Spontaneous Reporting Systems Outside the US

Wiholm, Bengt‐Erik; Olsson, Sten; Moore, Nicholas; Waller, P.J.

doi:10.1002/0470842555.ch11

Cited by 46 publications

(48 citation statements)

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“…Even though the spontaneous reporting system is a cornerstone of the early detection of previously unknown single drug-single ADR combinations (18), there is a clear overrepresentation of established associations. We deliberately used this phenomenon when selecting drug combinations (inclusion criteria ≥20 reports) to identify drug interaction categories reported on ICSRs.…”

Section: Discussionmentioning

confidence: 99%

Pharmacodynamic and pharmacokinetic drug interactions reported to VigiBase, the WHO global individual case safety report database

Strandell

Wahlin

2011

Eur J Clin Pharmacol

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Objective: Drug interactions resulting in adverse drug reactions (ADRs) represent a major health problem both for individuals and the community. Despite this, there is limited information in the literature regarding drug interaction categories responsible for causing ADRs.In this study we investigated the drug combinations most frequently co-reported as interacting in the WHO Global Individual Case Report (ICSR) Database, VigiBase, and categorised them in respect to the drug interaction mechanism. Methods: Reports with drug combinations coreported as interacting on at least 20 reports in VigiBase during the past 20 years were included in the study. Each drug combination was reviewed in the literature to identify the mechanism of interaction and classified as pharmacodynamic and/or pharmacokinetic. Report characteristics were also analysed. Results: In total 3766 case reports of drug interactions from 47 countries were identified. Of 123 different drug combinations 113 were described in the literature to interact. The mechanism were categorised as: pharmacodynamic in 46(41%), pharmacokinetic in 28(25%), a combination of both types in 18(16%), and unidentified in 21(19%) drug interactions. Pharmacodynamic drug interactions primarily concerned pharmacological additive effects whereas enzyme inhibition was the most frequent pharmacokinetic interaction. The reviewed combinations primarily implicated drugs such as warfarin, heparin, carbamazepine and digoxin. Conclusions: Drug interactions reported on globally collected ADR reports covers both pharmacodynamic, specifically additive pharmacological effects, and pharmacokinetic mechanisms primarily accredited inhibition of hepatic CYP enzymes. These ADR reports often concerns serious threats to patients' safety, particularly related to usage of high risk drugs such as warfarin and heparin.

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Section: Discussionmentioning

confidence: 99%

Pharmacodynamic and pharmacokinetic drug interactions reported to VigiBase, the WHO global individual case safety report database

Strandell

Wahlin

2011

Eur J Clin Pharmacol

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“…Cannabis causal involvement was measured by two pharmacologists (EJ, MLM) through the method of causality assessment used to evaluate drug safety. Hospitalizations for which causality assessment was at least 'possible' made up the final study sample [11,12].…”

Section: Settingmentioning

confidence: 99%

Cannabis‐related hospitalizations: unexpected serious events identified through hospital databases

Jouanjus

Leymarie

Tubery

et al. 2011

Brit J Clinical Pharma

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WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• The general knowledge on cannabis toxicity has improved, but quantitative data are still lacking.• Little is known about the somatic complications associated with cannabis exposure. Available data rest upon case reports and only a few studies have been conducted in this field.• Psychiatric disorders related to cannabis exposure are somehow still controversial.WHAT THIS STUDY ADDS• Quantitative estimates are key to comprehending the risks of medical outcomes in cannabis users, in particular the somatic complications of use. Our study suggests that cannabis use has to be linked to serious health defects, particularly neurological and cardiovascular disorders.• Our study gives estimates of the annual incidence of cannabis‐related hospitalizations.• Our study should contribute to enhancing the medical management of cannabis using patients.AIMS Cannabis is the most prevalent illicit drug used worldwide and can be responsible for serious health defects in users. However, the risk related to cannabis consumption is not well established. The present study aimed to assess cannabis‐related adverse events leading to hospitalization, and to estimate the corresponding annual risk for consumers.METHODS Participants were patients admitted to the public hospitals in the Toulouse area (France) between January 2004 and December 2007 in relation to the use of cannabis. Reasons for admission and other occurring events were identified through hospital discharge summaries. We described all observed adverse events (AEs) and estimated their regional incidence on the basis of cannabis consumption data.RESULTS We included 200 patients, and identified a total of 619 adverse events (AEs), one of which was lethal. Psychiatric disorders involved 57.7% of patients and accounted for 18.2% of AEs. Most frequent outcomes were central and peripheral nervous system disorders (15.8% of AEs), acute intoxication (12.1%), respiratory system disorders (11.1%) and cardiovascular disorders (9.5%). We estimated that in 2007 the incidence of cannabis‐related AEs in the Midi‐Pyrenees region ranged from 1.2 per 1000 regular cannabis users (95% confidence interval (CI) 0.7, 1.6) to 3.2 (95% CI 2.5, 3.9).CONCLUSIONS Cannabis use is associated with complications, considered to be serious since they lead to hospitalization. Beyond the well‐known and widely investigated psychiatric events, serious cerebro and cardiovascular complications have been identified. These findings contribute to improve the knowledge of cannabis‐related adverse events.

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“…Also, under reporting is usually not random but selective, which may introduce serious bias when comparing different drugs. 23 The aim of the present study was to quantify the incidence of renal disease in patients using 5-ASA for the treatment of IBD and to compare the risks of different 5-ASA types.…”

Section: Background and Aimsmentioning

confidence: 99%

5-aminosalicylic acids and the risk of renal disease: A large British epidemiologic study☆

et al. 2004

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Spontaneous Reporting Systems Outside the US

Cited by 46 publications

References 0 publications

Pharmacodynamic and pharmacokinetic drug interactions reported to VigiBase, the WHO global individual case safety report database

Pharmacodynamic and pharmacokinetic drug interactions reported to VigiBase, the WHO global individual case safety report database

Cannabis‐related hospitalizations: unexpected serious events identified through hospital databases

5-aminosalicylic acids and the risk of renal disease: A large British epidemiologic study☆

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