Pharmaceutical companies and some doctors in India are in a state of panic over a new code of medical ethics that bans physicians from accepting gifts, including travel and grants for attending CME meetings. The regulations were passed in December 2009 by the Medical Council of India (MCI) and sanctioned by the Indian government. And Dr. Ketan Desai, MCI president, has urged the health ministry to pass legislation "restraining pharmaceutical companies from these types of activities".
The press has had a field day exploiting violations of the new regulations governing professional conduct. Hindustan Timesreported that "Primal Healthcare took 200 doctors from India to Istanbul for a diabetes conference. Dr. Reddy's Laboratories paid for the travel and hospitality of another 200 in Hyderabad".
Under the headline "My name is BRIBE", an article in the Ahmedabad Mirror stated that Emcure Pharma took doctors and their families to a free movie screening; the company denied this and a manager claimed the event was sponsored by him. In another article, Dr. Desai was quoted as saying: "A friend who owns a pharma company ...told me that the MCI had made things difficult by banning gifts. ... they were paying doctors by check but would now have to do that in cash."
There appears to be no penalty if doctors violate the code, which is another reason there is pressure to regulate pharma. And the controversy comes just as the MCI is getting ready to propose a mandatory CME law by year end.
"European healthcare stakeholders can, and must, learn from mistakes made in the USA when developing a robust framework for CME in the region," says theExecutive Summary of the 2nd annual meeting of the European CME Forum, led by Eugene Pozniak. "The future of European CME will depend on how its stakeholders come together and interact," echoes a FirstWord Dossier just published.
Who are these stakeholders, and what must they do? Certainly they include the medical specialty societies, who produce most of the CME -- with or without commercial education company help. They include the National Authorities, who serve as the regulators of what credits are acceptable -- if credits are required. They include the specialty accreditation boards (ESABs) and the European Accreditation Council for CME (EACCME). Certainly the physicians and their patients should also be considered stakeholders. Considering these disparate forces, the FirstWord authors concluded: "European CME may become more dictatorial (i.e., strictly enforced mandatory CME with ... punitive measures for those failing to comply...), or more democratic, needs based, and controlled by the learners with guidance from the regulators."
Is the pharmaceutical industry a stakeholder? The report of the European CME Forum says: "CME without industry support is impossible -- but pharma needs to increase its engagement with CME and understand how it can be used to provide greater value to its customers" by taking on "greater responsibilities as educators".
These are serious challenges for a region with so many stakeholders and no central organization (other than EACCME, whose role is limited) to help develop some central guiding principles. The "mistakes" in the USA depend on definition. Some would say the whole accreditation system, based on very tight rules for providers, is at fault. Others would blame the pharma companies for abuses of education as promotion. Despite these problems, there is a level of uniformity to the US CME system that is lacking in Europe. Who will step up to remedy this?
Italy and the state of Bavaria, Germany, are developing new rules that apply principally to accrediting online learning for physicians. Italy is testing a system of accrediting providers instead of programs -- only for eCME, and the Bavarian Chamber of Physicians has evolved a new contract of cooperation with providers that applies only to eCME (and print).
In Italy, the Health Ministry no longer manages the CME system; it has been turned over to AGENAS, the national agency for regional health services, a body that sits between the Health Ministry and regional health systems. And starting in January, AGENAS is following a provider accreditation model for distance learning only, reports Dr. Alfonso Negri, a WentzMiller associate. He says the idea is to reduce dramatically the number of providers from about 12,000 to 1,000, because of strict new requirements. The annual fee for accreditation of a provider is about $3,500 -- but in addition a fee of the same amount or more is charged for each course, depending on the number of credits and participants. In contrast, the US Accreditation Council charges $8,500 for pre-application and initial accreditation, and $2,500 annually. But there is no course fee.
In Bavaria, the new contract of cooperation requires the provider of online or print CME to have two independent experts as content reviewers, and to set "adequate fees" for the learner if there is no outside sponsor, such as a pharmaceutical company. As yet, there is no guideline regarding the amount of the fee -- it could be as low as $7 per CME credit. The provider must also sign a declaration identifying any sponsors and affirming that there are no conflicts of interest, according to Dr. J. W. Weidringer of the Bavarian chamber.
1 We welcome back as a WentzMiller Associate Dr. Herve Maisonneuve of Paris, where he is associate professor of public health, quality assessment and medical information at Paris Sud 11 Medical School. He is immediate past president of GAME, and active in CME leadership in Europe. Dr. Maisonneuve took a brief sabbatical from our group when he served as medical education director for Pfizer France.
2 Two major CME meetings are coming up in Canada this spring: CACHE, the Canadian Assn. of Continuing Health Education, meets April 28-30 in St. John's Newfoundland. The theme is "Linking CHE to Educational Outcomes -- Closing the Loop". Then GAME, the Global Alliance for Medical Education, also takes participants to Canada -- this time, Montreal, for its 15th annual meeting, June 6-8. The theme is: "Innovation in CME," with speakers from Europe, North America, Asia and Latin America.Registration available on each site.
3 There are opportunities around the world -- but especially in China -- for globally oriented CME providers to improve health and reduce healthcare costs in managing diabetes. The need was emphasized in two recent articles in the American Journal of Managed Care. The first points up the effectiveness of a comprehensive disease management program. The second notes that China is suffering from a runaway epidemic of diabetes, affecting almost 8% of the population compared to 5% around the world. Too many Chinese diabetics wind up in high cost tertiary care hospitals when with better primary care, complications -- and costs -- could be greatly reduced.
There is substantial disparity among systems of CME in Europe in their recognition of the link between CME and Performance Improvement (PI). As reported in our November issue, the French, in their still-nascent plan, have a strong emphasis on practice audits, though not clearly linked to CME. The British see this as part of continuing professional development (CPD) in their revalidation effort. As noted in the article below, the Germans stay away from "improvement" and talk about quality "assurance". The Italian and Spanish systems, the first mandatory, the second voluntary, have no defined PICME programs.
Now the Rome CME-CPD Group, an informal organization of CME leaders in Europe and North America, are encouraging development of PICME. In a presentation at the European CME Forum in November 2009, Alfonso NEgri MD, secretary general, said, "Ideally CME programs should have the following Performance Improvement mechanism":
A relevant needs assessment
Pre-evaluation of physician knowledge or competency
Evaluation mechanism of knowledge/competency gained
Clear separation of funding organizations from the CME activity
Indpendent peer review process to verify quality, freedom from bia
System for assessing and managing conflict of interest
Clear process of assessing the results of activities
In the U.S., PICME is slowly gaining acceptance, in part because the Federal agency that pays physicians for Medicare services to patients offers a bonus to those who participate in a program of reporting performance data -- not improvement -- on groups of patients by diagnosis. The government may decide in the future to require improvement measures as well, but that hasn't happened yet.
In an exciting news item from Islamabad, a consultation group, including the Federal Ministry of Health,the Pakistan Medical & Dental Council (PMDC), and WHO, has recommended setting up an "apex body" at PMDC to formulate rules, regulations and accreditation of CPD programs. PMDC has decided to implement the program, probably within the next year.
Among the recommendations are that departments of medical education should be established at medical universities and institutions, that a monitoring and evaluation system should be established, and that institutions allocate funds to support the CPD activities. Prof. Rashid Jooma, director general of health, is spearheading the program, which had been proposed previously in a paper by Prof. Zarrin Seema Siddiqui of the University of Western Australia.
Meanwhile, Nigeria is struggling to implement a CME system developed in 2007. Each medical doctor must obtain 40 credit units in 2 years to qualify for the issuance of a license to practice; failure will result in "appropriate sanctions," according to an article in the Journal of Continuing Education in the Health Professions. However, the authors say the program has not taken off, and licenses are being issued to doctors who don't have the required credit. The problem, they suggest, may the "centralization of coordination by the Medical and Dental Council of Nigeria."
Engaging presentation, peer communication and informal support -- all were important characteristics of e-learning, according to a review of studies among UK physicians and other health professionals. The article in Journal of Continuing Education in the Health Professions offered some fascinating findings:
"Learners who perform less well in a traditional face-to-face learning environment may gain confidence from the time for reflection offered by ... asynchronous discussion groups and on-line group work."
"The ongoing moderating and supporting role" of a tutor enhances "information sharing and reciprocal learning" if the tutor is appropriately trained.
"Use of a variety of [presentation] techniques ... offers 'authentic learning', in which the learning experience is inseparable from the learn's professional reality."
A research report from Best Practices LLC notes that eCME is responsible for delivering 24% of CME content in the U.S. and 11% in Europe. Younger physicians, the report says, are more open to receiving eCME and eventually will increase the market dramatically. And by offering presentation variety, as suggested in the paragraphs above, the learner can enter at his/her appropriate place on the "spectrum of readiness-for- behavioral-change".
1. The term "quality improvement" is not used widely, say the authors of a analysis on "Revalidation of the Medical Profession in Germany", because it is "a notion that would acknowledge failures and weaknesses, runs against professionals' self-image and the public's expectations concerning medical providers." Instead, we "assure" quality, they said, based on the assumption "that quality is already good or excellent." Carrot better than the stick?
2. Pfizer recently has taken 2 steps to dramatically change its image in the funding of CME. First came the report that Pfizer Canada would provide $780,000 to fund new CME programs of the Canadian Medical Association, designed to inform physicians of new developments in medicine. Pfizer would have 2 persons on a board of 6 overseeing the program. A month later, Pfizer USannounced it was making a $3 million grant to Stanford University with "no say on how the 3-year grant would be spent." Makes one wonder what Pfizer's global CME grant policy really is.
3. Should physicians be required to take courses in cultural competency? The state of Connecticut says so. Effective in October, all doctors must get CME credits in cultural diversity to maintain their licenses. The mandate was the result of a survey that indicated that physicians in the state believe that such training would help them deliver better care to patients with diverse backgrounds. Results to be reported!
SEARCHING THIS SITE: PRESS CONTROL F AND ENTER YOUR SEARCH TERM. YOU CAN SEARCH ANY SECTION LISTED TO THE LEFT, ONE SECTION AT A TIME.
