This study aimed at using FMEA to prospectively identify failure modes, possible causes, and related corrective action, to improve the safety of the dispensing process at a selected tertiary care hospital in Sri Lanka. A total of 90 failure modes were identified by the two FMEA teams. They identified overcrowded medication counters, unclear prescriptions, distractive working environment, and communication issues as common causes for failures which could result in patients receiving wrong medications and/or medication doses, and in turn lead to poor medication adherence. Teams proposed the need for redesigning dispensing counters, dispensing shelves and medication labels to improve medication safety in the dispensing process, while supervision of the medication repacking process by a pharmacist, including two or more pharmacists in the medication dispensing process, and establishing a separate patient counseling unit with a dedicated pharmacist were prioritised as process improvements.
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(27). During this review, we found a number of studies using FMEA in areas such as chemotherapy (11-14), parenteral nutrition (28), medication management (2, 29, 30), medication administration (31, 32), medication use process (one or more steps from prescribing to dispensing) among in-patients (18, 33, 34) and paediatrics (12, 15-17, 23). We found only two studies (6, 21) on using FMEA to analyse the dispensing process of out-patients where both studies were carried out in the community. No studies had carried out FMEA on the dispensing process for ambulatory patients in hospitals. Therefore, 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.
This study was carried out to assess the safety of the dispensing process in the study setting which is a university based teaching hospital in Colombo, Sri Lanka. FMEA was conducted in two teams to minimise the disruption to routine dispensing services at the study hospital and was successfully completed by both teams. Although, most FMEA studies found in the literature proceeded with one team (2, 6, 13-15, 18, 21, 28, 31, 33), Shebl et al.,(9) reported the reliability of a FMEA study conducted using two teams in two settings and thus justifying the method we used. Some other researchers also used more than one group for scoring of failure modes (10) and to represent multiple units of a single setting (23).
Both teams mapped the dispensing process in a similar manner except when Team A identified two pathways of medication assembling while Team B identified this division at the sub process level. However, the dispensing process map identified by our team is similar to those mapped by others (6, 21) except where the step on rechecking medications before dispensing is missing in ours. Nevertheless, pharmacists in both teams identified this missing step as a cause of error, and Team B even suggested redesigning the dispensing process to include a rechecking step by a second pharmacist.
Among all 90 failure modes, 69 failure-modes were independently identified by both teams indicating the suitability and reliability of the FMEA process in diagnosing critical issues in a system. Failure modes identified by both teams such as, failure to identify prescription errors, incomplete and/or incorrect medication labeling, and insufficient verbal information given to patients were also identified by other researchers (6, 21). Similar to our findings, a study conducted in a community pharmacy in Serbia (6) stated that dispensing wrong medication/dose/quantity are also possible failure modes.
Causes of failure modes documented in this study were also consistent with studies done worldwide. FMEA studies conducted on areas such as chemotherapy (12, 35), medication prescribing, prescription validation and dispensing for in-patients (33) and on medication administration (9) in countries such as Netherland, China, Spain and the United Kingdom reported work overload due to inadequate staff as a major cause of medication errors which is similar to our findings. Like in this study, communication issues between healthcare professionals and patient was also reported as a cause of error by many others (2, 6, 14, 16, 21, 31). Environmental distractions, illegible handwriting of prescriptions and/or labels, knowledge deficit of healthcare professionals and lack of awareness of healthcare professionals acknowledged as causes in this study were also shared by many other researchers (6, 9, 11, 14, 16, 21, 30, 31).
Interestingly, corrective action suggested by team members in this study were also similar to those reported by other FMEA studies. Incorporating modern technology such as computerised prescription order systems, and bar code identification of patients (6, 9, 11, 18, 21, 23, 30), improving communication strategies, and double checking of any healthcare process (6, 9, 12, 14, 15, 18, 21, 23, 24, 30, 35, 36) were the most commonly highlighted solutions by many.
Although the inability to generalise results is an inherent limitation of FMEA, there were marked similarities of failure modes, causes, and solutions, of medication errors identified among different studies using this proactive tool across a variety of healthcare settings. Thus, we believe that the findings of this study too will be applicable to similar healthcare settings. However, we must acknowledge the subjective nature of FMEA studies which was apparent when assigning RPN values to failure modes by Teams, A and B. The mathematical accuracy of calculating RPN values has been a concern for other researchers as well (37) and is a known limitation of FMEA.
Failing to conduct a second FMEA after implementing corrective action is a limitation of this study but this model provides evidence that FMEA can be successfully used to identify possible failure modes of the dispensing process in out-patient care of hospitals. Conducting an FMEA makes pharmacists more aware of possible failure modes as they are personally involved in this activity. Feedback obtained from team members also revealed that this process helped them to think seriously on possible failure modes possible in day today practice and provided a good platform to share experiences among fellow colleagues.