ABSTRACT Clostridium difficile is the most common hospital-acquired pathogen in the US, and recur... more ABSTRACT Clostridium difficile is the most common hospital-acquired pathogen in the US, and recurrent C. difficile infection (CDI) is a major public health issue. Twenty per cent of CDI patients experience recurrence, and their risk of recurrence rises with each failure to achieve clinical resolution. Fecal microbiota transplantation (FMT) is a remarkably efficacious treatment for recurrent CDI. However, national health agencies are grappling with the appropriate regulatory paradigm to apply to this innovative treatment. Current FMT regulations in the US, Canada, Western Europe, Australia, and China are in varying degrees of flux, although many regulators are choosing to apply the drug and biologic framework. FMT regulations should allow recurrent CDI patients safe access to this treatment as research continues. Regulating FMT like a drug or biologic, although most convenient from a legal perspective, overly restricts access while under-regulating the methods by which the stool is screened, processed, stored, and used. Human tissue and tissue-based products regulations could achieve the desired level and kind of oversight, but fecal microbiota for transplantation fail to meet applicable statutory definitions. A custom regulatory solution would be more appropriate, but many pathways that regulators may take to achieve this goal require time and resources for health agencies to develop.
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, Jan 16, 2015
With the exception of Canada, all countries with universal health insurance systems provide unive... more With the exception of Canada, all countries with universal health insurance systems provide universal coverage of prescription drugs. Progress toward universal public drug coverage in Canada has been slow, in part because of concerns about the potential costs. We sought to estimate the cost of implementing universal public coverage of prescription drugs in Canada. We used published data on prescribing patterns and costs by drug type, as well as source of funding (i.e., private drug plans, public drug plans and out-of-pocket expenses), in each province to estimate the cost of universal public coverage of prescription drugs from the perspectives of government, private payers and society as a whole. We estimated the cost of universal public drug coverage based on its anticipated effects on the volume of prescriptions filled, products selected and prices paid. We selected these parameters based on current policies and practices seen either in a Canadian province or in an international c...
Background: Product listing agreements (PLAs) between drug manufacturers and drug plans are incre... more Background: Product listing agreements (PLAs) between drug manufacturers and drug plans are increasingly common worldwide. Use of PLAs by Canadian provinces has not previously been documented. Methods: We collected data from all provinces on funding and PLA use for 25 drugs that were reviewed by the Common Drug Review (CDR) in 2010 or 2011 and funded by at least one province as of May 2012. We measured correlations between coverage and PLA use, and CDR recommendations and PLA use.
Despite Canadians&amp... more Despite Canadians' pride in medicare and the values underpinning it, the system is conspicuously incomplete. Universal public health insurance in Canada ends as soon as a patient is handed a prescription to fill; yet prescription drugs are the second largest component of health system costs. We look back at key moments in Canadian healthcare history that shaped our pharmacare system - or lack thereof. We look forward to changes in demography and technology that will increase the need for pharmacare reform in the near future. We conclude that meaningful public engagement in pharmacare design may generate the clarity of goals and level of political support needed should windows of policy opportunity open again.
Canada's provincial pharmacare models have flaws not found in countries with comparable healthcar... more Canada's provincial pharmacare models have flaws not found in countries with comparable healthcare systems. Shortcomings include a funding system that limits the potential for healthcare managers and providers to consider the full benefits and opportunity costs of prescription drugs as an input into the broader healthcare system.
Social Psychiatry and Psychiatric Epidemiology, 2013
To conduct a systematic review and meta-analysis of published evidence on ethnic or racial dispar... more To conduct a systematic review and meta-analysis of published evidence on ethnic or racial disparities in the outpatient use versus non-use of antipsychotics and in the outpatient use of newer versus older antipsychotics. Electronic databases were searched for potentially relevant studies. Two independent reviewers conducted the review in three stages: title review, abstract review and full-text review. Included studies were those that: (a) report measures of disparity in the outpatient use of antipsychotic drugs in clearly defined racial or ethnic groups (b) have a primary focus on ethnic or racial disparities, and (c) have adjusted for factors known to influence medicine use. Odds ratios were pooled following the inverse-variance method of weighting effect sizes. I (2) statistics were calculated to quantify the amount of variation that is likely due to heterogeneity between studies. Funnel plots were produced and Egger's statistic was calculated to assess potential publication bias. No significant differences were found in the odds of using any antipsychotics among African Americans (OR = 1.01, CI = 0.99-1.02) compared with non-African Americans and among Latinos (OR = 0.98, CI = 0.86-1.13) compared with non-Latinos. Small to moderate but statistically non-significant disparities were also noted in other ethnic groups: Asians (OR = 1.10, CI = 0.88-1.36), Maoris (OR = 0.78, CI = 0.53-1.13) and Pacific Islanders (OR = 0.97, CI = 0.84-1.11). Among those who received antipsychotic medication, African Americans (OR = 0.62, CI = 0.50-0.78) and Latinos (OR = 0.77, CI = 0.73-0.81) appeared to have lower odds of receiving newer antipsychotics compared with non-African Americans and non-Latinos. No significant ethnic disparities in the use versus non-use of any antipsychotics were observed, but, among those who received antipsychotic treatment, ethnic minorities were consistently less likely than non-ethnic minorities to be treated with newer antipsychotics.
Purpose-To review the literature describing patterns of out-patient prescription drug use during ... more Purpose-To review the literature describing patterns of out-patient prescription drug use during pregnancy by therapeutic category, potential for fetal harm, and overall.
Canada is the only country in the world to offer universal comprehensive public health insurance ... more Canada is the only country in the world to offer universal comprehensive public health insurance that excludes outpatient prescription medicines. Few scholars have attempted to explain this policy puzzle. We study media coverage of prescription drug financing from 1990 to 2010 to elucidate how the policy problem and potential solutions have been framed in media discourse and identify the actors that have dominated media texts. We confirm previous analyses that have revealed the significant role played by policy elites in media coverage of health reform debates. We also find that proposed expansions to public coverage are presented as a financial liability that could "crowd out" the existing (and popular) public insurance program. Within the context of a predominantly public funded system, framing of incremental expansion reorients away from values and toward discourse related to costs--both of the current system and of potential reforms. This may reflect a strategic narrative used by actors to maintain "silos of values" for coverage for prescription medicines versus those for other services. This has significant implications for the motivation for reform among the electorate and politicians alike, and for the extent to which policy developments, if they occurred, would legitimately reflect societal values for health financing.
Canada is the only developed country that has established universal coverage for hospital care an... more Canada is the only developed country that has established universal coverage for hospital care and physician services that excludes medically necessary prescription drugs. Lack of public interest in expanding universal coverage to prescription medicines may be one critical factor in explaining this policy puzzle. Historical levels and patterns of attention to financing issues in the media may have implications for public awareness and support for such major health reform. We thus examined the quantity, context, and patterns of coverage of public drug financing in national print media in Canada from 1990 to 2010. We conducted a time series analysis of monthly newspaper article counts to quantify trends in coverage and analyzed article content by applying Down's theory of the "issue-attention cycle" of political attention. We found that baseline coverage of this issue was low throughout the past twenty years with few cycles of increased attention, initiated by focusing events related to general health reform. Issue-attention cycles were driven by coverage of proposed policy solutions simultaneously accompanied by lower levels of coverage of policy problems and barriers to change, before fading rapidly from attention. The observed patterns of media coverage and the intrinsic characteristics of this policy issue suggest that any momentum for reform (or lack thereof) is likely to be driven by elite members of the policy community rather than by way of public engagement. This has implications for the probability of reform and which options may be considered or eventually implemented, as policies developed within elite policy communities may tend to reflect niche interests rather than being reflective of principled policy goals.
Objectives: To describe recent changes and identify emergent trends in public drug benefit polici... more Objectives: To describe recent changes and identify emergent trends in public drug benefit policies in Canada from 2000 to 2010. Methods: For each province, we tracked pharmacare design (namely eligibility, premiums, and patient cost-sharing) over time for three beneficiary groups: social assistance recipients, seniors, and the general non-senior population. We assess which plan designs are emerging as a national standard, where the gaps in public coverage remain, and implications for progress towards national pharmacare. Results: Expansion of public drug coverage has been limited. For social assistance recipients, first-dollar coverage is the standard. Seniors coverage remains varied, though means testing of eligibility or cost-sharing is common. Seniors benefits were significantly expanded in only one province. As of 2010, six provinces have embraced age irrelevant catastrophic income-based coverage, in some, resulting in the elimination of seniors drug benefits. Conclusions: Universal income-based catastrophic coverage appears to be emerging as an implicit national standard for provincial pharmacare. However, due to the variation and high level of patient cost-sharing required under these programs, convergence on this model does not equate to substantial progress towards expanding coverage or reducing interprovincial disparities. Leverage of federal spending power to promote standards for public drug coverage is necessary to uniformly protect Canadians against high drug costs.
Despite first-dollar public coverage for hospital and physician services, Canadians spend more pr... more Despite first-dollar public coverage for hospital and physician services, Canadians spend more privately on health care than citizens of most other developed countries. We quantified recent growth in private payments by Canadian households for health care. Using data from 163,081 respondents to Statistics Canada's annual Survey of Household Spending from 1998 to 2009, we calculated inflation-adjusted per-household spending on private health insurance premiums and out-of-pocket payments on six types of health care services. Further, we estimated the prevalence and some socio-economic determinants of households spending over 10% of after-tax income on health care using logistic regression. We found that Canadian households spent $19.8 billion on private payments for health care in 2009. This represents an average of $1523 per household-a 37% increase over 1998. The top three spending categories in 2009 were private health insurance premiums ($5.9 billion), dental ($4.9 billion) and prescription drugs ($4.2 billion). Even after adjusting for inflation, expenditure on every category of health care spending increased between 1998 and 2009. The proportion of households spending more than 10% of after-tax income on health care increased by 56% (from 3.3% to 5.2%). Households including a senior, with a low income, and in British Columbia or the Atlantic Provinces were significantly more likely to reach this threshold. Over the period studied, the burden of private health care expenditures increased substantially for Canadian households. As direct charges reduce the use of necessary health care services, investigation into the health consequences of these increases is warranted.
Background: Owing to the paucity of evidence available on the risks and benefits of drug use in p... more Background: Owing to the paucity of evidence available on the risks and benefits of drug use in pregnancy, the use of prescription medicines is a concern for both pregnant women and their health care providers.
Background: Confidential product listing agreements (PLAs) negotiated between pharmaceutical manu... more Background: Confidential product listing agreements (PLAs) negotiated between pharmaceutical manufacturers and individual health care payers may contribute to unwanted price disparities, high administrative costs, and unequal bargaining power within and across jurisdictions. In the context of Canada's decentralized health system, we aimed to document provincial policy makers' perceptions about collaborative PLA negotiations.
ABSTRACT Clostridium difficile is the most common hospital-acquired pathogen in the US, and recur... more ABSTRACT Clostridium difficile is the most common hospital-acquired pathogen in the US, and recurrent C. difficile infection (CDI) is a major public health issue. Twenty per cent of CDI patients experience recurrence, and their risk of recurrence rises with each failure to achieve clinical resolution. Fecal microbiota transplantation (FMT) is a remarkably efficacious treatment for recurrent CDI. However, national health agencies are grappling with the appropriate regulatory paradigm to apply to this innovative treatment. Current FMT regulations in the US, Canada, Western Europe, Australia, and China are in varying degrees of flux, although many regulators are choosing to apply the drug and biologic framework. FMT regulations should allow recurrent CDI patients safe access to this treatment as research continues. Regulating FMT like a drug or biologic, although most convenient from a legal perspective, overly restricts access while under-regulating the methods by which the stool is screened, processed, stored, and used. Human tissue and tissue-based products regulations could achieve the desired level and kind of oversight, but fecal microbiota for transplantation fail to meet applicable statutory definitions. A custom regulatory solution would be more appropriate, but many pathways that regulators may take to achieve this goal require time and resources for health agencies to develop.
CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, Jan 16, 2015
With the exception of Canada, all countries with universal health insurance systems provide unive... more With the exception of Canada, all countries with universal health insurance systems provide universal coverage of prescription drugs. Progress toward universal public drug coverage in Canada has been slow, in part because of concerns about the potential costs. We sought to estimate the cost of implementing universal public coverage of prescription drugs in Canada. We used published data on prescribing patterns and costs by drug type, as well as source of funding (i.e., private drug plans, public drug plans and out-of-pocket expenses), in each province to estimate the cost of universal public coverage of prescription drugs from the perspectives of government, private payers and society as a whole. We estimated the cost of universal public drug coverage based on its anticipated effects on the volume of prescriptions filled, products selected and prices paid. We selected these parameters based on current policies and practices seen either in a Canadian province or in an international c...
Background: Product listing agreements (PLAs) between drug manufacturers and drug plans are incre... more Background: Product listing agreements (PLAs) between drug manufacturers and drug plans are increasingly common worldwide. Use of PLAs by Canadian provinces has not previously been documented. Methods: We collected data from all provinces on funding and PLA use for 25 drugs that were reviewed by the Common Drug Review (CDR) in 2010 or 2011 and funded by at least one province as of May 2012. We measured correlations between coverage and PLA use, and CDR recommendations and PLA use.
Despite Canadians&amp... more Despite Canadians' pride in medicare and the values underpinning it, the system is conspicuously incomplete. Universal public health insurance in Canada ends as soon as a patient is handed a prescription to fill; yet prescription drugs are the second largest component of health system costs. We look back at key moments in Canadian healthcare history that shaped our pharmacare system - or lack thereof. We look forward to changes in demography and technology that will increase the need for pharmacare reform in the near future. We conclude that meaningful public engagement in pharmacare design may generate the clarity of goals and level of political support needed should windows of policy opportunity open again.
Canada's provincial pharmacare models have flaws not found in countries with comparable healthcar... more Canada's provincial pharmacare models have flaws not found in countries with comparable healthcare systems. Shortcomings include a funding system that limits the potential for healthcare managers and providers to consider the full benefits and opportunity costs of prescription drugs as an input into the broader healthcare system.
Social Psychiatry and Psychiatric Epidemiology, 2013
To conduct a systematic review and meta-analysis of published evidence on ethnic or racial dispar... more To conduct a systematic review and meta-analysis of published evidence on ethnic or racial disparities in the outpatient use versus non-use of antipsychotics and in the outpatient use of newer versus older antipsychotics. Electronic databases were searched for potentially relevant studies. Two independent reviewers conducted the review in three stages: title review, abstract review and full-text review. Included studies were those that: (a) report measures of disparity in the outpatient use of antipsychotic drugs in clearly defined racial or ethnic groups (b) have a primary focus on ethnic or racial disparities, and (c) have adjusted for factors known to influence medicine use. Odds ratios were pooled following the inverse-variance method of weighting effect sizes. I (2) statistics were calculated to quantify the amount of variation that is likely due to heterogeneity between studies. Funnel plots were produced and Egger's statistic was calculated to assess potential publication bias. No significant differences were found in the odds of using any antipsychotics among African Americans (OR = 1.01, CI = 0.99-1.02) compared with non-African Americans and among Latinos (OR = 0.98, CI = 0.86-1.13) compared with non-Latinos. Small to moderate but statistically non-significant disparities were also noted in other ethnic groups: Asians (OR = 1.10, CI = 0.88-1.36), Maoris (OR = 0.78, CI = 0.53-1.13) and Pacific Islanders (OR = 0.97, CI = 0.84-1.11). Among those who received antipsychotic medication, African Americans (OR = 0.62, CI = 0.50-0.78) and Latinos (OR = 0.77, CI = 0.73-0.81) appeared to have lower odds of receiving newer antipsychotics compared with non-African Americans and non-Latinos. No significant ethnic disparities in the use versus non-use of any antipsychotics were observed, but, among those who received antipsychotic treatment, ethnic minorities were consistently less likely than non-ethnic minorities to be treated with newer antipsychotics.
Purpose-To review the literature describing patterns of out-patient prescription drug use during ... more Purpose-To review the literature describing patterns of out-patient prescription drug use during pregnancy by therapeutic category, potential for fetal harm, and overall.
Canada is the only country in the world to offer universal comprehensive public health insurance ... more Canada is the only country in the world to offer universal comprehensive public health insurance that excludes outpatient prescription medicines. Few scholars have attempted to explain this policy puzzle. We study media coverage of prescription drug financing from 1990 to 2010 to elucidate how the policy problem and potential solutions have been framed in media discourse and identify the actors that have dominated media texts. We confirm previous analyses that have revealed the significant role played by policy elites in media coverage of health reform debates. We also find that proposed expansions to public coverage are presented as a financial liability that could "crowd out" the existing (and popular) public insurance program. Within the context of a predominantly public funded system, framing of incremental expansion reorients away from values and toward discourse related to costs--both of the current system and of potential reforms. This may reflect a strategic narrative used by actors to maintain "silos of values" for coverage for prescription medicines versus those for other services. This has significant implications for the motivation for reform among the electorate and politicians alike, and for the extent to which policy developments, if they occurred, would legitimately reflect societal values for health financing.
Canada is the only developed country that has established universal coverage for hospital care an... more Canada is the only developed country that has established universal coverage for hospital care and physician services that excludes medically necessary prescription drugs. Lack of public interest in expanding universal coverage to prescription medicines may be one critical factor in explaining this policy puzzle. Historical levels and patterns of attention to financing issues in the media may have implications for public awareness and support for such major health reform. We thus examined the quantity, context, and patterns of coverage of public drug financing in national print media in Canada from 1990 to 2010. We conducted a time series analysis of monthly newspaper article counts to quantify trends in coverage and analyzed article content by applying Down's theory of the "issue-attention cycle" of political attention. We found that baseline coverage of this issue was low throughout the past twenty years with few cycles of increased attention, initiated by focusing events related to general health reform. Issue-attention cycles were driven by coverage of proposed policy solutions simultaneously accompanied by lower levels of coverage of policy problems and barriers to change, before fading rapidly from attention. The observed patterns of media coverage and the intrinsic characteristics of this policy issue suggest that any momentum for reform (or lack thereof) is likely to be driven by elite members of the policy community rather than by way of public engagement. This has implications for the probability of reform and which options may be considered or eventually implemented, as policies developed within elite policy communities may tend to reflect niche interests rather than being reflective of principled policy goals.
Objectives: To describe recent changes and identify emergent trends in public drug benefit polici... more Objectives: To describe recent changes and identify emergent trends in public drug benefit policies in Canada from 2000 to 2010. Methods: For each province, we tracked pharmacare design (namely eligibility, premiums, and patient cost-sharing) over time for three beneficiary groups: social assistance recipients, seniors, and the general non-senior population. We assess which plan designs are emerging as a national standard, where the gaps in public coverage remain, and implications for progress towards national pharmacare. Results: Expansion of public drug coverage has been limited. For social assistance recipients, first-dollar coverage is the standard. Seniors coverage remains varied, though means testing of eligibility or cost-sharing is common. Seniors benefits were significantly expanded in only one province. As of 2010, six provinces have embraced age irrelevant catastrophic income-based coverage, in some, resulting in the elimination of seniors drug benefits. Conclusions: Universal income-based catastrophic coverage appears to be emerging as an implicit national standard for provincial pharmacare. However, due to the variation and high level of patient cost-sharing required under these programs, convergence on this model does not equate to substantial progress towards expanding coverage or reducing interprovincial disparities. Leverage of federal spending power to promote standards for public drug coverage is necessary to uniformly protect Canadians against high drug costs.
Despite first-dollar public coverage for hospital and physician services, Canadians spend more pr... more Despite first-dollar public coverage for hospital and physician services, Canadians spend more privately on health care than citizens of most other developed countries. We quantified recent growth in private payments by Canadian households for health care. Using data from 163,081 respondents to Statistics Canada's annual Survey of Household Spending from 1998 to 2009, we calculated inflation-adjusted per-household spending on private health insurance premiums and out-of-pocket payments on six types of health care services. Further, we estimated the prevalence and some socio-economic determinants of households spending over 10% of after-tax income on health care using logistic regression. We found that Canadian households spent $19.8 billion on private payments for health care in 2009. This represents an average of $1523 per household-a 37% increase over 1998. The top three spending categories in 2009 were private health insurance premiums ($5.9 billion), dental ($4.9 billion) and prescription drugs ($4.2 billion). Even after adjusting for inflation, expenditure on every category of health care spending increased between 1998 and 2009. The proportion of households spending more than 10% of after-tax income on health care increased by 56% (from 3.3% to 5.2%). Households including a senior, with a low income, and in British Columbia or the Atlantic Provinces were significantly more likely to reach this threshold. Over the period studied, the burden of private health care expenditures increased substantially for Canadian households. As direct charges reduce the use of necessary health care services, investigation into the health consequences of these increases is warranted.
Background: Owing to the paucity of evidence available on the risks and benefits of drug use in p... more Background: Owing to the paucity of evidence available on the risks and benefits of drug use in pregnancy, the use of prescription medicines is a concern for both pregnant women and their health care providers.
Background: Confidential product listing agreements (PLAs) negotiated between pharmaceutical manu... more Background: Confidential product listing agreements (PLAs) negotiated between pharmaceutical manufacturers and individual health care payers may contribute to unwanted price disparities, high administrative costs, and unequal bargaining power within and across jurisdictions. In the context of Canada's decentralized health system, we aimed to document provincial policy makers' perceptions about collaborative PLA negotiations.
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Papers by Jamie Daw