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  • 1
    ISSN: 1432-1041
    Keywords: Acitretine ; Psoriasis ; ad hoc cohort tracing ; pharmacoepidemiology ; postmarketing surveillance ; adverse reaction monitoring
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary Etretinate has been detected in the blood of women taking acitretine. Because of the proven teratogenic effects of etretinate it was decided to try to trace all users of acitretine in The Netherlands via all drug dispensing outlets (1450 community pharmacies, 95 hospital pharmacies and 636 general practitioners). A request for information on the date of birth, sex, type of prescriber, and the number of capsules dispensed yielded a response rate of 87%. In 61% of all the responding dispensing outlets a prescription for acitretine had been filled. Of these 1153 outlets, 40% had dispensed acitretine to one patient and 52% had dispensed it to 2–5 patients. The 2717 patients comprised 1500 men (55%) and 1217 women, with mean ages of 48 and 53 y, respectively. As against 45% of all the male users, 31% of all the women were in the child-bearing age (15–45 y). The average numbers of dispensed capsules was 167 to users of 10 mg capsules, and 107 to users of the 25 mg capsules. In more than 80% of cases acitretine had been prescribed by dermatologists. Because the large majority of inhabitants in The Netherlands use one community pharmacy, and because most of them have automated records, it is possible to trace a cohort of users quickly and almost completely. Because most large-scale problems with adverse reactions are discovered within the first 2 years of marketing, at a time when exposure and morbidity registries are still collecting information, adhoc formation of a cohort in this way may be a useful resource for postmarketing surveillance.
    Type of Medium: Electronic Resource
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  • 2
    ISSN: 1573-739X
    Keywords: Acitretin ; Data collection ; Dermatologists ; Drug utilization ; Epidemiological methods ; Pharmacists ; Product surveillance, postmarketing
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract 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.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Springer
    Pharmacy world & science 13 (1991), S. 32-38 
    ISSN: 1573-739X
    Keywords: Drug utilization ; Epidemiological methods ; Lactation ; Pregnancy ; Prenatal care
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract In this study the use of prescribed drugs before, during and after pregnancy is described. The study is based on data obtained from pharmacy records of 1,948 women who delivered a live-born infant. Different measures to evaluate drug exposure are used. During the nine months of pregnancy 86% of the women used on average 4.2 prescriptions. During the course of pregnancy the use of gastro-intestinal and blood-forming drugs increased, whereas the use of cardiovascular, antiphlogistic and central nervous system drugs decreased. Anti-emetics were predominantly used in the first trimester, and antacids in the last trimester, whereas laxatives were especially used after delivery. The percentage of women who used a treatment for vaginal infections increased from 2 to 7 during pregnancy. Most of the women (73%) received one or more iron prescriptions during the course of pregnancy, however, the prescribed daily dose was low (prescribed daily dose/defined daily dose=0.6). At least 1% of the women filled a new prescription for anticonceptives in the first trimester of pregnancy. Most likely, our data reflect the general prescribing pattern for Dutch pregnant women who delivered a live-born baby. Therefore, they form a good and detailed base for further studies, for instance, on the exposure to drugs with known or suspected risks or on the use of drugs in patients with chronic concomitant diseases. Such studies may lead to recommendations that may improve prescribing behaviour.
    Type of Medium: Electronic Resource
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