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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: 1432-1041
    Keywords: Key words Cohort study ; Mefloquine ; Proguanil ; Psychic adverse effects ; Antimalarial drugs
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To study the neuro-psychiatric adverse effects of antimalarial drugs. Setting: Persons who visited a Travel Clinic in Rotterdam over a period of 3 months. Design: Prospective cohort study on 394 persons taking mefloquine, 493 persons taking proguanil and 340 persons not taking antimalarial drugs who visited Africa, South America, Asia, or the Middle East. Methods: All persons received a structured questionnaire within 14 days of their return to the Netherlands. The questionnaire consisted of questions regarding use of alcohol, smoking, general health, medical history, tropical diseases during the trip, and other medicines, and contained an extensive list of general complaints regarding all body systems at four levels of severity. A modified and validated version of the Profile of Mood States was included. Results: In the study period, 2541 persons visited the Travel Clinic, of whom 1791 (70%) were both eligible and willing to co-operate. Of these 1791, data were obtained from 1501 (84%). Insomnia was most frequently encountered in users of mefloquine and mouth ulcers in proguanil users. After adjustment for gender, age, destination, and alcohol use, the relative risk for insomnia to mefloquine versus non-users of antimalarials was 1.6, and the excess risk was 6 per 100 users over an average period of 2 months. There were no significant differences between groups in depression, anxiety, agitation, and confusion. Stratification by gender demonstrated that insomnia was more common in women on mefloquine, but not in men. Also, women more frequently mentioned palpitations as an adverse event. After adjustment for age, destination, and alcohol use in women, the relative risks for insomnia and palpitations to mefloquine versus non-use of antimalarials were 2.4, and 22.5, respectively. When travellers were specifically asked for the adverse reactions they had experienced, anxiety, vertigo, agitation, and nightmares were significantly more frequently mentioned by mefloquine users. Conclusion: Insomnia was more commonly encountered during use of mefloquine than proguanil or during non-use of antimalarials.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1432-1041
    Keywords: Key words Osteoporosis ; Treatment ; Bisphosphonates
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: To investigate whether the alkylbisphosphonate etidronate is associated with an increased risk of gastrointestinal symptoms. Methods: We conducted an observational follow-up study on a possible relationship between etidronate use and the risk of gastrointestinal symptoms in a cohort of 2754 women over 50 years of age. The study was performed with data on drug prescriptions obtained from the PHARMO database in the Netherlands. Women were included when they used either cyclical etidronate (n=1050) or estrogen (n=1704) for at least 14 days. They were followed-up for incident use of antiulcer drugs while on exposure medication. Results: The mean ages were 72 years and 59 years in the etidronate and estrogen groups, respectively. In total, there were 95 women with incident prescriptions for gastrointestinal events after a median duration of follow-up of 2.7 months (range 0.1–19.4 months). The crude relative risk of a gastrointestinal event for etidronate compared with estrogen use was 1.2 [95% confidence interval (95% CI) 0.8–1.8]. Adjusted for baseline age, use of corticosteroids, salicylates and nonsteroidal anti-inflammatory drugs, the relative risk reversed to 0.6 (95% CI 0.4–1.2). Conclusion: The use of cyclical etidronate is not associated with an elevated risk of symptoms of peptic ulcer disease.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1573-739X
    Keywords: Child ; Data collection ; Diabetes mellitus, insulin-dependent ; Epidemiologic methods ; Incidence ; Pharmacy records ; Prevalence
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract Objective To trace new cases of insulin-dependent diabetes mellitus (IDDM) on an ongoing basis and to estimate the incidence rate and prevalence of IDDM in children 0–19 years of age. Research design and methods The estimation of the prevalence and incidence rate of IDDM was based on, respectively, the prevalence and the rate of new users of insulin. The data were obtained from pharmacy, patient-based, drug dispensing histories in a well-defined population encompassing 257, 113 individuals in the Netherlands. Results The IDDM incidence rate was estimated at 11.5 (CI95 6.6–17.8) per 100,000 person years in 1989–1990 in children 0–19 years of age. The prevalence was estimated at 11.0 (CI95 8.6–13.4) per 10,000 children 0–19 years of age. Discussion The incidence rate is comparable to that found in a large, national survey among all paediatricians and internists in the Netherlands. The method offers ongoing monitoring of the incidence and prevalence of IDDM in children, 0–19 years of age, against low costs. The method is suitable for rapid and cost-efficient recruitment of cohorts of incident IDDM patients, which fosters research to identify and quantify the attribution of different types of aetiologic and prognostic factors of IDDM.
    Type of Medium: Electronic Resource
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  • 5
    Electronic Resource
    Electronic Resource
    Springer
    Pharmacy world & science 17 (1995), S. 133-137 
    ISSN: 1573-739X
    Keywords: Adverse effects ; Bromocriptine ; Cardiovascular diseases ; Cerebrovascular disorders ; Incidence ; Lactation ; Product surveillance, postmarketing
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology
    Notes: Abstract The use of bromocriptine for the suppression of postpartum lactation drew widespread attention to a potentially increased risk for cardiovascular and cerebrovascular adverse effects. To estimate the incidence of these events a follow-up study was performed among 2,130 women of 15–44 years of age who were treated with a course of bromocriptine in 1990–1992. None of these women were admitted to the hospital for cardiovascular or cerebrovascular events. However, the incidence of pregnancy hypertension and the use of cardiovascular drugs increased considerably in the last 2 months before delivery. Therefore, cardiovascular or cerebrovascular events can probably be explained by pre-existing morbidity rather than by the use of bromocriptine. We estimated, using a ‘worst-case’ analysis, that fewer than 2 Dutch women each year would develop serious cardiovascular or cerebrovascular events.
    Type of Medium: Electronic Resource
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  • 6
    ISSN: 1435-4373
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In order to monitor the use of antibiotics, it is essential to have comprehensive data on drug consumption. The findings of drug utilisation studies can serve to describe the pattern of drug use in a particular population, to detect areas of concern, and to evaluate the impact of interventions taken to influence the use of drugs. In the present study, the Anatomical Therapeutical Chemical Classification/Defined Daily Doses (ATC/DDD) system developed by the World Health Organisation was evaluated. The system measures the amount of drug use independentof package size and sales price, which allows comparisons not only within an institution but also within a region, a country, or even internationally. Obviously, there can be no modifications of this system. To illustrate the method, the pattern of quinolone use in the general population, in long-term care facilities, and within a single institution was analysed. These drugs were widely used in long-term care facilities in the Nijmegen region of the Netherlands, accounting for about 30% of the antibiotics used in these settings, whereas in the general population as well as in the University Hospital Nijmegen, these drugs constitute only about 6% of the total antibiotics used. These differences are large enough to warrant closer analysis of patterns of antibiotic usage in different settings to identify the reasons for the use of quinolones and to identify measures that might be taken to rationalise the prescription of these drugs.
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