Medication safety is a phenomenon of interest in most healthcare settings worldwide. Failure Mode and Effect Analysis (FMEA) is a prospective method to identify failures. We systematically reviewed the application of FMEA in improving medication safety in the medication use process. Electronic databases were searched using keywords ((failure mode and effect analysis) AND (pharmacy OR hospital)). Articles that fulfilled prespecified inclusion criteria were selected and were then screened independently by two researchers. Studies fulfilling the inclusion criteria and cited in articles selected for the study were also included. Selected articles were then analysed according to specified objectives. Among 27€706 articles obtained initially, only 29 matched the inclusion criteria. After adding four cited articles, a total of 33 articles were analysed. FMEA was used to analyse both existing systems and new policies before implementing. All participants of FMEA reported that this process was an effective group activity to identify errors in the system, although time-consuming and subjective.

Background Failure mode and effects analysis (FMEA) is a prospective, team based, structured process used to identify system failures of high risk processes before they occur. Medication dispensing is a risky process that should be analysed for its inherent risks using FMEA. The objective of this study was to identify possible failure modes, their effects, and causes in the dispensing process of a selected tertiary care hospital using FMEA. Methods Two independent teams (Team A and Team B) of pharmacists conducted the FMEA for two months in the Department of Pharmacy of a selected teaching hospital, Colombo, Sri Lanka. Each team had five meetings of two hours each, where the dispensing process and sub processes were mapped, and possible failure modes, their effects, and causes, were identified. A score for potential severity (S), frequency (F) and detectability (D) was assigned for each failure mode. Risk Priority Numbers (RPNs) were calculated (RPN=SxFxD), and identified failure modes were prioritised. Results Team A identified 48 failure modes while Team B identified 42. Among all 90 failure modes, 69 were common to both teams. Team A prioritised 36 failure modes, while Team B prioritised 30 failure modes for corrective action using the scores. Both teams identified overcrowded dispensing counters as a cause for 57 failure modes. Redesigning of dispensing tables, dispensing labels, the dispensing and medication re-packing processes, and establishing a patient counseling unit, were the major suggestions for correction. Conclusion FMEA was successfully used to identify and prioritise possible failure modes of the dispensing process through the active involvement of pharmacists.

The pharmacist is an important link between doctor and patient. To optimise patient care, it is essential that expectations of doctors and patients regarding pharmacy services are met. Hence the objective of this study was to assess the satisfaction levels of doctors and patients on pharmacy services currently provided, and their expectations from pharmacy services. This cross sectional study was conducted in selected clinics of a university based teaching hospital. Questionnaires developed in-house by referring previously published resources, content validated by a group of experts, and face validated through a pilot study were used. Doctors and patients of chronic disease clinics were selected for the study. All doctors involved in prescribing for more than six months, and patients or their regular care givers attending clinics for more than one year were included. Mentally incapacitated patients were excluded. An interviewee administered questionnaire was distributed to doctors and an interviewer administered questionnaire was used for patients. Exploratory factor analysis (EFA) (principal component analysis with Varimax rotation) was conducted to divide variables of the questionnaires into reliable components. Response rate of doctors was 82.3%. Among them 59.6% (50/84) doctors said that they have a good relationship with pharmacists, and 89.3% (75/84) expected communication with pharmacists more often. EFA for doctors’ perceptions resulted in four components. A statistically significant difference was observed between doctors’ expectation (95.9% - 81/84) and current practice (22.6% - 19/84) on communicating medication issues (p<0.001). A total of 380 patients participated. EFA for patients’ perceptions resulted in ten components. The majority considered pharmacists as an integral part of the healthcare system (98.7% - 375/380) and experts in medication (84.7% - 322/380). They further perceived that dispensed medications are safe (82.9% - 315/380) and of good quality (76.3% - 290/380). Further 95.5% (363/380) were satisfied with dispensing label information. A statistically significant difference was found between the expectations (93% - 353/380) and satisfaction levels (86.5% - 329/380) of patients on pharmacy services (p=0.003). According to findings, both doctors and patients held a positive perception on pharmacy services and pharmacists, but the statistically significant gap reported between expectations and current level of pharmacy service, highlighting both the potential and scope for service improvement.