The chaos in the medical circle is frequent, and the famous hospitals that are searched out by Baidu will also kill the dead. The drugs used in the hospital treatment will also cause blindness. Even if you walk out of the medical circle, you will find that the disposable chopsticks used are actually medical waste. ......
Oh My God!
I don't understand the world! The hospital that once saved the wounded and injured, and shouldered the expectations of countless people, has now reached a prohibitive level. The medical reforms that have been talked about are always talking about what kind of new heights have been reached, but medical accidents have occurred frequently. And how to solve these chaos in the true sense? On the one hand, it is necessary to rely on the introduction of national policies and regulations, use the rule of law to control the safe export of medical care, and on the other hand, rely on informational means to effectively supervise medical procedures and grasp the pulse of medical safety.
Today's medical care is full of chaos, and it is really worrying for this.
[chaos] two famous top three hospitals - the First Affiliated Hospital of Zhejiang University School of Medicine and the Fudan University Affiliated Tumor Hospital, suspected of fraudulent behavior due to clinical trial data...
The State Food and Drug Administration decided that the drug clinical trial data of the First Affiliated Hospital of Zhejiang University Medical College and the Fudan University Affiliated Tumor Hospital were suspected of fraudulent acts, and were investigated by Zhejiang and Shanghai Food and Drug Administration respectively. The clinical trial data of other drugs undertaken were extended for examination. On the basis of finding out the facts, the State Food and Drug Administration will clarify the responsibilities of the registered applicants, drug clinical trial institutions and relevant personnel of the contract research organization. The relevant responsible persons involved in the medical institutions shall be handled by the health and family planning department and suspected of committing crimes. Transferred to the public security organs. Relevant survey results and handling opinions will be announced separately.
The announcement pointed out that the first hospital affiliated to Zhejiang University Medical College conducted two bioequivalence evaluations of cefuroxime axetil capsules from April to October 2011. The results of the first test were not equivalent, and the results of the second test were Equivalent, the data reported for review uses the results of the second test. The batch number of the test preparation used twice before and after was the same as the drug test report, but the on-site inspection found that the test preparations used twice showed significant differences in appearance and traits. The content of cefuroxime axetil capsules in the Pharmacopoeia of the People's Republic of China was determined on site. The standard was determined to confirm that the ratio of the above two test preparations to the reference preparation content was 85.7% and 100.5%, respectively, and the difference was significant. The test preparations used twice for the bioequivalence test were not true, so the conclusion of the bioequivalence test of the preparation was not reliable.
The prescriptions, drug registration forms and course records of subjects at L052 of Fudan University Affiliated Tumor Hospital showed that the dosage of noratripe hydrochloride for injection in the first and second cycles was 1376.4 mg, and the number of drugs in the drug registration card (4) , 400mg / support) to confirm the data. However, the amount of noratriprol hydrochloride for injection in the first and second cycles of the Case Report Form (CRF) was changed from 1376.4 mg to 6882 mg (the dose prescribed in the test protocol). According to the requirements of the protocol, if the subject's dose is less than 50% of the prescribed dose, the subject is not included in the compliance set.
[Coping method] Hospital management system digital certificate CA certification, hospital information security audit system, hospital intelligent drug management system......
Features: Real-time monitoring of database operation behavior of various accounts of hospital database (such as super administrators, temporary accounts, etc.), accurately discovering various illegal and illegal operations, and timely responding to alarms, reducing database security risks and protecting hospital database assets; Comprehensively record and restore database operation information, provide rich audit information query methods and reports, facilitate security incident location analysis, and trace and collect evidence afterwards; implement the Ministry of Health's "unification" statistical management requirements, and increase the intensity of supervision and inspection.
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