NCT01467128

Adverse Drug Event Prevention Using Structured Pharmacist Review

Title of Study: Adverse Drug Event (ADE) Incidence in Older Patients Following Hospital Admission and Pharmacist Review to Older Persons' Prescriptions and Its' Effect on ADE Reduction in Hospital: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 720 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The next four decades will see a marked expansion of the elderly population in Ireland, in particular people aged over 80 yrs. Persons aged over 80 are the highest consumers of prescription medicines in Ireland and have the highest prevalence rates of major polypharmacy. Polypharmacy is intimately linked with serious adverse drug events (ADEs) and consequent major morbidity and mortality. Epidemiological data from the Unites States indicate that ADEs is the fifth most common cause of death nationally. Experts suggest that effective evidence based interventions can be applied to this major public health problem. A recently described approach to hospitalised older patients' medication optimisation is that of Spinewine and colleagues at Louvain University, Belgium. In this model, a pharmacist with expertise in geriatric pharmacotherapy routinely reviews the prescriptions of older patients from admission to discharge. The pharmacist provides a detailed pharmaceutical care plan for older patients and their carers where appropriate as well as feedback information to prescribers in the event of detecting instances of probable medication inappropriateness. Whenever an opportunity for medication optimisation is identified, the pharmacist discusses the opportunity with the prescriber who can accept or reject the intervention. At discharge from hospital, the pharmacist also provides written and verbal information on treatment changes to the patient / caregiver and GP. The intervention therefore represents a comprehensive pharmaceutical care approach that is based upon careful review and subsequent consensus on individualised pharmacotherapy. In an RCT comparison of this approach with standard care, older patients in the intervention arm of the study had significant improvements in medication appropriateness (medication appropriateness index (MAI), Beers' criteria, and Assessing Care of Vulnerable Elders (ACOVE) criteria.). Expert pharmacist review of older peoples' medication in hospital is a proven intervention in term of reducing inappropriateness of medication.

Conditions

• Adverse Drug Reactions

Interventions

Type	Name	Description
OTHER	Structured expert pharmacist review	The researcher will apply the pharmacist intervention to the cases randomised to this arm of the study. This consists of an expert pharmacist review of the patients prescribed medications at the time of recruitment into the study. Recommendations following the intervention will be communicated both verbally and in writing to the medical team with primary responsibility for the patient. Recommendations arising from the intervention will be printed out and inserted into the patients' notes, in addition to the relevant registrar being informed in person or via the telephone.
OTHER	No Intervention	Normal hospital pharmaceutical care

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-11-08
• Last updated: 2012-06-06

Locations

1 site across 1 country: Ireland