Under-reporting of adverse drug reactions

Requejo, Ana Alvarez; Carvajal, Alfonso; Bégaud, Bernard; Moride, Yola; Vega, Tomás; Arias, Luis H. Martín

doi:10.1007/s002280050498

Cited by 201 publications

(29 citation statements)

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“…This has been reinforced by many studies carried out in developed and developing countries [1,3], which have encompassed attitudes, perceptions and barriers towards ADR reporting. However, ADR reporting is considered an important component of the drug safety monitoring framework [4].…”

Section: Problem Backgroundmentioning

confidence: 99%

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Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Elkalmi¹,

lela²

2016

J Pharmacovigilance

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Spontaneous Adverse Drug Reactions (ADRs) reporting system is considered the back-bone for any pharmacovigilance system. Within this context, active Involvement of healthcare professionals is very crucial to improve the rate and quality of ADRs reporting. Despite the various techniques that have been adopted in order to improve the rate and quality of ADR reporting, there is a decline in the rate of ADRs notification. Under-reporting of ADRs is well-recognized phenomena associated with the almost all of pharmacovigilance systems around the world. Many logistic and personal barriers to ADRs reporting among healthcare professionals including resistance to change have been reported. This commentary focuses on the problem of resistance to change towards ADR reporting and the possibility of applying theory of Force Field Analysis (FFA) to overcome the problem of underreporting among these professionals.

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Section: Problem Backgroundmentioning

confidence: 99%

“…Different obstacles to detecting and reporting ADRs were proposed by Inman in the mid-eighties [3] and have since been mentioned in numerous studies [1]. Fear of litigation and fear of appearing ridiculous were reported as two of these barriers.…”

Section: Problem Backgroundmentioning

confidence: 99%

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Elkalmi¹,

lela²

2016

J Pharmacovigilance

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“…Healthcare systems have traditionally relied on patient and clinician self-reports, prescription-event monitoring and case-control studies. These approaches capture serious and unexpected ADRs, whilst minor to moderate ADRs are typically less well reported [26] but remain burdensome to service users. Despite the advantages of service user ADR reporting [27], under-reporting is widely recognised: in a clinical trial only 1.5–5.1% (5/328-11/216) of ADR-related problems were spontaneously reported to physicians, increasing to 29–49% (96/328-105/216) when a questionnaire on specific known ADRs was administered [28], and the overall ADR reporting rate may be around 1% [29].…”

Section: Introductionmentioning

confidence: 99%

Medication Monitoring in a Nurse-Led Respiratory Outpatient Clinic: Pragmatic Randomised Trial of the West Wales Adverse Drug Reaction Profile

et al. 2014

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ObjectiveTo assess the clinical effect of medication monitoring using the West Wales Adverse Drug Reaction (ADR) Profile for Respiratory Medicine.DesignSingle-site parallel-arm pragmatic trial using stratified randomisation.SettingNurse-led respiratory outpatient clinic in general hospital in South Wales.Participants54 patients with chronic respiratory disease receiving bronchodilators, corticosteroids or leukotriene receptor antagonists.InterventionFollowing initial observation of usual nursing care, we allocated participants at random to receive at follow up: either the West Wales ADR Profile for Respiratory Medicine in addition to usual care (‘intervention arm’ with 26 participants); or usual care alone (‘control arm’ with 28 participants).Main Outcome MeasuresProblems reported and actions taken.ResultsWe followed up all randomised participants, and analysed data in accordance with treatment allocated. The increase in numbers of problems per participant identified at follow up was significantly higher in the intervention arm, where the median increase was 20.5 [inter-quartile range (IQR) 13–26], while that in the control arm was −1 [−3 to +2] [Mann-Whitney U test: z = 6.28, p<0.001]. The increase in numbers of actions per participant taken at follow up was also significantly higher in the intervention arm, where the median increase was 2.5 [1]–[4] while that in the control arm was 0 [−1.75 to +1] [Mann-Whitney U test: z = 4.40, p<0.001].ConclusionWhen added to usual nursing care, the West Wales ADR Profile identified more problems and prompted more nursing actions. Our ADR Profile warrants further investigation as a strategy to optimise medication management.Trial RegistrationControlled-trials.com ISRCTN10386209

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“…These reports are not exhaustive and are known to suffer from underreporting bias [9,10]. One can therefore reasonably consider that conventional pharmacovigilance data (i) does not encompass all ADRs and (ii) provides little information on ADEs.…”

Section: Introductionmentioning

confidence: 99%

Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

Ficheur

Chazard

Beuscart

et al. 2014

BMC Med Inform Decis Mak

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Background: Adverse drug reactions and adverse drug events (ADEs) are major public health issues. Many different prospective tools for the automated detection of ADEs in hospital databases have been developed and evaluated. The objective of the present study was to evaluate an automated method for the retrospective detection of ADEs with hyperkalaemia during inpatient stays. Methods: We used a set of complex detection rules to take account of the patient's clinical and biological context and the chronological relationship between the causes and the expected outcome. The dataset consisted of 3,444 inpatient stays in a French general hospital. An automated review was performed for all data and the results were compared with those of an expert chart review. The complex detection rules' analytical quality was evaluated for ADEs.

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Under-reporting of adverse drug reactions

Cited by 201 publications

References 0 publications

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Motivations and Obstacles for Adverse Drug Reactions Reporting among Healthcare Professionals from the Perspective of Lewin?s Force Field Analysis Theory: Analytic Approach

Medication Monitoring in a Nurse-Led Respiratory Outpatient Clinic: Pragmatic Randomised Trial of the West Wales Adverse Drug Reaction Profile

Adverse drug events with hyperkalaemia during inpatient stays: evaluation of an automated method for retrospective detection in hospital databases

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