The role of pharmacists in the recruitment of a cohort for postmarketing surveillance
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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.
KeywordsAcitretin Data collection Dermatologists Drug utilization Epidemiological methods Pharmacists Product surveillance, postmarketing
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- 1.Wiegand UW, Jensen BK. Pharmacokinetics of acitretin in humans. In: Saurat JH, editor. Retinoids: 10 years on. Basel: Karger, 1991:192–203.Google Scholar
- 2.Howard WB, Willhite CC. Toxicology of retinoids in humans and animals. J Toxicol Toxin Rev 1986;5:55–96.Google Scholar
- 3.Kragballe K, Jansen CT, Geiger LMW, Bjerke JR, Falk ES, Gip L, et al. A double blind comparison of acitretin and etretinate in the treatment of severe psoriasis. Acta Derm Venereol Suppl 1989;69:35–40.Google Scholar
- 4.Camenzind M, Geiger JM, Saurat JH. Clinical efficacy of RO-1670, the main metabolite of Tigason, a pilot study in psoriasis. In: Saurat JH, editor. Retinoids: new trends in research and therapy. Basel: Karger, 1985:305–8.Google Scholar
- 7.Commissie Post marketing surveillance. Postmarketing surveillance in the Netherlands [Report 1991/12]. ′s-Gravenhage: Gezondheidsraad [Health Council], 1991.Google Scholar
- 8.Sturkenboom MCJM, de Jong-van den Berg LTW, Cornel MC, Stricker BHCh, Wesseling H. Alarm rond een geneesmiddel [A drug alert] [Report]. Groningen: Rijksuniversiteit Groningen, 1993.Google Scholar
- 9.Vandenbroucke JP, Hofman A. Grondslagen der epidemiologie [Principles of epidemiology]. 3rd ed. Utrecht: Bunge, 1991:15–21.Google Scholar