INNOVATIONS in pharmacy (Iip - E-Journal)
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Greater Expectations for Pharmaceutical Value: Better Care, Healthier People, Smarter Spending
Get PDFType: Commentar
Modeling Imaginary Worlds: Version 4 of the AMCP Format for Formulary Submissions
Get PDFThe question of demarcation between normal science and pseudoscience is critical to the discovery of new facts. The core elements supporting progress in science are: (i) empirically evaluable coherent theories and (ii) the testing of hypotheses through experimentation or systematic observation. If modeled or simulation-based claims for cost-effectiveness are to be accepted as a credible input to health care decision making than they must conform to these standards. Claims should be testable, falsifiable and replicable. If not then they are best seen as pseudoscience. This assessment of the latest version of the Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions (Version 4.0; April 2016) concludes that, in their recommendations for cost-effectiveness modeling, the proposed standards do not meet those of normal science. Rather, in common with previous versions of the AMCP Format, the modeling framework proposed not only puts to one side the issue of testable claims, but supports the modeling of imaginary worlds or thought experiments where claims are immune to falsification. In consequence, the payer or other recipient of a modeled or simulated claim that follows the AMCP Format has no idea, in the absence of observation or experimentation, whether the claim is right or even if it is wrong. The claims are potentially misleading, possibly harmful, but to an unknown extent. They have no place in evidence-based medicine.
Conflict of Interest
None
Type: Commentar
He Ao Pohewa: The PHARMAC Prescription for Pharmacoeconomic Analysis in New Zealand and the Standards of Normal Science
Get PDFIn common with a number of other single payer health systems, New Zealand has, through the Pharmaceutical Management Agency (PHARMAC), established guidelines for formulary submissions by pharmaceutical manufacturers. A question that is important to health system decision makers is to whether or not guidelines for economic evaluations in countries like New Zealand are consistent with the standards of normal science. Do the guidelines require those making the submission to put their claims in the form of testable hypotheses that can support falsification and replication? Are post-listing evaluations of these claims ever carried out? The purpose of this review is to consider whether the 2012 PHARMAC guidelines meet these standards. The assessment argues that the guidelines do not meet the standards of normal science. Instead, from this perspective, they are best characterized as supporting the creation of he ao pohewa (an imaginary world). There is no requirement in the guidelines for claims to be expressed as testable propositions; as hypotheses for expected impact that can be evaluated and the outcomes reported as part of ongoing disease area and therapeutic class reviews. There is no commitment to the discovery of new facts though falsification and replication. Our review concludes with suggestions for a reworking of the guidelines to meet the standards of normal science.
Type: Commentar
Supporting Formulary Decisions: The Discovery of New Facts or Constructed Evidence?
Get PDFA critical question, given the growing importance of more targeted therapies to support personalized and precision medicine, is the credibility of the evidence base to support formulary decisions and pricing. On the one hand, for those who subscribe to the reference case model of the National Institute of Health and Care Excellence (NICE) in the UK, the decision rests upon the creation of modeled or simulated imaginary worlds and the application of threshold willingness-to-pay cost-per-QALY thresholds. On the other hand, for those who subscribe to the standards of normal science, the decision rests upon the ability to evaluate competing claims, both clinical and cost-effective, in a timeframe that is meaningful to a formulary committee. If we subscribe to the scientific method where the focus is on the discovery of new facts, untestable claims for clinical benefit and cost-effectiveness, such as created claims for lifetime cost per-quality-adjusted discounted life years (QALYs), are properly relegated to the category of pseudoscience. We have no idea, and will never know, whether the claims are right or even if they are wrong. If formulary decisions are to respect the standards of normal science then there has to be a commitment to claims evaluation. A willingness to accept new products provisionally, subject to an agreed protocol to support the evaluation of clinical and cost-effectiveness claims. This dichotomy between the standards of normal science and pseudoscience is explored in the context of published claims for cost-effectiveness and recommendations for product pricing in the US.
Type: Commentar
Patients’ Awareness, Perceived Benefit, and Intent to Participate in Pharmacy Services
Get PDFObjective: To determine patient awareness, perceived benefit, and intent to participate in 1) adherence packaging 2) Medication therapy management (MTM), 3) delivery, 4) automatic refill, and 5) refill synchronization.
Methods: This cross-sectional exploratory study used convenience sampling to survey participants from January 26th, 2016 and March 28th, 2016. A 25-question survey and service sheet were developed. The survey consisted of four sections 1) awareness, 2) perceived benefit, 3) intent to participate, and 4) demographics. Descriptive statistics, linear regression, and logistic regression were conducted.
Results: A total of 336 people were approached. Thirty-four people only filled out the demographic section and 32 refused to participate. Therefore, 270 surveys were considered usable for statistical analysis (90.4% response rate). The majority of the participants were not aware of refill synchronization (77.0%), MTM (64.8%), and adherence packaging (87.0%). There were multiple factors that contributed to how patients perceived the benefits of adherence packaging and automatic refill. Participants who were middle aged or older (p<.05), had a higher income (p<.01), were on multiple medications (p<.01), and from Ohio (p<.05) saw a higher benefit in adherence packaging. Participants who were middle aged or older (p<.05), male (p<.01), had a higher income (p<.01), had a Bachelor’s degree or lower (p<.05), and were aware of the service (p<.01) were more likely to see a benefit in automatic refill. In contrast there was only one predictor for refill synchronization showing that non-white participants were more likely to see a benefit. There were not any factors that contributed to how patients perceived the benefits of delivery, refill synch, and MTM.
There were several predictors that increased a patient’s intent to participate in a service. Some of the key predictors for each service included, participants who felt that adherence packaging will help them feel more in control of taking their medications were 2.81 times more likely to participate. Participants who felt that delivery would allow them more time to do other things were 6.89 times more likely to participate. Those who believed that automatic refill would help them take their medications on time were 8.30 times more likely to participate. Participants who felt refill synchronization would decrease multiple trips to the pharmacy were 2.26 times more likely to participate. Those that felt MTM would build their relationship with their pharmacist were 0.47 times more likely to participate. Overall, a consistent predictor for every service was feeling in control of taking their medications.
Conclusion: Overall, there is a lack of awareness of pharmacy services. Specifically services such as medication therapy management, refill synchronization, and adherence packaging. Pharmacists should take a proactive approach in informing patients of the services offered at their pharmacy. Additionally to increase participation, pharmacists can educate patients on how a service may help them feel more in control of taking their medications.
Type: Original Researc
Use of A Comic Book to Assist Student Learning of Dimensions of Patient-Centered Care
Get PDFObjective: To evaluate the use of comic books as a supplemental reading to assist student learning of the dimensions of patient-centered care. The Innovation: A comic book titled Mom’s Cancer was used as a supplemental reading in a course that introduced 2nd year pharmacy students (in a 0-6 year program) to the social aspects of pharmacy practice. Students read the book and provide their reflections about the book and topic covered in it. Critical Analysis: A total of 100 students registered in two sections of the course provided their responses. Student responses to the comic book activity were overwhelmingly positive. More than half of the student reflections included their personal experience with the healthcare system. The comic book format helped illustrate patient experiences with chronic illness to students. The range of comic books is not enough to give a comprehensive coverage of all the topics in the pharmacy curriculum. Getting the appropriate comic book for the respective topic could be challenging. Also, the effectiveness of comics as an education tool may be limited, if readers are less likely to take information provided via this medium seriously. Next Steps: The positive responses from students highlight the point that pharmacy faculty could use comic books in their pharmacy courses. Further research is needed to determine topics that would be effectively addressed by comic books and best practices for comic book use in pharmacy curriculum.
Conflict of Interest
The author declares 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: Not
Critical Thinking Development in Pharmacy Education: A Meta-Analysis
Get PDFObjective: The investigators aimed to summarize prior studies of critical thinking development among pharmacy students, using the California Critical Thinking Skills Test (CCTST), Health Sciences Reasoning Test (HSRT), and Defining Issues Test (DIT).
Methods: Independently, two investigators (KLZ, MJP) systematically searched available literature using PubMed, Google Scholar, ERIC, PsychInfo, as well as pharmacy education conference abstracts in American Journal of Pharmaceutical Education. Their search terms were ‘pharmacy’, and [‘critical thinking’, ‘HSRT’, ‘CCTST’, and ‘DIT’]. Studies included were those that investigated pharmacy students, used one of the tests (CCTST, HSRT, DIT), and used a longitudinal design with test administration at two or more time-points for the same subjects (i.e., development). On review, the CCTST and HSRT seem more foundational to analytical/critical thinking, while the DIT appears to measure moral/complex thinking. Summarizing used meta-analysis with Cohen’s d and random-effects modelling.
Results: Five studies involved thinking development with 10 separate cohorts for meta-analysis (8 cohorts for CCTST, 2 for DIT, and 0 for HSRT). At 5 institutions, 407 and 1148 students were included (CCTST and DIT, respectively). For the CCTST, the overall effect was 0.33 (0.19-0.47 95%CI) with some heterogeneity among study cohorts (I2=52%). For the DIT, the overall effect was -0.23 (-0.83-0.37 95%CI) with considerable heterogeneity between study cohorts (I2=95%). For the CCTST and DIT, some studies showed effect-sizes greater than 0.5. Meta-analysis of the HSRT could not be conducted (i.e., 0 studies found).
Implications: While measuring different aspects of “critical thinking”, the CCTST and DIT showed responsiveness to change and appear to be promising measures of cognitive development. These tests should be used in further well-designed research studies that explore strategies for improving cognitive development in pharmacy education.
Conflict of Interest
We declare no conflicts of interest or financial interests that the we or members of our 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
Adverse effects and Drug Interactions Associated with Inhaled Recreational and Medical Marijuana
Get PDFObjectives: To provide an overview of the addiction potential; adverse effects (e.g., cardiovascular, immune dysfunction, respiratory system, mental health disorders); drug interactions; effects of accidental exposure; crime statistics; and pharmacist’s considerations for the use of inhaled medical marijuana.
Methods: A PubMed search was conducted from 1966 to March 2016 to identify articles in which the safety of inhaled medical marijuana was assessed. Key MeSH search terms included medical marijuana with a subheading for adverse effect. Only articles in adult patients were considered. In addition, medical marijuana or cannabis plus one of the following search terms were searched: drug interactions, herb-drug interactions, drug-related side effects and adverse drug reactions, substance-related disorders, addiction, and abuse. A free-text search was also conducted to identify articles not included in the MeSH term search. A bibliographic search was also conducted. Articles were included if they addressed adverse effects of medical marijuana for the treatment of a condition. Meta-analyses, randomized controlled clinical trials, and case reports were included in the review if the primary focus of the article related to the adverse effect profile of inhaled medical marijuana. Medical marijuana efficacy studies were not assessed. In the absence of this information, case reports or reports of inhaled recreational marijuana use was used. Studies were excluded if published in languages other than English. In addition, studies highlighting mechanisms of action, studies of pharmacodynamics or pharmacokinetic effects were excluded, unless these effects were due to drug-drug interactions. Prescription products containing marijuana or derivatives were excluded from evaluation. An Internet search was conducted to locate the most up-to-date information on the laws concerning medical marijuana.
Key findings: A PubMed search revealed 58 articles and 28 of those studies were included in this review. Several studies were located that evaluated the safety of medical marijuana; however, much of the review focused on inhaled, recreational marijuana use due to the paucity of information on inhaled medical marijuana. Since marijuana is a Schedule1 product, few clinical studies have been conducted to determine the adverse event profile of the product. As a result, several articles that characterized recreational inhaled marijuana were included. Recreational inhaled marijuana use may be associated with an increase in cardiovascular (CV)/ cerebrovascular effects (CVA); however, conflicting information exists in the literature. Recreational marijuana use may also increase risky behaviors that increase the transmission of infectious diseases and respiratory diseases. Many of the studies were retrospective in nature; therefore, it was difficult to determine a cause and effect relationship between inhaled marijuana use and the development of adverse reactions or drug-drug interactions.
Conclusions: There is a paucity of information related to the use of inhaled medical marijuana. Recreational marijuana use is associated with several adverse events including CV/CVA, respiratory, and transmission of infectious diseases. Theoretical literature indicates that medical marijuana may be associated with significant drug-drug interactions and adverse drug reactions. Legalization of medical marijuana may be associated with an increase in abuse/dependence and accidental exposures in children. Pharmacists need to be educated regarding the appropriate use of medical marijuana to avoid adverse reactions and potential drug-drug interactions between medical marijuana and other products.
Type: Original Researc
An Overview of Comic Books as an Educational Tool and Implications for Pharmacy
Get PDFObjective: To present an overview of comic books as an educational tool and discuss the use of comic books in pharmacy education.
Literature Identification: This research is comprised of a narrative literature review and critical analysis of the information retrieved. Key words included: comic(s), graphic novels, and pharmacy education. News articles, dissertations, theses, books, and scholarly articles from peer reviewed journals were selected and reviewed for inclusion in this article.
Results: Comics have been used as a pedagogical tool to motivate students to read, help them remember the content, and make the whole learning process fun. They have been used as supplemental readings in biochemistry, physics, and business ethics. Comic books have been used in educating patients about the challenges of dialysis, promoting health, and informing consumers about diseases such as AIDS and cancer.
Conclusion: In today’s media rich environment, comic books could be a visually interactive and innovative educational tool. Pharmacy faculty could use comic books or graphic novels as stand-alone texts or as part of a larger curriculum. Comic books could help students learn pharmacy-relevant content while enjoying the reading.
Conflict of Interest
The author declares 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: Revie
Next Generation Sequencing Claims in Precision Medicine: Questions a Formulary Committee Should Ask
Get PDFThe enthusiasm with which precision medicine has been embraced over the past 15 years has obscured the fact that the evidence base for biomarker-driven assessments, in particular for next generation sequencing (NGS), is limited. This applies both to the comparative performance of the various assessment tools as well as to the impact of biomarker driven decisions at the patient level. Where a genetic test is being evaluated there are five key questions a formulary committee should ask when assessing whether or not to recommend coverage and reimbursement for the test in target patient populations:
(i) has the test met required standards for analytic and clinical validity?
(ii) has the test been evaluated against competing tests for analytic and clinical validity?
(iii) have the test-based claims met standards for credibility, evaluation and replication?
(iv) has the test been accepted as part of the standard of care for patient management in the target disease state?
(v) has the introduction of the test improved outcomes, including survivorship, adverse events, quality of life and costs, in the targeted population?
The purpose of this commentary is twofold: first, to consider the appropriate evidentiary standards for the evaluation of a test and comparator tests; and, second, to identify questions that a formulary committee should address in submissions made for a test in health care systems. A critical issue is not only comparative claims for the test against the standard of care and comparator tests, but the assessment of test performance for the identified treatment pathways where mutations or variants are linked to recommendations for therapy options. Unless these issues are addressed it is unlikely that the promise of personalized medicine will be realized. The absence of an evidence base will deter both physicians and their patients from adopting NGS based recommendations.
Type: Commentar