加拿大指南要求納洛酮套組中包含注射、鼻噴霧劑
Kerry Dooley Young / 2023 年 8 月 29 日 / Medscape 醫學新聞
根據一項新指南，用於治療阿片類藥物過量的帶回家的納洛酮 (naloxone ) 試劑盒應在可能的情況下提供救生藥物的肌內和鼻內製劑。
該文件還呼籲訓練有素的應急人員提供人工呼吸，作為緊急情況應急的一部分。 最後，它建議將帶回家的納洛酮套件包裝為可識別的手提箱、呼吸面罩、非乳膠手套、如何服用納洛酮的說明、納洛酮以及如何使用納洛酮等用品。 試劑盒應包含三個或更多 0.4 毫克/毫升納洛酮安瓿或小瓶，它說，這取決於社區解決非法製造芬太尼和其他強效合成阿片類藥物的需要。
新指南於 8 月 28 日在線發表在《加拿大醫學會雜誌》上。
中毒死亡人數增加
據加拿大公共衛生局稱，去年加拿大共有 7,328 人因阿片類藥物中毒死亡，平均每天有 20 人死亡。 在 COVID-19 大流行之前，平均每天死亡人數為 10 人。
簡·巴克斯頓博士
指南作者、不列顛哥倫比亞省疾病控制中心前減害主管、MBBS 簡·巴克斯頓(Jane Buxton) 告訴Medscape 醫學新聞，自2016 年以來，不受監管的藥物市場中芬太尼 (fentanyl) 和苯二氮卓類(benzodiazepines) 等其他物質的數量有所增加。 人們往往不知道他們購買的藥物含有這些化合物，這使他們面臨更大的傷害風險。 「這些物質的毒性已經變得多麼可怕」，她說。
在加拿大健康研究所的資助下，納洛酮指南制定小組為開發、資助或監督帶回家的納洛酮計畫的人員起草了國家指南。 作者寫道，公共衛生工作者、分發地點和社區藥物過量反應人員也可能會對這份文件感興趣。
除了公共衛生專業人員、學者和臨床醫生之外，納洛酮指導制定小組還包括在藥物使用和過量反應方面具有經驗的人員。 該小組進行了系統審查，以識別和考慮所有類型文獻中發表的證據。 在起草建議時，它還考慮了社區的專業知識。 該小組要求透過外部審查委員會和公眾意見對其建議草案提供反饋。
新指南關於裝備和救援呼吸的建議被歸類為「強」，這意味著它們可以在大多數情況或地區作為政策進行調整。
但有關提供納洛酮噴霧劑和注射劑的建議被認為是「有條件的」，這意味著作者預計其採用將「需要在許多感興趣的團體中進行實質性辯論」。
作者指出，納洛酮噴霧劑的高成本可能是其納入家庭套件的障礙。 在研究過程中，他們發現噴霧劑的成本可能是同等肌肉注射製劑成本的 10 倍。 因此，作者寫道，提供兩種形式的納洛酮在經濟上可能並不總是可行。
真實世界的體驗
幾位作者強烈傾向於肌肉注射納洛酮，因為擔心鼻內製劑會引發戒斷反應。 參與者還指出了納洛酮注射液的缺點，包括擔心在給藥時被破碎的小瓶或安瓿割傷。 然而，大多數使用阿片類藥物的人更喜歡鼻內噴射納洛酮。
指導意見稱，生活貧困的人有時會因藥品供應污染或凍傷而失去手指甚至雙手，這使得他們難以進行注射。
寒冷的天氣還帶來了其他挑戰。 例如，針可能無法穿透衣服層，並且去除衣服層可能很困難或不安全。 指導意見稱，「諮詢會議的參與者報告說，他們的手在寒冷中變得麻木，使得肌肉注射變得困難」。
巴克斯頓說，這些關於納洛酮的第一手資料對於制定建議至關重要。 在評估納洛酮的使用時，研究人員無法查看其他醫學領域常規進行的研究結果。
她說，在現場進行臨床試驗來比較患者對納洛酮注射劑和鼻噴霧劑的反應是不可行的。 「文獻中並沒有太多內容能夠真正展示過去十年左右從事這項工作的數千人的經歷」。
一個醫療問題
埃德蒙頓阿爾伯塔大學的成癮專家S. Monty Ghosh（醫學博士、公共衛生碩士）在評論Medscape 的指南時表示，該指南在CMAJ 等著名期刊上的發表傳達了一個強烈的信息，即需要為經歷阿片類藥物過量人們提供納洛酮。 「它將其視為一個醫療問題，而不是一個道德問題」，他說。 Ghosh沒有參與該指南的起草。
Ghosh幫助建立了卡爾加里的快速成癮醫學計畫，這是該省最大的也是第一個綜合門診成癮治療計畫。
他對制定指南所採取的方法表示讚賞。
「他們認識到，我們使用納洛酮進行的絕大多數藥物過量反應實際上並不是由臨床醫生完成的」，Ghosh說。 「這是由社區成員和吸毒者完成的」。
加拿大衛生研究院 (The Canadian Institutes of Health Research ,CIHR) 的加拿大藥物濫用研究計畫阿片類藥物干預和服務實施科學計劃畫助了該指南。 巴克斯頓獲得了加拿大藥物濫用研究計畫的 CIHR 資助，用於由成癮和心理健康中心監督和管理的工作，以支持該指南。Ghosh 沒有透露任何相關的財務關係。
CMAJ。 2023 年 8 月 28 日在線發布。
克里·杜利·楊 (Kerry Dooley Young) 是駐華盛頓特區的自由記者。
引用此內容：加拿大指南要求注射納洛酮套件中的鼻噴霧劑 – Medscape – 2023 年 8 月 29 日。
Canadian Guidelines Call for Shots, Nasal Spray in Naloxone Kits
Kerry Dooley Young / August 29, 2023 / Medscape Medical News
Take-home naloxone kits for treating opioid overdoses should, where possible, offer intramuscular and intranasal formulations of the lifesaving drug, according to a new guidance.
The document also calls for trained responders to provide rescue breathing as part of the response to the emergency. Finally, it recommends packaging take-home naloxone kits with a recognizable carrying case, breathing mask, non-latex gloves, instructions on how to administer naloxone, naloxone, and supplies to administer naloxone. Kits should contain three or more 0.4-mg/mL naloxone ampoules or vials, it says, depending on the community’s need to address illicitly manufactured fentanyl and other potent synthetic opioids.
The new guidelines were published online August 28 in the Canadian Medical Association Journal.
Toxicity Deaths Increased
A total of 7328 apparent opioid toxicity deaths occurred in Canada last year, which comes to an average of 20 deaths per day, according to the Public Health Agency of Canada. Before the COVID-19 pandemic, the average number of deaths per day was 10.
Dr Jane Buxton
Since 2016, the amount of fentanyl and other substances such as benzodiazepines in the unregulated drug market has increased, guideline author Jane Buxton, MBBS, former harm reduction lead at the British Columbia Centre for Disease Control, told Medscape Medical News. People are often unaware that the drugs they are purchasing contain these compounds, which put them at greater risk for harm. “It’s just horrific how toxic these substances have become,” she said.
With funding from the Canadian Institutes of Health Research, the Naloxone Guidance Development Group drafted national guidance for people who develop, fund, or oversee take-home naloxone programs. The document may also be of interest to public health workers, distribution sites, and community overdose responders, the authors write.
In addition to public health professionals, academics, and clinicians, the Naloxone Guidance Development Group included people with experience in drug use and response to overdose. The group conducted systematic reviews to identify and consider evidence published in all types of literature. It also considered community expertise as it drafted its recommendations. The group requested feedback on its draft recommendations through an external review committee and public input.
The new guidelines’ recommendations on kit equipment and rescue breathing were classified as “strong,” meaning that they can be adapted as policy in most situations or regions.
But the recommendation about providing both naloxone spray and injection was deemed “conditional,” meaning that the authors anticipate that its adoption would “require substantial debate” among many interested groups.
The authors note that the high cost of naloxone spray may be a barrier to its inclusion in take-home kits. During their research, they found that the cost of the spray could be 10 times the cost of the equivalent intramuscular formulation. Thus, it may not always be financially feasible to offer both forms of naloxone, the authors write.
Real-World Experience
Several of the authors strongly prefer intramuscular naloxone because of concerns about withdrawal precipitated by the intranasal formulation. Participants also noted drawbacks to naloxone injections, including concerns about being cut by broken vials or ampoules while administering the drug. Yet most people who use opioids prefer to administer intranasal naloxone.
People who live in poverty sometimes have lost fingers and even hands to infections arising from contamination of drug supply or frostbite, making it difficult for them to administer shots, according to the guidance.
Cold weather poses other challenges as well. For example, needles may not be able to penetrate through layers of clothing, and it may be difficult or unsafe to remove layers. “Consultation-session participants reported that their hands become numb in the cold, making intramuscular administration difficult,” according to the guidance.
These kinds of firsthand insights about naloxone were critical to developing recommendations, said Buxton. In assessing naloxone use, researchers can’t look at the results of studies that are conducted routinely in other fields of medicine.
Conducting a clinical trial in the field to compare patients’ responses to naloxone injections and nasal spray is not feasible, she said. “There’s not much in the literature that actually shows what the thousands of people who have been doing this for the last 10 or so years have experienced.”
A Medical Problem
Commenting on the guidance for Medscape, S. Monty Ghosh, MD, MPH, an addiction specialist at the University of Alberta in Edmonton, said that its publication in a prominent journal such as CMAJ sends a strong message about the need to provide naloxone for people experiencing opioid overdoses. “It frames it as a medical problem, not as a moral problem,” he said. Ghosh was not involved in drafting the guidance.
Ghosh helped establish Calgary’s Rapid Access Addiction Medicine program, the province’s largest and first comprehensive outpatient addiction treatment program.
He applauded the approach taken in developing the guidelines.
“They recognize that the vast majority of our overdose response using naloxone is not actually done by clinicians,” Ghosh said. “It’s done by community members and people who use substances.”
The Canadian Institutes of Health Research (CIHR) for the Canadian Research Initiative in Substance Misuse Implementation Science Program on Opioid Interventions and Services funded the guidance. Buxton received a CIHR grant to the Canadian Research Initiative in Substance Misuse for the work overseen and managed by the Centre for Addictions and Mental Health in support of the guidance. Ghosh has disclosed no relevant financial relationships.
CMAJ. Published online August 28, 2023.
Kerry Dooley Young is a freelance journalist based in Washington, DC. Follow her on Mastodon and Threads as @kerrydooleyyoung and at BlueSky @kdooleyyoung.bsky.social.
Cite this: Canadian Guidelines Call for Shots, Nasal Spray in Naloxone Kits – Medscape – Aug 29, 2023.