FDA發起降低藥物相關傷害的計畫

作者：Brande Nicole Martin  
出處：WebMD醫學新聞

　　November 5, 2009 — 為了降低可預防之藥物相關傷害，美國食品藥物管理局（FDA）發起一項稱為安全使用新方案的計畫；有關當局日前在FDA的記者會中發表這項訊息。
　　
　　根據一份官方聲明稿，安全使用新方案的目的是透過找出特定、可預防的藥物風險，進而與致力於安全藥物使用的夥伴一起發展、執行及評估跨部門介入。
　　
　　FDA指出，每年有多達30億張處方，以及數百萬人是因為使用藥物而受到傷害。許多傷害是肇因於群眾們取得足夠藥物、風險或病患狀況的資訊有限，其他傷害則是由於不清楚藥物的指示、劑量與調劑錯誤、非故意或故意誤用藥物所造成。
　　
　　FDA專員Margaret Hamburg醫師在記者會上表示，醫療機構（Institute of Medicine）估計，在醫療機構就發生了至少150萬件與藥物相關之可避免的傷害，而據估計，有半數以上的藥物相關傷害，其實是可以藉由現今能取得之知識來避免掉的。
　　
　　FDA將與健康照護社群合作，包括健康照護專業人員、病患、藥局、保險公司、以及其他聯邦機構，有效地降低藥物的處置失當，以及避免藥物帶來的傷害。
　　
　　FDA藥物評估與研究中心主任Janet Woodcock醫師在記者會上表示，這是FDA一個重要的思考邏輯改變，他解釋當局計畫扮演甚於傳統廠商管理者的角色，作為健康照護系統中的召集者與催化劑。
　　
　　Woodcock醫師在FDA新聞稿中附帶表示，唯有透過聯合跨其他健康照護系統領域的介入，我們才能大幅降低因為使用藥物而造成之可預防的傷害。在降低藥物使用帶來的風險與預防傷害上，健康照護社群的所有參與者都有其角色。
　　
　　【下一步】
　　作為安全使用新方案的一部分，FDA計畫在接下來的幾個月採取一連串的行動。
　　
　　當局將會尋求來自健康照護社群、病患團體、所有其他利益相關者，以及觀察到牽涉不安全使用藥物受害最深的族群參與；他們認為我們應該處理，還有該以什麼方法進行處理。
　　
　　FDA也將會召開公聽會，提供與這項新計劃發展有關的回饋給大眾。
　　
　　與這些討論相關的特定問題、介入與標準最終將會公開。
　　
　　與安全使用新方案更多的資訊請造訪FDA網站。

FDA Launches Program to Reduce Drug-Related Injuries

By Brande Nicole Martin
Medscape Medical News

November 5, 2009 — The US Food and Drug Administration (FDA) has launched a new program called the Safe Use Initiative to reduce drug-related injuries from preventable sources of harm, agency officials announced at an FDA press conference yesterday.

"The goal of the Safe Use Initiative is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use," according to an agency news release.

The FDA indicates that as many as 3 billion prescriptions are written each year, and millions of people are injured from medication use. Many injuries are a result of people's limited access to adequate information about a drug, its risks, or the patient's condition. Other injuries occur because of misunderstanding of drug instructions, dosing and dispensing errors, and unintentional or intentional misuse of medications.

"The Institute of Medicine estimates that at least 1.5 million preventable drug-related injuries occur in healthcare settings alone...and it is estimated that up to half of all medication-related injuries could be prevented using currently available knowledge," FDA Commissioner Margaret Hamburg, MD, said at the press conference.

The FDA will collaborate with the healthcare community, including healthcare professionals, patients, pharmacies, insurers, and other federal agencies, to effectively reduce mismanagement of medication and prevent harm from medication.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said at the press conference that "this is a paradigm shift for the FDA," explaining that the agency plans to go beyond its traditional role as industry regulator and to serve as "the convener and catalyst" among members of the healthcare system.

"Only through coordinated interventions across all sectors of the health care system can we substantially reduce preventable injuries from using medications," Dr. Woodcock added in an FDA news release. "All participants in the health care community have a role to play in reducing the risks and preventing injuries from medication use."

Next Steps

As part of the Safe Use Initiative, the FDA plans to take a series of steps in the months ahead.

The agency will seek input from "the healthcare community, patient groups, and all the other stakeholders and what they see as the most serious problems involving unsafe use of medicine and what they think we should tackle and in what way we should tackle these,” Dr. Woodcock said.

The FDA will also hold public meetings and provide other resources for the public to provide feedback on developments related to the new program.

A list of specific problems, interventions, and metrics derived from these discussions will eventually be released.

More information about the Safe Use Initiative is available on the FDA Web site.