International Briefs

NOTES FROM THE REGISTRAR

Welcome to nearly the end of the first decade of the third millennium. Does that not sound like the future? As I review the issues faced by the College at this time, it is important to reiterate many of them will, in fact, have a major effect on the future practice of medicine in Manitoba for the next decades. Your president has identified several of these in her column. In particular, they are:

1. Labor Mobility – Agreement on Internal Trade. On Dec. 5, 2008, the Labor and Competitiveness Ministers across the country met and signed this agreement. The Premiers and the Prime Minister will ratify it early in 2009. It will require that all provinces introduce easy mobility for all professionals and trades across provincial borders. This means that, at the present time, any physician who is licensed in one province or territory may apply for and must be accepted for registration/licensure in any other province or territory in Canada. We have now received a copy of the document. There are many questions that arise from it, which must still be clarified. There are two areas of immediate concern. The first relates to ensuring that any physician who comes into the province provides information to assure us of fitness to practice. The second relates to the requirement that may be introduced for those who are presently under terms and conditions from the jurisdiction they are leaving.

2. Health Profession Regulatory Reform Initiative This is the formal title for the proposed umbrella health legislation which will put all Manitoba health professions under a single Act. We expect to receive further information on this early in 2009, and legislation may be introduced in the spring. Once that information is available, it will be placed on the College website for members to see and respond back to us. There has already been significant discussion about the Complaints/Investigations section and the reserved acts. The latter are those acts that only a member of a regulated health profession may perform (e.g., prescribing of medications).

3. Regulations for Nurse Practitioners, Optometrists and Podiatrists. As you know, the College was involved in the development of the regulation for the R.N. [E.P.] [nurse practitioner] over the past few years. The committee met again recently to review the regulation. In addition, we have requests from optometry and podiatry to be involved in the development of the regulations for their new Acts. The College appreciates the opportunity to be involved and make our support and concerns known to these professions as they develop a broader scope of independent practice.

4. Hospital Review Program. After several decades of doing rural hospital reviews on a five-year cycle, the Council voted at its meeting Dec. 12, 2008, to cease the program as of Dec. 31, 2008. Although we thought the program had its uses, the College had no authority to carry out the reviews. There were times when significant suggestions were not or could not be followed up. Furthermore, the call on the College resources was extensive. Accreditation Canada now reviews most of these hospitals. Some hospitals looked forward to the reviews and comments, while others clearly considered it an imposition. The introduction of Regional Health Authorities also provided a framework for hospitals to be more tightly controlled by the regions. No longer do they operate as independent facilities, which was the reason the program was introduced in the first place. The Standards Department resources can now be used to develop the Continuing Professional Development program, which the College will be bringing in over the next two years. The College will still carry out a hospital review if so invited by the region or the province.

5. Continuing Professional Development. Nearly six years ago, Council agreed a formalized CPD program should be developed for this College. In 2007, The Medical Act was amended to permit this to happen. Terry Babick, M.D., Deputy Registrar, and Anna Ziomek, M.D., Assistant Registrar, are working together to develop this program for the doctors of Manitoba. The program will be coordinated by Dr. Babick through Standards, as the intent is that it will be primarily educational. To view other models, Drs. Babick and Ziomek have visited the Colleges of Alberta, Ontario and Nova Scotia, which already have developed useful programs. Future newsletters will contain more details as they are finalized. On behalf of all those here at the College, I wish you the very best for 2009. Once again, we are living in “interesting times”!

COMMUNICATION FROM WINNIPEG HOSPITALS TO RURAL FACILITIES

There are many concerns noted about referring physicians' difficulties getting information about their patients from Winnipeg hospitals. Brock Wright, M.D., CMO for the WRHA, has provided the following information about patient information:

1. Referring physicians are always entitled to receive information about their patient's stay in the receiving hospital. However, if the doctor dictating the discharge summary does not request a copy be sent to the referring physician, it won't happen. If the referring physician later requests a copy it will be provided without patient consent.

2. A referring hospital (as opposed to a referring physician) may request information about a patient without patient consent if it is for review by a standards committee.

3. If a test result, such as a Pathology report, is received after the discharge summary is sent, a referring physician may request a copy. This will be provided without patient consent.

4. Finally, changes to PHIA legislation are expected shortly and the WRHA will be launching new educational sessions for staff. This will help to clear up misunderstandings staff may have about PHIA. PHIA should not (and is not) an impediment to the ability to provide information to referring physicians.

The CPSM reminds physicians that when dictating discharge summaries, they should request a copy of the discharge summary be sent to the referring physician and/or referring hospital. To complete a review of patient care, Standards Committees may, through their hospitals' Medical Records Departments, request information about a patient, so that a review of patient care can be completed. Standards Committees are advised to refer the matter to the CPSM Central Standards Department when there are concerns about care provided in facilities elsewhere.

If physicians are having difficulty obtaining the information they need about their referred patients, they should first seek assistance from the site Health Information Services Directors who are also the site PHIA Privacy Officers. If resolution with the site contact is not forthcoming, physicians should contact Evelyn Fondse, Regional Director, Health Information Services, WRHA, phone: (204) 926-7832, fax: (204) 947-9964

Reprinted from vol. 45 no. 1 issue of From the College, published by the College of Physicians and Surgeons of Manitoba.

PRESIDENT ADDRESSES KEY CHALLENGES

Speaking at the recent Annual Dinner of the Medical Council of Ireland (Council), held in the Royal College of Physicians of Ireland, Professor Kieran Murphy, president of the Medical Council of Ireland, said the key challenges for the new Council were:

• the full implementation of Medical Practitioners Act, 2007;

• reform and modernization of Medical Council structures;

• engagement with the Medical Profession; and

• establishing trust and confidence of the medical profession and the public.

Professor Murphy said, “historically, there has been a perception that the Medical Council is a secretive, opaque and remote institution. By involving both the public and the profession in our committees and working groups, we will not only change this perception but, more importantly, will improve the reality. The new Medical Practitioners Act gives the medical profession and the public the structures to be included more widely and deeply in the practical workings of the Council than ever before.”

Professor Murphy thanked his two predecessors, John Hillery and Colm Quigley, for their leadership of the last Council, the Medical Council staff led by John Lamont and the present Council members who have shown “expertise, wisdom, strength of purpose and the ability to work together to resolve difficult issues”.

Reprinted from the Medical Council of Ireland website.

REVALIDATION: THE NEXT STEPS

On Nov. 5, 2008, Council agreed the next steps for the ongoing work of the General Medical Council (GMC) toward implementing revalidation. In addition to planning the introduction of licensing, another crucial step is to establish a United Kingdom Revalidation Program Board to oversee the delivery of revalidation in the four United Kingdom countries.

The United Kingdom Revalidation Program Board, which will report to the GMC, will include representatives from the four administrations, the Academy of Medical Royal Colleges, the GMC, the British Medical Association (BMA) and patient organizations, as well as the National Health Service (NHS) and other health care providers. It will ensure revalidation is delivered in a coordinated and consistent way across the United Kingdom.

As part of our work to launch the Program Board we are in the process of recruiting a chair whom we expect to have in place by the end of the year. The board will meet for the first time early in 2009. In the meantime, the GMC continues to make progress on a number of projects, working closely with organizations across the United Kingdom to gain a better understanding of how key components of revalidation will work at a local level.

The effectiveness of revalidation will depend upon the capacity for systems in the NHS and elsewhere to generate the required information and assurances about doctors' practice. It is important, therefore, for the GMC to develop further its understanding of how these systems will operate. The emerging findings of these projects will be reported to the United Kingdom Revalidation Program Board and will help inform further projects and pilots as we move closer to introducing revalidation.

In particular, we have been working closely with two organizations, the School of Postgraduate Medical and Dental Education in Wales and NHS Professionals (Doctors). The project in Wales is looking at the readiness of appraisal and clinical governance systems in general practice in Wales to support revalidation.

In order to achieve this, we have developed a self-assessment appraisal and clinical governance checklist for use by local health boards in Wales. We consulted on the checklist widely with a number of organizations including community health councils as well as local health boards (LHB). In addition, we are testing the checklist with a number of volunteer LHBs from across Wales.

Katie Laugharne, who has been leading on the project in Wales and is Organizational Lead for Appraisal and Continuing Professional Development (CPD) at the Deanery, described her experience of working with the GMC: “Working on the project is a privilege. In Wales we are glad of the opportunity to work with the GMC to evaluate our existing systems with a view to sharing good practice and informing future plans for revalidation.”

The GMC is also acutely aware that locum doctors may face particular challenges in generating supporting information for revalidation. The project with NHS Professionals (Doctors) is looking at the type, quantity and quality of information locum doctors are currently able to present at their appraisal discussions. This will help us to identify any areas where locum doctors may find it difficult to provide the necessary information for revalidation.

Reflecting on the project so far, Kwee Matheson, M.D., Clinical Director at NHS Professionals (Doctors), said: “We have all been learning through this project: our locum doctors about collecting information; my team about making our appraisal system more robust; and the GMC about what is feasible.”

The GMC has also been continuing to work with the Academy of Medical Royal Colleges on the development of recertification, on multi-source feedback and on continuing professional development within revalidation. In particular the Council is developing principles for MSF within revalidation, which will be consulted on in the early part of 2009.

More information about the Council's work on licensing and revalidation can be found at www.gmc-uk.org/about/reform/index.asp.

PRESCRIBING OFF-LABEL

This year has seen much debate in the media about the cost effectiveness of various medicines. Here we look at the prescribing issues involved and outline the GMC's guidance for doctors.

Doctors prescribe medicines for use outside the terms of their license (off-label) every day and in a variety of situations, most frequently in caring for children. That's usually because there is no suitable, appropriately licensed alternative.

But there may be other reasons why doctors might consider prescribing off-label, including the relatively high cost of some licensed medicines. A recent debate focused on the relatively high cost of a licensed drug, ranibizumab (Lucentis), and the reported use (overseas, in private practice and in some NHS trusts) of a cheaper, off-label alternative, bevacizumab (Avastin), in the treatment of wet age-related macular degeneration (wet-AMD).

AMD is a major cause of vision loss in older people. The Royal College of Ophthalmologists pointed to the absence of long-term information on safety and efficacy of prescribing Avastin off-label in the treatment of AMD. The NHS-funded IVAN trial, due to report in 2010, is comparing the safety and effectiveness of the two drugs in a head-to-head trial which will provide evidence of potential savings to the NHS in using Avastin off-label.

This has been perhaps the most high-profile debate to date about the use of drugs off-label to save money, and the role of the pharmaceutical companies in deciding which of their drugs to have licensed for different uses. The GMC's guidance states that doctors must be satisfied that prescribing off-label would better serve the patient's needs than use of an appropriately licensed alternative. Does that mean that cost can never be a consideration? And how does that sit with the duty to make efficient use of available resources?

The Medicines and Healthcare products Regulatory Agency and European Medicines Agency are responsible for assessing the safety or efficacy of drugs. The cost effectiveness of medicines for use in the NHS is a question for NICE and its equivalents in the devolved countries. Nobody but a medicine's manufacturer can apply for a license, and NICE cannot evaluate the cost effectiveness of unlicensed or off-label use of medicines.

A decision to prescribe off-label is the prescribing doctor's. They should be satisfied that there is a sufficient evidence base or experience of using the medicine to demonstrate its safety and efficacy to justify prescribing off-label.

The costs of prescribing different drugs is often a concern for doctors, and rightly so if they are to make efficient use of available resources in caring for all their patients. But cost alone cannot be the determining factor in a doctor's decision about which drugs to prescribe.

The medicines licensing regime serves to ensure that licensed drugs are used safely and effectively for the purposes they have been developed and tested for. It is axiomatic that the prescription of licensed drugs for their indicated uses should be a doctor's first choice. Sometimes, though, the off-label use of one medicine might be the best – or only – option, particularly if the patient or whoever funds their care cannot or will not pay for a more expensive, appropriately licensed alternative.

WHAT DOES THE GMC ADVISE?

When prescribing a medicine for use outside the terms of its license physicians must:

1. Be satisfied that it would better serve the patient's needs than an appropriately licensed alternative.

2. Be satisfied that there is a sufficient evidence base and/or experience of using the medicine to demonstrate its safety and efficacy. The manufacturer's information may be of limited help, in which case the necessary information must be sought from other sources.

3. Take responsibility for prescribing the medicine and for overseeing the patient's care, monitoring and any follow up treatment, or arrange for another doctor to do so.

4. Make a clear, accurate and legible record of all medicines prescribed and, where physicians are not following common practice, their reasons for prescribing the medicine.

At times physicians not have the resources to provide the best treatment or care that their patients need. At such times physicians' decisions should be based on sound research information on efficiency and efficacy, and in line with their duties to protect life and health, to respect patients' autonomy and to treat justly. In providing care physicians must make good use of available resources.

Reprinted from the GMC in Scotland November/December online version of GMCtoday.