There is a consensus on off-label medication!

　　On August 25, the Shandong Pharmaceutical Association issued the "Shandong Province Expert Consensus on Drugs with Off-label Drugs (2022 Edition)"
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Off- label drug use is common in actual clinical practice, and it is inevitable that off-label drug use in various medical institutions urgently needs standardized management
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In order to further standardize the management of off-label drug use, better assist medical institutions in the province to record off-label use of drugs, and promote rational drug use, the Shandong Provincial Pharmaceutical Association Evidence-Based Pharmacy Professional Committee organized relevant experts to compile the "Shandong Province Off-label Use of Drugs".
The Expert Consensus on Medication (2021 Edition) aims to standardize off-label use of drugs based on sufficient evidence-based medical evidence, strengthen pharmacy supervision and management, reduce the practice risk of medical institutions and medical personnel, and improve the effectiveness and safety of drug treatment.
Provide evidence-based references
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The 2021 version of the "Consensus" is based on unmet clinical needs, according to research evidence, through tables and brief explanations to extract and summarize evidence, quickly evaluate evidence and realize decision-making transformation, and finally collect about 160 varieties and 246 consensus opinions.
, the full content was published in the "Guidelines and Consensus" column of the 6th issue of the "Journal of Clinical Drug Therapy" in 2021, which has a great influence in the industry and is in line with the new "Physician Law" implemented in March 2022.
The relevant laws and regulations on the use of medicines that are not specified in the Physician Law but have evidence-based medical evidence provide important technical support for medical institutions to use off-label drugs after the implementation of the Physician Law
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After a comprehensive evaluation by relevant pharmacy experts and clinical experts, it is recommended to popularize and use it in the whole province.
On January 10, 2022, the Shandong Pharmaceutical Association officially launched the website
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Through a year of practice and feedback, based on clinical needs and actual drug use, the 2022 updated version will be formed after the project expert group has demonstrated
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The new version of the catalog has increased or decreased the 2021 version of the drug varieties, condensed into 156 varieties and 247 recommended opinions, and released them in a list in the form of a catalog (see Appendix 1 to 8 for details) for reference by physicians in medical institutions and pharmacists reviewing prescriptions.

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In clinical practice, medication that is beyond the instructions of the drug should still be managed according to relevant requirements
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Previously (June 28, 2022), the Guangdong Pharmaceutical Association also released the "Catalogue of Drugs Off-label (2022 Edition)", which is the 8th edition since 2015
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Adalimumab, oxaliplatin and other 269 drugs can be used off-label, most of which are related to anti - tumor
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In this year's edition, 37 new medicines were added
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For details, please refer to: "Latest! 269 ​​drugs can be used off-label, adalimumab, oxaliplatin.
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(attached list) "Evidence requirements listed in the Shandong 2022 version of the catalogue ① Drugs are listed in 8 tables according to the subject application field.
Each table is arranged according to the Chinese pinyin of the generic name of the drug, which is convenient for reference and use
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Evidence and data are uniformly searched for newness until December 31, 2020; the evidence listed in the newly added varieties shall be the latest version
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Domestic drug inserts have been included, no reliable evidence has been found, or the latest literature is not recommended for use, and those that are rarely used in clinical practice will be deleted
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②For the collection of foreign drug inserts, check the official websites of various countries, search the Micromedex database, the US Food and Drug Administration (FDA) official website, the Electronic Medicines Compendium (EMC) official website, Yaozhi database and medication assistants Wait
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International/domestic mainstream guideline retrieval International Guideline Collaboration Network, National Guideline Clearinghouse (NGC), National Institute for Health and Clinical Excellence (NICE), Scottish Intercollegiate Guidelines Network ( Scottish Intercollegiate Guidelines Network, SIGN), Yimaitong and Medication Assistant,
etc.
Medical literature retrieval Foreign medical literature database, evidence-based guide network, Chinese medical literature database
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Search the Micromedex database 2.
0 for FDA-unapproved off-label uses, sources of evidence, grades of evidence, and grades of efficacy
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③ The item "Evidence Level and Basis" in the catalog only lists evidence levels 1 to 6.
To simplify the layout, the evidence is arranged from high to low, with no more than three levels at most
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Shandong 2022 Catalogue Evidence Level 1: Inclusion of foreign drug inserts: FDA-approved or European, Japanese and other drug inserts; Level 2: "Chinese Pharmacopoeia Instructions for Clinical Use", "Guidelines for Clinical Application of Drugs" ", "Clinical diagnosis and treatment guidelines" latest edition or "international mainstream guidelines", general higher education undergraduate national planning textbooks (the latest edition of Human Health Publishing House)
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International classic pharmaceutical reference books and reference books such as "Martindale Drug Encyclopedia" and "Fever" can be judged according to specific content; Level 3: The treatment is effective; there is a meta-analysis of randomized controlled trials or multiple well-designed, large-scale randomization Controlled clinical trials, i.
e.
RCT research literature [IBM Micromedex efficacy class I]; Level 4: Evidence of treatment supports efficacy; meta-analysis of randomized controlled trials (conclusions may be controversial), multiple randomized clinical trials [IBM Micromedex efficacy class IIa] ]; Level 5: industry mainstream guidelines/expert consensus; clinical meta, RCT studies and series of cases or case reports (core journals); professional reference books ("Baijia" Publishing House,  medicine and health) [IBM Micromedex Validity Level IIb Grade 6, there may be controversy]; Grade 6: relevant clinical research literature, etc.
(not seen by Micromedex)
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Antibacterial drugs off-label drug list (25 varieties) Pediatric drug off-label drug list (33 varieties) Obstetrics and reproductive drugs off-label drug list (35 varieties) Cardiovascular drug off-label drug list (14 varieties) Psychiatric and neurological drugs off-label drug list (16 varieties) Renal and wind immunity drugs off-label drug list (11 varieties) Antitumor drug off-label drug list (15 varieties) Other drugs beyond the drug label Drug Instructions and Drug List (11 varieties) Drug Cancer Shandong 2022 Catalogue Listed Evidence Requirements Literature Standards Shandong 2022 Catalogue Evidence Grade Medicine