The Ideal Nonsteroidal Anti-Inflammatory DrugPatient Information Leaflet

Roger Jones, DM, FRCP, FRCGP, FFPHM, FMedSci, Joanna Seager, BPharm, PhD

The prescribing of medicines is often at the heart ofthe physician–patient consultation for medicalproblems, yet patient compliance is erratic and

generally not in accordance with advice provided by phy-sicians, pharmacists, or the drug packaging itself. Indeed,patient nonadherence to medicine taking is the rule,rather than the exception. There are some extraordinaryexamples of patients’ failure to adhere to prescribed reg-imens. One of the most common causes of renal trans-plant rejection in children is failure to take their immu-nosuppressant drugs, representing a parental failure ofadherence as well as (or resulting in) patient noncompli-ance. For patients who have had a severe upper gastroin-testinal hemorrhage requiring hospitalization and bloodtransfusion, adherence rates to subsequent acid suppres-sion therapy are in the region of only 50% to 60%. Inhypertension, the rule of halves applies: Only half of thecases are ascertained, only half of these are started ontreatment, and only half of the treated patients stick totheir medication. Finally, the treatment of depression, atleast in primary care, is truly bedevilled by nonadherenceto medication. Recent work from London has indicatedthat after 2 and 3 months, respectively, only some 40%and 25% of patients started on antidepressant medicationby their physicians are still taking the drugs. These ex-traordinary figures apply not only to the anticholinergicgroup of drugs but also to the more modern selectiveserotonin reuptake inhibitors (SSRIs), which have amuch more benign side-effect profile.

Communication between physician and patient isclearly a central issue in encouraging compliance, butthere is evidence to show that patients can recall only asmall fraction of the information imparted in consulta-tions in primary and secondary care. It is not surprising,therefore, that other methods of providing informationto patients have been tried, and patient information leaf-lets (PILs) are among these. Indeed, since January 1, 1999,European law requires the inclusion of PILs in all pack-ages of medicine. There is some research evidence that theform and content of these leaflets fail to meet the pur-poses for which they are designed.1–3 In this article, wepresent suggestions for an “ideal” PIL for an imaginary

nonsteroidal anti-inflammatory drug (NSAID), seager-profen (Analgen), manufactured by a fictitious company(Hawkpharm plc) (Table 1).

It is important to realize that the provision of writteninformation alone is no substitute for good communica-tion between physicians and their patients. In recentyears, such concepts as concordance4 (agreement afternegotiation between physician and patient about the na-ture of the problem and the most likely beneficial coursesof action) and enablement5 (giving patients informationand responsibility for the management of their ownproblems) have emerged and are being incorporated intomodern thinking about physician–patient encounters.There is some evidence that when concordance isachieved between physician and patient, adherence tomedication is enhanced, and that patients who are pro-vided with prescriptions they do not want or do not un-derstand are extremely unlikely to even fill their prescrip-tion, much less take the medicine. The PIL, therefore,needs to be seen in the context of a patient-centered, ne-gotiated consultation in which physician and patientstrive for a concordant view of the problem and its solu-tion.

PRINCIPLES

In drafting the attached outline of the ideal NSAID PIL,we tried to adhere to the following principles:

● Clarity. To strive for clarity, both in terms of the pro-vision of information about the indications, action,and dosage of the drug and in the clarity of the languageused throughout the PIL.

● Truthfulness. To provide accurate information aboutthe natural history of the diseases likely to be treatedwith the medication and the effect of the drug on thenatural history.

● Evidence-based medicine. To accommodate, as much aspossible, the most recent evidence of efficacy and prob-lems (side effects, contraindications, and adverse reac-tions),6 possibly including a quantitative account ofthese issues.

● Comprehensiveness. To include all the important as-pects of drug taking that patients are likely to need toknow, although it is acknowledged that further quali-tative work may be required to establish patients’ in-formation needs with greater precision.

● Brevity. To make the first three principles compatiblewith this fourth principle of brevity, recognizing that

From the Department of General Practice and Primary Care, Guy’s,King’s and St. Thomas’ School of Medicine, London, United Kingdom;and the Cardiff Medicentre, Cardiff, United Kingdom.

Requests for reprints should be addressed to Roger Jones, DM, De-partment of General Practice and Primary Care, GKT School of Medi-cine, 5 Lambeth Walk, London SE11 6SP, United Kingdom.

38S © 2001 by Excerpta Medica, Inc. 0002-9343/01/$20.00All rights reserved. PII S0002-9343(00)00635-5

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long, tightly printed leaflets are unlikely to be read byanyone.

● Utility. To provide information that patients may needto act on, such as what to do in the case of accidentalunder- or overdosage, how to respond to an unex-pected and possibly adverse reaction, and how to ob-tain further information about the drug being taken.

CONCLUSIONS

There is a need for physicians to combine written infor-mation with good communication skills during theirconsultations with patients. The model we have providedfor an ideal PIL offers a template for the production ofthese leaflets in the future. However, the role of moderntechnology may also need to be considered. It may beappropriate in the not-too-distant future to consider theuse of an interactive website containing this and otherinformation for patients taking specific drugs. The possi-bility of providing patients with computerized informa-tion, tailored to their current medical problems, as well as

issues of comorbidity and coprescribing, is another sub-ject for future exploration.

REFERENCES1. Herxheimer A. Leaflets with NSAIDs do not warn users clear-

ly—a UK survey. Pharm J. 1999; 262:559–561.2. Wynne HA, Long A. Patient awareness of the adverse effects

of non-steroidal anti inflammatory drugs. Br J Clin Pharma-col. 1996;42:253–256.

3. Arthur V, Clifford C. Evaluation of information given to rheu-matology patients using non-steroidal anti-inflammatorydrugs. J Clin Nurs. 1998;7:175–181.

4. Howie JG, Heaney DJ, Maxwell M, Walker JJ. A comparisonof a patient enablement instrument (PEI) against two estab-lished satisfaction scales as an outcome measure of primarycare consultations. Fam Pract. 1998;15:165–171.

5. Royal Pharmaceutical Society of Great Britain. From Com-pliance to Concordance: Achieving Shared Goals in Medi-cine Taking. London: Royal Pharmaceutical Society, 1997.

6. Tramer MR, Moore RA, Reynolds DJM, McQuay HJ. Quan-titative estimation of rare adverse events which follow abiological progression: a new model approach to chronicNSAID use. Pain. 2000;85:109–182.

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