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Hospital Drug Use In Handan City Quality Supervision Management

Original Language Title: 邯郸市医疗机构药品使用质量监督管理办法

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(Summit No. 63 of 11 December 2007 of the Government of the Turkmen Government considered the adoption of the Decree No. 124 of 21 December 2007 of the Royal Government of the Republic of China, which was issued effective 1 February 2008)

Article 1, in order to enhance the quality supervision of the use of medicines by medical institutions and to guarantee the safety of human drug use, develop this approach in line with the laws, regulations, such as the People's Republic of China Drug Management Act, the People's Republic of China Act on the Control of Drugs.
Article II applies to institutions operating under the law within the city's administration in the areas of medical, health, prevention, family planning services (hereinafter referred to as health-care institutions), and to the management of quality surveillance in the areas of drug procurement, inspection, storage, conservation, distribution and distribution.
The use of narcotic drugs, mental medicine, medical toxic medicines, radioactive drugs and vaccines and their quality monitoring are carried out in accordance with national legislation, regulations and regulations.
Article 3 regulates the management of quality surveillance of drug use components in the urban health institutions.
In each district (commune, district) food drug surveillance management is responsible for the management of quality surveillance of the drug use components within the current jurisdiction.
Without the establishment of district-level food drug control surveillance offices, the quality supervision of the drug use components is directly responsible by the urban food drug control surveillance authorities.
The executive branch, such as health, prices, and business, should be responsible, within their respective responsibilities, for monitoring the management of pharmaceutical use by medical institutions.
More than tier 4 medical institutions should establish a drug management committee, and other medical agencies may establish a drug management team or identify (and)-time personnel responsible for the quality of the drug use component.
The composition of the Committee on Pharmaceutical Management is implemented in accordance with the provisional regulations on the management of medicines in the medical institutions.
Article 5 Medical institutions should establish a sound quality management system for the following medicines, as well as regular inspections and appraisal of the implementation of the nuclear system, with corresponding records:
(i) The drug quality management responsibility regime;
(ii) Human health management system;
(iii) Procurement of medicines, inspection management systems;
(iv) The quality information management system for medicines;
(v) Drug storage, conservation management systems;
(vi) The use management system for drug measurements and storage, conservation equipment;
(vii) Special drug management systems;
(viii) Health management systems;
(ix) Transdeployment management systems;
(x) Unqualified drug control and the shipment drug management system;
(xi) Management system for reporting on adverse responses to drugs;
(xii) Quality accident reports and management systems;
(xiii) Exemptive drug clearance and destruction systems.
Article 6. Medical institutions shall procure medicines from the manufacture of pharmaceutical products with a licence for the production of medicines, a licence for the operation of medicines and a licence for business.
Article 7. The acquisition of medicines by medical institutions should be strictly followed by the relevant provisions of the State, the establishment of a system for import inspection, the identification of qualified medicines and other markings, and the non-removability and use of medicines incompatible with the requirements.
Medical institutions should seek and identify relevant information in accordance with the relevant provisions when they occur for the first time in the manufacture of pharmaceutical products or in the operation of pharmaceutical companies, or in the procurement of the first purchase of medicines or imports.
Article 8. Medical institutions should establish authentic and complete drug purchase records. The drug acquisition record should have the following:
(i) The generic name, agent, specifications, quantifications and duration of medicines;
(ii) The number of purchases, the purchase price and the date of purchase;
(iii) Production plants, supply units;
(iv) Other provisions of laws, regulations and regulations.
The purchase of medicines shall not be kept for less than three years; the effective period for drugs exceeds three years and is maintained for one year after the period of effectiveness of medicines.
Article 9. Medical institutions shall establish appropriate pharmacies, pharmacies (pharmacies) in accordance with the subject of medical treatment and the scope of drug use approved by law.
Article 10 Medical institutions store medicines, and measures such as refrigeration, fire protection, philosophical, defence and ratification should be taken in accordance with the quality requirements of medicines to prevent drug contamination, variability, failure.
Medical institutions should conserve stored medicines and should not use obsolete, invalidated, phased-out, vincing, pests and qualitative drugs.
Article 11. The drug conservants should be able to monitor and manage the temperatures of the pharmacies, pharmacies (pharmacies). When temperatures, wetlands go beyond the specified scope, they should be followed in a timely manner and recorded. The normal temperature of the storage of medicines should be maintained at 10-30°C; the bleak temperature should not exceed 20°C; the temperature of the refrigeration (contra) should be maintained at 2-10°C; the relative humidity of the pharmacies and pharmacies should be maintained at 45-75 per cent.
Article 12 Medical institutions recognize, report, damage and destruction should be well-developed procedures and records for quality-neutral medicines and place quality-of-qualified medicines in unqualified drug banks (zones) or marked.
The medicines used by medical institutions should be adapted to the scope of the treatment, and no one could provide medicines to patients.
Article 14. Medical institutions should strictly rely on the transfer of medicines by the user, and the transfer of persons to the medicines listed by the other party shall not be subject to unauthorized change or replacement. For those with a veterans or supersses, it should be refused to redeploy, return to a doctor from the start-up, with a medical corrections from the opening-up or resigning the party.
The author's review, the drug transferee shall be signed by the head or chapter, and the other party shall maintain the record as specified.
Article 15. Medical institutions need to disprovide pharmaceuticals for the lowest packaging and should be kept with a minimal packaging of the same number. Distinctional medicines should include references to the name, specifications, use, use, ratifications, medical orders, and medical agency name. Special requests should be made in writing on matters of concern.
Article 16 Medical institutions may not sell drugs to non-institutes for patients, nor operate medicines outside the body.
Article 17 Medical institutions shall not use medical operations to advertise drug propaganda, and their configurations shall not be subject to advertising.
Article 18 Medical institutions have found a quality of suspicious drugs in the use of medicines and should immediately cease their use, maintain and report to the management of food medicine surveillance in the location. Food drug surveillance authorities should be treated in a timely manner in accordance with the law and, prior to the determination of their testing, medical institutions shall not be able to carry out their own transfers, freight or destruction.
Article 19 Medical institutions should strictly monitor the occurrence of ill-treatment of medicines, in accordance with national regulations. In identifying suspicious cases of malicious responses to drugs, records, surveys, analyses, evaluations and treatment should be made available, and reports are focused on local drug abuse monitoring bodies by 5 the first month of each quarter.
It was found that new or severe adverse responses to medicines should be taken immediately by medical institutions and reported to provincial drug abuse monitoring bodies within 7 days of the discovery, while reporting to provincial, municipal and district food drug surveillance authorities. It is important to report immediately to provincial drug abuse monitoring bodies, while reporting to provincial, municipal and district food drug surveillance authorities.
Article 20 Regulators for food drug control monitoring at all levels, the health administration sector should establish a coordination mechanism to combat the rapeutic, poor medicine to achieve information-sharing.
In granting new medical institutions, the sanitary administrative authorities in the municipalities, districts (markets, districts) should inform the management of the same-level food medicine surveillance, where no district-level food drug control monitoring management is established, and the district-level health administration is informed directly to the municipal food drug surveillance authorities.
Article 21, medical institutions violate the provisions of Articles 5, 7, 8 and 10 of this scheme by the location's food medicine surveillance management to provide warnings and to impose fines of up to €200 million; and by fines of up to $100,000.
Article 22, in violation of article 13 of the present approach, provides that medical treatment is not carried out in the direction of the patient; in violation of articles 18 and 19 of this scheme, the location's food drug surveillance management is fined by more than 1,000 dollars.
In violation of article 17 of this approach, medical institutions use medical operations to advertise drug propaganda or to issue the advertisement of the agents, which is governed by the law.
Article 24 does not have the authorization of the medical agency to use drugs in the name of the medical institution, which is governed by the law by the host health administration, in violation of article 14.
Article 25, in violation of the provisions of this approach, provides that the provisions of the law, regulations, regulations and regulations have been punished and are in accordance with their provisions.
Article 26