Comprehensive Drug-Class Review Framework for improved evidence-based drug policy and formulary modernization.

Formularies are used by payers to optimize access and ensure the appropriate use of medications. Lack of follow-up and re-evaluation can lead to outdated formularies that are not reflective of current evidence. Formulary modernization, an approach to re-align formularies with current evidence has proven successful. The Ontario Drug Policy Research Network (ODPRN) launched a framework for conducting comprehensive drug-class reviews. This commentary describes the individual components of this framework and lessons learned through completion of 12 reviews between 2013 and 2016. We present the ODPRN drug-class review of treatments for chronic hepatitis B as a case example to illustrate the components and impact. The incorporation of foundational health technology assessment components such as economic evaluations and knowledge synthesis with contextualizing evidence such as patient and clinician perspectives (through qualitative studies), real-world evidence (through data analytics), and cross-jurisdictional comparisons (through environmental scans and data analytics), successfully developed jurisdictionally specific policy recommendations grounded in up-to-date evidence. The ODPRN framework for conducting comprehensive drug-class reviews is a robust and feasible approach to conduct formulary modernization. This framework allows for actionable and specific policies which are likely to be considered by decision makers. Adoption of similar frameworks in other jurisdictions may improve uptake of evidence-informed policy recommendations.

Canadian expert consensus: management of hypersensitivity reactions to intravenous iron in adults.

BACKGROUND AND OBJECTIVES: Rare but potentially life-threatening hypersensitivity reactions can occur during the administration of intravenous iron. To provide guidance to healthcare professionals caring for adults receiving intravenous iron, a panel of 10 Canadian clinical experts developed a practical algorithm for the identification and management of hypersensitivity reactions to intravenous iron. MATERIALS AND METHODS: A systematic search of PubMed to February 2018 was performed. Articles related to hypersensitivity reactions were selected for review. The algorithm was developed during a 1-day live meeting based on the literature review and clinical expertise where evidence was lacking. The algorithm was then refined through an iterative process involving a web-based platform and virtual meetings. RESULTS: The algorithm provides guidance to healthcare professionals in preparing for and administering IV iron, as well as recognizing and managing hypersensitivity reactions to intravenous iron. Considerations for re-challenging patients who have experienced prior reactions are provided. CONCLUSION: Healthcare professionals who are involved in the care of patients receiving intravenous iron should be trained to anticipate, recognize and manage hypersensitivity reactions to intravenous iron to optimize patient care.

Factors that may be influencing the rise in prescription testosterone replacement therapy in adult men: a qualitative study.

OBJECTIVE: To explore and describe the factors that may be influencing the rise of prescribing and use of testosterone replacement therapy (TRT) in adult men. DESIGN: A rapid qualitative research design using semi-structured interviews with providers and patients. SETTING: Ontario, Canada. PARTICIPANTS: Nine men who have used TRT (referred to as "patients"), and six primary care clinicians and seven specialists (collectively referred to as "providers") who prescribed or administered TRT. METHOD: Patients' and providers' perspectives were investigated through semi-structured interviews. A purposive sampling approach was used to recruit all participants. We conducted qualitative analysis using the framework approach for applied health research. MAIN FINDINGS: Participants perceived the following factors to have influenced TRT prescriptions and use in adult men: provider factors (diagnostic ambiguity of age-related hypogonadism and beliefs about appropriateness of TRT) and patient factors (access to information on TRT and drug seeking behavior). They perceived that these factors have perpetuated a rise in prescription in the absence of clear clinical guidelines and unclear research evidence on the safety and efficacy of TRT. CONCLUSION: The findings of this study highlight that much work still needs to be done to improve diagnostic accuracy and encourage appropriate TRT prescription in adult men. In addition, both patients and providers need more information about the risks and long-term effects of TRT in men.

Interprovincial Variation in Antipsychotic and Antidepressant Prescriptions Dispensed in the Canadian Pediatric Population.

OBJECTIVE: Although antidepressants and antipsychotics are valuable medications in the treatment of select psychiatric disorders, there is increasing focus on the balance of risks and benefits of these drugs as prescribed, particularly in the pediatric population. We examined recent national trends and interprovincial variation in dispensing of antipsychotic and antidepressant prescriptions to the Canadian pediatric population. METHOD: We conducted a population-based cross-sectional study of antidepressant and antipsychotic prescriptions dispensed by Canadian pharmacies to the pediatric population (≤18 years) between 2010 and 2013. Prescription volumes were obtained from IMS Health. Analysis was stratified by drug, year, quarter, and province and population-standardized using age-adjusted population estimates. RESULTS: From the first quarter of 2010 to the fourth quarter of 2013, dispensing of antipsychotics to the pediatric population increased 33% (from 34 to 45 prescriptions per 1000) and dispensing of antidepressants increased 63% (from 34 to 55 per 1000). We observed a 1.5-fold interprovincial difference in dispensing rates for antidepressants (range: 189 per 1000 to 275 per 1000) and a 3.0-fold difference for antipsychotics (range: 85 per 1000 to 253 per 1000) in 2013. Among antidepressants, selective serotonin reuptake inhibitors were the most dispensed (76%), with fluoxetine being the leading agent. Among antipsychotics, atypical antipsychotics were the most dispensed (97%), with risperidone being the leading agent. CONCLUSIONS: Antipsychotic and antidepressant dispensing to the Canadian pediatric population increased from 2010 to 2013, with considerable interprovincial variation. Future research is required to explore reasons for observed patterns to optimize care for the Canadian pediatric population.

Triptans for Acute Migraine: Drug Class Review to Help Inform Policy Decisions.

BACKGROUND/OBJECTIVE: In Ontario, triptans are publicly funded through the Ontario Drug Benefit's Exceptional Access Program, a prior authorization program. However, it was unclear whether this listing aligned with current evidence of safety and effectiveness for triptans in migraine. Using a comprehensive and novel drug class review framework, we describe our review of triptans for the management of acute migraine to evaluate the appropriateness of triptan listing on the public drug formulary in Ontario. METHODS: This supplement in Headache highlights four key components of the triptan drug class review, including findings from a qualitative analysis of patient and clinician perspectives, a systematic review and network meta-analysis of clinical trial evidence, a pharmacoepidemiologic analysis comparing utilization trends across Canada, and a reimbursement-based economic analysis. RESULTS: We found that triptans were efficacious and safe for the treatment of acute migraine. However, Ontario has among the lowest rates of publically funded triptan use in Canada, which may be due to the highly restrictive nature of access to triptans in Ontario. Expanding access to triptans via a less restrictive listing (eg, Limited Use) would potentially increase use by 20-fold, with increase in costs of approximately 220%. CONCLUSION: Based on findings from our multi-faceted review and after stakeholder review and input from the Citizens' Panel, two policy options for triptans were recommended for Ontario's publically funded drug program: Limited Use access or coverage via the Exceptional Access Program, both options including quantity limits of 12 units per month.

Access to Triptans for Acute Episodic Migraine: A Qualitative Study.

OBJECTIVE: Our study aims to examine factors related to access of triptans among multiple stakeholder groups. BACKGROUND: Triptans are a cornerstone of pain management for the acute treatment of migraine, but actual utilization of triptans is lower than ideal. Initial and continued access to triptans may be an important clinical issue in the acute treatment of migraines, but factors affecting access at the patient, provider, and health-care system levels have not been comprehensively explored. METHODS: A qualitative study was conducted in Ontario, Canada, between August 2013 and January 2014. Three participant groups were recruited to the qualitative study: (1) migraineurs who have experience accessing triptans; (2) physicians, including primary care physicians (PCPs) and neurologists, who have prescribed triptans; and (3) pharmacists who have dispensed triptans. Qualitative data were collected through one-on-one, semi-structured telephone interviews. The framework approach was used for data collection and analysis. RESULTS: Data collected from 19 migraineurs, 6 physicians, and 8 pharmacists were included in the analysis. Study participants discussed various factors that facilitate or hinder access to triptans, which were synthesized into four themes that emerged at the patient, provider, and health-care systems levels: (1) awareness; (2) apathy; (3) advocacy; and (4) affordability. Across all participant groups, awareness of available treatments and coverage policies for those treatments were potential factors relating to timely drug provision. Participants describe apathy in terms of patients' health-seeking behaviors and physicians' lack of concern toward migraine, which were seen as factors that could delay diagnosis and provision of appropriate treatment. Patients engaging in self-advocacy enhanced their ability to seek timely and appropriate provision of triptans at the patient level. At the health-care provider level, pharmacists were identified by patients as advocates for receiving more effective treatments for their migraines; pharmacists also self-identified with the advocate role. The affordability of triptans was a key concern impacting access at the systems level, but coverage limitations (eg, quantity limits) were also described to influence the appropriateness of prescribed migraine treatment. CONCLUSION: This study fills a gap in knowledge about access to triptans and how this may be impacted by patient, provider, and health-care systems barriers. Overall, our study sheds light on the experiences of prescribing, dispensing, and accessing triptans for migraine treatment, and unveils important information that can impact how patients access these drugs.

Public Drug Coverage and Its Impact on Triptan Use Across Canada: A Population-Based Study.

BACKGROUND: Public drug coverage for triptan medications varies across jurisdictions in Canada, which may lead to differences in usage patterns and patient risk for medication overuse headache. METHODS: We conducted a population-based, cross-sectional analysis of publicly funded triptan use in seven provinces across Canada from January 1, 2012 to December 31, 2012. All patients who had filled at least one prescription for a triptan during the study period were included. We defined quantity limits of 6, 12, and 18 triptan units per month to assess the prevalence of high volumes of triptan use, which may place patients at risk for medication overuse headaches, and compared this prevalence between provinces with different funding restrictions. RESULTS: We identified 14,085 publicly funded users of triptans in 2012 in the seven provinces studied, 82.5% of whom were aged less than 65 years (N = 11,631). The prevalence of triptan use ranged substantially by province, from 0.04% in Ontario to a maximum of 1.0% in Manitoba (P < .001). Furthermore, the percentage of patients in each province using more than 6, 12, or 18 units per month differed significantly between provinces (P < .001). In particular, the percentage of patients treated with more than 6 units per month ranged from as low as 2.1% in Saskatchewan to 43.8% in Ontario. CONCLUSIONS: Differing public drug reimbursement criteria for triptans may be one contributing factor that has led to our observation of considerable variation in both prevalence of triptan prescribing and potential overuse of these medications. We offer that monthly quantity limits may be considered as a tool to decrease risks for medication overuse headache.

Immediate hypersensitivity to moxifloxacin with tolerance to ciprofloxacin: report of three cases and review of the literature.

OBJECTIVE: To report 3 cases of immediate hypersensitivity reactions to moxifloxacin in patients who tolerated ciprofloxacin. CASE SUMMARIES: A 71-year-old man, a 44-year-old woman, and a 70-year-old woman with a history of a moxifloxacin reaction developed an immediate hypersensitivity reaction upon oral challenge with moxifloxacin in our Drug Safety Clinic. The reaction was mainly characterized by pruritus and urticaria, although dyspnea and hypotension were noted in the first and second patient, respectively. Two of the patients had negative oral challenge tests with ciprofloxacin and all 3 patients tolerated full treatment courses of oral ciprofloxacin. In all 3 cases, use of the Naranjo probability scale indicated a highly probable adverse drug reaction. DISCUSSION: Moxifloxacin, similar to other fluoroquinolones, can cause immediate hypersensitivity reactions. Previous publications have reported both cross-reactivity and a lack of cross-reactivity among various fluoroquinolones. The 3 patients discussed demonstrated a lack of cross-reactivity between moxifloxacin and ciprofloxacin since they tolerated oral challenge tests and full treatment courses of ciprofloxacin. Moxifloxacin has unique side chains at positions 7 and 8 on its bicyclic ring structure. Antigenic specificity to particular side chains at positions 7 and 8 on the bicyclic ring structure of moxifloxacin may explain this lack of cross-reactivity. Higher reporting rates of anaphylaxis to moxifloxacin compared to other fluoroquinolones may also be related to side chain specificity, although definitive evidence for this is lacking. CONCLUSIONS: Based on our experience, patients who develop immediate hypersensitivity reactions to moxifloxacin may receive ciprofloxacin therapy in an appropriately monitored setting if they have previously tolerated full treatment courses of ciprofloxacin. Research into whether there is a specific side chain reaction unique to moxifloxacin is warranted.

Patch testing for the diagnosis of anticonvulsant hypersensitivity syndrome: a systematic review.

Anticonvulsant hypersensitivity syndrome (AHS), also known by the other names drug rash (reaction) with eosinophilia and systemic symptoms (DRESS) and drug-induced hypersensitivity syndrome (DIHS), is a rare and potentially fatal reaction that occurs in susceptible patients after exposure to certain drugs, including aromatic anticonvulsants. Because of its ill-defined clinical picture and resemblance to other diseases, the diagnosis of AHS is often difficult and requires a safe and reliable diagnostic test. The skin patch test has been proven to be very useful for prediction and diagnosis of some types of hypersensitivity reactions such as delayed drug eruptions to beta-lactam antibacterials. However, the diagnostic value of patch testing for AHS is yet to be determined and its negative predictive values (NPVs) and positive predictive values (PPVs) are still unknown. This systematic review attempts to evaluate the usefulness of patch tests in the diagnosis of AHS and to examine different technical aspects of patch testing that may contribute to its performance. We included studies in which aromatic anticonvulsant drugs are the likely causes of the hypersensitivity reaction. Analysis of original publications from 1950 to August 2008 and cited in PubMed, MEDLINE and EMBASE has revealed contradictory findings, possibly due mainly to the use of unstandardized methods. Numerous factors have been suggested to affect the final result of the test, including the following: type of drug tested; concentration of drug and vehicle used; timing of the test after exposure; and the clinical picture of the reaction. The PPV of the test in optimal conditions was as high as 80-90% depending on the drug tested. On the other hand, this value is around 10-20% in many other published studies. Although patch testing may be a useful diagnostic test for AHS, accurate determination of its sensitivity and specificity is yet to be achievable due to the lack of a gold standard test against which the performance of patch testing can be measured. Its PPV appears to be higher than its NPV, a matter that necessitates the use of other confirmatory tests in case of negative patch tests (e.g. careful systemic rechallenge). The benefit of testing appears to be maximal with certain drugs (i.e. carbamazepine and phenytoin) and for specific clinical manifestations (strong reactions). It should be performed 2-6 months after recovery from the date of the ADR for best results, with adequate vehicle control.

Clinical risk management of Stevens-Johnson syndrome/toxic epidermal necrolysis spectrum.

Clinical risk management concedes that risk is inherent to all health-care processes. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but potentially life-threatening reactions to medications. Risk management should be considered prior to starting, during, and after therapy. Prior to starting therapy, risks that need to be assessed include any specific patient groups that may be at greater risk for the development of SJS/TEN. Gene testing is in place for Chinese and Thai patients who are going to be exposed to carbamazepine. During therapy, it is important to recognize SJS/TEN as a possible adverse drug reaction. Diagnostic criteria have changed, and more data exist on drugs with an increased risk. Although there is no standardized treatment for all patients with SJS/TEN, options that have been used include cyclosporine, corticosteroids, and intravenous immunoglobulin. Standards of care are usually defined locally, but new treatments, such as amniotic membrane support for ocular damage, may need to be considered. Good communication skills are needed to allow practitioners to show empathy and to provide disclosure. Risk management after a reaction includes skills in acknowledging bad outcomes or error; freedom to say "sorry" as defined by "apology laws," and knowing the rights provided by "Quality Assurance Conferences," where the information discussed is protected. In other words, the patient is best supported after an event like SJS/TEN if the practitioner is knowledgeable about optimal care standards and their legal rights and obligations.

Sulfonamide Hypersensitivity: Fact and Fiction.

Sulfonamide antimicrobials are commonly reported as causing drug allergy and have been implicated in a variety of hypersensitivity reactions including immediate IgE-mediated reactions, benign T-cell-mediated rashes, and severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms. Cross-reactivity is unlikely between sulfonamide antimicrobials and sulfonamide non-antimicrobials. In patients who develop reactions to a sulfonamide non-antimicrobial, there is no evidence to suggest that sulfonamide antimicrobials and other sulfonamide non-antimicrobials would cross-react. Although immediate skin testing can be performed in patients with histories of immediate reactions, they are infrequently positive and wane over time. Delayed skin testing including patch tests to sulfonamides is rarely positive. Drug challenges are a useful tool for patients with both immediate and delayed reactions to sulfonamides. The role of sulfamethoxazole desensitization is controversial as rates of hypersensitivity reactions are similar between desensitization and drug challenge.

Variability in the validity and reliability of outcome measures identified in a systematic review to assess treatment efficacy of cognitive enhancers for Alzheimer's Dementia.

INTRODUCTION: Selection of optimal outcome measures is a critical step in a systematic review; inclusion of uncommon or non-validated outcome measures can impact the uptake of systematic review findings. Our goals were to identify the validity and reliability of outcome measures used in primary studies to assess cognition, function, behaviour and global status; and, to use these data to select outcomes for a systematic review (SR) on treatment efficacy of cognitive enhancers for Alzheimer's Dementia (AD). METHODS: Articles fulfilling the eligibility criteria of the SR were included in a charting exercise to catalogue outcome measures reported. Outcome measures were then assessed for validity and reliability. Two independent reviewers abstracted data on outcome measures and validity and reliability reported for cognition, function, behaviour and global status. RESULTS: 129 studies were included in the charting exercise; 57 outcome measures were identified for cognition, 21 for function, 13 for behaviour and 10 for global status. A total of 35 (61%) cognition measures, 10 (48%) functional measures, 8 (61%) behavioural measures and four (40%) of global status measures were only used once in the literature. Validity and reliability information was found for 51% of cognition measures, 90% of function and global status measures and 100% of behavioural measures. CONCLUSIONS: While a large number of outcome measures were used in primary studies, many of these were used only once. Reporting of validity and reliability varied in AD studies of cognitive enhancers. Core outcome sets should be used when available; when they are not available researchers need to balance frequency of reported outcome measures, their respective validity and reliability, and preferences of knowledge users. SYSTEMATIC REVIEW REGISTRATION: CRD#42012001948.

Publicly Funded Oral Chronic Hepatitis B Treatment Patterns in Ontario over 16 Years: An Ecologic Study.

BACKGROUND: Reimbursement for the use of hepatitis B virus (HBV) treatments has not been previously reported for public payers. OBJECTIVE: To describe the number of users and total cost of HBV treatments over the last 16 years among residents of Ontario, Canada, who were covered by the public drug program. METHODS: We conducted a repeated cross-sectional study for HBV treatments reimbursed by the public drug program in Ontario from January 1, 2000, to December 31, 2015. We projected total spending to 2020 based on current utilization trends. RESULTS: HBV drug users per year increased 30-fold, from 132 users in 2000 to 4,035 users in 2015. Total spending on HBV treatments increased 150-fold, from $136,368 annually in 2000 to $21.0 million in 2015. The spending on HBV agents is projected to increase by 65%, with an estimated drug cost of $34.6 million by 2020. CONCLUSIONS: Although not reimbursed as first-line therapy, tenofovir disoproxil fumarate has become the most commonly reimbursed HBV treatment and was associated with an increase in HBV treatment use and total spending. Results of this study found that rapid growth of HBV treatments led to a sustained increase in spending for public payers in Ontario. DISCLOSURES: This study was funded by grants from the Ontario Ministry of Health and Long-Term Care (MOHLTC) and Ontario Strategy for Patient-Orientated Research (SPOR) Support Unit, which is supported by the Canadian Institutes of Health Research and the Province of Ontario. This study was also supported by the Institute for Clinical Evaluative Sciences (ICES), a non-profit research institute sponsored by the Ontario MOHLTC. The opinions, results, and conclusions reported in this article are those of the authors and are independent from the funding sources. No endorsement by ICES or the Ontario MOHLTC is intended or should be inferred. Parts of this material are based on data and information compiled and provided by the Canadian Institute for Health Information (CIHI). However, the analyses, conclusions, opinions and statements expressed herein are those of the authors and not necessarily those of CIHI. Mamdani has received honoraria from Boehringer Ingelheim, Pfizer, Bristol-Myers Squibb, and Bayer. Janssen has received research support, consulting, and/or speaking fees from Gilead, Roche, Merck, AbbVie, Bristol-Myers Squibb, Arbutus, Janssen, and MedImmune. No other authors have any conflicts of interest to declare.

Management options for patients with aspirin and nonsteroidal antiinflammatory drug sensitivity.

OBJECTIVE: To evaluate and provide management strategies for patients with aspirin or nonselective nonsteroidal antiinflammatory drug (NSAID) sensitivity. DATA SOURCES: Literature retrieval was accessed through MEDLINE (1966-March 2007) using the terms acetaminophen, aspirin, antiinflammatory agents nonsteroidal, urticaria, angioedema, asthma, leukotriene antagonists, desensitization, and tacrolimus. Article references retrieved were hand-searched for other relevant articles. STUDY SELECTION AND DATA EXTRACTION: All studies published in English were evaluated. Studies, review articles, and commentaries on aspirin-induced asthma and aspirin- or NSAID-induced urticaria/angioedema were included in the review. DATA SYNTHESIS: Aspirin sensitivity is most often manifested as respiratory reactions (eg, bronchospasm, profuse rhinorrhea, conjunctival injection) or urticaria/angioedema. The primary mechanism is believed to be inhibition of the cyclooxygenase 1 (COX-1) enzyme; as such, patients with aspirin sensitivity often display cross-reactions to nonselective NSAIDs that inhibit the COX-1 enzyme. Management strategies include avoidance of aspirin and cross-reacting nonselective NSAIDs. However, desensitization to aspirin is a viable option for patients with aspirin-induced respiratory reactions, especially for those who require aspirin for thromboembolic prophylaxis. Aspirin desensitization is maintained indefinitely with a daily aspirin dose. There is limited evidence of the use of leukotriene modifiers in preventing aspirin-induced asthma. COX-2 selective NSAIDs, especially in patients with aspirin-induced asthma, have not been found to cross-react. However, approximately 4% of patients with a history of aspirin-induced skin reactions may experience a cutaneous reaction following a challenge to a COX-2 selective NSAID. Since acetaminophen is a weak inhibitor of the COX-1 enzyme, patients with aspirin-induced asthma should not take more than 1000 mg of acetaminophen in a single dose. CONCLUSIONS: Management of patients with aspirin/NSAID sensitivity includes avoidance of aspirin/nonselective NSAIDs, use of COX-2 selective NSAIDs, acetaminophen in doses less than 1000 mg, and desensitization. The role of leukotriene modifiers requires further study before they can be recommended for patients.

Recognition and management of severe cutaneous drug reactions.

Cutaneous drug reactions are among the most common types of adverse drug reactions. This article focuses on the recognition and management of severe cutaneous drug eruptions, including the drug-hypersensitivity syndrome, serum sickness-like reaction, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Cutaneous reactions are considered severe when they can result in serious skin damage or involve multiple organs. Some of these reactions can cause significant morbidity or death. Each may be confounded by diagnostic difficulties, confusion in ascertaining causality, and treatment challenges.

Allergic reaction to fluorescein dye: successful one-day desensitization.

CASE REPORT: An 86-year-old woman developed IgE-mediated generalized urticaria after a second fluorescein injection. A one-day desensitization protocol was successfully administered that permitted continuation of angiography for deteriorating vision. COMMENTS: We review the literature on adverse events associated with administration of fluorescein and suggest guidelines for testing and desensitization.

Prior Authorization and Canadian Public Utilization of Direct-Acting Oral Anticoagulants.

PURPOSE: Provincial public drug formularies in Canada have different mechanisms for reimbursement of direct-acting oral anticoagulants (DOACs). We investigate how these differences influence DOAC utilization and expenditure across the country. METHODS: We conducted a population-based, cross-sectional study of all out-patient prescriptions for OACs dispensed to public beneficiaries between January 1, 2010, and June 30, 2015. We calculated quarterly rates of OAC use and expenditures stratified by OAC type and province. RESULTS: The greatest increase in quarterly rates of DOAC utilization occurred in provinces with more liberal mechanism of drug coverage: Ontario by 462%, Alberta by 425% and Quebec by 1,924%. This translated to increased expenditure on overall OAC by 270%, 204% and 390%, respectively. In contrast, provinces with more stringent mechanisms had low rates of DOAC utilization and expenditure. CONCLUSIONS: DOAC utilization and expenditure is considerably different across Canada, associated with provincial difference in reimbursement mechanism.

Self-Monitoring of Blood Glucose: Impact of Quantity Limits in Public Drug Formularies on Provincial Costs Across Canada.

OBJECTIVES: For most patients with diabetes, routine use of blood glucose test strips (BGTS) has not been shown to be beneficial, yet the economic implications of broad publicly funded reimbursement for BGTS are substantial. We assessed the potential impact of BGTS quantity limits on utilization and costs for 6 publicly funded drug plans across Canada. METHODS: A cross-sectional analysis was conducted in 6 provinces (Alberta, Saskatchewan, Manitoba, Nova Scotia, Newfoundland and Labrador and Prince Edward Island) for patients who received at least 1 prescription for BGTS in 2014 through the public drug program. We determined the number of BGTS that would have exceeded the quantity limits and the associated costs to the provincial drug program. RESULTS: A total of $38,051,026 was spent on BGTS reimbursed through public drug programs among the 6 provinces. In provinces where BGTS use is largely restricted to patients using insulin, the potential annual savings were minimal, ranging from 0.4% to 2.3%, whereas in provinces with more liberal listings, potential savings ranged from 12.4% to 19.8%. Combining these results with data from a previous analysis in Ontario and British Columbia, the cost savings associated with BGTS quantity limits for 8 provinces across Canada (capturing approximately three-quarters of the Canadian population) is estimated to be $30.3 million annually. CONCLUSIONS: The national implementation of a quantity limit policy for BGTS that aligns with evidence of efficacy, optimal prescribing and patient safety can lead to considerable savings for most public drug plans across Canada.

Intravenous immunoglobulin use in patients with toxic epidermal necrolysis and Stevens-Johnson syndrome.

Intravenous immunoglobulin (IVIg) has been proposed as a treatment for toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS). A comprehensive search of the literature was conducted to examine the efficacy and safety of IVIg in TEN and SJS patients. Seventeen relevant articles (14 TEN, 3 SJS) were identified. Only three of the TEN studies and one of the SJS studies were prospective; retrospective studies were the most common study design published. Information regarding disease severity, IVIg use, response, and hospitalization were recorded and cumulated. Aggregate level statistics were calculated. The average IVIg doses used were 0.8 +/- 0.4 g/kg/day for a mean duration of 4.0 +/- 1.0 days in TEN patients and 0.8 +/- 0.2 g/kg/day for 3.4 +/- 1.0 days in SJS patients. The clinical experience of IVIg use in TEN and SJS patients was positive in most cases. However, more studies need to be conducted to confirm the benefit of IVIg use in patients with TEN or SJS.