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研究生: 陳奕志
Chen, Yi-Chih
論文名稱: 合理藥事作業之處方評估探討
Establishing the Model of Prescription Assessment in Pharmacy Practice
指導教授: 高雅慧
Yang, Yea-Huei Kao
張慧真
Chang, Huei-Jane
學位類別: 碩士
Master
系所名稱: 醫學院 - 臨床藥學研究所
Institute of Clinical Pharmacy
論文出版年: 2008
畢業學年度: 96
語文別: 中文
論文頁數: 127
中文關鍵詞: 合理藥事作業Medication Appropriateness Index (MAI)合適性處方資訊處方評估
外文關鍵詞: pharmacy practice, Medication Appropriateness Index (MAI), appropriateness, information on the priscription, priscription assessment
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  • 研究背景:
    近年來,病患安全的議題越來越受到矚目與重視,同屬於醫療團隊的藥師對於掌控用藥安全更是責無旁貸的首要任務。此外,在藥師法、藥品優良調劑作業準則或優良藥品調劑作業規範之中對於藥師在處方確認的步驟中,皆訂定了應遵循的項目。
    然而,一位藥師據以評估其手上的處方是否正確、合適且合乎目前法規大多僅能由處方箋上所載的資訊而已。因此,處方上所呈現資訊的完整性,是直接影響藥師執行判斷性服務最重要的因素。除了符合法規規定,對於患者、處方以及藥品方面能夠給予越多元、完整的資訊,對於藥師來說,便能夠有更多的證據來作出最正確的判斷。
    此外,想要評估處方的合適性,勢必得要建立一套評估處方的方法,如此一來不僅可以爲處方的合適性設定一個評估的標準,亦可為藥師在評估處方的同時,設定一個堪用的標準作業程序。

    研究目的:
    建立達成法規暨評估處方合適性必須之處方資訊,並建立處方評估的作業規範。

    研究方法:
    本研究為橫斷性 (cross-sectional)之描述性 (descriptive) 研究,研究對象為「合理調劑量與藥事服務品質之探討」計畫所收集之處方箋共計1545張。
    根據所設定的理想處方項目予以建檔,藉以分析上述處方箋之合法性及完整性並評估現行處方箋對於是否足以提供藥師執行判斷性服務。
    此外,也將參照Hanlon氏等所提之評估處方合適性指標:Medication Appropriateness Index (MAI)加以調整,並使用現有處方進行評估,藉以分析抽樣處方之合適程度並推測現行處方合適率,且建立處方合適性的評估指標。

    研究結果:
    目前所收集的處方多為提供藥劑部門調劑使用之調配單,因此對於符合法令規章方面,如應具備醫師簽章以及管制藥品使用證號等項目是不符合規範的。在臨床判讀需求方面,所收集的處方之中,雖以藥品資訊的提供最為完整,然而相關資訊主要還是用以應付調劑需求。此外,對於藥品劑型、單位含量、給藥途徑等,也有10-15%的處方並未給予完整的資訊。
    而使用經修訂MAI準則作為評估處方的方法,可以發現評估藥師們有極高的重測信度 (overall κ=0.762),但是由於處方資訊的完整性、對於處方的解讀以及每項指標的標準等因素,使得評估信度無法達到完美的等級 (overall κ=0.388)。
    分析藥品被評估為不合適的因素,主要是出自於所提供的資訊不齊全,尤其當診斷資訊缺乏時。約90%的不合適處方存在缺乏診斷或診斷資訊不齊全之問題。
    關於影響處方合適性部分,除了藥師個人的專業判斷以外,處方上藥品品項的多寡,是影響合適程度最大的因素。

    研究結論:
    依本研究所收集的處方來看,部分處方所能提供的資訊仍十分有限。
    使用經修訂的MAI準則可以提供藥師作為評估處方的標準作業流程,若能為進行評估作業的藥師提供適當的資訊及參考資料,並對於準則中各項指標能夠充分了解且加以完整的教育訓練,如此一來才可確保藥師得以為患者的用藥安全發揮其專業的判斷性服務。

    Background:
    In recent decade, the issue about patient safety was more emphasized than ever before. Pharmacist, being a member of health care team, plays an important role in ensuring medication safety. During the dispensing process, the information for a pharmacist to evaluate a prescription and perform pharmaceutical care came solely from prescription itself. The integrity of information on the prescription is the key factor for pharmacists to conduct their professional responsibility.

    Objective:
    To establish a standardized procedure to evaluate a prescription and to assess the appropriateness of prescriptions in Taiwan

    Method:
    This is a cross-sectional, descriptive study. We collected 1545 prescriptions from secondary and tertiary medical centers all over the Taiwan. The legitimacy of all these prescriptions would be evaluated. We modified the assessment tool from Hanlon’s Medication Appropriateness Index (MAI) for this study.
    Ten senior clinical pharmacists were participated in the assessment of prescriptions. The agreement of evaluation process using MAI was also analyzed.

    Result:
    Most of our collections were dispensing note instead of the original prescriptions, whisch was the common practice in Taiwan. Lack of physicians’ signature and registration number of controlled substance prescribing license were the two major problems in our samples. In addition, there were around 10-15% of prescriptions without inficating the dosage form, streagth and route.
    With the modified MAI, we found a highly reliability (overall κ=0.762) amount pharmacist in evaluation a given prescription but the reliability between pharmacists were no convincible(overall κ=0.388).
    To analyse the factor of the prescriptions which be assessed to inappropriateness, insufficient information was the main one, principally in diagnosis. About 90% of inappropriateness presciptions had the same problem of insufficient for diagnosis. Besides, the number of medication on the priscription is the key factor to influence the appropriateness of the prescriptions.

    Conclusion:
    From our study, there was insufficient information in prescription for pharmacist to perform cognitive services, which showed require regulatory intervention to improve the practice.
    Well training and sufficient information will provide pharmacist to perform their duties, and fulfill a function of controlling the medication safty.

    中文摘要 i Abstract iii 致謝 v 目錄 vi 表目錄 ix 圖目錄 xi 附表目錄 xii 第一篇 合理藥事作業之處方評估探討 1 第一章 研究緣起 1 第二章 研究目的 3 第三章 文獻回顧 5 第一節 國內外相關處方品質規範 5 3.1.1 國內法規規範 5 3.1.2 國外相關規範 5 3.1.3 國內研究現況 8 第二節 判斷性服務的重要性 10 第三節 處方合適性評估 11 3.3.1 評估處方合適性之工具 11 3.3.2 指標性測量 12 3.3.3 原則性測量 13 3.3.4 小結 13 第四節 Medication Appropriateness Index (MAI) 14 3.4.1 MAI的發展 14 3.4.2 MAI的總和評估 14 3.4.3 MAI的局部修訂 15 3.4.4 小結 16 第四章 研究方法 17 第一節 研究設計 17 4.1.1 研究類型 17 4.1.2 研究時間 17 4.1.3 研究對象 17 第二節 研究架構 18 第三節 研究工具 21 4.3.1 資料庫 21 4.3.2 MAI評估準則 21 4.3.3 評估用處方統一規格 21 4.3.4 MAI評估表填寫方式 21 第四節 研究變項及評估指標定義說明 23 4.4.1 研究變項 23 4.4.2 評估指標 30 第五節 資料彙整與分析 32 4.5.1 資料整合軟體 32 4.5.2 統計分析軟體 32 4.5.3 統計分析方法 32 第五章 研究成果 34 第一節 實測處方資料之分析 34 5.1.1 處方樣本統計量之描述 34 5.1.2 符合法令規範需求之描述 35 5.1.3 臨床判讀資訊需求之描述 40 第二節 MAI處方評估資料分析 56 5.2.1 處方評估資料之描述 56 5.2.2 修訂後之MAI準則信度分析 58 5.2.3 處方合適性評估 63 5.2.4 處方合適性迴歸分析 68 第六章 研究討論 78 第一節 資料品質 78 6.1.1 處方品質分析 78 6.1.2 藥品合適性評估 79 第二節 合理藥事作業模式 80 6.2.1 處方判讀性 80 6.2.2 處方合適性評估 85 第七章 研究限制與未來研究方向 90 第一節 研究限制 90 第二節 未來研究方向 91 第八章 結論與建議 92 第二篇 臨床藥事服務 94 第一章 背景與目的 94 第二章 處方討論 95 參考文獻 112

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