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Class II psychotropic drugs are widely used in the clinical management of special drugs, such as sedatives, hypnotics and anxiolytics barbiturates and benzodiazepines, central stimulant caffeine and so on. These drugs can directly act on the central nervous system, make them excited or inhibited, and have potential dependence and tolerance.

Chinese name: Class II psychotropic drugs

Features: Specially administered drugs

Introduction to Class II Psychotropic Drugs

The State Food and Drug Administration has issued a special notice to strengthen the supervision of the second class of psychotropic drugs. In 2005, the "Regulations on the Administration of Narcotic Drugs and Psychotropic Substances" issued by the State Council and the "Regulations on the Administration of Narcotic Drugs and Psychotropic Drug Prescriptions" issued by the Ministry of Health made some new regulations on the management of second-class psychotropic drugs. In order to strengthen the safety management of such drugs, ensure the rational application of drugs, and prevent the occurrence of malpractice, it is necessary to establish a standardized and effective drug management system in accordance with the requirements of laws and regulations and the use of drugs in medical institutions.

Regulations on the Administration of Second-Class Psychotropic Drugs

1. Class II psychotropic drugs 1. Designated management system.

Medical institutions purchasing second-class psychotropic drugs should be purchased from enterprises with the second-class psychotropic drug approval approved by the drug regulatory authority, and their business scope of the "Drug Business License" should indicate that the use of cash for drug procurement is prohibited. transaction.

2 Catalogue management system for 2 categories of psychotropic drugs 2

In September 2005, the State Food and Drug Administration, the Ministry of Public Security, the Ministry of Health and other departments jointly released a new Catalogue of Psychotropic Drug Varieties, which adjusted some of the drug varieties, of which the second category of psychotropic drugs + / The varieties used are: isoprene barbital, butorphinol and its injections, caffeine, norephedrine, annaka, dezocine and its injections, pentazocine, alprazolam, barbitur , Clozazep, diazepam, eszolam, fluoxazim, gamma hydroxybutyric acid, laurazepam, meprobamate, midazolam, nalbuphine and its injections, nitrazepam, pill Moline, phenobarbital, zolpidem, zaleplon, ergotamine caffeine. In the future, the state will adjust the inventory of drugs that have caused or may cause serious social harm due to abuse.

3. Class II psychotropic drugs 3. Regulations on special prescriptions and dosage.

The second category of special prescriptions for psychotropic drugs is white, and the top right corner of the prescription is marked with "Essence II", which consists of the predecessor, main text, and postscript. The prescription should not exceed 7 days, and the prescription is kept for 2 years for reference.

4. Class II psychotropic drugs 4. Declaration and destruction system.

The expired and damaged medicines shall be registered and registered with the health administrative department for destruction. Medical institutions shall report the purchase, use, and inventory of medicines to the departments of health, drug supervision, and public security every month.

Management history of second-class psychotropic drugs

In 1986, China approved the first compound preparation containing codeine for analgesic treatment. In 1998, when paracetamol and oxycodone were approved to enter the Chinese market, they were administered in accordance with the second category of psychotropic drugs. From July 1, 2004, the country The FDA has adjusted it to prescription drugs for management. The conversion of narcotic drug-containing compound preparations from special drugs to prescription drugs is managed to meet the medical needs of patients for analgesic treatment, but any deviation in circulation and use will cause serious social harm and there is a certain risk.

The 2007 edition of the Narcotic Drugs and Psychotropic Substances Catalogue has adjusted the management categories of some narcotic drugs and psychotropic drug species. Among them, Azu Tablets and Morphine Atropine Injection are included in the management of narcotic drugs. Uniform preparations), Buprenorphine hydrochloride sublingual tablets have been adjusted from the second category of psychotropic drugs to the first category of psychotropic drugs, tramadol (including its salts and unilateral preparations),

From May 1, 2015, according to the relevant regulations of the "Regulations on the Administration of Narcotic Drugs and Psychotropic Substances", the State Food and Drug Administration, the Ministry of Public Security and the National Health and Family Planning Commission decided to take codeine compound oral liquid preparations (including oral solutions) , Syrup) included in the second category of psychotropic drugs management.