Impact of patient package inserts on patients' satisfaction, adverse drug reactions and risk perception: The case of nsaids for posttraumatic pain relief

Abstract

Objective: The main objective of this study was to measure the impact of the patient package insert (PPI) of a nonsteroidal anti-inflammatory drug (NSAID) on patient satisfaction with medication information, on medication risk perception and on the reporting of adverse drug reactions (ADRs), as compared with the impact of the traditional (physician-oriented) insert. Design: A randomized clinical trial was conducted, with random allocation of the PPI and the traditional insert. The physicians were blinded for the experimental condition. A follow-up visit was scheduled after one week. Setting: 42 volunteering general practitioners (GPs) from the Dutch-speaking part of Belgium selected the patients. Patients: Every GP had to select, during a period of approximately 6 months between March 1989 and February 1990, a consecutive sample of patients with acute injuries of the locomotor system, for whom he would, for symptomatic therapy, prescribe an NSAID in his routine practice. A total of 366 patients was selected, 317 of whom completed the study. Intervention: All patients selected received a package of the NSAID pirprofen (30 capsules of 200 mg) from their GP. This package contained (at random) a PPI or a traditional insert. Measurements and main results: the GPs had to complete case records (clinical details, ADRs reported spontaneously). Patients received a self-administered questionnaire (identification, readership, satisfaction, risk perception, influences on decision taking and health problems that could be ADRs) at the second visit. Satisfaction, risk perception and influences on decision taking were measured on unlabeled semantic differential 7-point scales. On the whole, package inserts were read by 71% of the patients (N = 317). PPIs were not read more frequently than traditional inserts. PPIs were found to be more understandable (P < 0.001), but overall satisfaction with the inserts was high for both types. A less favorable assessment of the benefits as compared with the risks of the medication was found among patients who read the insert and within this group among patients who received the PPI. Patients who read the insert were more likely to report health problems that could be ADRs, both spontaneously (P < 0.001) and on a checklist (P = 0.025). They were also more likely to attribute health problems to the medication (P = 0.005) and to stop taking the medication because of ADRs. Patients who received a PPI were more likely to report possible ADRs as well, but this was statistically significant (P = 0.034) for spontaneous reporting only. Conclusions: The patients were very satisfied with both the traditional package insert and the PPI. Clear, understandable risk information in package inserts in the setting of an optional symptomatic treatment of an acute self-limiting disease, has some impact on how patients perceive, appraise and manage medication risks. Therefore, the PPI is an important instrument in adequate communication concerning the benefits and risks of drugs and should be drafted and handled in an appropriate way.