Patient-information leaflets andprescriber competenceFrom Jan 1, 1999, in accordance with European Union(EU) legislation (Council Directive 92/97 EEC),medicines dispensed in the Union must be accompaniedby printed information written for the patient. In mostcases, the information will be provided in a patient-information leaflet (PIL), in some on the package.Although primarily intended to help patients, PILs willhave far wider consequences.
Just as patients have a right to prescribing information,prescribers have a duty to explain (panel). Till now therehas been no way of standardising what might be conveyedduring the consultation. However, the PIL provides abasis for discussion. Its contents reflect what the EUconsiders the “responsible” patient needs to know. But tobe an equal partner in the therapeutic dialogue betweenthe patient and the prescriber, the latter will need to knowthe contents of the leaflet, although the patient mightreasonably expect the prescriber to know more than that.
As PILs become the currency of the therapeuticdialogue, so too will they provide a standard of minimumprescribing competence. Competence in prescribing, inlaw if not in practice, will be defined in terms ofknowledge of the content of PILs, and of an ability toanswer patients’ questions about the informationcontained. Crucially, this standard will be publiclyavailable and set by those other than medical academics,and it will apply to the teaching about medicines, whetherin a college or university, for a higher degree, or as part ofcontinuing professional education. It will also applyequally to doctors, nurses, and dentists. Even when theprescriber is a doctor or nurse acting as a member of apredefined prescribing team, each signatory, irrespective
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COMMENTARY
of profession or seniority, must have a working knowledgeof the PIL. However, if the patient wants more detailedinformation, more senior members of the prescribingteam will need to be able, and in a position, to provide it.
Since the amount of information in each PIL isextensive, achievement of a working knowledge of thecontents will be demanding. EU legislation requires thatPILs provide a lay-term equivalent of the contents of thesummary of product characteristics (SPC; formerly thedata sheet) and so be consistent with the product licence(marketing authorisation). Accordingly, PILs will includedetailed information on the product’s ingredient(s),indication(s), dosage regimen(s), expected beneficialeffects, warnings, contraindications, and possibleunwanted effects (and how to deal with them), togetherwith interactions with drugs or food, storage arrange-ments, and advice on what to do when doses are missedor overdose occurs. In some cases such information islikely to be very detailed. For example, the current leafletfor Innovace (enalapril; revised August, 1997) lists over60 unwanted effects, and the interaction section listssome 13 classes of drugs that interact with enalapril.
Leaflets reinforce the idea that the contents will beknown to the prescriber—for example, by statements that“your doctor knows about these [interactions] and willalter your treatment accordingly”. But the prescriber willalso need to know what is not in the PIL. Since the leafletcontains only information that reflects the contents of theSPC, it will not supply information on prescribing outsideof the licensed indications.
Once PILs have been adopted as the basis for thetherapeutic dialogue and for setting standards ofminimum competence, two major developments willfollow. First, it will become particularly important toensure that the information is up to date, reliable, andconsistent, and is presented in a usable way. Undercurrent arrangements PILs in the UK are drawn up bythe licence holder (the drug company) and the MedicinesControl Agency. However, others (consumers, patients,prescribers, pharmacists, and professional groups) willneed to be involved to ensure their contents areappropriate. Again with the Innovace PIL as an example,the list of unwanted effects is inordinately long,occasionally vague (“feeling generally unwell”), difficultto fathom (may cause an “abnormal accumulation ofsubstances in the lungs”), and often imprecise (does notstate the actual risks of the particular side-effect). Inreality, it is probably necessary to highlight only thoseunwanted effects that are common and those that areserious, giving in each instance some indication of thelikelihood of the risks (eg, in bands of >1%, 0·1–1%,<0·1%) and their implications. Leaflets will need to beregularly reviewed by the multidisciplinary teams, and therevised leaflets quickly distributed. Dispensing ofmedicines with out-of-date PILs would not be acceptable.
Second, explanations of the background to the variousstatements made would be helpful, indicating, forinstance, from where the material originated and thestrengths of the various arguments. Perhaps textbooksbased on PILs might be the answer.
The introduction of PILs will have profound effects onprescribing. These leaflets and the developments that willfollow should be embraced by the medical profession.
Joe CollierDepartment of Clinical Pharmacology, St George’s Hospital MedicalSchool, London SW17 0RE, UK
Patients’ rights, prescribers’ duties
Patients’ right to prescribing information• World Health Organization: “patients have the right to be
given factual, supportable, understandable and appropriateinformation, to be provided in such a way as to allow themto decide whether they wish to receive therapy” (WorldHealth Assembly declaration 1994).
• UK Department of Health: for patients treated in the NHS,“you have the right to have any proposed treatment,including any risks involved in that treatment and anyalternatives, clearly explained to you before you decidewhether to agree to it” (The Patient’s Charter and You,January, 1995).
• UK NHS: doctors in the NHS are advised that “patients areentitled to receive information in a way they can understandabout the proposed treatments, the possible alternativesand any substantial risks so that they can make a balancedjudgement”. (A guide to consent for examination andtreatment. NHS Management Executive 1990.)
Prescribers have a duty to explain• UK General Medical Council: doctors “must give patients
the information they ask for or need about their condition,its treatment and prognosis . . . in way they canunderstand” so that “wherever possible the patient hasunderstood what is proposed, and consents to it, before youprovide treatment . . .” (Good Medical Practice—RevisionDraft, May 1998).
• UK Medical Defence Union: “A doctor . . . has a duty toexplain to the patient in non-technical language the nature,purpose and material risks of the proposed treatment”(Consent to Treatment, Medical Defence Union, 1992).
