Pharmacoepidemiology and Drug Safety 

About: Pharmacoepidemiology and Drug Safety is an academic journal published by Wiley-Blackwell. The journal publishes majorly in the area(s): Population & Medicine. It has an ISSN identifier of 1053-8569. Over the lifetime, 4360 publications have been published receiving 108972 citations.

The new Swedish Prescribed Drug Register—Opportunities for pharmacoepidemiological research and experience from the first six months

Abstract: The new Swedish Prescribed Drug Register-Opportunities for pharmacoepidemiological research and experience from the first six months.

Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

Abstract: Objective The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the validity of the database for patients with a principal diagnosis of ischemic stroke. Study design and methods This cross-sectional study compares records in the NHIRD with those in one medical center. Patients hospitalized for ischemic stroke in 1999 were identified from both databases. The discharge notes, laboratory data, and medication orders during admission and the first discharge visit were reviewed to validate ischemic stroke diagnoses and aspirin prescribing in the NHIRD. Agreement between the two databases in comorbidities of ischemic stroke diagnosis was evaluated using ICD-9 codes. Results Three hundred and seventy two cases were identified from the NHIRD; among them, 364 cases (97.85%) were confirmed as ischemic stroke by radiology examination and clinical presentation. Among these confirmed cases, 344 (94.51%) were assigned ‘ischemic stroke’ as the principal diagnosis in the NHIRD. The overall agreement of comorbid diagnoses between the databases was 48.39%. The PPV for selected conditions also varied widely, from 0.50 for fracture to 1.00 for colon cancer. The accuracy of recorded aspirin prescriptions was higher in first post-discharge visits (PPV = 0.94) than during hospitalization (PPV = 0.88). Conclusion The accuracy of the NHIRD in recording ischemic stroke diagnoses and aspirin prescriptions was high, and the NHIRD appears to be a valid resource for population research in ischemic stroke. Copyright © 2010 John Wiley & Sons, Ltd.

Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports

Abstract: BACKGROUND: The process of generating 'signals' of possible unrecognized hazards from spontaneous adverse drug reaction reporting data has been likened to looking for a needle in a haystack. However, statistical approaches to the data have been under-utilised. METHODS: Using the UK Yellow Card database, we have developed and evaluated a statistical aid to signal generation called a Proportional Reporting Ratio (PRR). The proportion of all reactions to a drug which are for a particular medical condition of interest is compared to the same proportion for all drugs in the database, in a 2 x 2 table. We investigated a group of newly-marketed drugs using as minimum criteria for a signal, 3 or more cases, PRR at least 2, chi-squared of at least 4. FINDINGS: The database was used to examine retrospectively 15 drugs newly-marketed in the UK, with the highest levels of ADR reporting. The method identified 481 signals meeting the minimum criteria during the period 1996-8. Further evaluation of these showed that 70% were known adverse reactions, 13% were events which were likely to be related to the underlying disease and 17% were signals requiring further evaluation. IMPLICATIONS: Proportional reporting ratios are a valuable aid to signal generation from spontaneous reporting data which are easy to calculate and interpret, and various refinements are possible.

Methods for evaluation of medication adherence and persistence using automated databases.

Abstract: Purpose Our aim was to perform a systematic review of the methods currently being used to assess adherence and persistence in pharmacoepidemiological and pharmacoeconomic studies using automated databases. Methods A MEDLINE search of English language literature was performed to identify studies published between January 1, 1980 and March 31, 2004 that evaluated adherence, compliance, persistence, switching, or discontinuations of medications using automated dispensing data (pharmacy records). Two study investigators independently reviewed the abstracts and articles to determine relevant studies according to specified criteria. Results A total of 136 articles met the criteria for evaluation. The types of measures of adherence and persistence commonly reported include the medication possession ratio and related measures of medication availability (77 studies), discontinuation/continuation (58 studies), switching (34 studies), medication gaps (13 studies), refill compliance (7 studies), and retentiveness/turbulence (4 studies). Specific issues considered include the assessment of exposed time to drug therapy and specification of the follow-up period. Conclusions The terminology, definitions, and methods to determine adherence and persistence differ greatly in the published literature. The appropriateness and choice of the specific measure employed should be determined by the overall goals of the study, as well as the relative advantages and limitations of the measures. Copyright © 2006 John Wiley & Sons, Ltd.

A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions.

Abstract: SUMMARY Purpose A continuous systematic review of all combinations of drugs and suspected adverse reactions (ADRs) reported to a spontaneous reporting system, is necessary to optimize signal detection. To focus attention of human reviewers, quantitative procedures can be used to sift data in different ways. In various centres, different measures are used to quantify the extent to which an ADR is reported disproportionally to a certain drug compared to the generality of the database. The objective of this study is to examine the level of concordance of the various estimates to the measure used by the WHO Collaborating Centre for International ADR monitoring, the information component (IC), when applied to the dataset of the Netherlands Pharmacovigilance Foundation Lareb. Methods The Reporting Odds Ratio � 1.96 standard errors (SE), proportional reporting ratio � 1.96 SE, Yule’s Q � 1.96 SE, the Poisson probability and Chi-square test of all 17 330 combinations were compared with the IC minus 2 standard deviations. Additionally, the concordance of the various tests, in respect to the number of reports per combination, was examined. Results In general, sensitivity was high in respect to the reference measure when a combination of point- and precision estimate was used. The concordance increased dramatically when the number of reports per combination increased. Conclusion This study shows that the different measures used are broadly comparable when four or more cases per combination have been collected. Copyright # 2002 John Wiley & Sons, Ltd.