Background The management of errors by the hospital pharmacy department is a critical aspect for the conduct of clinical trials (CT).
Purpose To evaluate early identification and resolution of CT problems in order to improve our working procedures within a quality system.
Materials and methods Data about the identification and resolution of CT errors detected were recorded using the following items: date, person reporting, identification of the CT, department conducting the CT, process (protocol, reception, storage, prescription, validation, preparation, dispensing, administration, return, record keeping), professional involved, description of the problem and corrective measures. The findings recorded during 2009–2010 were reviewed.
Results 123 events were recorded in a total of 174 CTs conducted. The most frequent events were mainly related to the prescribing (50%), dispensing (19%), and reception (7%) phases. 1.8% of the prescriptions presented some finding (72/3928). The most common causes were: no specification that the patient was included in a CT (54%), incomplete prescription (22%) and non-adherence to the study protocol (21%). In these cases there was an immediate intervention with a communication to the investigator. In relation to dispensing the most frequent mistakes were the number of units dispensed (30%) and the omission of information to patients (26%). Other mistakes included dispensing commercial medicines instead of research samples (13%) and non-compliance with administrative requirements (13%). When receiving CT materials, discrepancies between the delivery note and the goods really delivered (33%) and delivery problems (33%), were the most common errors.
Conclusions The opportunities for improvement identified were to expand electronic prescribing, to implement and uphold standard operating procedures (SOPs) for conducting the CTs and to report all discrepancies noted to the staff involved (monitor, sponsor, carrier). The purpose of a process for identifying corrective and preventive actions is to ensure that discrepancies and non-compliance are visible and the causes are determined and resolved, improving the efficiency of the process.
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