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National pharmacare in Canada: Getting there from here

https://policybase.cma.ca/en/permalink/policy11959

Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
/PD13-02.pdf. Accessed 05/18/16. 42 Department of Finance Canada. Growing the middle class. http
  1 document  
Policy Type
Parliamentary submission
Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of 83,000 physician members, the Canadian Medical Association (CMA) welcomes this opportunity to provide input to the House of Commons Standing Committee on Health study on the Development of a National Pharmacare Program. Recognizing that the term “pharmacare” is used in different contexts, for the purposes of this brief, pharmacare is defined as a program whereby Canadians have comparable access to medically necessary prescription medications, irrespective of their ability to pay, wherever they live in Canada. The Canadian Medical Association (CMA) is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. Key Facts According to the Canadian Institute for Health Information (CIHI), in 2014, of the estimated $28.8 billion spent in Canada on prescription medications (representing 13.4% of total health spending), governmentsi accounted for 42.0%, and private insurers and out-of-pocket (OOP) payment accounted for 35.8% and 22.2% respectively.1 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. i Includes federal. Social security fund and provincial/territorial spending 1 Canadian Institute for Health Information. Prescribed drug spending in Canada, 2013: a focus on public drug programs. https://secure.cihi.ca/free_products/Prescribed%20Drug%20Spending%20in%20Canada_2014_EN.pdf. Accessed 05/15/16. 2 Royal Commission on Health Services. Report Volume One. Ottawa: Queen’s Printer, 1964. 3 Canadian Institute for Health Information. National Health Expenditure Database 1975 to 2015. Table D 3.1.1-D3.13.1 https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/08/16. 4 Statistics Canada. CANSIM Table 203-0022 Survey of household spending (SHS), household spending, Canada, regions and provinces, by household income quintile. Accessed 05/18/16. 5 Cancer Advocacy Coalition of Canada. 2014-15 Report Card on Cancer in Canada. http://www.canceradvocacy.ca/reportcard/2014/Report%20Card%20on%20Cancer%20in%20Canada%202014-2015.pdf. Accessed 05/08/16. 6 Canadian Cancer Society. Cancer drug access for Canadians. http://www.colorectal-cancer.ca/IMG/pdf/cancer_drug_access_report_en.pdf. Accessed 05/08/16. 7Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15. 8 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23. 9 Law M, Cheng L, Dhalla I, Heard D, Morgan S. The effect of cost on adherence to prescription medications in Canada. CMAJ 2012. 184)3):297-302. 10 Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care. Ann Inter Med 2014;160:441-50. Pharmacare is clearly part of the unfinished business of Medicare. Numerous authors have pointed out that Canada is the only developed country that does not include prescription medications as part of its universal health program. Table 1 below shows how Canada compares with the 22 member countries of the Organization for Economic Cooperation and Development (OECD) on the proportion of public spending for major categories of health expenditure in 2012. Table 1. Public spending as % of total spending: Major health spending categories, Canada and 22 OECD country average, 2012 % Public Spending Prescription Drugs Hospitals Doctors’ Offices Canada 42 91 99 OECD Average 70 88 72 Source: OECD.Stat, Doctors’ offices figure for Sweden is 2009 In the case of prescription medications, Canada was more than one-third (40%) below the OECD average. The Patchwork Quilt of Public-Private Coverage In 1964 the Hall Commission recommended 50/50 cost-sharing between the federal and provincial governments toward the establishment of a prescription drug program, with a $1.00 charge for each prescription. At the time, prescription medications represented 6.5% of spending on personal health services.2 This recommendation was not implemented. It might be further added that the Hall report contained 25 forward-looking recommendations on pharmaceuticals that remain current to this day, including bulk purchasing, generic substitution and a national formulary.2 As a result of the lack of inclusion of prescription medications in Medicare, there is wide variation today in public per capita spending on prescription drugs across the provinces. It may be seen in Table 2 that, for 2014, CIHI has estimated that public per capita expenditure ranged from $219 in British Columbia and $255 in Prince Edward Island (PE) to $369 in Saskatchewan and $437 in Quebec.3 CIHI does not provide estimates of private per capita prescription drug spending (private insurance plus OOP) below the national level. Table 2: Spending on prescription drugs: Selected indicators by province and territory, 2014 Province/ Territory Public spendinga ($ million) Public per capita spendinga ($ ) Private insuranceb ($ million) Average household out-of-pocketc $ NL 156.7 297 177 454 PE 37.3 255 32 516 NS 302.2 321 337 429 NB 210.8 280 284 477 QC 3,588.7 437 2,369 466 ON 4,730.4 346 4,626 324 MB 411.3 321 249 516 SK 415.4 369 192 514 AB 1,383.7 336 1,065 409 BC 1,015.8 219 894 456 YT 14.0 383 - - NT 17.5 400 - - NU 13.6 372 - - Territories 45.1 385 23 - Canada 12,297.4 334d 10,247 408 a CIHI, National Health Expenditure Database 1975-2015, includes all public funding sources b Canadian Life and Health Insurance Association c Statistics Canada, Survey of Household Spending, 2014 d Provincial/territorial average Table 2 also shows the significant role of private insurance in every region of Canada. Data provided by the Canadian Life and Health Insurance Association, shown in Column 3 of Table 2, show that private health insurance companies paid out $10.2 billion for prescription drug claims in 2014, representing 83% of the $12.3 billion paid for by governments. In three provinces — Newfoundland and Labrador, Nova Scotia and New Brunswick — the amount paid by private insurance exceeds that paid by governments. Table 2 also shows that there is wide variation in average household OOP spending on prescription drugs, according to Statistics Canada’s Survey of Household Spending (SHS). In 2014 this ranged from a low of $324 in Ontario to a high of $516 in PE and Manitoba.4 Even more striking variation is evident when looking at household out-of-pocket spending on prescription drugs by income quintile (detailed data not shown). According to the 2014 SHS the poorest one-fifth (lowest income quintile) of PE households spent more than twice as much ($645) OOP on prescription drugs than the poorest one-fifth in Ontario ($300).4 Aside from overall differences in public spending there are also differences in which medications are covered, particularly in the case of cancer drugs. The Cancer Advocacy Coalition of Canada reported in 2014 that four provinces have fully funded access to cancer medications taken at home. In Ontario and Atlantic Canada however, cancer drugs that must be taken in a hospital setting and are on the provincial formulary are fully funded by the provincial government; if the drug is taken outside of hospital (oral or injectable), the patient and family may have to pay significant costs out-of-pocket.5 More generally the Canadian Cancer Society has reported that persons moving from one province to another may find that a medication covered in their former province may not be covered in the new one. 6 Other sources confirm that prescription medication spending is an issue for many Canadians. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.7 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.8 At least two Canadian studies have documented the impact that out-of-pocket costs, lack of insurance and low income have on non-adherenceii to prescription regimens. Law et al. examined cost-related non-adherence in the 2007 Canadian Community Health Survey and found that those without drug insurance were more than four times as likely to report non-adherence than those with insurance. The predicted rate of non-adherence among those with high household incomes and drug insurance was almost 10 times as high as that among those with low incomes and no insurance (35.6% vs. 3.6%).9 Based on a large-scale study of the incidence of primary non-adherence (defined as not filing a new prescription within nine months) in a group of some 70,000 Quebec patients, Tamblyn et al. reported that there was a 63% reduction in the odds of non-adherence among those with free medication over those with the maximum level of co-payment. They also reported that the odds of non-adherence increased with the cost of the medication prescribed.10 ii Non-adherence can be defined as doing something to make a medication last longer or failing to fill or renew a prescription. Previous Pharmacare Proposals In a recent monograph Katherine Boothe has contrasted the development of national prescription medication programs in Australia and the United Kingdom with the failure to do so in Canada.11 11 Boothe K. Ideas and the pace of change: national pharmaceutical insurance in Canada, Australia and the United Kingdom. Toronto: University of Toronto Press, 2015. 12 National Forum on Health. Directions for a pharmaceutical policy in Canada. http://www.hc-sc.gc.ca/hcs-sss/pubs/renewal-renouv/1997-nfoh-fnss-v2/index-eng.php. Accessed 05/18/16. 13 National Forum on Health. Canada health action: building on the legacy. Ottawa: Minister of Public Works and Government Services, 1997. 14 Bank of Canada. Inflation calculator. http://www.bankofcanada.ca/rates/related/inflation-calculator/?page_moved=1. Accessed 05/18/16. 15 Statistics Canada. Table 051-0001 Estimates of population, by age group and sex for July 1, Canada, provinces and territories. Accessed 05/15/16. 16 Canadian Institute for Health Information. National health expenditure database 1975 to 2015. Table C.3.1. Public health expenditure by use of funds, Canada, 1975 to 2015. https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/25/16. 17 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965. 18 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1969. Ottawa: Queen’s Printer for Canada, 1969. 19 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1972. Ottawa: Information Canada, 1972. 20 Privy Council Office. Speech from the Throne to open the first session thirty-sixth Parliament of Canada. http://www.pco-bcp.gc.ca/index.asp?lang=eng&page=information&sub=publications&doc=aarchives/sft-ddt/1997-eng.htm. Accessed 05/18/16. 21 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. Ottawa, 2002. 22 Commission on the Future of Health Care in Canada. Building on values: the future of health care in Canada. Ottawa, 2002. 23 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ accord on health care renewal. http://www.scics.gc.ca/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 05/18/16. 24 Council of the Federation. Premiers’ action plan for better health care: resolving issues in the spirit of true federalism. Communiqué July 30, 2004. http://canadaspremiers.ca/phocadownload/newsroom-2004/healtheng.pdf. Accessed 05/18/16. 25 Canadian Intergovernmental Conference Centre. A 10-year plan to strengthen health care. http://www.scics.gc.ca/CMFiles/800042005_e1JXB-342011-6611.pdf. Accessed 05/18/16. 26 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 05/18/16. 27 Canadian Intergovernmental Conference Secretariat. Backgrounder: national pharmaceutical strategy decision points. http://www.scics.gc.ca/english/conferences.asp?a=viewdocument&id=112. Accessed 05/18/16. 28 Canada’s Premiers. The pan-Canadian Pharmaceutical Alliance: April 2016 Update. http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance. Accessed 05/18/16. 29 Canadian Medical Association. General Council Resolution GC15-C16, August 26, 2015. 30 Gagnon M. The economic case for universal pharmacare. 2010. https://s3.amazonaws.com/policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2010/09/Universal_Pharmacare.pdf. Accessed 05/18/16. 31 Gagnon M. A roadmap to a rational pharmacare policy in Canada. Ottawa: Canadian Federation of Nurses Unions, 2014. 32 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ. 2015 Apr 21;187(7):491-7. doi: 10.1503/cmaj.141564. 33 Morgan S, Martin D, Gagnon M, Mintzes B, Daw, J, Lexchin, J. Pharmacare 2020. The future of drug coverage in Canada. http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf. Accessed 05/18/16. 34 Canadian Medical Association. Policy resolution GC15-C19, August 26, 2015. 35 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 05/18/16. 36 Government of the United Kingdom. Written statement to Parliament NHS charges from April 2016. https://www.gov.uk/government/speeches/nhs-charges-from-april-2016. Accessed 05/18/16. 37 Appleby J. Prescription charges: are they worth it? BMJ 2014;348:g3944 doi: 10.1136/bmj.g3944. Among the several Canadian attempts that she describes, the most activity occurred in the decade following the National Forum on Health (NFH), which was struck in 1994 and reported in 1997. A NFH working group paper on pharmaceutical policy recommended first dollar coverage for prescription medications, but acknowledged that it could not occur overnight: “over time we propose to shift private funding on prescribed pharmaceuticals (estimated at $3.6 billion in 1994) to public funding”.12 The NFH included this recommendation in its final report, noting that “the absorption of currently operating plans by a public system may involve transfer of funding sources as well as administrative apparatus”.13 It is instructive to place the 1994 prescription drug expenditure cited by the NFH in today’s context. According to the Bank of Canada’s inflation calculator, the $6.5 billion in 1994 would have cost $9.5 billion in 2014.14 CIHI estimates that actual spending in 2014 was $28.7 billion1 – 203% above the level of 1994 spending, compared to population growth of 23% over the same time period.15 Annual prescription drug spending increases averaged 7.3% over the period, although they have averaged just over 1% since 2009. 16 A significant shift from private to public funding is not without precedent. A study prepared for the Hall Commission estimated that 9.6 million Canadians, representing 53% of the total population, had some form of not-for-profit or commercial insurance coverage for medical and/or surgical services in 1961.17 With the passage of the Medical Care Act in 1966 these plans were all displaced as the provinces joined Medicare. The funding shift did not occur overnight, although it did move quickly. In the first year, 1968/69, Ottawa paid out $33 million to the provinces pursuant to the Medical Care Act, which grew quickly to $181 million in 1969/70, and reaching $576.5 million in 1971/72.18,19 Since the 1997 NFH report the closest that the federal government has come to acting on pharmacare was a commitment in the 1997 Speech from the Throne to “develop a national plan, timetable and a fiscal framework for providing Canadians with better access to medically necessary drugs”, but nothing further was ever made public.20 Pharmacare was subsequently examined in two national studies, both of which recommended federal involvement in reimbursing “catastrophic” prescription drug expenditures above a threshold of household income. The Senate study on the State of the Health Care System in Canada, chaired by Michael Kirby, was authorized in March 2001 and the Commission on the Future of Health Care in Canada, headed by Roy Romanow, was approved in April 2001. Both issued their final reports in 2002. The Kirby plan was designed so as to avoid the necessity of eliminating existing private plans or the provincial/territorial public plans, not unlike the approach taken by Quebec in 1997. In the Kirby plan, in the case of public plans, personal prescription medication expenses for any family would be capped at 3% of total family income. The federal government would then pay 90% of prescription drug expenses in excess of $5,000. In the case of private plans, sponsors would have to agree to limit out-of-pocket costs to $1,500 per year, or 3% of family incomes, whichever was less. The federal government would then agree to pay 90% of drug costs in excess of $5,000 per year. Both public and private plans would be responsible for the difference between out-of-pocket costs and $5,000, and private plans would be encouraged to pool their risk. Kirby estimated that this plan would cost approximately $500 million per year.21 The Romanow Commission recommended a $1 billion Catastrophic Drug Transfer through which the federal government would reimburse 50% of the costs of provincial and territorial drug insurance plans above a threshold of $1,500 per person per year.22 The advantage of these proposals is that they are fully scalable. The federal government could adjust either the out-of-pocket household income threshold, the ceiling above which it would assume costs, or the percentage of costs that it would pay above the ceiling. Following the Kirby and Romanow reports there was a back and forth exchange between the federal and provincial-territorial (PT) governments on a plan for catastrophic coverage. In their February 2003 Accord, First Ministers agreed to ensure that Canadians would have reasonable access to catastrophic drug coverage by March 2006.23 At their annual summer meeting in 2004 the Premiers later called on the federal government to “assume full financial responsibility for a comprehensive drug program for all Canadians”, with compensation to Quebec for its drug program.24 In the September 2004 Health Accord, First Ministers directed health ministers to develop a nine-point National Pharmaceuticals Strategy (NPS), including costing options for catastrophic coverage.25 A federal-provincial-territorial Ministerial Task Force on the NPS was struck and a progress report was issued in June 2006. The estimates of catastrophic spending were markedly higher than those of the Kirby and Romanow reports. Using a variable percentage of income threshold it estimated that, based on public plan costs, only catastrophic spending represented 42% of total prescription drug spending. If private plan costs were also considered, catastrophic spending would represent 55% of total prescription drug spending. This report proposed four options for catastrophic coverage with estimates for new public funding ranging from $1.4 to $4.7 billion.26 Although no account of the methods was provided it is evident that a significant proportion of existing plan costs were included in the estimates of catastrophic expenditure. At their September 2008 meeting, the PT health ministers called for a national standard for drug coverage not to exceed 5% of net income and for the federal government to share 50/50 in the estimated $5.03 billion cost.27 The uncertainty about the projected cost of a pharmacare plan resulting from widely varying estimates has doubtless contributed to a reluctance of governments to engage on advancing this issue. Recent Developments At the PT level, there has been a concerted effort on price negotiations during the past few years through the pan-Canadian Pharmaceutical Alliance (pCPA) that was established in 2010. As of March 31, 2015, the pCPA reported that price reductions in generic and brand-name prescription medications result in annual savings of an estimated $490 million.28 The federal drug plans are now participating in the pCPA and the CMA has recommended that the pCPA should also invite the participation of private health insurance companies.29 The prospect of savings through lower prices has been foundational to two recent studies that have made the case that a single public payer pharmacare program with little or no co-payment is affordable. The first was by Marc-André Gagnon in 2010. The proposal was developed on the basis of a review of cross-provincial and international practices in pharmaceutical policy. The review formed the basis of a set of 11 assumptions that were used to develop four scenarios that resulted in estimates of prescription drug cost savings over the 2008 baseline expenditure of $25.1 billion that ranged to $2.7 billion to $10.7 billion.30 In a 2014 update Gagnon estimated that a first dollar coverage program would save 10% to 41% of prescription drug costs, representing savings of as much as $11.4 billion annually on a 2012-13 base of $27.7 billion.31 Steve Morgan and colleagues (2015) have estimated that a universal public plan with small co-payments could reduce prescription drug spending by $7.3 billion.32 Subsequently, in Pharmacare 2020 Morgan et al. set out five recommendations calling for the implementation of a single payer system with a publicly accountable management agency by 2020.33 Taking a First Step Forward At its 2015 annual meeting, the CMA adopted a policy resolution that supports the development of an equitable and comprehensive national pharmacare program.34 Reflecting on the experience of the past 40 years since the enactment of the Established Programs Financing Act in 1977 that eliminated 50:50 cost-sharing, it seems highly unlikely that the federal government would take on a new open-ended program in the health and social arena, cost-shared or not. However, notwithstanding the progress of the pCPA, we are unlikely to address the significant access gaps in prescription medication coverage without the involvement of the federal government. These are fiscally challenging times for both levels of government, with budget deficits expected for several years to come. As noted previously, the Kirby and Romanow proposals for a federal funding role in pharmacare are scalable. In 2015 the CMA commissioned the Conference Board of Canada to model the cost of covering prescription medication expenditure beyond a household spending threshold of $1,500 or 3% of gross household income, based on Statistics Canada’s 2013 Survey of Household Spending. The projected costs over the 2016 to 2020 are shown in Table 3 below. The cost to the federal government of covering the entire amount above the ($1,500 – 3%) threshold would be $1.6 billion in 2016.35 Recommendation 1: The Canadian Medical Association recommends that the House of Commons Standing Committee on Health request the Parliamentary Budget Officer to conduct a detailed examination of the financial burden of prescription medication coverage across Canada and to develop costing options for a federal contribution to a national pharmacare program. Recommendation 2: As a positive step toward comprehensive, universal coverage for prescription medications, the Canadian Medical Association recommends that the federal government establish a cost-shared program of coverage for prescription medications. First dollar coverage? The issue of co-payment arises in most discussions of pharmacare. Hall recommended a $1.00 prescription charge in 1964. In England, which does include prescription medications in the National Health Service (NHS), the current prescription charge is £8.40, although the government has previously noted that 90% of prescription items are provided free of charge.36 Appleby has noted however that the NHS’s in Wales, Northern Ireland and Scotland have eliminated prescription charges.37One observational study of dispensing rates in Wales found that the overall impact of removing prescription charges was minimal.38 Table 4 shows the total volume of prescriptions dispensed in Scotland over the period 2009-2015, which straddles the removal of prescription charges on April 1, 2011. It indicates that percentage increases in the annual dispensing volume diminished after 2012 and the increase observed in 2015 was just 1.4%. It should be added, however, that patient charges accounted for less than 4% of Scotland’s dispensing expenditures in 2010.39 It will be interesting to see the results of further studies in these jurisdictions. 38 Cohen D, Alam M, Dunstan F, Myles S, Hughes D, Routledge P. Abolition of prescription copayments in Wales: an observational study on dispensing rates. Value in Health 2010;13(5):675-80. 39 ISD Scotland. Prescribing and medicines. Data tables. http://www.isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Publications/data-tables.asp?Co=Y. Accessed 05/15/16. 40 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 05/18/16. 41 Canadian Medical Association. Vision for e-prescribing; a joint statement by the Canadian Medical Associaiton and the Canadian Pharmacists Association. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-02.pdf. Accessed 05/18/16. 42 Department of Finance Canada. Growing the middle class. http://www.budget.gc.ca/2016/docs/plan/budget2016-en.pdf. Accessed 05/18/16. Table 4 Prescription Dispensing in Scotland, 2009 – 2015 Year Number of Prescriptions % increase from previous year (million) 2009 88.4 3.8 2010 91.0 3.0 2011 93.8 3.1 2012 96.6 3.0 2013 98.4 1.9 2014 100.6 2.2 2015 102.0 1.4 Source: annual tabulations - Remuneration and reimbursement details for all prescribing made in Scotland.39 Other Elements of a National Pharmaceuticals Strategy It was noted previously that the Hall Report contained 25 recommendations on pharmaceuticals, and the 2004 Health Accord called for a 9-point National Pharmaceuticals Strategy. Two of the NPS points that the CMA would emphasize are the need to influence prescribing behaviour and the need to advance electronic prescribing (e-prescribing). The CMA refers to the first of these points as “optimal prescribing” and defines it as the prescription of a medication that is: the most clinically appropriate for the patient’s condition; safe and effective; part of a comprehensive treatment plan; and the most cost-effective available to best meet the patient’s needs. Toward this end the CMA has identified principles and recommendations to promote optimal prescribing, including the need for current information on cost and cost-effectiveness.40 The CMA believes that e-prescribing has the potential to improve patient safety, to support clinical decision-making and medication management, and to increase awareness of cost and cost-effectiveness considerations. In 2012 the CMA and the Canadian Pharmacists Association adopted a joint vision statement calling for e-prescribing to be the means by which prescriptions are generated for Canadians by 2015.41 Clearly that date has come and gone and we are not there yet. The current state primarily consists of demonstration projects and “workarounds”. The CMA was pleased to see an amount of $50 million allocated to Canada Health Infoway in the 2016 federal budget to support the advancement of e-prescribing and telehomecare.42 Finally the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures governments might take to implement a pharmacare program these must not exacerbate drug shortages. Recommendation 3: The Canadian Medical Association recommends that the Federal/Provincial/Territorial health Ministers direct their officials to convene a working group on a comprehensive National Pharmaceuticals Strategy that will consult widely with stakeholders representing patients, prescribers, and the health insurance and pharmaceutical industries to report with recommendations by spring 2017. Conclusion In conclusion, few would argue that prescription medications are less vital to the health and health care of Canadians than hospital and medical services. We would not have had the Medicare program that Canadians cherish today without the leadership and financial contribution of the federal government, and similarly without it now we will not have any form of a national pharmacare program.

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Guiding principles for the optimal use of data analytics by physicians at the point of care

https://policybase.cma.ca/en/permalink/policy11812

Last Reviewed
2020-02-29
Date
2016-02-27
Topics
Health information and e-health
information [CMA policy]. CMAJ 2002 167(4):393-4. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD02-09
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2016-02-27
Topics
Health information and e-health
Text
Electronic tools are now being used more widely in medicine than ever before. A majority of physicians in Canada have adopted electronic medical records (EMRs)-75% of physicians use EMRs to enter or retrieve clinical patient notes, and 80% use electronic tools to access laboratory/diagnostic test results. The increased use of point-of-care tools and information repositories has resulted in the mass digitization and storage of clinical information, which provides opportunities for the use of big data analytics. Big data analytics may come to be understood as the process of examining clinical data in EMRs cross-referenced with other administrative, demographic and behavioural data sources to reveal determinants of patient health and patterns in clinical practice. Its increased use may provide opportunities to develop and enhance clinical practice tools and to improve health outcomes at both point-of-care and population levels. However, given the nature of EMR use in Canada, these opportunities may be restricted to primary care practice at this time. Physicians play a central role in finding the right balance between leveraging the advantages of big data analytics and protecting patient privacy. Guiding Principles for the Optimal Use of Data Analytics by Physicians at the Point of Care outlines basic considerations for the use of big data analytics services and highlights key considerations when responding to requests for access to EMR data, including the following: * Why will data analytics be used? Will the safety and effectiveness of patient care be enhanced? Will the results be used to inform public health measures? * What are the responsibilities of physicians to respect and protect patient and physician information, provide appropriate information during consent conversations, and review data sharing agreements and consult with EMR vendors to understand how data will be used? As physicians will encounter big data analytics in a number of ways, this document also outlines the characteristics one should be looking for when assessing the safety and effectiveness of big data analytics services: * protection of privacy * clear and detailed data sharing agreement * physician-owned and -led data collaboratives * endorsement by a professional or recognized association, medical society or health care organization * scope of services and functionality/appropriateness of data While this guidance is not a standalone document-it should be used as a supplemental reference to provincial privacy legislation-it is hoped that it can aid physicians to identify suitable big data analytics services and derive benefits from them. Introduction This document outlines basic considerations for the use of big data analytics services at the point of care or for research approved by a research ethics board. This includes considerations when responding to requests for access to data in electronic medical records (EMRs). These guiding principles build on the policies of the Canadian Medical Association (CMA) on Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records,1 Principles Concerning Physician Information2 and Principles for the Protection of Patients' Personal Health Information,3 the 2011 clinical vignettes Disclosing Personal Health Information to Third Parties4 and Need to Know and Circle of Care,5 and the Canadian Medical Protective Association's The Impact of Big Data on Healthcare and Medical Practice.6 These guiding principles are for information and reference only and should not be construed as legal or financial advice, nor is this document a substitute for legal or other professional advice. Physicians must always comply with all legislation that applies to big data analytics, including privacy legislation. Big data analytics in the clinical context involves the collection, use and potential disclosure of patient and physician information, both of which could be considered sensitive personal information under privacy legislation. Big data analytics has the potential to improve health outcomes, both at the point of care and at a population level. Doctors have a key role to play in finding the right balance between leveraging the advantages of big data (enhanced care, service delivery and resource management) and protecting patient privacy.7 Background A majority of physicians in Canada have adopted EMRs in their practice. The percentage of physicians using EMRs to enter or retrieve clinical patient notes increased from 26% in 2007 to 75% in 2014. Eighty percent of physicians used electronic tools to access laboratory/diagnostic test results in 2014, up from 38% in 2010.8 The increasingly broad collection of information by physicians at the point of care, combined with the growth of information repositories developed by various governmental and intergovernmental bodies, has resulted in the mass digitization and storage of clinical information. Big data is the term for data sets so large and complex that it is difficult to process them using traditional relational database management systems, desktop statistics and visualization software. What is considered "big" depends on the infrastructure and capabilities of the organization managing the data.9 Analytics is the discovery and communication of meaningful patterns in data. Analytics relies on the simultaneous application of statistics, computer programming and operations research. Analytics often favours data visualization to communicate insight, and insights from data are used to guide decision-making.10 For physicians, big data analytics may come to be understood as the process of examining the clinical data in EMRs cross-referenced with other administrative, demographic and behavioural data sources to reveal determinants of patient health and patterns in clinical practice. This information can be used to assist clinical decision-making or for research approved by a research ethics board. There are four types of big data analytics physicians may encounter in the provision of patient care. They are generally performed in the following sequence, in a continuous cycle11,12,13,14: 1. Population health analytics: Health trends are identified in the aggregate within a community, a region or a national population. The data can be derived from biomedical and/or administrative data. 2. Risk-based cost analysis: Populations are segmented into groups according to the level of risk to the patient's health and/or cost to the health system. 3. Care management: Clinicians are enabled to manage patient care according to defined care pathways and clinical protocols informed by population health analytics and risk-based cost analysis. Care management includes the following: o Clinical decision support: Outcomes are predicted and/or alternative treatments are recommended to clinicians and patients at the point of care. o Personalized/precision care: Personalized data sets, such as genomic DNA sequences for at-risk patients, are leveraged to highlight best practice treatments for patients and practitioners. These solutions may offer early detection and diagnosis before a patient develops disease symptoms. o Clinical operations: Workflow management is performed, such as wait-times management, mining historical and unstructured data for patterns to predict events that may affect care. o Continuing education and professional development: Longitudinal performance data are combined across institutions, classes, cohorts or programs with correlating patient outcomes to assess models of education and/or develop new programs. 4. Performance analytics: Metrics for quality and efficiency of patient care are cross-referenced with clinical decision-making and performance data to assess clinical performance. This cycle is also sometimes understood as a component of "meaningful" or "enhanced" use of EMRs. How might physicians encounter big data analytics? Many EMRs run analytics both visibly (e.g., as a function that can be activated at appropriate junctures in the care pathway) and invisibly (e.g., as tools that run seamlessly in the background of an EMR). Physicians may or may not be aware when data are being collected, analyzed, tailored or presented by big data analytics services. However, many jurisdictions are strengthening their laws and standards, and best practices are gradually emerging.15 Physicians may have entered into a data sharing agreement with their EMR vendor when they procured an EMR for their practice. Such agreements may include provisions to share de-identified (i.e., anonymized) and/or aggregate data with the EMR vendor for specified or unspecified purposes. Physicians may also receive requests from third parties to share their EMR data. These requests may come from various sources: * provincial governments * intergovernmental agencies * national and provincial associations, including medical associations * non-profit organizations * independent researchers * EMR vendors, service providers and other private corporations National Physician Survey results indicate that in 2014, 10% of physicians had shared data from their EMRs for the purposes of research, 10% for chronic disease surveillance and 8% for care improvement. Family physicians were more likely than other specialists to share with public health agencies (22% v. 11%) and electronic record vendors (13% v. 2%). Specialists were more likely than family physicians to share with researchers (59% v. 37%), hospital departments (47% v. 20%) and university departments (28% v. 15%). There is significant variability across the provinces with regard to what proportion of physicians are sharing information from their EMRs, which is affected by the presence of research initiatives, research objectives defined by the approval of a research ethics board, the adoption rates of EMRs among physicians in the province and the functionality of those EMRs.16 For example, there are family practitioners across Canada who provide data to the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). The CPCSSN is a multi-disease EMR surveillance and research system that allows family physicians, epidemiologists and researchers to understand and manage chronic care conditions for patients. Health information is collected from EMRs in the offices of participating family physicians, specifically information about Canadians suffering from chronic and mental health conditions and three neurologic conditions, including Alzheimer's and related dementias.17 In another example, the Canadian Partnership Against Cancer's Surgical Synoptic Reporting Initiative captures standardized information about surgery at the point of care and transmits the surgical report to other health care personnel. Surgeons can use the captured information, which gives them the ability to assess adherence to the clinical evidence and safety procedures embedded in the reporting templates, to track their own practices and those of their community.18 The concept of synoptic reporting-whereby a physician provides anonymized data about their practice in return for an aggregate report summarizing the practice of others -can be expanded to any area in which an appropriate number of physicians are willing to participate. Guiding principles for the use of big data analytics These guiding principles are designed to give physicians a starting point as they consider the use of big data analytics in their practices: * The objective of using big data analytics must be to enhance the safety and/or effectiveness of patient care or for the purpose of health promotion. * Should a physician use big data analytics, it is the responsibility of the physician to do so in a way that adheres to their legislative, regulatory and/or professional obligations. * Physicians are responsible for the privacy of their individual patients. Physicians may wish to refer to the CMA's policy on Principles for the Protection of Patients' Personal Health Information.19 * Physicians are responsible for respecting and protecting the privacy of other physicians' information. Physicians may wish to refer to the CMA's policy on Principles Concerning Physician Information.20 * When physicians enter into and document a broad consent discussion with their patient, which can include the electronic management of health information, this agreement should convey information to cover the elements common to big data analytics services. * Physicians may also wish to consider the potential for big data analytics to inform public health measures and enhance health system efficiency and take this into account when responding to requests for access to data in an EMR. * Many EMR vendors provide cloud-based storage to their clients, so information entered into an EMR may be available to the EMR vendor in a de-identified and/or aggregate state. Physicians should carefully read their data sharing agreement with their EMR vendor to understand how and why the data that is entered into an EMR is used, and/or they should refer to the CMA's policy on the matter, Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records.21 * Given the dynamic nature of this emerging tool, physicians are encouraged to share information about their experiences with big data analytics and its applications with colleagues. Characteristics of safe and effective big data analytics services 1. Protection of privacy Privacy and security concerns present a challenge in linking big data in EMRs. As data are linked, it becomes increasingly difficult to de-identify individual patients.22 As care is increasingly provided in interconnected, digital environments, physicians are having to take on the role of data stewardship. To that end, physicians may wish to employ conservative risk assessment practices-"should we" as opposed to "can we" when linking data sources-and obtain express patient consent, employing a "permission-based" approach to the collection and stewardship of data. 2. A clear and detailed data sharing agreement Physicians entering into a contract with an EMR vendor or other third party for provision of services should understand how and when they are contributing to the collection of data for the purposes of big data analytics services. There are template data sharing agreements available, which include the basic components of safe and effective data sharing, such as the model provided by the Information and Privacy Commissioner of Ontario.23 Data sharing agreements may include general use and project-specific use, both of which physicians should assess before entering into the agreement. When EMR access is being provided to a ministry of health and/or regional health authority, the data sharing agreement should distinguish between access to administrative data and access to clinical data. Physicians may wish to refer to the CMA's policy on Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records.24 3. Physician-owned and -led data collaboratives In some provinces there may exist opportunities to share clinical data in physician-owned and -led networks to reflect on and improve patient care. One example is the Physicians Data Collaborative in British Columbia, a not-for-profit organization open to divisions of family practice.25 Collaboratives such as this one are governed by physicians and driven by a desire to protect the privacy and safety of patients while producing meaningful results for physicians in daily practice. Participation in physician-owned data collaboratives may ensure that patient data continue to be managed by physicians, which may lead to an appropriate prioritization of physicians' obligations to balance patient-centred care and patient privacy. 4. Endorsement by a professional or other recognized association or medical society or health care organization When considering use of big data analytics services, it is best to select services created or endorsed by a professional or other recognized association or medical society. Some health care organizations, such as hospitals, may also develop or endorse services for use in their clinical environments. Without such endorsement, physicians are advised to proceed with additional caution. 5. Scope of services and functionality/appropriateness of data Physicians may wish to seek out information from EMR vendors and service providers about how big data analytics services complement the process of diagnosis and about the range of data sources from which these services draw. While big data analytics promises insight into population health and practice trends, if it is not drawing from an appropriate level of cross-referenced sources it may present a skewed picture of both.26 Ultimately, the physician must decide if the sources are appropriately diverse. Physicians should expect EMR vendors and service providers to make clear how and why they draw the information they do in the provision of analytics services. Ideally, analytics services should integrate population health analytics, risk-based cost analysis, care management services (such as point-of-care decision support tools) and performance analytics. Physicians should expect EMR vendors to allocate sufficient health informatics resources to information management, technical infrastructure, data protection and response to breaches in privacy, and data extraction and analysis.27,28 Physicians may also wish to consider the appropriateness of data analytics services in the context of their practices. Not all data will be useful for some medical specialties, such as those treating conditions that are relatively rare in the overall population. The potential for new or enhanced clinical practice tools informed by big data analytics may be restricted to primary care practice at this time.29 Finally, predictive analytics often make treatment recommendations that are designed to improve the health outcomes in a population, and these recommendations may conflict with physicians' ethical obligations to act in the best interests of individual patients and respect patients' autonomous decision-making).30 References 1 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 2 Canadian Medical Association. Principles concerning physician information [CMA policy]. CMAJ 2002 167(4):393-4. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD02-09.pdf 3 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2010. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 4 Canadian Medical Association. Disclosing personal health information to third parties. Ottawa: The Association; 2011. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Disclosure_third_parties-e.pdf 5 Canadian Medical Association. Need to know and circle of care. Ottawa: The Association; 2011. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Need_to_know_circle_care-e.pdf 6 Canadian Medical Protective Association. The impact of big data on healthcare and medical practice. Ottawa: The Association; no date. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_14_big_data_design-e.pdf 7 Kayyali B, Knott D, Van Kuiken S. The 'big data' revolution in US health care: accelerating value and innovation. New York: McKinsey & Company; 2013. p. 1. 8 College of Family Physicians of Canada, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada. National physician survey, 2014. National results by FP/GP or other specialist, sex, age and all physicians. Q7. Ottawa: The Colleges and Association; 2014. Available: http://nationalphysiciansurvey.ca/wp-content/uploads/2014/08/2014-National-EN-Q7.pdf 9 Anonymous. Data, data everywhere. The Economist 2010 Feb 27. Available: www.economist.com/node/15557443 10 Anonymous. Data, data everywhere. The Economist 2010 Feb 27. Available: www.economist.com/node/15557443 11 Canada Health Infoway. Big data analytics in health. Toronto: Canada Health Infoway; 2013. Available: www.infoway-inforoute.ca/index.php/resources/technical-documents/emerging-technology/doc_download/1419-big-data-analytics-in-health-white-paper-full-report (accessed 2014 May 16). 12 Ellaway RH, Pusic MV, Galbraith RM, Cameron T. 2014 Developing the role of big data and analytics in health professional education. Med Teach 2014;36(3):216-222. 13 Marino DJ. Using business intelligence to reduce the cost of care. Healthc Financ Manage 2014;68(3):42-44, 46. 14 Porter ME, Lee TH. The strategy that will fix health care. Harv Bus Rev 2013;91(10):50-70. 15 Baggaley C. Data protection in a world of big data: Canadian Medical Protective Association information session [presentation]. 2014 Aug 20. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_2014_carmen_baggaley-e.pdf 16 College of Family Physicians of Canada, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada. National physician survey, 2014. National results by FP/GP or other specialist, sex, age and all physicians. Q10. Ottawa: The Colleges and Association; 2014. Available: http://nationalphysiciansurvey.ca/wp-content/uploads/2014/08/2014-National-EN-Q10.pdf 17 Canadian Primary Care Sentinel Surveillance Network. Available: http://cpcssn.ca/ (accessed 2014 Nov 15). 18 Canadian Partnership Against Cancer. Sustaining action toward a shared vision: 2012-2017 strategic plan. Toronto: The Partnership; no date. Available: www.partnershipagainstcancer.ca/wp-content/uploads/sites/5/2015/03/Sustaining-Action-Toward-a-Shared-Vision_accessible.pdf 19 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 20 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 21 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 22 Weber G, Mandl KD, Kohane IS. Finding the missing link for big biomedical data . JAMA 2014;311(24):2479-2480. doi:10.1001/jama.2014.4228. 23 Information and Privacy Commissioner of Ontario. Model data sharing agreement. Toronto: The Commissioner; 1995. Available: www.ipc.on.ca/images/Resources/model-data-ag.pdf 24 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 25 Physicians Data Collaborative. Overview. Available: www.divisionsbc.ca/datacollaborative/home 26 Cohen IG, Amarasingham R, Shah A, Xie B, Lo B. The legal and ethical concerns that arise from using complex predictive analytics in health care. Health Aff 2014;33(7):1139-1147. 27 Rhoads J, Ferrara L. Transforming healthcare through better use of data. Electron Healthc 2012;11(1):e27. 28 Canadian Medical Protective Association. The impact of big data and healthcare and medical practice. Ottawa: The Association; no date. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_14_big_data_design-e.pdf 29 Genta RM, Sonnenberg A. Big data in gastroenterology research. Nat Rev Gastroenterol Hepatol 2014;11(6):386-390. 30 Cohen IG, Amarasingham R, Shah A, Xie B, Lo B. The legal and ethical concerns that arise from using complex predictive analytics in health care. Health Aff 2014;33(7):1139-1147.

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