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INSIDE March 2016 VOL. 4 • NO. 3

20 Questions

InsidePatientCare.com

Technology Te

Answered with Matthew Osterhaus

24 Screening for

Diabetes in Asymptomatic Adults

25 Long-Term

Immunity in Influenza

27 Updated

Typhoid Vaccine Recommendations

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Telemedicine, Text Messaging, and Drones: 8 Emerging Healthcare Trends PAGE 15

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INSIDE

The Pharmacy

17 WHAT QUALITIES OF A PHARMACY STAFF ARE PREDOMINANT IN HIGHPERFORMING PHARMACIES?

INSIDE

Technology

COLUMNS PAGE

11

THE FIRST WORD

Donald J. Dietz, RPh, MS

Health & Wellness

CMS Introduces Professional Dispensing Fees for Pharmacies

19 FIVE TIPS TO PREVENT SUDDEN INFANT DEATH SYNDROME

Business Perspective

8 EDITORIAL BOARD 9 LETTER FROM THE EDITOR 13 THE VITALS

20 QUESTIONS ANSWERED WITH MATTHEW C. OSTERHAUS, BSPHARM, FASCP, FAPHA

30 PRODUCTS & SERVICES

Diabetes

24 USPSTF UPDATES RECOMMENDATIONS FOR SCREENING FOR DIABETES IN ASYMPTOMATIC ADULTS

Influenza Readiness

25 TAKING A STEP TOWARD LONG-TERM IMMUNITY IN INFLUENZA

Infectious Disease

27 ACIP PUBLISHES UPDATED TYPHOID VACCINE RECOMMENDATIONS

Pediatric Health

28 KNOWING THE SIGNS, RISKS, AND PREVENTION METHODS FOR VARICELLA

STARTS ON PAGE

15

COVER STORY I INSIDE TECHNOLOGY

Telemedicine, Text Messaging, and Drones: 8 Emerging Healthcare Trends

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❚ Review developing trends that are changing healthcare for the better ❚ Understand the benefits of moving toward telemedicine ❚ Adopt evolving electronic communication tools ❚ Explore innovative methods for drug and supply delivery

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Online First

INTEGRATING COMMUNITY PHARMACIES INTO PRIMARY CARE DELIVERY Community-based pharmacies in the United States began incorporating convenience clinics— developed to provide affordable, accessible, and quality medical care to patients—into their business models in 2000.

This article provides a quantitative modeling of the potential demand for a range of primary care services delivered via pharmacy-based convenience clinics throughout the United States. The aim was to gain perspectives on consumer engagement with the primary care healthcare system, the role of the pharmacy profession in the provision of care services, and payers’ willingness to reimburse pharmacy-directed primary care services. This article is available online first. Visit our website to read the full article before its publication in print. uu

Poll Results

Media Library

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Top Headlines Trending Online

#1 Growing into the Specialty Market Phyllis Houston, MSOL http://goo.gl/KE8m7i

#2 Five Considerations When Selecting Your First Pharmacist Position Liza Senic, BS, PharmDc http://goo.gl/TQEdGk

#3 Pharmacy’s Role in the Fight Against Antibiotic Resistance Donald J. Dietz, RPh, MS http://goo.gl/syxB7T

#4 Clinical Pharmacy: Improving Communication with Patients James Beaumariage, RPh http://goo.gl/JMaZTY

#5 Patients Taking Misoprostol Misunderstood: How to Manage Patients with Miscarriages Paige Schultz, PharmDc, Jamie Fery, PharmDc, Stacie Lampkin, PharmD, BCACP, AE-C, and Nicole E Cieri, PharmD, BCPS http://goo.gl/TV4fs2

100% of the voters voted yes 0% of the voters voted no Last month, we asked our online readers whether they discuss methods for avoiding asthma attack triggers with their patients who have asthma. This question was based on the article published in the February issue titled “Triggers to Discuss with Patients with Uncontrolled Asthma.”

MEDICATION SYNCHRONIZATION: THE IMPACT OF THE “HANGOVER” EFFECT James Beaumariage, RPh, Editorial Board member of Inside Patient Care, talks about the long-term “hang over” effect and medication synchronization.

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the Editorial Board

The board members contribute expertise and analysis that help shape the content of Inside Patient Care

Editor-in-Chief Donald J. Dietz, RPh, MS Vice President Pharmacy Healthcare Solutions, Inc Pittsburgh, PA

Deputy Editor-in-Chief Harry Leider, MD, MBA, FACPE Chief Medical Officer and Group Vice President Walgreens Co. Deerfield, IL

Associate Editor-in-Chief Marc R. Watkins, MD, MSPH, FACOEM Vice President & Corporate Medical Director The Little Clinic Nashville, TN

James S. Beaumariage, RPh Principal Beaumariage Consulting, LLC Franklin, MA

Scott R. Drab, PharmD, CDE, BC-ADM Professor, Department of Pharmacy & Therapeutics, School of Pharmacy University of Pittsburgh, Pittsburgh, PA

Stacie Lampkin, PharmD, BCACP, AE-C

John O. Beckner, RPh Senior Director, Strategic Initiatives National Community Pharmacists Association Alexandria, VA

Marc Drummond, PsyD, MBA Clinical Psychologist, Managing Partner Creekside Natural Therapeutics

Kevin Letz, DNP, MBA Chairman/Founder Advanced Practice Provider Executives Palo Alto, CA

Mitch Betses, RPh Senior Vice President Retail Pharmacy Services CVS Caremark Corporation Woonsocket, RI Ami Bhatt Senior Director, Operations Health & Wellness, Wal-Mart Bentonville, AR Thomas R. Bizzaro, RPh Vice President, Health Policy and Industry Relations First Databank Indianapolis, IN

Barbara Campbell, RPh, CCN

Michael Feehan, PhD Visiting Professor Department of Pharmacotherapy University of Utah Salt Lake City, UT Albert Garcia Executive Vice President Navarro Health Services, Medley, FL Mark J. Gregory, RPh Vice President Healthcare Solutions Ateb, Inc , Raleigh, NC Erin J. Hoffman, MPAS, PA-C Assistant Professor Nebraska Medical Center, Omaha, NE

Pharmacist and Certified Clinical Nutritionist Peoples Rx Austin, TX

Kevin James, RPh, MBA Vice President of Payer Strategy US Bioservices, Frisco, TX

Lisa Cervantes, PA-C

Alexandra Jung Principal, Advisory Services Ernst & Young, LLP; former Senior Vice President Corporate Strategy, Walgreens

UW Health Clinics Digestive Health Center, Madison, WI Rebecca Wheeler Chater, RPh, MPH, FAPhA Executive Healthcare Strategist Ateb, Inc, Raleigh, NC

Kim Curry, PhD, ARNP-C

Clinical Associate Professor College of Nursing, University of Florida Gainesville, FL

Jack Kelly, RPh National Director Managed Markets & Trade Relations Arbor Pharmaceuticals, LLC Easton, PA Scott L. Kemme Vice President/General Manager, Chain Segment McKesson Pharmacy Systems & Automation Livonia, MI

Assistant Professor D’Youville College School of Pharmacy Women & Children’s Hospital, Buffalo, NY

Tripp Logan, PharmD Vice President Logan & Seiler, Inc, Charleston, MO Stephen C. Mullenix, RPh Senior Vice President Public Policy & Industry Relations NCPDP, Scottsdale, AZ Richard J. Ptachcinski, PharmD, FCCP President American Pharmacotherapy, Pittsburgh, PA Ernie Richardsen, RPh, MBA Group Vice President Pharmaceutical Purchasing and Managed Care Rite Aid Corporation, Camp Hill, PA

Debra Shelby, PhD, DNP

President National Academy of Dermatology Nurse Practitioners Tampa, FL Debbie Sheppard Vice President, Sales and Marketing Ateb, Inc, Raleigh, NC Elliott M. Sogol, PhD, RPh, FAPhA Vice President Professional Relations Pharmacy Quality Solutions, Inc Springfield, VA

Letter from the Editor Encouraging Transformations in the Healthcare Industry

by FREDERIQUE H. EVANS, MBS, Editorial Director, Inside Patient Care

The healthcare industry is undergoing a transformation as a result of changes in technology, economics, societal forces, and other factors. Although it may be challenging for healthcare professionals to adapt to certain changes, some of them are having a positive impact on the industry. }} }} CHALLENGES WITH adapting to the ongoing changes in healthcare delivery have been discussed before, but there are several emerging trends, such as the evolution of quality measures and the return of at-home care, that are changing healthcare for the better that must be highlighted. In this issue of Inside Patient Care, we touch on 8 trends that are having a positive impact on the healthcare industry (see “Telemedicine, Text Messaging, and Drones: 8 Emerging Healthcare Trends” on page 15).

We review vaccine recommendations and updates, including a more effective influenza vaccine approach that may be a productive step in formulating a vaccine that causes long-term immunity (see “Taking a Step Toward Long-Term Immunity in Influenza” on page 25). “When stimulated by a new exposure (infection or vaccination), memory cells can re-enter germinal centers and undergo new rounds of somatic hypermutation and selection. The net effect of this ongoing selection across the entire population exposed to the virus is a virus-im-

munity ‘arms race,’” explain Aaron G. Schmidt, Laboratory of Molecular Medicine, Children’s Hospital, Harvard Medical School, Boston, MA, and colleagues. The importance of the prevention of typhoid fever with vaccination is also reviewed, which highlights that vaccinated travelers must still be cautious in their selection of food and beverages (see “ACIP Publishes Updated Typhoid Vaccine Recommendations” on page 27). Further changes in the industry include the Centers for Medicare & Medicaid Services’ professional dispensing fees for pharmacies, which hope to serve as a basis for compensation for pharmacist-provided services (see “CMS Introduces Professional Dispensing Fees for Pharmacies” on page 11).

As part of this issue, we have included data on the US Preventive Services Task Force update to their 2008 recommendations for diabetes screening in asymptomatic adults (see “USPSTF Updates Recommendations for Screening for Diabetes in Asymptomatic Adults” on page 24).

“Clinical trials and additional modeling studies are needed to better elucidate the optimal frequency of screening and the age at which to start screening,” the researchers concluded.

In an interview with Inside Patient Care, Matthew C. Osterhaus, BSPharm, FASCP, FAPhA, Co-Owner/Opera­tor of Osterhaus Pharmacy in Maquoketa, IA, and Immediate Past President of the American Pharmacists Association, discusses how to incorporate patient-centered care into your practice. “Identifying a need that is not being met, or an area that the physician is having trouble getting their patients to—even if it’s just a logistical issue for the physician, such as not being able to see a patient as often as they need to—can be a good start,” he stated.

This issue’s Products and Services section also includes an update from the US Food and Drug Administration regarding its stance on blood donations from patients who may have been exposed to the Zika virus.

As always, we hope you will enjoy this issue of Inside Patient Care. ❚

The First Word CMS Introduces Professional Dispensing Fees for Pharmacies

by DONALD J. DIETZ, RPH, MS, Editor-in-Chief, Inside Patient Care

“

For pharmacies, the changeover to an

AAC-based methodology built on AMP will occur in the next year.”

T

he Centers for Medicare & Medicaid Services (CMS) recently issued a 658-page final rule, Medicaid Program; Covered Outpatient Drugs (CMS2345-FC; ie, the “final average manufacturer price [AMP] rule”), which takes effect on April 1, 2016.1 One section of the final rule involves using an AMP to calculate reimbursement Federal Upper Limits (FULs) when determining pharmacy reimbursement for generic drugs covered by state fee-for-service Medicaid programs. This final rule has been 10 years in the making, and started with the Deficit Reduction Act of 2005.

The National Association of Chain Drug Stores (NACDS) and National Community Pharmacists Association (NCPA) have fought to ensure that the change in reimbursement to an actual acquisition cost (AAC) methodology would be fair to community pharmacies.2 The final AAC methodology uses the AMP for generic drugs; AMPs represent the price at which a manufacturer sells their drug

5 factors to consider: ❚ The “final AMP rule” takes effect on April 1, 2016 ❚ “Professional dispensing fee” will replace the regulatory term “dispensing fee” ❚ Professional dispensing fee compensates for costs beyond that of outpatient drug ingredient cost ❚ Costs from operating covered outpatient drug benefits are not part of the professional dispensing fees ❚ Pharmacists should review how AAC reimbursement is implemented across the country

product to a community pharmacy or wholesaler.

For pharmacies, the changeover to an AAC-based methodology built on AMP will occur in the next year.

Although the new AMP rule is complex—relative to definitions of community pharmacy, which drugs are to be included or excluded, and other components—I wanted to make you aware of the change to a “professional dispensing fee” in the new AMP rule.

Addressing Dispensing Fee Disparities For third-party insurance prescriptions, pharmacies receive a payment for the negotiated ingredient cost of the drug, plus a dispensing fee. The basis for determination of the ingredient cost and dispensing fee are contractually defined terms in the pharmacy network contract between the pharmacy and the pharmacy benefit manager (PBM). For fee-for-service Medicaid, this reimbursement has usually been based upon FULs that reference list prices (ie, average wholesale price or wholesale acquisition cost) of a prescription product, and not the AAC. Today, dispensing fees for commercial insurance prescriptions are often less than $1 per prescrip-

The First Word tion, with fee-for-service Medicaid prescriptions costing a couple of additional dollars. This, however, in no way covers the cost of dispensing a prescription in a community pharmacy. Pharmacy has become accustomed to ingredient cost arbitrage, or, buying a drug at a lower cost than the reimbursed amount paid by the PBM in the pharmacy network contract to maintain profitability. Because of the nominal dispensing fees, pharmacy has depended on the ingredient cost margin to maintain profitability.

The mandated change to the AAC model will pay pharmacies an ingredient cost amount close to what the pharmacy pays for the product; this necessitates a dispensing fee greater than a couple of dollars, which was a key component of the NACDS and NCPA efforts on behalf of community pharmacies.

Professional Dispensing Fees In the “final AMP rule,” the CMS replaces the regulatory term “dispensing fee” with “professional dispensing fee,” reinforcing their “position that the dispensing fee should reflect the pharmacist’s professional services and costs to dispense the prescription to a Medicaid beneficiary.”1 The professional dispensing fee, which compensates for costs beyond the ingredient cost of a covered outpatient drug, is gained at the point of sale or service each time a covered outpatient drug is dispensed. The CMS also states that it only includes

AAC reimbursement is positive for the profession. pharmacy costs related to ensuring that appropriate covered outpatient drug possession is transferred to a Medicaid beneficiary. According to the CMS, reasonable expenses related to a pharmacist’s time that fall under the category of pharmacy costs include, but are not limited to: • Looking up information about a patient’s coverage on the computer • Carrying out drug use reviews and preferred drug list review activities • Measuring or mixing the covered outpatient drug • Filling the container • Beneficiary counseling • Physically giving the Medicaid beneficiary their completed prescription • Special packaging • Overhead associated with facility and equipment maintenance necessary to the pharmacy’s operation.

The CMS also adds that administrative costs the state incurs by operating covered outpatient drug benefits— including systems costs for interfacing with pharmacies—are not a part of the professional dispensing fee.

This detailed list of pharmacist activities included in the professional dispensing fee further demonstrates our value as healthcare practitioners.

In a few states where an acquisition cost–based system has been implemented for fee-for-service Medicaid, the dispensing fees have been in the $9 to $13 range per prescription. More importantly, the CMS will require states to submit State Plan Amendments (SPAs), including changes to both the AAC ingredient cost reimbursement methodology, and the professional dispensing fee.

The CMS will evaluate total pharmacy reimbursement when deciding whether to approve or deny the SPA.

Conclusion As pharmacists seek to expand their role as healthcare practitioners, AAC reimbursement is positive for the profession, because it focuses on the services pharmacists provide to their patients. Pharmacists should carefully review how this new reimbursement methodology is implemented, not only in their state, but across the country.

Hopefully the newly defined professional dispensing fee will serve as a basis and model for compensation for additional pharmacist-provided services. ❚ References

1. Centers for Medicare & Medicaid Services; Department of Health & Human Services. Medicaid Program; Covered Outpatient Drugs. https://s3.ama zonaws.com/public-inspection.federalregister. gov/2016-01274.pdf. Accessed February 22, 2016.

2. National Association of Chain Drug Stores.

NACDS, NCPA urge CMS for prompt guidance to states on Medicaid dispensing fees. www.nacds.org/ Home/114/2012-01-27/nacds,-ncpa-urge-cms-forprompt-guidance-to-states-on-medicaid-dispensingfees. Published January 27, 2012. Accessed February 22, 2016.

DO YOU HAVE A CLINICAL CHALLENGE TO SHARE? We are currently accepting clinical challenges, including a case and a commentary explaining best practice. We want to hear from pharmacists, nurse practitioners, physician assistants, and medical directors about how they have managed patients/customers.

Contact info@insidepatientcare.com with your clinical challenge

theVitals HIGH-CHOLESTEROL FOODS MAY NOT INCREASE RISK FOR CORONARY ARTERY DISEASE Although the effects of dietary cholesterol on blood cholesterol concentrations are largely modest, the influence is stronger in patients who have a ε4 allele in the apolipoprotein E gene (ApoE4).

Little is known about the association between cholesterol intake and the risk for coronary artery disease (CAD) in this patient population.

To further explore this association, Jyrki K. Virtanen, PhD, Adjunct Professor, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland, and colleagues investigated the relationship between intake of cholesterol and eggs—which are a main source for dietary cholesterol—and the risk for incident CAD in men. The study included 1032 men who were aged 42 to 60 years at the baseline examinations of the prospective, population-based Kuopio Ischaemic Heart Disease Risk Factor Study.

“The ApoE4 phenotype was found in 32.5% of the men.

During the average follow-up of 20.8 years, 230 CAD events occurred,” the study authors noted. “Egg or cholesterol intakes were not associated with the risk of CAD.” The study authors concluded that egg or cholesterol intakes were not associated with an increased risk for CAD, even in carriers of ApoE4.

Virtanen JK, Mursu J, Virtanen HEK, et al.

Associations of egg and cholesterol intakes with carotid intima-media thickness and risk of incident coronary artery disease according to apolipoprotein E phenotype in men: the Kuopio Ischaemic Heart Disease Risk Factor Study. Am J Clin Nutr. 2016 Feb 10. Epub ahead of print.

Examining the News Affecting Pharmacy & Clinics

NEW LIQUID BIOPSY DETECTS NSCLC BIOMARKERS Personalized medicine has changed cancer treatment with the introduction of molecular targeted therapies. Although biopsy-based genotyping is the current clinical practice, biopsy procedures can result in morbidity, according to a presentation by David T. W. Wong, DMD, DMSc, Professor, University of California, Los Angeles, and colleagues at the 2016 American Association for the Advancement of Science Annual Meeting.

“To overcome these issues, technologies are needed for rapid, cost-effective, and noninvasive identification of biomarkers at various time points during the course of disease,” explained Dr Wong and colleagues.

Liquid biopsy is an emerging method that can address the need for this type of technology. The use of cell-free circulating tumor DNA through liquid biopsies will facilitate an analysis of tumor genomics, which is urgently required for molecular targeted therapy. Most existing targeted approaches are based on a polymerase chain reaction and/or next-generation sequencing for liquid biopsy applications.

“We have developed a liquid biopsy technology, ‘electric field induced release and measurement (EFIRM) liquid biopsy (eLB),’ [which] provides the most accurate detection that can assist clinical treatment decisions for the most common subtype of lung cancer, non–small-cell lung cancer (NSCLC),” Dr Wong and colleagues stated.

The study authors explained that eLB can detect actionable epidermal growth factor (EGFR) gene mutations in patients with NSCLC, in 100% agreement with biopsy-based genotyping.

Minimally/noninvasive, eLB detects the most common EGFR gene mutations treatable with tyrosine kinase inhibitors to effectively extend the progression-free survival of patients with NSCLC. Wong D. Saliva liquid biopsy for cancer detection. Presented at: 2016 American Association for the Advancement of Science Annual Meeting; February 11-15, 2016; Washington, DC.

theVitals MARIJUANA USE ASSOCIATED WITH WORSE VERBAL MEMORY, HAS NO EFFECT ON OTHER COGNITIVE DOMAINS Marijuana use has increased in the United States, but its long-term effects on memory and other aspects of cognitive function are uncertain.

In their study, Reto Auer, MD, MAS, Postdoctoral Scholar, Department of Epidemiology and Biostatistics, University of California San Francisco, and colleagues examined the association between lifetime exposure to marijuana use and cognitive performance.

They used data from the Coronary Artery Risk Development in Young Adults study, which included a cohort of 5115 black and white men and women aged 18 to 30 years at baseline, and followed up with them for >25 years to assess associations between cumulative years of marijuana exposure and cognitive function.

At year 25, the 3 domains of cognitive function that were assessed were verbal memory, processing speed, and executive function.

“Current use of marijuana was associated with worse verbal memory and processing speed; cumulative lifetime exposure was associated with worse performance in all 3 domains of cognitive function,” Dr Auer and colleagues explained. “After excluding current users and adjusting for potential confounders, cumulative lifetime exposure to marijuana remained significantly associated with worse verbal memory.”

As a result, the study authors concluded that although previous exposure to marijuana is associated with worse verbal memory, marijuana use does not seem to affect processing speed or executive function.

Auer R, Vittinghoff E, Yaffe K, et al. Association between lifetime marijuana use and cognitive function in middle age: the coronary artery risk development in young adults (CARDIA) study. JAMA Intern Med. 2016 Feb 1. Epub ahead of print.

FDA REVEALS EXHAUSTIVE OPIOID POLICY CHANGES

According to a special US Food and Drug Administration (FDA) report published in The New England Journal of Medicine, physicians have witnessed devastating results of opioid abuse and misuse in people, including addicted patients who had been prescribed opioids for pain treatment, as well as those who have not received a prescription for the drugs.

“Many Americans are now addicted to prescription opioids, and the number of deaths due to prescription opioid overdose is unacceptable,” stated Robert M. Califf, MD, Commissioner of Food and Drugs, FDA, Silver Spring, MD, and colleagues. “We are launching this renewed effort in the context of a broad national campaign that includes a major initiative led by the Department of Health and Human Services…designed to attack the problem from every angle.”

The FDA plans to begin with broadly re-examining their approach, including thinking about how to best apply existing policies, which policies need to be updated, and whether new policies must be developed. This includes consulting with the National Academy of Medicine to create a framework for opioid reviews, approvals, and monitoring. In addition, the FDA Science Board will convene in March to advise the development of alternative pain medications and postmarketing surveillance activities.

The FDA has also promised to expand requirements for drug companies to generate postmarketing data on the long-term impact of extended-release/long-acting opioid use to provide better data on the risks for misuse and abuse. The agency is working with the industry and the National Institutes of Health to develop alternative medications without opioids’ addictive properties. The Department of Health & Human Services’ agencies and FDA program for mandated industry-funded studies are also developing a plan to conduct evidence-based research that will guide opioid use and consider new approaches to pain prevention and management.

“Regardless of whether we view these issues from the perspective of patients, physicians, or regulators, the status quo is clearly not acceptable,” Dr Califf and colleagues stated. “As the public health agency responsible for oversight of pharmaceutical safety and effectiveness, we recognize that this crisis demands solutions.”

Califf RM, Woodcock J, Ostroff S. A proactive response to prescription opioid abuse. N Engl J Med. 2016 Feb 4.

Epub ahead of print.

NEW DUE DATE CALCULATOR APPLICATION REPLACES PREGNANCY WHEEL The American College of Obstetricians and Gynecologists (ACOG) recently launched a new Estimated Due Date (EDD) Calculator for determining pregnancy due dates. This is the first mobile application based on joint recommendations from ACOG, the American Institute of Ultrasound in Medicine, and the Society for Maternal-Fetal Medicine. The EDD Calculator is the only obstetrics/gynecology-related application that reconciles the inaccuracy in due dates that occurs between the first ultrasound and the date of the patient’s last menstrual period.

The EDD Calculator can also recalculate due dates based on an ultrasound, or assisted reproductive technology, which helps healthcare providers with patients who undergo embryo transfers in adherence to the Committee Opinion. In addition, the application has functionality that allows the user to determine the gestational age of the fetus.

“The EDD Calculator has ACOG guidelines built into the logic, therefore it is the most accurate tool available for [obstetricians/gynecologists] and their staff,” explained Nathaniel DeNicola, MD, MSHP, FACOG, ACOG Digital & Social Media Expert Consultant, and Senior Fellow, Penn Social Media & Health Innovation Lab, Penn Medicine Center for Health Care Innovation, Philadelphia, PA, in a statement released

by ACOG. “This is the only app that is based on ACOG guidelines and was beta tested by [obstetrics/gynecology] experts.”

Although the EDD Calculator is geared toward obstetric providers, its simple format is easy to use for other members of the healthcare team, and even patients. According to a press release by ACOG, the organization will phase out the physical plastic wheel in favor of the EDD Calculator.

The new EDD Calculator is part of the primary ACOG application, which can be downloaded for free on Apple Inc and Android devices.

ACOG reinvents the pregnancy wheel [news release]. Washington, DC; The American College of Obstetricians and Gynecologists; January 22, 2016. www.acog.org/About-ACOG/News-Room/NewsReleases/2016/ACOG-Reinvents-the-Pregnancy-Wheel. Accessed March 1, 2016.

INSIDE

Technology

Cover Story

Telemedicine, Text Messaging, and Drones: 8 Emerging Healthcare Trends

by THOMAS R. BIZZARO, RPH

Healthcare delivery is changing drastically. }} }} DEMOGRAPHICS, TECHNOLOGY, economics, societal forces, and many other factors are prompting the industry’s transformation as we begin 2016 and beyond. Although change is always a bit jarring, sometimes it actually makes sense. Here are 8 emerging trends that are changing healthcare for the better:

1/ The Move Toward Telemedicine

Is there anyone out there who can honestly admit they are thrilled about traveling to a provider’s facility to receive care? In today’s world, time has value, and patients are much less willing to spend their time waiting for care. In some cases, it is critical to have face-toface interactions with your healthcare provider; however, in many cases, it is just an inconvenience. I am pretty sure that surgery and treating a broken bone won’t lend themselves to a virtual visit, but think about all the things that do: using Skype for virtual physician visits; reading of medical images taken in Indianapolis, IN, by a physician in Australia; and using a kiosk to get access to a nurse consultation have become commonplace—and much more is expected to take place as telemedicine continues to expand.

2/

The Adoption of Evolving Electronic Communication Tools I read recently that people aged <25 years prefer text messaging as a means of communication with their physicians. It seems that phone calls— and even e-mails—are too intrusive and time-consuming. In a world where e-mail is too slow, people are cutting the cord to cable television, and print newspapers are the last place young people get their news, healthcare organizations must stay on top of their patients’ constantly changing communication preferences.

3/ The Return of At-Home Care

Although patients are pushing healthcare providers to adopt the latest technologies, at the same time, they say that “what is old is new again.” Inhome healthcare services are growing because aging Americans want to stay in their own homes for as long as possible. Pharmacists are making home visits to the most at-risk patients to manage medication therapy. Physicians are making house calls to help improve care and decrease hospital readmissions. Nurses are performing all types of infusion therapy within patients’ homes.

Thomas Bizzaro

Inside Technology Update Getting drugs and supplies to needy patients is always a challenge, and one worthy of tackling with the most recent technologies.

COVER STORY

4/

The Rise of Nontraditional Care Providers Local drug stores are becoming convenient alternative care options. Many retail outlets are providing care services via pharmacists and nurse practitioners delivering on-demand immunizations, physicals, medication therapy management consults, blood pressure readings, blood glucose checks, as well as treatments for a variety of minor illnesses and injuries. Pharmacist education is changing to ensure that they have the skills required for their expanding roles within the pharmacy.

5/

Innovative Drug and Supply Delivery Methods Getting drugs and supplies to needy patients is always a challenge, and one worthy of tackling with the most recent technologies. As such, even drones are being tested as a means to deliver drugs to rural and remote patients. Drones were used to deliver small aid packages during Haiti’s earthquake in 2012. The Mayo Clinic is even suggesting blood products and antivenin for snake bites as candidates for delivery by drones.1

6/

The Evolution of Quality Measures Quality measures will move away from focusing on processes, toward zeroing in on outcomes. For example, instead of assessing the quality of diabetes care based on whether a physician checked the hemoglobin A1c levels of a patient with diabetes, quality will be evaluated through the actual changes in a patient’s blood glucose levels over time. In addition, patients themselves can start to chime in on quality by reporting on outcomes as they pertain to quality-of-life measures (eg, perceived energy levels, or the capacity to climb a flight of stairs).

Mr Bizzaro is Vice President, Health Policy and Industry Relations, First Databank, Indianapolis, IN.

7/ The Increased Focus on Costs

With high-deductible health plans becoming more common, consumers, too, will become more involved in the

decision-making aspect of their care— and they will be doing so with an eye on costs. As such, patients will partner with providers to choose and implement the most cost-effective treatment plans.

8/

The Use of Evidence at Point of Care The delivery of drug information via Internet services is paving the way for new methods for accessing clinical decision support. Healthcare is moving toward value-based reimbursement, with a focus on quality and improved outcomes. The traditional definition of point-of-care delivery of services is changing, and will continue to broaden.

As such, we have a significant opportunity to make healthcare more accessible, enhance quality, and improve outcomes. Choosing the best treatment plans often requires access to knowledge; using drug knowledge from FDB can help improve outcomes in any setting or location.

Conclusion Personally, I have some mixed feelings about the changes that are happening in healthcare. As a traditionalist, I love holding the newspaper in my hands as I have my first cup of coffee in the morning. I like seeing my physician in person and face-to-face. But, as I think about what’s ahead, I quickly come to the realization that many of these changes are, indeed, for the better. In this modern era, I can’t afford to take the time to get all the healthcare services I need in the traditional manner.

Time is money, and both take away from my family and leisure time. So, as far as I’m concerned, I am going to be much more careful about how I spend my time, and where and how I access my healthcare—how about you? ❚ Reference

1. Mayo Foundation for Medical Education and Research.

Medical drones poised to take off. www.mayoclinic.org/med ical-professionals/clinical-updates/trauma/medical-dronespoised-to-take-off. Accessed February 1, 2016.

INSIDE

Pharmacy What Qualities of a Pharmacy Staff Are Predominant in HighPerforming Pharmacies?

This month, we asked the experts on our editorial board to provide their thoughts about the qualities of a pharmacy staff in a high-performing pharmacy. }} }} HERE IS WHAT they had to share: The pharmacy staff of a highperforming pharmacy contributes to the success of the company, and knows that their personal success only comes from making the company more successful. They are not bound by the clock for when they start or stop work— rather, they are bound to getting the job done no matter how early they start or late they finish.

The staff members exceed their job descriptions; for them, their job description is just what they do before they help out with other things. They are individually responsible for looking for what to do next as soon as they finish their current task, and when things go wrong, they look at how to make them right instead of who is to blame.

These staff members fill voids and do the jobs that nobody wants because they need to get done. No necessary task is beneath them, and they have spirits

A:

that keep them from bringing down the company or their colleagues. They know that problems are solved not by complaining, but by mending; they communicate any concerns to management,

Pharmacy staff at high-performing pharmacies are committed to the concept of patient care. and seek help and improvement versus whispering through the grapevine.

In addition, pharmacy staff at highperforming pharmacies are committed to the concept of patient care; after all, what is best for the patient drives all activities. Being able to cultivate relationships within the medical community, “unsilo” their thinking, and have an entrepreneurial spirit are also predominant qualities, in addition to being passionate about lifelong learning, and

Inside Pharmacy

Q&A

having a “challenges are opportunities” mind-set.—John O. Beckner, RPh, Senior Director, Strategic Initiatives, National Community Pharmacists Association, Alexandria, VA.

“High-performing pharmacies typically have a pharmacy team that understands they are valuable members of the local healthcare team, engages patients, and continually works to improve patient care and outcomes.”

A:

Qualities of high-performing pharmacy staff include patient empathy (ie, when they put themselves in the shoes of their patients and don’t look at them as just another customer), having a great attitude—a smile goes a long way in making a patient’s day— and being open to critique and able to quickly correct mistakes. A team within a high-performing pharmacy works together and helps each other on tasks that need to get done. This includes people who ask to do more, learn more, and focus on standard operating procedures.—Ami Bhatt, Senior Director, Operations, Health & Wellness, WalMart, Bentonville, AR.

A:

Predominant qualities include being caring (ie, really caring about the patient—not just the prescription/transaction—making eye contact, engaging them in conversation, and displaying gratitude for providing them with a service); having integrity (honest and forthright, won’t hide behind a corporate line); being productive (proactive, timely in responding and making sure patients are not waiting); having a good sense of humor (putting the patient at ease—especially if that patient has a serious illness—and using lighthearted humor to make them

feel better); and being knowledgeable (well-informed, and able to educate patients about the latest information and facts regarding their therapy).— Alexandra Jung, Principal, Advisory Services, Ernst & Young, LLP; former Senior Vice President, Corporate Strategy, Walgreens.

A:

To me, the most important quality in an employee of a high-perf­ orming pharmacy is being of high character. These are staff members who have high integrity and a strong work ethic.

They work hard even when no one is watching. Working with a team consisting of people with high characters will, in turn, create a high-performing pharmacy. Another quality is having an owner-like mentality. These employees have an intuitive mind-set for business and customer service. They know that every interaction with a patient is not a battle to be won or lost, and realize that creating a long-term relationship is more important than any single interaction.—Barbara Campbell, RPh, CCN, Pharmacist and Certified Clinical Nutritionist, Peoples Rx, Austin, TX.

A:

High-performing pharmacies typically have a pharmacy team that understands they are valuable members of the local healthcare team, engages patients, and continually works to improve patient care and outcomes.

They understand what metrics define the pharmacy’s quality and performance, and view people seeking care at the pharmacy as patients, not customers.

Other characteristics of high-performing pharmacies include having a nonpharmacist team that is a seamless extension of their pharmacists, having a pharmacy team that knows what is important to their local healthcare provider partners as well as their mutual patients, and fully understanding the clinical services offered by their pharmacy, in addition to why they offer them.—Tripp Logan, PharmD, Vice President, Logan & Seiler, Inc, Charleston, MO. ❚

PATIENT TIP

Inside Patient Care

Health & Wellness 5 TIPS TO PREVENT SUDDEN INFANT DEATH SYNDROME Although the incidence of sudden infant death syndrome (SIDS) has decreased since 1992, when the American Academy of Pediatrics (AAP) recommended that infants sleep in a nonprone position, this trend has plateaued.1 The frequencies of other causes of sudden sleep-related deaths have also increased since the AAP published its last statement on SIDS in 2005. The following tips may help in continuing to decrease the risk for SIDS and sleep-related deaths:

1 Place Infants on Their Backs for Sleep Time

2 Always Use a Firm Sleep Surface

3 Share Your Room, but Avoid Bed-Sharing

Because side sleeping is unsafe, you should always place infants on their backs for every sleep until they reach age 1 year. When your infants are able to roll from their back onto their chest and vice versa, they can remain in whichever sleep position they desire.

Cover a firm crib mattress with a fitted sheet to reduce infants’ risks for SIDS and suffocation. Do not use cribs with missing hardware, or attempt to fix broken parts of a crib. Also refrain from using sitting devices (eg, car seats, strollers, infant carriers, swings) for routine sleep.

Room-sharing without bed-sharing can decrease your infant’s risk for SIDS by ≤50%, and prevent suffocation, strangulation, and entrapment, which may occur when infants sleep in adult beds. Place the crib in close proximity to your bed to help with feeding, comforting, and monitoring your child.

4 Remove All Soft Objects from the Crib

5 Create a Smoke-Free Environment

â

Keep soft objects and loose bedding out of the crib to reduce the risk for SIDS, suffocation, entrapment, and strangulation. Remove all pillows, pillow-like toys, quilts, and loose-fitting blankets and sheets, which may be hazardous to your infant’s sleeping environment.

Mothers must avoid smoking during and after pregnancy, and others should not smoke near pregnant women or infants. Encourage your family to maintain smoke-free homes and cars, and to eliminate secondhand smoke around you and your child.

MORE ONLINE

More patient tips are available online at InsidePatientCare.com

Source: Task Force on Sudden Infant Death Syndrome, Moon RY. SIDS and other sleep-related infant deaths: expansion of recommendations for a safe infant sleeping environment. Pediatrics.

2011;128:e1341-e1367.

Inside Patient Care

INTERVIEW

Business Perspective Questions Answered with Matthew C. Osterhaus, BSPharm, FASCP, FAPhA In an interview with Inside Patient Care, Matthew C. Osterhaus, BSPharm, FASCP, FAPhA, Co-Owner/Operator of Osterhaus Pharmacy in Maquoketa, IA, and Immediate Past President of the American Pharmacists Association, discussed the importance of patient-centered services and how to incorporate them into your practice.

What is your background?

A: I am a community and consultant pharmacist from Maquoketa, IA; at Osterhaus Pharmacy, we have a very patientfocused practice.

One of the bonuses of being in a small town is, if you are interested in providing a wide variety of services, and are willing to expend some resources, opportunities abound.

Our practice is broad in that we have a long-term care pharmacy, medical equipment, and are involved with hospice care.

We also provide compliance packaging, perform laboratory work within the pharmacy, and medication therapy management. We are very much a broad practice, but one that is focused on its patients.

How did your practice become so diversified?

A: In 2015, our pharmacy celebrated its 50th anniversary; we have been around for a long time.

My dad bought a traditional drug store, and we have established a very progressive pharmacy practice. We are constantly looking for ways to fulfill the needs of the patients in our area.

We are not the kind of team who wants to sit around and rest on our laurels. We are looking for what’s new, and what’s different, to really match it up with the needs of our patients. That is how we have developed our patient care services.

One of our first big projects back in the 1990s, which we worked on

WE SEE OURSELVES AS A HEALTHCARE CENTER. WE STARTED A SERVICE WHERE WE PROVIDED POSTMASTECTOMY CARE TO PATIENTS IN A COMMUNITY PHARMACY. through the American Pharmacists Association Foundation, was Project ImPACT: Hyperlipidemia.

At that point, we were seeing patients with issues

managing their cholesterol, who would be prescribed medication and then would not have adequate follow-up by their healthcare provider.

We began doing cholesterol tests in the pharmacy, and continued to do so every 3 months during the year of this study. As we started to closely monitor their cholesterol and educate patients, it was amazing to see how there was an opportunity for them to be more involved in their own care. The physicians in our community started to get more serious about monitoring their patients’ cholesterol, and making dosage changes and adjustments to maximize outcomes.

We see ourselves as a healthcare center. One

INTERVIEW

Inside Patient Care

Business Perspective of the other things we identified in our practice, is we had patients who travelled 40 or 50 miles to access services after having mastectomies. We started a service where we provided postmastectomy care to patients in a community pharmacy. We looked at that opportunity, and we expanded it. Now we have patients who are driving 40 or 50 miles to see us because of the way we provide those services, the way we identify with patients and their needs, and help them by working together with them and the rest of their healthcare team to maximize outcomes and get through the rough period a patient who has been diagnosed with cancer goes through.

We look at the needs of our patients and how we can help fulfill them in the most efficient way.

If we can partner with a local physician to work with our mutual patients with hypertension to achieve goals faster and adhere to their medication, then we find ways to do that. If it involves working with a physical therapist or local podiatrist, we take a very broad look at what we can do within our site, and the ways our actions will impact the rest of the community.

How do you extend your network to include physicians?

A: As is the case with a lot of other things, I think the key is starting a relationship in a way that allows everybody involved to see there is a mutual benefit to being a part of that relationship team.

Identifying a need is not being met, or an area the physician is having trouble getting their patients to—even if it’s just a logistic issue for the physician, such as not being able to see a patient as often as he or she needs to—can be a good start; finding that little niche with a particular group of physicians, or single physician within a group, is where we began.

For example, we looked at different opportunities to help and explained to a physician, “You start a patient on a new medication for hypertension. You need to schedule a follow-up appointment and see them in 1 or 3 months.” What we have seen is if we can check patients’ blood pressures in the pharmacy in the first 2 weeks after they started a new hypertension medication, we may find we are on the right or wrong track, and, if on the wrong track, we have an opportunity to turn that around early. When we communicated this idea to one of our local physicians,

DON’T GO IN WITH THE IDEA “THIS IS HOW WE DO IT”; GO IN ASKING, “HOW CAN WE DO IT IN THE BEST WAY TO MEET EVERYBODY’S NEEDS?” she said, “Let’s try this.”

We see patients when they start a new hypertension medication, get baselines, and do initial hypertension education with them to talk about possible lifestyle changes that they can make to help improve their care.

We check their blood pressure, and report these data along with any therapy recommendations to the physician using a 1-page fax form, because that’s the easiest way to integrate that into her workflow.

Creating a relationship with a physician needs to be mutually beneficial.

Pharmacists need to find something a physician doesn’t want to do or is not able to do in their own workflow, and then help them with that. You also need to find a way to communicate as easy as possible for both of your workflows. Some people

prefer communicating via e-mail, whereas others like faxes or phone calls.

Don’t go in with the idea “this is how we do it”; go in asking, “How can we do it in the best way to meet everybody’s needs?”

How do you raise patient awareness about your role as a pharmacist in their healthcare?

A: We really started to change our practice in the early 1990s, from a personnel and layout standpoint, when we physically set up our pharmacy to provide patient care. We now have 7 different areas in our pharmacy where pharmacists and patients can talk privately.

Having a place where you can have a private conversation with a patient starts to change the relationship you have with them. They know they can confide in you and you can give them advice that is not being shared with everybody else in the room. I think that’s a great place to start.

Initially, patients were very skeptical to walk into these little areas.

They would hang out on the outside, because they didn’t know what to expect. Now, our patients understand pretty well that this is how it’s done at Osterhaus Pharmacy.

There are probably some people who don’t like

Inside Patient Care

INTERVIEW

Business Perspective that—and maybe they have chosen a different place to go—but I think, given that this provides a place where you can establish a relationship in a way that is the most beneficial to you and your patient, it is a great place to start.

I think the other part of it is the physician or physicians you are working with need to create, in the patient’s mind-set, the idea that the pharmacist and physician are working together. The physician also needs to reinforce that the patient should stop at the pharmacy in 2 weeks to have his or her blood pressure checked after a change in therapy, for example.

When the message comes from the pharmacist and the physician, there is no question you will get a better response from most patients. We continually work on communicating with patients and other members of their healthcare team, letting physicians know, for instance, when we have shared information about lifestyle choices or disease state education with a patient. We also let the patient know we have communicated information to their physician. We close the loop, which makes such a big difference in getting peo-

WE USE EVERY OPPORTUNITY FOR ADDITIONAL PATIENT CARE. IT’S REALLY ABOUT GETTING EVERYBODY INVOLVED SO YOU ARE USING PEOPLE’S TALENTS IN THE RIGHT WAY. ple to buy in and say, “Yeah, this makes sense to me. Now I’ve got a team that’s working for me.”

How can pharmacists make time to incorporate primary care services?

A: To really get the whole team on board, we have to work efficiently. Our technicians and students are coming through our practice and fully integrated into our workflow, and the care we provide.

We also have a community pharmacy resident in our practice, whose primary focus is to provide patient care.

When a patient identified in our system as being in our hypertension program comes through the door and is greeted by a technician, or is waiting

for their prescription, our staff will receive a notification that this is an opportunity for a patient care service. While we are processing their order, we can start that conversation with the patient, discuss any problems the patient is having with their medication, and direct the patient to a student who can check his or her blood pressure.

We take every opportunity to provide needed patient care services. It’s really about getting everybody involved so you are using people’s talents in the right way, while being aware of your time, and the patient’s time too.

Most patients do not want to stay in the pharmacy for half an hour; however, they may have to wait for their prescription to be filled, and if we can start providing some service or setting them up to provide them with a service, that is just the most efficient way to go about it. You have to staff up enough to be ready to provide services. You can’t do it on a shoestring. If you have a pharmacist who is in a practice trying to fill 200 prescriptions a day, and they’re the only one there, I don’t see how you can make that work.

You have to have enough pharmacists on staff.

Again, be as efficient

as you possibly can by using your technicians, and working with your patients. For example, if you have an adherencebased program for your patients and you’re calling them to say, “We’re filling all of your prescriptions. They’ll be ready for you on Wednesday. Does Wednesday work for you to pick them up?” and they say, “No, I want to come in on Thursday,” you might ask them, “Morning or afternoon?

When do you think you might come in?” If they are going to come in Thursday morning, then you know that 3 or 4 days in advance. You can be ready to say, “I want a pharmacist to be available to see Mrs Smith when she comes in.”

We aren’t going to be scrambling to figure out who is going to take care of her; we have a better idea of what to expect.

Get yourself to a place where patients have some expectation when they come in they are going to be able to see a pharmacist, and an appointment-based experience where their medications will be synced. That way they can come in only once a month, or once every 3 months—instead of coming in every week to pick up this, that, or the other thing—and that can really help.

INTERVIEW

Inside Patient Care

Business Perspective I think it sets, in the mind of the patient, that there is going to be a discussion each time they are in the pharmacy. I think it gives you the opportunity to say, “Here’s a time when we’re ready for you—you’re ready to be educated or have a service provided.” It really works best for everybody that way.

Why are patient-centered services so crucial for pharmacists?

A: I think the bottom

I THINK THE BIG PICTURE IS THAT WE ARE CARE PROVIDERS; WE ARE BEING TRAINED AS CARE PROVIDERS, AND WE NEED TO BE ABLE TO PRACTICE AT THE TOP OF OUR LICENSE. line is, all this is what our profession is about.

Yes, we can efficiently distribute medications to patients; but the bottom line is it’s got to be the right medication.

Patients have to understand what their role is in

taking their medication if we want that to be successful. I think the big picture is, we are care providers; we are being trained as care providers, and we need to be able to practice at the top of our license.

It’s fulfilling as a phar-

macist to know how much more of an impact you can have on patient care than saying, “I filled 300 prescriptions today.” When you get down to it and you know you have impacted someone, and improved their healthcare, it’s a great feeling.

It is what we are trained to do, and there is no question, we need to move forward in that direction. It’s the way our profession needs to go, and we are going to get there. ❚

Inside Patient Care

CLINICAL GUIDELINE UPDATE

Diabetes USPSTF Updates Recommendations for Screening for Diabetes in Asymptomatic Adults

by SOPHIE GRANGER

IN DECEMBER 2015, the US Preventive Services Task Force (USPSTF) published an update to their 2008 recommendations for diabetes screening in asymptomatic adults.1 The USPSTF recommends that all adults aged 40 to 70 years be screened for abnormal blood glucose, and that asymptomatic adults with hypertension (ie, sustained blood pressure of >135/80 mm Hg) be screened for diabetes. However, people with a family history of diabetes, gestational diabetes, or polycystic ovarian syndrome, or who are of certain races/ethnicities (eg, African Americans, Asian Americans, American Indians, or Alaskan Natives) may have an increased risk for diabetes despite being younger or having a lower body mass index than patients who are typically diagnosed with diabetes.

Citing estimates from 2012, the USPSTF reports

that approximately 86 million Americans aged ≥20 years have impaired fasting glucose or impaired glucose tolerance, and approximately 15% to 30% of this population will have diabetes ≤5 years if they fail to make healthimproving lifestyle changes. Such lifestyle changes include methods for modifying being overweight or obese, lowering the percentage of abdominal fat, increasing physical activity, and stopping smoking.

In its last recommendation statement, the USPSTF reported that although there was evidence of an association between measuring blood glucose and short-term anxiety, the harms of lifestyle interventions to reduce the incidence of diabetes are few to none.1 In addition, 6 new studies of lifestyle interventions have shown that lifestyle modifications can prevent or delay progression to diabetes, improving clinical outcomes

as a result. This new data has led the USPSTF to the conclusion that there is a moderate net benefit to measuring blood glucose in adults who are at increased risk for diabetes.

Although intensive behavioral interventions combining dietary counseling and physical activity have an effect on delaying or avoiding the progression of glucose abnormalities to type 2 diabetes, the USPSTF previously found that there was insufficient evidence that pharmacologic interventions provide the same benefits (eg, weight loss or reducing glucose levels, blood pressure, and lipid levels). A review of 8 studies published since the previous recommendations, how­ ever, revealed that metformin, thiazolidinediones, and α-glucosidase inhibitors were effective in preventing or delaying diabetes progression.1 Despite being unable to find any trials that eval-

uated the benefits of initiating interventions at the time of diabetes screening versus after clinical diagnosis, the USPSTF identified 3 trials where intensive lifestyle modification interventions in patients with impaired fasting glucose or impaired glucose tolerance was associated with better quality of life at follow-up 3 years later.

“Clinical trials and additional modeling studies are needed to better elucidate the optimal frequency of screening and the age at which to start screening,” the researchers concluded.

“More US data are also needed on the benefits and harms of lifestyle interventions and medical treatments for screen-detected [impaired fasting glucose], [impaired glucose tolecare], and diabetes over a longer follow-up period.” ❚ 1. Siu AL; US Preventive Services Task Force. Screening for abnormal blood glucose and type 2 diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015;163:861-868.

IMMUNIZATION

Inside Patient Care

Influenza Readiness Taking a Step Toward Long-Term Immunity in Influenza

by CHRISTINE ERICKSON

THE ANTIGENICITY of the influenza virus changes so that it can evade the immune protection of the host, and antibody lineages of the host then become more potent. Approaches for creating a universal influenza vaccine that produces antibody lineages that do not undergo these changes and protects against seasonal variation and pandemic viruses require directing B-cell ontogeny to focus the humoral response on conserved epitopes on the viral hemagglutinin (HA). A more effective influenza vaccine approach would protect against several rounds of seasonal influenza variations, and, hopefully, the initiation of new serotypes from other circulating viruses.

To further explore this subject, Aaron G. Schmidt, PhD, Laboratory of Molecular Medicine, Children’s Hospital, Harvard Medical School, Bos-

ton, MA, and colleagues analyzed how immunologic memory impacted 1 study participant’s response to later influenza exposures. They found that the unmutated common ancestors (UCAs) of 6, individual, broadly neutralizing antibody lineages had bound the HA of a virus that had been circulating at the time of the study participant’s birth in 1990, and that although the HAs of viruses circulating >5 years later no longer bound the UCAs, they did bind mature antibodies in the lineages’ bound strains from the participant’s birth up to age 18 years. This suggests that early imprinting by the right influenza antigen may enhance the possibility of a longer immunologic span, according to the study authors.

“When stimulated by a new exposure (infection or vaccination), memory cells can re-enter germinal centers and undergo

A MORE EFFECTIVE INFLUENZA VACCINE APPROACH WOULD PROTECT AGAINST SEVERAL ROUNDS OF SEASONAL INFLUENZA VARIATIONS. new rounds of somatic hypermutation and selection,” Dr Schmidt and colleagues explained.

“The net effect of this ongoing selection across the entire population exposed to the virus is a virus-immunity ‘arms race.’”

The study participant was aged 18 years at the time of the 2008 study, and had no previous vaccination history to report.

The authors prepared a

panel of HA1 head domains from H1 strains circulating since 1990, and evaluated their similarities to the UCAs of antibodies in 6 lineages of receptor-binding site (RBS)directed antibodies. The authors deduced that the antibodies identified in the day 7 samples represented a recall response, and that mutation may have occurred as a result of an influenza virus infection the participant contracted between 1990 and 2006, and also during the response to the vaccine.

At least 90% of the 174 HA-positive antibodies from the participant had somatic mutation levels >2.5%; therefore, the lineages that were analyzed were part of a secondary response.

The results indicate that RBS-directed antibodies from the participant’s lineages amplified by the short-term, 7-day response to vaccination bound strongly to HAs

Inside Patient Care

IMMUNIZATION

Influenza Readiness from most of the potential previous exposures, but that their UCAs dated back to the earliest exposure, and lost affinity as the virus mutated. The majority of the antibodies from the participant had somatic mutation levels high enough to signify a recall rather than a primary response. Therefore, the antigenic distance, regardless of epitope, between influenza virus isolates and well-separated time points, appears to

This indicates that successive influenza virus infections or vaccinations update the existing collection, but do not add many new elements.

“The results show that we can study the virusimmunity arms race in humans by sampling an appropriate cohort of individuals and that we can reconstruct patterns of B-cell affinity maturation in those individuals,” the study authors explained.

Their analysis that early

WE CAN STUDY THE VIRUSIMMUNITY ARMS RACE IN HUMANS

BY SAMPLING AN APPROPRIATE COHORT OF INDIVIDUALS. be within a range that strongly supports recall.

exposure seems to have caused predisposed immunologic memory in the participant proposes that administering vaccines in infants with HA immunogens selectively exposing conserved epitopes may be a productive step in formulating a vaccine that causes long-term immunity. ❚ Schmidt AG, Do KT, McCarthy KR. Immunogenic stimulus for germline precursors of antibodies that engage the influenza hemagglutinin receptor-binding site. Cell Rep. 2015;13:2842-2850.

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CLINICAL GUIDELINE UPDATE

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Infectious Disease ACIP Publishes Updated Typhoid Vaccine Recommendations THE ADVISORY COMMITTEE on Immunization Practices (ACIP) has revised its recommendations for the use of the typhoid vaccine to include updated information on the 2 currently available vaccines, the epidemiology of enteric fever in the United States, and the importance of vaccination and other preventive methods for typhoid fever. The typhoid vaccine, coupled with avoiding certain foods and beverages, is becoming increasingly important for foreign travelers in the prevention of typhoid fever.

The 2 typhoid vaccines currently available for use in the United States include a Vi capsular polysaccharide vaccine for parenteral use (Typhim Vi), and an oral, live-attenuated vaccine (Vivotif). They have moderate efficacy in populations where typhoid is widespread. One study showed that the estimated 2.5- to 3.0-year cumulative efficacy was 55% (95% confidence interval [CI], 30%-

70%) for the parenteral vaccine, and 48% (CI, 34%-58%) for the oral vaccine. However, studies conflict regarding the effectiveness of this vaccine in young children. One trial found effectiveness of 80% (CI, 53%-91%) in children aged 2 to 4 years, whereas another trial showed no protection in patients from the same age-group. Another study of US travelers estimated 80% protection, but did not address the specific vaccines.

Typhoid (caused by Salmonella enterica serotype Typhi) and paratyphoid (caused by S enterica serotypes Paratyphi A, Paratyphi B, and Paratyphi C) fevers are collectively referred to as enteric fever. Most commonly occurring when water or food has been contaminated by the feces of an infected person, enteric fever can be severe and sometimes life-threatening. The incubation period is 6 to 30 days, and illness onset includes gradually increasing fatigue and fever. Malaise,

headache, and anorexia are common symptoms, and a transient macular rash can occur. Serious complications, such as intestinal hemorrhage or perforation, generally occur after 2 to 3 weeks.

Untreated patients have been shown to have fatality rates >10%, whereas the overall fatality rate in patients who receive early and correct antibiotic treatment is <1%.

Typhoid fever is uncommon in the United States; however, approximately 90% of cases occur in the United States, in people returning from foreign travel.

Most travelers (≥55%) reported that their reason for travel was visiting friends or relatives, and even short-term travel to high-incidence areas is associated with risk for typhoid fever. Although routine typhoid vaccination is not recommended in the United States, the Centers for Disease Control and Prevention recommends that travelers visiting several Asian, African, and Latin Amer-

ican countries receive typhoid vaccination.

The importance of typhoid vaccination in these populations is amplified by the increasing resistance of Salmonella serotype Typhi to antimicrobial medicines (eg, fluoroquinolones) in several areas of the world. Strains of Salmonella serotype Typhi that are multidrug-resistant have become common in many regions, and typhoid fever can be fatal in patients who are treated with drugs to which the organism is resistant.

Therefore, pharmacists and clinicians should warn travelers that the typhoid vaccination is not a replacement for careful selection of food and beverages; typhoid vaccines are not 100% effective, and vaccine-induced protection can be weakened by large amounts of Salmonella serotype Typhi. ❚ Jackson BR, Iqbal S, Mahon B. Updated recommendations for the use of typhoid vaccine—Advisory Committee on Immunization Practices, United States, 2015. MMWR Recomm Rep. 2015; 64:305-308.

Inside Patient Care

IMMUNIZATION

Pediatric Health Knowing the Signs, Risks, and Prevention Methods for Varicella

by CHRISTINE ERICKSON

VARICELLA (CHICKENPOX) is caused by the varicella-zoster virus, which falls under the herpes virus category.1 After primary infection, the varicella-zoster virus remains in the sensory nerve ganglia as a dormant infection. The incubation period of varicella is 14 to 16 days after varicella rash or herpeszoster rash exposure.

Mainly in adults, mild fever and malaise can occur 1 to 2 days before rash onset; in children, rash is commonly the first indication of the disease.

Varicella is highly contagious, and spreads when an infected patient coughs or sneezes, or when the virus is touched or inhaled via varicella lesions. Patients with varicella are contagious 1 to 2 days before rash onset until the lesions crust. Varicella is largely mild in healthy children, but there is higher risk for severe disease and complications in adults with varicella. The most common complications in children are bacterial infections of the skin

and soft tissues, and, in adults, pneumonia. Recovery from varicella typically offers patients life-long immunity, and recurrence of varicella is uncommon in otherwise healthy people.

High-Risk Populations Immunocompromised patients with varicella are at risk for visceral dissemination, which can lead to pneumonia, hepatitis, encephalitis, and disseminated intravascular coagulopathy.2 These patients can have more lesions and remain ill longer than immunocompetent patients with varicella.

Children with human immunodeficiency virus (HIV) infection may have new lesions for several weeks or months. Typical maculopapular vesicular lesions may develop into nonhealing ulcers that become necrotic, crusted, and hyperkeratotic. This is more likely to occur in children with HIV who have low CD4 counts.

Most adults with HIV have already had varicella,

IMMUNOCO­ MPROMISED PATIENTS WITH VARICELLA ARE AT RISK FOR VISCERAL DISSEMINATION, WHICH CAN LEAD TO PNEUMONIA, HEPATITIS, ENCEPHALITIS, AND DISSEMINATED INTRAVASCULAR COAGULOPATHY. so the disease is uncommon in this population.

Pregnant women with varicella are at high risk for pneumonia, and may die of varicella in certain cases. If varicella is contracted in the first or early second trimester, the baby has a small risk for congenital varicella syndrome, and may have skin scarring, low birth weight, and limb, brain, or eye abnormalities. If a pregnant woman develops the

varicella rash from 5 days before or to 2 days after delivery, the baby is at risk for neonatal varicella.

Signs and Symptoms Illness from varicella lasts approximately 5 to 10 days.3 The classic symptoms are an itchy rash with fluid-filled blisters that eventually crust. The rash may first appear on the face, chest, and back, and then spread to other parts of the body. It takes approximately 1 week for all the blisters to crust. Common symptoms that may appear 1 to 2 days before rash include high fever, tiredness, loss of appetite, and headache. Some people who have been vaccinated against chickenpox can still get the disease, but their symptoms are often milder.

Varicella Vaccine Vaccination is the best way to protect patients from contracting varicella.4 The Centers for Disease Control and Prevention recommends that children receive the first

IMMUNIZATION

Inside Patient Care

Pediatric Health dose of the varicella vaccine at ages 12 through 15 months, and the second dose at ages 4 through 6 years. People aged ≥13 years who have not had varicella or have not been vaccinated should receive 2 doses of the vaccine ≥28 days apart. Receiving 2 doses of the vaccine helps prevent severe disease, complications, and death.

In addition, people who receive the vaccine help protect others in their

PEOPLE AGED ≥13 YEARS WHO HAVE NOT HAD VARICELLA OR HAVE NOT BEEN VACCINATED SHOULD RECEIVE 2 DOSES OF THE VACCINE ≥28 DAYS APART.

community from varicella, which is important for pregnant women and people with weakened immune systems who cannot receive the vaccine. The cost of the vaccine is covered by most health insurance plans. The Vaccines for Children Program may be able to help patients who do not have health insurance, or have insurance that does not cover vaccines, gain access to the vaccine. ❚

References

1. Centers for Disease Control and Prevention. Chickenpox (varicella): clinical overview. www.cdc.gov/ chickenpox/hcp/clinical-overview. html. Updated August 22, 2013.

Accessed January 19, 2016.

2. Centers for Disease Control and Prevention. Chickenpox (varicella): people at high risk for complications. www.cdc.gov/chickenpox/hcp/highrisk.html. Updated September 10, 2014. Accessed January 19, 2016.

3. Centers for Disease Control and Prevention. Chickenpox (varicella): signs & symptoms. www.cdc. gov/chickenpox/about/symptoms. html. Updated November 16, 2011.

Accessed January 19, 2016.

4. Centers for Disease Control and Prevention. Chickenpox can be serious. www.cdc.gov/features/prevent chickenpox/. Updated August 21, 2015. Accessed January 19, 2016.

Inside Drug Update

Products and Services And other news from the US Food and Drug Administration

New Drugs The following are recent approvals announced by the US Food and Drug Administration (FDA): • Briviact (Brivaracetam) has been approved by the FDA as a supplemental treatment to other medications for patients aged ≥16 years with epilepsy who have partial onset seizures. Drowsiness, dizziness, fatigue, and nausea and vomiting were the most commonly reported adverse effects associated with the drug.

• Zepatier (elbasvir and grazoprevir) has been approved, with or without ribavirin, for adult patients with chronic hepatitis C virus (HCV) genotypes 1 and 4 infections. Fatigue, headache, and nausea were the most commonly reported adverse effects of Zepatier monotherapy, and anemia and headache were the most common adverse effects of Zepatier with ribavirin. The FDA recommends that healthcare professionals determine the dosage regimen and duration by screening genotype 1a–infected patients for certain viral genetic variations before initiating Zepatier.

• Cosentyx (secukinumab) has received FDA approval for use in

BRIVIACT (BRIVARACETAM) HAS BEEN APPROVED BY THE FDA AS A SUPPLEMENTAL TREATMENT TO OTHER MEDICATIONS FOR PATIENTS AGED ≥16 YEARS WITH EPILEPSY WHO HAVE PARTIAL ONSET SEIZURES. adult patients with moderate-tosevere plaque psoriasis. Administered as a subcutaneous injection, Cosentyx is intended for candidates of systemic therapy, phototherapy, or both. Because serious allergic reactions have been reported with use of the drug, healthcare providers should use caution when considering Cosentyx for patients with a chronic infection or history of recurrent infection, and in patients with active Crohn’s disease. Diarrhea and upper respiratory infections are among the most common adverse effects reported with Cosentyx use.

Announcements • The FDA recently announced that Robert Califf, MD, MACC, FDA Deputy Commissioner for Medical Products and Tobacco, and other agency officials have responded to the opioid abuse endemic by requesting a broad reassessment of the FDA’s opioid medication policies. The review will include re-examination of the risk–benefit profile of opioids, meeting with the Pediatric Advisory Committee to discuss pediatric opioid labeling, and encouraging the creation of abuse-deterring opioid product formulations.

• According to a recent announcement by the FDA, the organization has issued a new guidance recommending that blood establishments postpone accepting blood donations from patients who have visited areas where the Zika virus is active, were possibly exposed to the virus, or have had a confirmed Zika virus infection. Although no news of the Zika virus entering the US blood supply has been reported, the risk for blood transmission is considered a possibility by the FDA. ❚ US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/News room/PressAnnouncements. Updated February 22, 2016. Accessed February 22, 2016.