ISSN:1053-8569    

DOI:10.1002/pds.2630040602

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractThe incidence of acute pancreatitis appears to have increased in the USA, Denmark and in the United Kingdom and one suggested explanatory factor is a simultaneously increased use of certain drugs.This report surveys the available information on the association between drugs and acute pancreatitis in the literature and in spontaneous reporting systems in Denmark, Sweden and in the United Kingdom, supplemented with information from the WHO data base.Apart from one case‐control study which provided evidence for an association between diuretic use and acute pancreatitis, the information in the literature is based on single case reports. About 15 drugs are frequently reported both in literature, and in spontaneous reporting systems, to be associated with pancreatitis and can be regarded as adverse reaction signals. The validity of such data is often low and does not provide information on relative or absolute risks, if any, for a drug adverse reaction association.To elucidate the possible role of drugs in etiology of acute pancreatitis, further formal epidemiologic studies are neede

ISSN:1053-8569    

DOI:10.1002/pds.2630040603

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractObjective— To use a large computerized data base to evaluate the relationship between beta‐blockers and psychiatric side‐effects.Design— The hybrid design included retrospective cohort and case‐control studies.Setting— A Swedish municipality of around 20,000 inhabitants during 1980–1982.Participants— All new users of beta‐blockers (N= 542) were identified. Unexposed individuals without previous use of cardiovascular drugs were assigned from the data base through category matching by age and sex.Main outcome measure— Prescriptions of sedatives, hypnotics, and antidepressants filled in the 365 days preceding or following the index date.Results— The case‐control analysis showed that previous use of sedatives, hypnotics or antidepressants was common among new users of beta‐blockers, demonstrating a history of psychiatric problems.The cohort analysis showed that new users started using sedatives, hypnotics, or antidepressant drugs to a greater extent than those who were not exposed to beta‐blockers, after controlling for three confounding variables: previous use of sedatives, hypnotics, or antidepressants; heavy use of physician visits; and heavy use of prescription drugs. There were no statistically significant differences in psychotropic use between users of propranolol and users of other beta‐blockers.Conclusions— In spite of the positive finding, we did not establish a causal relationship between beta‐blockers and psychiatric side‐effects. Our data base lacked information to control for confounders like personality, stress, life events, or working environment. Neither could we control for confounding by indication, which must be important, considering the strong relationship between prior use of psychotropics and new use of beta‐blockers. The methodological problems in this study illustrate some of the difficulties of using large computerized data bas

ISSN:1053-8569    

DOI:10.1002/pds.2630040604

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractIn preparation for a clinical trial to be performed in Thailand, a study was undertaken to evaluate the reliability of a Thai version of the General Well‐Being Adjustment Scale (GWB) and Physical Symptoms Distress Index (PSDI) questionnaires previously used in an important US clinical trial of the effects of antihypertensive therapy on quality‐of‐life. Included were 46 consecutive patients with no major clinical complaints, attending general internal medicine clinic for regular follow‐up. Those who might have a significant alteration in their clinical course, e.g. change of medications, were not included. Thai version questionnaires were first translated, back‐translated, and assessed for cultural equivalence to the original version. Questionnaires were then completed by the patients twice, 7 days apart, and then a third time during the same day as the second administration. The item numbers on the third set of questionnaires were randomly reassigned to minimize patients' recall of their previous response. Internal consistency, intra‐day reliability, and inter‐day reliability of each subscale of GWB and the total PSDI questionnaires were analysed using the Cronbach's alpha and intra‐class correlation coefficients. Items in the General Health subscale of the GWB showed somewhat low internal consistency. However, for whole instruments, all parameters showed satisfactory results; the internal consistency of the whole GWB range from 0.90 to 0.93 for the three tests. Inter‐day and intra‐day reliability were 0.78 and 0.95, respectively. For the Thai version of PSDI questionnaires, internal consistencies were over 0.80 for all tests while inter‐day reliability was 0.78 and intra‐day reliability was 0.93. In conclusion, the Thai version of both questionnaires appeared to be reliable. Further study of the criterion validity of the questionnaires, however, is still needed before they can be used m

ISSN:1053-8569    

DOI:10.1002/pds.2630040605

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractBackground— Safety packaging has been shown to be effective in preventing childhood poisoning; however similar data for adults is lacking. In February 1993 the Australian packaging for carbamazepine was changed from bottles of tablets to blister packs.Objective— To assess whether there has been a change in the amount of carbamazepine taken per overdose or the severity of poisoning coinciding with this change.Design— Comparison of cohorts of patients presenting before and after repackaging.Setting— Newcastle, Australia.Subjects— Sixty‐seven patients who ingested carbamazepine and presented to a general hospital which serves a well‐defined geographic area.Main outcome measures— Number of tablets and total dose ingested, peak carbamazepine level, degree of sedation, need for intubation and the time in hospital and ventilated.Results— Significantly fewer tablets and a lesser amount was ingested by patients presenting after the repackaging. Though clinical measures were improved slightly after repackaging the differences did not reach statistical significance.Conclusions— Repackaging resulted in less carbamazepine reported to have been ingested in overdose. Clinical measures did not reflect the extent of this change. This may be due to effects of treatment or coingested drugs obscuring any difference or the reported differences may be due to a reporting bias associated with packaging. Repackaging is a promising means of reducing the severity of deliberate self poisoning but further study, including out of hospital mortalit

ISSN:1053-8569    

DOI:10.1002/pds.2630040606

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractDespite the critical role of adverse drug reaction (ADR) reporting in ensuring the safety of drugs in clinical practice, fewer than 10% of such reactions are reported. We analysed the views of 207 doctors in Ireland and, although well disposed towards reporting, most doctors (97%) were uncertain about the reporting criteria of the regulatory agency, the National Drugs Advisory Board (NDAB), and unclear as to the purposes of the reporting scheme. The unavailability of report forms (52%) or the address of the NDAB (28%), together with being too busy or unsure how to report were identified as major deterrents to reporting. There was general agreement about the factors important in the decision to report—seriousness of the reaction, an unusual reaction or a reaction to a new product. Almost 90% of doctors requested guidelines on reporting and regular bulletins on ADRs. Our survey indicates that doctors need ongoing education and information about this important area of drug safety if the benefits of their positive attitudes towards it are to be realize

ISSN:1053-8569    

DOI:10.1002/pds.2630040607

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

摘要:

AbstractThis paper reports the development over the past 10 years of an innovative patient self‐monitoring method of (1) signalling possible adverse drug reactions (ADRs) and unexpected beneficial drug reactions, and (2) providing incidence estimates and relative risks. The system's validity has been well documented in a series of published papers. There is no other existing postmarketing surveillance method that can obtain early reliable and accurate patient reports about possible side‐effects. We thought that, having successfullydeveloped and validatedthe method, both the US Food and Drug Administration (FDA) and the pharmaceutical industry would recognize the need to support itsapplicationas an important complementary approach to existing postmarketing surveillance methods. Despite our repeated requests, however, neither FDA nor industry has shown any interest in helping to sustain this research, in part because pharmacoepidemiologists tend to focus on the detection of serious ADRs as defined and diagnosed by physicians, but also because it has become patently clear that the US pharmaceutical industry does not want its new drugs to be monitored for possible ADRs. Thus there is virtually no systematic attention being paid to the possible importance of less serious ADRs as inferred from accurate patient reports of behavioural and subjective symptoms — which, especially with CNS‐acting drugs, may often be essential for obtaining reliable ADR p

ISSN:1053-8569    

DOI:10.1002/pds.2630040608

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040609

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040610

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY

ISSN:1053-8569    

DOI:10.1002/pds.2630040611

出版商:John Wiley&Sons, Ltd.    

年代:1995

数据来源: WILEY