2016newsletter april post-npa mailing - carekinesis · cotherapy criteria, we designed it as a...

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April 2016 www.CareKinesis.com 888-9-PharmD In this Issue: page CAP News 2 EireneRx Review 2 Hep C & PGx 3 Our Locations 6 CE Credits 6 Calendar 7 QT Interval 7 Beers Criteria Update 8 In the Community 10 Our Leadership Team 11 Our NPA event 12 Copyright © 2016 by CareKinesis, Inc. All rights reserved Who are we? CareKinesis is a comprehensive pharmacy solution for PACE providers. The CareKinesis model improves medication-related outcomes and PACE clinic operational efficiency. Personalizing medication management Advancing pharmacy knowledge Promoting participant safety When we (CareKinesis) started working in PACE in 2011, our goal was to help chronically ill persons optimize the use of medication. I had some significant personal experience with my late father who was multiple co-morbid and suffered from an array of Adverse Drug Events (ADEs), which, retrospectively were preventa- ble. We set out to develop software that would support physicians, nurses and pharmacists helping patients with their medication regimens. The main issue (for the past 30+ years) is that the software that has been used in Electronic Health Records, and in every pharmacy in the US, is only capable of detecting one-drug-to- one-drug interactions. In other words, if a patient is taking ten chronic medications, the provider would need to perform dozens of dif- ferent one-drug-to-one-drug analyses, which no one is capable of doing in short order. Further, in addition to drug interactions, serious and frequent ADEs are also caused by accumulative side effects of similar medications (e.g., the patient is taking 3 or 4 medications that cause sedation). As background, ADEs remain a leading cause of mortality in our nation, responsible for more than 100,000 deaths/year, as well as millions of ED visits, falls and countless morbidities. Without an instantaneous automated process to analyze all the medication interactions and accumulative side effects simultaneously, clini- cians prescribe and dispense medications with the hope that nothing bad happens to the patient. And, as we age, many specialists are often in- volved, adding to the medication regimen bur- den. Thus, the incidence of unintended ADEs presents a chilling public health problem. In 2013, we launched our comprehensive Medi- cation Risk Mitigation Matrix ® functionality inside of EireneRx ® , for use initially by our clinical pharmacists in their daily PACE medication management functions. Then, in 2015, we offered the Matrix to members of our Clinical Advisory Panel (mostly PACE medical directors) and to other clinicians who provided input throughout development. This MRM Matrix platform permits us to simul- taneously analyze various types of medication risk for an individual participant. While the MRM Matrix incorporates some pertinent population-based or evidence-based pharma- cotherapy criteria, we designed it as a Personal- ized MRM Matrix. This MRM Matrix makes available to pharma- cists and other clinicians a real-time, multifacto- rial snapshot of common medication risk components that underlie pharmacotherapy- induced hazard such as: fall risk, sedation risk, cognitive risk, heart arrhythmia risk, time-of- day dosing risk, drug-gene risk, renal clearance risk, and more. (continued on page 3) Medication Risk Mitigation Matrix ® A Personal Mission Dr. Calvin H. Knowlton, Founder, CareKinesis See more from our NPA event in Washington, D.C. on page 12.

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Page 1: 2016Newsletter april post-NPA mailing - CareKinesis · cotherapy criteria, we designed it as a Personal-ized MRM Matrix. This MRM Matrix makes available to pharma-cists and other

April 2016

www.CareKinesis.com 888-9-PharmD

In this Issue: page

CAP News 2

EireneRx Review 2

Hep C & PGx 3

Our Locations 6

CE Credits 6

Calendar 7

QT Interval 7

Beers Criteria Update 8

In the Community 10

Our Leadership Team 11

Our NPA event 12

Copyright © 2016 by CareKinesis, Inc. All rights reserved

Who are we?

CareKinesis is a comprehensive

pharmacy solution for PACE providers.

The CareKinesis model

improves medication-related

outcomes and PACE clinic operational

efficiency.

Personalizing medication management • Advancing pharmacy knowledge • Promoting participant safety

When we (CareKinesis) started working in PACE in 2011, our goal was to help chronically ill persons optimize the use of medication. I had some significant personal experience with my late father who was multiple co-morbid and suffered from an array of Adverse Drug Events (ADEs), which, retrospectively were preventa-ble. We set out to develop software that would support physicians, nurses and pharmacists helping patients with their medication regimens. The main issue (for the past 30+ years) is that the software that has been used in Electronic Health Records, and in every pharmacy in the US, is only capable of detecting one-drug-to-one-drug interactions. In other words, if a patient is taking ten chronic medications, the provider would need to perform dozens of dif-ferent one-drug-to-one-drug analyses, which no one is capable of doing in short order. Further, in addition to drug interactions, serious and frequent ADEs are also caused by accumulative

side effects of similar medications (e.g., the patient is taking 3 or 4 medications that cause sedation). As background, ADEs remain a leading cause of mortality in our nation, responsible for more than 100,000 deaths/year, as well as millions of ED visits, falls and countless morbidities. Without an instantaneous automated process to analyze all the medication interactions and accumulative side effects simultaneously, clini-cians prescribe and dispense medications with the hope that nothing bad happens to the patient. And, as we age, many specialists are often in-volved, adding to the medication regimen bur-den. Thus, the incidence of unintended ADEs presents a chilling public health problem. In 2013, we launched our comprehensive Medi-cation Risk Mitigation Matrix® functionality inside of EireneRx®, for use initially by our clinical pharmacists in their daily PACE

medication management functions. Then, in 2015, we offered the Matrix to members of our Clinical Advisory Panel (mostly PACE medical directors) and to other clinicians who provided input throughout development. This MRM Matrix platform permits us to simul-taneously analyze various types of medication risk for an individual participant. While the MRM Matrix incorporates some pertinent population-based or evidence-based pharma-cotherapy criteria, we designed it as a Personal-ized MRM Matrix. This MRM Matrix makes available to pharma-cists and other clinicians a real-time, multifacto-rial snapshot of common medication risk components that underlie pharmacotherapy-induced hazard such as: fall risk, sedation risk, cognitive risk, heart arrhythmia risk, time-of-day dosing risk, drug-gene risk, renal clearance risk, and more. (continued on page 3)

Medication Risk Mitigation Matrix®

A Personal Mission

Dr. Calvin H. Knowlton, Founder, CareKinesis

See more from our NPA event in Washington, D.C. on page 12.

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Clinical Advisory

Panel

Looking for Comprehensive

Pharmacy Services?

• Prescriber Support with

PACE-experienced clinicians

• Medication Risk Mitigation and e-prescribing platform customized for PACE

• Multiple adherence packaging options

• Technology solutions for on-site medication access

• Part D plan management resources

• Documented improved outcomes, including quality and costs, when partnering with CareKinesis.

Call us today!

The PACE world is constantly growing and changing, as is the healthcare indus-try. CareKinesis stays ahead of the curve by continually innovating and reiterating

our PACE technology solutions.

Years ago, we learned of the problems of transparency and accuracy of medication profiles for PACE organizations. We knew that too often PACE staff were man-aging disparate participant medication lists and were unaware of updates and changes to these lists. EireneRx® helped to solve both of those problems for PACE organi-zations through CareKinesis partnerships.

EireneRx rapidly grew into a leading-edge software platform offering real-time com-munication with our PACE clinicians; PACE-specific ter-minology and functionality; elec-tronic Medication Administration Records; lab tracking and trend-ing; robust reporting; sophisticat-ed medication risk mitigation/precision prescribing systems; point of care medication decision

support and more.

In the past 12 months alone, EireneRx has achieved Meaningful Use II Certification and earned DEA certification and approval for e-Prescribing of

Controlled Substances (EPCS).

And, as of March 2016, CareKinesis achieved certification that allows EireneRx to transmit prescriptions, includ-ing those for controlled substances, to other pharmacies electronically, with the same validity as a hard copy. EireneRx prescribers now can utilize our medication risk mitigation tools and expert clinical services, then have the prescriptions trans-mitted (by us) to a third party pharmacy electronically. Our electronic transmission

workflow maintains our superior medica-tion support, ensuring that our pharmacists provide clinical insights and oversight be-fore prescription fulfillment, and deliver

the expert services our clients trust.

This new transmit function also extends to prescriptions sent via our EPCS offering: now, controlled substances can be legally signed and transmitted to other pharma-cies using EireneRx. We’ve eliminated the need for duplicate prescriptions (electronic + hard copy) when medications are

obtained from third party pharmacies.

Furthermore, EireneRx meets all ePre-scribing requirements that became effec-tive this year for New York State, along

with other states.

As PACE continues to evolve, we will continue to innovate to provide PACE clients with the superior technology and services they associate with CareKinesis. As always, clients who have feedback or suggestions for improvement, please share

with your client liaison!

Continued Advancements to PACE Pharmacy Technology

The CAP met last Septem-ber in Florida, where 20+ geriatric experts engaged in productive discussions about measuring and improving medication safety in PACE. In September, we look for-ward to expounding on those discussions, and, spe-cifically, further exploring Hepatit is C treatment considerations and drug-related QT prolongation.

Page 2 www.CareKinesis.com

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More than 3 million people in the United States are chronically infect-ed with the hepatitis C virus (HCV).1-3 An estimated 50% to 75% of these people have not re-ceived a diagnosis and are untreat-ed.1,4,5 Left untreated, many will progress to decompensated cirrho-sis, hepatocellular carcinoma, and other liver complications.1,4,5 Early diagnosis and treatment of hepatitis C are essential to reduce morbidity and mortality and to improve long-term health outcomes in this popu-lation.1 The goal of hepatitis C treatment is to achieve sustained virologic response (SVR), which is tantamount to virologic cure.3 There is a recognized need for sim-ple, safe drug regimens with short duration of treatment that can provide high SVR rates in a broad range of patients.1,8 Yet, the rapid evolution of highly-effective antivi-ral therapies for HCV infection, coupled with their enormous costs, has driven a need for personalized drug regimens, according to patient-specific factors. The choice and duration of hepatitis C treatment is usually based on pa-tient-specific factors, including hep-atitis C genotype, HCV RNA

levels, co-morbidities, previous treatment for hepatitis C, concomi-tant use of other drugs, drug adher-ence, patient preferences, and which drugs the payer prefers and/or the patient can afford. In theory, consideration of genetic makeup in addition to other patient-specific factors may help to accu-rately identify which patients might respond to a shorter duration of treatment (without compromise of effectiveness). In fact, both histori-cal and recent hepatitis C treatment data suggest that patients’ genetic make-up plays a role in personaliz-ing patients’ drug regimens, includ-ing duration of treatment. Decreas-ing the duration of treatment with HCV drugs could yield substantial healthcare cost savings.9

Hepatitis C Treatment The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, in collaboration with the International Antiviral Society, have developed a web-based, dy-namic process for the rapid formu-lation and dissemination of evidence-based, expert-developed recom-

(Continued next page)

THE HEFTY PRICE OF HEP C TREATMENT...

Can PGx Provide any Relief?

Treatment for HCV genotype 1 Es�mated Cost13

daclatasvir 60mg (Daklinza®) + sofosbuvir 400mg (Sovaldi®) daily

$150,000-$175,000

ledipasvir 90mg/sofosbuvir 400mg (Harvoni®) daily $95,000-$110,000

ombitasvir 25mg/paritaprevir 150mg/ritonavir 100mg daily with dasabuvir 250mg (Viekira Pak®) twice daily + weight-based ribavirin

$85,000-$100,000

simeprevir 150mg (Olysio®) + sofosbuvir 400mg (Sovaldi®) daily

$150,000-$180,000

Duration of treatment is 12 weeks for all treatments and estimated cost is per 12-week course.

www.CareKinesis.com 888-9-PharmD

Medication Risk Mitigation Matrix

® A Personal Mission! (continued from cover) Today, the MRM Matrix is fully embed-ded in EireneRx for PACE clinicians and our pharmacists to apply. EireneRx houses our ePrescribing module and in-tegrates with various Electronic Health Records. We are also in discussions with insurance companies and financially at-risk health systems where there is con-cern about the effects of medication misadventures resulting in costly down-stream sequalae (e.g., falls, preventable ED visits, hospitalizations). Additional-ly, the MRM Matrix has been launched in the NiaRx web-based software plat-form used in ten schools of pharmacy. Early returns resulting from MRM Matrix use in PACE are encouraging. We have had almost a dozen PACE organizations report to us their quarterly stats regarding falls, ED visits and hospitalizations over the past few years. Our clients have seen: decreases in the number of new prescriptions per year, decreases in the number of chronic med-ications per participant, decreases in ED visits, and decreases in percentage of hospitalizations by 20-60% over time. We continue to apply the sciences of pharmacogenomics, pharmacokinetics and pharmacodynamics to further per-sonalize the MRM Matrix. To those PACE clinicians who have actively helped us develop the Medication Risk Mitigation Matrix, as members of our Clinical Advisory Panel, and to those prescribers who have collaborated with us to apply the MRM Matrix, we offer

our sincere appreciation.

The early returns demonstrate a strong diminution in ADEs and preventable morbidities, which contributes to a more normative Quality of Life for the PACE participants and ROI for our PACE organizations. Read more about our technol-ogy innovations on page 2.

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(continued from previous page)

mendations for hepatitis C management.3 The guidelines provide clinicians with timely recommendations as new drugs for treating hepatitis C emerge and are inte-grated into drug regimens. (The guide-lines are available at hcvguidelines.org.) Prior to 2011, standard treatment for HCV genotype 1 consisted of combination pegylated interferon alpha (PEG-IFN-α) and ribavirin (RBV) for 48 weeks.12 This drug regimen achieved SVR rates of only »40%, was poorly tolerated by many patients, required injection and frequent dosing, was associated with significant drug-drug and drug-disease interactions, and required a long duration of treat-ment.12 In 2011, two first-generation HCV protease inhibitors, boceprevir and telaprevir, were approved to treat HCV genotype 1 infection as part of a combina-tion drug regimen with PEG-IFN-α and RBV.12 The combination drug regimen was preferred over PEG-IFN-α and RBV treatment alone and it led to improved SVR rates (65-75%) for patients with HCV genotype 1 infection naïve to HCV treatment. However, the combination reg-

imen was associated with many side effects, lasted 24-48 weeks, and was much more expensive than standard treat-ment at that time.12 Newer options represent remarkable ad-vancements for treating hepatitis C. These treatments are far less complex, require shorter duration of treatment, are asso-ciated with fewer significant side effects, and achieve much higher SVR rates (80-99%).12 The newer, IFN-α-free treatments for HCV promise tremendous benefits and have already replaced IFN-α-based treat-ments as standard of care. However, their high costs are a barrier for some patients.9,14 According to evidence-based recom-mendations,3 most patients with hepatitis C genotype 1 should be treated with one or two of the new oral drugs listed in the table. On average, the cost of the newer treatments is $100,000 per 12-week course. Shortening treatment duration could reduce the cost, improve patients’ access, and reduce the risk of side effects.9 Hepatitis C Pharmacogenomics

Pharmacogenomics (PGx) holds the promise to predict HCV treatment response. PGx may translate into personalized regimens and, ultimately, shorter duration of treatment for subgroups of patients. Duration of hepatitis C therapy is important for clinicians and patients to consider before initiat-ing therapy because of the side effect burden and costs. A growing body of evidence indicates that patients with favorable genotypes are more likely to respond to short-er HCV treatment courses,12 which may translate into lower risks of side effects and reduced costs.

IFN-α-based Regimens Interferon lambda 3 (IFNL3), also

known as IL28B, conducts signals and modulates antiviral activity against the HCV.12 Evidence suggests that IFNL3 genetic variation (e.g., rs12979860 C > T) is the strongest established pretreatment predictor of HCV treatment response for treatment-naïve patients with HCV geno-type 1; albeit, this depends on treatment selection.12,15-17 The evidence was first established prior to 2011, when the standard treatment for HCV genotype 1 consisted of com-bination PEG-IFN-α and RBV. Specifi-cally, four genome-wide association studies found an independent association between IFNL3 genetic variation and treatment-induced clearance of HCV following PEG-IFN-α and RBV treat-ment.18-21 These findings were later validated in candidate gene studies.22-24

These studies showed that favorable response IFNL3 genotype is associated with an approximate two-fold increase in SVR for HCV genotype 1 patients treated with combination PEG-IFN-α and RBV treatment; specifically, about a 70% and 30% chance for SVR after 48 weeks of treatment in those with favorable response IFNL3 genotype and unfavorable response IFNL3 genotype, respectively.12 While the original discovery of IFNL3 genotype came from studies of treatment-naïve patients with HCV genotype 1 treat-ed with combination PEG-IFN-α and RBV, subsequent studies have evaluated IFNL3 genotype in IFN-α-based, protease inhibitor combination drug regimens.12 Overall, all treatment-naïve patients with genotype 1 infection who are treated with protease inhibitor combination regimens, independent of IFNL3 genotype, have im-proved SVR rates (about 70%) compared with patients treated with traditional PEG-IFN-α and RBV only (about 40%).12 However, evidence shows that patients with the favorable IFNL3 genotype have even higher SVR rates (>80%) with the protease inhibitor combination in treatment-naïve patients.12

(Continued f rom page 3)

Continued on page 5)

Page 4

Hefty Price HCV / PGx (continued)

Page 4 www.CareKinesis.com

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www.CareKinesis.com 888-9-PharmD

IFN-α-free Regimens More recently conducted analyses provide additional evidence that the association be-tween IFNL3 genotype and SVR rates is not restricted to response to treatment with IFN-α-based regimens.9 Associations between IFNL3 genetic variants and response to sofosbuvir-based regimens are emerging9,26 and are consistent with results from studies of other IFN-α-free, direct acting antiviral drug regimens.27 In the ION-3 trial, which explored the feasibility of shortening the treatment duration of HCV treatment with the com-bination ledipasvir/sofosbuvir (LDV/SOF), the SVR rate was lower in patients with the unfavorable response IFNL3 genotype than in patients with the favorable response IFNL3 genotype.1 Specifically, the SVR rate with the 8-week LDV/SOF regimen was 93.1% compared with 96.4% in patients with the IFNL3 non-CC geno-type and CC genotype, respectively. Comparatively, the SVR rates with the 12-week LDV/SOF regimen were 95.0% and 96.4%.1 In a subgroup analysis of published ION-3 trial data, researchers found that SVR rates varied significantly by IFNL3 genotype, exceeding 98% in patients with the favora-ble response IFNL3 genotype.9 The very high and similar SVR rates in subgroups of patients with the favorable IFNL3 geno-type suggest that this genetic factor might be considered in selecting patients to receive 8 weeks – as opposed to 12 weeks – of treatment with LDV/SOF.9

Duration of Treatment Implications Identifying factors that allow for shorter duration of HCV treatment in selected patients is imperative. A substantial body of evidence suggests that patients with favorable IFNL3 genotypes are more like-ly to respond to shorter treatment dura-tions.12 As an example, patients receiving boceprevir, as part of their drug regimen, may be eligible for 24- or 28-week regi-mens instead of the standard 48-week regi-men if HCV RNA is undetectable by week 8.12,28 In the boceprevir phase III clinical trial for treatment-naïve patients, patients with the favorable IFNL3 genotype were more likely to have undetectable HCV RNA at week 8 (89%) than patients with either the CT (53%) or TT (42%) geno-types.25 Additionally, in the ION-3 trial, patients with the favorable IFNL3 geno-type achieved exceptionally high SVR rates with both 8- and 12-weeks of treat-ment with the combination LDV/SOF regimen.1,9 Conclusions Newer HCV treatments can only change lives if they are accessible to patients who need them. The evidence that SVR rates vary by IFNL3 genotypes suggests that this factor might help determine the opti-mal

duration of treatment for individual patients. Given the side-effect burden of HCV treatments, especially traditional IFN-α-based regimens, and the cost burden of newer HCV treatments, such as LDV/SOF, the possibility of shorter treatment duration may influence treatment choice for some patients. Additionally, decreasing the duration of treatment for hepatitis C could yield sub-stantial healthcare savings in the US. With >3 million people chronically infected with HCV, assuming that the cost of treat-ment with LDV/SOF will be >$1,000/day, for every 100,000 patients who could be treated for 4 fewer weeks (e.g., 8 weeks rather than 12 weeks), costs savings of >$2 billion dollars might be achieved.9

Visit www.CareKinesis.com/white-papers

for the full version of this article, with

references. CareKinesis Clients: For access to our recently published HCV Therapy Protocol, contact your Client Liaison today!

Favorable Response IFNL3 genotype: (rs12979860 CC)

Unfavorable Response

IFNL3 genotype: (rs12979860 CT or TT)

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Page 6 www.CareKinesis.com

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The QT interval of the surface electrocardiogram reflects the cycle of cardiac ventricular de- and repolarization (ventricular systole). As heart rate increases, the QT inter-val shortens; as the heart rate slows, the QT interval lengthens. Cardiac ventricular rhythm disorders can be either congenital or acquired. The Long QT syndrome is a heart rhythm disorder that can cause fast, chaotic heart-beats (polymorphic ventricular tachycardia, known as torsade de pointes) and can lead to fainting and even sudden death. Use of QT-prolonging drugs is the most frequent cause of acquired long QT syndrome. Patients at highest risk are those using certain cardiac and non-cardiac drugs, with the effect most likely caused by drug-drug and drug-gene interactions. Some medications in the following drug clas-ses have the potential to lengthen this interval: antiarrhythmic, anti-infectives, antipsychotics, gastro-intestinal drugs, opiates, and antifungals. CareKinesis is expanding our clinical decision-support tools to include information and alerts on QT-interval prolonging drugs for high-risk participants. For more information visit http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110870/ http://www.ncbi.nlm.nih.gov/pubmed/16107909 or http://www.ncbi.nlm.nih.gov/pubmed/26660066

QT INTERVAL PROLONGATION:

Relevant for PACE?

www.CareKinesis.com 888-9-PharmD Page 7

Sightings

In the upcoming months, CareKinesis is attending the NPA Spring Policy Forum in Washington, D.C.; the NC PACE

Association Conference in Durham, N.C.; the Leading Age & PACE Association of Michigan Annual Conference and the

NPA Summer Conference in Charlotte, N.C.

We would love to see you—please stop by our booths and our hosted events!

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The American Geriatrics Society (AGS) has released its second version of the Beers Criteria for Potentially

Inappropriate Medication Use in Older

Adults.1 The specific aim of this version was to update and expand the 2012 AGS Beers Criteria using a comprehensive, systematic literature review and grading the quality of the evidence on the use of potentially inappropriate medications (PIMs) in older adults. Like the 2012 AGS Beers Criteria, the updated criteria is an explicit list of PIMs best avoided, used with extra caution, or used at reduced dosage in older adults in general and in those with certain diseases or syndromes. In addition to updating existing criteria, by incorporating new evidence on cur-rent PIMs and adding new evidence for medications or conditions not addressed in the 2012 version, the 2015 AGS Beers Criteria have been expanded with two new areas of evidence on drug-drug interactions and drug-dosage adjust-ments based on kidney function. Fur-ther, in an accompanying publication to the 2015 Beers Criteria, AGS provides the first-ever list of alternatives to the Beers Criteria PIMs.2 The Beers Criteria are an essential, evidence-based tool for a comprehensive approach to medication decision-making for older adults. Healthcare profession-als who care for older adults should know the purpose of the Beers Criteria, understand how to use (and not use) the criteria in clinical practice, familiarize themselves with the changes imple-mented with the 2015 AGS update, and recognize how the criteria are used: it is both a clinical tool and a public health tool. History of the Beers Criteria In 1991, gerontologist Dr. Mark H. Beers and colleagues developed a con-sensus list of PIMs to be avoided in older adults.3 These criteria were origi-nally intended to be applied for older

adults receiving care in long-term care settings, particularly nursing homes.3 Since then, the Beers Criteria have been adopted by the Centers for Medicare & Medicaid Services (CMS) for nursing home regulation; updated in 1997, 2003, and 20124-6; deemed appropriate for all older adults, including those receiving care in outpatient settings, but excluding those receiving palliative or hospice care; widely utilized in research for studying prescribing patterns and out-comes in older adult populations;7-11 and incorporated into national quality measures.2,12,13

The Beers Criteria aim to:

improve medication selection; reduce adverse drug events (ADEs); educate healthcare professionals and older adults; and serve as a tool for evaluating quality of care, cost, and patterns of medication use of older adults.1 They are not intended to be applied in a punitive manner nor are they designed to supplant good clinical judgment or be applied in inflexible, dogmatic ways.14

How to Use

(and Not Use)

Beers Criteria An AGS workgroup developed seven key principles to guide use and application of the 2015 AGS Beers Criteria.14 These prin-ciples are explained in detail in the workgroup’s publica-tion,14 which includes suggestions for how older adults, healthcare profes-sionals, and health systems and payers can apply the key principles to improve pharmaceutical care of older adults.

Highlighted Updates of the

2015 AGS Beers Criteria Since the 2012 AGS Beers Criteria, medications have been modified, removed, and added. Several changes are highlighted in the table to the right.

The 2015 AGS Beers Criteria have been expanded to include the following major new areas: 1) select drug-drug interac-tions proven to be associated with harm-ful outcomes in older adults and 2) select drugs that should be avoided or for which the dosage should be adjusted based on a specific degree of kidney function to avoid harm in older adults. Neither of these new additions is intend-ed to be comprehensive, nor do they include anti-infectives; rather, the AGS expert panel focused on including medi-cations for which there is evidence that older adults are at risk of serious harm if a drug-drug interaction is overlooked or if the dosage is not adjusted to account for kidney function.1 (continued next page)

(Continued on page 9)

Seven Key Principles to Guide Intended Use

of the 2015 AGS Beers Criteria14

Principle 1 Medications in the criteria are “potentially inappropriate” and merit special scrutiny, but are not definitely inappro-priate in all older adults.

Principle 2 The caveats included in the rationale and recommenda-tions statements for each criterion are essential and, therefore, should be read.

Principle 3 Understand why medications are included in the criteria and use the information provided in the rationale state-ment to guide decision-making.

Principle 4 Optimal application of the criteria involves not only iden-tifying PIMs but also offering safer alternatives, where appropriate.

Principle 5 The criteria should be used as a “starting point” for a comprehensive process of reviewing an individual older adult’s entire medication regimen.

Principle 6 Access to medications included in the criteria should not be excessively restricted by prior authorization and/or other coverage policies.

Principle 7 Appreciate that the criteria were developed chiefly based on medications available in the U.S. and are not equally applicable to other countries.

Page 8

Highlights

of the 2015 update of the

AGS BEERS Criteria

www.CareKinesis.com

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Drug-drug interactions in this new area include using two or more CNS-active medications concomitantly (e.g., anti-psychotics and opioids), which signifi-cantly increases the risk of falls; and using two or more medications with anticholinergic properties, which sig-nificantly increases risk of cognitive, functional, and physical decline.1

Medications that should be avoided, or for which the dosage should be adjusted based on a specific degree of kidney function, include using dabigatran in older adults with creatinine clearance less than 30mL/min, which significantly increases the risk of bleeding; and using a histamine H2-receptor antagonist (e.g., famotidine or ranitidine) in older adults with creatinine clearance less than 50mL/min, which significantly increas-

es the risk for mental status changes.1

How the Beers Criteria are

Used: Focus on Quality The Beers Criteria continue to be useful and necessary as both a clinical tool and public health tool to improve medica-tion selection and safety in older adults and can be used for quality and perfor-mance measurement across populations of older adults and large groups of providers.14 Indeed, since their introduc-tion, widespread efforts to use the Beers Criteria in quality assurance and perfor-mance improvement initiatives have had meaningful impacts on the quality of care of older adults.8,9,14,15 The Beers Criteria have been used to develop the quality measure Use of High-Risk Med-ications in the Elderly(HRM),2,12 which CMS uses in Part D Star Ratings to monitor and evaluate the quality of care provided to Medicare beneficiaries.2,13

Summary Healthcare professionals often use con-sensus criteria to decide medication appropriateness in certain populations, particularly when precise clinical infor-mation is lacking. In the US, the most widely used consensus criteria for deciding medication appropriateness in older adults are the Beers Criteria. These continually evolving criteria are to be used by healthcare professionals as one component of a comprehensive medication use process, but they are not meant to override clinical judgment. Appropriate use of the Beers Criteria should lead to improved quality of care for older adults. The Beer’s Criteria is a risk component of the EireneRx Medication Risk Miti-gation participant safety system. For more information, email [email protected] or contact your client liaison. Visit www.CareKinesis.com/white-papers

for the full version of this article, with

references.

(Continued from page 8)

www.CareKinesis.com 888-9-PharmD

Selected Changes to the 2015 AGS Beers Criteria1

PIMs Independent of Diagnoses or Condi�ons

Nitrofurantoin

The recommendation to avoid this medication in older adults with a CrCl <60mL/min has been modified because evidence indicates that it can be used with relative safety and efficacy in individuals with a CrCl >30mL/min.

The use of nitrofurantoin for long-term suppression of infection should still be avoided.

Non- benzodiazepine hypnotics

The recommendation to avoid the nonbenzodiazepine hypnotics (eszopiclone, zaleplon, and zolpidem) has been modified to avoid usage entirely without consideration of duration of use because evi-dence suggests that risks outweigh benefits.

The 90-day duration of use caveat has been removed.

Antiarrhythmics

The recommendation to avoid antiarrhythmics (Classes Ia, Ic, III) as first-line treatment for atrial fibrillation has been removed because new evidence suggests that rhythm control can be as effective as or better than rate control.

Nevertheless, certain antiarrhythmics (e.g., amiodarone) remain in the criteria.

Proton pump inhibitors

The recommendation to avoid proton pump inhibitor use beyond 8 weeks duration without a strong indication has been added because evidence supports an association between long-term proton pump inhibitor exposure and Clostridium difficile infection, bone loss, and fractures.

PIMs or Syndrome Interac�ons

Nonbenzodiaze-pine hypnotics

The nonbenzodiazepine hypnotics (eszopiclone, zaleplon, and zolpidem) have been added to the list of medications to avoid in older adults with cognitive impairment or dementia because of evi-dence of their adverse CNS effects.

Opioids Opioids have been added to the list of CNS medications that should be avoided in older adults with a history of falls or fractures because of evidence of their adverse CNS effects.

Antipsychotics

Antipsychotics have been added to the list of medications that should be avoided as first-line treatment of delirium because of con-flicting evidence on their effectiveness and the potential for adverse effects, including worsening delirium and mortality in older adults with underlying dementia.

This list is not meant to be comprehensive. CNS = central nervous system, CrCl = creatinine clearance, PIMs = potentially inappropriate medications.

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www.CareKinesis.com 888-9-PharmD

CareKinesis Gives! Last month, CareKinesis hosted our third annual blood

drive. Our team continues to overachieve, as this year we

exceeded our goal with 29 units of blood donated

to the American Red Cross.

Page 10

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Our Leadership Team

Recognized for Excellence

Copyright © 2016 by CareKinesis, Inc. All rights reserved Page 11

South Jersey Biz Magazine has announced their 2016 Women to Watch. Orsula Voltis

Knowlton, PharmD, MBA,

President of CareKinesis, was recognized as a female profes-sional who is leading the way in South Jersey’s business com-munity. The publication honors women who are making a sig-nificant impact on the area’s economy, and highlights their experiences and their insights for other women entering and conquering their fields. Dr. Knowlton was quoted as say-ing, “it is a misconception that having a family is a limitation to the amount of responsibility that can be undertaken by women.”

CareKinesis Chief Scientific Officer, Jacques Turgeon,

BPharm, PhD, FCAHS, was “enthroned” as a member of the Academy of Medicine, France in December, 2015. He was one of the only pharmacists to be inducted into the Academy. Dr. Turgeon served as CEO and Di-rector of Research of the Centre hospitalier de l’Université de Montréal, a leading university hospital in Quebec.

Philadelphia SmartCEO has announced its 2016 Executive Management Award winners. Joseph J. Filippoli, MBA, Chief Technology Officer for CareKinesis was honored with the 2016 Executive Manage-ment Award at a gala ceremony on March 8, 2016 at the Ball-room of the Ben in Philadelph-ia, PA. The award recognizes

“the leadership and accom-plishments of the Philadelphia

Region’s all-stars. These indi-viduals uphold the highest

ethics, lead collaboratively and

creatively, and enhance and

support the organization’s

mission.”

Clinical Recognition

CareKinesis is pleased to announce that the following team members

recently earned their Certification in Geriatric Pharmacy:

Jenny Dinh

PharmD, CGP (CA)

Ourania (Rainey) Landry RPh, CGP (NJ)

Daniel Hsu PharmD, CGP (NJ)

Dr. Orsula V. Knowlton Dr. Jacques Turgeon Joseph J. Filippoli

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Phone: 888-9-PharmD Phone: 888-974-2763 Fax: 856-234-7957

110 Marter Ave. Suite 309 Moorestown, NJ 08057

Greetings from Washington, D.C. Scenes from our exhibiting booth and Nightcaps & Networking event

on Monday, April 4th at the NPA Spring Policy Forum.