility for informed consent. Advice by the pharmacist should be supplementary and complementary.

The problem at the moment is that most general practices are not able to print prescriptions or CPI electronically. Master copies of CPI may be available in the near future. Information may also be available on computer disk at a later date. Industry insists that it is not favouring pharmacists by using them as the primary source of supply of CPI. It should, however, be noted that the claim that pharmacy was already significantly computerised belied the fact that most of the computer equipment was not capable of providing the CPI.

We have a duty to ensure that patients are not confused by conflicting advice. The availability of master copies will ensure that CPI can be provided in the short term. Longer consultations will be necessary to provide the level of counselling required for informed consent. This may increase medical fees which must also cover the cost of the equipment to produce CPI. For general practitioners, emergency care and after-hours home visits pose particular problems. These problems pale into insignificance compared to those faced by anaesthetists, but obtaining informed consent from patients suffering from impaired mental capacity, in nursing homes and hostels, or even at home, and certainly patients with psychiatric illness will bedevil the profession for years to come. Nevertheless, it is a challenge to which the profession must rise, and an opportunity to resume its proper role.