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
Secondary identifying numbers N/A
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

Study designProspective study comparing a baseline period with an intervention period.
Primary study designInterventional
Secondary study designCohort study
Study setting(s)Hospital
Study typePrevention
Participant information sheet N/A
Scientific titleOn-ward participation of a hospital pharmacist in a Dutch Intensive Care Unit reduces prescribing errors and related patient harm: an intervention study
Study objectivesPatients 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) studiedPreventable Adverse Drug Events (ADEs); pharmacist participation; drug prescribing
InterventionThe 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 typeOther
Primary outcome measureThe incidence of prescribing errors per 1000 monitored patient-days.
Secondary outcome measuresThe number of prescribing errors per 1000 monitored patient days that resulted in patient harm (preventable Adverse Drug Events).
Overall study start date03/10/2005
Completion date30/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsMedication orders of 1173 patients were reviewed by the hospital pharmacists involved in the study
Key inclusion criteriaAll patients admitted to the ICU between October 3, 2005 and June 30, 2006
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment03/10/2005
Date of final enrolment30/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor information

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research council

Postbox 93 245
The Hague
2509 AE
Netherlands

Email info@zonmw.nl
Website http://www.zonmw.nl/nl/
ROR logo "ROR" https://ror.org/01yaj9a77

Funders

Funder type

Research council

Netherlands Organization for Health Research and Development (ZonMW) (Netherlands) - partially funded by research grant

No information available

Academic Medical Centre (AMC) (Netherlands) - Hospital Pharmacy Department and Adult ICU Department

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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