The appointment-based model in community pharmacies: Patient demographics and reimbursable clinical services uptake in Ontario.

Background: Community pharmacies typically require patients to request medication refills. The appointment-based model (ABM) is a proactive approach that synchronizes refills and schedules patient-pharmacist appointments. These appointments provide opportunities for medication reviews, medication optimization and health promotion services.

On-time denosumab dosing recovered rapidly during the COVID-19 pandemic, yet remains suboptimal.

Timely administration of denosumab every 6 mo is critical in osteoporosis treatment to avoid multiple vertebral fracture risk upon denosumab discontinuation or delay. This study aimed to estimate the immediate and prolonged impact of the COVID-19 pandemic on the timing of denosumab doses. We identified older adults (≥66 yr) residing in the community who were due to receive denosumab between January 2016 and December 2020 using Ontario Drug Benefit data.

Methodological guidance for the use of real-world data to measure exposure and utilization patterns of osteoporosis medications.

Observational studies of osteoporosis medications can provide critical real-world evidence (RWE) that fills knowledge gaps left by clinical trials. However, careful consideration of study design is needed to yield reliable estimates of association. In particular, obtaining valid measurements of exposure to osteoporosis medications from real-world data (RWD) sources is complicated due to different medication classes, formulations, and routes of administration, each with different pharmacology.

Clinical practice guideline for management of osteoporosis and fracture prevention in Canada: 2023 update.

Background: In Canada, more than 2 million people live with osteoporosis, a disease that increases the risk for fractures, which result in excess mortality and morbidity, decreased quality of life and loss of autonomy. This guideline update is intended to assist Canadian health care professionals in the delivery of care to optimize skeletal health and prevent fractures in postmenopausal females and in males aged 50 years and older.

Methods: This guideline is an update of the 2010 Osteoporosis Canada clinical practice guideline on the diagnosis and management of osteoporosis in Canada.

Implementation of the appointment-based model in community pharmacies: An analysis of refills and adherence.

Background: Traditionally, much of community pharmacy practice relies on patients to request their own medication refills. These refills are often not aligned, which has been shown to decrease adherence and workflow efficiencies. The appointment-based model (ABM) is designed to proactively synchronize refills and schedule patient-pharmacist appointments.

Comparison of Fracture Identification Using Different Definitions in Healthcare Administrative (Claims) Data.

We identified inconsistency in fracture definitions in a prior review of studies that utilized claims data. Here, we aimed to compare fracture rates estimated using thirteen hip and seven radius/ulna fracture definitions. Our primary analysis compared results in a cohort of 120,363 older adults treated with oral bisphosphonates for ≥3 years.

Comparative Fracture Risk During Osteoporosis Drug Holidays After Long-Term Risedronate Versus Alendronate Therapy : A Propensity Score-Matched Cohort Study.

Background: An osteoporosis drug holiday is recommended for most patients after 3 to 5 years of therapy. Risedronate has a shorter half-life than alendronate, and thus the residual length of fracture protection may be shorter.

Objective: To examine the comparative risks of drug holidays after long-term (≥3 years) risedronate versus alendronate therapy.

Fracture outcome definitions in observational osteoporosis drug effects studies: a scoping review protocol.

Objective: The objective of this review is to describe fracture outcome definitions in observational osteoporosis drug effects studies from Canada and the United States.

Introduction: Health care administrative data are commonly utilized in pharmacoepidemiologic studies. These data are used to define outcomes, such as fractures, and are critical to determining real-world safety and effectiveness of medications.

Observational study methods used to assess pharmacotherapy effects of type 2 diabetes on fracture risk: a scoping review protocol.

Objective: The objective of this review is to summarize observational research methods employed to study fracture risk and the use of type 2 diabetes mellitus medications. The methods summary will be used as a case study to illustrate current practices in the study of medication effects on fracture risk.

Introduction: Observational studies examining drug effects on fracture risk fill knowledge gaps left by clinical trials but require specific design considerations.

The Use of Active Comparators in Self-Controlled Designs.

For self-controlled studies of medication-related effects, time-varying confounding by indication can occur if the indication varies over time. We describe how active comparators might mitigate such bias, using an empirical example. Approaches to using active comparators are described for case-crossover design, case-time-control design, self-controlled case-series, and sequence symmetry analyses.

Duration of Bisphosphonate Drug Holidays in Osteoporosis Patients: A Narrative Review of the Evidence and Considerations for Decision-Making.

Bisphosphonates are first-line therapy for osteoporosis, with alendronate, risedronate, and zoledronate as the main treatments used globally. After one year of therapy, bisphosphonates are retained in bone for extended periods with extended anti-fracture effects after discontinuation. Due to this continued fracture protection and the potential for rare adverse events associated with long-term use (atypical femoral fractures and osteonecrosis of the jaw), a drug holiday of two to three years is recommended for most patients after long-term bisphosphonate therapy.

Strategies for measuring prescription medication switching with pharmacy claims data: a scoping review protocol.

Objective: This scoping review will aim to compare strategies for measuring prescription medication switching with pharmacy claims data, with a focus on psychotropic vs non-psychotropic medications.

Introduction: Medication switching (ie, the replacement of one medication for another) is common and occurs due to several factors (such as adverse effects to a specific medication). In pharmacoepidemiology studies that use pharmacy claims data, it is important to identify and account for switches; however, due to data limitations and lack of a methodological standard, this can be challenging.

Control yourself: ISPE-endorsed guidance in the application of self-controlled study designs in pharmacoepidemiology.

Purpose: Consensus is needed on conceptual foundations, terminology and relationships among the various self-controlled "trigger" study designs that control for time-invariant confounding factors and target the association between transient exposures (potential triggers) and abrupt outcomes. The International Society for Pharmacoepidemiology (ISPE) funded a working group of ISPE members to develop guidance material for the application and reporting of self-controlled study designs, similar to Standards of Reporting Observational Epidemiology (STROBE). This first paper focuses on navigation between the types of self-controlled designs to permit a foundational understanding with guiding principles.

External validation of clinical prediction rules for complications and mortality following Clostridioides difficile infection.

Background: Several clinical prediction rules (CPRs) for complications and mortality of Clostridioides difficile infection (CDI) have been developed but only a few have gone through external validation, and none is widely recommended in clinical practice.

Methods: CPRs were identified through a systematic review. We included studies that predicted severe or complicated CDI (cCDI) and mortality, reported at least an internal validation step, and for which data were available with minimal modifications.

Design choices for observational studies of the effect of exposure on disease incidence.

The purpose of this paper is to help readers choose an appropriate observational study design for measuring an association between an exposure and disease incidence. We discuss cohort studies, sub-samples from cohorts (case-cohort and nested case-control designs), and population-based or hospital-based case-control studies. Appropriate study design is the foundation of a scientifically valid observational study.

Temporal Trends and Factors Associated with Bisphosphonate Discontinuation and Restart.

Adverse events related to long-term use of bisphosphonates have raised interest in temporary drug discontinuation. Trends in bisphosphonate discontinuation and restart, as well factors associated with these decisions, are not fully understood at a population level. We investigated temporal trends of bisphosphonate discontinuation from 2010 to 2015 and identified factors associated with discontinuation and restart of osteoporosis therapy.

Impact of the 2016 Policy Change on the Delivery of MedsCheck Services in Ontario: An Interrupted Time-Series Analysis.

MedsCheck (MC) is an annual medication review service delivered by community pharmacists and funded by the government of Ontario since 2007 for residents taking three or more medications for chronic conditions. In 2010, MC was expanded to include patients with diabetes (MCD), home-bound patients (MCH), and residents of long-term care homes (MCLTC). The Ontario government introduced an abrupt policy change effective 1 October 2016 that added several components to all MC services, especially those completed in the community.

Characteristics of patients vaccinated against influenza in physician offices versus pharmacies and predictors of vaccination location: a cross-sectional study.

Background: Little is known about those vaccinated against influenza after pharmacists were added to the Ontario Universal Influenza Immunization Program, in 2012. Our aim was to identify characteristics of patients vaccinated against influenza and predictors of vaccination at a physician's office versus a community pharmacy.

Methods: We conducted a cross-sectional study of Ontario residents who had a record of receipt of an influenza vaccine between October and March in the 2013/14 and 2015/16 influenza seasons in Ontario using health administrative databases.

Analysis of Trends in Insulin Utilization and Spending Across Canada From 2010 to 2015.

Objectives: To describe insulin utilization and spending across Canada and investigate how interprovincial variations in long-acting insulin uptake impact provincial spending.

Methods: We conducted a cross-sectional time-series analysis of insulin products dispensed nationally from January 1, 2010, to December 31, 2015, using data from IQVIA (Durham, North Carolina, United States). Analysis was stratified according to insulin type, payer and province.

Denosumab and breast cancer risk in postmenopausal women: a population-based cohort study.

Background: Denosumab inhibits the receptor activator of nuclear factor κB (RANK) pathway and is used to treat osteoporosis. Emerging evidence suggests RANK-blockade may play a role in mammary tumourigenesis. Thus, we undertook a population-based study of denosumab use and breast cancer risk in a large cohort of postmenopausal women.