Healthy Skepticism Library item: 11055

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Publication type: report

British Columbia Medical Association
A Prescription for Quality: Improving Prescription Drug Policy in BC A Policy Paper by BC’s Physicians
: British Columbia Medical Association 2007 Jul
http://www.bcma.org/public/patient_advocacy/APrescriptionforQuality.pdf

Abstract:

Executive Summary
Concern over prescription drug policy in Canada is fuelled primarily by the growth in expenditures.
Prescription drugs are the fastest growing component of Canadian health care expenditures. As drug
costs escalate, questions have emerged about how to ensure the optimal use of medications, guarantee
patient safety, and better manage public prescription drug benefits.

This policy paper offers recommendations on six areas of particular importance to physicians in British Columbia:
1. Prescription drug expenditures
2. BC’s PharmaCare program
3. The promotion of prescription drugs (to both doctors and patients)
4. Information technology (and its relationship to patient safety)
5. Professional roles in prescribing
6. The National Pharmaceuticals Strategy
Twenty-four recommendations are offered.

The British Columbia Medical Association (BCMA) Prescription Drug Project Group conducted a review of the relevant peer-reviewed literature, a review of the literature produced by various stakeholders including governments and policy think tanks, and a survey of the BCMA membership in November 2006 on prescription drug policy. A description of the survey methodology is provided in Appendix A.

Drug costs
Research on prescription drug costs reveals several interesting trends, often contrary to conventional wisdom:
 Public spending on prescription drugs is increasing at a rapid pace across Canada. In British
Columbia, expenditure growth has increased faster than the national average, with average annual
growth of 11.3% from 1986 – 2006 (versus 10.6% nationally).
 Most of the growth is not due to increases in manufacturers’ prices or the aging of the population, but rather the volume and selection of drugs prescribed. Drugs classified by the Patented Medicine Prices Review Board (PMPRB) as “Category 3”, i.e., a new drug or dosage form of an existing drug that provides moderate, little, or no improvement over existing drugs, are leading cost drivers.1
 Increases in prescription drug use and expenditures per se are not necessarily problematic. In many cases, the health of the population benefits from increased prescribing. In other cases, additional spending on prescription drugs may represent a poor investment. The challenge for health care policymakers is to determine if and when the investment in prescription drugs, particularly in light of continued growth, is worth the expected return.

1 The PMPRB is the Patented Medicine Prices Review Board. It is “an independent quasi-judicial tribunal that limits the prices set by manufacturers for all patented medicines, new and existing, sold in Canada, under prescription or over the counter, to ensure they are not excessive.” (Patented Medicine Prices Review Board 2006).

Lessons from Abroad
Canada is not alone in its efforts to control prescription drug expenditures. Nearly all OECD
(Organisation for Economic Co-operation and Development) nations are spending significantly more each year on prescription drugs. We examined four countries whose public prescription drug programs
contained elements similar to those found here: Germany, New Zealand, Australia, and the Netherlands.
Several important lessons emerged:
1. Attempts by governments to impose solutions without the support of the medical profession (e.g.,
physician drug budgets in Germany) do not succeed. Efforts to control drug spending should be
managed collaboratively by physicians and the government.
2. Both the Australian and Dutch experiences demonstrate the difficulty of achieving drug cost
containment even with policies that have been successfully implemented elsewhere. Given the
unique policy environment in each jurisdiction, one cannot assume that “one size fits all.”
3. Every country studied had adopted some form of physician education for prescribing. The BCMA
believes that there may be opportunities for the programs like the Education for Quality Improvement
in Patient Care (EQIP), which operate as partnerships of the Ministry of Health, the BCMA, and other
relevant stakeholder organizations, to provide physicians with unbiased education on the efficacy,
cost, and cost-effectiveness of prescription drugs.

Because of its high profile in recent policy discussions, the New Zealand experience merits particular attention. Elements of New Zealand’s policies, including direct negotiations with manufacturers on drug prices, may be useful in BC. However, caution should be taken in following New Zealand’s example of a capped budget for public prescription drug expenditures. Even with a special authority mechanism in place, a budget cap means that some medication decisions are based purely on fiscal, not clinical, considerations. This is not appropriate.

BC’s PharmaCare Program
The lack of integration between hospital and outpatient drug formularies must be addressed. Failure to integrate hospital and outpatient formularies compromise patient care if prescriptions change upon hospital discharge or if patients receive new prescriptions upon discharge.

The BCMA is concerned about the lack of transparency in the PharmaCare formulary approval process.
PharmaCare must ensure the transparency of drug coverage decisions, as specified in the 2005
PharmaCare Review Implementation Final Report. These decisions should be binding on the BC
government. Moreover, all Canadian Expert Drug Advisory Committee (CEDAC) decisions should be
brought forward to the PharmaCare Drug Benefit Committee for review.

The involvement of the University of British Columbia’s (UBC’s) Therapeutics Initiative (TI) in the
formulary approval process is a unique feature of BC’s PharmaCare program. A significant minority
(26%) of physicians did not agree with the statement, “I trust the TI to provide independent information on prescription drugs.” This is problematic. Common criticisms suggest that the TI is too closely tied to government to provide objective information and that there is a lack of transparency in the TI decisionmaking process as well as the appointment of its members. An independent review of the membership appointments, decision-making processes, and the arms-length nature of the TI would help improve the profession’s perception of it.

The BCMA supports, in principle, Reference-Based Drug Pricing (RDP) provided it is clinically focused, fiscally responsible, and patient sensitive. However, BC physicians remain concerned over the implementation of RDP, particularly with respect to the potential for negative clinical impacts and limited patient access to necessary medications. For these reasons, BCMA support for RDP in British Columbia is contingent on the following.:
1. Implementation of a transparent process for careful evaluation of the therapeutic equivalence of drugs in current and future reference drug categories. This process must be ongoing, include a thorough assessment of the peer-reviewed literature, and be conducted by a working group whose
membership includes practising physicians, some of whom should be selected by the BCMA;
2. An assessment of the impact on health outcomes of RDP for all drug classes in the BC Reference
Drug Pricing Program, both current and future, on a short- and long-term basis;
3. Creation of a working group whose membership includes practising physicians, some of whom should
be selected by the BCMA for examining additional categories of reference-based drugs in the BC
Reference Drug Pricing Program; and
4. Appropriate reimbursement for physicians for the completion of special authority forms.
Promotion of Prescription Drugs

There is a palpable tension between prescription drug manufacturers and regulators over the proper role of advertising in the industry. The legitimate desire of manufacturers – who operate in a market and are accountable to shareholders – is to increase sales and market share. On the other hand, the equally legitimate desire of regulators and others is to curb excessively optimistic claims that could compromise patient safety. The BCMA recommends that:
 Direct-to-consumer advertising for prescription drugs be banned in Canada; and
 Health Canada appoint a watchdog to oversee and regulate drug manufacturers’ promotional
activities to the public and all health care providers and prescribers.
The BCMA supports the Canadian Medical Association (CMA) guidelines on appropriate relationships
between physicians and the pharmaceutical industry and encourages other health care providers to adopt similar guidelines.

Patient Safety and Information Technology
A number of information technology (IT) interventions have been introduced to reduce errors in
medication management, including e-prescribing or computerized physician order entry (CPOE), clinical decision support systems, electronic medical records (EMRs), and automated dispensing. In British Columbia, the implementation of PharmaNet in 1995, and its more recent expansion to physicians’ offices through the Medical Practitioner Access to PharmaNet (MPAP) program can facilitate further advances in e-prescribing. However, government should ensure that the integration and expansion of IT in prescribing is accompanied by a greater level of standardization than currently exists, the privacy of patient information is protected, start-up and ongoing funding for physicians to use e-prescribing systems is available, and the provision of physician access to PharmaNet is at no cost to physicians.

Professional Roles in Prescribing
In May 2006, the Alberta government approved the Pharmacists Profession Regulation, which allows for
a greatly expanded scope of practice for pharmacists. Similar efforts are likely to follow in other
provinces, and the implications for the practice of medicine are significant. The BCMA examined the
legislation in Alberta, activities in British Columbia and elsewhere in Canada, and experiences abroad, and recommends the following policy on professional prescribing:
 The right to prescribe medications independently for medical conditions must be reserved for qualified practitioners who are adequately trained to take a medical history, perform a physical examination, order and interpret appropriate investigations, and arrive at a working diagnosis.
 The BCMA endorses a role for pharmacists to independently renew prescriptions on a short-term
basis (maximum 30 days) under defined circumstances when a renewal cannot be readily obtained
from the patient’s physician. The pharmacist must notify the original prescribing physician and/or
regular family physician of the prescription renewal, in writing, as soon as reasonably possible.
 Delegated professional prescribing is acceptable provided that:
− It is part of a multidisciplinary practice (i.e., takes place in the physician’s office or as part of a virtual team).
− The multidisciplinary practice is led by a clinical team leader with ultimate responsibility for patient care and who is the best-trained generalist (in the majority of instances, this would be the GP).

The National Pharmaceuticals Strategy
In 2004, the First Ministers established a Ministerial Task Force (MTF) to develop the National
Pharmaceuticals Strategy (NPS). This task force is part of the larger 10-Year Plan to “Strengthen Health Care” and coordinates the efforts of federal, provincial, and territorial Health Ministers. In the two years since the creation of the MTF, stakeholders have expressed their views on the NPS through conferences and policy statements dedicated to exploring issues of pharmaceutical policy. Despite this interest from stakeholders, as well as the publicly-stated assurance from the MTF that “key stakeholders including patient groups, health care providers, insurers and industry – will be engaged as part of the development and implementation process to ensure the long-term success and viability of a National Pharmaceuticals Strategy”, the development of the NPS has taken place without meaningful input from any stakeholder.

The BCMA calls upon the NPS to honour its commitment to include meaningful physician input in the
development of its policies and recommendations. Further, the BCMA recommends that the NPS
expediently develop positions on the remaining four focus areas: (1) physician prescribing behaviour and optimal drug therapy; (2) e-prescribing; (3) generic drugs; and (4) improving analytic capability. The CMA’s joint statement on the NPS, written with the Coalition for a Canadian Pharmaceutical Strategy, provides a framework for undertaking this task.

List of Recommendations

Prescription Drug Policy
Recommendation #1. PharmaCare should negotiate directly with wholesalers and drug manufacturers to secure the best prices for PharmaCare-insured drugs.

Recommendation #2. PharmaCare should involve practising physicians in the decision-making process behind policies to control prescription drug expenditures.

Recommendation #3. PharmaCare should not implement a strict budget cap on public drug expenditures.

Recommendation #4. The BCMA supports the provision of educational materials on the efficacy and cost of prescription medications to BC physicians. This must be done on a regular basis through a continually funded, collaborative organization such as the program for Education for Quality Improvement in Patient Care (EQIP) with representation from the BCMA, the Ministry of Health, and other relevant stakeholder organizations.

British Columbia’s PharmaCare Program
Recommendation #5. The BC Ministry of Health should improve the integration and harmonization of hospital and outpatient formularies.

Recommendation #6. PharmaCare should ensure the transparency of drug coverage decisions, as specified in the 2005 PharmaCare Review Implementation Final Report. These decisions should be binding on the BC government.

Recommendation #7. All Canadian Expert Drug Advisory Committee (CEDAC) decisions should be brought forward to the BC PharmaCare Drug Benefit Committee for review.

Recommendation #8. PharmaCare should, no later than December 31, 2007, implement a process for regularly assessing the cost-effectiveness of existing drugs in the formulary as recommended in the BC Auditor General’s 2006 report on managing PharmaCare.

Recommendation #9. There should be an independent review of the membership appointments, decision-making processes, and the arms-length nature of the BC Therapeutics Initiative (TI), intended to improve transparency and objectivity, to be completed no later than December 31, 2007.

Recommendation #10. The BCMA supports, in principle, Reference-Based Drug Pricing (RDP) provided it is clinically focused, fiscally responsible, and patient sensitive. Support for the BC Reference Drug Pricing Program is contingent on the implementation of recommendations 11 – 14 below.

Recommendation #11. There must be a transparent process for evaluating the therapeutic equivalence of drugs in current and future reference drug categories. This process must be ongoing, include a thorough assessment of the peer-reviewed literature, and be conducted by a working group whose membership includes practising physicians, some of whom should be selected by the BCMA.

Recommendation #12. There must be an assessment of the impact on health outcomes of RDP for all drug classes in the BC Reference Drug Pricing Program, both current and future, on a short- and
long-term basis. This process must show that the application of reference-based drug pricing avoids
significant negative clinical outcomes.

Recommendation #13. A working group whose membership includes practising physicians, some of whom must be selected by the BCMA, must be created for examining additional categories of reference-based drugs in the BC Reference Drug Pricing Program.

Recommendation #14. Physicians must be appropriately reimbursed for the completion of special authority forms.

Promotion of Prescription Drugs
Recommendation #15. The prohibition on direct-to-consumer advertising for prescription drugs should continue and be enforced in Canada.

Recommendation #16. Health Canada should appoint a watchdog to oversee and regulate drug manufacturers’ promotional activities to the public and all health care providers and prescribers.

Recommendation #17. The BCMA supports the CMA guidelines on appropriate relationships between physicians and the pharmaceutical industry and encourages other health care providers to adopt similar guidelines.

Recommendation #18. The BC Ministry of Health, in conjunction with the BCMA and other health professional organizations, including but not limited to the College of Registered Nurses of British
Columbia, the College of Pharmacists of British Columbia, the Canadian Association of Chain Drug Stores, and the College of Physicians & Surgeons of British Columbia, should develop and provide accurate, unbiased prescription drug information to patients.

Information Technology
Recommendation #19. The BC Ministry of Health should provide adequate start-up and ongoing funding for physicians to use e-prescribing systems as part of BC’s e-health strategy and in support of the Physician Information Technology Office (PITO). The BC government must enable all physicians to have access to PharmaNet at no direct cost to physicians.

Professional Roles in Prescribing
Recommendation #20. The right to prescribe medications independently for medical conditions must be reserved for qualified practitioners who are adequately trained to take a medical history, perform a physical examination, order and interpret appropriate investigations, and arrive at a working diagnosis.

Recommendation #21. The BCMA endorses a role for pharmacists to independently renew prescriptions on a short-term basis (maximum 30 days) under defined circumstances when a renewal cannot be readily obtained from the patient’s physician. The pharmacist must notify the original prescribing physician and/or regular family physician of the prescription renewal, in writing, as soon as reasonably possible.

Recommendation #22. Delegated professional prescribing is acceptable provided that:
− it is part of a multidisciplinary practice (i.e., takes place in the physician’s office or as part of a virtual team), and
− the multidisciplinary practice is led by a clinical team leader with ultimate responsibility for patient care and who is the best-trained generalist (in the majority of instances, this would be the GP).

National Pharmaceuticals Strategy
Recommendation #23. The National Pharmaceuticals Strategy Ministerial Task Force must honour its 2004 commitment to include meaningful physician input in the development of its policies and recommendations.

Recommendation #24. The National Pharmaceuticals Strategy Ministerial Task Force must expediently develop positions on the remaining four focus areas: physician prescribing behaviour and optimal drug therapy; e-prescribing; generic drugs; and improving analytic capability.

Notes:

Full report accessible free at link to BCMA site. (.pdf file 61 pages)