Medication monitoring in general practice: clinical impact of implementing a nurse-led Adverse Drug Reaction (ADRe) Profile in older adults with 5 or more prescribed medicines
Authors:   , Logan Vera 
Published: May 2024

Adverse drug reactions (ADRs), especially in the context of polypharmacy, remain a persistent, unresolved problem for patients and healthcare professionals. Interventions that identify medicine-related harms early and support their resolution can improve care quality and prevent future problems. Objective The main objective of this study was to assess the effectiveness of the ADRe Profile (https://www.swansea.ac.uk/adre/) in UK general practices, through investigation of clinical gains, assessed as impact on the number and nature of problems identified and addressed, and changes in prescribed medicines. Methods Following a systematic review, the ADRe Profile’s validity and reliability was investigated using complementary mixed methods: content validity index, contrast group construct validity, cognitive interviewing, and inter-rater reliability. Feasibility of implementation was tested before a cluster-randomized trial evaluated effectiveness. The trial, conducted in 6 practices in Southwest Wales, aimed to enrol 10 service users from each practice aged 65 or older, taking 5 or more regular medicines. A process evaluation provided insights into how the intervention worked. Results Systematic Review. From 1437 unique records, 49 studies underwent full review. Eight papers from six randomized controlled trials were included. Trials using medicine-related symptoms for adverse drug reaction identification showed promising results, particularly when combining questionnaires with prescriber consultations. While multidisciplinary collaborations enhanced patient safety, the heterogeneity of data called for further research to optimise strategies. Validity and Reliability Testing. Cognitive interviews led to 15 adjustments to the ADRe Profile. The scale-level content validity index was 0.67. Significant differences in adverse drug reactions between service users taking different numbers of regular prescribed medicines confirmed construct validity (t-test: t60.799 -7.091, P<0.001). Inter-rater reliability showed substantial agreement, with 10 items having 100% agreement. Overall kappa mean was 0,71 (range: 0.31-1). Feasibility Testing: Testing confirmed the suitability and manageability of participant recruitment procedures. General practice recruitment strategies were modified. Trial: The intervention arm received ADRe, and the control arm received usual care. An exact sign test confirmed that ADRe identified more problems than were recorded in medical notes (median 11.50, 25th-75th percentiles 7-21.25 versus median 1.00, 25th-75th percentiles 0.25-2.00, z 5/1, P<0.001). ADRe arm participants were significantly more likely to have two or more problems addressed than control arm participants (OR 6.33, 95% CI 1.97-20.38). Twenty of 28 intervention arm participants experienced at least one substantive clinical gain, for example, resolved pain, fatigue or sleep problems, and all had some expected gains. Conclusions and relevance This study found that that the ADRe Profile is valid, reliable, and suitable for use in general practices. The ADRe intervention benefits patients and is adaptable to varied clinical contexts. ADRe identifies, and offers decision support, in addressing real-time problems. It is person-centred and welcomed by service users. ADRe complements medicine reviews and could be used to support medicines optimisation in general practices in the longer term.