Method
This study was carried out in a tertiary care respiratory center, Masih Daneshvari hospital, a university affiliated center, located in Tehran-Iran during a 1-year period. Currently, in this institution, IV medications are mostly prepared by the nurses in the wards and pharmacist involvement is minimal in medication preparation.
One hundred patients regardless of their gender, age or diagnosis who were admitted to different wards of the hospital (medical and surgical ICU, internal, oncology, CCU and post-CCU) were enrolled in the study. The patients were supposed to receive at least one IV medication in order to be included in the study.
A pharmacist who was trained in observation based medication error research, accompanied nurses during IV drug preparation and administration rounds. All data including patients’ demographic data, name of the responsible nurse, physicians’ name and the name of the IV medication were collected in a questionnaire.
These data were then evaluated based on the medical guidelines from different resources in order to recognize any possible physicochemical incompatibility of each IV medications with diluents and solvents as well as other medications prescribed concomitantly. Physicochemical incompatibility and rate of administration data was extracted from two different references (
14,
15).
Drug interaction data were also recorded for each patient. Drug-drug interactions data were obtained from two different references (
16,
17).
Direct observation method was used to detect potential errors. The investigator followed the process of preparation and administration without any intervention as long as no serious or life-threatening condition (e.g. precipitation of medication) was encountered. In case of life-threatening situations or any error which was likely to cause imminent harm, the observer intervened during the observation process due to ethical issues although it might have changed the results of the study. The final outcomes of the study were categorized in four following concepts:
- Concordance of the physicians' orders with existing medical guidelines and selected references.
- Concordance of the nurses' administration method in terms of the dose, rate and dilution method with the physician's order.
Recognizing potential physicochemical incompatibilities during the preparation phase.
- Observance of drug-drug interactions during preparation of more than one IV drug.
In order to remove between session variations, we applied a correction factor since the number of observations for each medication was different. Correction factor expresses the number of opportunities for errors for each prescribed medication. In this way, we were able to find the rate of errors for each medication under equal conditions.
Nurses' demographic data including age, gender, level of education, work experience and employment status were retrieved from hospitals' nurse office for further analysis. All of the included nurses remained anonymous during and after the study. Needed to mention that enrolled nurses were serving under four different categories of employment status described as 1. Official contracts 2. Three-year contract staff (renewed every 3 years) 3. Intern nurses 4. One-year contract personnel (renewed annually).
Statistical analysis was performed by SPSS 19.0 (SPSS Inc., Chicago, IL). The method of statistical analysis was General Estimating Equation (GEE).