US accrediting agency tightens rules for continuing medical education
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《英国医生杂志》
The Accreditation Council for Continuing Medical Education, which accredits the continuing medical education (CME) courses required of most US physicians, has announced changes to limit the influence of the pharmaceutical industry. The council抯 seven members, including the American Medical Association, approved the changes, which affect the council抯 nearly 700 accredited providers of education.
The changes have come about, in part, because leading doctors who speak on the courses often have ties to pharmaceutical firms. Previously experts exposed their industry ties, but were free to speak about off label or investigational uses of drugs梪ses not approved by the Food and Drug Administration. Although speakers may still discuss such uses, they must confine their discussions to evidence based medicine.
Experts with ties to pharmaceutical companies should not be asked to make presentations on topics that involve their industry ties. The aim of the guidelines is to prevent speakers or planners with a financial relationship to commercial interests from having an opportunity to control the content of continuing education.
The changes have been in the works for almost a decade, Murray Kopelow, head of the council, told the BMJ. New courses must comply with the rules beginning May 2005; all courses should be in full compliance by January 2006. Courses already planned can be completed under the old rules.
Continuing medical education is provided by hospitals and medical centres, professional societies, and medical communications companies. The internet is increasingly used. Funding often comes from pharmaceutical, device, and biological companies, and sometimes from clinical care companies, nursing homes, and for-profit hospitals.
Dr Kopelow told the BMJ that the council accredits the providers of continuing education. These providers梚ntermediaries separate from the funder梞ust determine whether there is a conflict of interest, resolve it, and expose it to the learners, he said. In future, providers must also see that speakers or authors present only evidence based medicine, such as peer reviewed studies or information from the Cochrane Collaboration, and include negative as well as positive studies.
The guidelines emphasise that education providers "must be guided by what is in the best interest of the public . . . always deferring to independence from commercial interests, transparency, and keeping continuing medical education separate from product promotion." The provider, not the pharmaceutical company, must determine the content of the educational programme. Likewise, the provider determines the payments to speakers, planners, or authors. Income and expense statements must be available for review by the council.
The updated guidelines call for participants to disclose ties to commercial interests. The providers of the continuing education programme must resolve problems梑y picking a different speaker or author or by asking the presenter to tackle a topic in the subject area different from the one for which he or she has received funding. Presenters?commercial relationships must be disclosed in course materials.
The new guidelines also state that education must be separated from promotional activities, materials, and messages. In printed continuing education materials, there cannot be an advertisement within the article on which the educational activity is based, although there can be one between articles. Exhibits are to be separate from the educational activity.
Sandwiches and coffee are acceptable, but champagne and caviar are not, the guidelines suggest, "Using commercial support to pay for modest meals and social events at CME activities has been allowed for years. However, providers must avoid making meals or social events longer or more important or more costly than the educational activity, for example."(New York Janice Hopkins T)
The changes have come about, in part, because leading doctors who speak on the courses often have ties to pharmaceutical firms. Previously experts exposed their industry ties, but were free to speak about off label or investigational uses of drugs梪ses not approved by the Food and Drug Administration. Although speakers may still discuss such uses, they must confine their discussions to evidence based medicine.
Experts with ties to pharmaceutical companies should not be asked to make presentations on topics that involve their industry ties. The aim of the guidelines is to prevent speakers or planners with a financial relationship to commercial interests from having an opportunity to control the content of continuing education.
The changes have been in the works for almost a decade, Murray Kopelow, head of the council, told the BMJ. New courses must comply with the rules beginning May 2005; all courses should be in full compliance by January 2006. Courses already planned can be completed under the old rules.
Continuing medical education is provided by hospitals and medical centres, professional societies, and medical communications companies. The internet is increasingly used. Funding often comes from pharmaceutical, device, and biological companies, and sometimes from clinical care companies, nursing homes, and for-profit hospitals.
Dr Kopelow told the BMJ that the council accredits the providers of continuing education. These providers梚ntermediaries separate from the funder梞ust determine whether there is a conflict of interest, resolve it, and expose it to the learners, he said. In future, providers must also see that speakers or authors present only evidence based medicine, such as peer reviewed studies or information from the Cochrane Collaboration, and include negative as well as positive studies.
The guidelines emphasise that education providers "must be guided by what is in the best interest of the public . . . always deferring to independence from commercial interests, transparency, and keeping continuing medical education separate from product promotion." The provider, not the pharmaceutical company, must determine the content of the educational programme. Likewise, the provider determines the payments to speakers, planners, or authors. Income and expense statements must be available for review by the council.
The updated guidelines call for participants to disclose ties to commercial interests. The providers of the continuing education programme must resolve problems梑y picking a different speaker or author or by asking the presenter to tackle a topic in the subject area different from the one for which he or she has received funding. Presenters?commercial relationships must be disclosed in course materials.
The new guidelines also state that education must be separated from promotional activities, materials, and messages. In printed continuing education materials, there cannot be an advertisement within the article on which the educational activity is based, although there can be one between articles. Exhibits are to be separate from the educational activity.
Sandwiches and coffee are acceptable, but champagne and caviar are not, the guidelines suggest, "Using commercial support to pay for modest meals and social events at CME activities has been allowed for years. However, providers must avoid making meals or social events longer or more important or more costly than the educational activity, for example."(New York Janice Hopkins T)