To enhance the quality of supervision and management of medical institutions, pharmaceutical, medical institutions to further regulate the use of drugs act, October 11, the State Food and Drug Administration (SFDA) promulgated the "Drug Administration medical institutions (Provisional)" (hereinafter referred to as "measures ").
According to statistics, as of 2009, China has various medical institutions 900 000, 80% of drugs in medical end-consumer. According to SFDA person in charge, the drug agency for drug production, distribution and other aspects of drug quality monitoring has formulated a number of regulations and normative documents, but has not been put to use for medical institutions, pharmaceutical aspects of drug quality control measures. In recent years, medical institutions, drug safety risks become increasingly apparent, Shanghai Ruijin Hospital, A Sting "eye gate" the use of drugs and other medical institutions due to frequent incidents of injury, attracted nationwide attention. As regulatory authorities, medical institutions should be strengthened for quality control of drugs, to further regulate the medical use of drugs act. "Development" approach "is the" Drug Administration Law, "" Drug Administration Law Enforcement Regulations "in the medical institutions, pharmaceutical quality management requirements to improve and supplement is safe and effective drug to protect the people the necessary means." The person in charge said.
"Measures" the purchase of medical drugs, storage, deployment, use and other actions proposed norms, and legal responsibilities related to specific provisions. Has the following characteristics: First, learn business aspects of pharmaceutical quality control ways and means of medical institutions in the drug purchase, storage, deployment, using the process conditions and the behavior of the relevant provisions; two drugs for use in medical institutions weak links and strengthen the deployment of drugs and medicines and other aspects of the demolition of zero quality control; third is to encourage medical institutions to achieve through the implementation of electronic monitoring pharmaceutical drugs can be traced throughout the flow; fourth recall of medicines put forward specific requirements to meet the relevant drug regulatory requirements.
Light of existing individual medical institutions or medical staff by profit, or privately with smuggling drugs to consumers in patients, resulting in serious acts of medical malpractice, and some medical organizations to adopt email sales, Internet sales, the counter medicines and other open-shelf choice disguised drug sales act, "means" prohibited. "Measures" Article VI expressly provides that medical institutions should be in accordance with the provisions of the drug by the special department of procurement, prohibited medical institutions and medical personnel of other departments on their own purchases. Article 23 stipulates that medical institutions may not use email sales, Internet trading, counter-demand, etc. open-shelf sales of prescription drugs directly to the public.
January 30, the Ministry of Health and State Administration of TCM, Ministry of Health, the General Logistics Department jointly issued the "Pharmacy provision of medical institutions" to regulate the medical institutions of Pharmacy. The official said that the introduction of the "way" is a "Pharmacy provision of medical institutions," the echoes, reflecting the health authorities and Drug Administration as a collaborative, roles, to enhance the medical institutions, pharmaceutical management level, to protect people safe and effective drugs.
The legal responsibility, the official said, the purpose of punishment is not a regulatory, medical institutions consciously and actively promote their drug use behavior is normative purpose. "Measures" in addition to the provisions of those who violate provisions of the act in accordance with the "Drug Administration Law" and other punishment, it also convert regulatory philosophy, take notice, notification, credit files recorded violations and other new approach, urging medical norms of drug use behavior.