藥物不良反應(yīng)通訊doc-展示頁
2024-07-30 22:28本頁面
【正文】 standards will ensure that risks and benefits can be assessed, explained and acted upon openly and in a spirit that promotes general confidence and trust. The following statements set forth the basic requirements for this to happen, and were agreed upon by all participants from 34 countries at Erice:1. Drug safety information must serve the health of the public. Such information should be ethically and effectively municated in terms of both content and method. Facts, hypotheses and conclusions should be distinguished, uncertainty acknowledged, and information provided in ways that meet both general and individual needs. 2. Education in the appropriate use of drugs, including interpretation of safety information, is essential for the public at large, as well as for patients and healthcare providers. Such education requires special mitment and resources. Drug information directed to the public in whatever form should be balanced with respect to risks and benefits. 3. All the evidence needed to assess and understand risks and benefits must be openly available. Constraints on munication parties, which hinder their ability to meet this goal must be recognised and overe. 4. Every country needs a system with independent expertise to ensure that safety information on all available drugs is adequately collected, impartially evaluated, and made accessible to all. Adequate nonpartisan financing must be available to support the system. Exchange of data and evaluations among countries must be encouraged and supported. 5. A strong basis for drug safety monitoring has been laid over a long period, although sometimes in response to disasters. Innovation in this field now needs to ensure that emergent problems are promptly recognised and efficiently dealt with, and that information and solutions are effectively municated.2006年5月8月共收到不良反應(yīng)報(bào)告13例，其中新的一般不良反應(yīng)3例，嚴(yán)重不良反應(yīng)1例。，但長期以來藥物安全監(jiān)測(cè)系統(tǒng)已奠定了基礎(chǔ)。應(yīng)排除偏見，提供充足的經(jīng)費(fèi)支持該系統(tǒng)。4.必須使人們?nèi)菀椎玫皆u(píng)價(jià)及了解風(fēng)險(xiǎn)和利益所需要的一切證據(jù)。針對(duì)公眾的藥物信息，無論采用何形式，在藥物的風(fēng)險(xiǎn)和利益方面要得到平衡。關(guān)于藥物正確使用的教育，包括對(duì)安全信息的解釋，對(duì)廣大公眾、病人和醫(yī)務(wù)工作者都是至關(guān)重要的。事實(shí)、假說和結(jié)論要加以區(qū)別，承認(rèn)不確定性，信息的提供要適合一般性的需要和個(gè)別的需要。藥物安全信息必須為公眾健
法律信息相關(guān)推薦
鄂ICP備17016276號(hào)-1