INNOVATIONS in pharmacy (Iip - E-Journal)
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Multiple Sclerosis and the Comparative Value Disease Modifying Therapy Report of the Institute for Clinical and Economic Review (ICER)
Get PDFOn January 26, 2017, the Institute for Clinical and Economic Review (ICER) posted its final report on treatments for multiple sclerosis (MS) with disease modifying therapies (DMTs). The objective was to provide a modeled assessment of the effectiveness and value of the various DMTs against each other and supportive care. The model considered both relapsing-remitting and primary-progressive MS with hypothetical patient cohorts tracked from therapy initiation to death in a lifetime cost-utility framework. Recommendations were made for possible DMT package price discounts given benchmark willingness-to-pay cost per QALY thresholds. The purpose of this commentary is to assess this modeled analysis from the criteria of normal science: are the claims presented for the competing DMTs credible, evaluable and replicable? The review concludes that the ICER model does not meet required standards. The claims made for comparative effectiveness and value are non-evaluable. They are immune to failure. The review concludes that if models are to contribute to improving our understanding of the effectiveness and costs of DMTs then they should be evaluable in the short-term to allow feedback to formulary committees in a meaningful timeframe.
Type: Commentar
An Evaluation of the Distribution, Scope, and Impact of Community Pharmacy Foundation Grants Completed by Academic Principal Investigators between 2002 and 2014
Get PDFObjective: From a total of 107 grants, a subset evaluation of 58 grants awarded to and completed by pharmacy faculty by the Community Pharmacy Foundation (CPF) from 2002 through 2014 was conducted to: (a) evaluate the representativeness across principal investigator (PI) academic institutions, (b) compare the scope of CPF grants completed by academic PIs across time, and (c) compare the impact of CPF grants completed by academic PIs across time.
Methods: Quantitative data for all 107 CPF grants awarded between 2002 and 2014 were obtained from the CPF website and CPF personnel. Qualitative ethnographic data was generated from principal investigator (PI) interviews by email communications. All 107 grants, including a subset of 58 grants awarded to pharmacy faculty, were analyzed and compared between ‘Initial Years’ (2002-2008) and ‘Recent Years’ (2009-2014) using descriptive statistics for quantitative data and an extraction of dominant themes from PI reflections for qualitative data.
Results: In the initial years (2002-2008), 54% of grants awarded to pharmacy faculty were from public academic institutions. This proportion increased to 80% in recent years (2009-2014). In recent years, pharmacy faculty projects were increasingly focused on higher AHRQ Impact Categories, such as changing policies and programs, clinical care and practice patterns, and health outcomes (AHRQ Impact Levels 2-4), rather than simply adding to the knowledge base (Impact Level 1). Academic investigators reported that funding positively influenced practice development (59%), promotion & advancement (59%), and expanded collaborations (38%). Diverse geographic representation of funding recipients was achieved.
Conclusions: CPF funding has been invaluable for investigators seeking experience securing grant funding. And the impact of CPF funding has transitioned from studies that add to the knowledge base only, toward studies that effect actual health outcomes or that profoundly change practice.
Conflict of Interest
Anne Marie Kondic is Executive Director and Grants Administrator for the Community Pharmacy Foundation.
Type: Original Researc
Atypical Antipsychotic-Induced Parkinsonism: A Patient Case with CYP Enzyme Implications
Get PDFObjective: To report a case of Parkinsonism potentially caused by neuroleptic medications.
Summary: The case analyzed is that of a 57-year-old male patient referred to a pharmacotherapy service by a neurologist after organic causes of tremor had been ruled out. Iatrogenic cause was suspected and referral expectation was to identify the offending agent or agents and propose alternative therapy.
Conclusion: This case illustrates iatrogenic risk associated with neuroleptic medications while illustrating mechanisms of drug interaction via CYP enzymes that can lead to iatrogenic disease.
Abbreviations: DIP = Drug-induced Parkinsonism; MTM = Medication Therapy Management; PD = Parkinson’s Disease
Type: Clincial Experienc
Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis
Get PDFIn April 2017, the Institute for Clinical and Economic Review (ICER) issued its evidence report on the value of targeted immune modulators (TIMs) in rheumatoid arthritis. The report made the case that for the TIMs to be accepted for formulary placement in the US, where notional willingness-to-pay thresholds are the ICER gateway criteria, manufacturers should be prepared to offer substantial unit price discounts. The purpose of this commentary is to make the case that the methodology underpinning the ICER claims for value assessment does not meet the required standards of normal science. None of the claims made for clinical and comparative cost-effectiveness are credible, evaluable and replicable. As such, formulary committees have no idea whether ICER recommendations are right or even if they are wrong. They are, in fact, immune to failure and should be rejected. Utilizing ICER claims generated by simulated projections, this review points out that it is entirely possible to justify the current WAC or net pricing structure of TIMS. The review concludes that if ICER is to contribute to the successful formulary placement of drugs and devices the methodology for pricing recommendation should be re-assessed. As it stands, questions must be raised regarding recommendations for, possibly unnecessary, price discounts. ICER needs to develop an assessment framework that focuses on developing claims for competing therapies that are robust, evaluable and replicable together with recommendations on how these claims are to be evaluated in a timeframe meaningful to health care decision makers.
Type: Commentar
The Imaginary Worlds of ISPOR: Modeled Cost-Effectiveness Claims Published in Value in Health from January 2016 to December 2016
Get PDFIn 2016, a review of modeled cost-effectiveness studies published in Value in Health between January 2015 and December 2015 was presented. The purpose of the review was to consider whether these modeled claims for cost-effectiveness met the standards of normal science: were the claims made credible, evaluable and replicable? The review concluded that none of the 16 studies assessed met this standard. They should be seen as thought experiments; the construction of imaginary worlds which should be categorized as pseudoscience. The reader, or health care decision maker, would have had no idea, and would never know, whether the claims were right, wrong or misleading. Similar reviews were undertaken in Pharmacoeconomics and the Journal of Medical Economics and came to the same conclusion. The purpose of this second review is to consider the modeled claims published in Value in Health between January 2016 and December 2016, applying the same criteria. Unfortunately, for those who subscribe to the standards of normal science, we must come to the same conclusion. Of the 13 economic evaluations reviewed, 12 simulated claims that were immune to failure. The model structures ensured that the claims were neither evaluable nor replicable. They were categorized as pseudoscience; they failed to meet the standards of normal science. Five of these studies were supported by manufacturers and all supported the manufacturer’s product. Three systematic reviews were also evaluated. Once again, there was a failure to consider meeting the standards of normal science in presenting modeled claims for cost-effectiveness.
Type: Commentar
Drug-induced Adverse Events and Prescribing Cascades in Older Adults: Pharmacy Stakeholder Survey
Get PDFObjectives: The aim of this study was to assess pharmacists’ and student pharmacists’ understanding of drug-induced adverse events (DIAEs) and prescribing cascades (PC) and assess their willingness to use system-level approaches to identify DIAEs and PC for future patient interventions.
Methods: Following a continuing education presentation on DIAEs and PC, pharmacists and student pharmacists completed a survey. A retrospective post-then-pre method was used to assess knowledge. McNemar tests and chi-square analyses were used to determine differences in understanding of DIAEs and PCs, as well as between pharmacists and student pharmacists.
Results: A total of 53 participants completed the survey including pharmacists (n=39) and student pharmacists (n=14). Fewer participants had previously heard of the term (40%; p<0.001) and concept (60%; p<0.001) of PC compared to the term and concept (98% in both) of DIAE. Student pharmacists were less likely to have heard of the term PC (14%) compared to pharmacists (40%; p=0.029). There was no difference in knowledge of the concept of PC. Nearly all respondents were willing to assess for DIAE and PC in their patients, and over 75% of respondents were willing to receive systems-based alerts for DIAE and PC.
Conclusion: There was a differential in understanding DIAE and PC among respondents. Programs aimed at building understanding, as well as systems-level alerts for PC, are needed.
Conflict of Interest
Disclosures: This author declare no conflicts of interest for this manuscript.
Support: This publication was supported by the Washington University Institute of Clinical and Translational Sciences grant UL1TR000448, sub-award KL2TR000450, from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH).
Type: Student Projec
A Modern Method to Monitor Office Blood Pressure
Get PDFThe diagnosis and management of hypertension relies on accurate and precise blood pressure (BP) measurements and monitoring techniques. Variability in traditional office based BP readings can contribute to misclassification and potential misdiagnosis of hypertension, leading to inappropriate treatment and possibly avoidable adverse drug events. Both home blood pressure monitoring (HBPM) and 24-hour ambulatory blood pressure monitoring (ABPM) can improve characterization of BP status over traditional office values and can predict cardiovascular morbidity and mortality risk; however, they are limited by availability and/or practical use in many situations. Available in-office blood pressure measuring methods include manual auscultation, automated oscillometric, and automated office blood pressure (AOBP) devices. A strong correlation exists between AOBP and awake ABPM measurements and has been linked to better prediction of end-organ damage and white coat response compared to standard office BP methods. While AOBP does not provide nocturnal BP readings, it can be utilized in several outpatient settings, and has the capability to decrease utilization of ABPM, white coat effect, and improve optimization of cardiovascular assessment, evaluation, and therapeutic assessment in clinical practice.
Hypertension affects over 80 million adults in the United States (US) and is a major risk factor for cardiovascular morbidity and mortality [1]. The condition’s ubiquitous nature and broad impact potentially makes understanding the diagnosis and treatment of hypertension key elements of managing cardiovascular risk. Though much attention is paid to the treatment of hypertension, from 2009 to 2012, 45.9% of US patients with hypertension were uncontrolled [1]. Appreciating the aspects of proper assessment of blood pressure is crucial and creates the foundation for approaching hypertension management. Until recently, hypertension was defined as an appropriately measured office systolic blood pressure (SBP) of greater than or equal to 140 mmHg and/or diastolic blood pressure (DBP) greater than or equal to 90 mmHg, with the patient seated and resting for 5 minutes in a proper position, and preferentially, measured as an average of two readings taken 1 or 2 minutes apart [1-5]. While serving as the primary method, standard office blood pressure assessment with either manual or traditional automated BP cuffs is limited in accuracy and application in everyday practice, and faces many challenges. As such, an understanding of the potential limitations of current BP strategies, and the roles and rationale for novel assessment techniques are of value to clinicians [6].
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: Revie
Another Imaginary World: The ICER Claims for the Long-Term Cost-Effectiveness and Pricing of Vesicular Monoamine Transporter 2 (VMAT2) Inhibitors in Tardive Dyskinesia
Get PDFThe recently released value assessment of vesicular monoamine transporter 2 (VMAT2) inhibitors in tardive dyskinesia by the Institute for Clinical and Economic Review (ICER) relies upon a long-term modeling exercise to support recommendations for what the ICER sees as the appropriate pricing for these products if prices are to be judged ‘cost-effective’. In this case, the recommendations are for a substantive price reduction of some 90% over WAC. Needless to say, this recommendation is unlikely to be welcomed with open arms by the respective manufacturers of valbenazine and deutetrabenazine. Unfortunately, as has been argued in a number of commentaries published over the past 18 months in INNOVATIONS in Pharmacy, the ICER endorsed health technology assessment methodology that underpins this exercise in building a modeled imaginary world to justify product pricing recommendations is fatally flawed: it does not meet the standards of normal science. Rather than addressing the issue of claims validation for VMAT2 products, the question of generating modeled evaluable claims, among others, for clinical, quality of life and resource utilization outcomes, the analysis focuses on claims that are neither credible nor evaluable and, of course, non-replicable. A more positive and useful approach would be for ICER to focus on a framework where claims could be assessed in the short term to provide feedback to health system decision makers, physicians and patients. Instead, we are asked to believe that we can model 20 or 30 years into the future to establish non-evaluable claims for pricing and, ultimately, access.
Conflict of Interest: None
Type: Commentar
Community Pharmacists’ Classification of Prescription Drugs into an Expanded Class of Nonprescription Drugs under the FDA's Proposed NSURE Initiative
Get PDFObjectives: There has been considerable debate over the last few decades about creating a third class of drugs that would not require a prescription or not be available freely over the counter, but require a pharmacist’s consultation upon purchase. These debates reignited again in 2012, when the Food and Drug Administration (FDA) held a hearing about a third class of drugs positioned as an expanded nonprescription drug class under the FDAs Nonprescription Safe-Use Regulatory Expansion (NSURE) Initiative. The objective of this study was to determine which prescription drugs community pharmacists believe are acceptable additions to an expanded definition of nonprescription drugs that would be available pending pharmacists’ consultation with a patient.
Methods: This cross-sectional study was conducted using a self-report, web-based survey administered to a national panel of community pharmacists. The survey contained a list of 24 current “prescription-only” drugs which may be potential candidates for an expanded nonprescription drug class, based on criteria outlined by the FDA, and questions related to respondent demographic and practice characteristics. The respondents were asked to indicate whether a particular drug should be marketed as a prescription drug, nonprescription drug or as part of an expanded non-prescription drug class. Descriptive analyses were conducted to determine the drugs that community pharmacists believed would be suitable additions to an expanded non-prescription drug class under the NSURE initiative.
Results: 462 completed surveys were received. Most respondents indicated that clopidogrel bisulfate (85.3%) and zolpidem (86.6%) should continue to be dispensed as prescription drugs. Atorvastatin, metformin, and sildenafil (among others) were considered appropriate to be marketed as an expanded nonprescription drug, in other words, dispensed without a prescription but upon pharmacist consultation. Desloratadine (64.6%) and pre-natal vitamins (50.2%) were considered appropriate for nonprescription status (over-the-counter, without pharmacist intervention).
Conclusions: Respondents suggested that 18 out of 24 drugs (75%) on the list provided could be categorized into an expanded class of nonprescription drugs. Adding more drugs to an expanded nonprescription drug class has the potential to expand pharmacists’ provision of patient care under the FDA’s proposed NSURE program.
Type: Student Projec
Risk Factor Management with Guideline-Based Medications for Prevention of Recurrent Ischemic Stroke: A Retrospective Chart Review
Get PDFBackground: Implementation of new practice guidelines for stroke prevention has decreased the number of patients experiencing recurrent stroke. Clinical trials show antihypertensives, high-intensity statins, and antithrombotics to be beneficial after stroke.
Objective: The objective of this study was to determine if recurrent stroke patients were discharged on guideline-based medications for secondary stroke prevention, and to identify potential errors in appropriate prescribing of medications.
Methods: A retrospective chart review was conducted at a community hospital and included patients 19 years and older diagnosed with their second, third, or fourth stroke (transient ischemic attack or cerebrovascular accident). Descriptive statistics were used to describe collected information. Collected data included relevant patient demographics, diagnosis, past medical history, medications, and readmission rates. The primary objective was the percentage of patients appropriately discharged on guideline-based secondary stroke prevention medications. Appropriate treatment was based upon the 2010 and 2014 American Heart Association/American Stroke Association Guidelines for the Prevention of Stroke in Patients with Stroke and Transient Ischemic Attack.
Results: A total of 124 charts were reviewed, 106 charts met the inclusion criteria. Guideline-based and appropriate medication-use was initiated in 9% and 4% of patients with noncardioembolic and cardioembolic stroke, respectively. Therapy deemed not guideline-based, but appropriate was initiated in 20% and 9% of patients with noncardioembolic and cardioembolic stroke, respectively. Errors in appropriate prescribing of secondary prevention medications were related to statins and antihypertensives.
Conclusion: Better adherence to preventative recurrent stroke measures is needed at the time of patient discharge.
Type: Student Projec