Adverse Drug Event Prevention Using Structured Pharmacist Review

Adverse Drug Reactions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467128
• Other study ID #: HRA_HSR/2010/14(a)
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2011
• Last updated: June 5, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Health Research Board: Ireland
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adverse Drug Reactions
• Drug-Related Side Effects and Adverse Reactions

Intervention

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.
• No Intervention
Normal hospital pharmaceutical care

Locations

Country	Name	City	State
Ireland	Cork University Hospital	Cork	Munster

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Hamilton H, Gallagher P, Ryan C, Byrne S, O'Mahony D. Potentially inappropriate medications defined by STOPP criteria and the risk of adverse drug events in older hospitalized patients. Arch Intern Med. 2011 Jun 13;171(11):1013-9. doi: 10.1001/archinternmed.2011.215. — View Citation

Spinewine A, Dhillon S, Mallet L, Tulkens PM, Wilmotte L, Swine C. Implementation of ward-based clinical pharmacy services in Belgium--description of the impact on a geriatric unit. Ann Pharmacother. 2006 Apr;40(4):720-8. Epub 2006 Mar 28. — View Citation

Spinewine A, Swine C, Dhillon S, Lambert P, Nachega JB, Wilmotte L, Tulkens PM. Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial. J Am Geriatr Soc. 2007 May;55(5):658-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with definite and possible adverse drug events during their hospital admission		From point of randomization to Day 14	Yes
Secondary	Drug ingredient cost at hospital discharge		Up to Day 14	No
Secondary	Medication Appropriateness Index score		measured at Day 14 and again at three months post hospital discharge.	Yes
Secondary	Composite health resource utilization including hospital admissions and primary care consultations		Measured at 3 months post hospital discharge	No

External Links

•   Health Research Board (Ireland) website