The role of pharmacists in opioid stewardship: Protocol.

BACKGROUND: The opioid crisis is a worldwide public health concern. In North America, evidence suggests that the increase in opioid prescriptions correlates with the observed increase in opioid-related mortality and morbidity. Pharmacists are in a strategic position to promote effective opioid stewardship as they have a central role on healthcare teams. However, in many contexts, pharmacists do not have a harmonized scope of practice and no standardized opioid stewardship approach has been implemented. OBJECTIVES: A scoping review will be conducted to identify and summarize evidence on the role of pharmacists in opioid stewardship and identify areas for future study. METHODS: The scoping review will be conducted according to the methodological framework proposed by Arksey and O'Malley, which was further modified by the Joanna Briggs Institute. Six databases will be searched which include PubMed, Embase, International Pharmaceutical Abstracts, Scopus, Cochrane Library, and APA PsycInfo. PROJECT IMPACT: The findings of this review will identify opioid stewardship activities that can contribute towards reducing the impact of the opioid crisis. Additionally, it will provide foundational strategies to promote policy level change and foster a harmonized scope of practice. This review has the potential to inform future research, impact pharmacy practice, and drive policy change.

Economic Evaluation of Sedative Deprescribing in Older Adults by Community Pharmacists.

BACKGROUND: Sedative use in older adults increases the risk of falls, fractures, and hospitalizations. The D-PRESCRIBE (Developing Pharmacist-Led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly), pragmatic randomized clinical trial demonstrated that community-based, pharmacist-led education delivered simultaneously to older adults and their primary care providers reduce the use of sedatives by 43% over 6 months. However, the associated health benefits and cost savings have yet to be described. This study evaluates the cost-effectiveness of the D-PRESCRIBE intervention compared to usual care for reducing the use of potentially inappropriate sedatives among older adults. METHODS: A cost-utility analysis from the public health care perspective of Canada estimated the costs and quality-adjusted life-years (QALYs) associated with the D-PRESCRIBE intervention compared to usual care over a 1-year time horizon. Transition probabilities, intervention effectiveness, utility, and costs were derived from the literature. Probabilistic analyses were performed using a decision tree and Markov model to estimate the incremental cost-effectiveness ratio. RESULTS: Compared to usual care, pharmacist-led deprescribing is less costly (-$1392.05 CAD) and more effective (0.0769 QALYs). Using common willingness-to-pay (WTP) thresholds of $50 000 and $100 000, D-PRESCRIBE was the optimal strategy. Scenario analysis indicated the cost-effectiveness of D-PRESCRIBE is sensitive to the rate of deprescribing. CONCLUSIONS: Community pharmacist-led deprescribing of sedatives is cost-effective, leading to greater quality-of-life and harm reduction among older adults. As the pharmacist's scope of practice expands, consideration should be given to interprofessional models of remuneration for quality prescribing and deprescribing services.

Economic burden of opioid crisis and the role of pharmacist-led interventions.

Opioids are often used to treat pain and improve function. Canada and the United States are one of the highest users of opioids per capita worldwide and are experiencing the devastating consequences of the opioid crisis. The objectives of this commentary are 2-fold: first, highlight the economic burden of the opioid crisis in the United States and Canada; second, define the role of pharmacists to address this crisis. A body of literature delineates the cost of this crisis to health care system, lost productivity, and law enforcement. Contemporary data indicate that the economic burden of the opioid crisis was $78.5 billion and $3.5 billion in the United States and Canada, respectively. Community pharmacists are often the first health care providers who identify issues with opioid prescriptions, signs of misuse, abuse, and diversion. Contemporary studies highlight their critical role to address this crisis by ensuring the safe and appropriate use of opioids, which can decrease morbidity, mortality, use of health services and societal resources, and costs. The expanding scope of practice and the amendment of existing regulations and legislations have the potential to maximize the contribution of pharmacists to address this crisis. Pharmacists should be reimbursed for the services they provide to be sustainable.

Cost-Effectiveness of Pharmacist-Led Deprescribing of NSAIDs in Community-Dwelling Older Adults.

OBJECTIVES: Older adults are often prescribed potentially inappropriate medications associated with adverse health outcomes and increased health services utilization. Developing Pharmacist-led Research to Educate and Sensitize Community Residents to the Inappropriate Prescriptions Burden in the Elderly (D-PRESCRIBE), a pragmatic randomized clinical trial, demonstrated how a community pharmacist-led evidence-based educational intervention successfully empowered community-dwelling older adults and their physicians to reduce chronic use of inappropriate medications. The objective of this study was to evaluate the cost-effectiveness of the D-PRESCRIBE intervention for discontinuing nonsteroidal anti-inflammatory drugs (NSAIDs). DESIGN: Cost-effectiveness analysis. SETTING: Canada. PARTICIPANTS: Community-dwelling adults aged 65 years and older. MEASUREMENTS: Decision analysis combining decision tree and Markov state transition modeling was developed to estimate the cost-effectiveness of D-PRESCRIBE (NSAIDs) compared with usual care from a Canadian healthcare system perspective with a time horizon of 1 year. Data from the D-PRESCRIBE trial and published literature were used to calculate effectiveness, utilities, and costs. Reference case and scenario analyses were conducted using probabilistic modeling. Sensitivity analyses assessed the robustness of the reference case model. RESULTS: D-PRESCRIBE (NSAIDs) was less costly (-$1008.61) and more effective (.11 quality-adjusted life-years [QALYs]) than usual care and was the dominant strategy. At willingness-to-pay thresholds of $50 000 per QALY and $100 000 per QALY, D-PRESCRIBE (NSAIDs) incurred a positive incremental net benefit compared with usual care, suggesting it is cost-effective. Compared with the reference case, scenario analyses gave comparable QALYs with modest variation in cost estimates. CONCLUSION: For community-dwelling older adults, D-PRESCRIBE (NSAIDs) provides greater benefits at lower system costs, making it a compelling strategy to reduce the use and harms associated with chronic NSAID consumption. Our findings support reimbursing community pharmacists' clinical professional services for deprescribing inappropriate NSAIDs in community-dwelling older adults. J Am Geriatr Soc 68:1090-1097, 2020.

Systematic Review of Economic Evaluations of Services Provided by Community Pharmacists.

BACKGROUND: Community pharmacists' scope of practice has been evolving from a traditional dispensing role to providing patient-centered services. Given the constraints in healthcare budget and a need for efficient use of finite resources, decision makers may require convincing evidence of value to recommend these services for public funding. Several economic evaluations have aimed to demonstrate the value of services provided by community pharmacists. OBJECTIVE: The objective of this study was to systematically review the reporting and methodological quality of full economic evaluations of services provided by community pharmacists. METHODS: A literature search was conducted in the bibliographic databases MEDLINE, EMBASE, and the NHS Economic Evaluations Database since their inception to February 2019. Two independent reviewers performed title, abstract, full text screening, and data abstraction and assessed the quality of reporting and methodological approaches using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Quality of Health Economic Studies (QHES) checklists. RESULTS: Twenty full economic evaluations were included in the review. Most of these studies were conducted in the UK (40%), followed by the USA (35%), Canada (10%), the Netherlands (5%), Thailand (5%), and Australia (5%). The efficacy or effectiveness data were drawn from individual level or cluster randomized trials, or observational studies. About half of these studies (45%) adopted the perspective of the public healthcare system. Four studies used decision analytic modeling. We identified issues in these studies with selection of study population, efficacy or effectiveness data, time horizon, outcomes measured, measurement or resources used and cost estimation, analytical approaches, and handling of uncertainty with study parameters. The quality of reporting and methodological considerations was variable across these studies, with none of the studies adequately fulfilling all 24 items of CHEERS or 16 questions of QHES checklists. CONCLUSIONS: Our findings suggest there are various issues related to the quality of conduct and reporting of economic evaluations of services provided by community pharmacists. Interpretation of these studies should be treated with caution to facilitate decision making in the local context. In an era of scarce resources and demand for evidence-informed decision making, there may be a need for guidance on methodological approaches to assess the value of these services.

Community-Based Services by Pharmacists: A Systematic Review of Cost-Utility Analyses.

OBJECTIVES: To conduct a systematic review of cost-utility studies of community-based services provided by pharmacists and to examine their reporting and methodological quality. METHODS: A comprehensive literature search was performed in February 2019 using a replicable search strategy in bibliographic databases MEDLINE, EMBASE, and the NHS Economic Evaluations Database from their inception onwards. Two reviewers independently screened the literature, abstracted data from full-text articles, and assessed reporting and methodological quality using the Consolidated Health Economic Evaluation Reporting Standards and Quality of Health Economic Studies checklists. RESULTS: Twenty studies were included in this review, representing the healthcare systems of the United Kingdom, Spain, France, The Netherlands, Belgium, Italy, Canada, the United States of America, and Brazil. Descriptions of the context in which the studies were done, justification of data sources on patient and process outcomes, choices of model, and generalizability of study findings were often inadequately reported. Seven studies (35%) were deemed of high methodological quality, 11 studies (55%) of fair quality, and 2 studies (10%) of poor quality. In addition, various methodological issues related to the randomized controlled trials and observational studies used to generate effectiveness estimates were identified. CONCLUSIONS: In view of the lack of standardized definitions of expanded services, heterogeneity in study objectives, settings, comparators, methodology, outcomes, and the variable quality of these studies, the value of these services (in terms of costs) compared with quality-adjusted survival remains inconclusive.

Cost-effectiveness and budget impact of the management of uncomplicated urinary tract infection by community pharmacists.

BACKGROUND: Urinary tract infections (UTI) are one of the most common infections treated in primary care and the emergency department. The RxOUTMAP study demonstrated that management of uncomplicated UTI by community pharmacists resulted in high clinical cure rates similar to those reported in the literature and a high degree of patient satisfaction. The objective of this study was to assess the cost-effectiveness and budget impact of community pharmacist-initiated compared to family or emergency physician-initiated management of uncomplicated UTI. METHODS: A decision analytic model was used to compare costs and outcomes of community pharmacist-initiated management of uncomplicated UTI to family or emergency physician-initiated management. Cure rates and utilities were derived from published studies. Costs of antibiotic treatment and health services use were calculated based on cost data from Canada. We used a probabilistic analysis to evaluate the impact of treatment strategies on costs and quality-adjusted-life-months (QALMs). In addition, a budget impact analysis was conducted to evaluate the financial impact of community pharmacist-initiated uncomplicated UTI management in this target population. This study was conducted from the perspective of the public health care system of Canada. RESULTS: Pharmacist-initiated management was lower cost ($72.47) when compared to family and emergency physician-initiated management, $141.53 and $368.16, respectively. The QALMs gained were comparable across the management strategies. If even only 25% of Canadians with uncomplicated UTI were managed by community pharmacists over the next 5 years, the resulting net total savings was estimated at $51 million. CONCLUSION: From a Canadian public health care system perspective, community pharmacist-initiated management would likely be a cost-effective strategy for uncomplicated UTI. In an era of limited health care resources, expanded roles of community pharmacists or other non-physician community based prescribers are important mechanisms through which accessible, high-quality and cost-effective care may be achieved. Further studies to evaluate other conditions which can be managed in the community and their cost effectiveness are essential.

Economic evaluations of eHealth technologies: A systematic review.

BACKGROUND: Innovations in eHealth technologies have the potential to help older adults live independently, maintain their quality of life, and to reduce their health system dependency and health care expenditure. The objective of this study was to systematically review and appraise the quality of cost-effectiveness or utility studies assessing eHealth technologies in study populations involving older adults. METHODS: We systematically searched multiple databases (MEDLINE, EMBASE, CINAHL, NHS EED, and PsycINFO) for peer-reviewed studies published in English from 2000 to 2016 that examined cost-effectiveness (or utility) of eHealth technologies. The reporting quality of included studies was appraised using the Consolidated Health Economic Evaluation Reporting Standards statement. RESULTS: Eleven full text articles met the inclusion criteria representing public and private health care systems. eHealth technologies evaluated by these studies includes computerized decision support system, a web-based physical activity intervention, internet-delivered cognitive behavioral therapy, telecare, and telehealth. Overall, the reporting quality of the studies included in the review was varied. Most studies demonstrated efficacy and cost-effectiveness of an intervention using a randomized control trial and statistical modeling, respectively. This review found limited information on the feasibility of adopting these technologies based on economic and organizational factors. CONCLUSIONS: This review identified few economic evaluations of eHealth technologies that included older adults. The quality of the current evidence is limited and further research is warranted to clearly demonstrate the long-term cost-effectiveness of eHealth technologies from the health care system and societal perspectives.

The role of unregulated care providers in Canada-A scoping review.

AIMS AND OBJECTIVES: This scoping review explored: (i) the role of unregulated care providers in the healthcare system; (ii) their potential role on interprofessional teams; (iii) the impact of unregulated care provider's role on quality of care and patient safety; and (iv) education and employment standards. BACKGROUND: Unregulated care providers in Canada assist older adults with personal support and activities of daily living in a variety of care settings. As the care needs of an aging population become increasingly complex, the role of unregulated care providers in healthcare delivery has also evolved. Currently, many unregulated care providers are performing tasks previously performed by regulated health professionals, with potential implications for quality of care and patient safety. Information is fragmented on the role, education and employment standards of unregulated care providers. METHODS: A scoping review was conducted following the methods outlined by Arksey and O'Malley (International Journal of Social Research Methodology, 8, 2005, 19) and Levac, Colquhoun, and O'Brien (Implementation Science, 5, 2010, 69). An iterative search of published and grey literature was conducted from January 2000 to September 2016 using Medline, CINAHL, SCOPUS and Google. Inclusion and exclusion criteria were applied to identify relevant studies published in English. RESULTS: The search yielded 63 papers for review. Results highlight the evolving role of unregulated care providers, a lack of recognition and a lack of authority for unregulated care provider decision-making in patient care. Unregulated care providers do not have a defined scope of practice. However, their role has evolved to include activities previously performed by regulated professionals. Variations in education and employment standards have implications for quality of care and patient safety. CONCLUSIONS: Unregulated care providers are part of an important workforce in the long-term care and community sectors in Canada. Their evolving role should be recognised and efforts made to leverage their experience on interprofessional teams and reduce variations in education and employment standards. IMPLICATIONS FOR PRACTICE: This study highlights the evolving role of unregulated care providers in Canada and presents a set of recommendations for implementation at micro, meso, and macro policy levels.

Management of localized and advanced prostate cancer in Canada: A lifetime cost and quality-adjusted life-year analysis.

BACKGROUND: To the authors' knowledge, the literature to date lacks studies examining lifetime costs and quality-adjusted life-years (QALYs) of prostate cancer (PCa) management strategies that integrate localized and advanced disease. The objective of the current study was to assess lifetime costs and QALYs associated with contemporary PCa management strategies across risk groups by integrating localized and advanced disease. METHODS: The authors' validated Markov chain Monte Carlo model was used to predict lifetime direct costs and QALYs. The health states modeled were active surveillance, initial treatments (radical prostatectomy or radiotherapy), PCa recurrence, PCa recurrence free, metastatic castration-resistant prostate cancer, and death (cause specific/other causes). Data regarding treatment distribution, state transition probabilities, adverse effects of management options, costs, utilities, and disutilities were derived from the published literature. RESULTS: The total cost per patient for the overall cohort increased from $18,503 at 5 years to $28,032 and $39,143, respectively, at 10 years and 15 years. Furthermore, the results indicated the influence of risk group on total cost, with the high-risk group accruing the maximum per patient cost followed by the intermediate-risk and low-risk groups. Active surveillance was found to confer the most QALYs (12.5 years) and was the least costly strategy ($18,452) for individuals at low risk. For all risk groups, radical prostatectomy was less costly and conferred modestly more QALYs compared with intensity-modulated radiotherapy modalities. CONCLUSIONS: Public health care systems in Canada and elsewhere are operating under budget constraints to allocate finite resources. The findings of the current study might inform discussions concerning budget planning to provide health care services.

Clinical management and burden of prostate cancer: a Markov Monte Carlo model.

BACKGROUND: Prostate cancer (PCa) is the most common non-skin cancer among men in developed countries. Several novel treatments have been adopted by healthcare systems to manage PCa. Most of the observational studies and randomized trials on PCa have concurrently evaluated fewer treatments over short follow-up. Further, preceding decision analytic models on PCa management have not evaluated various contemporary management options. Therefore, a contemporary decision analytic model was necessary to address limitations to the literature by synthesizing the evidence on novel treatments thereby forecasting short and long-term clinical outcomes. OBJECTIVES: To develop and validate a Markov Monte Carlo model for the contemporary clinical management of PCa, and to assess the clinical burden of the disease from diagnosis to end-of-life. METHODS: A Markov Monte Carlo model was developed to simulate the management of PCa in men 65 years and older from diagnosis to end-of-life. Health states modeled were: risk at diagnosis, active surveillance, active treatment, PCa recurrence, PCa recurrence free, metastatic castrate resistant prostate cancer, overall and PCa death. Treatment trajectories were based on state transition probabilities derived from the literature. Validation and sensitivity analyses assessed the accuracy and robustness of model predicted outcomes. RESULTS: Validation indicated model predicted rates were comparable to observed rates in the published literature. The simulated distribution of clinical outcomes for the base case was consistent with sensitivity analyses. Predicted rate of clinical outcomes and mortality varied across risk groups. Life expectancy and health adjusted life expectancy predicted for the simulated cohort was 20.9 years (95%CI 20.5-21.3) and 18.2 years (95% CI 17.9-18.5), respectively. CONCLUSION: Study findings indicated contemporary management strategies improved survival and quality of life in patients with PCa. This model could be used to compare long-term outcomes and life expectancy conferred of PCa management paradigms.

The utilization of antidepressants and benzodiazepines among people with major depression in Canada.

OBJECTIVE: Although clinical guidelines recommend monotherapy with antidepressants (ADs) for major depression, polypharmacy with benzodiazepines (BDZs) remains an issue. Risks associated with such treatments include tolerance and dependence, among others. We assessed the prevalence and determinants of AD and BDZ utilization among Canadians who experienced a major depressive episode (MDE) in the previous 12 months, and determined the association of seeing a psychiatrist on the utilization of ADs and BDZs. METHOD: Data were drawn from the 2002 Canadian Community Health Survey: Health and Well-Being, a nationally representative sample of Canadians aged 15 years and older. Descriptive statistics quantified utilization, while logistic regression identified factors associated with utilization, such as sociodemographic characteristics or type of physician seen. Sampling weights and bootstrap variance estimations were used for all analysis. RESULTS: The overall prevalence of AD and BDZ utilization was 49.3% of respondents who experienced an MDE in the past 12 months and reported AD use. Key determinants of utilization were younger age and unemployment in the past week (OR 2.6; P < 0.001). Being seen by a psychiatrist increased utilization (OR 2.5; P < 0.001), possibly because psychiatrists were seeing patients with severe depression. CONCLUSION: A large proportion of people with past-year MDEs utilized ADs and BDZs. It is unclear how much of this is appropriate given that evidence-based clinical guidelines recommend monotherapy with ADs in the treatment of major depression.

Prevalance and determinants of antidepressant use among Canadian Forces members experiencing major depressive episodes.

BACKGROUND: Major depression affects a significant proportion of individuals including those serving in the military; but, there is less information on the pharmacological treatment they receive. OBJECTIVES: We assessed the prevalence and determinants of past year antidepressant use among regular and reservist members of the Canadian Forces who have experienced major depressive episodes in the past 12 months. METHODS: The 2002 Canadian Community Health Survey Cycle 1.2 Canadian Forces Supplement (CCHS1.2-CFS) surveyed 8441 active members of the Canadian Forces. Individuals who reported experiencing major depressive episodes (MDE) in the past 12 months, according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), were examined with data from the CCHS1.2-CFS. Regression models assessed sociodemographic determinants and service factors of antidepressant use employing appropriate weights and bootstrapping variance estimation methods. RESULTS: Overall, 7.4% of members of the Canadian Forces experienced MDE in the past 12 months, and of those only 32.1% reported to have taken an antidepressant. Significant predictors of antidepressant use were marital status i.e. married/common law (OR=3.6, 95%CI 2.0-6.4), widowed/separated/divorced (OR=4.0, 95%CI 2.0-8.4), and being in both combat and peacekeeping missions (OR=2.2, 95%CI 1.3-3.8). CONCLUSION: Findings highlight the characteristics that predispose individuals in the Canadian Forces with MDE to use antidepressant, and serves as a baseline to determine the effectiveness of ongoing programs for diagnosis, treatment and prevention of major depression. Continued research involving the Canadian Forces will foster better understanding of mental health outcomes and effective interventions to improve care.

Coping strategies used by patients infected with hepatitis C virus who are facing medication costs.

BACKGROUND: The prevalence of infection with hepatitis C virus (HCV) is increasing worldwide. Antiviral therapy, prescription and nonprescription medications, and nondrug therapies to treat HCV infection and to manage associated adverse effects are costly. OBJECTIVE: To determine whether individuals infected with HCV attending a hepatology clinic were negatively affected by the costs of prescription medications, and if so, to determine coping strategies they adopted. METHODS: Patients infected with HCV attending Hepatology Services, a clinic within the Queen Elizabeth II Health Sciences Centre in Halifax, Nova Scotia, were interviewed as part of an exploratory study (April 2 to July 8, 2008). The interview was based on a validated survey adapted for Nova Scotia. Information collected included demographic characteristics; types of prescription, nonprescription, and complementary medications used by patients; and strategies patients adopted to pay their medication costs. RESULTS: Fifty patients (age 33-64 years) participated in the interviewer-administered survey, including 35 (70%) men and 19 people (38%) with household income less than $30 000. Frequently used medications were antidepressants (19 patients [38%]), antihypertensive agents (12 [24%]), anxiolytics (10 [20%]), and nonsteroidal anti-inflammatory drugs (10 [20%]). More than half (29 [58%]) were concerned about having sufficient money to pay for their medications. Coping strategies adopted in response to costs of prescription medications were either self-initiated or undertaken in consultation with physicians and/or other health care professionals. Sixteen (32%) of the respondents expressed the belief that physicians usually do not consider patients' concerns about affordability when prescribing medications. Seven (14%) indicated they would seek help from a pharmacist to buy low-cost substitutes for their medications. CONCLUSION: This study highlighted a range of coping strategies adopted by patients infected with HCV in response to medication costs. It underscores that cost may limit access to essential medications within this patient population, even in a publicly funded health care system. Some of the coping strategies adopted might reduce patients' persistence and adherence with medication therapy, which could lead to adverse health outcomes. Hospital and community pharmacists need to be aware of the challenges faced by patients in terms of paying for medications and should consider possible proactive responses to address potentially detrimental coping strategies.

The relationship between type of drug therapy and blood glucose self-monitoring test strips claimed by beneficiaries of the Seniors' Pharmacare Program in Nova Scotia, Canada.

BACKGROUND: The healthcare expenditure on self-monitoring of blood glucose (SMBG) test strips under the Nova Scotia Seniors' Pharmacare Program (NSSPP) has increased significantly in recent years. The objective of this study was to identify the frequency and cost of claims for blood glucose monitoring test strips by NSSPP beneficiaries in the fiscal year 2005/06 and to explore the variation in the use of test strips by type of treatment, age and sex. METHODS: Retrospective analysis was conducted using pharmacy administrative claims data for NSSPP beneficiaries. Study subjects were aged > or = 65 years on October 1, 2004, received SMBG test strips in the 110 days prior to April 1, 2005, and were alive throughout the twelve month study period. Subjects were categorized into four groups: insulin only, oral antihyperglycemic agents (OAA) only, both OAA and insulin; and no reimbursed diabetes medications. Statistical analysis was performed to identify differences in expenditure by medication group and in frequency of SMBG test strips claimed by medication group, age, and sex. RESULTS: Of 13,564 included beneficiaries, 13.2% were categorized as insulin only, 53.5% OAA only, 7.2% both OAA and insulin, and 26.0% no reimbursed diabetes medications. Over half (58.7%) were femle. The insulin only category had the highest mean (+/- SD) number of SMBG test strips claimed per day (2.0 +/- 1.5) with a mean annual total cost of $615 +/- $441/beneficiary. Beneficiaries aged 80 years and above claimed fewer test strips than beneficiaries below 80 years. CONCLUSION: This population based study shows that in Nova Scotia the SMBG test strips claimed by the majority of seniors were within Canadian guidelines. However, a small proportion of beneficiaries claimed for SMBG test strips infrequently or too frequently, which suggests areas for improvement. The provincial drug plan covers the majority of the costs of test strip utilization, suggesting that the majority of test strips claimed did not exceed the maximum allowable cost (MAC) established in the program's MAC policy. Drug insurance programs need to work with healthcare providers to determine if patients are using test strips optimally; and to determine their impact on patient outcomes. In addition, they need to determine the cost-effectiveness of their SMBG test strip reimbursement policies.