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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
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 40 (1991), S. 367-371 
    ISSN: 1432-1041
    Keywords: Anaphylaxis ; glafenine ; contrast media ; hospital admission ; indomethacin ; penicillin ; adverse reaction monitoring ; postmarketing surveillance
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Summary In 1981 generalized anaphylaxis was registered on 166 occasions in Dutch general and academic hospitals. Clinical details of 120 of those patients revealed that in 107 anaphylaxis was either probable (n=90) or possible (n=17), whereas in 13 cases some other reaction than anaphylaxis had occurred. The series of confirmed cases contained 46 men and 61 women, with mean ages of 47 y and 48 y, respectively. There was a complete recovery in 102 patients and two patients died. Hypotension was present in 79 cases (74%), dyspnoea in 34 cases (32%) and a skin reaction, mainly urticaria, erythema or angioedema, was mentioned in 62 cases (58%). Most cases of anaphylaxis were drug-induced (76%), the main causes being the analgesic glafenine and contrast media. Glafenine was mentioned as the cause in 36% of all admissions for drug-induced anaphylaxis. Only 3.7% of cases had been reported to the voluntary reporting scheme of the Netherlands Centre for Monitoring of Adverse Reactions to Drugs. On the basis of reimbursement data, the risk of developing severe anaphylaxis to glafenine was estimated at 11.7–19.3-fold relative to indomethacin, and 13.4–20.2-fold relative to oral penicillins.
    Type of Medium: Electronic Resource
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  • 3
    Electronic Resource
    Electronic Resource
    Springer
    European journal of clinical pharmacology 47 (1994), S. 305-309 
    ISSN: 1432-1041
    Keywords: Sumatriptan ; Migraine ; pharmacoepidemiology ; adverse reaction ; angina pectoris ; postmarketing surveillance ; general practitioner
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug in The Netherlands. With assistance of 86% of the drug dispensing general practitioners in The Netherlands, 1727 patients who had received sumatriptan were traced in July, 1992. Via their general practitioners, a questionnaire about use of sumatriptan, adverse reactions and other medication was sent to the patients in December 1992. During the study period, seven patients were lost to follow-up. Of the 1720 remaining patients, 1202 (70%) responded to the questionnaire, of whom 1187 had actually used sumatriptan. The most frequently reported suspected adverse reactions were paraesthesiae (139 patients, 95% CI 9.9%–13.5%) and dizziness (96 patients, 95% CI 6.5%–9.7%). Chest pain after use of sumatriptan was reported by 94 patients (7.9%, 95% CI 6.4%–9.4%), and according to the close temporal relationship with the intake of sumatriptan and a positive rechallenge, a causal relationship was probable in most of those patients. The frequency of chest pain attributed to sumatriptan was higher in females (9.0% vs 4.6%; relative risk 1.9, 95% CI 1.1–3.4). Age and hypertension were not associated with chest pain attributed to sumatriptan. Dyspnoea attributed to sumatriptan was reported by 26 patients (2.2%), and was associated with obstructive lung disease (relative risk 5.4 95% CI 1.7–16.9). Thus, in view of the high frequency of chest pain after use of sumatriptan and reports in the literature of cardiac disturbances, including myocardial infarction, cautious use of the drug is advised.
    Type of Medium: Electronic Resource
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  • 4
    Publication Date: 2019-06-27
    Description: The DORCA Applications study has been directed at development of a data bank management computer program identified as DORMAN. Because of the size of the DORCA data files and the manipulations required on that data to support analyses with the DORCA program, automated data techniques to replace time-consuming manual input generation are required. The Dynamic Operations Requirements and Cost Analysis (DORCA) program was developed for use by NASA in planning future space programs. Both programs are designed for implementation on the UNIVAC 1108 computing system. The purpose of this Executive Summary Report is to define for the NASA management the basic functions of the DORMAN program and its capabilities.
    Keywords: COMPUTERS
    Type: NASA-CR-137368 , ATR-74(7335)-1-VOL-1
    Format: application/pdf
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  • 5
    Publication Date: 2019-06-27
    Description: A number of analyses have been performed using the DORCA program for several NASA-funded Aerospace Corporation studies in the past few years. The data decks containing the input data for these analyses have been compiled and are submitted, under separate cover. A few of the data decks are full (basic) decks containing every data item and are used as reference decks in the data bank. The other data decks were obtained by differencing a full deck with respect to one of the reference decks. Using the DORMAN program, a full deck can be recreated from the modified deck and its reference deck when and if desired. The content and structure of the data bank are described. A description of each of these data decks is presented. Three of the cases that are included in this volume have become so widely recognized and accepted that additional descriptive material has been provided. The three cases are: Case 500 Costs, Case 506 Costs, and Case 403.
    Keywords: COMPUTERS
    Type: NASA-CR-137366 , ATR-74(7335)-1-VOL-3
    Format: application/pdf
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