Communicating a drug alert. A case study on acitretin in The Netherlands.
In October 1990, a recall procedure was initiated for the teratogenic drug acitretin, and the recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years due to the possibility of its conversion to the lipophilic compound etretinate. The aim of the present study was to evaluate the communication procedures and their effects as a drug alert from the health authorities, the pharmaceutical company and professional associations of health professionals to the population at risk. A model was used to evaluate communication between three hierarchical levels. Data were obtained via semi-structured interviews and structured questionnaires. Communication procedures were evaluated according to channel characteristics and by analysis of their contents. The effect was measured as whether the drug dispensers identified acitretin users, contacted physicians, and whether physicians communicated in person with the population at risk. The penetration of direct mail from the health authorities and from the pharmaceutical company ranged from 97-98% and 65-94% at Level 2 (health professionals). The population at risk was informed via personal communication with health professionals, and/or the mass media. Of the women at risk, 19% were contacted by a dermatologist, 30% by their GP, and 39% by the pharmacist. 35% was never informed by any health professional. The Dutch health care system is adequately equipped for effective communication between health authorities, pharmaceutical industry and health professionals.(ABSTRACT TRUNCATED AT 250 WORDS)
Sturkenboom
M C
MC
Department of Pharmaceutical Pharmacology and Clinical Pharmacy, University of Groningen, The Netherlands.
de Jong-van den Berg
L T
LT
Cornel
M C
MC
Stricker
B H
BH
Wesseling
H
H
D017255:Acitretin / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D015331:Cohort Studies; D003142:Communication; D004345:Drug Industry; D004346:Drug Information Services / Q000592:standards*; D004335:Drug and Narcotic Control; D005069:Evaluation Studies as Topic; D005260:Female; D006282:Health Personnel; D006801:Humans; D008402:Mass Media; D008875:Middle Aged; D009426:Netherlands; D011177:Postal Service; D011358:Product Surveillance, Postmarketing
D017255:Acitretin