Application Of Risk Management In The PIVAS

Drug as a special commodity, its quality is closely related to the patient’s life. Drug quality has been further improved with the new version of GMP (2010 Edition). However, the vast majority of drug is used in medical institutions. Dissolution and configuration of intravenous drug are performed in the non-clean environment in most medical institutions. This situation can lead to drug pollution, drug compatibility which is caused by unreasonable, adverse reactions, drug cross-infection, cross-resistance and personnel long-term inhalation for the operators and contact with chemotherapy drugs and antibiotics. This may cause physical damage and other issues.In order to ensure the clinical transfusion safety in the medical institutions and protect the rights of patients, Chinese government promulgated the standards of intravenous drug centralized deployment quality management and operation procedures of intravenous drug centralized deployment in April 2010. These documents ask for the establishment of PIVAS in medical institutions (Pharmacy intravenous admixture service, referred to as PIVAS). In 2011, the Chinese Ministry of Health promulgated and implemented the Provisional Regulations of pharmacy management in medical institutions. It suggests that the parenteral nutrition and the harm of drugs intravenous medication should be centralized supply, including tumor chemotherapy drug, catatonic drugs. According to the clinical need, medical institutions should be established according to PIVAS. Drug distribution without PIVAS also comply with the provisions of "intravenous drug centralized deployment quality management standards".Pharmacy intravenous admixture means that in the pharmaceutical department of medical of medical institutions, pharmaceutical professional and technical personnel prepare the intravenous drug mixture according to the prescription, assess the suitability in accordance with the requirements of the aseptic operation, in a clean environment to makes it available for clinical use.This hospital started to constructed the PIVAS in August 2013. From the step of drawings design, material choose to the construction, risk management method was been applied to avoid risks and ensure every link of the construction meeting the specified requirements.This paper mainly focus on the study of the construction of PIVAS of a municipal hospital. We have used the risk management tools and methods to make the risk assessment and control the PIVAS’s construction, facilities, equipment, daily management and so on. The corresponding control measures are taken to ensure the quality of products by intravenous infusion and the drug safety of patients. In addition, because the PIVAS is still a relatively fresh things, the aspects related to the construction of PIVAS documents are not too mu ch, this paper can serve as a good case to provide experience for other medical institutions and can improve the construction of PIVAS jointly.