INNOVATIONS in pharmacy (Iip - E-Journal)
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Validating Imaginary Worlds? The AdViSHE Assessment Tool
Get PDFThe publication in April 2016 of the Assessment of the Validation Status of Health-Economic Decision Models (AdViSHE) checklist for decision models raises a number of issues that the health technology assessment literature has yet to address. The principal issue being the role of decision models in generating claims that are evaluable and replicable. Unfortunately, this is not addressed in this new checklist which is intended to address the perceived need for a tradeoff between confidence in a decision model and the need to allocate resources by developers and payers to validating the model. Irrespective of the degree of confidence a developer or payers may have in the sufficiency of the model in representing ‘reality’ unless the model has generated evaluable claims and evidence for those claims in target treating populations, the model fails the standards of normal science. Apart from the absence of a commitment in the AdViSHE checklist to the modeling of claims that are evaluable and replicable, the validation check list makes no allowance for a product pricing strategy that may commits a manufacturer to regular and substantial annual or semi-annual product price increases. Indeed, product pricing assumptions are conspicuous by their absence. The commentary argues that failure to accommodate anticipated pricing behavior renders lifetime cost-per-QALY models and the application of willingness-to-pay thresholds meaningless.
Type: Commentar
HAS Should Not Be NICE: Rejecting Imaginary Worlds in the French Technology Assessment Guidelines
Get PDFPricing decisions and access to pharmaceuticals should be evidence based. Unfortunately, the French guidelines for technology assessment, in their adoption of the National Institute for Health and Clinical Excellence (NICE) reference case modeling standard ensure that this is not the case. Rather than requiring the submission of claims that are credible, evaluable and replicable, the Haute Autorité de Sante (HAS) mandates the creation of imaginary worlds to support comparative effectiveness and cost-outcome claims. The purpose of this commentary is to make the case that HAS should reconsider this commitment to standards for health technology assessment that are more appropriately seen as pseudoscience. The recommendation is that HAS should put to one side mandating lifetime cost-per-quality adjusted life year (QALY) or life years saved claims in favor of short-term claims that can be evaluated and reported to health system decision makers as part of a provisional assessment of new products as well as supporting ongoing disease area and therapeutic class reviews.
Type: Commentar
Opportunities for Pharmacists and Student Pharmacists to Provide Clinical Preventive Services
Get PDFPharmacists and student pharmacists can play an important role in providing clinical preventive services as specified by the United States Preventive Services Task Force (USPSTF). The USPSTF guidelines provide evidence-based recommendations about clinical preventive services for the general population. The purpose of this paper is to provide information to pharmacists and student pharmacists developing and implementing preventive health care services. Examples of successful pharmacy-based programs are also provided. Pharmacists and student pharmacists can provide preventive health care interventions by conducting screenings, providing education, and making referrals.
Conflict of Interest
We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties
Type: Idea Pape
Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014
Get PDFPurpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9%) of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%). The three most frequently reported labeling changes were warnings (68.7%), precautions (58.6%), and patient package insert/medication guide (23.2%). Case reports resulted in the greatest number of documented literature types (n = 791), followed by randomized controlled trials (n = 76), and case control/cohort studies (n = 74). Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%), compared to LOE A (17.1%), and LOE C (14.1%) (p = 0.007). Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients.
Conflict of Interest
We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.
Type: Original Researc
Community Pharmacist Attitudes on Medication Synchronization Programs
Get PDFBackground: Medication synchronization is a service offered by an increasing number of community pharmacies that aligns refilling of a patient’s multiple medications. Purported benefits include increased adherence and improved dispensing efficiency.
Objective: To assess community pharmacist agreement with a set of declarative statements about medication synchronization programs and to identify variation related to pharmacist characteristics.
Methods: In 2015, a cross-sectional survey was mailed to 1,000 pharmacists from 5 Midwestern U.S. states using 4-contacts and an online option. Respondents used a 7-point Likert scale to agree or disagree with 5 statements about medication synchronization. Demographic and workplace characteristics were collected. Data were analyzed using descriptive statistics and factor analysis. Multiple linear regression tested the relationship between pharmacist characteristics and a 4-item attitude composite.
Results: There were 258 usable responses for a response rate of 28.8%. About half (45.0%) reported their pharmacy offered medication synchronization. Most pharmacists (82.6%) agreed this service has a positive impact on patient adherence but 57% agreed that a “significant change to workflow” was or would be required. Pharmacist agreement that the program provides financial benefits to the pharmacy was higher than agreement that the service provides more opportunities for patient interactions (p<0.001). In the multiple regression analysis, having a PharmD and working at a pharmacy offering Medication Therapy Management were associated with more positive scores on the medication synchronization benefits composite whereas working in a staff role (rather than a manager/owner) was lower. No demographic predictors were significantly associated with agreeing that a significant change to workflow would be required for implementation.
Conclusions: Pharmacists generally were positive about medication synchronization programs, although some negative views were present, especially regarding the need for workflow change. Research is needed to understand barriers and facilitators to how medication synchronization programs are implemented and maintained and their effects on outcomes.
Conflict of Interest
We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.
Type: Original Researc
True North: Building Imaginary Worlds with the Revised Canadian (CADTH) Guidelines for Health Technology Assessment
Get PDFIn March 2017 the Canadian Agency for Drugs and Technologies in Health (CADTH) released the 4th edition of their Guidelines for the Economic Evaluation of Health Technologies: Canada. These guidelines, which were first published and revised for a 3rd edition in 2006 are intended to help decision makers, health systems leaders and policy makers make well-informed decisions. They are designed, apparently, to support best practice in conducting health technology assessments in Canada. The purpose of this commentary is to consider whether or not the evidence standards proposed and the consequent modeled claims for economic effectiveness meet the standards of normal science: are the CADTH standards capable of generating claims for competing products that are credible, evaluable and replicable? The review argues that the standards proposed by CADTH do not meet the standards expected in normal science. Technical sophistication in building reference case imaginary worlds is not a substitute for claims that are experimentally evaluable or capable of assessment through systematic observation. There is no way of judging whether imaginary claims are right or even if they are wrong. CADTH is not alone in setting standards that fail to meet the standards of normal science. Recent commentaries on formulary submission guidelines in a number of other countries, to include Ireland, the Netherlands, France, Australia, the UK and New Zealand conclude that they are subject to the same criticism. If the CADTH guidelines were never intended to support feedback to health system decision makers, then this should be made clear. If not, then consideration should be given to withdrawing the guidelines to ensure they conform to these standards. Hopefully, future versions of the CADTH guidelines will address this issue and focus on a rigorous research program of claims assessment and feedback and not the building of imaginary worlds.
Type: Commentar
Rush to Judgement: Imaginary Worlds and Cost-Outcomes Claims for PCSK9 Inhibitors
Get PDFPricing by the manufacturers of the two PCSK9 inhibitors recently approved by the FDA, evolocumab and alirocumab, has led to an ongoing debate over the value of these interventions in clinical practice. In the US, the Institute for Clinical and Economic Review (ICER) has been in the forefront of those who have argued that, in the context of notional incremental willingness-to-pay thresholds, manufacturers should reduce drug prices substantially. This conclusion has been echoed in a number of other technology assessments, notably in assessments by the National Institute of Health and Care Excellence (NICE) in the UK. At the same time, other evaluations have reported favorably, arguing that at current US prices, the two products meet willingness-to-pay benchmarks. The purpose of this commentary is not to argue for or against current PCSK9 pricing policies but to point out that the case made for possible price adjustments rest upon technology assessments that fail to meet the standards of normal science. Modeled claims that are properly classified as pseudoscience. The claims made are non-evaluable. Formulary committees, rather than accepting these claims at face value, should step back and work with manufacturers to develop claims that are targeted, robust, evaluable and replicable in a timeframe where feedback on PCSK9 outcomes are meaningful to health system decision makers.
Type: Commentar
Associations between Modifiable Health-Risk Behaviors and Personality Types
Get PDFObjectives: The first objective for this study was to explore if characteristics of personality type (using the Preferred Communication Style Questionnaire) are associated with the following modifiable health-risk behaviors: smoking, exercise, alcohol consumption, nutrition, sleep, depression-related stress, anxiety-related stress, healthcare professional usage, and self-discipline. The second objective for this study was to explore if characteristics of personality type are associated with (1) the quality of patient-physician relationships, (2) patient-physician communication, and (3) preferred method for receiving information.
Methods: Data were collected from 10,500 adult individuals residing in the United States via an on-line, self-administered survey coordinated by Qualtrics Panels from March 14-30, 2016. Chi-square analysis was used for making comparisons between categories of personality types and items related to health-risk behaviors. Statistical significance was set at p < 0.05. However, chi-square analysis with large sample sizes (e.g. 10,500 in this study) readily yields statistical significance. Practical significance was set at four or more percentage points above or below the overall mean.
Results: Regarding objective 1, personality type was associated with all nine health-risk behaviors studied. Personality types within the Experiencer temperament (17% of the U.S. population) accounted for 46% of the undesirable scores we computed for health-risk behaviors. The Idealist temperament (17% of population) accounted for 32% of the undesirable scores. Conceptualizers (10% of population) accounted for 17% of the undesirable scores and Traditionalists (46% of population) accounted for 5% of the undesirable scores. Regarding objective 2, the findings showed that personality type was associated with (1) the importance people place on the patient-physician relationship, (2) which characteristics of that relationship are most desirable, (3) desire for more communication with their physician, and (4) the preferred method for receiving information.
Discussion and Conclusions: Precision medicine has been proposed as a way to create a new taxonomy of disease that uses individual specific data to develop accurate diagnosis, targeted treatment, and improved health outcomes. Based on the findings of this study, we propose that inclusion of personality type is an important component of these efforts so that the health care system can conform more to the individual patient in order to increase engagement and adherence, reduce errors, minimize ineffective treatment and waste, and can be cost effective.
Conflict of Interest
Co-author, Paul Tieger is CEO of SpeedReading People, LLC which holds copyright for the Individual Wellness Plan and Adherence Predictive Index tools that are mentioned in this manuscript.
Type: Original Researc
The Innovation Opportunity in Pharmacy Education Standards
Get PDFThe changing landscape of healthcare and recent formal Standards for innovation in pharmacy education presents a unique opportunity. To realize this opportunity, pharmacy should learn from the successes of other fields to make use of the rich environment for improvement in healthcare. The University of Pittsburgh School of Pharmacy presents one example of a Program that utilizes a curriculum, projects, and partners to realize innovation. Educators in pharmacy can make use of the opportunity for innovation by learning from successful examples and embracing the process’s challenges of iteration.
Type: Commentar
Injudicious Provision of Subtherapeutic Doses of Antibiotics in Community Pharmacies
Get PDFBackground: Egyptian pharmacists routinely provide antibiotics without a prescription. A few pills of common cold products are offered under the name “cold group”. A cold group may contain one or more pills of antibiotics. This study aimed to estimate the proportion of pharmacies that provide subtherapeutic doses of antibiotics in community pharmacies as part of a CG or upon direct request from a simulated client. Methods: A probability sample of community pharmacies in Alexandria, Egypt was selected. A simulated client approached pharmacy staff using a standardized scenario. He initially requested a cold group and followed by requesting two antibiotic pills.Results: The simulated client visited 104 pharmacies and was sold an antibiotic at 68 pharmacies in total. A cold group with one or more antibiotic pills was provided in 31 pharmacies. Upon request for two antibiotic pills, 2-8 antibiotic pills were provided in 30 pharmacies whereas an antibiotic carton was provided in three pharmacies. In four pharmacies, the simulated client was sold a cold group containing an antibiotic as well as another antibiotic upon request. Beta-lactam antibiotics comprised 76% of antibiotics provided. In five encounters, the simulated client was told that the cold group contained an antibiotic when, in fact, it did not. Conclusions: Subtherapeutic doses of antibiotics are provided at dangerous rates in Alexandria’s community pharmacies. Interventions are urgently needed to tackle different factors contributing to this dangerous practice.
Conflict of Interest
We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties
Type: Original Researc