The Pharmaceutical Journal Vol 267 No 7158 p120
28 July 2001

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Why medicines information leaflets do nothing to promote concordance

By Theo Raynor and Nicky Britten

Medicines are the most common form of health care intervention and there is increasing worldwide focus on empowering patients through being informed about their medicines. This can then facilitate a greater role in the prescribing and managing of their medicines. Two recent initiatives concerning medicines reflect this growing movement. The first is the concordance initiative, which promotes a model of prescribing and medicine-taking based on patients and health care professionals negotiating agreements that respect the beliefs and wishes of patients (see www.concordance.org). The second initiative is a European directive on labelling and leaflets (EC Directive 92/27), which was first drafted in 1992 and fully implemented in 1999. This has resulted in the provision of mandatory patient leaflets with all medicines. Manufacturers have to produce these comprehensive leaflets, basing the information on the Summary of Product Characteristics (previously known as the Data Sheet). This means that all points must be included in the leaflet, but in a form understandable to the patient. It is unfortunate that concordance and these mandatory information leaflets are mutually incompatible.

The concordance model of medicine taking is grounded in the wider philosophy of greater involvement of patients in their care. The need for patients to be involved in such decision-making clearly depends on them being fully informed about their medicines in the widest sense. In contrast, the mandatory medicines information leaflets, as described above, are in most senses narrow, and actually undermine the concordance model. There are three main failings. The first is that patients only receive the full written information once they get home and open the medicine pack. (The packs are sealed with the leaflets inside and are supposed to be handed to the patient unopened.) Any information that questions the appropriateness of the drug is thus too late, since the drug has already been obtained. Secondly, patients need to be informed about the various options for treating their condition, including other drugs and non-drug options. The leaflets, as currently constituted, only include information about the drug in question. Thirdly, patients need balanced information (the pros and the cons of taking the medicine) but, in their current form, leaflets present mainly negative information, ie, contraindications and side effects. The regulations permit positive information, but this generally does not appear, because companies fear it being interpreted as promotional (outlawed by the regulations) and because it would lengthen the leaflets (space is at a premium on leaflets provided as package inserts).

There are other difficulties associated with the new leaflets. Research during the first year after the regulations came into force in the UK found that nearly a fifth of patients failed to notice the package insert leaflet (paradoxically, since one reason this delivery method was chosen was that it guaranteed delivery to the patient). Of those who did recall receiving a leaflet, only 40 per cent read some of it and 21 per cent all of it.¹ Such standard information leaflets cannot be easily modified. In contrast, leaflets generated in pharmacies by pharmacy-based computers (as developed in North America and Australasia²) have the potential to be personalised and individualised, with associated benefits in terms of relevance and patient acceptance. Such leaflets can also be printed just at the first supply (and subsequently only when required), preventing a “familiarity breeds contempt” scenario which must occur when leaflets fall out of a pack every time the patient gets a medicine. Computer-generation also means the pharmacist can go through the leaflet with the patient. Availability in electronic form also allows transformation into other media which provide access to blind and partially sighted people.

Surgery computers are already able to print condition-specific leaflets at the doctor’s desk. Such leaflets could be adapted to become decision-making aids for the patient and hence help to facilitate concordance. The doctor makes a diagnosis and supplies a leaflet which includes all the treatment options (including non-drug and no-treatment options). Having read and digested this information, the patient can return in order to make a treatment decision jointly with the prescriber. This may well reduce misunderstandings, but could also mean an increase in the number of consultations. However, consultations for common conditions like depression and hypertension will already involve more than one consultation, before the long-term treatment option is decided. The rise of web-based information means that, in the future, some patients will be able to access such information directly.

The introduction of comprehensive information leaflets about medicines could be described as the most significant development in the provision of health information for patients in recent years. However, it has been a lost opportunity to support the introduction of concordance in medicine-taking, now supported by the Department of Health as part of the national plan for the NHS. The general inadequacies of these package insert leaflets may result in them becoming a legal backstop, with patients choosing to use more relevant, individualised and wide-ranging information generated electronically.

However, in the meantime, health professionals need to make the most of the currently supplied leaflets. The narrow focus of the leaflets in terms of treatment options needs to be addressed at the prescribing stage. The prescriber needs to describe the treatment options verbally, although some such written information is already available on some conditions. The lack of positive information in the leaflets (ie, the benefits of treatment) can be counter-balanced verbally both when prescribing and supplying the medicine. However, it is difficult to convey such risk-benefit information verbally.

Pharmacists could encourage the patient to open the pack in the pharmacy, when the medicine is handed over, and at the same time that verbal information is provided. This is clearly most appropriate when a medicine is first supplied. The pharmacist could then simply point out the leaflet and encourage the patient to read it at home. However, ideally the pharmacist could go through the leaflet, using it as an aide-memoire, pointing out the key points as the verbal information is given. Professionals also need to be aware of the availability of web-based versions of the leaflets. They are accessible via the Electronic Medicines Compendium (EMC) (www.emc.vhn.net), although coverage is not yet comprehensive. Pharmacists may wish to print out the leaflets for selected medicines on which they focus their verbal information provision. These leaflets can then be stored near the counter, and as an aide-memoire, as described above. This provides a valuable structure around which to base the verbal information provided to patients. The EMC may also be useful if the use of split packs results in extra leaflets being required.

The European Union is currently revising the regulations relating to pharmaceuticals. The shortcomings of the laws relating to medicine information leaflets that are described above, need to be rectified. This will allow pharmacists and other health professionals, to maximise the support they can give in informing and educating patients.

References
1. Raynor DK, Knapp P. Do patients see, read and retain the new mandatory medicines information leaflets. Pharm J 2000;264:268–70.
2. Raynor DK. PILS — on the wrong track? Pharm J 1998;260:55.

Theo Raynor is professor of pharmacy practice , medicines and their users at the University of Leeds. Nicky Britten is director of the concordance unit at the department of general practice and primary care, King’s College London