藥袋副作用標示－民眾需求之探討

The Lay Perspective of Labeling Side Effects on Drug Containers

洪增陽(Tseng-Yang Hung)

指導教授 ： 丁志音

國立臺灣大學/公共衛生學院/衛生政策與管理研究所/碩士(2008年)

https://doi.org/10.6342/NTU.2008.01977

摘要

摘要

不良的用藥標示，包括過多或過少的資訊提供，經常是影響用藥依從性（medication adherence）的一個潛在因素，在倫理上，醫療有關的資訊應該充分提供給病患，但所謂「足夠的」資訊指的是什麼？資訊根據多少的證據才算足夠？數量需要呈現多少？誰來決定資訊的呈現？以及，要讓這樣的「足夠」去做什麼？在本研究所要探討的藥袋副作用標示，也經常面臨到這樣的問題，這些問題應該會引起許多的討論，並仍持續考驗著醫病雙方的智慧。
在過去用藥資訊不甚透明的時代，直到今天大多數醫療院所合乎標示的規定，當中又以副作用的標示屬空前的措施，呈現一種醫病雙方皆不曾有過的新時代與新體驗。2007年我國公布施行的藥師法第十九條修正，藥師於藥劑之容器包裝上應記明警語或副作用，使得這項標示已非醫療道德上的高標準，而是法律上所規範的最低標準了。
為了進一步了解民眾究竟怎樣看待與利用藥袋標示，尤其是藥物副作用標示的部份，對它的需求以及偏好，在人群中的分佈的情形如何？有沒有副作用經驗信念上的相關？為了得到這些解答，於是以制式問卷及便利取樣之方式來進行資料收集與研究。
研究結果有以下重要發現：
1. 多數的民眾（67.3%）在每次領藥時會閱讀與使用藥袋副作用標示，但年輕族群比率顯著偏低；而經驗上曾因為只看到藥袋標示的副作用而放棄服藥者，比率則顯著較高。
2. 民眾多數（56.9%）認為藥袋非常有必要標示副作用，其中以年輕、高學歷、具有副作用相關經驗者則顯著認為有標示的必要。
3. 在副作用標示數量上，大多數民眾（73.4%）認為應該全數標示，而偏好全數標示與民眾特質、副作用經驗及信念大致無關，僅年輕族群略有顯著之偏好。
4. 大多數民眾（74.6%）可以同意以「警語」取代副作用標示，但需要長期服藥者與信念上覺得藥物都有副作用者，其同意之傾向則顯著較低。
5. 三項建議標示裡，以「主要適應症」（major indications）獲多數民眾（57.7%）認為是最重要的標示，「主要副作用」（major side effects）則居末（16.7%），教育程度最高與最低兩端，以及需要長期服藥者認為副作用標示最為重要的比率顯著偏低。
大致而言，民眾對藥袋副作用標示的期待，存有社會人口特質與個人副作用經驗與信念的差異。具有指示屬性與資訊櫥窗功能標示的藥袋，則是多數民眾期待它扮演的角色，超越實際的副作用標示。建議實務上應同時配合其它用藥教育的方式，來強化病患自我照護與知藥用藥的能力與權利。

關鍵字

藥袋標示 ； 副作用 ； 警語 ； 用藥依從性 ； 藥物資訊

並列摘要

Abstract

In medically ethic terms, patients should be well-informed, and optimal information provided -- inadequate or superfluous – challenges the patients’ adherence of medication. This lends to the significance of such scholarly inquiries as: what is “optimal” amount disclose of medical information; upon what confidence-level these labeling are based; who exerts the legitimate power to determine with what effects. All of these underline the importance of an issue which remains under-researched and unanswered for medical professionals.
In Taiwan, the debate regarding the optimal amount has surfaced over the decade, challenging the doctor-patient relationships. The legal and law enforcement agencies saw it as an opportunity to inform the publics and increase the transparency of labeling. Given these good deeds, in a major revision of the pharmacist law in 2007, an additional requirement was mandated to disclose the information better suited what patients need to know, among which label side effects and warnings were championed as unprecedented and progressive move. Indeed, witnessing was the huge stride: the pharmacies across Taiwan have improved the labeling system in response to the change.
In this context, this study is conducted to analyze how the patients in Taiwan perceive and adhere with these labels with what effect. It focuses on how the perception of side-effect labeling interacts with some demographic factors such as sex, age and medical history. A structured questionnaire was formulated to help collect data using convenience sampling scheme. The results are shown as below:
1. While most patients (67.3 %) read the side effect labeling; younger people pay significantly less attention on it. Those who have given up on medication due to the side effect labeling are likely more aware of these labels.
2. Side effect labeling is considered as necessary (56.9%). Significantly more demanding was found among the young, highly-educated and those who were affected by the side effects.
3. A large percentage of patients (73.4%) think that all side effects should be labeled. These patients are not correlated with any other characteristics of personalities or experiences.
4. Most patients (74.6%) agreed that side effect labels can be replaced with warning statement. However, this is not applicable to the patients suffering from chronic illnesses or believing side effects are ubiquitous.
5. Of three important labels, “major indications” were found most important (57.7%); whereas major side effects are the least important. The most and least educated patients, or chronic illness sufferers value the label of side effect less.
Although the side effect labeling is important information disclosed, the expectation for the labeling from the public varies, depending on socio-demographic and medical background. Not only expected to instructional, the labeling on drug containers (or bags) has also become a place to display educational information beyond the disclosure of side effects. At the practice level, this study suggests that education programs should be offered to improve knowledge of medication and self-care for patients.

並列關鍵字

drug labeling ； side effect ； precaution/warning ； medication adherence ； drug information

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