DOCSLIB.ORG

Summary of APSMI Country Report 2019

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Summary of APSMI Country Report 2019 Summary of APSMI Country Report 2019 0 Contents Introduction…………………………………………………………………………… 2 I. Summary of OTC Regulation in Member Countries………………………. 3 II. Activities to Promote Self-Medication by Member Associations…………11 III. OTC Market in Asia-Pacific Region…………………………………………..23 Annex 1: Dossier Requirements for OTC Registration Annex 2: Rx-to-OTC Switch Products in Member Countries Annex 3: New and Amended Regulation from 2016 to 2019 in Member Countries 1 Introduction Thanks to the contributions by its member associations and magnanimous provision of the market analysis by Nicholas Hall, Asia-Pacific Self-Medication Industry (APSMI) compiled the APSMI Country Report 2019 in October 2019. The Report was published on the occasion of the 12th Global Self-Care Federation Asia-Pacific Regional Conference & 4th APSMI General Assembly held in Beijing, October 2019, made available to the meeting participants and the APSMI members. The Report outlines the OTC regulations and the activities to promote self- medication in APSMI member countries; i.e. China, Chinese Taipei, Indonesia, Japan, Korea, and Thailand. It also includes analyses of global and Asian OTC markets as well national markets in the region. Though the access to the full Report remains to be the members’ privilege, APSMI has decided to publish its summary to the open public. The APSMI sincerely hopes that the information contained in the Summary Report will contribute to the OTC market growth, harmonization of OTC regulation, and promoting self-medication in the region. APSMI Secretariat November 2019 2 I. Summary of OTC regulations in member countries -Notes – The description of each country is simplified for the ease of comparison. 3 1. Category of drugs (OTC and Prescription and others?) China OTC and Rx. Herbal medicines are classified into OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Some are general sales line items. Chinese OTC, RX and Traditional Chinese Drugs. OTCs are Taipei subcategorized into Pharmacy-only and general sales drugs. Indonesia OTC and Rx. Herbal medicines form another category different from OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Some are general sales line items. Japan OTC and Rx. Herbal medicines are classified into OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Korea OTC and Rx. Except for little exception, OTCs are sold only at pharmacies. Philippines OTC and Rx. Herbal medicines form another category. OTCs are sold only at pharmacies. Thailand Rx, Modern OTC, and Traditional OTC. OTCs are subcategorized into drug store-only and general sales drugs. 2. Abridged approval applications (for e.g. OTC with precedents, monograph- compatible OTCs, etc.) China Full application only. There is no difference in required data between Rx and OTC. Chinese Abbreviated applications for switch OTC and monographs- Taipei compatible OTCs Indonesia Abbreviated applications for drugs with precedents. Japan Abbreviated applications for switch OTC and monographs- compatible OTCs Korea Abbreviated applications for switch OTC and monographs- compatible OTCs Philippines Abbreviated applications for switch OTC and monographs- compatible OTCs Thailand No abbreviated application for OTC. OTC applications follow the guidelines for new drugs or generic drugs. 3. Review track /Review department specially for OTCs 4 China The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Chinese The authority has no specially designated review track or review Taipei department for OTC. Approval application for OTC is reviewed not differently from new drugs. Indonesia The authority has specially designated review track and review department for OTC. Japan The authority has specially designated review track and review department for OTC. Korea The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Philippines The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. Thailand The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs. 4. Regulatory permission on Advertisement of OTC to the general public China Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Chinese Need of regulatory permission for advertisement in all media Taipei (TV, Radio, Internet, Printed materials). Indonesia Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Japan No regulatory permission is needed. But the Japanese OTC industry has self-imposed guideline on advertisement as well as a committee to survey member companies’ advertisements as to their adherence to the guidelines and to recommend rectification when there are any violations. Korea Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). Philippines Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). 5 Thailand Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials). 5. Regulatory permission on revising labelling of OTCs China Necessary Chinese Necessary Taipei Indonesia Necessary Japan Necessary, but only for the essential part on the drug’s indication, dosage, and caution on use. Other parts to provide information of more promotional nature can be revised without permission. Korea Necessary Philippines Necessary Thailand Necessary 6. Standards and Guidelines applicable to OTC drugs (1) GMP China GMP applied to OTC is aligned to PIC/S GMP Chinese GMP applied to OTC is aligned to PIC/S GMP Taipei Indonesia GMP applied to OTC is aligned to PIC/S GMP Japan GMP applied to OTC is aligned to PIC/S GMP Korea GMP applied to OTC is aligned to PIC/S GMP Philippines GMP applied to OTC is aligned to PIC/S GMP Thailand GMP applied to OTC is aligned to PIC/S GMP (2) Pharmacopoeia China The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Chinese The authority applies its domestic pharmacopoeia to OTC. Other Taipei countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Indonesia The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. 6 Japan The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Korea The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Philippines The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. Thailand The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees. (3) ICH guidelines applicability i. Q1, 3, 6, 7 China Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Chinese Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally Taipei applicable to both Rx and OTC. Indonesia Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Japan All ICH Q Guidelines are applicable to RX and direct OTC (new chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines. Korea Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Philippines Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC. Thailand Relevant ASEAN guidelines apply. ICH Guidelines are used as reference. Q1 : Stability Q3: Impurities Q6 : Specifications Q7 : GMP for Active Pharmaceutical Ingredients ii. S4 (Chronic Toxicity Testing) 7 China S4 Guideline is applicable to both Rx and OTC. Chinese S4 Guideline is applicable to OTC that is new drugs (direct Taipei OTC). Indonesia S4 Guideline is not applicable to OTC. Japan All ICH S Guidelines are applicable to RX and direct OTC (new chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines. Korea S4 Guideline is applicable to OTC. Philippines S4 Guideline is applicable to OTC. Thailand S4 Guideline is applicable to OTC. iii. E2B, E2D, E6 China E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation. Chinese E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR Taipei reporting, OTC and Rx undergo the same regulation. Indonesia E2D and E6 are all applicable to OTC. Japan E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation. Korea E2B, E2D, E6 are all applicable to Rx and OTC. E2B is partly applicable. Philippines E2B, E2D, E6 are all applicable to Rx and OTC. Thailand E6 Applies to OTC. E2B and E2D are not implemented in Thailand (for Rx or OTC). E2B : Individual Case Safety Reports E2D : Standards for Expedited Reporting E6 : Good Clinical Practice iv. M1 and M4 China Pilot of M1 and China CTD (similar to M4) are implemented. Chinese M1 and M4 are applicable to OTC. Taipei Indonesia M1 and M4 are applicable to OTC. Japan M1 is applicable to both Rx and OTC. M4 is applicable to direct OTC. Other types of OTC are exempted from M4 application. Korea M1 is being applied to OTC in stages. M4 is not applicable to OTC. Philippines M1 is not applicable to OTC. M4 is applicable to OTC. 8 Thailand M1 and M4 are not applicable to OTC.
Load more

Recommended publications
  • Research Article the Protective Effect of Teprenone on Aspirin-Related Gastric Mucosal Injuries
    Hindawi Gastroenterology Research and Practice Volume 2019, Article ID 6532876, 7 pages https://doi.org/10.1155/2019/6532876 Research Article The Protective Effect of Teprenone on Aspirin-Related Gastric Mucosal Injuries Jing Zhao ,1,2 Yihong Fan ,1,2 Wu Ye ,1 Wen Feng ,1 Yue Hu ,1,2 Lijun Cai ,1,2 and Bin Lu 1,2 1Department of Gastroenterology, First Affiliated Hospital of Zhejiang Chinese Medical University, 54 Youdian Road, Hangzhou 310006, China 2Key Laboratory of Digestive Pathophysiology of Zhejiang Province, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China Correspondence should be addressed to Bin Lu; [email protected] Received 16 July 2018; Accepted 28 November 2018; Published 18 June 2019 Academic Editor: Haruhiko Sugimura Copyright © 2019 Jing Zhao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Objective. Aspirin usage is associated with increased risk of gastrointestinal bleeding. The present study explored the potential of teprenone, an antiulcerative, in preventing aspirin-related gastric mucosal injuries. Methods. 280 patients with coronary diseases, naïve to aspirin medication, were admitted between 2011 and 2013 at the First Affiliated Hospital of Zhejiang Chinese Medical University and randomized into two groups (n = 140). The aspirin group received aspirin enteric-coated tablets 100 mg/day, while the aspirin+teprenone group received teprenone 50 mg 3 times/day along with aspirin. The patients were recorded for gastrointestinal symptoms and gastric mucosal injuries during a follow-up period of 12 months with 3-month intervals.
    [Show full text]
  • Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
    Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany).
    [Show full text]
  • Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
    The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11.
    [Show full text]
  • UNIVERSITE DE NANTES Thomas Gelineau
    UNIVERSITE DE NANTES __________ FACULTE DE MEDECINE __________ Année 2011 N° 139 THESE pour le DIPLÔME D’ÉTAT DE DOCTEUR EN MÉDECINE DES de médecine générale par Thomas Gelineau né le 29 janvier 1983 à Cholet __________ Présentée et soutenue publiquement le 06/12/2011 __________ LE RHUME DE L'ENFANT ET SON TRAITEMENT: DECISION PARTAGEE AVEC LES PARENTS D'APRES UN QUESTIONNAIRE __________ Président : Monsieur le Professeur Olivier MALARD Directeur de thèse : Madame le Professeur Jacqueline LACAILLE 1 Table des matières IIntroduction................................................................................................................ 7 IIDéfinition, état des connaissances...........................................................................8 1Le rhume.......................................................................................................................................8 APhysiopathologie............................................................................................................................. 8 aL'origine virale.................................................................................................................................... 8 bLa saisonnalité................................................................................................................................... 8 cL'âge de survenue.............................................................................................................................. 9 dLe sexe..................................................................................................................................................
    [Show full text]
  • Partial Agreement in the Social and Public Health Field
    COUNCIL OF EUROPE COMMITTEE OF MINISTERS (PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD) RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies, and superseding Resolution AP (82) 2) AND APPENDIX I Alphabetical list of medicines adopted by the Public Health Committee (Partial Agreement) updated to 1 July 1988 APPENDIX II Pharmaco-therapeutic classification of medicines appearing in the alphabetical list in Appendix I updated to 1 July 1988 RESOLUTION AP (88) 2 ON THE CLASSIFICATION OF MEDICINES WHICH ARE OBTAINABLE ONLY ON MEDICAL PRESCRIPTION (superseding Resolution AP (82) 2) (Adopted by the Committee of Ministers on 22 September 1988 at the 419th meeting of the Ministers' Deputies) The Representatives on the Committee of Ministers of Belgium, France, the Federal Republic of Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 23 September 1969, 21 April 1988 and 5 May 1964, respectively, Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this
    [Show full text]
  • Aggravation by Paroxetine, a Selective Serotonin Re-Uptake Inhibitor, of Antral Lesions Generated by Nonsteroidal Anti-Inflammatory Drugs in Rats
    JPET Fast Forward. Published on June 24, 2011 as DOI: 10.1124/jpet.111.183293 JPET ThisFast article Forward. has not been Published copyedited andon formatted.June 24, The 2011 final versionas DOI:10.1124/jpet.111.183293 may differ from this version. JPET #183293 . Aggravation by Paroxetine, A Selective Serotonin Re-Uptake Inhibitor, of Antral Lesions Generated by Nonsteroidal Anti-inflammatory Drugs in Rats Downloaded from Koji Takeuchi, Akiko Tanaka, Kazuo Nukui, Azusa Kojo, Melinda Gyenge, and Kikuko Amagase jpet.aspetjournals.org at ASPET Journals on September 25, 2021 Division of Pathological Sciences Department of Pharmacology and Experimental Therapeutics Kyoto Pharmaceutical University Misasagi, Yamashina, Kyoto 607-8414, Japan (K.T., A.T., K.N., A.K., M.G., K.A.) 1 Copyright 2011 by the American Society for Pharmacology and Experimental Therapeutics. JPET Fast Forward. Published on June 24, 2011 as DOI: 10.1124/jpet.111.183293 This article has not been copyedited and formatted. The final version may differ from this version. JPET #183293 . Short title: Aggravation by SSRIs of NSAID-Induced Antral Damage Address correspondence to: Dr. Koji Takeuchi Division of Pathological Sciences Department of Pharmacology and Experimental therapeutics Kyoto Pharmaceutical University Downloaded from Misasagi, Yamashina, Kyoto 607-8414, Japan Tel: (Japan) 075-595-4679; Fax: (Japan) 075-595-4774 E-mail: [email protected] jpet.aspetjournals.org Document statistics: text ------------------------ 21 pages (page 4~page 25) at ASPET Journals on September 25, 2021 figures ----------------------- 10 figures references ----------------------- 43 references (page 27~page 31) Number of words: abstract ----------------------- 247 introduction ----------------------- 410 discussion -----------------------1685 Recommended section: Gastrointestinal, Hepatic, Pulmonary, & Renal 2 JPET Fast Forward.
    [Show full text]
  • Elecampane/Eprazinone Hydrochloride 1559
    Elecampane/Eprazinone Hydrochloride 1559 Adverse effects from ingestion of ephedrine-containing OTC pha- and beta-adrenergic activity and has pronounced Micturition disorders. Ephedrine salts have been used in noc- preparations, including herbal products (usually in high doses stimulating effects on the CNS. It has a more pro- turnal enuresis, although other treatments are usually preferred, and/or long term) have included coronary artery thrombosis,10 and have been tried in patients with stress incontinence but the myocardial infarction, seizures,11 psychotic reactions,12 nephro- longed though less potent action than adrenaline. In value of such treatment is not clear. lithiasis,13-15 and myocarditis;16 a number of fatalities have been therapeutic doses it raises the blood pressure by in- reported. Frank dependence has been reported in female weight- creasing cardiac output and also by inducing peripheral Spinal anaesthesia. Parenteral sympathomimetics such as lifters following long-term use of high doses.17 ephedrine and phenylephrine have been advocated for the cor- vasoconstriction. Tachycardia may occur but is less rection of hypotension associated with local anaesthesia. The For a report of urinary calculi developing in a patient who had frequent than with adrenaline. Ephedrine also causes risk of hypotension with spinal or epidural block is greater than ingested a preparation containing guaifenesin and ephedrine, see bronchodilatation, reduces intestinal tone and motility, many other forms of nerve block (see Adverse Effects of Central Abuse, under Guaifenesin, p.1561. 1,2 relaxes the bladder wall while contracting the sphincter Block, p.1850). Ephedrine has been used although not always 1. WHO. Recommendations from the Expert Committee on Drug 3 muscle but relaxes the detrusor muscle of the bladder successfully for the correction of such hypotension.
    [Show full text]
  • Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
    MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01
    [Show full text]
  • Use of Antitussives After the Initiation of Angiotensin-Converting Enzyme Inhibitors
    저작자표시-비영리-변경금지 2.0 대한민국 이용자는 아래의 조건을 따르는 경우에 한하여 자유롭게 l 이 저작물을 복제, 배포, 전송, 전시, 공연 및 방송할 수 있습니다. 다음과 같은 조건을 따라야 합니다: 저작자표시. 귀하는 원저작자를 표시하여야 합니다. 비영리. 귀하는 이 저작물을 영리 목적으로 이용할 수 없습니다. 변경금지. 귀하는 이 저작물을 개작, 변형 또는 가공할 수 없습니다. l 귀하는, 이 저작물의 재이용이나 배포의 경우, 이 저작물에 적용된 이용허락조건 을 명확하게 나타내어야 합니다. l 저작권자로부터 별도의 허가를 받으면 이러한 조건들은 적용되지 않습니다. 저작권법에 따른 이용자의 권리는 위의 내용에 의하여 영향을 받지 않습니다. 이것은 이용허락규약(Legal Code)을 이해하기 쉽게 요약한 것입니다. Disclaimer 약학 석사학위 논문 안지오텐신 전환 효소 억제제 개시 이후 진해제의 사용 분석 Use of Antitussives After the Initiation of Angiotensin-Converting Enzyme Inhibitors 2017년 8월 서울대학교 대학원 약학과 사회약학전공 권 익 태 안지오텐신 전환 효소 억제제 개시 이후 진해제의 사용 분석 Use of Antitussives After the Initiation of Angiotensin-Converting Enzyme Inhibitors 지도교수 홍 송 희 이 논문을 권익태 석사학위논문으로 제출함 2017년 4월 서울대학교 대학원 약학과 사회약학전공 권 익 태 권익태의 석사학위논문을 인준함 2017년 6월 위 원 장 (인) 부 위 원 장 (인) 위 원 (인) Abstract Use of Antitussives After the Initiation of Angiotensin-Converting Enzyme Inhibitors Ik Tae Kwon Department of Social Pharmacy College of Pharmacy, Seoul National University Background Angiotensin-converting enzyme inhibitors (ACEI) can induce a dry cough, more frequently among Asians. If healthcare professionals fail to detect coughs induced by an ACEI, patients are at risk of getting antitussives inappropriately instead of discontinuing ACEI. The purpose of this study was to examine how the initiation of ACEI affects the likelihood of antitussive uses compared with the initiation of Angiotensin Receptor Blocker (ARB) and to determine the effect of the antitussive use on the duration and adherence of therapy in a Korean population.
    [Show full text]
  • General Pharmacology
    GENERAL PHARMACOLOGY Winners of “Nobel” prize for their contribution to pharmacology Year Name Contribution 1923 Frederick Banting Discovery of insulin John McLeod 1939 Gerhard Domagk Discovery of antibacterial effects of prontosil 1945 Sir Alexander Fleming Discovery of penicillin & its purification Ernst Boris Chain Sir Howard Walter Florey 1952 Selman Abraham Waksman Discovery of streptomycin 1982 Sir John R.Vane Discovery of prostaglandins 1999 Alfred G.Gilman Discovery of G proteins & their role in signal transduction in cells Martin Rodbell 1999 Arvid Carlson Discovery that dopamine is neurotransmitter in the brain whose depletion leads to symptoms of Parkinson’s disease Drug nomenclature: i. Chemical name ii. Non-proprietary name iii. Proprietary (Brand) name Source of drugs: Natural – plant /animal derivatives Synthetic/semisynthetic Plant Part Drug obtained Pilocarpus microphyllus Leaflets Pilocarpine Atropa belladonna Atropine Datura stramonium Physostigma venenosum dried, ripe seed Physostigmine Ephedra vulgaris Ephedrine Digitalis lanata Digoxin Strychnos toxifera Curare group of drugs Chondrodendron tomentosum Cannabis indica (Marijuana) Various parts are used ∆9Tetrahydrocannabinol (THC) Bhang - the dried leaves Ganja - the dried female inflorescence Charas- is the dried resinous extract from the flowering tops & leaves Papaver somniferum, P album Poppy seed pod/ Capsule Natural opiates such as morphine, codeine, thebaine Cinchona bark Quinine Vinca rosea periwinkle plant Vinca alkaloids Podophyllum peltatum the mayapple
    [Show full text]
  • Elif Fatma Sen BW.Indd
    Use and Safety of Respiratory Medicines in Children E. F. Şen EEliflif FFatmaatma SSenen BBW.inddW.indd 1 003-01-113-01-11 115:175:17 The work presented in this thesis was conducted at the Department of Medical Informatics of the Erasmus University Medical Center, Rotterdam. The research reported in thesis was funded by the European Community’s 6th Framework Programme. Project number LSHB-CT-2005-005216: TEDDY: Task force in Europe for Drug Development for the Young. The contributions of the participating primary care physicians in the IPCI, Pedianet and IMS-DA project are greatly acknowledged. Financial support for printing this thesis was kindly provided by the department of Medical Informatics – Integrated Primary Care Information (IPCI) project of the Erasmus University Medi- cal Center; and by the J.E. Jurriaanse Stichting in Rotterdam. Cover: Optima Grafi sche Communicatie Printed by: Optima Grafi sche Communicatie Elif Fatma Şen Use and Safety of Respiratory medicines in Children ISBN: 978-94-6169-003-6 © E.F. Şen, Rotterdam, the Netherlands, 2011. All rights reserved. No part of this thesis may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, without prior written permission of the holder of the copyright. EEliflif FFatmaatma SSenen BBW.inddW.indd 2 003-01-113-01-11 115:175:17 Use and Safety of Respiratory Medicines in Children Het gebruik en de bijwerkingen van respiratoire medicijnen in kinderen Proefschrift Ter verkrijging van de graad van doctor aan de Erasmus Universiteit Rotterdam op gezag van de rector magnifi cus Prof.dr.
    [Show full text]
  • Jp Xvii the Japanese Pharmacopoeia
    JP XVII THE JAPANESE PHARMACOPOEIA SEVENTEENTH EDITION Official from April 1, 2016 English Version THE MINISTRY OF HEALTH, LABOUR AND WELFARE Notice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic. The Ministry of Health, Labour and Welfare Ministerial Notification No. 64 Pursuant to Paragraph 1, Article 41 of the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia (Ministerial Notification No. 65, 2011), which has been established as follows*, shall be applied on April 1, 2016. However, in the case of drugs which are listed in the Pharmacopoeia (hereinafter referred to as ``previ- ous Pharmacopoeia'') [limited to those listed in the Japanese Pharmacopoeia whose standards are changed in accordance with this notification (hereinafter referred to as ``new Pharmacopoeia'')] and have been approved as of April 1, 2016 as prescribed under Paragraph 1, Article 14 of the same law [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of March 31, 2016 as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the Same Law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the new Pharmacopoeia before and on September 30, 2017.
    [Show full text]