Solomon Shiferaw Nadew’s research while affiliated with Addis Ababa University and other places

Standard operating procedure (SOP) is detailed, written step-by-step instructions for achieving uniformity while performing specific tasks to minimize variations of repeated tasks and plays a key role in the implementation of a quality management system. It is a document that describes the procedures that will be followed to accomplish various tasks. The procedures are organic documents and best-written SOPs fail if they are not followed. Poorly written, unavailable, and inadequate SOPs hamper working processes and lead to non-compliance in the implementation of quality management systems. A well-crafted SOP offers clear direction and instruction that minimizes deviations at different times using different personnel. The SOPs should be user-friendly and describes the processes in the sequential manner in which they are intended to occur and thus leading to a logical flow of events. In this article, SOP writing is summarised in seven steps, namely (i) Preparing, (ii) Reviewing, (iii) Updating, (iv) Maintaining, (v) Distributing, (vi) Archiving, and (vii) Training.

Introduction Adverse drug reactions (ADRs) are global public health problems. In its severe form it may cause hospital admission, morbidity and mortality. Early reporting of suspected ADRs to regulatory authorities is known to be appropriate measure toinsure health and safety of public form such adverse drug reaction of drugs. In Addis Ababa, there is limited information on ADR reporting practices among medical doctors. Hence, this study aimed to assess ADR reporting practices and associated factors among doctors in government hospitals in Addis Ababa. Methods An institution based cross-sectional mixed-methods study design was used. Data werecollected from 407 doctors using self-administered questionnaire and five key informants using semi-structured questionnaire from October 01 to December 31, 2017. Binary logistic regression and thematic analysis methods for quantitative and qualitative data analysis were used respectively. Results Only 94(27.4%) of doctors had ever reported ADRs to national pharmacovigilance center. The study showed that sex (AOR = 3.51, 95% CI: 1.76–7.03), level ofeducation (AOR = 5.01, 95% CI: 2.23–11.28), work experience (AOR = 4.59, 95% CI: 1.21–17.40), existence of ADR reporting form (AOR = 3.96, 95% CI: 1.07–14.61) and reporting to respective marketing authorization holders (AOR = 21.41, 95% CI: 5.89–77.88) were significantly associated with ADR reporting practices. Poor awareness and training on risk of under-reporting, feeling that reporting is minor, absence of appropriate reporting tools, delay and/or absence of feedback on reported ADRs, overly burdened doctors, negligence, fear of legal liabilityand communication gap were cited by key informants as barriers for reporting practice. Conclusions Adverse drug reaction reporting practice among doctors wasfound to be low. Sex, level of education, work experience, existence of reporting form and reporting to marketing authorization holderswere significantly associated with ADR reporting practice. In addition, there are gaps in availabilities of guidelines, reporting systems and structure, pre-service and in-service training, and awareness of doctors on impact of reporting. Hence, improving access to ADR reporting form, decentralize safety monitoring system, and conducting awareness training on ADR reporting are essential to improve the ADR reporting practice.