Medication safety is a global concern and a matter of interest for healthcare professionals and researchers worldwide. As a result, in 2017, the World Health Organization (WHO) initiated the “Third Global Patient Safety Challenge with a theme on medication safety” along with the challenge to “reduce the frequency and impact of medication errors” . The National Coordinating Council for medication error reporting and prevention defines medication errors as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer” . Medication errors are further classified as prescribing, dispensing, and medication administration errors. If any failure in communication occurs at prescribing or dispensing in ambulatory care it will further result in patient compliance errors . It is reported that these errors are caused mainly due to faulty systems and rarely due to human neglect .
WHO estimates that the annual cost of medication errors is around US$42 billion . It is estimated that National Health Service (NHS) of the United Kingdom spends £1 billion per annum as extra hospitalisation costs due to preventable adverse effects . Gathering the knowledge from various regions of the world, WHO demonstrates that older patients (> 75 years), patients with poly-pharmacy, and patients at transition of care (either discharge after hospitalisation or transfer from primary care to secondary care) are most vulnerable for medication errors . Studies on medication errors have been reported from countries of different regions of the world such as the United Kingdom, Saudi Arabia, Sweden, and Mexico . These findings demonstrate that medication errors are a global issue and highlight the importance of addressing the issue through research and other scientific moves.
The focus of the present study was on dispensing errors. Dispensing is an important element of pharmaceutical care, which in turn is an indispensable aspect of total patient care. As the American Pharmaceutical Association describes, the pharmacist must be “responsible for the appropriate use of medications, devices, and services to achieve optimal therapeutic outcomes”  and must be responsible for ensuring patient safety. Especially in ambulatory care, a pharmacist dispensing medication is the last healthcare professional and any error that takes place in this step directly reaches to the patient . A systematic review on dispensing errors reports that dispensing error rate varies from 0.015 to 33.5% . Concerning the error type, dispensing the wrong medication was the most common one. Other identified frequent error types were dispensing wrong medication strength, and wrong dosage form. “High workload, low staffing, mixing of Look Alike Sound Alike (LASA) medications, issues in knowledge/experience, distractions, and communication issues” were identified as common reasons of dispensing errors . In United Kingdom, ~ 17% of reported medication errors were related to dispensing . It is reported that 37% of dispensing errors are organisational or system problems while 30% are related to the individual professional, 17% to prescription, 10% to medication, and 4% to the patient . Thus, proactive efforts taken to prior identification of possible failures of the dispensing process would clearly benefit in improving patient safety.
Various Human Reliability Analysis (HRA) methods are available to identify errors and weaknesses in systems. HRA techniques aim to identify failures of systems and people involved but without blaming or shaming . The three approaches of HRA methods include retrospective, prospective and on-line analysis methods . Most HRA methods are of commercial origin and are not found in scientific literature. A review of HRA techniques states that methods like CREAM (Cognitive Reliability and Error Analysis), MORT (Management Oversight Risk Trees Method) and THERP (Human Error Rate Prediction) methods are still not used in healthcare . Historically, Root Cause Analysis (RCA) was the commonly used method to find out root causes of errors that occurred in the healthcare sector. RCA is a means of identifying WHAT, HOW and WHY an event occurred .
The National Academy of Medicine recommends conducting prospective risk analysis studies on medication safety in pharmacy rather than basic epidemiological studies . The Failure Mode and Effects Analysis (FMEA) is an ideal tool for this purpose as it is able to identify potential failures before harmful events occur . FMEA offers a proactive approach to detecting failures in contrast to incident analysis and Root Cause Analysis which are performed retrospectively. As FMEA is able to identify errors before it happens, industries such as aviation, aerospace, nuclear power and automobiles  use it widely. Lately, FMEA has been adopted to assess risks in healthcare and to identify areas that need improvement in the healthcare system. The United Kingdom National Patient Safety Agency recommends to apply FMEA to assess new policies and procedures before implementing them  and the Joint Commission, USA has asked its accredited institutes to carry out an annual proactive risk assessment study such as FMEA [15, 16].
FMEA is used in many healthcare specialties including chemotherapy [17,18,19,20], paediatrics [18, 21,22,23], and pharmacy, and in different settings such as in-patient settings [16,17,18, 24], intensive care units [23, 25], community clinics , and community pharmacies [12, 27]. FMEA has even been successfully used to analyse new policies before implementing them . However, there were no reports on using FMEA to assess the safety of the dispensing process of out-patients in hospitals.
FMEA is a systematic and step-wise procedure starting with selecting a clearly defined process to assess and assemble a multidisciplinary team. Afterwards processes and sub processes of the selected process are mapped using the team’s collective knowledge and by focusing on key components of the process. After mapping the process, the team does a brainstorming to identify potential failure modes for each sub process. Then team identifies the effects and causes of potential failure modes and enters the results into the spreadsheet. Professional knowledge and personal experience of team members and information from literature is useful in this step. The team then prioritises the potential failure modes, considering the severity, frequency and detectability of failure modes. Finally the team redesigns or modifies the process to avoid or minimise the failures [13, 29].
With the intention of having a comprehensive understanding on FMEA prior to starting the present study, authors conducted a systematic review on application of FMEA on different medication use processes. PubMed, JSTOR, Emerald, SAGE, Wiley online, Oxford journals, Web of science, Scopus and Cochrane library databases were searched for relevant studies from January 2006 to December 2017 . During this review, we found a number of studies using FMEA in areas such as chemotherapy [17,18,19,20], parenteral nutrition , medication management [2, 32, 33], medication administration [34, 35], medication use process (one or more steps from prescribing to dispensing) among in-patients [24, 36, 37] and paediatrics [18, 21,22,23, 38]. We found only two studies [12, 27] using FMEA to analyse the dispensing process of out-patients where both studies were carried out in the community. There were no reports on FMEA carried out on the dispensing process for ambulatory patients in hospitals. So, to the best of our knowledge, this study is the first model for using FMEA in an out-patient hospital pharmacy to analyse the safety of the dispensing process.
Therefore, the objective of this study was to identify possible failures in the dispensing processes serving out-patients of a tertiary care hospital, their effects, and causes, using failure mode and effects analysis and to recommend corrective actions for selected failure modes.