Lessons Learned from Medication Errors Fatal Outcome Related

Lessons Learned from Medication Errors: Fatal Outcome Related to Rocuronium Loubna Alj, Amina Tebaa, Rachida Soulaymani Bencheikh Centre Anti Poison et de Pharmacovigilance du Maroc World Health Organization Collaborating Center for Strengthening Pharmacovigilance Practices INTRODUCTION Neuromuscular blocking agents (NBA) are high-alert medications because of their well-documented history of leading injuries even death when used by error. MEDICATION ERROR DESCRIPTION The Moroccan Pharmacovigilance Center (MPVC) received a call from a maternity hospital in Rabat regarding 6 newborns who experienced serious adverse events a few minutes following the administration of the hepatitis B vaccine (HBV). The Preliminary investigation by the medical team revealed that the nurse administered the Rocuronium 10 mg/ml intramuscularly instead of the HBV. An investigation was initiated by the Ministry of Health involving a multidisciplinary team including the MPVC. MAIN CAUSES AND CONTRIBUTING FACTORS Proximal causes • The administration of rocuronium instead of HBV • The look-alike packaging of rocuronium and HBV. Contributing factors were related to working conditions, education and training, equipment and resources and tasks factors. Working conditions • • The shortage of human resources: lack of a full time pharmacist in the hospital maternity The lack of neonatology intensive care unit in the Maternity University Hospital Equipment and ressources • • Eduction and training • • The lack of knowledge of healthcare professionals regarding drugs names (INN and brand names) used in daily practice The hospital staff unfamiliar with vaccines and immunization session The lack of secure and lidded container for high-risk medications storage: NBA requires particular storage conditions as well as labeling precautions Lightning issue: The cold room in the hospital pharmacy was poorly lighted Cold Room Lightning in the pharmacy Tasks • • • The use of the same storage area of rocuronium with other drugs: high-alert medications should be stored separately The first time running of HB immunization for newborns in the maternity university hospital should involve a medical team and not a staff person only The lack of double checking vaccines name before administration PROPOSED RISK MINIMIZATION ACTIONS • The nomination of a full time pharmacist • The reassessment of the safety of drug storage and dispensing of medicines at the hospital pharmacy particularly for high-alert medications • Raising awareness of nurses ensuring vaccination about the importance of implementing procedures related to immunization practices • Raising awareness of healthcare professionals about the risks due look-alike sound-alike medications as well as the importance of reporting medication errors and learning from cases • Placing warning labels on all storage bins and final medication containers (e. g. , vials, syringes, IV bags) of neuromuscular blockers that state: “Warning: paralyzing agent—causes respiratory arrest” • The availability of the NBA antidote in health facilities that have neuromuscular paralyzers. CONCLUSION • Medication errors related to NBA should not happen since there is an evidence that they have occurred in the past, they are wholly preventable and thus considered as “never events” • Pharmaceutical companies should commit to introduce mandatory warning statements for labels of medicines containing NBA worldwide to minimize the risk of such us errors • The pharmacovigilance community should issue medication error alerts to share lessons learned from pharmacovigilance databases.