This study aimed to generate evidence on the strengths and challenges of health care regulation in Ethiopia, with particular emphasis on health professionals’ regulation and use evidence to improve systems, processes, and practices of human resources for health regulation, and ultimately improve quality and safety of health services in Ethiopia.

A cross-sectional study design was used at a nationally representative sample of public health institutions in Ethiopia. Because of the multifaceted nature of the subject, both quantitative and qualitative approaches that complemented each other were used. Semi-structured data collection tools were used to capture quantitative data, and key informant interview guides were applied to collect qualitative data. Among others, needed information on regulation systems, processes, and practices-registration, licensure, continuing professional development (CPD), the scope of practice (SoP), medical ethics, the institutional capacity of potential CPD providers and accreditors, facilitators, and barriers of compliance to regulatory standards were gathered.

This nationwide study recruited multidisciplinary professional categories comprising medical doctors, health officers, nurses, midwives, medical laboratory professionals, pharmacy professionals, and anesthesia professionals a total sample of 554 health professionals was recruited from a total of 73,514 targeted health professionals in Ethiopia.

In addition, key informants representing key stakeholders were identified, including 23 health professional associations, 35 in-service training centers, 11 Regional Health Bureaus (RHB), the Federal Ministry of Health (FMOH), the Food, Medicine and Health Care Administration, and Control Authority (FMHACA), 11 Regional Regulatory Bodies (RRB), and 11 health facility managers. Three study tools (questionnaires) were used to capture the quantitative data, and two tools (key informant interview guides) were applied to collect qualitative data. Therefore, data were collected from March 16 through March 31, 2015, and quantitative data were analyzed using STATA Version 13 statistical software package. Descriptive and inferential statistical analysis was performed for the quantitative part. Qualitative data were thematically analyzed using Open Code Software version 3.6 statistical software package.

Finding from this study revealed, current professional registration and licensure practices do not comply with national regulatory standards, and a majority of professionals practicing at public health facilities did not renew their professional licenses. Registration and licensing practices at regions are not supported by an automated human resource management information system. Presenting fraudulent academic credentials and Certificate of Competency is not uncommon. Professionals’ awareness of scope-of-practice is very limited. The Federal regulatory authority had not yet released the directive on scope-of-practice. Violation of scope-of-practice is pervasive. The uptake of CPD or Continuing Medical Education activities among health professionals was not optimum. Professional code of conduct and medical ethics guidelines were not available at health facilities.  The level of involvement of key stakeholders concerned with health professional regulation was not encouraging.

• Health professionals
• Regulations
• Cross-sectional study
• Qualitative and quantitative
• National representative
• Public health institutions
• CPD
• Scope-of-practice
• medical ethics
• licensure

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Three study tools (questionnaires) were used to capture the quantitative data, and two tools (key informant interview guides) were applied to collect qualitative data. The first questionnaire, which was devoted to examining the practice of Ethiopian health professionals, consisted of five sections.

In response to the practice of Ethiopian health professionals, the dataset encompasses identification of health facilities, health professional profile, continuing professional development, the scope of practice, and ethics/licensure/registration. A total of 72 questions (both closed- and open-ended) were used in this category, which was the major component of the dataset.

The other components of the dataset include information’s to assess the institutional capacity of potential CPD providers. Apart from the CPD provider identification data, a total of 43 questions were used to address all issues relating to the provision of CPD activities, including physical facilities and staff profile, follow-up/evaluation of the effectiveness of CPD, measures to be taken on those health professionals who do not participate in CPD, and opportunities and challenges to implementing CPD in Ethiopia.

The third questionnaire was intended to examine the institutional capacity of potential CPD accreditors. In addition to the identification part of the questionnaire, a total of 29 questions were used to address all issues relating to reviewing of training courses, including mechanisms used for recognition of CPD providers, monitoring/evaluating CPD programs/providers, collaboration with other organizations, choosing CPD, measures to be taken on those health professionals who do not participate in CPD, and opportunities and challenges to implementing CPD in Ethiopia.

Apart from the quantitative components of the study, qualitative methods were applied to explore the shared perceptions and experiences of the target populations with regard to the regulation of health professionals in Ethiopia. The use of key informant interviews was designed to supplement the quantitative techniques by answering the why and how questions. In this regard, the fourth and fifth tools (checklists) were prepared by taking account of the target populations under consideration. The key informant guide for regulatory bodies (the fourth tool) was used to interview the potential CPD accreditors and included questions that were closely related to those of the third tool of the quantitative method. On the other hand, the key informant interview guide for health managers (the fifth tool), the last tool of the research work, gave emphasis to CPD, scope-of-practice, ethics, and competence-related questions.

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