摘要:

AbstractOne way to identify an excess risk of an adverse event during drug exposure is to use administrative, medical, and pharmacy records data, such as Medicaid or HMO (Health Maintenance Organization) records, to compare the relative frequency of the suspect event in exposed and unexposed periods. Such estimates can be seriously biased if there is clustering in patient visits to physicians and pharmacies. This paper presents two simple tests for determining whether the patient visit dates in such a database are Poisson processes of visits or clustered processes. The paper shows that this test is quite powerful at detecting both clustered sequences and nearly regular sequences of visits. Finally, it gives a straightforward SAS program which will carry out the tests.

ISSN:1053-8569    

DOI:10.1002/pds.2630040402

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractWe report on the results of the registration of SJS, SJS/TEN overlap and TEN with maculae in West‐Germany and Berlin from 01.04.90 to 31.12.92. The results are based on the ‘Dokumentationszentrum schwerer Hautreaktionen’, a registry on severe skin reactions, which regularly contacts more than 1500 hospitals (departments of dermatology, departments of pediatrics, burn units and internal medicine departments with intensive care facilities). With a response rate ranking from 77% to 95% over a period of 33 months 270 cases of SJS, SJS/TEN overlap and TEN have been included into the registry. More than 1690 single drugs had been taken two weeks prior to the skin reaction. Among those drugs ranitidine was found in 25 patients. Other H2‐antagonists were taken in 12 cases (famotidine in 11 cases and cimetidine in one case). Evaluation of drug risk incidences for these drugs were calculated based on prescription data in defined daily doses (DDD), which were obtained from the ‘Wissenschaftliches Institut der Ortskrankenkassen’ (WIDO), Heidelberg, Germany. For ranitidine incidences of 0.19, 0.14, 0.10 could be evaluated, compared to 0.11, 0.29 for famotidine and 0.06 for cimetidine for 1990, 1991 and 1992, respectively. Over the observation period the incidences for ranitidine were stable in contrast to famotidine. As probable confounding factors co‐medication with phenytoin, dexamethasone, heparin and, in addition, concomitant illnesses as brain‐tumours and cerebral metastasis could be found. The example of the H2‐antagonists shows that incidence data should be interpreted cautiously. To avoid misinterpretation incidences should be observed over a period of several years, and in every case confounding factors should be t

ISSN:1053-8569    

DOI:10.1002/pds.2630040403

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractStudy objective— To provide an exploratory description of a dynamic population of Belgian patients treated with reimbursable peptic ulcer medications (ATC Class A20B) and to estimate the annual number (prevalence) of patients treated with reimbursable peptic ulcer medications per 1000 inhabitants in Belgium in 1991.Setting— Community pharmacies in Belgium, a country with 107inhabitants, where reimbursement of attack therapy (3 months) and maintenance therapy (9 months) is only possible after endoscopic or radiologic confirmation of ulcer or severe esophagitis.Design— Cross‐sectional two month registration study of consecutive recipients of reimbursable peptic ulcer medication in a convenience sample of 31 volunteer community pharmacists (a 0.5% sample of Belgian community pharmacies).Methods— Data from a simple, self‐administered (with assistance from the pharmacist) questionnaire of two pages were used to classify patients in one of four patterns of therapy (attack therapy, relapse therapy, maintenance therapy for 9 months, maintenance therapy longer than 9 months) and to determine the average consumption of medication packages within each pattern. The number of patients using reimbursable peptic ulcer medication over one year was estimated from these observational data and from the annual sales volume with a theoretical model.Results— The questionnaire was completed by 432 of 481 elegible patients (an 89.9% response rate) in 27 participating pharmacies. Ninety‐two per cent of the patients had requested or had obtained reimbursement; 74% had at least one EDG in the past 12 months (1/3 combined with at least one X‐ray). Only nine patients of the small subgroup of 34 patients without reimbursement had undergone diagnostic examinations.Discussion— The study of complex utilization patterns with a simplified model provides a rough estimation of the annual number of medication users.Conclusions— In Belgium, a country with strict reimbursement control, mainly based on EGD performed by medical specialists, the annual prevalence of patients using reimbursable peptic ulcer medication is estimated at 30.5 patients/1000 inhabitants/ year. In this country, there is a high utilization of EGD, a high rate of 9 months maintenance therapy and some evidence for channelling of omeprazole. Further longitudinal follow up and comparison with different reimbursement systems in other countries is needed to evaluate the cost‐effectiveness and the impact of different regulatory approaches to reimbursement regulation on

ISSN:1053-8569    

DOI:10.1002/pds.2630040404

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractThe extent of compliance and drug exposure characteristics among NSAID users has not been extensively studied. We measured drug compliance in patients who obtained a NSAID in one of four German pharmacies, by an interview four weeks later.The study population consisted of 526 persons with an average age of 57 years, and two‐thirds of the participants were women. We observed that only half of the patients had followed the recommended dosage regimen for the NSAID. Persons with complaints lasting three months or less were more likely to be compliant than chronically ill patients (OR = 5.0, 95 per cent CI: 3.0–8.2).We concluded that this heterogeneity in drug utilization must be considered in the design of observational stud

ISSN:1053-8569    

DOI:10.1002/pds.2630040405

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractBackground— A small number of published reports have provided estimates of incidence rates of symptomatic liver dysfunction in NSAID users, and most information has pertained to cases admitted to the hospital.Methods— We studied members of a health maintenance organization who were age 20 to 64 years in 1989–1991. Beginning with health insurance claims data for over 68,000 users of NSAIDs, and obtaining abstracts of medical records of potential cases, we ascertained the frequency of liver function abnormalities, including only cases with documented symptoms treated either as outpatients or hospital inpatients.Results— Overall, symptomatic liver dysfunction was rare, with 25 cases confirmed in the cohort of 68,028 people (0.37 cases per 1000 users of NSAIDs). For people who received a prescription NSAID in the previous six months, the crude incidence rate was 24 cases in 46,636 person‐years, or 0.51 per 1000 person‐years. For people who did not have a prescription NSAID in the previous six months, the crude incidence rate was 1 case in 13,303 person‐years, or 0.075 per 1000 person‐years. Of the 25 confirmed cases, 19 (76%) had alanine aminotransferase and/or aspartate aminotransferase at least 1.5 times the upper limit of normal values; the remaining six had abnormal results but of lesser magnitude. In five cases (20%) physician's notes document that a diagnosis of drug‐induced hepatic dysfunction was considered. Only 3 (12%) of the 25 cases were admitted to the hospital.Conclusion— Although symptomatic liver dysfunction was relatively more frequent during the six months following NSAID use than at later times, the overall risk was low. Given the limitations of the available data, the apparent association with NSAID use may be confounded by other causes of liver dysfunction that could not be fully evaluated, such as other hepatotoxic medications, viral infections, or other

ISSN:1053-8569    

DOI:10.1002/pds.2630040406

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractData bases that are created to administer health care benefits and to record financial aspects of medical care in the United States are useful for epidemiologic research in certain circumstances. Case finding and verification in such records is complex and rarely described in detail in research reports because of space limitations. This report describes portmarketing surveillance for peptic ulcer, upper gastrointestinal hemorrhage and hepatic dysfunction in 68, 180 people who took non‐steroidal anti‐inflammatory drugs (NSAIDs), by using an automated data base together with review of selected medical records. Cases included both mild diseases treated on an outpatient basis and more severe illnesses that required hospital admission. Using computer programs we identified 9642 subjects who had at least one insurance claim suggesting a possible case event. We manually reviewed chronological profiles of their insurance claims, to select 833 subjects for medical record reviews, of whom 152 were verified as cases. Our algorithms for case identification were sensitive, but not very specific. If we had restricted our manual review to people who had at least five relevant claims during the study period, we would have avoided 42% of the reviewing workload and lost only 5% of the ca

ISSN:1053-8569    

DOI:10.1002/pds.2630040407

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040408

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040401

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY