Abstract
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
Highlights
Iatrogenic harm is a persistent concern [1]
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 21 [23 to +2] [Mann-Whitney U test: z = 6.28, p,0.001]
In the UK, about 6.5% of hospital admissions are due to Adverse Drug Reaction (ADR), most of which are preventable [8,9]; we know less about the prevalence of ADRs in the community not associated with hospital admission [10]
Summary
Iatrogenic harm is a persistent concern [1]. No pharmacological therapy that is effective is free of adverse effects [2]. Five per cent of inpatients experience ADRs [6], rising to 14% in elderly care wards [7]. Healthcare systems have traditionally relied on patient and clinician self-reports, prescription-event monitoring and casecontrol 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. Further investment is needed to develop feasible evidence-based strategies, that engage service users [32], and are not overly time consuming, and explore their clinical impact [18,19,20,23,24,38,39,40,41,42,43]
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