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

Abstract

Objectives: This study aimed to review and critically appraise the published literature on 2 selected prospective risk analysis tools, Failure Mode and Effects Analysis and Socio-Technical Probabilistic Risk Assessment, as applied to the dispensing of medicines in both inpatient and outpatient pharmacy settings.Methods: A comprehensive search of electronic databases (PubMed and Scopus) was conducted (January 1990-March 2016, supplemented by hand search of reference lists. Eligible articles were assessed for data sources used for the risk analysis, uniformity of the risk quantification framework, and whether the analysis teams assembled were multidisciplinary.Results: Of 1011 records identified, 11 articles met our inclusion criteria.These studies were mainly focused on dispensing of high-alert medications, and most were conducted in inpatient settings. The main risks identified were transcription, preparation, and selection errors, whereas the most common corrective actions included electronic transmission of prescriptions to the pharmacy, use of barcode, and medication safety training. Significant risk reduction was demonstrated by implementing corrective measures in both inpatient and outpatient pharmacy settings. The main Failure Mode and Effects Analysis limitations were its subjectivity and the lack of common risk quantification criteria. Conclusions:The prospective risk analysis methods included in this review revealed relevant safety issues and hold significant potential for risk reduction. They were deemed suitable for application in both inpatient and outpatient pharmacy settings and should form an integral part of any patient safety improvement strategy.

Prospective systemic risk analysis of the dispensing process in German community pharmacies

“…Invented back in the 1960s, FMEA was primarily used in industries involving a high level of risk, aiming to provide “simultaneous analysis of failure modes, their consequences and associated factors, in order to identify and prevent process incidents before they occur” . However, since then, FMEA has come a long way toward serving other purposes, such as a proactive risk reduction in various healthcare processes, including dispensing of medicines, where it has proved to be highly effective . Yet, within the context of pharmacy practice, this type of analyses has mostly been conducted in the hospital setting .…”

Community Pharmacists’ Attitudes and Professional Practice in Relation to the Patient Safety Incidents

“…Along with the development of modern approach to medication errors, an increasing emphasis has been laid on the prospective risk analysis, since this type of risk management allows implementation of corrective measures before a preventable adverse event has occurred and caused harm to the patient. 27 It is exactly the reason why it is of crucial importance to examine pharmacists' attitudes related to the risk management in the medicines dispensing process, in order to identify causes of dispensing errors as well as potential preventive measures to avoid them in the community pharmacy setting. Study results indicate that more than a third of the participants in this study (35.4%) indicated that the risk of dispensing errors was increasing, which was lower compared to 44.7%, 62% and 82.2% of the community pharmacists from Ethiopia, 24 Saudi Arabia 25 and Australia, 18 respectively, who demonstrated such attitude.…”

A literature review of human factors and ergonomics within the pharmacy dispensing process

“…the combining, mixing, or altering of pharmaceutical ingredients). Studies conducting quantitative prospective risk assessment of the dispensing process were excluded as this has been reviewed recently by Stojkovic et al in 2017, 22 although the findings of the current review will be discussed in context with that review.…”

“…20 A medical error is defined by the WHO as a preventable, unintended consequence of a medical intervention, which can range from patients receiving the wrong medicinal treatment or surgical procedure, to a misdiagnosis. 21 Variable system performance within pharmacy settings can result in medical errors which can cause serious harm or death, 22 with key areas of risk for medical errors being the transcription of prescribed medication and the preparation and selection of pharmaceutical products. 22 As these areas of risk typically exist throughout the pharmacy dispensing process, these sub-set of medical errors are referred to as dispensing errors, with common examples including the supply of the incorrect drug, strength, dosage form, quantity or instructions to patients.…”

“…21 Variable system performance within pharmacy settings can result in medical errors which can cause serious harm or death, 22 with key areas of risk for medical errors being the transcription of prescribed medication and the preparation and selection of pharmaceutical products. 22 As these areas of risk typically exist throughout the pharmacy dispensing process, these sub-set of medical errors are referred to as dispensing errors, with common examples including the supply of the incorrect drug, strength, dosage form, quantity or instructions to patients. 23 Although the frequency of such dispensing errors varies considerably internationally and is compounded by the application of varied calculation methods, within the community pharmacy setting in the UK, the incidence of dispensing errors has been reported as 0.04-3.32%.…”