Medical network - on September 18, recently, liaoning, sichuan, fujian provinces of 17 pharmaceutical trading enterprises to "fly", among them, the four companies GSP certificate has been revoked, 12 were asked to make correction; Hainan, guangxi, xinjiang and other provinces and cities to clinic drugstore for centralized drug quality and safety regulation, integration of urban and rural areas and rural areas is the key, check several pharmacies and clinics was sent, details are as follows:
Liaoning: "flying inspection" 14 pharmaceutical wholesale enterprises
Recently, the food and drug administration of liaoning province announced the results of the flight inspection of 14 wholesale drug companies. The details are as follows:
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企業(yè)名稱
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發(fā)現(xiàn)的主要問題
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處理措施
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A
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1.企業(yè)涉嫌虛構(gòu)藥品銷售流向
2.企業(yè)部分經(jīng)營數(shù)據(jù)未納入計(jì)算機(jī)系統(tǒng)管理，經(jīng)營行為無法追溯。
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撤銷GSP證書
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B
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1.企業(yè)2015年4月15日變更法定代表人、企業(yè)負(fù)責(zé)人，但未進(jìn)行專項(xiàng)內(nèi)審。
2.企業(yè)留存的上游供貨商江西濟(jì)華醫(yī)藥有限公司銷售人員法人授權(quán)委托書未標(biāo)明授權(quán)區(qū)域。
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整改
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C
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1.企業(yè)2016年4月17日變更倉庫地址，但未進(jìn)行專項(xiàng)內(nèi)審。
2.現(xiàn)場檢查時(shí)中藥飲片庫溫濕度均超標(biāo)（濕度為82.7%、溫度為25.4℃），保管員未進(jìn)行有效調(diào)控。
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整改
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D
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1.驗(yàn)收員金鳳波兼職采購員。
2.部分藥品不符合該品種的貯存要求,企業(yè)未拒收。
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整改
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E
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1.16號溫濕度監(jiān)測終端人工干預(yù)超溫至32℃，無聲光報(bào)警及短信報(bào)警。
2.庫房濕度超標(biāo)，養(yǎng)護(hù)員未及時(shí)采取有效的調(diào)控措施。
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根據(jù)對問題核查的結(jié)果作出最終處理決定。
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F
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相關(guān)人員未按藥品溫濕度監(jiān)控系統(tǒng)管理規(guī)定進(jìn)行及時(shí)調(diào)查、有效調(diào)控。溫濕度探頭（陰涼庫1）聲光報(bào)警后，企業(yè)人員未接收到報(bào)警短信。
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整改
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G
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企業(yè)2017年7月10日銷售紅霉素腸溶膠囊（數(shù)量：300盒，批號：161250）隨貨同行單未加蓋藥品出庫專用章。
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整改
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H
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企業(yè)未及時(shí)更新個(gè)別供貨單位印章樣式。
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整改
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I
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企業(yè)未及時(shí)更新個(gè)別供貨單位印章樣式。
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整改
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J
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企業(yè)銷售國家有專門管理要求的藥品時(shí)，未對藥品向下游企業(yè)銷售情況進(jìn)行有效管控。
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整改
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K
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1.企業(yè)計(jì)算機(jī)系統(tǒng)不能對超出診療范圍的下游客戶進(jìn)行銷售管控。
2.企業(yè)未對購貨單位的相關(guān)證明文件進(jìn)行核實(shí)，不能保證藥品銷售流向真實(shí)、合法。
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整改
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L
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1.企業(yè)運(yùn)輸冷鏈藥品的運(yùn)輸記錄隨意涂改。
2.企業(yè)計(jì)算機(jī)系統(tǒng)不能自動(dòng)生成藥品運(yùn)輸記錄。
3.企業(yè)未按照收貨管理程序?qū)徣胨幤返碾S貨同行單與留存樣式進(jìn)行核對。
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整改
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M
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企業(yè)經(jīng)營中藥飲片，但配備驗(yàn)收員李欣專業(yè)為藥學(xué)專業(yè)，也無中藥學(xué)專業(yè)技術(shù)職稱。
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整改
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N
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1.企業(yè)2017年1月至今計(jì)算機(jī)管理系統(tǒng)退貨藥品未形成銷售退回驗(yàn)收記錄。
2.企業(yè)陰涼庫7號表模擬溫度超標(biāo)，無就地聲光報(bào)警功能。
3.2016年1月16日、2016年4月4日分別入庫20盒復(fù)方氨基酸注射液，計(jì)算機(jī)系統(tǒng)中進(jìn)貨采購人均為“無”，未自動(dòng)生成采購人員。
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整改
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Hainan: sanya inspects the pharmacy clinic 64
Recently, sanya, according to the food and drug administration announced since July this year, the bureau of sanya urban-rural fringe and pharmacy clinics in rural areas for centralized drug quality and safety regulation, so far, a total of check pharmacies 39, clinic, 25, 51 issued a rectification notice, warning 18, 7 fine on the spot, case 4 cases, 1 cases adjudicated, FaMeiKuan totaling 7900 yuan.
Regulation: mainly through self-inspection and special inspection. Organization retail pharmacies and clinics for since January 1, 2016 drugs purchase channels, storage conditions and pharmaceutical care checking etc., on the problems existing in the rectification, form the comprehensive rectification report; Special inspection through adopts the method of divided area of responsibility to the people, giving play to the role of grass-roots accesses and coordinator, and more to the villages and towns market, pharmaceutical trading enterprises and medical organizations of supervision and inspection and dynamic monitoring.
Check key: antibiotics, Chinese medicine yinpian, precursor drugs, including special drugs compound preparations, biological products, human assisted reproductive technology commonly used drugs, illegal medical hairdressing drugs and devices, and treatment of sexual dysfunction, rheumatism arthritis pain, cervical spondylosis, lumbar disease, high blood pressure, diabetes and other chronic diseases commonly used drugs.
Main random drug purchase, acceptance record, monitoring the supply unit legal qualification, check its purchase channels is lawful, of dubious quality, source of drugs targeted of proper supervision, timely discover and investigate to produce fake and inferior drugs illegal.
Sichuan: panzhihua 1 pharmacy GSP certificate has been revoked
Recently, panzhihua. 1 food and drug administration for pharmacy flight check, found that there is a serious violation of the drug supply quality management norms "(GSP) behavior, decided to cancel the pharmacy drugs management quality management standard certification.
Guangxi: the quality and safety of pharmaceutical products carried out by wule food medicine
In order to thoroughly check the drug quality and safety hazards of drug stores and clinics in rural areas, regulate drug circulation order. Since July, the wule food and drug administration has organized and urged three pharmacies and 9 clinics in the area to conduct self-examination on the purchase, sale and use of drugs. Currently, it has recovered 11 copies of the self-report. According to various drug stores and clinics, in August, the drug control group organized the drug quality safety centralized operation. As of now, there are 3 pharmacies, 1 health clinic and 9 clinics.
Discovery of problems:
Some pharmacies have not been approved by licensed pharmacists to sell prescription drugs;
Do not ask for purchase invoices when purchasing drugs;
The drug is not strictly stored according to the storage requirements of the drug.
The result: the law enforcement personnel issued "notice of correction" on the spot, required the party to rectify and submit the rectification report and rectification photos within a time limit.
The next step will be to further expand the scope of the treatment to ensure the safety of people's drug use.
Xinjiang: aksu district carries out pharmacy drug quality safety centralized control
Food drug administration announced recently, aksu region, on September 11 - December 31, in the aksu area (county) city drugstores to carry out the centralized drug quality and safety regulation, to investigate and punish drug sales using link violation behavior, and ensure the safe and effective.
Key points:
Whether the pharmacist in the pharmacy is on duty;
Whether prescription drugs are sold by prescription;
According to the seasonal temperature change and whether to take necessary heat preservation or refrigeration measures;
The problems of drug and non-medicine, drug administration and drug administration, and the separation of drugs and general medicine.
Law enforcement officials require the drugstores to conscientiously do their own research, implement effective rectification measures, eliminate safety hazards and ensure drug market safety.
Fujian: the GSP certificate of 2 enterprises in xiamen was revoked
Recently, the fujian xiamen food, according to the food and drug administration announced to flight check of two pharmaceutical trading enterprises, two business a serious breach of drug quality management standard, decided to withdraw the drug supply quality management standard certification certificate.
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