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1.  New oral anticoagulants 
doi:10.1503/cmaj.1150037
PMCID: PMC4435879  PMID: 25991854
2.  Sex differences in the risk of receiving potentially inappropriate prescriptions among older adults 
Age and Ageing  2016;45(4):535-542.
Objectives: to measure sex differences in the risk of receiving potentially inappropriate prescription drugs and to examine what are the factors that contribute to these differences.
Design: a retrospective cohort study.
Setting: community setting of British Columbia, Canada.
Participants: residents of British Columbia aged 65 and older (n = 660,679).
Measurements: we measured 2013 period prevalence of prescription dispensations satisfying the American Geriatrics Society's 2012 version of the Beers Criteria for potentially inappropriate medication use in older adults. We used logistic regressions to test for associations between this outcome and a number of clinical and socioeconomic factors.
Results: a larger share of women (31%) than of men (26%) filled one or more potentially inappropriate prescription in the community. The odds of receiving potentially inappropriate prescriptions are associated with several clinical and socioeconomic factors. After controlling for those factors, community-dwelling women were at 16% higher odds of receiving a potentially inappropriate prescription than men (adjusted odds ratio = 1.16, 95% confidence interval = 1.12–1.21). Much of this sex difference stemmed from women's increased odds of receiving potentially inappropriate prescriptions for benzodiazepines and other hypnotics, for tertiary tricyclic antidepressants and for non-selective NSAIDs.
Conclusion: there are significant sex differences in older adults' risk of receiving a potentially inappropriate prescription as a result of complex intersections between gender and other social constructs. Appropriate responses will therefore require changes in the information, norms and expectations of both prescribers and patients.
doi:10.1093/ageing/afw074
PMCID: PMC4916346  PMID: 27151390
inappropriate; Beers criteria; older adults; sex and gender; socioeconomic disparities; older people
3.  Access to new cancer medicines in Australia: dispelling the myths and informing a public debate 
Despite the high level of spending on cancer medicines in Australia, consumer organisations and the pharmaceutical industry often make claims of delayed or lack of access to new cancer medicines—claims that are frequently supported by prominent coverage in the Australian media. These claims, while morally and psychologically compelling, tend to ignore the complexity of medicines funding decisions. In this commentary we summarise the current situation regarding the registration and funding of cancer medicines in Australia, elucidate the main challenges associated with access to cancer medicines in the Australian context, and describe some of the steps that have been taken to address these challenges.
doi:10.1186/s40545-016-0062-x
PMCID: PMC4823878  PMID: 27057313
Cancer medicines; Funding; High prices; Consumer engagement; Transparency; Public debate
4.  The Tip of the Iceberg of Misleading Online Advertising 
Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved ("off-label") use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.
doi:10.15171/ijhpm.2016.19
PMCID: PMC4852003  PMID: 27239883
Direct-to-Consumer Advertising (DTCA); Online Promotion of Prescription Drugs; Food and Drug Administration (FDA); Medication Safety
5.  Postpartum domperidone use in British Columbia: a retrospective cohort study 
CMAJ Open  2016;4(1):E13-E19.
Background:
Domperidone is commonly used off-label to stimulate milk production in mothers who have low milk supply. The aim of this study was to describe trends, patterns and determinants of postpartum domperidone use.
Methods:
This is a retrospective, population-based study involving all women with a live birth between Jan. 1, 2002, and Dec. 31, 2011, in the province of British Columbia. We examined administrative data sets containing person-specific information on filled prescriptions and use of medical services, and we used logistic regression to examine associations between domperidone use and maternal characteristics.
Results:
The study population consisted of 225 532 women with 320 351 live births. The prevalence of postpartum domperidone use more than doubled between 2002 and 2011. In 2011, 1 in 3 women with a preterm birth and 1 in 5 women with a full-term birth were prescribed domperidone in the first 6 months postpartum. Women who were older, had a higher body mass index, had a chronic disease, were first-time mothers, delivered more than 1 baby (multiple pregnancy), had a preterm birth or had a cesarian delivery were more likely to fill a postpartum domperidone prescription.
Interpretation:
We found an increase in postpartum domperidone use over a 10-year period. More research is needed on maternal and infant health outcomes.
doi:10.9778/cmajo.20150067
PMCID: PMC4866923  PMID: 27280111
6.  Trends and Determinants of Prescription Drug Use during Pregnancy and Postpartum in British Columbia, 2002–2011: A Population-Based Cohort Study 
PLoS ONE  2015;10(5):e0128312.
Purpose
To describe trends, patterns, and determinants of prescription drug use during pregnancy and postpartum.
Methods
This is a retrospective, population-based study of all women who gave birth between January 2002 and 31 December 2011 in British Columbia, Canada. Study population consisted of 225,973 women who had 322,219 pregnancies. We examined administrative datasets containing person-specific information on filled prescriptions, hospitalizations, and medical services. Main outcome measures were filled prescriptions during pregnancy and postpartum. We used logistic regressions to examine associations between prescription drug use and maternal characteristics.
Results
Approximately two thirds of women filled a prescription during pregnancy, increasing from 60% in 2002 to 66% in 2011. The proportion of pregnant women using medicines in all three trimesters of pregnancy increased from 20% in 2002 to 27% in 2011. Use of four or more different types of prescription drug during at least one trimester increased from 8.4% in 2002 to 11.7% in 2011. Higher BMI, smoking during pregnancy, age under 25, carrying multiples, and being diagnosed with a chronic condition all significantly increased the odds of prescription drug use during pregnancy.
Conclusions
The observed increase in the number of prescriptions and number of different drugs being dispensed suggests a trend in prescribing practices with potentially important implications for mothers, their neonates, and caregivers. Monitoring of prescribing practices and further research into the safety of most commonly prescribed medications is crucial in better understanding risks and benefits to the fetus and the mother.
doi:10.1371/journal.pone.0128312
PMCID: PMC4444135  PMID: 26011706
9.  Pharmaceutical Sales Representatives and Patient Safety: A Comparative Prospective Study of Information Quality in Canada, France and the United States 
Journal of General Internal Medicine  2013;28(10):1368-1375.
ABSTRACT
INTRODUCTION
The information provided by pharmaceutical sales representatives has been shown to influence prescribing. To enable safe prescribing, medicines information must include harm as well as benefits. Regulation supports this aim, but relative effectiveness of different approaches is not known. The United States (US) and France directly regulate drug promotion; Canada relies on industry self-regulation. France has the strictest information standards.
METHODS
This is a prospective cohort study in Montreal, Vancouver, Sacramento and Toulouse. We recruited random samples of primary care physicians from May 2009 to June 2010 to report on consecutive sales visits. The primary outcome measure was “minimally adequate safety information” (mention of at least one indication, serious adverse event, common adverse event, and contraindication, and no unqualified safety claims or unapproved indications).
RESULTS
Two hundred and fifty-five physicians reported on 1,692 drug-specific promotions. “Minimally adequate safety information” did not differ: 1.7 % of promotions; range 0.9–3.0 % per site. Sales representatives provided some vs. no information on harm more often in Toulouse than in Montreal and Vancouver: 61 % vs. 34 %, OR = 4.0; 95 % CI 2.8–5.6, or Sacramento (39 %), OR = 2.4; 95 % CI 1.7–3.6. Serious adverse events were rarely mentioned (5–6 % of promotions in all four sites), although 45 % of promotions were for drugs with US Food and Drug Administration (FDA) “black box” warnings of serious risks. Nevertheless, physicians judged the quality of scientific information to be good or excellent in 901 (54 %) of promotions, and indicated readiness to prescribe 64 % of the time.
DISCUSSION
“Minimally adequate safety information” did not differ in the US and Canadian sites, despite regulatory differences. In Toulouse, consistent with stricter standards, more harm information was provided. However, in all sites, physicians were rarely informed about serious adverse events, raising questions about whether current approaches to regulation of sales representatives adequately protect patient health.
Electronic supplementary material
The online version of this article (doi:10.1007/s11606-013-2411-7) contains supplementary material, which is available to authorized users.
doi:10.1007/s11606-013-2411-7
PMCID: PMC3785667  PMID: 23558775
health policy; patient safety; primary care; health services research
10.  Patterns of psychotropic medicine use in pregnancy in the United States from 2006 to 2011 among women with private insurance 
Background
Psychiatric disorders are equally common during pregnancy as among non-pregnant women, and many of these conditions are treated with psychotropic medicines. Relatively little is known about patterns of use of many these agents during pregnancy, and specifically of how rates may have shifted during the last decade. We aimed to quantify the rate of pregnancy related exposures to categories of psychotropic medicines stratified according to the primary indication for use (antidepressants, antipsychotics, anxiolytics, and psychostimulants), trimester of pregnancy, trends over time and region, and indication for use.
Methods
We conducted a retrospective cohort study of pregnancies among women in the Truven Health MarketScan database (source population 70 million Americans), which captures person-specific clinical use and includes detailed information on filled prescriptions, hospitalizations and outpatient visits for all privately insured employees and their dependents. We classified psychotropic medicines of interest using ATC level 3 accordingly: antipsychotics (N05A); anxiolytics (N05B); antidepressants (N06A); psychostimulants, agents used for ADHD and cognitive enhancement (N06B). We also examined temporal and regional trends in use.
Results
We included 343,299 women who had a live birth between Jan 1, 2006 and Dec 31, 2011, of whom 10.3% were dispensed one or more psychotropic medicines during pregnancy. This rate varied from 6% to 15% between states. The rate of use of psychotropic medicines was relatively stable between 2006 and 2011. The most commonly used psychotropic medicines were selective serotonin reuptake inhibitors (5.1%) and benzodiazepine or benzodiazepine-like medicines (3.9%). Among psychotropic users, the most commonly associated psychiatric diagnosis was depression (25.0%), followed by anxiety disorders (24.4%). Approximately 1.6% of women used more than one category of psychotropic medicine in pregnancy, most commonly an antidepressant and an anxiolytic medicine (1.2%).
Conclusions
Given this relatively high rate of use, the lack of evidence that the most frequently used medications improve birth outcomes and the safety concerns associated with both early and late pregnancy use for many frequently-used medications, there is a need for further study of factors driving psychotropic medication use during pregnancy.
doi:10.1186/1471-2393-14-242
PMCID: PMC4223368  PMID: 25048574
Pregnancy; Prescription drugs; Psychiatric conditions in pregnancy; Psychotropic medicines; Administrative data; Depression; Anxiety
11.  Too Few, Too Weak: Conflict of Interest Policies at Canadian Medical Schools 
PLoS ONE  2013;8(7):e68633.
Introduction
The education of medical students should be based on the best clinical information available, rather than on commercial interests. Previous research looking at university-wide conflict of interest (COI) policies used in Canadian medical schools has shown very poor regulation. An analysis of COI policies was undertaken to document the current policy environment in all 17 Canadian medical schools.
Methods
A web search was used to initially locate COI policies supplemented by additional information from the deans of each medical school. Strength of policies was rated on a scale of 0 to 2 in 12 categories and also on the presence of enforcement measures. For each school, we report scores for all 12 categories, enforcement measures, and summative scores.
Results
COI policies received summative scores that ranged from 0 to 19, with 0 the lowest possible score obtainable and 24 the maximum. The highest mean scores per category were for disclosure and ghostwriting (0.9) and for gifts and scholarships (0.8).
Discussion
This study provides the first comprehensive evaluation of all 17 Canadian medical school-specific COI policies. Our results suggest that the COI policy environment at Canadian medical schools is generally permissive. Policy development is a dynamic process. We therefore encourage all Canadian medical schools to develop restrictive COI policies to ensure that their medical students are educated based on the best clinical evidence available, free of industry biases and COI relationships that may influence the future medical thinking and prescribing practices of medical students in Canada once they graduate.
doi:10.1371/journal.pone.0068633
PMCID: PMC3701639  PMID: 23861928
14.  Antidepressants and pregnancy 
doi:10.1503/cmaj.111-2027
PMCID: PMC3060191  PMID: 21422144
15.  Pfizer conducts survey of French patients on information provided by industry 
BMJ : British Medical Journal  2007;334(7602):1027.
doi:10.1136/bmj.39216.672847.DB
PMCID: PMC1871796  PMID: 17510132
16.  Should patient groups accept money from drug companies? No 
BMJ : British Medical Journal  2007;334(7600):935.
Patient groups provide valuable support and advocacy for vulnerable people but funding the work can be difficult. Alastair Kent argues that not accepting industry money will unnecessarily limit the groups' effectiveness, but Barbara Mintzes believes that the money undermines their independence
doi:10.1136/bmj.39185.394005.AD
PMCID: PMC1865416  PMID: 17478846
17.  Twelve Years' Experience with Direct-to-Consumer Advertising of Prescription Drugs in Canada: A Cautionary Tale 
PLoS ONE  2009;4(5):e5699.
Background
Direct-to-consumer advertising (DTCA) of prescription drugs is illegal in Canada as a health protection measure, but is permitted in the United States. However, in 2000, Canadian policy was changed to allow ‘reminder’ advertising of prescription drugs. This is a form of advertising that states the brand name without health claims. ‘Reminder’ advertising is prohibited in the US for drugs that have ‘black box’ warnings of serious risks. This study examines spending on DTCA in Canada from 1995 to 2006, 12 years spanning this policy shift. We ask how annual per capita spending compares to that in the US, and whether drugs with Canadian or US regulatory safety warnings are advertised to the Canadian public in reminder advertising.
Methodology/Principal Findings
Prescription drug advertising spending data were extracted from a data set on health sector spending in Canada obtained from a market research company, TNS Media Inc. Spending was adjusted for inflation and compared with US spending. Inflation-adjusted spending on branded DTCA in Canada grew from under CAD$2 million per year before 1999 to over $22 million in 2006. The major growth was in broadcast advertising, accounting for 83% of spending in 2006. US annual per capita spending was on average 24 times Canadian levels. Celebrex (celecoxib), which has a US black box and was subject to three safety advisories in Canada, was the most heavily advertised drug on Canadian television in 2005 and 2006. Of 8 brands with >$500,000 spending, which together accounted for 59% of branded DTCA in all media, 6 were subject to Canadian safety advisories, and 4 had US black box warnings.
Conclusions/Significance
Branded ‘reminder’ advertising has grown rapidly in Canada since 2000, mainly due to a growth in television advertising. Although DTCA spending per capita is much lower in Canada than in the US, there is no evidence of safer content or product choice; many heavily-advertised drugs in Canada have been subject to safety advisories. For governments searching for compromise solutions to industry pressure for expanded advertising, Canada's experience stands as a stark warning.
doi:10.1371/journal.pone.0005699
PMCID: PMC2682647  PMID: 19479084
20.  Medications for obesity 
Canadian Family Physician  2008;54(6):848-849.
PMCID: PMC2426986  PMID: 18556487
21.  Questions about Adderall XR 
doi:10.1503/cmaj.1060004
PMCID: PMC1435951  PMID: 16636331
22.  Disease Mongering in Drug Promotion: Do Governments Have a Regulatory Role? 
PLoS Medicine  2006;3(4):e198.
Most regulatory agencies, says Mintzes, fail to treat regulation of drug promotion as a public health concern. Unless this changes, she says, the public can expect more unfettered disease mongering.
doi:10.1371/journal.pmed.0030198
PMCID: PMC1434509  PMID: 16597181
24.  Summary Basis of Decision in context 
doi:10.1503/cmaj.1050055
PMCID: PMC1150238

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