The Ontario Medical Association (OMA) represents Ontario's nearly 25,000 physicians
and our mission is "To serve the medical profession and the people of Ontario
in the pursuit of good health and excellence in health care." Physicians
prescribe the vast majority of medications used by Ontarians and are dedicated
to seeking improvements to this important component of medical practice and,
as such, we welcome the opportunity to provide input into the Drug Strategy
Review.
We have structured our response based upon the questions posed by the Drug Strategy Review (DSR) Steering Committee and have attached a summary of key points at the end.
1. Achieving more patient-centred pharmaceutical care
DSR questions - how can the ODB program and pharmaceutical care be more responsive to patient needs and involve the patient in his/her care; how can ODB and pharmaceutical care focus on improving health outcomes; what are the most effective ways to promote optimal prescribing and use; and how can patient education be enhanced?
System level
Responsiveness to patient needs is impeded in the current system by the fact that the government drug budget is considered independent of other components of the health care system. As a result, pharmaceutical advances that save money in other parts of the system (eg. PPIs that have dramatically reduced the need for surgical interventions and multiple investigations/consultations) are not "credited" to the drug budget. The Ministry needs to engage in more integrated planning and management across divisions.
From the perspective of practising physicians, a genuine commitment to improving health outcomes requires that the government clearly prioritize medical necessity over fiscal considerations. This does not imply that prudent financial stewardship is not important; it simply means that meeting patient needs is the predominant value. In addition, physicians believe that cost-benefit calculations should go beyond drug prices and take into account issues such as increased productivity and quality of life considerations.
Many physicians have expressed concern about the lack of access to medications for low-income working people and it is suggested that the government explore the development of a pharmacare program with a means-based co-payment and a cap upon patient expenditures that could be available to a wider range of Ontarians than the current ODB, Special Drugs and Trillium programs.
Drug expenditures represent a significant and growing portion of the provincial budget and yet there does not appear to be a focussed and coordinated research agenda in this area. Evidence-based prescribing, by definition, requires on-going funding to support therapeutic best practices. The Ministry of Health and Long-term Care (MOHLTC) should initiate a process to begin such work. Stakeholders should be involved in priority setting and then the MOHLTC should deal directly with bodies such as the Institute for Clinical Evaluative Sciences to undertake the research. In addition, greater targeting of efforts towards patient groups that are at high risk would be of benefit.
When considering the DSR Steering Committee question relating to means to promote optimal prescribing and use, we were struck by the definitions associated with this item in the footnotes and respectfully disagree with the approach taken. Optimal prescribing should focus upon the clinical needs of the patient and should not be unduly influenced by the cost of the therapy. It has to take into account the unique aspects of the individual and be adaptable in order to accommodate the cutting edge of medical practice, as promoted by expert consensus. For example, the DQTC and Ministry have not kept up with practice changes relating to the use of gabapentin (Neurontin). We do recognize that affordability is important at the system level and agree that cost-effectiveness analyses are appropriate. Further, we appreciate that in instances where the clinical indications for two or more medications are equal, prescribers should be mindful of cost.
The OMA believes that there is a great deal of potential for cooperation and collaboration between government and the medical profession and recommends that processes be established to facilitate communication between the Drug Programs Branch (DPB) and the OMA. This might include such things as: input into drug reviews; participation at DQTC; assistance with finding experts in various specialty areas; and cooperation around communications to the medical profession.
Practice level
Physicians identified a variety of means by which prescribing could be optimized, many of which involve changes to DPB processes and will thus be addressed under the next section.
Physicians believe strongly that treatment decisions should be taken within the context of the doctor-patient relationship and that government intrusion into this relationship is inappropriate.
Physicians recognize the value of objective, evidence-based information and are supportive of self-teaching, clinical rounds and academic detailing (both individual and group) as means to acquire information about prescribing on an on-going basis. The OMA has long advocated for a comprehensive physician Drug Utilization Review as a method of affecting positive, incremental, improvements in physician prescribing. At present, physicians have no useful information available to them about their own prescribing, normative prescribing, or best prescribing practices in order to self-assess and make necessary changes. We urge the DSR Steering Committee to support this important concept.
In clear contrast to the benefits anticipated as a result of the introduction of a physician DUR program are the clear disadvantages associated with current practices related to pharmaceutical drug detailing targeted at physicians in their offices, based upon individual practice patterns. The use of this information by industry sales representatives clearly has an impact upon prescribing/sales, otherwise the pharmaceutical industry would not pay to obtain it. The OMA asks that the DSR Steering Committee recommend to government the introduction of legislation, similar to British Columbia, prohibiting the sale of physician prescribing information by pharmacists to third parties. This would not prevent industry detailing, but would take away information about individual prescribing patterns from sales representatives.
It is very difficult at present for physicians to get reliable and consolidated practice guideline information. The MOHLTC/OMA Guidelines Advisory Committee is building a solid reputation in this regard and the OMA recommends that the DPB utilize this resource. Generally speaking, prescribing guidelines should be integrated into broader clinical practice guidelines and should not stand-alone and therefore, the role of OPOT should be reviewed with a view to considering integrating this work with the Guidelines Advisory Committee. The Ministry may also wish to finance a new edition of the well-regarded 1998 book entitled "Drugs of Choice".
There is physician interest in the receipt of clear and focussed information from either the DPB or the DPB and OMA in cooperation. Such bulletins should provide usable practitioner information including: the most commonly treated conditions and treatments; efficacy; key drug interactions; and long-term benefit of the therapy. The Medical Letter was cited as a useful model to emulate.
With a few exceptions, the current OHIP Schedule of Benefits does not recognize or remunerate physicians for the time associated with medication review. Owing to the increased complexity of drug regimens and the greater reliance upon pharmaceuticals as the principal health intervention for many patients, physicians believe that consideration should be given to the introduction of such a code in order to enable the medical profession to improve medication management practices.
With respect to the use of medications, physicians seek better reconciliation between what they prescribe and what is actually taken by the patient. The DPB and pharmacists hold a great deal of useful information in this regard and the OMA recommends that some of this be shared with prescribers. Discussions including the DPB, OMA and Ontario Pharmacists' Association would be a useful first step in this area.
Patient Education
Patient education could be enhanced by the development of standardized drug information sheets that outline the purpose for which the medication is taken, common side effects, possible drug (and food) interactions. This would replace the information prepared by individual pharmacies and eliminate real or apparent contradictions between the information provided by doctors and pharmacists.
Patient education materials should make it clear that the medications provided under the ODB and other programs are a benefit and in accepting the benefit the patient assumes some responsibility for his/her own care (eg. compliance, provide best information possible to physician). Multiple formats and languages for these educational materials would be useful. The MOHLTC might wish to partner with patient advocacy groups in the preparation and/or dissemination of such materials in order to benefit from the existing grassroots expertise at such organizations. We note that patient education might also be enhanced if the government were to formally recognize the provider role in patient education and compensate it accordingly.
2. Improving ODB processes
DSR questions - how can the ODB program and processes be improved for Ontarians; how can we assure timely access to new and existing drug therapies that are effective and safe; what types of ODB program information should be available to the public, physicians, pharmacists and others and what would be the most effective communication strategies?
General
Ontario's physicians have a number of suggestions to improve the DPB and its programs. The first relates to the time it takes for the government of Ontario to list new drugs subsequent to receipt of federal Notice of Compliance and efforts should be made to shorten this time lag. In the event that Ontario participates in the Common Drug Review, we urge that the province use its leverage to ensure that the process meets Ontario's needs with respect to both effectiveness and cost reviews so that it is not then necessary to duplicate review efforts at the provincial level.
While the OMA is not directly involved in issues relating to pharmaceutical pricing, many physicians suggested that it might be useful for the government to consider the direct bulk purchase of certain medications in order to achieve discounts and then use the savings to off-set the need for fiscal management strategies such as LU and Section 8.
With respect to existing internal process, physicians have suggestions for the improvement of the over-all system, the DQTC, the Section 8 program and the Limited Use program, as follows.
Physicians question the need for the myriad of access mechanisms under the DPB (ie. Trillium, Special Drugs Program, Section 8, Limited Use and general benefits listing) and recommend that the DSR Steering Committee consider methods to streamline and consolidate these programs in order to reduce red tape and improve patient access to needed medications.
The OMA is unclear as to the need for Cabinet approval for all formulary changes and suggests that an internal review be undertaken to develop a change in legislation that allows certain decisions to be taken at lower levels. The present system is problematic in that it causes unnecessary delays in decision-making and, because of the level of confidentiality attached to cabinet documents, creates undue secrecy in the process (ie. closed DQTC process, lack of physician awareness or input, limited communication even after a decision is taken) and sometimes causes unwise decisions to be made.
As noted earlier in the submission, physicians are very concerned that the DPB seems to be driven primarily by cost-constraint, at the expense of patient access to medications. The current DQTC process appears to be biased towards cost as a determinant of listing status. At the same time, physicians believe that the DQTC is not always open to advances in the field and, therefore, the ODB, Section 8 and LU programs lag behind current practice. It is suggested that the clinical and cost functions of the DQTC be separated into sub-groups, each of which will independently review the relevant evidence and make recommendations to the full DQTC, which would be charged with bringing together the clinical effectiveness and cost considerations. This would permit a fulsome discussion of the clinical benefits to be tabled independent of financial arguments. It is recommended that the review relating to clinical effectiveness be managed by a clinician and that formal mechanisms be established for input from the medical profession. The clinical review body should also be charged with considering prominent "off label" indications for identified medications (eg. Topamax in bi-polar disorder).
Section 8 and Limited Use
When considering the LU and Section 8 processes, the DSR Steering Committee should not underestimate the depth and intensity of physician enmity to these programs. They are literally hated by the profession and the government's apparent unwillingness to consider alternatives is a cause of tremendous rancor. This frustration does not create a useful foundation for cooperative endeavours to better manage the drug budget. That having been said, physicians have a number of suggestions for the improvement of these programs.
There is a serious lack of transparency throughout the DPB, one of the most glaring of which is the lack of information available to prescribers about the Ministry's criteria for approval of Section 8 drugs. This must be remedied. Physicians also have concerns about the practice of keeping the identities of Section 8 reviewers secret and would have more confidence in the process if they knew the qualifications of the "experts" reviewing their requests.
Physicians find the current, letter-based, Section 8 system time consuming and inefficient. The turn-around times have become so long that they now routinely interfere with good medical care and must be shortened. The number of Section 8 drugs is escalating at an alarming rate and this needs to be addressed. Many of these drugs have 90% or higher approval rates, suggesting that physicians are not misapplying the rules. The OMA recommends, therefore, that consideration be given to alternatives to this process for such medications.
Under the current system, physicians not only bear the cost of system management through the paperwork burden and lost time, they must also pay for calls and faxes to the Ministry. It is recommended that the government develop a fee code for physician management of Section 8 requests and that the DPB establish a toll-free telephone and fax line for physicians to communicate with the Branch.
In the event that the government is unwilling to consider alternatives to Section 8, or as a transition while such mechanisms are being developed, it is suggested that the DPB consider expedited criteria and/or processes for certain Section 8 drugs and consider the feasibility of either a provider or patient registry to facilitate access to particular drugs or classes of drugs.
Physicians also have concerns about the short eligibility periods for Section 8 drugs and suggest that improvements be made in this area, particularly as it relates to loading dose and maintenance doses. In addition, medications for chronic conditions should not require annual approval.
A clear and transparent process needs to be established to facilitate the movement of medications from Section 8 to Limited Use and general benefits. This process should be supported by a continued and enhanced focus upon "modernization" activities at the DPB (ie. drug/class reviews) and the OMA believes that both of these processes should include input from practising physicians.
Like Section 8, the growing number of medications on the LU list poses a serious administrative burden for physicians. It should also be noted that this program is disproportionately more difficult for general and family practitioners, owing to the large number of codes that are used covering a wide range of conditions. Any improvements in this program will, therefore, be especially helpful to our over-taxed family physicians.
Physicians do not understand why the government insists upon the use of the "official" LU prescription pad. This is particularly problematic for physicians who do house calls, such as palliative care physicians, and prescribe a large number of LU drugs. It would be very helpful to be able to simply print the LU code on the regular prescription. Physicians who have moved to electronic systems have also expressed frustration about the LU pads, since the DPB will not accept a computer-generated version of the LU form. Not only is this administratively frustrating, it is a backwards step for patient safety, given the well-documented problems associated with hand-written prescriptions.
Also with respect to technology, physicians feel that it would be useful to have the capacity for electronic access in the submission of Section 8 claims. They would also like to have a MOHLTC version of the LU codes on a searchable database that is available for palm pilot or pocket PC formats.
3. Sustaining the ODB program for the future
DSR questions - how can we ensure that we obtain the best value in what we fund in order to sustain the ODB program for the future; how can we encourage investment and innovation in pharmaceutical/biotech research and development while ensuring that the ODB is focused on improving health outcomes through the use of good quality evidence of effectiveness and cost-effectiveness?
Physicians had no explicit comments with respect to the innovation aspect of the question, but with respect to sustainability, felt that it is important for the government to address the escalating cost of drugs.
SUMMARY OF OMA POINTS
Recommendation 1 - That the DSR Steering Committee support the introduction
of a comprehensive physician Drug Utilization Review program in order to give
physicians objective, evidence-based information about their own practice, normative
practices and best practice. The program would include use of clinical practice
guidelines, research findings, academic detailing, educational materials and
individualized feedback based upon prescribing profile.
Recommendation 2 - That the government clearly prioritize medical necessity over fiscal considerations as a commitment to improved health outcomes.
Recommendation 3 - That the DSR Steering Committee amend the definition of "optimal prescribing" it uses and that the government and DQTC modify current review processes in order to ensure that clinical effectiveness can be fully studied separate from cost considerations.
Recommendation 4 - That the DSR Steering Committee recommend to government the introduction of legislation, similar to British Columbia, prohibiting the sale of physician prescribing information by pharmacists to third parties.
Recommendation 5 - That there be consideration of the development of a fee code, or other mechanism, to remunerate physicians for the time associated with a comprehensive medication review.
Recommendation 6 - That discussions be pursued by the Drug Programs Branch, the Ontario Pharmacists' Association and the OMA in respect of an information loop back to physicians so that they can better reconcile what they prescribe with what patients actually take (or at least buy).
Recommendation 7 - That the DSR Steering Committee support the development of standardized drug information materials for patients in order to reduce actual or perceived contradictions between the information provided by doctors and pharmacists.
Recommendation 8 - That the government streamline the various programs relating to access to medications under its jurisdiction in order to reduce red tape and improve patient access to needed medications.
Recommendation 9 - That steps be taken to remove the requirement that Cabinet approve all formulary changes.
Recommendation 10 - That the DSR Steering Committee emphasize to government the depth and intensity of physician enmity to the Section 8 and Limited Use programs and seek alternatives to them. In the interim, steps should be taken to ameliorate the burden that has been placed upon providers for system management. Several suggestions can be found in the main text of the OMA submission.
Recommendation 11 - That the DSR Steering Committee closely examine the structure and processes within the Drug Programs Branch with a view to improving transparency throughout. For example, the clinical criteria upon which Section 8 approvals are granted are kept secret from physicians.
Prepared by OMA Health Policy Department