Medicine information leaflets fail concordance test

BMJ 2001; 322 doi: http://dx.doi.org/10.1136/bmj.322.7301.1541 (Published 23 June 2001) Cite this as: BMJ 2001;322:1541
  1. D K Theo Raynor (D.K.Raynor{at}leeds.ac.uk), professor of pharmacy practice, medicines, and their users,
  2. Nicky Britten, director of concordance unit
  1. Division of Academic Pharmacy Practice, University of Leeds, Leeds LS2 9JT
  2. Department of General Practice and Primary Care, Guy's, King's, and St Thomas's School of Medicine, King's College, London SE11 6SP

    EDITOR—Two initiatives about the use of medicines reflect the growing movement towards involving patients in their health care. The first is concordance, which promotes a model of prescribing based on negotiated agreements that respect the patient's perspective.1 The second is a European directive requiring mandatory patient leaflets with all medicines.2 Manufacturers must produce these comprehensive leaflets, including all datasheet information, in a form understandable to patients. Unfortunately, concordance and such mandatory leaflets seem to be mutually incompatible.

    Concordance requires that patients be fully informed about their medicines in the widest sense. Perversely, the mandatory leaflets are in most senses narrow and undermine concordance. Firstly, patients only receive the information when they open their medicines. Any information throwing doubt on the appropriateness of the drug therefore comes too late. Secondly, patients need to know the various options for treatment. Currently leaflets include only information about the drug in question. Thirdly, patients need balanced information, but the leaflets present mainly negative information, such as side effects.

    Other problems exist. Recent research found that nearly a fifth of patients failed to notice the package leaflet. Of those who recalled receiving a leaflet, only two fifths read some of it and two tenths all of it.3 Unlike computer generated pharmacy leaflets (which are used in the United States and Australasia), the leaflets cannot be individualised.3 Computer generation allows pharmacists to use leaflets as aides mémoire and go through them with patients. The electronic form also gives options for providing access to partially sighted people.4

    Surgery computers are already able to print condition-specific leaflets at doctors' desks.5 They could be adapted as decision making aids for patients and hence facilitate concordance. The doctor makes a diagnosis and supplies a leaflet, which includes all treatment options. Having read and digested this information, the patient returns to make a decision jointly with the prescriber. This may reduce misunderstandings but might increase the number of consultations. But common conditions such as hypertension already necessitate multiple consultations before long term treatment options are decided.

    The introduction of comprehensive medicine leaflets is an important development in the provision of information, but the opportunity has been lost to support concordance in medicine taking, which is now endorsed by the NHS Plan. The inadequacies of such leaflets mean that they may become a legal backstop, with patients accessing more relevant, individualised, and wideranging information generated electronically. European law needs amending to reflect this.


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