Objective. Concerns persist about a possible association between tumor necrosis factor ␣ (TNF␣) antagonist treatment and development of cancers in patients with rheumatoid arthritis (RA). This study was undertaken to estimate the association between treatment with biologic disease-modifying antirheumatic drugs (DMARDs) and development of cancer in patients with RA.Methods. We conducted a cohort study pooling administrative databases from 2 US states and 1 Canadian province. A cohort of patients who had received a diagnosis of RA on >1 occasion and had been prescribed DMARDs was identified. We categorized patients with a prescription for a biologic DMARD as biologic DMARD users, and those with a prescription for methotrexate (MTX) but no biologic DMARD as MTX users. We used time-varying propensity scores to adjust for the large number of possible confounders and stratified proportional hazards regression to estimate the effects of biologic DMARDs on cancer. The primary end points were hematologic malignancies (lymphoma, multiple myeloma, and leukemia) and common solid tumors (colorectal, lung, stomach, breast, prostate, uterine, ovarian, urinary tract/bladder, and melanoma).

Both men and women who take thiazolidinediones could be at increased risk of fractures. Pioglitazone may be more strongly associated with fractures than rosiglitazone. Larger observational studies are needed, and fracture data from clinical trials need to be fully published so that fracture risks can be known with greater certainty.

No abstract

The individualized prescribing portrait had a significant beneficial effect on new statin prescribing for primary prevention but not secondary prevention. Provincial drug plan costs appear to have been reduced to a level that exceeded the cost of the program.

SummaryWe compared the patterns of osteoporosis medication prescribing between two provinces in Canada with different public drug coverage policies. Oral bisphosphonates were the primary drugs used, yet access to the second-generation oral bisphosphonates (alendronate, risedronate) was limited in one region. Implications of differential access to oral bisphosphonates warrants further study.IntroductionApproved therapies for treating osteoporosis in Canada include bisphosphonates, calcitonin, denosumab, raloxifene, and teriparatide. However, significant variation in access to these medications through public drug coverage exists across Canada. We sought to compare patterns of osteoporosis medication prescribing between British Columbia (BC) and Ontario.MethodsUsing dispensing data from BC (PharmaNet) and Ontario (Ontario Drug Benefits), we identified all new users of osteoporosis medications aged 66 or more years from 1995/1996 to 2008/2009. We summarized the number of new users by fiscal year, sex, and index drug for each province. BC data were also stratified by whether drugs were dispensed within or outside public PharmaCare.ResultsWe identified 578,254 (n = 122,653 BC) eligible new users. Overall patterns were similar between provinces: (1) most patients received an oral bisphosphonate (93% in BC and 99% in Ontario); (2) etidronate prescribing declined after 2001/2002, reaching a low of 41% in BC and 10% in Ontario in 2008/2009; and (3) the proportion of males treated increased over time, from 7% in 1996/1997 to 25% in 2008/2009. However, we note major differences within versus outside the BC PharmaCare system. In particular, <2% of drugs dispensed within PharmaCare compared to 79% of drugs dispensed outside PharmaCare were for a second-generation bisphosphonate (alendronate or risedronate).ConclusionsOral bisphosphonates are the primary drugs used to treat osteoporosis in Canada. Prescribing practices changed over time as newer medications came to market, yet access to second-generation bisphosphonates through BC PharmaCare was limited. Implications of differential access to oral bisphosphonates warrants further study.

Randomized pragmatic trials of drugs, physician education and drug policies are needed to improve pharmacosurveillance and cost-effectiveness of prescribing. Since 1994, we have developed and tested methods for low-cost education and policy trials to improve prescribing in primary care in Canada. We review methodology for using drug claims and other health services data to evaluate prescribing improvement programs and policies. We apply the lessons to a proposed trial of physician education tools (PET) for quality improvement of prescribing. Design issues for the trial include defining the potential programme in causal terms using counterfactuals, narrowing the denominator to the population affected, excluding noise from the numerator, calculating the prescribing preference, adjusting for baseline differences, controlling for modifiers and confounders, accounting for uncertainty when measuring impacts, and grouping practices for feedback and recognition. Data from a randomized trial of academic detailing illustrate measurement challenges. A decade of progress on methods for evaluating prescribing improvement programs with drug claims data has enabled planning of routine randomized pragmatic trials of education and policies in primary care in Canada.Two connected challenges in pharmacology are how to improve pharmacosurveillance (Laupacis et al. 2003), and how providers and payers can share responsibility and credit for improving the cost-effectiveness of prescribing (Ashworth et al. 2004). For both purposes, we need low-cost randomized pragmatic trials of drugs, physician education and drug policies in primary care. Recalling the philosophy of pragmatism with its focus on outcomes in normal life (Wiener 1973), the adjective 'pragmatic' means the trials are done in real-world settings with everyday patients and practices (Godwin et al. 2003). To establish capacity and infrastructure for such trials, we are focusing initially on the second challenge.A systematic review of research on implementing guidelines for practice improvement concluded that a) disseminating printed educational materials, b) audit with feedback, and c) multifaceted interventions with educational outreach, change physician behaviours by only about 6% to 8%

See also commentary on page 237 and at

Purpose: To describe a rapid monitoring plan to assess the impacts of a shift in drug coverage for biosimilar drugs in British Columbia following the introduction of a new policy on 27 May 2019. The Biosimilars Initiative requires users of originator infliximab or etanercept to switch to biosimilar versions of those drugs to maintain coverage. We propose a signal-detection method to provide near-real-time information to policymakers on the impacts of the policy change. Methods: The exposure will be the Biosimilars Initiative, a policy affecting patients using originator infliximab (Remicade) and etanercept (Enbrel) for approved rheumatologic or dermatologic indications. Two policy cohorts and six historical control cohorts of patients using originator infliximab or etanercept will be assembled using linked and de-identified data from the British Columbia Ministry of Health. Patients will be identified during the 6-month period before the policy anniversary. Outcomes will include medication refills and switching, hospital admissions, emergency department visits, and physician visits. Summary outcome measures, such as cumulative incidence or average quantity as applicable, will be examined daily and reported monthly for 1 year. Outcomes in the policy cohorts will be compared with historical controls using likelihood ratios. Results: The results of this rapid monitoring plan will be based on analyses involving approximately 9000 patients: four infliximab cohorts of approximately 430 patients and four etanercept cohorts of approximately 1800 patients. Conclusions: Rapid monitoring results will inform ongoing policy decisions related to the Biosimilars Initiative, in terms of impacts on both patient health and health services utilization.