Avoidability of Adverse Drug Reactions Spontaneously Reported to a French Regional Drug Monitoring Centre

Jonville-Béra, Annie Pierre; Saissi, Hassan; Bensouda-Grimaldi, L.; Beau-Salinas, F.; Cissoko, H.; Giraudeau, Bruno; Autret-Leca, É.

doi:10.2165/00002018-200932050-00006

Cited by 31 publications

(25 citation statements)

References 48 publications

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“…This study showed that in spontaneously reported ADRs in Sweden a total of 14% was considered preventable, a figure which is in accordance with a similar study from France [12].…”

Section: Discussionsupporting

confidence: 92%

“…The classification system used in our study was related to the objectives of the study. A study focusing on preventable ADRs due to inappropriate prescribing have used a slightly different classification system [12].…”

Section: Discussionmentioning

confidence: 99%

“…To the best of our knowledge there is no validated system for classification of the reason for preventability. We therefore modified a previously used grouping [12] of the reports, classifying the preventability as being related to prescribing, administration or monitoring, as described in table 2.…”

Section: Methodsmentioning

confidence: 99%

“…The strengths of these systems are numerous; they are already an established part of many health care systems and they monitor all patients and care settings. However, few efforts have been made to use these reports to extract information on how to prevent ADRs [12,13]. Therefore, this study was undertaken to investigate the proportion and pattern of preventable ADRs scrutinizing spontaneously reported suspected ADRs and to study the feasibility of using the Swedish ADR reporting system for this purpose.…”

Section: Introductionmentioning

confidence: 99%

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A prospective analysis of the preventability of adverse drug reactions reported in Sweden

Lövborg

Eriksson

Jönsson

et al. 2012

Eur J Clin Pharmacol

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+46 10 103 43 26Conflict of interest, summary: Henrik Lövborg declares that his wife is an employee of a company (MEDAC) whose products are part of this study (as is the case for many other companies). We believe a statement is not necessary to publish since this type of study includes all drugs on the market, thereby limiting the risk of conflict of interest. AbstractPurpose Adverse drug reactions (ADRs) are a major patient safety issue and a substantial proportion of ADRs are in fact preventable. The aim of this study was to describe the proportion and pattern of preventable ADRs in spontaneously reported suspected ADRs and to study the feasibility of using data from an ADR reporting system for this purpose.Methods All reports of ADRs, except those where a vaccine was the suspected drug, submitted to the regional pharmacovigilance centre of south eastern Sweden between 2008 and 2009 were analysed. Causality between the suspected ADR and the medication was assessed using WHO criteria and preventability was assessed using Hallas criteria.Results During the study period 1290 ADRs were received and 1255 were classified as having at least a possible causality between a reaction and a drug. Of these 172 (14%) ADRs were considered preventable, 35 (20%) were classified as definitely preventable and 137 (80%) as possibly preventable. Of all preventable ADRs, 96 (56%) were related to issues relating to prescribing, 35 (20%) to administration of drugs and 41 (24%) to clinical and laboratory monitoring of treatment. Warfarin, oxycodone and ioversol were the most common drugs with preventable ADRs. ConclusionsThis study found that a substantial part of reported ADRs are preventable. Most of these are related to drug prescription suggesting that interventions aiming to reduce preventable ADRs should focus on this process. Moreover, systems for ADR reporting may be useful in the mission of reducing the unsafe use of drugs.

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“…This study showed that in spontaneously reported ADRs in Sweden a total of 14% was considered preventable, a figure which is in accordance with a similar study from France [12].…”

Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

A prospective analysis of the preventability of adverse drug reactions reported in Sweden

Lövborg

Eriksson

Jönsson

et al. 2012

Eur J Clin Pharmacol

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“…Our results do not support a causal role of serum uric acid for type 2 diabetes and hence do not encourage the initiation of clinical trials or an expansion of serum-uric-acid-lowering interventions with the aim of preventing type 2 diabetes. This might be of major relevance as allopurinol is one of the drugs most frequently involved in adverse reactions following inappropriate prescription [35], which might in part be due to confusion by the ongoing discussion on a causal role of serum uric acid for type 2 diabetes and other metabolic disease [36]. However, some of the non-pharmacological interventions recommended for the lowering of serum uric acid levels, such as weight loss, diet modifications, restriction of alcohol consumption and physical exercise, have positive effects beyond the lowering of serum uric acid and are clearly appropriate in metabolic high-risk individuals [37].…”

Section: Discussionmentioning

confidence: 99%

No evidence for a causal link between uric acid and type 2 diabetes: a Mendelian randomisation approach

et al. 2011

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Aims/hypothesis Epidemiological and experimental evidence suggests that uric acid has a role in the aetiology of type 2 diabetes. Using a Mendelian randomisation approach, we investigated whether there is evidence for a causal role of serum uric acid for development of type 2 diabetes. Methods We examined the associations of serum-uric-acidraising alleles of eight common variants recently identified in genome-wide association studies and summarised this in a genetic score with type 2 diabetes in case-control studies including 7,504 diabetes patients and 8,560 non-diabetic controls. We compared the observed effect size to that expected based on: (1) the association between the genetic score and uric acid levels in non-diabetic controls; and (2) the meta-analysed uric acid level to diabetes association. Results The genetic score showed a linear association with uric acid levels, with a difference of 12.2 μmol/l (95% CI 9.3, 15.1) by score tertile. No significant associations were observed between the genetic score and potential confounders. No association was observed between the genetic score and type 2 diabetes with an OR of 0.99 (95% CI 0.94, 1.04) per score tertile, significantly different (p=0.046) from that expected (1.04 [95% CI 1.03, 1.05]) based on the observed uric acid difference by score tertile and the uric acid to diabetes association of 1.21 (95% CI 1.14, 1.29) per 60 μmol/l. Conclusions/interpretation Our results do not support a causal role of serum uric acid for the development of type 2 diabetes and limit the expectation that uric-acid-lowering drugs will be effective in the prevention of type 2 diabetes.

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Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability

Aronson¹

2011

Stephens' Detection and Evaluation of Adverse Drug Reactions

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Avoidability of Adverse Drug Reactions Spontaneously Reported to a French Regional Drug Monitoring Centre

Abstract: Preventive actions should focus on more systematic allergy checks when prescribing drugs and on dose adaptation in cases of altered renal function.

Cited by 31 publications

References 48 publications

A prospective analysis of the preventability of adverse drug reactions reported in Sweden

A prospective analysis of the preventability of adverse drug reactions reported in Sweden

No evidence for a causal link between uric acid and type 2 diabetes: a Mendelian randomisation approach

Adverse Drug Reactions: History, Terminology, Classification, Causality, Frequency, Preventability

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