Safety Assessment of Pharmaceutical Distribution in a Hospital Environment

Abstract

Many of the catastrophic errors in health care are related to inadequate procedures. Robust preventative actions are therefore required to minimize the risks inherent to the prescribing, dispensing and administration of medicines. The redesigning of subsystem processes is a goal that should be undertaken to improve the overall safety of hospitals. Many organizations are beginning to apply traditional aerospace engineering methodologies to the study of patient safety. In a hospital setting, the pharmacy department is responsible for the procurement, distribution, and control of all medicines used within the organization. Pharmacists should ensure that medicines are delivered to patient care areas in a safe and secure manner and that they are available to the administration within a time frame that meets the essential needs of patients. A Failure mode analysis applied to pharmaceutical distribution has been carried out in the S.G.Battista Hospital in Turin (Italy), from the receiving of the goods stage to the delivery to the departments. Two main high risk activities have been identified from risk matrices and risk priority number analysis. The first activity concerns the picking and packing phases and the second one is due to the low efficiency of the random controls of pharmacists. The analysis has also pointed out some medium risk activities in the refill request control, storage temperature control and consignment to delivery service departments. The present analysis has offered the opportunity of quantifying safety within a specific hospital environment and of designing feasible corrective actions. The real effectiveness of the proposed actions will be verified during a subsequent experimental phase.

Using Prospective Risk Analysis Tools to Improve Safety in Pharmacy Settings: A Systematic Review and Critical Appraisal

“…All analyses conducted in inpatient setting used FMEA. [18][19][20][21][22][23][24][25][26][27] The majority of them did not assess dispensing separately, but as part of the entire medication use process. Only 2 studies were undertaken to specifically assess dispensing as an individual process.…”

“…Only 2 studies were undertaken to specifically assess dispensing as an individual process. 18,27 Furthermore, most studies considered only highalert medications such as chemotherapy 19,21,22 or pediatric medicines. [23][24][25] Only 2 analyses evaluated the dispensing of all medication categories.…”

“…[23][24][25] Only 2 analyses evaluated the dispensing of all medication categories. 20,26 The studies included in this review identified various failure modes throughout the dispensing process, most commonly related to the transcription, [18][19][20][22][23][24][25] selection, 18,20,21,26,27 preparation, 18,19,23,25 and validation 19,20,24,25 phases (Table 2). Accordingly, the reviewed publications propose numerous general and stage-specific corrective actions, out of which the introduction of computerized prescribing and electronic transmission of prescriptions to the pharmacy, 19,22,25 use of bar code technology in the picking and packing phase, 27 direct label printing from the server (i.e., prescription), 19,25 as well as automation of compounding 25 proved to be the most effective ones (Table 3).…”

“…The risk reassessment conducted in some FMEA studies after the actual 18,20 or hypothetical implementation 23,27 of the corrective actions proposed demonstrated a significant potential for overall risk reduction in the dispensing process (Table 4). Various methods were employed for this activity, including using the same risk analysis technique (i.e., conducting a second FMEA) after implementation of corrective measures 18,23,27 as well as performing a before-and-after observation study on the rate of dispensing errors. 20 In this study, a significant risk reduction was obtained after the actual implementation of the corrective actions proposed as part of the FMEA (19.4% and 38.5% for the validation and dispensing phases, respectively).…”

“…18,19,21,22,[24][25][26] Only a few research teams used factual data on the incidence and types of medication errors in addition to brainstorming. 20,23,27 The study using ST-PRA also considered data from published literature to complement expert opinion for defining potential failure modes in an abbreviated FMEA (Table 5). 28 Regarding risk quantification, all studies using FMEA employed a framework based on the estimation of failure mode occurrence, severity, and detectability.…”