Contact information
Type
Scientific
Primary contact
Prof Margreeth Vroom
ORCID ID
Contact details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
m.b.vroom@amc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
On-ward participation of a hospital pharmacist in a Dutch Intensive Care Unit reduces prescribing errors and related patient harm: an intervention study
Acronym
Study hypothesis
Patients admitted to an Intensive Care Unit (ICU) are at high risk for medication errors and related patient harm (preventable Adverse Drug Events [ADEs]), due to the critical nature of their illnesses, polypharmacy, use of high-risk drugs, and a high frequency of changes in pharmacotherapy.
Several studies have shown that on-ward, daily participation of a clinical pharmacist in the ICU can effectively and efficiently reduce the number of medication errors and related patient harm.
Given the increasing awareness of medication safety problems in The Netherlands, a proactive on-ward involvement of Dutch hospital pharmacists (an active approach) seems also desirable. Within the current organization model of the hospital pharmacy in The Netherlands, mostly a passive approach is utilized in the form of on-call consultation duty by a hospital pharmacist.
The aim of this trial is to investigate whether participation of a hospital pharmacist can be an effective approach in reducing prescribing errors and related patient harm (preventable Adverse Drug Events [ADEs]) in Dutch healthcare setting.
Ethics approval
The Medical Ethics Committee of the Academic Medical Centre/University of Amsterdam confirmed that this trial does not require ethics approval under the Medical Research Involving Human Subjects Act (WMO) on the 23rd of June 2010 (ref: 10.17.1044)
Study design
Prospective study comparing a baseline period with an intervention period.
Primary study design
Interventional
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
N/A
Condition
Preventable Adverse Drug Events (ADEs); pharmacist participation; drug prescribing
Intervention
The intervention was an on-ward participation program for a hospital pharmacist consisting of the following activities: The hospital pharmacist assigned for this study evaluated each new medication order for its appropriateness of indication and duration of therapy, drug dosage and frequency, risk of drug-drug and drug-disease interactions as well as pharmacological duplications and omissions. The international and national pharmacotherapy guidelines and local evidence-based pharmacotherapy protocols were used for this evaluation. For each prescribing issue detected, the ICU hospital pharmacist recorded the date, patient characteristics, admission type, medication details and his recommendation. The detected prescribing issues and the recommendations were discussed with the attending ICU physicians during the daily multidisciplinary patient review meeting. If consensus was reached between the ICU hospital pharmacist and the attending ICU physicians on a recommendation regarding a prescribing issue, then that issue was scored as a prescribing error and the medication order was corrected by the responsible attending ICU physician. If consensus could not be reached, the prescribing issue was not scored as a prescribing error and medication order was regarded as 'appropriate'.
The total duration of the intervention was 8 months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The incidence of prescribing errors per 1000 monitored patient-days.
Secondary outcome measures
The number of prescribing errors per 1000 monitored patient days that resulted in patient harm (preventable Adverse Drug Events).
Overall trial start date
03/10/2005
Overall trial end date
30/06/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients admitted to the ICU between October 3, 2005 and June 30, 2006
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Medication orders of 1173 patients were reviewed by the hospital pharmacists involved in the study
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
03/10/2005
Recruitment end date
30/06/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
Postbox 93 245
The Hague
2509 AE
Netherlands
info@zonmw.nl
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Netherlands Organization for Health Research and Development (ZonMW) (Netherlands) - partially funded by research grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Academic Medical Centre (AMC) (Netherlands) - Hospital Pharmacy Department and Adult ICU Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20920322
Publication citations
-
Results
Klopotowska JE, Kuiper R, van Kan HJ, de Pont AC, Dijkgraaf MG, Lie-A-Huen L, Vroom MB, Smorenburg SM, On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study., Crit Care, 2010, 14, 5, R174, doi: 10.1186/cc9278.