Issued "measures of drug supervision and administration of medical institutions
days before the State Food and Drug Administration (for Trial Implementation)" (hereinafter referred to as the rules), definite regulations on medical institutions pharmaceutical purchase and storage, distribution and use of supervision and inspection, etc., to strengthen the medical quality awareness, protect people’s drug safety. This reporter interviewed the State Food and drug administration responsible person in charge of the relevant departments.
special department procurement, prohibit other departments and medical staff to purchase
approach is clear, medical institutions must be from the pharmaceutical production, business qualifications of enterprises to buy drugs. The drugs used by medical institutions shall be uniformly purchased by special departments in accordance with the provisions, and other departments of the medical institutions and medical personnel shall not be allowed to purchase them. At the same time, the medical institutions should have a special department responsible for the daily management of the quality of drugs; no special departments, should designate a person responsible for drug quality management.
medical institutions to purchase drugs to obtain, retain the legitimate documents supply unit, and the establishment of the purchase records, so that votes, accounts, goods consistent. Legal bills including stamps and detailed list of the list must contain the supplier’s name, drug name, manufacturer, batch number, quantity, price and other content, notes the preservation period of not less than 3 years.
in addition, medical institutions must establish and implement the purchase inspection system, the purchase of drugs should be approved by the batch, and the establishment of a true and complete drug acceptance records. Medical institutions, drug donations from other medical institutions in emergency medicine shall also comply with the provisions of. Acceptance records must be kept until the expiration date is 1 years, but not less than 3 years.
step by step electronic management, source traceability, whereabouts can be identified
medical institution shall, in accordance with the drug attributes and categories, sub pools for storing drugs, and the implementation of color management. The drug is separated from the drug, and the traditional Chinese medicine pieces, Chinese patent medicines and chemical drugs are stored and stored separately; the drugs, such as expired, deteriorated or contaminated, shall be placed in the unqualified Library (area). Narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive drugs shall be kept in strict accordance with the provisions of the relevant administrative regulations, and shall be provided with appropriate safety measures.
approach emphasizes that medical institutions should establish a system of effective management of drugs, and follow the principle of "first in, first out". Set up the minimum packaging drug zero allocation management system, to ensure the quality of drugs can be traced back. Gradually establish an electronic management system covering the purchase, storage, distribution, use of the whole process of drug quality control, to achieve traceability of drug sources, whereabouts can be identified, and docking with the national drug electronic monitoring system.
way clear, medical institutions found that counterfeit and substandard drugs, should immediately stop using, local storage and safekeeping, and promptly to the local drug regulatory department reports; found that unsafe drugs, should immediately stop using, notify the drug manufacturers or suppliers, and promptly to the local drug regulatory department to report; recall, the medical institution shall assist.