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Adverse Drug Event Prevention Using Structured Pharmacist Review

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 8, 2011
Last Update Posted: June 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Denis O'Mahony, University College Cork

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 Intervention Phase
Adverse Drug Reactions Other: Structured expert pharmacist review Other: No Intervention Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Denis O'Mahony, University College Cork:

Primary Outcome Measures:
  • Number of patients with definite and possible adverse drug events during their hospital admission [ Time Frame: From point of randomization to Day 14 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 720
Study Start Date: June 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients aged 65 years and over presenting to CUH Accident and Emergency Departments with acute illness for admission under a medical team will be eligible for the study.

Exclusion Criteria:

  1. Age less than 65 years.
  2. Patient to be admitted under the care of a Geriatrician Psychiatrist of Old Age or Clinical Pharmacologist, or having been admitted under these services or attended their outpatient clinics in the previous 12 months. (These doctor groups are likely to minimise inappropriate medications in this population).
  3. Terminally ill patient attended by palliative care team.
  4. Critically ill patient e.g. admitted to Intensive Care Unit.
  5. Patients who do not wish to participate in the study.
  6. Patients whose hospital physician does not wish to participate in the study ver, its efficacy in terms of ADE prevention is not yet demonstrated.
  Contacts and Locations
Information from the National Library of Medicine

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
Sponsors and Collaborators
University College Cork
Study Director: David O'Sullivan, MPharm University College Cork, Ireland
  More Information

Additional Information:
Responsible Party: Denis O'Mahony, Senior Lecturer, Dept. of Medicine, University College Cork
ClinicalTrials.gov Identifier: NCT01467128     History of Changes
Other Study ID Numbers: HRA_HSR/2010/14(a)
First Submitted: September 2, 2011
First Posted: November 8, 2011
Last Update Posted: June 6, 2012
Last Verified: June 2012

Keywords provided by Denis O'Mahony, University College Cork:
Adverse Drug

Additional relevant MeSH terms:
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders