UGT1A1 genotype-guided dosing of irinotecan: A prospective safety and cost analysis in poor metaboliser patients.

AIM: To determine the safety, feasibility, pharmacokinetics, and cost of UGT1A1 genotype-guided dosing of irinotecan. PATIENTS AND METHODS: In this prospective, multicentre, non-randomised study, patients intended for treatment with irinotecan were pre-therapeutically genotyped for UGT1A1∗28 and UGT1A1∗93. Homozygous variant carriers (UGT1A1 poor metabolisers; PMs) received an initial 30% dose reduction. The primary endpoint was incidence of febrile neutropenia in the first two cycles of treatment. Toxicity in UGT1A1 PMs was compared to a historical cohort of UGT1A1 PMs treated with full dose therapy, and to UGT1A1 non-PMs treated with full dose therapy in the current study. Secondary endpoints were pharmacokinetics, feasibility, and costs. RESULTS: Of the 350 evaluable patients, 31 (8.9%) patients were UGT1A1 PM and received a median 30% dose reduction. The incidence of febrile neutropenia in this group was 6.5% compared to 24% in historical UGT1A1 PMs (P = 0.04) and was comparable to the incidence in UGT1A1 non-PMs treated with full dose therapy. Systemic exposure of SN-38 of reduced dosing in UGT1A1 PMs was still slightly higher compared to a standard-dosed irinotecan patient cohort (difference: +32%). Cost analysis showed that genotype-guided dosing was cost-saving with a cost reduction of €183 per patient. CONCLUSION: UGT1A1 genotype-guided dosing significantly reduces the incidence of febrile neutropenia in UGT1A1 PM patients treated with irinotecan, results in a therapeutically effective systemic drug exposure, and is cost-saving. Therefore, UGT1A1 genotype-guided dosing of irinotecan should be considered standard of care in order to improve individual patient safety.

Cost-Effectiveness Assessment of Monitoring Abiraterone Levels in Metastatic Castration-Resistant Prostate Cancer Patients.

OBJECTIVES: Abiraterone acetate is registered for the treatment of metastatic castration-sensitive and resistant prostate cancer (mCRPC). Treatment outcome is associated with plasma trough concentrations (Cmin) of abiraterone. Patients with a plasma Cmin below the target of 8.4 ng/mL may benefit from treatment optimization by dose increase or concomitant intake with food. This study aims to investigate the cost-effectiveness of monitoring abiraterone Cmin in patients with mCRPC. METHODS: A Markov model was built with health states progression-free survival, progressed disease, and death. The benefits of monitoring abiraterone Cmin followed by a dose increase or food intervention were modeled via a difference in the percentage of patients achieving adequate Cmin taking a healthcare payer perspective. Deterministic and probabilistic sensitivity analyses were performed to assess uncertainties and their impac to the incremental cost-effectiveness ratio (ICER). RESULTS: Monitoring abiraterone followed by a dose increase resulted in 0.149 incremental quality-adjusted life-years (QALYs) with €22 145 incremental costs and an ICER of €177 821/QALY. The food intervention assumed equal effects and estimated incremental costs of €7599, resulting in an ICER of €61 019/QALY. The likelihoods of therapeutic drug monitoring (TDM) with a dose increase or food intervention being cost-effective were 8.04%and 81.9%, respectively. CONCLUSIONS: Monitoring abiraterone followed by a dose increase is not cost-effective in patients with mCRPC from a healthcare payer perspective. Monitoring in combination with a food intervention is likely to be cost-effective. This cost-effectiveness assessment may assist decision making in future integration of abiraterone TDM followed by a food intervention into standard abiraterone acetate treatment practices of mCRPC patients.

Cost-utility and cost-effectiveness analysis of a clinical medication review focused on personal goals in older persons with polypharmacy compared to usual care: Economic evaluation of the DREAMeR study.

AIMS: The ageing society may lead to increasing healthcare expenditure. A clinical medication review (CMR) could potentially reduce costs. The aim of this study is to perform a cost-utility and cost-effectiveness analysis from a societal perspective of a patient-centred CMR. METHODS: A trial-based cost-utility and cost-effectiveness analysis was performed as part of the DREAMeR study, a pragmatic controlled trial that randomised patients aged ≥70 years using at least seven drugs to either CMR or usual care. Over six months, healthcare consumption and drug use were collected to estimate costs, and effects were collected in terms of quality-adjusted life years (QALYs) measured with EQ-5D-5 L and EQ-VAS and as reduced health-related complaints with impact on patients' daily lives. RESULTS: The total mean costs per patient (n = 588) over six months were €4,189 ± 6,596 for the control group (n = 294) and €4,008 ± 6,678 for the intervention group (n = 294), including estimated intervention costs of €199 ± 67, which resulted in a mean incremental total cost savings of €181 for the intervention group compared to the control group. Compared to the control group, for the intervention group, the mean incremental QALYs over six months were: -0.00217 measured with EQ-5D and 0.003 measured with EQ-VAS. The incremental effect of reduced health-related complaints with impact was -0.34. There was a likelihood of >90% that the intervention was cost-saving. CONCLUSIONS: The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5 L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives. Additionally, a CMR could potentially be cost saving from a societal perspective.

Increasing the information provided by probabilistic sensitivity analysis: The relative density plot.

BACKGROUND: Results of probabilistic sensitivity analyses (PSA) are frequently visualized as a scatterplot, which is limited through overdrawing and a lack of insight in relative density. To overcome these limitations, we have developed the Relative Density plot (PSA-ReD). METHODS: The PSA-ReD combines a density plot and a contour plot to visualize and quantify PSA results. Relative density, depicted using a color gradient, is transformed to a cumulative probability. Contours are then plotted over regions with a specific cumulative probability. We use two real-world case studies to demonstrate the value of the PSA-ReD plot. RESULTS: The PSA-ReD method demonstrates proof-of-concept and feasibility. In the real-world case-studies, PSA-ReD provided additional visual information that could not be understood from the traditional scatterplot. High density areas were identified by color-coding and the contour plot allowed for quantification of PSA iterations within areas of the cost-effectiveness plane, diminishing overdrawing and putting infrequent iterations in perspective. Critically, the PSA-ReD plot informs modellers about non-linearities within their model. CONCLUSIONS: The PSA-ReD plot is easy to implement, presents more of the information enclosed in PSA data, and prevents inappropriate interpretation of PSA results. It gives modelers additional insight in model functioning and the distribution of uncertainty around the cost-effectiveness estimate.

Benchmarking health technology assessment agencies-methodological challenges and recommendations.

OBJECTIVES: The objectives of the study were to establish a benchmarking tool to collect metrics to enable increased clarity regarding the differences and similarities across health technology assessment (HTA) agencies, to assess performance within and across HTA agencies, identify areas in the HTA processes in which time is spent and to enable ongoing performance improvement. METHODS: Common steps and milestones in the HTA process were identified for meaningful benchmarking among agencies. A benchmarking tool consisting of eighty-six questions providing information on HTA agency organizational aspects and information on individual new medicine review timelines and outcomes was developed with the input of HTA agencies and validated in a pilot study. Data on 109 HTA reviews from five HTA agencies were analyzed to demonstrate the utility of this tool. RESULTS: This study developed an HTA benchmarking methodology, comparative metrics showed considerable differences among the median timelines from assessment and appraisal to final HTA recommendation for the five agencies included in this analysis; these results were interpreted in conjunction with agency characteristics. CONCLUSIONS: It is feasible to find consensus among HTA agencies regarding the common milestones of the review process to map jurisdiction-specific processes against agreed metrics. Data on characteristics of agencies such as their scope and remit enabled results to be interpreted in the appropriate local context. This benchmarking tool has promising potential utility to improve the transparency of the review process and to facilitate both quality assurance and performance improvement in HTA agencies.

What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings.

BACKGROUND AIMS: Recent technical and clinical advances with cell-based therapies (CBTs) hold great promise in the treatment of patients with rare diseases and those with high unmet medical need. Currently the majority of CBTs are developed and manufactured in specialized academic facilities. Due to small scale, unique characteristics and specific supply chain, CBT manufacturing is considered costly compared to more conventional medicinal products. As a result, biomedical researchers and clinicians are increasingly faced with cost considerations in CBT development. The objective of this research was to develop a costing framework and methodology for academic and other small-scale facilities that manufacture cell-based therapies. METHODS: We conducted an international multi-center costing study in four facilities in Europe using eight CBTs as case studies. This study includes costs from cell or tissue procurement to release of final product for clinical use. First, via interviews with research scientists, clinicians, biomedical scientists, pharmacists and technicians, we designed a high-level costing framework. Next, we developed a more detailed uniform methodology to allocate cost items. Costs were divided into steps (tissue procurement, manufacturing and fill-finish). The steps were each subdivided into cost categories (materials, equipment, personnel and facility), and each category was broken down into facility running (fixed) costs and operational (variable) costs. The methodology was tested via the case studies and validated in developer interviews. Costs are expressed in 2018 euros (€). RESULTS: The framework and methodology were applicable across facilities and proved sensitive to differences in product and facility characteristics. Case study cost estimates ranged between €23 033 and €190 799 Euros per batch, with batch yield varying between 1 and 88 doses. The cost estimations revealed hidden costs to developers and provided insights into cost drivers to help design manufacturing best practices. CONCLUSIONS: This framework and methodology provide step-by-step guidance to estimate manufacturing costs specifically for cell-based therapies manufactured in academic and other small-scale enterprises. The framework and methodology can be used to inform and plan cost-conscious strategies for CBTs.

A novel method for predicting the budget impact of innovative medicines: validation study for oncolytics.

BACKGROUND: High budget impact (BI) estimates of new drugs have led to decision-making challenges potentially resulting in restrictions in patient access. However, current BI predictions are rather inaccurate and short term. We therefore developed a new approach for BI prediction. Here, we describe the validation of our BI prediction approach using oncology drugs as a case study. METHODS: We used Dutch population-level data to estimate BI where BI is defined as list price multiplied by volume. We included drugs in the antineoplastic agents ATC category which the European Medicines Agency (EMA) considered a New Active Substance and received EMA marketing authorization (MA) between 2000 and 2017. A mixed-effects model was used for prediction and included tumor site, orphan, first in class or conditional approval designation as covariates. Data from 2000 to 2012 were the training set. BI was predicted monthly from 0 to 45 months after MA. Cross-validation was performed using a rolling forecasting origin with e^|Ln(observed BI/predicted BI)| as outcome. RESULTS: The training set and validation set included 25 and 44 products, respectively. Mean error, composed of all validation outcomes, was 2.94 (median 1.57). Errors are higher with less available data and at more future predictions. Highest errors occur without any prior data. From 10 months onward, error remains constant. CONCLUSIONS: The validation shows that the method can relatively accurately predict BI. For payers or policymakers, this approach can yield a valuable addition to current BI predictions due to its ease of use, independence of indications and ability to update predictions to the most recent data.

Efficacy gap between phase II and subsequent phase III studies in oncology.

AIMS: There is a trend for more flexibility in timing of evidence generation in relation to marketing authorization, including the option to complete phase III trials after authorization or not at all. This paper investigated the relation between phase II and III clinical trial efficacy in oncology. METHODS: All oncology drugs approved by the European Medicines Agency (2007-2016) were included. Phase II and phase III trials were matched based on indication and treatment and patient characteristics. Reported objective response rates (ORR), median progression-free survival (PFS) and median overall survival (OS) were analysed through weighted mixed-effects regression with previous treatment, treatment regimen, blinding, randomization, marketing authorization type and cancer type as covariates. RESULTS: A total of 81 phase II-III matches were identified including 252 trials. Mean (standard deviation) weighted difference (phase III minus II) was -4.2% (17.4) for ORR, 2.1 (6.7) months for PFS and -0.3 (5.1) months for OS, indicating very small average differences between phases. Differences varied substantially between individual indications: from -46.6% to 47.3% for ORR, from -5.3 to 35.9 months for PFS and from -13.3 to 10.8 months for OS. All covariates except blinding were associated with differences in effect sizes for at least 1 outcome. CONCLUSIONS: The lack of marked average differences between phases may encourage decision-makers to regard the quality of design and total body of evidence instead of differentiating between phases of clinical development. The large variability emphasizes that replication of study findings remains essential to confirm efficacy of oncology drugs and discern variables associated with demonstrated effects.

Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection.

Gene and cell-based therapies (GCTs) are said to hold great promise as treatments for previously untreatable and high-burden diseases. Here, we provide insight into GCT development and regulation activities in Europe, quantify clinical and regulatory success, and compare these with other medicinal products in order to reflect on regulatory changes and challenges.

Differences in Health Technology Assessment Recommendations Among European Jurisdictions: The Role of Practice Variations.

BACKGROUND: Health technology assessment (HTA) plays an important role in reimbursement decision-making in many countries, but recommendations vary widely throughout jurisdictions, even for the same drug. This variation may be due to differences in the weighing of evidence or differences in the processes or procedures, which are known as HTA practices. OBJECTIVE: To provide insight into the effects of differences in practices on interpretation of intercountry differences in HTA recommendations for conditionally approved drugs. METHODS: HTA recommendations for conditionally approved drugs (N = 27) up until June 2017 from England/Wales, France, Germany, the Netherlands, and Scotland were included. Recommendations and practice characteristics were extracted from these five jurisdictions and this data was validated. The effect of nonsubmissions, resubmissions, and reassessments; cost-effectiveness assessments; and price negotiations on changes in the percentage of negative recommendations and the interpretation of intercountry differences in HTA outcomes were analyzed using Fisher exact tests. RESULTS: The inclusion of cost-effectiveness assessments led to significant increases in the proportion of negative recommendations in England/Wales (from 4% to 50%, P<.01) and Scotland (from 21% to 71%, P<.01). The subsequent inclusion of price negotiations led to significant reductions in the proportion of negative recommendations in England/Wales (from 50% to 14%, P<.01), France (from 31% to 3%, P=.012), and Germany (from 34% to 0%, P<.01). Results indicated that the inclusion of nonsubmissions and resubmissions might affect Scottish negative HTA recommendations (from 7% to 21%), but this effect was not significant. No significant effects were observed in the Netherlands, possibly owing to sample size. CONCLUSION: Variations in HTA practices between international jurisdictions can have a substantial and significant impact on conclusions about recommendations by HTA bodies, as exemplified in this cohort of conditionally approved products. Studies comparing international HTA recommendations should carefully consider possible practice variations between jurisdictions.

Affordability of oncology drugs: accuracy of budget impact estimations.

Background: In many countries, Budget Impact (BI) informs reimbursement decisions. Evidence has shown that decision-makers have restricted access based on high BI estimates but studies show that BI estimates are often inaccurate. Objective: To assess the accuracy of BI estimations used for informing access decisions on oncology drugs in the Netherlands. Study Design: Oncology products for which European Medicines Agency Marketing Authorisation was granted between 1-1-2000 and 1-10-2017 were selected. Observed BI data were provided by FarmInform. BI estimates were extracted from the reimbursement dossiers of the Dutch Healthcare Institute. Products without an estimated BI in the reimbursement dossier were excluded. Accuracy is defined as the ratio observed BI/estimated BI. Setting: General community, the Netherlands. Results: Ten products were included in the base case analysis. Mean accuracy was 0.64 and observed BI deviated by more than 40% and 100% from the estimated BI for 4 and 5 products, respectively. For all products together, €141 million BI was estimated and €82 million BI was observed, a €59 million difference. Conclusions: The findings indicate that BI estimates for oncology drugs in the Netherlands are inaccurate. The role and use of BI in reimbursement decisions for these potentially life-saving drugs should therefore be considered carefully, as well as BI estimation methodology.

Managing Uncertainties Due to Limited Evidence in Economic Evaluations of Novel Anti-Tuberculosis Regimens: A Systematic Review.

BACKGROUND: Limited evidence for the implementation of new health technologies in low- and middle-income countries (LMICs) may lead to uncertainties in economic evaluations and cause the evaluations to produce inaccurate information for decision making. We performed a systematic review of economic evaluations on implementing new short-course regimens (SCR) for drug-sensitive and drug-resistant tuberculosis (TB), to explore how uncertainties due to the limited evidence in the studies were dealt with and to identify useful information for decision making from these studies. METHODS: We searched in electronic databases PubMed, EMBASE, NHSEED, and CEA registry for economic evaluations addressing the implementation of new anti-TB SCRs in LMICs published until September 2018. We included studies addressing both the cost and outcomes of implementing a new regimen for drug-sensitive and drug-resistant TB with a shorter treatment duration than the currently used regimens. The quality of the included studies was assessed using The Consensus Health Economic Criteria checklist. We extracted information from the included studies on uncertainties and how they were managed. The management of uncertainties was compared with approaches used in early health technology assessments (HTAs), including sensitivity analyses and pragmatic scenario analyses. We extracted information that could be useful for decision making such as cost-effectiveness conclusions, and barriers to implementing the intervention. RESULTS: Four of the 322 studies found in the search met the eligibility criteria. Three studies were model-based studies that investigated the cost effectiveness of a new first-line SCR. One study was an empirical study investigating the cost effectiveness of new regimens for drug-resistant TB. The model-based studies addressed uncertainties due to limited evidence through various sensitivity analyses as in early HTAs. They performed a deterministic sensitivity analysis and found the main drivers of the cost-effectiveness outcomes, that is, the rate of treatment default and treatment delivery costs. Additionally, two of the model-based studies performed a pragmatic scenario analysis and found a potential barrier to implementing the new first-line SCR, that is, a weak health system with a low TB care utilization rate. The empirical study only performed a few scenario analyses with different regimen prices and volumes of TB care utilization. Therefore, the study could only provide information on the main cost drivers. CONCLUSION: Using an approach similar to that used in early HTAs, where uncertainties due to the limited evidence are rigorously explored upfront, the economic evaluations could inform not only the decision to implement the intervention but also how to manage risks and implementation barriers.

Phase I/II Clinical Trial-Based Early Economic Evaluation of Acalabrutinib for Relapsed Chronic Lymphocytic Leukaemia.

OBJECTIVES: The objective of this study was to construct an early economic evaluation for acalabrutinib for relapsed chronic lymphocytic leukaemia (CLL) to assist early reimbursement decision making. Scenarios were assessed to find the relative impact of critical parameters on incremental costs and quality-adjusted life-years (QALYs). METHODS: A partitioned survival model was constructed comparing acalabrutinib and ibrutinib from a UK national health service perspective. This model included states for progression-free survival (PFS), post-progression survival (PPS) and death. PFS and overall survival (OS) were parametrically extrapolated from ibrutinib publications and a preliminary hazard ratio based on phase I/II data was applied for acalabrutinib. Deterministic and probabilistic sensitivity analyses were performed, and 1296 scenarios were assessed. RESULTS: The base-case incremental cost-effectiveness ratio (ICER) was £61,941/QALY, with 3.44 incremental QALYs and incremental costs of £213,339. Deterministic sensitivity analysis indicated that survival estimates, utilities and treatment costs of ibrutinib and acalabrutinib and resource use during PFS have the greatest influence on the ICER. Probabilistic results under different development scenarios indicated that greater efficacy of acalabrutinib would decrease the likelihood of cost effectiveness (from 63% at no effect to 2% at maximum efficacy). Scenario analyses showed that a reduction in PFS did not lead to great QALY differences (- 8 to - 14% incremental QALYs) although it did greatly affect costs (- 47 to - 122% incremental pounds). For OS, the opposite was true (- 89 to - 93% QALYs and - 7 to - 39% pounds). CONCLUSIONS: Acalabrutinib is not likely to be cost effective compared with ibrutinib under current development scenarios. The conflicting effects of OS, PFS, drug costs and utility during PFS show that determining the cost effectiveness of acalabrutinib without insight into all parameters complicates health technology assessment decision making. Early assessment of the cost effectiveness of new products can support development choices and reimbursement processes through effective early dialogues between stakeholders.

Balancing traditional activities and cognitive pharmaceutical services by community pharmacists: a work sampling study.

Background Community pharmacy is undergoing a transition, shifting focus from traditional roles to the provision of cognitive pharmaceutical services. However, traditional activities performed by community pharmacists reduce the amount of available time for implementing and providing such services. Therefore, hampering the community pharmacist in the transition. Objective The aim of this study was to identify characteristics of community pharmacists that spend a higher proportion of their time on cognitive pharmacy services and to identify activities that compete with time spent on such activities by community pharmacists. Setting Daily community pharmacy practice. Method Self-reporting work sampling using smartphone technology was used to register the activities of community pharmacists. Participating pharmacists recorded their current activity five times per working day for 6 weeks and also completed an online survey about baseline characteristics. Main outcome measure Time utilization. Results Ninety-one Dutch community pharmacists provided work-sampling data. The results showed that Dutch community pharmacists are predominantly spending less time on managerial activities when spending more time on cognitive services (from 25.7% to 14.5%, p = 0.016). Pharmacists who are spending more time on such services, want to spend even more time on direct patient contact compared to pharmacists who spend less time on it (p = 0.030). Conclusion This study shows that community pharmacists that spend more time on cognitive pharmacy services are devoting less time on managerial activities, logistics and other activities. Pharmacists spending more time on cognitive pharmaceutical services are mostly locum pharmacists or work at a pharmacy located in a residential area with largely older inhabitants.

Accuracy of budget impact estimations and impact on patient access: a hepatitis C case study.

BACKGROUND: High budget impact (BI) estimates of new drugs limit access to patients due to concerns regarding affordability and displacement effects. The accuracy and methodological quality of BI analyses are often low, potentially mis-informing reimbursement decision making. Using hepatitis C as a case study, we aim to quantify the accuracy of the BI predictions used in Dutch reimbursement decision-making and to characterize the influence of market-dynamics on actual BI. METHODS: We selected hepatitis C direct-acting antivirals (DAAs) that were introduced in the Netherlands between January 2014 and March 2018. Dutch National Health Care Institute (ZIN) BI estimates were derived from the reimbursement dossiers. Actual Dutch BI data were provided by FarmInform. BI prediction accuracy was assessed by comparing the ZIN BI estimates with the actual BI data. RESULTS: Actual BI, from 1 Jan 2014 to 1 March 2018, was €248 million whilst the BI estimates ranged from €388-€510 million. The latter figure represents the estimated BI for the reimbursement scenario that was adopted, implying a €275 million overestimation. Absent incorporation of timing of regulatory decisions and inadequate correction for the introduction of new products were main drivers of BI overestimation, as well as uncertainty regarding the patient population size and the impact of the final reimbursement decision. DISCUSSION: BI in reimbursement dossiers largely overestimated actual BI of hepatitis C DAAs. When BI analysis is performed according to existing guidelines, the resulting more accurate BI estimates may lead to better informed reimbursement decisions.

What does it cost to redispense unused medications in the pharmacy? A micro-costing study.

BACKGROUND: Redispensing unused medications that have been returned to outpatient pharmacies by patients may reduce waste and healthcare costs. However, little is known regarding the extra costs associated with this process, nor the price level of medications for which this is economically beneficial. The objective of this study was to assess costs associated with redispensing unused medications in the pharmacy and the price level at which redispensing becomes cost-beneficial. METHODS: A micro-costing study was conducted in four Dutch outpatient pharmacies for medications requiring room-temperature storage and requiring refrigeration. First, the pharmacy's necessary additional process steps and resources for redispensing were identified. Second, time required for each process step was simulated. Third, required resources were quantified by calculating labour, purchasing and overhead costs. Lastly, a model with different scenarios was constructed to calculate the price of a medication package at which redispensing becomes cost-beneficial. RESULTS: Three main additional process steps for redispensing were identified: (1) pack medications with product quality indicators before dispensing, (2) assess quality of medications returned to the pharmacy (temperature storage, package integrity, expiry date) and (3a) restock medications fulfilling quality criteria or (3b) dispose of medications not fulfilling criteria. Total time required for all steps up to restock one medication package was on average 5.3 (SD ±0.3) and 6.8 (SD ±0.3) minutes for medications stored at room-temperature and under refrigeration, respectively, and associated costs were €5.54 and €7.61. Similar outcomes were found if a medication package would ultimately be disposed of. The price level primarily depended upon the proportion of dispensed packages returned unused to the pharmacy and fulfilling the quality criteria: if 5% is returned, of which 60% fulfils quality criteria, the price level was €101 per package for medications requiring room-temperature storage and €215 per package for those requiring refrigeration. However, if 10% is returned, of which 60% fulfils the quality criteria, the price level decreases to €53 and €109, respectively (arbitrary proportions). CONCLUSIONS: Redispensing unused medications in the pharmacy is at least cost-beneficial if applied to expensive medications.

Pharmacy in transition: A work sampling study of community pharmacists using smartphone technology.

INTRODUCTION: The nature of community pharmacy is changing, shifting from the preparation and distribution of medicines to the provision of cognitive pharmaceutical services (CPS); however, often the provision of traditional services leaves little time for innovative services. This study investigated the time community pharmacists spend on the tasks and activities of daily practice and to what extent they are able to implement CPS-related services in daily practice. METHODS: Self-reporting work sampling was used to register the activities of community pharmacists. A smartphone application, designed specifically for this purpose, alerted participants to register their current activity five times per working day for 6 weeks. Participants also completed an online survey about baseline characteristics. RESULTS: Ninety-one Dutch community pharmacists provided work-sampling data (7848 registered activities). Overall, 51.5% of their time was spent on professional activities, 35.4% on semi-professional activities, and 13.1% on non-professional activities. The proportion of time devoted to CPS decreased during the workweek, whereas the time spent on traditional task increased. DISCUSSION AND CONCLUSION: This study shows it is feasible to collect work-sampling data using smartphone technology. Community pharmacists spent almost half of their time on semi-professional and non-professional activities, activities that could be delegated to other staff members. In practice, the transition to CPS is hampered by competing traditional tasks, which prevents community pharmacists from profiling themselves as pharmaceutical experts in daily practice.

How community pharmacists prioritize cognitive pharmaceutical services.

INTRODUCTION: There is broad consensus that community pharmacists should focus on the provision of pharmaceutical care. Studies, however, have shown that community pharmacists still spend a considerable amount of time on traditional activities such as dispensing instead of cognitive pharmaceutical services (CPS). It is not clear whether community pharmacists prefer their current time-utilization or if they are willing to spend more time on CPS. AIM: The aim of this study was to identify how community pharmacists ideally would prioritize CPS compared to other daily activities. METHODS: A cross-sectional study design with Q-methodology was used to identify different viewpoints regarding task prioritization. Community pharmacists were asked to rank a total of 48 daily activities. Data was collected online using FlashQ©. Q-sorts were analyzed by principal component factor analysis and varimax rotation using PQmethod 2.35. RESULTS: In total, 166 community pharmacists participated in this study. Three distinguishing groups were found based on task prioritization explaining 59% of the total variance among respondents. All groups ranked the provision of CPS as important, in differing degrees. Group 1 ranked CPS as most important and was also the group that contained most participants. Group 2 and 3 ranked quality assurance as most important with CPS as second. Logistics and pharmacy management were ranked low by all groups. DISCUSSION AND CONCLUSION: Community pharmacists rank the provision of CPS as important. So factors, probably other than task prioritization, are keeping the pharmacist from focusing on CPS in daily practice. In other studies, time constraints are mostly mentioned as major barrier. Activities such as logistics and pharmacy management are given less priority and should be delegated to supporting staff members as much as possible, to enable pharmacists to focus their available time on activities they deem important.

Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs.

This study assessed whether five Health Technology Assessment (HTA) bodies in Europe were more negative about drugs with a Conditional Marketing Authorization (CMA) that are approved without controlled studies compared to CMA drugs that are approved based on controlled studies. The HTA recommendations were categorized into positive, restricted, and negative. A total of 92 HTA recommendations were available for 27 drugs. Thirty of 62 (48%) and 17 of 30 (57%) of the recommendations were negative for drugs with and without controlled studies, respectively. Overall, only 12 (13%) recommendations were positive. In all jurisdictions, recommendations between drugs with and drugs without controlled data were comparable, which suggests that the presence of controlled data is not decisive in HTA evaluations. The small proportion of unrestricted positive recommendations highlights difficulties with recommending the drugs in this cohort, which may be caused by scientific uncertainty or other factors. Earlier collaboration between stakeholders is advised in order to improve patient access.