Adverse Drug Event Prevention Using Structured Pharmacist Review
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|ClinicalTrials.gov Identifier: NCT01467128|
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : June 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reactions||Other: Structured expert pharmacist review Other: No Intervention||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Active Comparator: Structured expert pharmacist review||
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 Name: expert pharmacist review
|No Intervention: Normal pharmaceutical care in hospital||
Other: No Intervention
Normal hospital pharmaceutical care
- Number of patients with definite and possible adverse drug events during their hospital admission [ Time Frame: From point of randomization to Day 14 ]
- Drug ingredient cost at hospital discharge [ Time Frame: Up to Day 14 ]
- Medication Appropriateness Index score [ Time Frame: measured at Day 14 and again at three months post hospital discharge. ]
- Composite health resource utilization including hospital admissions and primary care consultations [ Time Frame: Measured at 3 months post hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01467128
|Cork University Hospital|
|Cork, Munster, Ireland|
|Study Director:||David O'Sullivan, MPharm||University College Cork, Ireland|