The role of pharmacists in the recruitment of a cohort for postmarketing surveillance. A case study of acitretin in The Netherlands.
In October 1990, a recall procedure was issued regarding the drug acitretin. The recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years. For a postmarketing surveillance study, we recruited a cohort from the source population of women aged 15-45 years who were exposed to acitretin. Recruitment occurred through dermatologists, and pharmacists plus dispensing general practitioners. We describe the speed of and the response to the recruitment procedures, and the representativeness of the recruited cohort. We also studied whether the individuals who gave informed consent would have preferred to be recruited by either dermatologists or pharmacists, and whether the information obtained from pharmacists and dispensing general practitioners was valid. This study revealed that pharmacists and dispensing general practitioners (drug dispensers) recruited their subjects rapidly, with no or little selection; they attained a 42% response. Dermatologists recruited their subjects slowly and selectively; they attained a 24% response. The majority of women (60%) recruited by dermatologists would have given their informed consent if they would have been recruited by their pharmacists. Drug dispensers are essential contributors to the recruitment of a study population. We do advise that such recruitment for a postmarketing surveillance study occurs by means of a collaboration between pharmacists and physicians.
Sturkenboom
M C
MC
Groningen Institute for Drug Studies, Department of Social Pharmacy and Pharmacoepidemiology, University of Groningen, The Netherlands.
Stricker
B H
BH
de Jong-van den Berg
L T
LT
Cornel
M C
MC
Wesseling
H
H
D017255:Acitretin; D003625:Data Collection; D011307:Drug Prescriptions; D004363:Drug Utilization; D005260:Female; D006801:Humans; D010560:Personnel Selection; D010595:Pharmacists; D011358:Product Surveillance, Postmarketing
D017255:Acitretin