呼吸照護藥理學簡介(專業版)

　　

【正文】 New Drug Application)。 與編號 (採用數字 )不同的是 ， 學名是基於藥物的化學結構 ， 如 isoproterenol有isopropyl group連在胺基酸鏈的末端氮上(terminal nitrogen)與商標名 (brand name)不同的是 g e n e r i c n a m e 是非專利名(nonproprietary) Official Name(正式名 ) 當試驗藥品完全通過可做一般用途 ， 且被收錄於美國藥典 國家處方集 (United States p h a rm a co p ei a N a t i o nal Formulary)， 學名就成為正式名 ， 因為正式核可的藥品可能由很多藥廠以不同的名字在市場銷售 ， 建議臨床醫師使用無專利性的正式名 ，而非商標名 。the United States Pharmacopeia (USP) and the National Formulary (NF) were given official status. 1914 The Harrison Narcotic Act is passed to control the importation, sale, and distribution of opium and its derivatives, as well as other narcotic analgesics. 1938 The Food, Drug, and Cosmetic Actbees law. This is the Federal Food, Drug, and Cosmetic Act to protect the pnblic health and protect physicians from irresponsible drug act is enforced by the Food and Drug Administration(FDA). 1952 The DurhamHumphrey Amendment defines the drugs that may sold by the pharmacist only on prescripition. 1962 The KefauverHarris Law is passed as an amendment to the Food, Drug, and Cosmetic Act of act requires proof of safety and efficacy of all drugs introduced since in use before that time have not been reviewed but are under study. 1963 1971 The Controlled Subsances Act bees effective。 案例： 第一級管制藥品： Morphine、 Heroin、 Opium、 Cocaine等 。Investigational New Drug)。 The prescription(處方 ) 處方係指藥物之開立 ， 及關於調劑和服用方式之特別指示 醫師 (physician)， 整骨師 (osteopath)， 牙醫師(dentist)， 獸醫 (veterinarian)可開處方 ， 脊椎指壓治療師 (chiropractors)及驗光師 (opticians)則不可開 。 想要了解藥品相關的資訊可以查詢 【 MIMS臺灣藥品手冊 、 MIMS簡明處方藥典 、 常用藥品手冊 】 等 ，這些收錄臺灣上市藥品的藥品資料 ， 不過內容較為簡略 。 examples: opium, morphine, certain barbiturates Schedule Ⅲ : Prescription must be rewritten after 6 months, or five refills。 二 、 影響精神藥品 。 。了解藥物的藥理作用，對臨床上藥物治療的療效，以及可能產生的副作用，才能充分的掌握。fasttrack B=Modest therapeutic gain C=Important options。 examples: phenobarbital, barbital, chloral hydrate, meprobamate (Equanil, Miltown), and zolpidem (Ambin) Schedule Ⅴ : As for any nonopioid prescription drug。 examples: narcotics contanining nonnarcotics in mixture form, such as cough preparations or Lomotil (diphenoxylate, narcotic with mg and atropine sulfate,nonnarcotic). Rau’ s Respiratory Care Pharmacology. 7th edition, 2023, Mosby 1906 國會通過第一個藥物食品法 。 little or no therapeutic gain Orphan Drugs (孤兒藥 ) 治療罕見疾病之藥 罕見： (.) a. 少於二十萬人或發生率 萬分之五 萬分之五，但不預 期可回收藥物開發之成本 Examples of orphan drugs of interest to respiratory care clinicians showing either a proposed use or an approved use*by the food and Drug Administration DRUG Acetylcysteine α 1 Proteinase inhibitor (Prolastin)* Beractant (Survanta)* Colfosceril palmitate(Exosurf Neonatal)* Cystic fibrosis transmembrane conductance regulator Dornase alfa(Pulmozyme)* Nitric oxide (INOmax) Tobramycin by inhalation (TOBI)* PROPOSED USE IV for moderate to severe acetaminophen overdose Replacement therapy in the α 1 proteinase inhibitor congenital defect Prevention or treatment of RDS in the newborn Prevention or treatment of RDS in the newborn Treatment of cystic fibrosis Reduce mucus viscosity and increase airway secretion clearance in cystic fibrosis Treatment of persistent pulmonary hypertension of the newborn, or acute respiratory distress in adults Treatment of Pseudomonas aeruginosa in cystic in cystic fibrosis or bronchiectasis 臺灣新藥研究發展與核準上市過程 (與美國差不多 ) ，汰選找出具有發展潛力之新化學物質 (NEC。 Thank You For Your Attention！ 謝謝觀看 /歡迎下載 BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES. BY FAITH I BY FAITH 。 ，包括動物體內及動物體外試驗。分為五等級，級數越高，其濫用之 可能性越低，醫療用途越高及成癮性越低 美國藥物管理之發展 第一級 (scheduleⅠ ): 非研究用途皆為非法，如 heroin, marijuana, LSD, peyotemescaline 第二級 (scheduleⅡ ): 不得以電話處方，非經診察不得單純領藥 (refill)，如 :opium, morphine, certain barbituates, amphetamines 第三級 (scheduleⅢ ): 處方在 6個月後需重新開立，或只可單純領藥五