Impact of Benefit Messages in Patient Package Inserts on Subjective Drug Perception
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0092-8615/2002 Copyright 0 2002 Drug Information Association Inc.
Printed in the USA. All rights reserved.
IMPACT OF BENEFIT MESSAGES IN PATIENT PACKAGE INSERTS ON SUBJECTIVE DRUG PERCEPTION R. H. VANDERSTICHELE, MD Heymans Institute of Pharmacology, Ghent University, Ghent, Belgium
A. VANDIERENDONCK, PHD, G. DE VOOGHT,PHD,
B. REYNVOET, MSc,
AND
J. LAMMERTYN,MSc
Department of Experimental Psychology, Ghent University, Ghent, Belgium
Objective: To explore the impact of the inclusion of a benefit message in a patient package insert on knowledge about medicines and on subjective benefithisk perception. Setting: Female members of community social organizations, female relatives of psychology students, and caregivers to psychotic patients. Nature of the study: Randomized, controlled healthy human volunteer study with three parallel experiments, involving the inserts of cisapride, itraconazol, and risperidon. Design: Subjects were recruited in a convenience sample and randomized to one control and two intervention groups (one with a normal insert and one with an insert with a benefit message). Material and methods: Subjects were asked to read the inserts (using mock text in the control group) in 5 to 15 minutes. Knowledge of the medication was tested with 20 simple questions (to be answered Yes/ No/Don k know) and benefithisk perception with a five-point bipolar Likert scale. Results: In the three experiments respectively 89, 102, and 83 subjects were recruited. The provision of inserts increased the knowledge about medication in all the intervention groups. Thirtyone percent, 41 %, and 54% of the subjects who read a normal insert agreed that the benefit of the medicine was greater than its risks. compared to 62%, 64%, and 70% of subjects who read an insert with a benefit message included ( P < 0.05 in all 3 experiments). Discussion: A hypothesis for further research is formulated: adding a section on benefit information within a patient package insert helps to integrate increased knowledge about medication into a more balanced benefit/risk perception. Key Words: Drug labeling; Attitude toward health; Risk; Cognition; Pharmaceutical preparations
INTRODUCTION SUCCESS I N modern medicine still relies heavily on the repeated self-administration of medicines by the patient. At the start of treatment, the patient
Reprint address: R. H. Vander Stichele, MD, Heymans Institute of Ph-acology, Ghent University, De Pint+ laan 185. B-9000, Ghent, Belgium. E-mail: Robert. [email protected].
must be persuaded of the need to take the medicine, and at the same time, he/she must be informed about its risks. Moreover, the patient should be able to react appropriately when something harmful occurs, expected or not. The first step toward provision of such information began in 1992, when the European Union issued a Directive (1) imposing the insertion Of a leaflet (in most cases 400 to 600 words 10%) in each drug package (2,3). In the United
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R. H. Vunder Stichele, A. Vundierendonck, G. De Vooght, B. Reynvoet, an
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