俄亥俄州藥物委員會羥氯喹禁令激民憤 昨日宣佈放棄執行

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新聞簡述:俄亥俄州藥物委員會此前禁止使用氯喹和羥氯喹治療CCP新冠病毒的公告遭到醫護人員和患者群體抗議,迫於壓力和州長的明確要求下,該協會於7月30日宣佈撤銷該規定及相關條例。

Requirements for Dispensing or Selling Chloroquine and Hydroxychloroquine in Ohio

關於羥氯喹在俄亥俄州的出藥和銷售要求

Updated 7/30/2020

更新於7/30/2020

As a result of the feedback received by the medical and patient community and at the request of Governor DeWine, the State of Ohio Board of Pharmacy has withdrawn proposed rule 4729:5-5-21 of the Administrative Code. Therefore, prohibitions on the prescribing of chloroquine and hydroxychloroquine in Ohio for the treatment of COVID-19 will not take effect at this time. This will allow the Board to reexamine the issue with the assistance of the State Medical Board of Ohio, clinical experts, and other stakeholders to determine appropriate next steps. Licensees should be aware that emergency rule 4729-5-30.2 is no longer effective and the requirements of that rule, including the inclusion of a diagnosis code on any prescription for chloroquine and hydroxychloroquine, are no longer applicable

鑒於來自醫護人員和相關患者的反饋 ,並應州長DeWine的要求,俄亥俄州醫藥協會特此撤回擬議條例4729:5-5-21 。由此,禁止在俄亥俄州開處方氯喹和羥氯喹用於治療COVID-19 的規定即日起失效。協會將在俄亥俄州醫學委員會,臨床專家及相關機構和人員的協助下重新審查該條例並確定適當的後續步驟。具醫療資質人員請注意,緊急條例4729-5-30.2不再有效,其規定在任何氯喹和羥基氯喹的處方上注明診斷代碼將不再適用。

閱讀英文公告原文

【附錄:俄亥俄州長DeWine敦促俄亥俄州藥物委員會終止羥氯喹禁令的推特截圖】

【附錄:俄亥俄州藥物委員會此前發佈的限制使用羥氯喹的公告如下】

4729:5-5-21 Prescription requirements for chloroquine and hydroxychloroquine. 

4729:5-5-21氯喹和羥氯喹的處方要求

(A) No prescription for chloroquine or hydroxychloroquine may be dispensed by a pharmacist or sold at retail by a licensed terminal distributor of dangerous drugs, including prescriptions for patients residing in Ohio dispensed or sold at retail by nonresident terminal distributors of dangerous drugs as defined in rule 4729:5-8-01 of the Administrative Code, unless the prescription bears a written diagnosis code from the prescriber or a statement indicating its veterinary medical purpose. 

(A)氯喹或羥氯喹的處方藥將不允許通過藥劑師配給或在有危險藥品特許銷售資質的零售點出售,包括配給俄亥俄州本地居民的或由有危險藥品特許銷售資質的非本地零售點出售的符合第4729:5-8-01號條例定義的處方藥。除非處方上開處方者的書面診斷代碼或聲明為獸醫用。

(B) Except as provided in paragraph (C) of this rule, prescriptions issued for chloroquine or hydroxychloroquine for prophylactic use related to COVID-19 or for the treatment of COVID-19 are strictly prohibited unless otherwise approved by the board’s executive director in consultation with the board president, at which time a resolution shall issue. Upon the effective date of this rule, all previous approvals for the use of chloroquine or hydroxychloroquine shall be deemed void and must be approved using the process outlined in this paragraph. 

(B)除非如條款(C)另有規定,嚴格禁止開具氯喹或羥氯喹作為預防或治療COVID-19相關治療的處方藥,除非經由經董事會執行董事與董事會主席協商同意,屆時將正式決議。在本規定生效後,在此之前所有使用氯喹或羥氯喹的批准均應視為無效,必須按照本條款規定程序進行審批。

(C) The prohibition in paragraph (B) of this rule does not apply to prescriptions issued as part of a documented institutional review board-approved clinical trial to evaluate the safety and efficacy of the drugs to treat COVID-19. Prescriptions must include documentation that the patient is enrolled in a clinical trial. 

(C)條款(B)中的禁令不適用於已獲得機構審查委員會批准的臨床試驗的處方,該處方用於評估治療COVID-19的藥物的安全性和有效性。處方必須包括有關該患者已參加臨床試驗的文件。

(D) Paragraphs (B) and (C) of this rule shall also apply to medication orders and outpatient prescriptions dispensed by institutional pharmacies as defined in agency 4729 of the Administrative Code

4729:5-5-21 2 

(D)條款(B)和(C)也應適用於代理條例第4729條所定義的公共藥房配給的藥品訂單和門診處方藥

4729:5-5-21 2

Replaces: 4729-5-30.2 

替代:4729-5-30.2

Effective: 7/30/2020

生效日期:2020年7月30日

 Five Year Review (FYR) Dates: 07/30/2025

五年審查(FYR)日期:07/30/2025

CERTIFIED ELECTRONICALLY Certification 

07/20/2020 

電子認證日期

07/20/2020 

Date Promulgated Under: 119.03 

頒布日期:119.03

Statutory Authority: 4729.26, 3719.28

法定機構:4729.26,3719.28

 Rule Amplifies: 4729.26, 4729.54, 4729.55 

細則:4722.96、4725.94、4729.55

Prior Effective Dates: 03/22/2020 (Emer.)

先前生效日期:03/22/2020(Emer。)

閱讀此公告英文原文

翻譯:【一花一世界】編輯整理:【Isaiah4031】

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