Nicole W. Tsao

Factors associated with pharmacists' perceptions of their working conditions and safety and effectiveness of patient care.

Background: In recent years, the role of pharmacists has changed, as have various provincial legislations, which now allow pharmacists to provide additional health services to patients. With these changes comes growing concern about how well the current pharmacy working environment is adapting and whether it may also be creating work-related stress that may contribute to potentially unsafe practices of patient care. Methods: To characterize the current working conditions of pharmacists in British Columbia, an online survey was developed and distributed to all College of Pharmacists of BC (CPBC) registrants by email. The survey consisted of questions on pharmacists’ demographics, practice setting and perceptions of workplace conditions. Responses were collected from October 1 to November 10, 2013. All data were summarized using descriptive statistics, and regression models were constructed to assess the association between various factors and pharmacists’ self-reported working conditions. Results: Twenty-three percent (1241/5300) of pharmacists registered with the CPBC responded, with 78% working in the community pharmacy setting (58% chain, 19% independent). Pharmacists mostly disagreed with the statements that they had enough time for breaks or lunches or to do their jobs, as well as enough staffing support. Pharmacists’ perceptions of their workplace environment were negatively associated with workplace-imposed advanced service quotas (for medication reviews, immunizations and prescription adaptations); being employed at chain store pharmacies, compared to independent pharmacies or hospitals/long-term care settings; and higher prescription volume. Discussion: Pharmacists working in chain community pharmacies who are required to meet monthly quotas for expanded services reported a substantial negative impact on their working conditions and perceived safety of patient care. Can Pharm J (Ott) 2016;149:xx-xx.

The issue of comparators in economic evaluations of biologic response modifiers in rheumatoid arthritis

INTRODUCTION Over the last decade, a number of biologic response modifiers (BRMs) have emerged and transformed rheumatoid arthritis (RA) management. Due to their relatively high costs, economic evaluations have attempted to determine their place in the RA treatment armamentarium. This article reviews three key areas where changes to the treatment paradigm challenges findings of existing economic evaluations. METHODS We performed a literature search of economic evaluations examining BRMs approved for use in North America for RA. Only economic evaluations that examined relevant direct costs and health outcomes were included. Data were extracted and summarised, then stratified by patient population and comparators. Reported incremental cost-effectiveness ratios (ICERs) were compared across studies. RESULTS It appears that tumour necrosis factor (TNF) alpha inhibitors are less cost effective compared to disease-modifying anti-rheumatic drugs (DMARDs) for first-line treatment. In addition, it appears that treatment with a TNF alpha inhibitor in patients who were refractory to previous DMARD therapies is more cost effective, compared to switching to another DMARD. Finally, after an inadequate response to a TNF alpha inhibitor, it appears that therapy with rituximab is more cost effective than treatment with another TNF alpha inhibitor or abatacept. DISCUSSION It is important to acknowledge that cost effectiveness depends on which comparators are included in the analyses and the evidence for the comparators. The most typical comparator in the studies was traditional DMARDs, mainly methotrexate. However, as more BRMs come into the market and new clinical evidences emerge on the comparative effectiveness of BRMs, new economic evaluations will need to incorporate this information such that reimbursement decisions can be fully informed regarding relative value.

Quantifying preferences for asthma control in parents and adolescents using best–worst scaling

BACKGROUND Understanding the views of parents and children is critical to designing effective asthma management programs. It was hypothesized that parents and adolescents would exhibit heterogenous preferences with regard to asthma control. METHODS Fifty parents of children with asthma and 51 adolescents with asthma participated in a best-worst scaling study to quantify preferences regarding night-time symptoms, wheezing/chest tightening, changes in asthma medications, emergency visits and physical activity limitations. RESULTS A latent class analysis revealed heterogeneity inherent in the preferences of parents and adolescents. Two classes of parents emerged from the analysis that displayed significantly different preferences. The first displayed strong preferences for averting night-time symptoms, wheezing/chest tightening, physical activity limitations and emergency room visits with odds ratios (OR) of 42 (95% CI 24, 72), 40 (95% CI 23, 68), 26 (95% CI 15, 44) and 21 (95% CI 12, 35), respectively, compared to an OR of 1 for 10 physical activity limitations per month. A second smaller parent class displayed more balanced preferences. Most adolescents displayed similar preferences for averting night-time symptoms, wheezing/chest tightening, physical activity limitations and emergency room visits, with ORs of 28 (95% CI 16, 48), 25 (95% CI 14, 44), 27 (95% CI 15, 46) and 20 (95% CI 11, 34) respectively. CONCLUSIONS This study revealed the importance placed on averting night-time symptoms, wheezing and chest tightening, emergency room visits and physical activity limitations by parents and adolescents alike, with greater emphasis on symptom aversion by parents. Preference heterogeneity exists and should be considered in customized asthma management programs.

Perceptions of British Columbia residents and their willingness to pay for medication management services provided by pharmacists

Background: Across Canada, pharmacists have expanded their scope of practice by performing medication management (MM) services. However, little is currently known about the opinions and attitudes of patients and the general population toward MM services. Methods: A cross-sectional online survey, including a best-worst scaling task, was designed to understand the general public’s opinions, preferences and willingness-to-pay with respect to MM services in British Columbia. Results: Of 977 individuals contacted, 819 responded to the questionnaire (84% response rate). The mean age was 45 years (standard deviation [SD] 16 years), and 37% were male. Overall, 93% of respondents felt that the medication advice from their pharmacist resulted in improvement in patient outcomes and/or medication use. This was also selected as the “best” attribute of MM, while other preferred attributes of MM included being able to obtain an appointment with the pharmacist on the same day or via walk-in, improved patient-physician relationships and MM sessions able to be completed in 15 minutes with the pharmacist. The average willingness to pay for MM was

Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review

24.55 (SD

BC Medication Management Project: Perspectives of pharmacists, patients and physicians.

21.44). Younger males with higher household income and those who had had MM in the past were willing to pay more for MM services out of pocket. Discussion and Conclusion: The accessibility of pharmacists was valued highly by respondents who, overall, were supportive of MM services and recognized the potential of pharmacists’ involvement in drug therapy management to improve patient outcomes and medication use. Alternative models of funding are worth considering for the sustainability of MM service provision.

Potential impact of subsequent entry biologics in nephrology practice in Canada

BackgroundSubsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Understanding the worldwide experience with these agents will be valuable to Canadian clinicians.ObjectivesTo compare the efficacy and safety data between SEBs used in nephrology practice and their reference biologic.DesignSystematic review.Sources of informationOvid MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Database of Abstracts of Review of Effects, Cochrane Central Register of Controlled Trials.PatientsAdult patients with chronic kidney disease (CKD).MethodsOur systematic review follows the process outlined by Cochrane Reviews. For efficacy data, all randomized controlled trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. For safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well.ResultsOnly epoetin SEBs trials were published in the literature. Ten studies involving three different epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the reference product. For epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the reference epoetin. The HX 575 studies reported a mean absolute change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of safety data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous administration of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the reference biologic.LimitationsOur analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled results.ConclusionsLittle clinical difference was found between epoetin SEBs and the reference product. Although not deemed clinically important, the financial implication of a possible dose difference between epoetin zeta and reference product should be considered in pharmacoeconomic studies. Ongoing trials are expected to address the risk of pure-red-cell aplasia with HX 575.AbrégéContexteIl est possible que les produits biologiques ultérieurs (PBU) soient bientôt utilisés en néphrologie. Afin de guider la pratique en néphrologie au Canada, il est important de comprendre l’ensemble des expériences produites, à l’échelle mondiale, en matière d’efficacité et d’innocuité de ces agents.ObjectifsComparer les données relatives à l’efficacité et l’innocuité entre les PBU utilisés en néphrologie et leurs médicaments biologiques de référence.Type d’étudeRevue systématique.Sources de donnéesLa recherche en vue de la revue de littérature a été effectuée en interrogeant les bases de données suivantes : Ovid Medline, Embase, la base de données de revues systématiques Cochrane Reviews, la Database of Abstracts of Reviews of Effects, et la Cochrane Central Register Controlled Trials.PatientsLes patients d’âge adulte atteints de néphropathie chronique.MéthodesNotre revue systématique suit la méthode suggérée par la Collaboration Cochrane (Cochrane Reviews). Pour les données se rapportant à l’efficacité, l’ensemble des essais randomisés contrôlés (ERC) et des modèles quasi expérimentaux et des études observationnelles du domaine de la néphrologie ont été comptabilisés. Pour les données se rapportant à l’innocuité, tous les ERC, les modèles quasi expérimentaux, les études observationnelles, les études ou séries de cas, ainsi que les revues d’articles en néphrologie clinique et de programmes en pharmacovigilance ont été comptabilisés.RésultatsNous nous sommes attardés à l’époétine biologique ultérieure, puisqu’aucune documentation sur d’autres produits biologiques ultérieurs (PBU) n’était disponible. Nous avons utilisé dix études présentant trois époétines biologiques ultérieures différentes (époétine zeta, époétine HX575 et époétine thêta). Il n’existait pas de différence significative entre les doses moyennes des PBU et d’époétine biologique de référence. La dose moyenne d’époétine utilisée ne variait pas de façon significative entre les PBU et le produit de référence. Pour les époétines zeta et thêta, les taux moyens d’hémoglobine obtenus dans les diverses études entre les PBU et les époétines de référence étaient similaires. Les études se rapportant à l’époétine HX575 montraient un changement absolu du taux moyen d’hémoglobine à l’intérieur de l’intervalle d’équivalence prédéfini, lorsque comparé au médicament biologique de référence. En ce qui concerne les données d’innocuité, deux cas d’érythroblastopénie chronique acquise ont été liés à l’administration sous-cutanée de l’époétine HX575. Sinon, les taux d’effets indésirables recensés pour l’époétine biologique ultérieure et son médicament biologique de référence étaient similaires.Limites de l’étudeNotre analyse est limitée par la rareté de l’information accessible sur l’utilisation des PBU en néphrologie, à l’exception de l’époétine biologique ultérieure. Une faille sur le plan méthodologique a été retrouvée dans une des études sur l’époéine zeta. Celle-ci se rapportait à 45 % des résultats regroupés.ConclusionsPeu de différences sur le plan clinique ont été trouvées entre l’époétine biologique ultérieure et l’époétine de référence. Même si elles ne sont pas cliniquement significatives, les répercussions financières qui sont entraînées par la possible différence de dose entre l’époétine zeta et le produit de référence devraient être considérées dans les études pharmacoéconomiques. Il existe certaines préoccupations entourant les risques d’érythroblastopénie chronique acquise et l’époétine HX575, mais des essais présentement en cours tentent de faire le tour de la question.What was known beforeSEBs pertinent to nephrology practice are available commercially in other countries. Epoetin SEBs have been compared with reference epoetins in clinical studies involving CKD patients.What this addsThis systematic review summarizes the efficacy data comparing epoetin SEBs to the reference epoetins in patients with CKD and provides an overview of the European experience in terms of safety data for epoetin SEBs. No other SEBs pertinent to nephrology practice have published data as yet.

Patterns of biologics utilization and discontinuation before and during pregnancy in women with autoimmune diseases: A population-based cohort study.

Background: The BC Medication Management Project (BCMMP) was developed by the BC Ministry of Health and the BC Pharmacy Association. This pilot project ran from September 2010 to January 2012. Pharmacists reviewed patients’ medication histories, discussed best use of medications, provided education and monitored for adverse effects, developed a plan to deal with medication issues and created a best possible medication history. Methods: To evaluate the experience of participating in the BCMMP, challenges and strengths of the project and the alignment of these experiences with the overarching goals, focus groups and interviews were conducted with 6 stakeholder groups. Themes were compared within and across stakeholder type and descriptively analyzed. Results: A total of 88 people participated in the focus groups/interviews. Pharmacists stated that providing BCMMP services was professionally satisfying and concurred with patients that the service did benefit them. However, participating in the BCMMP was not seen as financially sustainable by pharmacy owners, and there were concerns about patient selection. Physicians expressed concerns about increased workload associated with the BCMMP, for which they were not compensated. The computer system and burden of documentation were identified as the greatest problems. Conclusions: The BCMMP pilot project was enthusiastically received by pharmacists and patients who felt that it benefited patients and moved the pharmacy profession in a positive direction. It was widely felt that the BCMMP could be successful and sustainable if the identified challenges are addressed.

A Budget Impact Analysis of the Introduction of Erythropoiesis Stimulating Agent Subsequent Entry Biologics for the Treatment of Anemia of Chronic Kidney Disease in Canada

Purpose of reviewSubsequent entry biologics may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce health care costs, these agents pose unique challenges that must be met for successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This report provides an executive summary of the information required to guide decisions to use or implement subsequent entry biologics by comparing Canadian regulations to other developed nations, discussing their clinical issues and predicting their impact on the Canadian market and nephrology practice. We hope that this review will assist clinicians and policy makers to navigate this complex subject and to make informed decisions in the best interest of their patients.Sources of informationSources of information include published literature and reports available in the public domain including guidelines obtained from regulatory agencies and information shared by Pharmaceutical companies. Lastly, we generated information from our own focus group consisting of nephrologists, a regulatory body representative, a hospital formulary representative, a patient representative, a hospital administrator, and a health economist.FindingsThere exists a common and robust approach in the G20 countries for approval and regulation of subsequent entry biologics. Although by definition these agents do not have advantages (other than costs) or disadvantages compared to the original biologic, there are potential concerns and economic uncertainties regarding their implementation. Where SEBs are on the market, their market share is variable and modest.LimitationsWe did not purchase third party reports for up to the minute marketing data. Since there are no subsequent entry biologics currently on the Canadian market, the information is only predictive.ImplicationsThe nephrology community will have to work with patients, payers, and regulatory bodies to ensure safe and effective use of subsequent entry biologics. Cost savings can be achieved but these agents should only be used after fully understanding their unique challenges. At this time, they should not be automatically substitutable and only used for Health Canada-approved indications. Only through good pharmacovigilence will health care providers and patients become better informed.ABRÉGÉObjectif de la revueL’utilisation des produits biologiques ultérieurs pourrait bientôt devenir réalité en néphrologie au Canada. Ces agents, qui permettent possiblement des réductions de coûts en soins de santé, présentent des défis particuliers qui doivent être évalués pour une introduction réussie sur le marché. À cet effet, arriver à comprendre les différentes expériences qui se sont déroulées partout dans le monde en matière de réglementation et de mise en œuvre de ces agents est un exercice précieux qui pourrait guider les praticiens canadiens. Ce rapport fournit un résumé des informations requises pour guider la prise de décision pour l’utilisation et l’introduction des produits biologiques ultérieurs : comparaison des réglementations canadiennes à celles d’autres pays; discussion des enjeux cliniques entourant les produits biologiques ultérieurs et prévision de l’impact de leur utilisation sur le marché canadien et sur la pratique de la néphrologie. Nous espérons que cette revue aidera les cliniciens et les décideurs dans l’exploration de ce sujet complexe et dans une prise de décision optimale pour leurs patients.Sources d’informationPlusieurs sources d’information ont été utilisées, dont des publications et des rapports du domaine public, sous la forme de lignes directrices d’organismes de réglementation et de documents provenant de compagnies pharmaceutiques. De plus, nous avons utilisé l’information générée par notre propre groupe de discussion. Ce dernier est composé de néphrologues, d’un représentant d’organisme de réglementation, d’un représentant de la Liste des médicaments des hôpitaux, un représentant des patients, d’un directeur d’hôpital et d’un économiste de la santé.RésultatsDans les pays membres du G20, il existe une approche robuste communément adoptée pour l’approbation et la réglementation des produits biologiques ultérieurs. Par définition, ces agents ne présentent aucun avantage (sauf économique),ou désavantage particulier lorsqu’on les compare aux produits biologiques originaux, mais certaines préoccupations persistent quant à leur introduction sur le marché. Par ailleurs, lorsque les produits biologiques ultérieurs sont disponibles sur le marché, leur part de marché reste modeste et variable.Limites de l’étudeNous n’avons pas fait l’acquisition de rapports en provenance de tiers contenant des données de commercialisation récentes. De plus, puisqu’il n’existe pas de produits biologiques ultérieurs sur le marché canadien à l’heure actuelle, l’information de cette revue n’est que de nature prédictive.ImplicationsL’ensemble des néphrologues auront à collaborer avec les organismes de régulation, les patients, et les contribuables afin d’assurer une utilisation efficace des produits biologiques ultérieurs. Des économies peuvent être réalisées, mais ces agents ne devront être utilisés qu’après avoir tout à fait compris les défis particuliers qu’ils présentent. En ce moment, ils ne peuvent pas remplacer automatiquement d’autres produits et ne devraient être utilisés que selon les recommandations officielles de Santé Canada. Ce n’est qu’en exerçant une bonne pharmacovigilance que les patients et prestataires de soins de santé deviendront mieux informés.

Community pharmacist surveillance of hypertension in pregnancy: Are we ready for prime time?

To characterize patterns of biologics use and discontinuation before and during pregnancy in women with autoimmune diseases in British Columbia, Canada.