On-ward participation of a hospital pharmacist in a Dutch Intensive Care Unit reduces prescribing errors and related patient harm

ISRCTN	ISRCTN92487665
DOI	https://doi.org/10.1186/ISRCTN92487665
Protocol serial number	N/A
Sponsor	Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Funders	Netherlands Organization for Health Research and Development (ZonMW) (Netherlands) - partially funded by research grant, Academic Medical Centre (AMC) (Netherlands) - Hospital Pharmacy Department and Adult ICU Department

Submission date: 02/08/2010
Registration date: 19/08/2010
Last edited: 05/10/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Margreeth Vroom
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Email	m.b.vroom@amc.nl

Study information

Primary study design	Interventional
Study design	Prospective study comparing a baseline period with an intervention period.
Secondary study design	Cohort study
Study type	Participant information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	The incidence of prescribing errors per 1000 monitored patient-days.
Key secondary outcome measure(s)	The number of prescribing errors per 1000 monitored patient days that resulted in patient harm (preventable Adverse Drug Events).
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1173
Key inclusion criteria	All patients admitted to the ICU between October 3, 2005 and June 30, 2006
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	03/10/2005
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 9

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes