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研究生: 曾詠新
Tseng, Yung-Hsin
論文名稱: 風險溝通之手機應用程式的可行性及可用性之初探性研究
A pilot study of feasibility and usability of mobile application for risk communication
指導教授: 高雅慧
Yang, Yea-Huei Kao
鄭靜蘭
Cheng, Ching-Lan
學位類別: 碩士
Master
系所名稱: 醫學院 - 臨床藥學與藥物科技研究所
Institute of Clinical Pharmacy and Pharmaceutical sciences
論文出版年: 2017
畢業學年度: 105
語文別: 中文
論文頁數: 131
中文關鍵詞: 風險溝通手機應用程式藥物安全資訊資訊傳遞
外文關鍵詞: risk communication, mobile application, drug safety information, information dissemination
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  • 研究背景
    國家衛生主管單位為確保上市後藥物使用的安全,建立了風險管理的機制,如進行風險溝通和建置藥物不良反應通報系統。其中風險溝通是減緩風險以及使風險最小化的重要措施。而根據過去的研究顯示,國家衛生主管單位針對醫療人員進行風險溝通後,不一定會達到預期的效果,其中風險溝通的方式和媒介皆可能是造成效果未如預期的影響因子。
    在現今藥物安全資訊數量龐大、獲得訊息管道多元化及資訊傳播速度愈趨快速,醫療人員可能出現資訊過載(information overload)的情形,使醫療人員難以更新並聚焦在重要的藥物安全資訊。如能建置有效的整合平台,提供即時且符合所需的藥物安全資訊,將可使資訊的傳遞更有效率。因此,本研究擬開發能夠傳遞即時藥物安全資訊且提供訂閱功能之手機應用程式(mobile application;APP),並對手機應用程式之可行性及可用性進行研究與探討。

    研究目的
    1.利用問卷調查醫療人員獲知藥物安全資訊與藥物不良反應通報的現況。
    2.建置風險溝通之手機應用程式並分析其可用性。

    研究方法
    1.問卷由研究人員及專家學者共同設計並執行專家效度的測試。調查對象則是依照研究目的針對「焦點團體」,包含公、私立醫療院所、社區藥局之醫療人員,藉由發送紙本問卷的方式提供問卷填寫。
    2.手機應用程式與國立成功大學資訊工程研究所共同開發。第一版建置於Android系統,於國立成功大學附設醫院內科會議推廣使用,並蒐集使用者數據及使用者回饋意見,經過彙整分析後,進一步對手機應用程式進行優化及改版。

    研究結果
    1.醫療人員合計回覆282份有效問卷(藥師195份、醫師54份、護理師33份)。雖然90%左右的醫療人員認為藥物安全資訊對臨床照護有其重要性,但是高達70%-90%並未收到台灣食品藥物管理署(TFDA)發佈的重要藥物安全資訊。而醫療人員對利用手機應用程式接收藥物安全資訊的意願,約85%-95%表示願意或非常願意。
    2.第一版手機應用程式於成大醫院推廣後至2017年4月底為止,平均安裝的裝置數約為52部,累計安裝應用程式使用者人數為93人,累計解除應用程式使用者人數為42人,整體解除安裝率為45.2%。而根據使用者意見回饋,第二版手機應用程式針對「修正藥物類別訂閱之資訊遺漏」、「優化訂閱搜尋功能」、「新增iOS系統」以及「優化藥物安全資訊傳遞效能」等項目執行改進。

    結論
    本研究發現,就現行之風險溝通方式而言,對醫療人員的效果不佳,應運用資訊科技促使更有效而即時的溝通模式。本研究之手機應用程式蒐集各國衛生主管單位最新之藥物安全資訊,同時具備訂閱之功能,有利於使用者獲取即時、精確且重要的藥物安全資訊。而藉由推廣、蒐集使用者意見回饋、優化與改版的過程,能使手機應用程式有更佳的可用性。

    Risk communication and adverse drug reaction reporting are major strategies employed in the risk management of post-market pharmaceutical products. However, previous studies revealed that risk communication to health care providers did not always achieve the intended effects. Therefore, we developed a mobile application(APP) for risk communication, which could provide up-to-date drug safety information as needed. Meanwhile, the feasibility and usability of mobile application were also assessed by questionnaire, user data, and users’ feedback.
    The result revealed most of the health care providers acknowledged the importance of safety information, but they did not receive the information delivered directly from Taiwan Food and Drug Administration (TFDA). Besides, most of the health care providers were willing to use mobile application for receiving drug safety information. It is suggested to improve the efficiency of risk communication and construct mobile application of information technology, since the current media did not deliver safety information effectively. The mobile application developed in our study collected the timely drug safety information from health authorities, and the users could receive immediate, accurate and important drug safety information via “Subscribe” function. Moreover, by the process of promoting, collecting user feedback, modifying and updating the mobile application, the usability of mobile application could be improved.

    摘要 I Extended abstract III 誌謝 VI 目錄 VII 表目錄 X 圖目錄 XI 第一篇 風險溝通之手機應用程式的可行性及可用性之初探性研究 1 第一章 研究背景 1 第二章 文獻回顧 3 第一節 治療風險管理 3 第二節 風險溝通 3 2.1 風險溝通的定義 3 2.2 風險溝通的職責與對象 4 2.3 風險溝通的重要性 5 2.4 風險溝通的方式 6 2.5 風險溝通的媒介 11 2.6 風險溝通的有效性 11 2.7 醫療人員對風險溝通的認知與需求 15 第三節 風險溝通之手機應用程式 18 3.1 手機應用程式於醫療人員之接受度 18 3.2 現行風險溝通之手機應用程式 19 第三章 研究目的 20 第四章 研究材料與方法 21 第一部分 醫療人員獲知藥物安全資訊與不良反應通報現況之問卷調查 21 第一節 研究設計 21 1.1 研究類型 21 1.2 研究時間 21 1.3 研究對象 21 1.4 收樣方法 21 第二節 研究架構與流程 22 第三節 研究工具 23 3.1 問卷內容 23 3.2問卷效度評估 23 第四節 統計分析 24 4.1 統計分析軟體 24 4.2 統計分析方法 24 第二部分 建構風險溝通之手機應用程式及可用性評估 25 第一節 研究設計 25 1.1 研究類型 25 1.2 研究時間 25 1.3 研究對象 25 第二節 研究架構與流程 25 第三節 研究工具 27 3.1 手機應用程式內容 27 3.2 手機應用程式開發系統環境與運作流程 33 第四節 研究變項與分析指標定義 34 4.1 使用者數據分析 34 4.2 藥物安全資訊數據分析 34 第五節 統計分析 35 5.1 統計分析軟體 35 5.2 統計分析方法 35 第五章 結果 36 第一部分 醫療人員獲知藥物安全資訊與不良反應通報現況之問卷調查 36 第一節 問卷調查回收率 36 第二節 問卷調查對象之基本資料 36 2.1 藥師 36 2.2 醫師 37 2.3 護理師 37 第三節 獲知藥物安全資訊的現況 39 3.1 藥師 39 3.2 醫師 39 3.3 護理師 39 第四節 藥物不良反應通報的現況 51 4.1 藥師 51 4.2 醫師 52 4.3 護理師 52 第二部分 風險溝通之手機應用程式可用性評估 63 第一節 使用者數據 63 第二節 藥物安全資訊數據 65 第三節 滿意度調查及使用者意見 67 第四節 手機應用程式之修正與優化 70 4.1 修正藥物類別訂閱之資訊遺漏 70 4.2 優化訂閱搜尋功能 72 4.3 新增iOS系統 73 4.4 優化藥物安全資訊傳遞效能 74 第六章 討論 75 第一節 風險溝通效率之探討 75 1.1 風險溝通之現況 75 1.2 風險溝通之需求 76 第二節 藥物不良反應通報之探討 77 2.1 藥物不良反應通報之現況 77 2.2 藥物不良反應通報之需求 78 第三節 風險溝通之手機應用程式的可用性 79 3.1 數據分析 79 3.2 風險溝通手機應用程式之發展 81 第七章 研究限制與未來研究方向 83 第八章 結論與建議 84 第二篇 臨床藥事服務 85 第一章 臨床藥事服務緣起 85 第一節 服務背景 85 第二節 研究材料與方法 86 第二章 結果與討論 88 第一節 編碼結果 88 第二節 討論 91 2.1 數據分析 91 2.2 MedDRA與DAIDS AE Grading Tables之探討 92 第三章 結論與建議 94 參考文獻 95 附錄一 99 附錄二 107 附錄三 115 附錄四 123 附錄五 127

    1. Piening, S., et al., Impact of safety-related regulatory action on clinical practice. Drug safety, 2012. 35(5): p. 373.
    2. Mayall, S.J. and A.S. Banerjee, Therapeutic Risk Management of Medicines. 2014: Elsevier Science.
    3. FDA-Drug Safety and Availability. [cited 2017 May 15]; Available from: https://www.fda.gov/Drugs/DrugSafety/default.htm.
    4. Guidance for Industry and FDA Staff/Dear Health Care Provider Letters: Improving Communication of Important Safety Information. 2014, U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)
    5. FDA Launches Drug Safety Newsletter. [cited 2017 June 20]; Available from: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107799.htm.
    6. Guideline on good pharmacovigilance practices (GVP) Module XV - Safety Communication. 2013, European Medicines Agency and Heads of Medicines Agencies.
    7. TFDA-藥品安全資訊. [cited 2017 June 10]; Available from: http://www.fda.gov.tw/TC/siteList.aspx?sid=1571.
    8. 藥物安全簡訊. [cited 2017 June 20]; Available from: http://www.tdrf.org.tw/ch/03_message/mes_03_list.asp?offset=0.
    9. Physician Outlook Survey. 2013, Wolters Kluwer Health/IPSOS.
    10. Aronson, J.K., S. Derry, and Y.K. Loke, Adverse drug reactions: keeping up to date. Fundamental & clinical pharmacology, 2002. 16(1): p. 49-56.
    11. Strom, B.L., Pharmacoepidemiology. 2006: Wiley.
    12. Guidance Drug Safety Information-FDA's Communication to the Public. 2012, U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER).
    13. Burke, S.P., K. Stratton, and A. Baciu, The Future of Drug Safety: Promoting and Protecting the Health of the Public. 2007: National Academies Press.
    14. FDA's Strategic Plan for Rsk Communication. 2009, U.S. Department of Health and Human Services Food and Drug Administration.
    15. Urushihara, H., et al., Pharmaceutical company perspectives on current safety risk communications in Japan. SpringerPlus, 2014. 3(1): p. 51.
    16. Ishikawa, H. and T. Kiuchi, Health literacy and health communication. BioPsychoSocial medicine, 2010. 4(1): p. 18.
    17. Managing the Risks from Medical Product Use: Report to the FDA Commissioner from the Task Force on Risk Management. 1999, US Food and Drug Administration.
    18. Bahri, P. and M. Harrison-Woolrych, Focusing on Risk Communication About Medicines: Why Now? Drug Safety, 2012. 35(11): p. 971-975.
    19. Phillips, J., et al., Retrospective analysis of mortalities associated with medication errors. American Journal of Health-System Pharmacy, 2001. 58(19): p. 1835-1841.
    20. Lesar, T.S., L. Briceland, and D.S. Stein, Factors related to errors in medication prescribing. JAMA, 1997. 277(4): p. 312-317.
    21. Leape, L.L., et al., Systems analysis of adverse drug events. JAMA, 1995. 274(1): p. 35-43.
    22. Brodsky, E., Prescribing Information: Resources and Review Process 2016, U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER).
    23. FDA-Drug Safety Communications. [cited 2017 June 10]; Available from: https://www.fda.gov/Drugs/DrugSafety/ucm199082.htm.
    24. EMA-Patient Safety Communications. [cited 2017 June 10]; Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/pha_listing.jsp&mid=WC0b01ac058001d126.
    25. Mazor, K.M., et al., Communicating safety information to physicians: an examination of dear doctor letters. Pharmacoepidemiology and drug safety, 2005. 14(12): p. 869-875.
    26. Guidance for marketing authorisation holders on drafting direct healthcare professional communications. 2014, Medicines and Healthcare products Regulatory Agency.
    27. Human medicines highlights. [cited 2017 June 20]; Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/document_listing/document_listing_000331.jsp#section2.
    28. FDA's Risk Communication Research Agenda. 2010, U.S. Food and Drug Administration.
    29. Piening, S., et al., Impact of safety‐related regulatory action on drug use in ambulatory care in the Netherlands. Clinical Pharmacology & Therapeutics, 2012. 91(5): p. 838-845.
    30. Dusetzina, S.B., et al., Impact of FDA Drug Risk Communication on Health Care Utilization and Health Behaviors: A Systemic Review. Medical Care, 2012. 50(6): p. 466-478.
    31. Guthrie, B., et al., Differential impact of two risk communications on antipsychotic prescribing to people with dementia in Scotland: segmented regression time series analysis 2001–2011. PLoS One, 2013. 8(7): p. e68976.
    32. Alqvist-Radstad, J., et al., SCOPE Work Package 6 Healthcare Professional Survey/Medicines Safety Communications and their Effectiveness. 2016, SCOPE Joint Action.
    33. Screen to Script-The Doctor's Digital Path to Treatment. 2012, Google/Manhattan Research.
    34. MedWatcher. [cited 2017 May 28]; Available from: https://medwatcher.org/.
    35. Web-RADR (Recognizing Adverse Drug Reactions). [cited 2017 May 29]; Available from: https://web-radr.eu/mobile-applications-for-adr-submission.
    36. Burns, N. and S.K. Grove, The Practice of Nursing Research: Conduct, Critique, and Utilization. 2005: Elsevier/Saunders.
    37. Polit, D.F., C.T. Beck, and S.V. Owen, Is the CVI an acceptable indicator of content validity? Appraisal and recommendations. Research in nursing & health, 2007. 30(4): p. 459-467.
    38. 成大醫院藥劑部-藥物安全警訊. [cited 2017 June 11]; Available from: http://140.116.253.135/NewHomePage/FDA.asp?page=1&Kind=&SearchText=.
    39. WHO ATC classification system. [cited 2017 June 12]; Available from: https://www.whocc.no/atc/structure_and_principles/.
    40. DeSimone, J.A., P.D. Harms, and A.J. DeSimone, Best practice recommendations for data screening. Journal of Organizational Behavior, 2015. 36(2): p. 171-181.
    41. Gupta, V. and G.S. Lehal, A survey of text mining techniques and applications. Journal of emerging technologies in web intelligence, 2009. 1(1): p. 60-76.
    42. Stopwords: Performance Versus Precision. [cited 2017 April 10]; Available from: https://www.elastic.co/guide/en/elasticsearch/guide/current/stopwords.html.
    43. Ventola, C.L., Mobile devices and apps for health care professionals: uses and benefits. PT, 2014. 39(5): p. 356-364.
    44. 林信樺, 藥品資訊傳遞機能之探討-醫師獲取藥品資訊現況調查, in 臨床藥學研究所. 2005, 國立臺灣大學: 台北市. p. 149.
    45. Bell, S.G., et al., New antiepileptic drug safety information is not transmitted systematically and accepted by US neurologists. Epilepsy & Behavior, 2013. 29(1): p. 36-40.
    46. Piening, S., et al., Healthcare professionals’ self-reported experiences and preferences related to direct healthcare professional communications. Drug safety, 2012. 35(11): p. 1061-1072.
    47. 藥物安全簡訊 (Drug Safety Newsletter). 2017 March, 財團法人藥害救濟基金會/全國藥物不良反應通報中心.
    48. Reports Received and Reports Entered into FAERS by Year. [cited 2017 June 21]; Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm.
    49. Lopez-Gonzalez, E., M.T. Herdeiro, and A. Figueiras, Determinants of Under-Reporting of Adverse Drug Reactions. Drug Safety, 2009. 32(1): p. 19-31.
    50. Ribeiro-Vaz, I., et al., How to promote adverse drug reaction reports using information systems – a systematic review and meta-analysis. BMC Medical Informatics and Decision Making, 2016. 16(1): p. 27.
    51. Charani, E., et al., An analysis of the development and implementation of a smartphone application for the delivery of antimicrobial prescribing policy: lessons learnt. Journal of Antimicrobial Chemotherapy, 2012. 68(4): p. 960-967.
    52. App Uninstall Report. 2016, AppsFlyer.
    53. Selim Ickin, Kai Petersen, and J. Gonzalez-Huerta, Why Do Users Install and Delete Apps? A Survey Study. 2017.
    54. Bahk, C.Y., et al., Increasing patient engagement in pharmacovigilance through online community outreach and mobile reporting applications: an analysis of adverse event reporting for the Essure device in the US. Pharmaceutical medicine, 2015. 29(6): p. 331-340.
    55. Härmark, L., Where mobile tech meets medicines safety, in Uppsal Reports. 2016. p. 21.
    56. de Vries, S.T., et al., Factors Influencing the Use of a Mobile App for Reporting Adverse Drug Reactions and Receiving Safety Information: A Qualitative Study. Drug safety, 2017. 40(5): p. 443-455.
    57. Morley, G., Adverse event reporting: A brief overview of MedDRA. Medical Writing, 2014. 23(2): p. 113-116.
    58. Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0. 2009, U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS.
    59. Mozzicato, P., MedDRA. Pharmaceutical Medicine, 2009. 23(2): p. 65-75.
    60. MedDRA Data Retrieval and Presentation: Points to Consider 2012, International Conference on Harmonization (ICH).
    61. Mozzicato, P., Standardised MedDRA Queries. Drug safety, 2007. 30(7): p. 617-619.
    62. 《嚴重藥物不良反應通報辦法》. 2004, 行政院衛生福利部.

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