Adverse Drug Reactions Spontaneously Reported at a Tertiary Care Hospital and Preventable Measures Implemented.

WHAT IS KNOWN: Limitations of clinical trials in determining all safety concerns related to a drug are well recognized. Monitoring spontaneous adverse drug reaction (ADR) reports remains an easy and relatively inexpensive method for overseeing that a drug remains a safe and effective option for patients. OBJECTIVE: To characterize and describe ADR reports at one of the largest healthcare institutions in the region and share the measures implemented by the team. METHODS: We conducted a retrospective analysis of all ADRs submitted by healthcare providers in a tertiary healthcare system in Saudi Arabia between January 2016 and December 2019. The main outcome measures included reporting rate, patient characteristics, suspected drugs involved, seriousness and reporting specialities. RESULTS AND DISCUSSION: Throughout this study, 1156 ADR reports were submitted. The top reported ADR was immune system disorders (87.8%). The most represented class were antimicrobials (56.8%), followed by analgesics (11.4%) and diagnostic agents (5.1%). The ADRs were deemed definitely avoidable in 11.4% (132/1156) of the cases, and 24.2% (280/1156) were deemed possibly avoidable. Reporting ADRs has steadily increased over the years at our institution, but there continues to be a lack of reporting by physicians. Almost one-third of the reported ADRs were considered to be avoidable or possibly avoidable, which is a driver to continue pharmacovigilance activates on an institutional level and provide specific and tailored preventative measures guided by the specific types of ADRs reported. WHAT IS NEW AND CONCLUSION: This is the first study to report trends of ADRs spontaneously reported at one of the largest healthcare institutions in the Middle East. It shows similar trends to what has been reported by other institutions, with mainly immediate immunological ADRs being the top reported ADRs, which could be explained by the immediate onset which simplifies the temporal association. Every institution should support and maintain an active ADR team, with responsibilities of evaluating incidents, monitoring trends and most importantly identifying opportunities to improve medication and patient safety. We share here our workflow and hope it serves as a guide for other institutions.

Misoprostol-Induced Fever and Unnecessary Antibiotic Prescribing: A Retrospective Study.

INTRODUCTION: Misoprostol is widely used for medication abortion and postpartum hemorrhage. However, it has been associated with the adverse effect of fever, which can pose challenges in management and potentially contribute to unnecessary antibiotic use. The incidence of misoprostol-induced fever in the context of medical abortion has not been extensively studied. METHODS: This retrospective cohort study aimed to determine the incidence of fever following misoprostol administration at a tertiary care hospital in Saudi Arabia. The study included female patients who received misoprostol for pregnancy termination or management of missed or incomplete abortion between January 2017 and December 2019. Data on demographics, misoprostol dosage and route, fever characteristics, outcome of abortion, and antibiotic use were collected. Statistical analysis was preformed using appropriate tests. RESULTS: A total of 213 patients were included in the study. The incidence of fever post-misoprostol administration was 8%. Patients who developed fever had a higher gestational age and received higher doses of misoprostol. However, no significant associations were found between other patient variables and fever incidence. Antibiotic therapy was administered to a almost half of the patients who developed fever post-misoprostol but was determined to be unnecessary in all cases. CONCLUSION: This study contributes to the understanding of misoprostol-induced fever in the context of medical abortion. Further research is needed to explore strategies for reducing unnecessary antibiotic use in this population.

Reducing Nonsentinel Harm Events due to Medication Errors by Using Mini-Root Cause Analysis and Action.

Introduction: A full root cause analysis (RCA) such as that required following a sentinel event is time-consuming, labor-intensive, and expensive. This quality improvement project used a similar but abbreviated process (mini-RCA and action; mini-RCA2) in response to medication errors that caused less serious harm. Methods: In 2018, all medication errors that caused harm due to system failures but were not sentinel events were investigated by mini-RCA2. The incidence of similar medication errors reported in the year before and in the year after the introduction of mini-RCA2 was compared to determine the impact of this intervention. Similar events were identified by searching the safety reporting system database for reported medication errors by drug name (e.g., Humate® P) and/or event type (e.g., prescribing error-omission of a patient's home medications on admission to hospital). The time and labor costs of this intervention were estimated. Results: Seven medication errors were investigated by mini-RCA2. More than 48 members of staff from 11 clinical and nonclinical departments contributed to the identification of 39 system failures and made 42 recommendations, of which 22 (52%) were implemented. This reduced the recurrence of reports of similar events from 35 (0.57%) to 21 (0.36%). Although this 0.21% absolute decrease did not achieve statistical significance, recurrence of similar harm events was reduced from 7 (0.11%) to 0 (p = 0.016). Benefits were greatest when the mini-RCA2 recommendations were fully implemented. This reduced the recurrence of similar events from 9 (0.21%) to 0 (p = 0.007). A total of 251 hours (mean ± SD, 35.9 ± 16.6 hours) were required for this intervention. The associated labor cost was Saudi Arabia Riyal (SAR) 34,181 (US $8256; mean SAR ± SD, 4883 ± 1302 [mean US $ ± SD, $2102 ± $561]). Conclusion: The use of mini-RCA2 to review medication errors provided a structured process to manage reported events, monitor the implementation of recommendations, and assess the effectiveness of implemented actions. The use of this rapid process to investigate errors that cause harm but are not sentinel events reduced recurrence of similar medication errors. Although the time and cost required for this intervention is not insignificant, the cumulative benefit to patients, healthcare professionals, and the organization are greater.

Meeting the American Diabetic Association standards of diabetic care.

Although there are numerous studies on diabetes mellitus in Saudi Arabia, data on the extent to which American Diabetic Association (ADA) standards of diabetic care are met, is scarce. We studied the computerized records of adult diabetic patients followed-up in outpatient internal medicine clinics at our tertiary care center in Riyadh, Saudi Arabia to find out how many of them met the ADA standards of diabetic care regarding fasting blood glucose, HbA1c, LDL-C, hypertension, proteinuria screening and use of anti-platelet, lipid lowering or recommended anti-hypertensive medications. Out of 1,188 type-2 diabetic patients studied, blood pressure readings were available in 1180 (99%) while results of fasting blood glucose, HbA1c, LDL-C and albuminuria screening were available for 1123 (95%), 968 (81%), 1037 (87%) and 307 patients, (26%) respectively. Patients achieving the ADA targets for overall, systolic and diastolic blood pressure, fasting blood glucose, HbA1c, LDL-C and albuminuria screening were 39.0%, 40.6%, 74.6%, 25.0%, 21.8%, 55.5% and 34.9%, respectively. For prevention of cardiovascular events, 61.0%, were using angiotensin converting enzyme inhibitors (ACE-I) or angiotensin-2 receptor blockers (ARBs) or both, while 71.5% and 72.3% of our patients were on anti-platelet and statin medications, respectively. In conclusion, as reported in most other studies, we also found that ADA standards of diabetic care are not met in most of our diabetic patients, indicating that these standards are easy to preach than to practice. There is need for further research to investigate the reasons for this failure and to adopt better multi-disciplinary approach and realistic targets in the future.