Legal framework for the implementation and execution of pharmaceutical services related to clinical pharmacy

Abstract

The clinical pharmacist's activities are crucial to the process of patient care. The implementation and execution of these activities must be guided by technical criteria and legal regulations. Therefore, this study aims to identify and compile legal norms which supports the implementation of pharmaceutical care services. National legal norms were addressed to the following topics: sanitary control of medicines and pharmaceutical supplies; patient safety; rational drug use; quality of health services; pharmaceutical care; health information technology; users rights, duties and access to pharmaceutical care and inspection practice of pharmaceutical activities. Then, legal regulations with relevant information for the pharmacist's clinical performance were selected and a list of legal references was created. Eleven federal laws were found, ten ordinances from the Ministry of Health, ten resolutions from the Federal Pharmacy Council (CFF), seven resolutions from the National Health Surveillance Agency (ANVISA) and one from the World Health Organization (WHO). Finally, from this study it was possible to elaborate a compilation of regulations that subsidize pharmaceutical care performance.