MyMedR

Displaying all 6 publications

Abstract:

Sort:

Fulltext Using VigiBase to Identify Substandard Medicines: Detection Capacity and Key Prerequisites

Juhlin K, Karimi G, Andér M, Camilli S, Dheda M, Har TS, et al.

Drug Saf, 2015 Apr;38(4):373-82.
PMID: 25687792 DOI: 10.1007/s40264-015-0271-2

Substandard medicines, whether the result of intentional manipulation or lack of compliance with good manufacturing practice (GMP) or good distribution practice (GDP), pose a significant potential threat to patient safety. Spontaneous adverse drug reaction reporting systems can contribute to identification of quality problems that cause unwanted and/or harmful effects, and to identification of clusters of lack of efficacy. In 2011, the Uppsala Monitoring Centre (UMC) constructed a novel algorithm to identify reporting patterns suggestive of substandard medicines in spontaneous reporting, and applied it to VigiBase(®), the World Health Organization's global individual case safety report database. The algorithm identified some historical clusters related to substandard products, which were later able to be confirmed in the literature or by contact with national centres (NCs). As relevant and detailed information is often lacking in the VigiBase reports but might be available at the reporting NC, further evaluation of the algorithm was undertaken with involvement from NCs.
Characterization of Statin-Associated Myopathy Case Reports in Thailand Using the Health Product Vigilance Center Database

Boonmuang P, Nathisuwan S, Chaiyakunapruk N, Suwankesawong W, Pokhagul P, Teerawattanapong N, et al.

Drug Saf, 2013 Sep;36(9):779-87.
PMID: 23615756 DOI: 10.1007/s40264-013-0055-5

HMG-CoA reductase inhibitors [statins], a widely prescribed cholesterol-lowering therapy, are associated with muscle-related adverse events. While characteristics of such events are well documented in Western countries, little data exists for the Thai population.
Sequence Symmetry Analysis as a Signal Detection Tool for Potential Heart Failure Adverse Events in an Administrative Claims Database

Wahab IA, Pratt NL, Ellett LK, Roughead EE

Drug Saf, 2016 Apr;39(4):347-54.
PMID: 26798053 DOI: 10.1007/s40264-015-0391-8

The potential for routine sequence symmetry analysis (SSA) signal detection in health claims databases to detect new safety signals of medicines is unknown.
Risk management from an Asian/Pacific Rim regulatory perspective

McEwen J

Drug Saf, 2004;27(8):491-7.
PMID: 15154822

This article reviews the state of adverse drug reaction monitoring in five Asian/Pacific Rim countries (Australia, Japan, Malaysia, New Zealand and Singapore). Each country has an active pharmacovigilance programme managed by a national regulatory agency. Current methods for assessing risks and current methods used for risk management and communication are compared with the 'tools' used by the US FDA. Major positive attributes of the programmes in all five countries include active involvement of independent expert clinical advisory committees in identifying and evaluating risks through the assessment of reports of serious and unusual reactions, and regular communications about risks from the national agencies to doctors and pharmacists by means of pharmacovigilance bulletins. Most components of the risk-management toolbox are currently used, in some instances without legislated support. Variations in the way risk-management tools are implemented within individual national health systems are illustrated.
Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study

Rashed AN, Wong IC, Cranswick N, Hefele B, Tomlin S, Jackman J, et al.

Drug Saf, 2012 Jun 1;35(6):481-94.
PMID: 22612852 DOI: 10.2165/11597920-000000000-00000

Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied.

Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries.

Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia, Germany, Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs.

Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and the UK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) and median length of hospital stay was 4 days (IQR 3-7). A total of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95% CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed in Malaysia and the UK. 65.3% (n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.

Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children.
Prevalence, Causes and Severity of Medication Administration Errors in the Neonatal Intensive Care Unit: A Systematic Review and Meta-Analysis

Henry Basil J, Premakumar CM, Mhd Ali A, Mohd Tahir NA, Mohamed Shah N

Drug Saf, 2022 Dec;45(12):1457-1476.
PMID: 36192535 DOI: 10.1007/s40264-022-01236-6

INTRODUCTION: Neonates are at greater risk of preventable adverse drug events as compared to children and adults.
OBJECTIVE: This study aimed to estimate and critically appraise the evidence on the prevalence, causes and severity of medication administration errors (MAEs) amongst neonates in Neonatal Intensive Care Units (NICUs).
METHODS: A systematic review and meta-analysis was conducted by searching nine electronic databases and the grey literature for studies, without language and publication date restrictions. The pooled prevalence of MAEs was estimated using a random-effects model. Data on error causation were synthesised using Reason's model of accident causation.
RESULTS: Twenty unique studies were included. Amongst direct observation studies reporting total opportunity for errors as the denominator for MAEs, the pooled prevalence was 59.3% (95% confidence interval [CI] 35.4-81.3, I2 = 99.5%). Whereas, the non-direct observation studies reporting medication error reports as the denominator yielded a pooled prevalence of 64.8% (95% CI 46.6-81.1, I2 = 98.2%). The common reported causes were error-provoking environments (five studies), while active failures were reported by three studies. Only three studies examined the severity of MAEs, and each utilised a different method of assessment.
CONCLUSIONS: This is the first comprehensive systematic review and meta-analysis estimating the prevalence, causes and severity of MAEs amongst neonates. There is a need to improve the quality and reporting of studies to produce a better estimate of the prevalence of MAEs amongst neonates. Important targets such as wrong administration-technique, wrong drug-preparation and wrong time errors have been identified to guide the implementation of remedial measures.