contemporary pharmacy practice · • Social, mobile and digital marketing tools ... goal is to help strengthen your business so you can get back to focusing on what matters most—your

journal of

contemporarypharmacy practice

vol. 64, no. 2 • 2017

www.jcphp.com

Vaccinations:A State’s Call

ImmunizationUpdate

California Immunization Registration Update

Adjunctive Azithromycin Prophylaxis for Cesarean Delivery

New California Compounding Regulations

A Review of Community Pharmacy Smartphone Applications

Health Mart® is designed for today’s independent pharmacy owner. Our member pharmacies are locally owned and focused on great service, but they’re also gaining a competitive edge and national recognition in ways that community pharmacies never have before. That’s what happens when thousands of independently owned pharmacies come together, using our comprehensive portfolio of marketing, clinical and business solutions to help care for the health of your patients.

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Health Mart® is designed for today’s independent pharmacy owner. Our member pharmacies are locally owned and focused on great service, but they’re also gaining a competitive edge and national recognition in ways that community pharmacies never have before. That’s what happens when thousands of independently owned pharmacies come together, using our comprehensive portfolio of marketing, clinical and business solutions to help care for the health of your patients.

GAIN ACCESS TO PREFERRED NETWORKS • Managed-care contracting and support provided by AccessHealth®

• Tools to help track and improve patient adherence and clinical outcomes• Programs to implement medication synchronization

BRING PATIENTS TO YOUR STORE• Local marketing tools and support with matching funds• National brand with co-branding flexibility• Physician prescribing data and marketing materials• Social, mobile and digital marketing tools• Customizable signage and décor with retail design services

EXPAND YOUR SERVICES FOR ADDED REVENUE• Manufacturer-sponsored clinical services• Vaccines and immunizations• Specialty solutions • MTM and medication synchronization

We’re Leveling the Playing Field So You Can Grow Your Business

READY TO LEARN MORE?Call 866.329.0113 Visit www.betterpharmacyhealth.com

© 2015 Health Mart. All rights reserved. HM-09344-04-15

Health Mart is proud to be a member of the McKesson family, sharing in the collective industry

McKesson has been committed to the success of independent pharmacies through the delivery of innovative programs and reliable distribution services. Learn more at www.mckesson.com.

Visit RxOwnership.com for more information.

As advocates for independent pharmacy, RxOwnership® is fully dedicated to helping you achieve your goals at every step along the way.

We partner with current and prospective pharmacy owners, pharmacy associations, buying groups and pharmacy schools to help independent pharmacy thrive. Let us guide you to your pharmacy ownership goals.

• No-fee planning advice, industry experience and resources

• Confidentiality, trust and respect• Financing options• Individualized matching of

qualified buyers and sellers• Career, internship and junior

equity opportunities

John Richards, Pharm.DProfessional Village Pharmacy

Sacramento, CACommunity Pharmacy

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Journal of Contemporary Pharmacy Practice | vol. 64, no. 2 | www.jcphp.com 5

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Journal of Contemporary Pharmacy Practice (ISSN 2573-2757) is published quarterly by:California Pharmacists Association (CPhA) © 2017 CPhA. All rights reserved. 4030 Lennane Drive, Sacramento, CA 95834 Phone: (916) 779-1400 | Fax: (916) 779-1401 www.jcphp.com

Journal of Contemporary Pharmacy Practice is a professional, peer-reviewed journal devoted to informing pharmacists and enabling them to better serve the health and welfare of their patients.Articles express the opinions of the authors and do not necessarily reflect the view or policies of CPhA. Nothing in this publication may be reproduced in any manner, either in whole or in part, without specific written permission of the publisher.

Journal of Contemporary Pharmacy Practice is distributed as a regular membership service, paid for through allocation of membership dues. Subscription rate is $100 per year. Periodicals postage paid in Sacramento, California and at additional mailing offices.

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Publisher assumes no responsibility for unsolicited material.

executive editor letterFocusing on the Bright SpotsJon R. Roth, MS, CAE

editorialWhat My Son Doesn't Know About Leadership but Taught Me AnywayKarl Hess, PharmD, APh, FCPhA

revewA Review of Community Pharmacy Smartphone ApplicationsJason Lam, PharmD, CSSBB; Nova Edusada

contents

6

7

9

contributeSubmit an article or peer review.Register at jcphp.com/em or scan the QR code to be contacted by an editorial staff member.

special articleNew California Compounding Regulations Chris Munoz, PharmD

reviewVaccinations -- A State's CallClipper F. Young, PharmD, MPH, CDE, BC-ADM

clinical practice capsuleImmunization Update Keri Hurley, PharmD, MPH

evidence-based reviewAdjunctive Azithromycin Prophylaxis for Cesarean Delivery Genene Salman, PharmD, BCPS, BCCCP, CNSC; Henry Hua, PhD, Noelle de Leon, PharmD, BCPS, BCCCP; LaDonna Oelschlaeger, PharmD, BCPS

Law UpdateA Guide to the California Immunization Registry and its Use to Enhance the Delivery of Immunization Services Albert Bach, PharmD; Jeffery Goad, PharmD, MPH; Steven P. Nickell, Ph.D.

16

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vol. 64, no. 2 • 2017

ISSN 2573-2757

vol. 64, no. 2 • 2017 www.jcphp.com

6 www.jcphp.com | vol. 64, no. 2 | Journal of Contemporary Pharmacy Practice

Surviving the Winter Blues … and the Flu!

executive editor letter

Fall has finally arrived after a very hot and dry summer here in Northern California. Many of you across the country undoubtedly read news reports about the devastating wildfires that have affected California, Washington, and Montana, as well as many other western states. Couple those disasters with the very active and destructive hurricane season experienced by residents of our southern states, and I think we would all agree that winter cannot arrive soon enough!

As the leaves change and the first flakes of snow begin to fall, this time of year reminds us how much we depend on the services of pharmacists — not only to help us stave off seasonal flus, but to prevent the winter blues. Fortunately, technological advances are making those services more effective and easier to obtain … and to provide.

Indeed, technology continues to evolve at a pace that is truly remarkable, and to touch every aspect of our lives, including our health care. In this edition of JCPhP, author Dr. Jason Lam reviews some of the pharmacy-based smartphone apps that are available today to assist patients and consumers with everything from reminding us to refill our prescriptions and helping us find a pharmacy to understanding the possible side effects of (and interactions between) the medications we take. Not only do these apps empower patients by providing a host of self-management tools, but they also enable pharmacists to extend their reach beyond the physical pharmacy or hospital to help patients who need more assistance managing their medications at home. By serving as important clinician “extenders,” these apps can help patients feel more secure and more connected to their health care providers — and because they offer easy and immediate access to information, the apps can ameliorate the isolated feeling that some patients (particularly those who are homebound or underserved) can experience when they are home alone, trying to manage their medications on their own.

One of the many useful features such smartphone apps typically offer is a pharmacy locator for such services as immunizations. As pharmacists prepare to ramp up and deliver these services in fall and winter, they will be pleased to read Dr. Keri Hurley-Kim’s update on the immunization recommendations by the Advisory Committee on Immunization Practices (ACIP) at the Centers for Disease Control and Prevention. In particular, Dr. Hurley-Kim discusses the latest influenza; human papilloma virus (HPV); meningococcal serogroups A, C, Y, W-135; meningococcal serogroup B; cholera; and yellow fever. These updates are timely and important for clinicians who are preparing to meet the preventive health care needs of the public as diseases like the flu begin their traditional seasonal ramp-up.

We hope you enjoy all the manuscripts in this edition of JCPhP, and we look forward to featuring many more contemporary practice features in coming editions. Wishing each of you a wonderful holiday season, filled with health and well-being!

Warm regards,

Jon R. Roth, MS, CAE

Executive Editor

executive editorJon R. Roth, MS, CAE

managing editorJoseph R. Page

editor-in-chiefKarl Hess, PharmD, APh, FCPhA

associate editorsVeronica Bandy, PharmD

Jack Chen, PharmD, FASCP, FCCP,

BCPS, BCGP, APh

Sonya Frausto, PharmD

Janice Hoffman, PharmD

editorial committee

Gary Besinque, PharmD

Alexander Cao, PharmD

Valerie Clinard, PharmD

Richard Dang, PharmD

Karl Hess, PharmD, Chair

Ethan Huynh, PharmD

Cynthia Jackevicius, PharmD

Amy Kang, PharmD

Noelle Lee, PharmD

Eric Mack, PharmD

Sarah McBane, PharmD

David Q. Pham, PharmD, BCPS, CDE,

BC-ADM

Daniel Robinson, PharmD

Craig S. Stern, PharmD, MBA

Debbie Veale, PharmD

Fred Weissman, PharmD

advertisingDiana Granger Granger Marketing Works(530) 642-0111 or [email protected]


What My Son Doesn't Know About Leadership but Taught Me Anyway

editorial

My most prized possession is a four-inch tall Despicable Me figurine, aptly named “Carl,” which my son gave me around two years ago. At the time, I had developed appendicitis, was admitted to the hospital for about a week, and received treatment with antibiotics. The plan was to treat the infection until my abscess subsided and then remove my appendix a few months later after it had healed and the infection contained. Unbeknownst to me at the time, treatment with antibiotics was (and is) increasingly becoming an acceptable alternative for patients with uncomplicated acute appendicitis.1,2 At the time however, I wished an appendectomy was performed right away just to get things over with.

While I was in the hospital, I was visited by my wife and her family (my family resides in Utah). My kids initially did not see me, perhaps because my wife and I did not know how they would react to seeing me confined to a bed, but after being in the hospital for a couple of days, they came to visit. When they did come, it was a shock to them to see all the tubes and monitors I was connected to and to listen to the physicians when they entered the room. I believe this was shocking more so for my son, so as a reward for being “brave,” my wife took both of them to the toy store. The next time they came to visit, my son brought the Despicable Me toy with him. When he entered the room, I thought he was going to show me what he got, but instead he told me that he had used his own money to buy this for me and wanted me to keep it. My wife confirmed this. I was speechless. He never had done something like this before!

As heartwarming as this story may be, and while my son can certainly give, he can also take away (opening my Star Wars figures from their original packaging comes to mind). However, he has his moments, and this one reminds me of his selflessness and compassion for others, which challenges me to be the same. But why am I telling you this? What relevance does this story have to pharmacy, or to this Journal? I believe that this short story reflects some attributes of leadership traits and I believe that these, or more importantly the pursuit of these traits, can be applied to the advancement of pharmacy practice. So my son is a leader? Well, not quite, or maybe not just yet…

In the book The 9 Virtues of Exceptional Leaders: Unlocking Your Inner Potential by N. Karl Haden and Rob Jenkins,

Karl Hess, PharmD, APh, FCPhA

virtues that the authors contend are essential for leadership are detailed: humility, honesty, courage, perseverance, hope, charity, balance, wisdom, and justice.3 The main points in this book are: 1) that each virtue is equally important, 2) that each virtue needs to be practiced daily for the duration of one’s life, and 3) that each virtue may never be fully obtained or that all virtues may never be obtained at the same time.While my son has certainly not mastered all of these, I do believe he portrayed several of them with this one act:

• Humility: to think about others over himself

• Courage: to walk into the hospital room, not knowing what to expect

• Perseverance: to walk back into the hospital room

• Hope: to believe things will improve, even though they may not look good

• Charity: to serve others by providing for them

• Wisdom: to know when to put aside personal needs for the needs of others

The key to leadership however is in the daily pursuit of these virtues and the continuous attempt towards them as a means to improve not only ourselves, but the organizations and causes we serve. This key to leadership is also key to the advancement of pharmacy practice — a continuous pursuit toward something greater outside of ourselves.

When I graduated from the Massachusetts College of Pharmacy and Allied Health Sciences in Boston, my career options seemed to be 1) community pharmacy, 2) hospital pharmacy, or 3) residency (with the intent of going into community or hospital practice afterward). There are many more career options for pharmacy school graduates today, and the possibilities seem to be endless (informatics, clinical and regulatory affairs, and veterinary practice, to name a few). More to the point, the ability and scope of entry-level pharmacy school graduates has greatly expanded.


The enactment of laws such as Senate Bill 493 here in California, which authorizes all licensed pharmacists to administer vaccines to those three years of age and older as well as to provide smoking cessation, hormonal contraceptive, and travel health services in addition to ordering drug therapy-specific laboratory tests greatly expands our reach and helps to improve patient care. However, advancement in pharmacy practice (particularly when undertaken through the legislative route) is not a straight line. The path is long and arduous and may come with setbacks, but we must believe that things will ultimately improve for the better provided we persist and remain true in our efforts.

Today, this Despicable Me toy sits on my desk at work as a reminder of my son, his actions when I was hospitalized, and what being a leader means. Like many other parents, I am excited to see how my children will continue to grow and develop and to see what path they choose to take in life. Likewise, I am excited to see where the practice of pharmacy will be in the future. Let us all continue to push for the advancement of our profession so that we may better serve the needs of our patients and of the healthcare system and to leave the profession better off than when we entered it for the next generation of pharmacists. We (the practice of pharmacy) can get to this place if we take note of the nine virtues of leadership, practice them daily in our routines, and continuously strive to improve.

Happy reading!

Karl Hess, PharmD, APh, FCPhA

Editor-in-Chief, Journal of Contemporary Pharmacy Practice

Vice Chair of Clinical and Administrative Sciences

and Associate Professor

Keck Graduate Institute School of Pharmacy

Email: [email protected]

References

1. Salminen P, Paajanen H, Rautio T, et al. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. Journal of the American Medical Association 2015; 313(23): 2340-8.

2. Livingston E and Vons C. Treating Appendicitis Without Surgery. Journal of the American Medical Association 2015; 313(23): 2327-8.

3. Haden, N. Karl and Jenkins, Rob. The 9 Virtues of Exceptional Leaders: Unlocking Your Inner Potential. Deeds Publishing, 2015. Print.

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A Review of Community Pharmacy Smartphone Applications

review

IntroductionSmartphones are powerful, mobile devices that provide users with the ability to make phone calls, listen to music, connect with people on social media, and much more. In 2015, a technology study conducted in the United States showed that 92% of adults owned a mobile phone, and of those users 68% owned a smartphone. Demographic data from that study, as seen in Table 1, revealed that percent ownership was highest for adults between 18 and 49 years old (above 80%) and lowest for adults over 65 years old (30%).1

The popularity of smartphones has been driven by the growth in smartphone applications, or apps, developed to meet public demands for everything from news to gaming to health and wellness. The two smartphone operating systems with the largest number of apps available for download are on the Apple App store and Google Play store. In 2014, a report showed that the Google Play store had over 1.4 million apps followed by the Apple App store with over 1.2 million apps.2 There are other smartphones that operate on other platforms (Windows, Blackberry), but they were not included in this review.

In 2003, community pharmacies dispensed over 3.22 billion prescriptions in the United States.3 As an added value to patients, pharmacy chains have developed smartphone apps to meet the needs of their tech-savvy customers. These pharmacy apps allow customers to find the nearest pharmacy location, see the hours of operation, and request prescription refills or transfers. Some pharmacy apps had more innovative features such as text alerts and reminders to promote medication adherence, or drug identification features. A few apps provide information about additional clinical services offered at their pharmacy chain, including immunization clinics and medication therapy management (MTM).

Numerous articles have been written on the principals of smartphone app design. Two essential elements in building app loyalty are design focus and its navigation. Design focus is the belief that apps should not add excess features at the expense of the quality of each feature.4 Secondly, an app’s navigation or user interface focuses on the ease and speed of how a user can find the information they are looking for.5

Jason Lam, PharmD, CSSBB; Nova Edusada

Beyond design, the success of a smartphone app hinges on the value that it brings to its user. The user’s experience and impression is formed as soon as the first time an app is launched. A common statistic used to evaluate an app’s adoption is the retention rate. In 2015, a mobile app market study showed that users who actively used an app during the first week after download had an 83% retention rate after 3 months, versus a 37% rate if the app was not used during the first week.6

Research on the usefulness of smartphone apps related to medications have mostly focused on medication adherence through the use of reminders and texts.7 A PubMed search of peer reviewed journals revealed very few publications on the topic of community pharmacy smartphone app and feature review. A study conducted in 2016 reviewed a single grocery store pharmacy chain’s smartphone app and determined that patients found most value in features that: 1. improve the convenience of their pharmacy experience, 2. enable them to self-manage their health, and 3. increase their access to their pharmacist.8 Publications comparing the common features seen in dif ferent community pharmacy chains apps were not found.

MethodsMany community pharmacy chains have a smartphone app for patients. Apps for pharmacy chains with operations in California were downloaded from the Apple App and Google Play stores. All features from each app were collected and tabulated to identify which were the most prevalent. This review was conducted between June and September of 2016.

ResultsA search of the Apple App and Google Play stores revealed 10 pharmacy chain smartphone apps. All 10 apps were available for download on both stores, and most required a user account to be set up to access all of the features. The names of the pharmacy chains are not shown to allow readers to focus on the apps’ features, and to remove any of the authors’ bias for or against any of the apps reviewed.

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It’s a fact of doing business: if you have employees, you must have workers’ compensation insurance. It’s required by law in California. Looking to the California Pharmacists Association for a comprehensive program is one of the best ways to make use of your member benefi ts. CPhA partners with Mercer and Preferred Employers Insurance to provide safety, stability, service and savings to pharmacies participating in the program.

Stability: Preferred prides itself on its stability, which includes maintaining some of the best and most consistent pricing available for CPhA members. And because of its Medical Provider Network of credentialed medical professionals, claim costs can be closely monitored and managed while providing quality care to injured employees.

Safety: In addition to mandatory CalOSHA information and videos on workplace safety, Preferred’s team of Risk Advisors are available for consultations when you need them. They also have a strong fraud prevention policy and as a California-based carrier, they know exactly what it takes to do business successfully in this State.

Service: Mercer’s team of advisors is knowledgeable about the pharmacy industry and is available to walk you through the application process, either by phone, or in person. Preferred handles and manages its own claims, rather than using third-party adjusters. This means more effi cient and expert claim handling for pharmacies. With Preferred, injured employees tend to return to work faster than the industry average and effective management of medical fraud means lower overall insurance costs for CPhA members.

All of these features add up to Savings for CPhA members!

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Table 2 lists the prevalence of each feature amongst the smartphone apps. The top 6 features were related to pharmacy store and prescription-related information. Pharmacy store information included store location (100%), store hours (90%), and clinical services available at the pharmacy (70%). Prescription-related information included the ability for one to see their patient profile or medication list (70%), request a prescription refill (100%), and transfer a prescription (70%). For refills and transfers, there was variability in how the transaction was done. Most apps prompted the user to manually type the prescription number or medication name, while other apps allowed the user to take a photo of the prescription label.

Some apps had unique features for medication adherence. The first adherence tool was a text alert feature that would remind patients to pick up a refill once it is filled by the pharmacy. Another adherence feature was a daily schedule or virtual pill box where the patient can enter medications they take on a daily basis.

The drug information features were similar to resources found on drug information websites and databases. Some apps had a drug-drug interaction checker that allowed the patient to enter multiple medications to review the presence and severity of relevant interactions. Another feature provided a drug monograph with information focused on medication side effects. One app had the ability to identify a tablet or capsule after a user manually entered a pill’s description such as its shape, color, and imprints.

DiscussionPatients find value in pharmacy apps that provide convenience, help with medication management, and connect them with the pharmacy team. Traditionally, patients met these needs by walking into a pharmacy, calling the pharmacy, or using the pharmacy website. A smartphone app offers another alternative for patients to handle these transactions.

In general, most of the community pharmacy smartphone apps had simple menus and navigation designs. The common navigation of the app is to have all of the features on the main page when the app is launched. A user account was often needed to access all of the app’s features. For most pharmacy chains, this had to be done separately on their pharmacy website. If a patient had a prior account created, accessing their account through the app was easier. A user account is essential as it offers security in protecting the patient’s private health information and medication list.

Although they provide additional convenience, most apps did not have features to help a patient manage their medications beyond seeing their medication profile and requesting refills.

A few apps did offer unique features for medication adherence and drug information. The feature that sends the patient a text alert when a refill is ready for pick up seems to be convenient alternative to calling the pharmacy and asking the pharmacy staff. There have not been any studies evaluating the feature’s impact on the number of phone calls pharmacies receive. The second feature was a daily schedule that serves as a virtual pill box to remind patients when to take various medications at different times throughout the day. Despite its intent, the daily schedule was difficult to manage, as the data entry was very laborious. To create a calendar of daily reminders, users had to manually enter each medication and their doses. Research is needed to evaluate if these features increase medication adherence.

Drug information features such as drug-drug interaction and medication side effects information were also available on a few of the apps. A review of the content in the features revealed that most but not all of the content was available in lay language for the patient. If the language is too complicated, it may be difficult for patients to understand and cause confusion and misinterpretation. The information was also only available in English.

Community pharmacy apps can also serve as a patient-specific medication resource for other clinicians across the continuum of care. For example, a hospital emergency department may not have access to a patient’s medication list to conduct medication reconciliation. Efforts by hospital clinicians to obtain the medication list from the patient’s community pharmacy or physician’s office could lead to a delay in the patient’s care.9-12 If a patient has a community pharmacy app available, the medication list could be retrieved and provided to other clinicians.

It is important that pharmacists are familiar with the smartphone app available at their pharmacy and be ready to assist patients on how to most effectively use it. Patients with a smartphone may benefit from a consultation on how to download and set up the app’s features. For patients who do not own a smartphone, pharmacists can partner with a family member or caretaker to utilize the app on the patient’s behalf.

Smartphone ownership has become widespread and patients are using their devices on a daily basis.1 A 2015 report shows that users check their smartphones an average of 46 times a day.13 As community pharmacy apps continue to be updated, new features will be developed and existing features will become more common. We need to promote our community pharmacy apps and empower patients to make it a part of their everyday lives.

Preferred’s rates for the CPhA-sponsored Workers’ Compensation program have been stable for three consecutive years! (Some counties have even received decreases!)

It’s a fact of doing business: if you have employees, you must have workers’ compensation insurance. It’s required by law in California. Looking to the California Pharmacists Association for a comprehensive program is one of the best ways to make use of your member benefi ts. CPhA partners with Mercer and Preferred Employers Insurance to provide safety, stability, service and savings to pharmacies participating in the program.

Stability: Preferred prides itself on its stability, which includes maintaining some of the best and most consistent pricing available for CPhA members. And because of its Medical Provider Network of credentialed medical professionals, claim costs can be closely monitored and managed while providing quality care to injured employees.

Safety: In addition to mandatory CalOSHA information and videos on workplace safety, Preferred’s team of Risk Advisors are available for consultations when you need them. They also have a strong fraud prevention policy and as a California-based carrier, they know exactly what it takes to do business successfully in this State.

Service: Mercer’s team of advisors is knowledgeable about the pharmacy industry and is available to walk you through the application process, either by phone, or in person. Preferred handles and manages its own claims, rather than using third-party adjusters. This means more effi cient and expert claim handling for pharmacies. With Preferred, injured employees tend to return to work faster than the industry average and effective management of medical fraud means lower overall insurance costs for CPhA members.

All of these features add up to Savings for CPhA members!

See how safety, stability and service can save you money by requesting a premium indication today! Call a Mercer Client Advisor at 888-926-CPhA to get started. Or, visit www.CPhAMemberInsurance.com for more information and download a premium indication request form or application.

78325 CPhA WC Ad (10/17)Full Size: 8.5” x 11” Bleed: .125” = 8.75” x 11.25”Fold: N/AColors 4c = CMYKStock: N/APostage: N/AMisc: N/AM

ERCER

Proven StabilityProven Reliability

Administered by:

Sponsored by:

PREFERRED EMPLOYERS Insurance| a Berkley Company

Underwritten by:

Scan for more information.

Program Administered by Mercer Health & Benefi ts Insurance Services LLC

CA Insurance License #0G39709777 South Figueroa Street, Los Angeles, CA 90017 • [email protected] • www.CPhAMemberInsurance.com78325 (10/17) Copyright 2017 Mercer LLC. All rights reserved.

78325 CPhA Fall2017 WC Ad.indd 178325 CPhA Fall2017 WC Ad.indd 1 10/24/17 4:48 PM10/24/17 4:48 PM

12 www.jcphp.com | vol. 64, no. 2 | Journal of Contemporary Pharmacy PracticeLearn more at www.medicationsafety.org or call us at (866) 365-7472.The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

Protect yourpatients.Protect your pharmacy. ERRORS CAN INJURE PATIENTS AND PUTYOUR PHARMACY INFINANCIAL JEOPARDY.

The PQC+ QA program can improve efficiency andincrease patient safety as well as help you meet accreditation,credentialing, PBM and state Quality Assurance requirements.• Training, Quality Assurance CE, and resources • Patient Safety Organization protection for your QA work • Practical tools to collect and analyze patient safety data


Age Group Percent Smartphone OwnershipOverall 68%18 to 29 years old 86%30 to 49 years old 83%50 to 64 years old 58%65 years old and older 30%

Conclusion

People who own a smartphone utilize apps on a routine basis. It is important for pharmacists to be familiar with the features available in their pharmacy’s smartphone app, and be ready to educate patients on how to best use it.

About the AuthorsJason Lam, PharmD, CSSBB is a Lean Six Sigma Black Belt at Sharp Healthcare and Volunteer Clinical Faculty at UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. Dr. Lam’s research has been focused on technology and clinical decision support tools for clinicians. Dr. Lam has no conflicts of interest to report.

Nova Edusada is a 2019 PharmD Candidate at UC San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences. Ms. Edusada has no conflicts of interest to report.

Table 1. Percentages of Smartphone Ownership, By Age Group

Table 2. Prevalence of Feature Across Community Pharmacy Apps

App Feature Feature PrevalenceRefill prescription 10Pharmacy location 10Pharmacy hours 9Patient profile 7Transfer prescription 7Clinical service information 7Text alerts 5Family member profile 4Drug-drug interaction checker 3Daily schedule/reminder 3Side effects information 2Personal insurance information 2New prescription request 2Pill identifier 1Co-payment information 1

Learn more at www.medicationsafety.org or call us at (866) 365-7472.The Alliance of Medication Safety (APMS) is a federally listed Patient Safety Organization (PSO).

Protect yourpatients.Protect your pharmacy. ERRORS CAN INJURE PATIENTS AND PUTYOUR PHARMACY INFINANCIAL JEOPARDY.

The PQC+ QA program can improve efficiency andincrease patient safety as well as help you meet accreditation,credentialing, PBM and state Quality Assurance requirements.• Training, Quality Assurance CE, and resources • Patient Safety Organization protection for your QA work • Practical tools to collect and analyze patient safety data


References1. Anderson M, The Demographics of Device Ownership. Pew Research Center http://www.pewinternet.org/2015/10/29/the-demographics-of-device-ownership/ (accessed 2016 Oct 21).

2. Ranger S, iOS versus Android. Apple App Store versus Google Play: Here comes the next battle in the app wars. ZDnet. http://www.zdnet.com/article/ios-versus-android-apple-app-store-versus-google-play-here-comes-the-next-battle-in-the-app-wars/ (accessed 2016 Oct 21).

3. Law AV, Okamoto MP, Chang PS. Prevalence and Types of Disease Management Programs in Community Pharmacies in California. Journal of Managed Care Pharmacy. 2005;11(6):505-512.

4. The 10 principles of mobile interface design. Creative Bloq. http://www.creativebloq.com/mobile/10-principles-mobile-interface-design-4122910 (accessed 2016 Oct 21).

5. Weevers I, Seven Guidelines For Designing High-Performance Mobile User Experiences. Smashing Magazine. https://www.smashingmagazine.com/2011/07/seven-guidelines-for-designing-high-per formance-mobile-user-experiences/ (accessed 2016 Oct 21).

6. The Smartphone App Retention Challenge. eMarketer. http://www.emarketer.com/Article/Smartphone-App-Retention-Challenge/1013356 (accessed 2016 Oct 21).

7. Dayer L, Heldenbrand S, Anderson P, et al. Smartphone medication adherence apps: potential benefits to patients and providers. J Am Pharm Assoc. 2013 Mar-Apr;53(2):172-81.

8. McCartney E, Bacci JL, Ossman KL, et al. Mobile application features sought after by patients of a regional grocery store chain pharmacy. J Am Pharm Assoc. 2016 Jan;56(1):62-66.

9. UCSD Hillcrest Emergency Department pharmacist and technician interview, July 26, 2016.

10. Sharp Chula Vista Emergency Department pharmacist and technician interview, July 28, 2016.

11. Abdelaziz H, Al-Anany R, Elmalik A, et al. Impact of Clinical Pharmacy Services in a Short Stay Unit of a Hospital Emergency Department in Qatar. Int J Clin Pharm. 2016 Aug;38(4):776-9.

12. Rubin EC, Pisupati R, Nerenberg SF. Utilization of Pharmacy Technicians to Increase the Accuracy of Patient Medication Histories Obtained in the Emergency Department. Hosp Pharm. 2016 May;51(5):396-404.

13. Eadicicco, L. Americans Check Their Phones 8 Billion Times a Day. Time.com. http://time.com/4147614/smartphone-usage-us-2015/ (Accessed 2017 Feb 20).

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New California Compounding Regulations

special article

IntroductionThe California regulations for pharmacy compounding have undergone a significant revision. Effective January 1, 2017, all compounding pharmacies in California along with non-resident pharmacies doing business in California will be expected to comply with these new laws. This article will summarize some major changes in the upcoming regulations for pharmacy compounding including new definitions, prescriber office use, beyond use dating, and quality assurance for sterile compounding. While this is not a comprehensive review, the objective is to provide a foundation and point of reference for compounding pharmacists to make the necessary changes to their practices.

Compounding Definitions

Definitions germane to both sterile and non-sterile compounding are now included in section 1735.1 “Compounding Definitions.” Previously, California compounding laws did not include such definitions. Compounders should carefully review this section and pay particular attention to the language, as it specifies the scope and limitations of compounding operations. For example, looking at hazardous drugs compounding, a cleanroom must maintain a specific range of negative air pressure stated in this section. Further, the definition of a biological safety cabinet required for hazardous drugs compounding is also stated in this section. Compounders should note this language requires that exhaust from the BSC be vented externally. This may have significant implications for compliance, as compounders may be limited by their pharmacy’s physical location and ability to modify the building’s heating, venting, and air conditioning (HVAC) system.

An important addition in this section which pertains to sterile compounding is the classification of a “segregated sterile compounding area.” Whether in the community or hospital setting, if compounding within this definition, the beyond use date of the compounded preparation is distinct from those compounded in a cleanroom. This definition may have more important implications for hospitals than for community pharmacies, as hospitals commonly have multiple areas where intravenous and injectable drugs must be compounded.

Chris Munoz, PharmD

Prescriber Office UseCompounding for prescriber office use has historically been a controversial topic with regulatory enforcement agencies. In recent times, either inadvertently or intentionally, the rules pertaining to “office use” compounding have been neglected by US pharmacies, often times with such abandon that the FDA has dealt a strict crackdown on compounding pharmacies with loose practices on said service.1 The following is a portion of the newly approved language for California’s new laws on compounding for prescriber office use which aim to clarify the conditions and responsibilities surrounding this practice.

A “reasonable quantity” that may be furnished to a prescriber for office use by the prescriber as authorized by Business and Professions Code section 4052, subdivision (a)(1), means that amount of compounded drug preparation that: (1) Is ordered by the prescriber or the prescriber’s agent using a purchase order or other documentation received by the pharmacy prior to furnishing that lists the number of patients seen or to be seen in the prescriber’s office for whom the drug is needed or anticipated, and the quantity for each patient that is sufficient for office administration; and (2) Is delivered to the prescriber’s office and signed for by the prescriber or the prescriber’s agent; and (3) Is sufficient for administration or application to patients solely in the prescriber's office, or for furnishing of not more than a 120-hour supply for veterinary medical practices, solely to the prescriber's own veterinary patients seen as part of regular treatment in the prescriber's office, as fairly estimated by the prescriber and documented on the purchase order or other documentation submitted to the pharmacy prior to furnishing; and... Prior to January 1, 2017, the burden of proof for demonstrating the type and quantities of compounded preparations provided to prescribers for office use were sufficient for a finite treatment window (72 hours) lay ambiguously between the prescriber and pharmacist. In many practices, pharmacists would not provide compounded preparations for prescriber office use unless entering into a written agreement with the prescribing party attesting to compliance with these rules. Under this revised verbiage, the responsibility appears to be pointed toward the pharmacist to provide a credible basis for determining the limits of a “reasonable quantity” for each instance of compounding for prescriber office use. The criteria each pharmacist uses to


determine these limits will depend on the relationship with the prescriber, the nature of the treatment, and the prescriber’s estimate of the required quantities. Further, the duty of first procuring documentation which specif ies the number of expected patients and required quantities for prescriber treatment has been added as an additional measure of ensuring responsible practice.

Beyond Use Date

One way to extend the beyond use date (BUD) of a compounded preparation, whether sterile or non-sterile, beyond the recommended BUDs established by the USP is to test the stability of each active ingredient in the preparation under specific conditions. This is known as the stability study. Stability testing of compounded preparations has commonly been treated differently by compounding pharmacists.2,3 Simple potency assays have been passed for stability tests, yielding scientifically unsound data used to assign beyond use dates to compounded preparations.4 Scientists from contract analytical laboratories will accurately explain to pharmacists that a study using stability-indicating methods is required to determine the stability of a compounded preparation over a given time frame. Within the new regulations is a mandate to utilize stability-indicating methods, which include a method suitability test. This test ensures the correct analytical methods are utilized for the analyte(s) being detected. Contract labs can provide documentation showing that methods used for testing are in fact validated for the specific preparation to be analyzed. If a method cannot be validated for a given analyte, conducting the stability test will not guarantee accurate results, and any subsequent use of its data for assigning a BUD will not be in compliance with these new regulations. Pharmacists should verify with contract labs that stability studies have validated methods and request this accompanying documentation with the stability study.

A second new requirement is the container-closure integrity test. Container-closer integrity tests are commonly used for manufactured sterile drugs and compounded sterile preparations. The United States Pharmacopeia (USP) chapter 797 states that “Prerelease inspection [of a sterile compounded preparation] also includes container–closure integrity and any other apparent visual defect”.5 This chapter refers to container-closure integrity inspection in several areas and also refers to the use of tamper-evident seals on containers so that any fault in the seal may be easily recognized. Improperly applied or damaged container seals may negatively impact the sterility of compounded sterile preparations, potentially leading to microbial contamination and subsequent harm to patients. Because the time it takes for microbes to multiply to harmful levels depends on the medium, the BUD of a sterile preparation cannot be assigned without the certainty of an intact container

seal. The following regarding beyond use date is an excerpt from section 1735.2(i):

3) Extension of a beyond use date is only allowable when supported by the following:

(A) Method Suitability Test,

(B) Container Closure Integrity Test, and

(C) Stability Studies

Hazardous Drugs Compounding

In stark contrast to the United States Pharmacopeia (USP) Chapter 800 “Hazardous Drugs - Handling in the Healthcare Setting,” California’s definition of “hazardous” identifies only those drugs classified by the National Institute for Occupational Health and Safety (NIOSH) as antineoplastic. Additional drugs that should be considered hazardous must be identified by the pharmacist-in-charge. A common approach in identifying additional hazardous drugs is to perform a compounding risk assessment. Pharmacists may start by identifying all drugs other than antineoplastic agents in the 2016 “NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings” that the pharmacy uses for compounding. When this list has been compiled, the pharmacist should identify which of these agents may pose a potential health risk to the public and to employees. Because the criteria differ from pharmacy to pharmacy, the pharmacist may consider factors such as the volume of the drug compounded, the dosage form of the preparations, the safety measures in place to limit inadvertent exposure, and the nature of the potential risk of exposure to their employees. If the pharmacist determines any of these identified drugs to be of substantial risk, then those drugs must be compounded in compliance with this definition of hazardous. Pharmacies compounding with any hazardous drugs, whether sterile or non-sterile, will now be mandated to do so in specially designed facilities with strict environmental conditions. These new requirements found in section 1735.6 are as follows:

(e) Hazardous drug compounding shall be completed in an externally vented physically separate room with the following requirements:

(1) Minimum of 30 air changes per hour except that 12 air changes per hour are acceptable for segregated compounding areas with a BSC or CACI when products are assigned a BUD of 12 hrs or less or when non- sterile products are compounded; and

(2) Maintained at a negative pressure of 0.01 to 0.03 inches of water column relative to all adjacent spaces (rooms, above ceiling, and corridors); and

(3) Each PEC in the room shall also be externally vented; and

(4) All surfaces within the room shall be smooth, seamless, impervious, and non-shedding.

Many compounding pharmacists have spoken publicly at

meetings held by the board of pharmacy to alert the board

to the extent of remodeling that will have to take place to

meet these new requirements.6 As a result, the board has

written into these new regulations provisions for granting a

waiver of compliance with these requirements for a period of

time sufficient to complete necessary changes providing the

request is related to physical construction. Granting of this

waiver will still be at the discretion of board on an individual

basis.

End Product Validation

New clarifications have been made regarding end product

validation for compounded sterile preparations. The following

language is found in section 1751.7 Sterile Compounding

Quality Assurance and Process Validation:

(e)(1) Batch-produced sterile drug preparations compounded

from one or more non-sterile ingredients, except as

provided in paragraph (2), shall be subject to documented

end product testing for sterility and pyrogens and shall be

quarantined until the end product testing confirms sterility

and acceptable levels of pyrogens. Sterility testing shall be

USP chapter 71 compliant and pyrogens testing shall confirm

acceptable levels of pyrogens per USP chapter 85 limits,

before dispensing. This requirement of end product testing

confirming sterility and acceptable levels of pyrogens prior to

dispensing shall apply regardless of any sterility or pyrogen

testing that may have been conducted on any ingredient or

combination of ingredients that were previously non-sterile.

Exempt from pyrogen testing are topical ophthalmic and

inhalation preparations.

(2) The following non-sterile-to-sterile batch drug preparations do not require end product testing for ster i l i ty and pyrogens:

(A) Preparations for self-administered ophthalmic drops in a quantity sufficient for administration to a single patient for 30 days or less pursuant to a prescription.

(B) Preparations for self-administered inhalation in a quantity sufficient for administration to a single patient for 5 days or less pursuant to a prescription.

There is now a direct reference to USP for conducting sterility and pyrogen testing of compounded sterile preparations. These USP chapters outline the specific methodologies and limits

for determining when sterile preparations are safe for use by patients. When using contract labs, pharmacists should look for accredited labs that can provide documentation that USP methods are utilized for these tests. The results of these tests are also a requirement for establishing a sound beyond use date for sterile compounded preparations. An important inclusion many pharmacists have advocated for is the exemption of certain sterile preparations from these requirements. Because end product validation may take up to 14 days to complete, exemptions like these allow pharmacists to better provide patients critical access to compounded therapies in a timely manner.

Conclusion

Several major changes have been made to the regulations governing pharmacy compounding. These revisions were developed over the past few years with the input of several pharmacy stakeholders with the goal of making the practice of compounding safer for the public. Compounding pharmacists may notice the similarity to standards found in current USP chapters for pharmacy compounding. Those familiar with USP 797 will notice that many parts of these new regulations reflect similar standards pertaining to such areas as beyond use dating, personnel training competencies, environmental monitoring, and quality assurance. Much like USP, the new regulations continue to hold compounders to the highest standards of practice while offering patients the much needed and highly valued service of personalized medication therapy.

Select laws for the practice of pharmacy in the state of California can be found at http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf.

About the Author

Chris Munoz, PharmD is a compounding pharmacist, healthcare business consultant, and faculty at the University of Southern California School of Pharmacy where he teaches pharmaceutical compounding.


References

1. United States Government Accountability Office, Drug Compounding - FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges, Report to Congressional Committees, GAO-17-64 (November 2016).

2. Williams L, Hastings M. Identifying the criteria of a valid stability study. International Journal of Pharmaceutical Compounding 2009; 3(1): 32-36.

3. Allen, L. Basics of Compounding: Potency and stability testing. International Journal of Pharmaceutical Compounding 2013; 17(3): 220-224.

4. Thomson, C. Standards of practice, professional judgment, and scientific evidence to establish and extend a beyond-use date. International Journal of Pharmaceutical Compounding. 2014; 18(6): 456-460.

5. USP39-NF32, 39th Revision, Through 1st Supplement Effective Through December 1, 2016, Chapter 797 Pharmaceutical Compounding - Sterile Preparations, 626-670.

6. California State Board of Pharmacy. (2016, August 31). Enforcement and Compounding Committee Meeting Minutes. Retrieved from http://www.pharmacy.ca.gov/meetings/minutes/2016/16_aug_enf.pdf.

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© 2016 CBRE, Inc. This information has been obtained from sources believed reliable. We have not verified it and make no guarantee, warranty or representation about it. Any projections, opinions, assumptions or estimates used are for example only and do not represent the current or future performance of the property. You and your advisors should conduct a careful, independent investigation of the property to determine to your satisfaction the suitability of the property for your needs.

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Vaccinations – A State’s Call

review

DocumentationThere has been a long history of battles between an individual’s willingness to receive vaccinations and the government requiring citizens to receive vaccines. Throughout the history of the United States, citizens had been given the freedom to decline vaccinations due to religious and/or personal belief exemptions. The National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control and Prevention (CDC) reported that all 50 states allowed medical exemptions, 48 allowed religious exemptions, 19 allowed philosophical exemptions, and two – Mississippi and West Virginia – allowed neither religious nor philosophical exemptions during the 2015–2016 school year.1 Have these exemption policies gone too far?

In December 2014, a measles outbreak started in Orange County, California, leading to a record number of 667 measles cases reported in 2014 and 188 cases in 2015 in the United States.2 Amongst these measles cases, the majority of the people affected were unvaccinated.2 This recent measles outbreak was the impetus for Californians to reconsider the possibility of mandatory vaccinations in California after the modern MMR (measles, mumps, and rubella) vaccine controversy started when Dr. Andrew Wakefield’s study was published in The Lancet in 1998, arguing vaccines might cause autism. Although Wakefield’s study on vaccinations has been retracted, the impact on how the public perceives the relationship between MMR vaccine and autism is still significant. There has been a long history of anti-vaccination movements from smallpox and the anti-vaccination leagues in England and the United States to the international diphtheria, tetanus, and pertussis vaccine controversy to the recent measles, mumps, and rubella vaccine controversy.3 Although there has been an anti-vaccination force, Healthy People 2020 aims to achieve a 95% vaccination coverage for MMR vaccine, DTaP (diphtheria, tetanus, and acellular pertussis) vaccine, and varicella vaccine among kindergartners.4 A recent report from the CDC revealed that during the school year 2015–2016 among the 50 states, the median MMR (2-dose series) vaccination coverage was 94.6%, DTaP vaccine was 94.2%, and varicella (2-dose series) vaccine was 94.3%.4 This report further discussed that 22 states reached the vaccination coverage target for MMR vaccine, 20

Clipper F. Young, PharmD, MPH, CDE, BC-ADM

for DTaP vaccine, and 18 for varicella vaccine.4 In California, during the school year 2015–2016, the median vaccination coverages among kindergartners were 94.5% for 2-dose MMR vaccine, 94.2% for DTaP vaccine, and 96.3% for first-dose varicella vaccine;4 thus, California, as a state, is approaching the vaccination coverage goal of 95% set by Healthy People 2020 for the aforementioned vaccines.

Table 1 shows immunization status in California preschoolers, kindergarteners, and 7th- graders who did not receive vaccinations due to personal belief exemptions during the 2014–2016 school years. Overall, the numbers of cases that requested exemptions due to personal belief or religious belief trended down from the 2014/2015 to the 2015/2016 school years.5,6,7

The numbers of requests for personal belief exemptions in Cali fornia among preschoolers, k indergar teners, and 7th-graders were mostly below 5% during the two school years captured in Table 1. Some parents might have been concerned about the linkage between thimerosal (used in multi-dose-vial vaccines to prevent bacterial and fungal growth) and the development of autism. Data generated by many well-designed and well-executed studies have not confirmed the connection between autism and thimerosal.8 In addition, many vaccine manufacturers revealed that their vaccines never contained thimerosal, for example, varicella vaccine (Varivax) and MMR vaccine (M-M-R-II) produced by Merck & Co., Inc.9 There are three brands of DTaP vaccines: two (Infanrix by GlaxoSmithKline Biologicals and Daptacel by Sanofi Pasteur, Ltd.) are free of thimerosal and one (Tripedia by Sanofi Pasteur, Ltd.) contains a trace amount (< 0.3 microgram Hg/0.5 mL dose).9

The passing of SB 493 has restructured how California pharmacists provide vaccinations for the public via a uniform, statewide protocol. Pharmacists across the spectrum might face situations where they need to discuss vaccination myths and regulations with whom they serve, so it is essential for pharmacists to recognize patients’ perceptions and to understand regulations pertaining to vaccinations.


A misconception has been that the federal government has total control over vaccinations, mandating citizens to receive vaccines. In fact, each state has the authority to require vaccinations, hence following recommendations published by the Centers for Disease Control and Prevention.10 In all 50 states, children are required to receive specific vaccinations; therefore, completing these vaccinations has become a condition for them before entering schools. Children with an immune disorder or cancer, however, can be exempted from such requirements. Some parents, who are concerned that vaccines are harmful, might choose to decline vaccinating their children, thereby requesting exemptions, e.g., religious exemption or personal belief exemption. Many of these vaccination exemptions started during the Nixon administration, when many Christian Scientists advocated for people who believed in faith healing, thus asking for exemptions via the religious route.1 Little did they know that these requests could potentially lead to the return of childhood infectious diseases that had been previously eradicated.

Epidemiological Aspects of the Issue

A 2006 study revealed that “states with easy procedures for granting nonmedical exemptions had approximately 50% higher rates of whooping cough.”10 The design of this study focused on collecting data on state-level rates of nonmedical exemptions at school entry (from 1991 to 2004) and pertussis incidence data from those who were 18 years or younger (from 1984 to 2004).11

The degree of ease in obtaining a nonmedical exemp-tion was grouped into three categories: easy, medium, and difficult.11 An unpaired t-test was used to compare states with religious only exemptions against personal belief exemptions. Comparisons were also made between easy and medium exemption-granting processes as wee as between easy and difficult exemption-granting processes via unpaired t-tests. Data were then report-ed as incidence rate ratios (IRRs) to reveal the associa-tions between pertussis incidence and state policies (religious only exemptions vs. personal belief exemp-tions as well as the degree of ease in obtaining a non-medical exemption – easy, medium, and difficult).11

Geographically clustered, nonmedical exemptions were identified as a pattern in some cities (Ashland, Oregon; Vashon, Washington), leading to much higher individual and community risks.11 State-level vaccine refusal rates had not been fully captured, thus the risks of disease outbreaks were increased by social clustering of exemptions.11 Biases could have come from data collection processes; for example, self-reported exemption rates by schools as well as various methodologies to collect and report exemption data in different states.11

Table 1. Personal Belief and Religious Belief Exemptions Requested (presented in %) in California, 2014–2016 School Years5,6,7

2014 - 2015 2015 - 2016

Public Private All Public Private All

Preschoolers

Number of Children 129,636 283,310 486,634 131,751 282,986 484,979

Personal Belief Exemptions 1.62% 3.68% 2.67% 1.27% 3.23% 2.31%

Health Practioner Counseled 0.71% 1.47% 1.11% 0.77% 2.06% 1.47%

Religious 0.25% 0.47% 0.35% 0.23% 0.38% 0.30%

Kindergarteners

Number of Children 494,636 40,598 535,234 508,458 42,665 551,123


Heatlh Practitioner Counseled 1.54% 2.85% 1.64% 1.64% 3.93% 1.81%

Religious 0.50% 0.81% 0.52% 0.52% 1.00% 0.56%

7th-Graders

Number of Children 453.832 35,811 489,643 460,148 36,657 496,805


Health Practitioner Counseled - - - 0.92% 2.42% 1.03%

Religious - - - 0.60% 0.96% 0.63%


Management of the Issue

Some public health experts have suggested the removal of personal and philosophical exemptions, allowing religious exemptions.10 To address the potential outbreaks of vaccine-preventable diseases, California Governor Jerry Brown signed Senate Bill (SB) 277 into law on June 30, 2015, and this new law went into effect on July 1, 2016. SB 277 removes the personal belief exemptions for 10 school-required vaccinations, requiring immunizing children in public or private schools and child care centers.12 All students must meet the vaccination requirements, with the exceptions of a medical exemption, home-schooled students, or students receiving independent studies with no classroom instruction.12 Since this new law has become effective, parents can either make plans to have their children vaccinated or choose an alternative option for children to continue their education. This new legislation has created a powerful incentive for parents to immunize their school-aged children, thus reducing the incidence of many vaccine-preventable diseases.

Summary

As the most accessible healthcare providers, pharmacists have both the opportunity and the responsibility to advocate for immunizations.13 With the implementation of SB 493, California pharmacists have been granted the authority to initiate and administer immunizations independently, making the pharmacist’s role of educator even more crucial on a multidisciplinary healthcare team. As educators, facilitators, and immunizers, pharmacists reach out to not only healthy adults but also school-aged children, vulnerable geriatric patients, and immunocompromised patients, aiming to maximize immunization rates. Surely, every citizen has the right to refuse vaccinations; however, if many of us refuse to receive immunizations, the public is then more prone to vaccine-preventable diseases, increasing the risk of outbreaks. As members of our own community, we should all consider receiving vaccines to protect the less fortunate – those who cannot receive vaccines due to medical reasons – so that we might be able to avoid future outbreaks such as the measles outbreak during late 2014 to early 2015 in Orange County, California. Receiving vaccinations, after all, is not only an individual's choice but also a public health matter.

About the Author

Clipper F. Young, PharmD, MPH, CDE, BC-ADM, is an Assistant Professor at Touro University California College of Osteopathic Medicine. Dr. Young is also a clinical pharmacist at Solano County Family Health Services, specializing in diabetes management and cardiovascular reduction. In addition, his research interests include the psychosocial aspect of diabetes management and the application of biopsychosocial model in diabetes management. Dr. Young has no conflicts of interest to report.

References

1. SchoolVaxView Interactive! (2016). School Vaccination Coverage and Exemption Methods. Centers for Disease Control and Prevention. http://www.cdc.gov/vaccines/imz-managers/coverage/schoolvaxview/data-reports/coverage.html. Accessed on November 26, 2016.

2. Measles Cases and Outbreaks. (2017). Centers for Disease Control and Prevention. http://www.cdc.gov/measles/cases-outbreaks.html. Accessed February 6, 2017.

3. The College of Physicians of Philadelphia. (2016). History of Anti-vaccination Movements. http://www.historyofvaccines.org/content/articles/history-anti-vaccination-movements. Accessed February 17, 2017.

4. Morbidity and Mortality Weekly Report (MMWR). (2016). Vaccination Coverage Among Children in Kindergarten – United States, 2015 – 2016 School Year. October 7, 2016/ 65(39): 1057–1064. http://www.cdc.gov/mmwr/volumes/65/wr/mm6539a3.htm. Accessed on November 26, 2016.

5. 2015–2016 Child Care Immunization Assessment. (2016). California Depar tment of Public Health, Immunization Branch. ht tps://www.cdph.ca.gov/programs/ immunize/Documents/2015-16_CA _ChildcareSummaryRepor t.pdf. Accessed on November 26, 2016.

6. 2015–2016 Kindergar ten Immunization Assessment. (2016). California Department of Public Health, Immunization Branch. ht tps://www.cdph.ca.gov/programs/ immunize/Documents/2015-16_CA_KindergartenSummaryReport.pdf. Accessed on November 26, 2016.

7. 2015–2016 7th Grade Immunization Assessment. (2016). California Department of Public Health, Immunization Branch. https://www.cdph.ca.gov/programs/immunize/Documents/2015-16CA7thGradeReport.pdf. Accessed on November 26, 2016.


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Immunization Update

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IntroductionThe Center for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) makes recommendations regarding the use of immunizations in the United States. The committee’s evidence-based recommendations are published in the CDC’s Morbidity and Mortality Weekly Report (MMRW) and incorporated into the annual CDC Immunization Schedules for children and adults. ACIP meets three times per year to review clinical research, pharmacoeconomic studies, and other data related to vaccines, and recommendations can change with the same frequency.

In add i t ion to regu la r l y eva lua t ing and updat ing recommendations for the clinical use of vaccines currently on the market in the US, ACIP reviews data related to new vaccines following licensing approval by the FDA. Currently, there are dozens of vaccines in various stages of development including late-phase clinical trials. One of those likely to be reviewed by the FDA in the near future is a novel type of herpes zoster (shingles) vaccine whose trial results have been promising. Remaining up-to-date in this rapidly changing field ensures that practice is consistent with the best and most current evidence available.

The updates discussed below provide a review of substantive changes to ACIP recommendations during the last 18 months, and are further summarized in Table 1. Pharmacists are also encouraged to periodically review CDC publications as well as other professional and patient resources that are updated frequently. Important sources of comprehensive vaccine-related information include the MMWR (www.cdc.gov/mmwr/index.html) and the Immunization Action Coalition (www.immunize.org), both of which are freely available to the public.

Influenza

The intranasal live attenuated influenza vaccine (LAIV, FluMist®) was FDA approved in 2003. Research during multiple seasons prior to 2010 compared the efficacy of trivalent live attenuated influenza vaccine (LAIV3) and trivalent inactivated influenza vaccine (IIV3). These studies indicated that, in adults and children, LAIV3 was statistically at least as effective as IIV3.1-

4 LAIV was reformulated as a quadrivalent vaccine (LAIV4) in 2012 with an H1N1 vaccine virus that was different from the

Keri Hurley-Kim, PharmD, MPH

2009 pandemic virus included in all other influenza vaccine formulations. Studies and analysis of observational data conducted after this change found no significant efficacy at preventing influenza infection, particularly H1N1 influenza.5,6

For this reason, ACIP recommended against the use of LAIV4 in all populations for the 2016-17 flu season.6 During the June 2017 ACIP meeting, the committee voted to continue this recommendation for the 2017-18 flu season as minimal impact on overall vaccination rates was noted for 2016-17.7,8

Aside from LAIV4, there are a multitude of types and formulations of tri- and quadrivalent flu vaccines available. Each is approved for specific age groups, so familiarity with the particular product being administered is important. In 2016, a quadrivalent cell culture-based IIV4 (ccIIV4, Flucelvax®) was approved by the FDA for use in ages 4 years and older. The previously marketed formulation, trivalent ccIIV, was only approved for individuals over age 18 years.6

Human papilloma virus (HPV)

As of December 2016, ACIP recommends a simplified two-dose series of nine-valent HPV vaccine (9vHPV, Gardasil-9®) administered at 0 and 6 months for individuals who receive the first dose prior to their 15th birthday.9 This recommendation is based on recent evidence of non-inferiority of the two-dose series compared to the standard three-dose series (administered at 0, 1-2, and 6 months) in study participants between the ages of 9 and 14 years.10

Routine vaccination with HPV vaccine is recommended between 11 and 12 years of age, but girls and boys as young as 9 years may begin the two-dose series. A three-dose series is still recommended for adolescents and young adults who initiate vaccination at age 15 years or later. Individuals who were previously vaccinated with 2vHPV, 4vHPV or 9vHPV vaccine on a schedule consistent with the current recommendations should be considered adequately vaccinated. Incomplete series can be completed with 9vHPV, the only formulation currently available, regardless of the initial product(s) used and need not be restarted.9 A simplified schedule is significant due to its potential to improve rates of complete vaccination and cost effectiveness.


Meningococcal serogroups A, C, Y, W-135

During the past two decades, a growing body of evidence has indicated an increased risk of meningococcal disease among HIV-positive persons.11,12 As a result, ACIP reviewed available data on the immunogenicity, safety, and cost-effectiveness of quadrivalent meningococcal vaccines in this population. In the Fall of 2016, the committee subsequently recommended that all HIV-positive individuals 2 months and older receive conjugated quadrivalent meningococcal vaccines (MenACWY-D, Menactra® or MenACWY-CRM, Menveo®) to reduce the risk of serogroups A, C, Y, and W-135 infection. This recommendation is aligned with recommendations for the use and dosing of meningococcal vaccines in patients with other specific types of immunocompromising conditions.13

Meningococcal serogroup B

The populations for whom serogroup B meningococcal vaccines are recommended continue to be somewhat narrower than those for the quadrivalent meningococcal vaccines. Vaccination with either of two available formulations, MenB-FHbp (Trumenba®) or MenB-4C (Bexsero®), is recommended by ACIP for individuals age 10 years and older at increased risk and during serogroup B outbreaks. Additionally, there is a permissive recommendation for adolescents and young adults between the ages of 16 and 23 years.14,15

In October 2016, ACIP considered data regarding the immunogenicity of a simplified two-dose regimen for MenB-FHbp as compared to a three-dose series. This followed an April 2016 change in the FDA approved dosing schedule to include use as either a two- or three-dose series with doses at 0 and 6 months and 0, 1-2, and 6 months, respectively. Based on published and unpublished data, ACIP aligned its recommendation with the FDA licensed dosing such that a two-dose series may be used for healthy individuals age 16-23 years. While the two-dose series has the same dosing timeline as MenB-4C, the two vaccines are not interchangeable and a single formulation must be used to complete all doses in the series.16

ACIP continues to recommend that the three-dose series be used for patients at increased clinical risk for meningococcal infection and in outbreak situations. However, in the case that the second dose is administered 6 months or longer after the first dose, the series may be considered complete.16

Cholera

Oral cholera vaccines have been available internationally for some time; however, it was only recently that one was licensed in the United States. Lyophilized cholera serogroup O1 vaccine (CVD 103-HgR, Vaxchora®) received FDA approval in 2016.17 ACIP recommends this vaccine in addition to personal protective measures for adults age 18-64 years who plan to visit areas of active cholera transmission. While this is typically not applicable to most tourist itineraries, individuals who may be at risk of cholera exposure include healthcare workers and other humanitarian workers as well as those who are visiting friends and relatives.18

Yellow Fever

Based on clinical research, the World Health Organization (WHO) amended International Health Regulations to such that a single dose of yellow fever is considered protective for the life of the person vaccinated. Prior to this 2014 change, revaccination was recommended every 10 years for individuals at continued risk and was required as a condition for entry into certain countries.19-21

ACIP aligned its recommendation with the WHO in 2015, and the new international health regulation officially took effect in July 2016.21,22 A recently published systematic review provides further evidence of lifelong immunity following a single dose of yellow fever vaccine.23 Specific patient populations, including those vaccinated during pregnancy, those who are HIV positive, and some hematopoietic stem cell recipients may still require revaccination if they remain at continued risk.22

Due to manufacturing complications and a transition to a new production facility, Sanofi Pasteur is anticipating a complete depletion of supply of YF-VAX® from mid-2017 until 2018. Until Sanofi’s new facility is operational, the FDA, CDC, and U.S. Department of Defense have worked with the company to implement an emergency IND protocol under which certain clinics may administer Stamaril®, a live yellow fever vaccine product similar to YF VAX® that is licensed in many countries and produced in France.24

About the Author

Keri Hurley-Kim, PharmD, MPH is an assistant professor in the Department of Pharmacy Practice at West Coast University School of Pharmacy in Los Angeles, California. Dr. Hurley-Kim has no conflicts of interest to report.


Table 1. Summary of recent updates to ACIP vaccine recommendations:

Vaccine ACIP recommended for: Update(s)

Influenza All individuals over age 6 months (FDA approval for different age groups varies by formulation)

• ACIP recommends against use of live attenuated influenza vaccine (LAIV, Flumist Quadrivalent®).

• Cell culture inactivated influenza vac-cine (Flucelvax®) is now quadrivalent and approved for children and adults 4 years and older.

Human Papilloma Virus (HPV) • Females age 9-26 years

• Males age 9-21 years (up to age 26 may be vaccinated)

• A two-dose series is recommended for adolescents who initiate vaccination before their 15th birthday.

• Nine-valent HPV vaccine (Garadasil-9®) is the only HPV vaccine currently on the market.

Meningococcal Serogroups ACYW • Routine pediatric and adolescent vac-cination

• First-time college students

• Certain immunocompromised patients

• Persons at risk due to an outbreak or international travel to a high-risk area

• Certain laboratory workers

• Military recruits

ACIP now recommends quadrivalent meningococcal vaccine for all HIV-positive patients 2 months and older.

Meningococcal Serogroup B • Certain immunocompromised patients

• Persons at risk due to an outbreak

• Certain laboratory workers

• Permissive recommendation for adoles-cents and young adults age 16-23 years

MenB-FHbp (Trumenba®) may now be administered as a two-dose series in cer-tain patients.

Cholera Adults age 18-64 years traveling inter-nationally to an area with active cholera transmission

A new vaccine, lyophilized CVD 103-HgR covering cholera serogroup O1 (Vaxchora®), was approved in 2016 and is recommended by ACIP for a select patient.

Yellow Fever Persons age 9 months and older travel-ing to or residing in an area with yellow fever virus transmission

• A single dose is now considered to be protective for life - revaccination is not necessary for most travelers.

• A severe shortage of the only FDA approved vaccine, YF VAX®, is expect-ed to continue through mid-2018.


References

1) Ohmit SE, Victor JC, Teich ER, et al. Prevention of symptomatic

seasonal influenza in 2005–2006 by inactivated and live

attenuated vaccines. J Infect Dis. 2008; 198: 312–7.

2) Monto AS, Ohmit SE, Petrie JG, et al. Comparative efficacy of

inactivated and live attenuated influenza vaccines. N Engl J Med.

2009; 361: 1260–7.

3) Ambrose CS, Levin MJ, Belshe RB. The relative efficacy of

trivalent live attenuated and inactivated influenza vaccines in

children and adults. Influenza Other Respi Viruses. 2011; 5: 67–75.

4) Belshe RB, Edwards KM, Vesikari T, et al.; CAIV-T Comparative

Efficacy Study Group. Live attenuated versus inactivated influenza

vaccine in infants and young children. N Engl J Med. 2007; 356:

685–96.

5) Chung JR, Flannery B, Thompson MG, et al. Seasonal

effectiveness of live attenuated and inactivated influenza vaccine.

Pediatrics. 2016; 137: e20153279.

6) Grohskopf LA, Sokolow LZ, Broder KR, et al. Prevention and

control of seasonal influenza with vaccines: recommendations

of the advisory committee on immunization practices – United

States, 2016-17 influenza season. Mortal Wkly Rep. 2016; 65(5):

1–54.

7) Ferdinands J. Influenza vaccine effectiveness update.

Presentation at CDC Advisory Committee on Immunization

Practices meeting. Atlanta, GA; 2017 June.

8) Grohskopf L. Proposed recommendations. Presentation at

CDC Advisory Committee on Immunization Practices meeting.

Atlanta, GA; 2017 June.

9) Meites E, Kempe A, Markowitz LE. Use of a 2-dose

schedule for human papillomavirus vaccination — updated

recommendations of the advisory committee on immunization

practices. Morb Mortal Wkly Rep. 2016; 65(49): 1405–8.

10) Iversen O-E, Miranda MJ, Ulied A, et al. Immunogenicity of the

9-valent HPV vaccine using 2-dose regimens in girls and boys vs

a 3-dose regimen in women. JAMA. 2016; 316: 2411–21.

15) MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel

M, Martin SW. Use of Serogroup B Meningococcal Vaccines

in Adolescents and Young Adults: Recommendations of the

Advisory Committee on Immunization Practices, 2015. Morb

Mortal Wkly Rep. 2015; 64(41): 1171-6.

16) Patton ME, Stephens D, Moore K, MacNeil JR. Updated

Recommendations for Use of MenB-FHbp Serogroup B

Meningococcal Vaccine — Advisory Committee on Immunization

Practices, 2016. Morb Mortal Wkly Rep. 2017; 66(19): 509–13.

17) Food and Drug Administration. FDA approves vaccine to

prevent cholera for travelers. (2016 June). https://www.fda.gov/

newsevents/newsroom/pressannouncements/ucm506305.htm

(accessed 2017 July 6).

18) Wong KK, Burdette E, Mahon B, et al. Recommendations

of the advisory committee on immunization practices for use of

cholera vaccine. Mortal Wkly Rep. 2017; 66(18): 482–5.

19) Gotuzzo E, Yactayo S, Cordova E. Efficacy and duration of

immunity after yellow fever vaccination: systematic review on the

need for a booster every 10 years. Am J Trop Med Hyg. 2013;

89(3): 434-44.

20) World Health Organization. Updated Annex 7 of the

International Health Regulations (2005) (2014 May). http://www.

who.int/ith/A67_2014_Annex-7-en.pdf?ua=1 (accessed 2017 July

6).

21) World Health Organization. Amendment to International Health

Regulations (2005), Annex 7 (yellow fever). http://www.who.int/ith/

annex7-ihr.pdf?ua=1 (accessed 2017 July 6).

22) Staples JE, Bocchini Jr JA, Rubin L, Fischer M. Yellow

fever vaccine booster doses: recommendations of the advisory

committee on immunization practices, 2015. Morb Mortal Wkly

Rep. 2015; 64(23): 647-50.

23) Wieten RW, Jonker EFF, van Leeuwen EMM, et al. A single

17D yellow fever vaccination provides lifelong immunity;

characterization of yellow-fever-specific neutralizing antibody

and T-cell responses after vaccination. PLoS One. 2016; 11(3):

e0149871.

24) Gershman MD, Angelo KM, Ritchey J, et al. Addressing a

yellow fever vaccine shortage – United States 2016-2017. Morb

Mortal Wkly Rep. 2017; 66(17): 457–9.

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Adjunctive Azithromycin Prophylaxis for Cesarean Delivery

evidence-based review

Genene Salman, PharmD, BCPS, BCCCP, CNSC; Henry Hua, PhD; Noelle de Leon, PharmD, BCPS, BCCCP; LaDonna Oelschlaeger, PharmD, BCPS

• Patient population: 2,013 women were pregnant with one child for ≥ 24 weeks and underwent unplanned cesarean section.

• Intervention: 1,019 women received azithromycin 500 mg intravenously plus standard antibiotic prophylaxis (cefazolin) or the alterna-tive antibiotic prophylaxis (clindamycin ± gentamicin) in the case of penicillin allergy.

• Comparison: 994 women received the standard or alternative antibiotic prophylaxis and a saline placebo.

• Outcome: The primary outcome was a composite of maternal postoperative infections with a follow-up period of 6 weeks; secondary outcomes included neonatal death and serious neonatal complications until 3 months of age and maternal adverse events occurring within 6 weeks.

Trial Validity Risk of Bias

Start of Trial High Possible / Unclear

Low

Randomization / Concealment• Patients were randomized in a 1:1 manner via a computer-generated block-designed system, which stratified patients by site. The computer-generated block-designed concealment minimized the introduction of bias.

XBaseline Characteristics• Baseline characteristics including age, body-mass index, diagnosis of gesta-tional diabetes mellitus and chronic hypertension, and use of alcohol and illegal substances were comparable between azithromycin and placebo groups.

• The azithromycin and placebo groups had similar characteristics relating to the cesarean procedures, including primary indication for cesarean deliv-ery, receipt of standard antibiotic prophylaxis, and timing of the study-drug administration.

• The placebo group consisted of greater percentage of patients who smoked during pregnancy than the azithromycin group (12.3% vs. 9.5%; p=0.047). Smoking during pregnancy may be linked to a wide range of complications, potentially biasing the placebo group for worse outcomes than the azithromycin group. In addition, the degree of smoking was not mentioned.

• The study represented a diverse population spanning 14 hospitals across the United States. There were a similar number of non-Hispanic black (34%) and white (35%) women, in comparison to Hispanic women (20%) and those categorized as others (10%). On average, the women were 28 years old and had a body-mass index of approximately 35 kg/m2.

X



During Trial High Possible / Unclear

Low

Blinding• The patients, clinical research staff, outcome assessors, data collectors, and analysts were unaware of the treatment assignments throughout the study. However, the investigational pharmacists involved in the preparation of azithro-mycin were able to view the identity of the patients’ treatment assignments via a secure website.

X

Equal Treatment• Azithromycin is available by prescription. The open-label use of azithromycin was not explicitly stated.

• Patients receiving antimicrobial therapy for reasons other than group B streptococcus were excluded, reducing the likelihood of unequal treat-ment between the groups. The percentage of patients who tested positive for group B streptococcus was found to be similar between the groups. However, since the exact percentage of patients who received antibiotics for group B streptococcus and the identity of medications were not disclosed, bias may have been introduced. The impact of this bias is unknown.

• According to the study protocol, supplemental doses of cefazolin to patients who were morbidly obese or who had significant hemorrhage may have been given at the discretion of the clinician. Details of any dose varia-tions may have been helpful to show homogeneity of dosing between the groups, but this information was not provided. Thus, differences in clinician dosing may have resulted in unequal treatment, and the direction of bias is unclear.

• Additionally, the alternative antibiotics (clindamycin alone or in com-bination with gentamicin) were given to patients with a penicillin allergy. Gentamicin is an antibiotic with a broader spectrum of coverage in com-parison to cefazolin and may have enhanced the treatment. Since it was not clear how many patients received this alternative treatment and if it was evenly distributed between the two groups, there may be the possibility that the study groups were not treated equally. However, the direction of this bias is uncertain.

X

577921_Hayslip.indd 1577921_Hayslip.indd 1 09/03/12 3:24 PM09/03/12 3:24 PM



End of Trial High Possible / Unclear

Low

Completeness of Outcome Date• The total percentage of mothers who did not follow up at 6 weeks was 2.6% (52 out of 2,013), while the total percentage of infants who were not evaluated at the 3-month follow-up was 5.4% (109 out of 2,013). The percentage of mothers and infants that did not complete the trial was similar between the two groups.

• Of the 52 mothers who did not complete the trial at 6 weeks, 25 (2.6%) were from the azithromycin group, and 27 (2.7%) were from the placebo group. Of the 109 infants who did not reach the 3-month child follow-up, 54 (5.3%) were from the azithromycin group, and 55 (5.5%) were from the placebo group.

• Comparing the total percentage of mothers who were lost to follow-up within 6 weeks (2.6%) to the absolute risk reduction of the primary composite outcome (5.9%), the primary composite outcome is not likely to be affected by the incom-plete data. However, since the absolute risk increase in maternal gastrointestinal (GI) symptoms (1.3%) was lower than the total percentage of mothers lost to follow-up (2.6%), the results may be skewed with an unknown direction.

• The total percentage of infants lost to follow-up (5.4%) was greater than the absolute risk increase in neonatal respiratory distress (0.8%) at 3 months, result-ing in a possibility that the results may be distorted due to the missing data.

X

Method of Outcome Analysis• The intention-to-treat analysis was utilized to determine the primary and sec-ondary outcomes. This method of analysis prevents the bias that may arise when patients do not complete the study.

X

Trial ResultsEfficacy Outcome

[Azithromycin + Standard Antibiotic

Prophylaxis]

N=1019

[Standard Antibiotic

Prophylaxis]

N=994

Relative Risk (RR) and 95% Confidence

Interval

Relative Risk Reduction

(RRR)

Absolute Risk Reduction

(ARR)

P-value Number Needed to Treat (NNT)

Primary Composite Outcome1

62 (6.1%) 119 (12.0%) RR 0.51 (0.38-0.68)

49% 5.9% <0.001 NNT= 17

1The primary composite outcome consisted of endometritis, wound infection, which included necrotizing fasciitis and deep wound infection, and other infections such as abdominal or pelvic abscess, septic pelvic thrombophlebitis, maternal sepsis, pyelonephritis, pneumonia, and meningitis. The azithromycin group had a significantly lower rate of endometritis as compared to placebo (3.8% vs. 6.1%; p=0.02) as well as wound infection (2.4% vs. 6.6%; p<0.001). The primary composite outcome was based on the number of patients who were found to have one or more infections. Accordingly, one patient who had multiple infections would still be counted as one outcome occurrence.


Adverse Events Azithromycin Group

N=1019

Placebo Group

N=994

Absolute Risk Increase (ARI)

p-value

Neonatal complication: respiratory distress syn-drome2

42 (4.1%) 33 (3.3%) 0.8% 0.34

Maternal GI symptoms3 (any vomiting, diarrhea, or ileus)

79 (7.8%) 64 (6.4%) 1.3% 0.25

2Respiratory distress syndrome was a component of the composite neonatal complications and was not significantly different between the two groups. 3The occurrence of maternal GI symptoms was a component of other/individual maternal adverse events composite outcome.

All maternal serious adverse events were a secondary composite outcome, which included maternal death, severe maternal allergic reaction, any adverse event with discontinued study medication, pulmonary embolism, intensive care unit admission, and cardiac events. The secondary composite outcome of all maternal serious adverse events was significantly lower in the azithromycin group (1.5%) versus placebo (2.9%) (p=0.03).

Trial Appicability

Patient Applicability• The results of this study would be applicable to women who are pregnant with one child for 24 weeks or greater and are undergo-ing an unplanned cesarean delivery. This study would not apply to women pregnant with more than one child or with a scheduled cesarean section. Further, patients with co-morbid conditions such as severe liver dysfunction, renal dysfunction, and cardiac abnormalities did not participate in this trial.

• Extended-spectrum prophylaxis with azithromycin would broaden coverage to ureaplasma organisms compared to standard antibiotic prophylaxis regimens. Since culture results of ureaplasma from the infected patients were not reported, it is unclear if all patients matching the study’s eligibility criteria should be assumed to carry ureaplasma as part of their lower genital tract flora or if clinicians should further streamline therapy based on history and risk factors.

Intervention Applicability• Azithromycin is a Category B extended-spectrum antibiotic used to treat many infections and is available in oral and intravenous routes by prescription at an affordable cost.

• The standard antibiotic prophylaxis regimens are commonly used preoperatively in practice.

Patient-Important Outcomes Measured• The primary and secondary outcomes were clinical endpoints that were relevant and essential for understanding the clinical impli-cations of patients undergoing non-elective cesarean section. Tita et al. reported results of the overall composite outcomes as well as the corresponding components. For a detailed description of the composite outcomes and the criteria clinicians used to make their diagnosis, it is recommended to refer to the study and the supplementary appendix.

• The determination of the primary composite outcome was based on the number of infected post-partum patients, instead of the total of number of infections. (Some patients may have had multiple infections.) It is unclear if counting the total number of infec-tions would have any bearing on the results. Similarly, secondary composite outcomes were based on the number of patients expe-riencing adverse event(s) or complication(s). It is unknown if a different approach to reporting the secondary composite outcome would affect the results.

• Azithromycin has been associated with cardiovascular adverse effects, including QTc prolongation and ventricular arrhythmias. The results did not show an increase in cardiac events, and patients with a history of arrhythmias or cardiomyopathy were excluded from the study.


About the Authors

Genene Salman, PharmD, BCPS, BCCCP, CNSC received her PharmD from USC. She worked in a variety of inpatient phar-macy settings as a clinical pharmacist before joining Marshall B. Ketchum University College of Pharmacy in Fullerton, California, as an Assistant Professor. She is also pursuing specialized certifications in Biostatistics and Clinical Trials Design and Management at UC San Diego.

Henry Hua received his PhD in cognitive psychology from the University of Memphis. He currently teaches communications, social sciences, and statistics at Marshall B. Ketchum University in Fullerton, California.

LaDonna Oelschlaeger is an Associate Professor at Marshall B. Ketchum University College of Pharmacy. She received her PharmD from Purdue University and completed a Pharmacy

Practice Residency at the Veterans Administration. Dr. Oelschlaeger practices in an acute care setting and is board certified in pharmacotherapy.

Noelle de Leon, PharmD, BCPS, BCCCP is a Clinical Pharmacist specializing in Critical Care at UC San Francisco Medical Center and an Assistant Clinical Professor at the UC San Francisco

School of Pharmacy in San Francisco, California.

References

Tita ATN, Szychowski JM, Boggess K, Saade G, Longo S, Clark E, et al. Adjunctive Azithromycin Prophylaxis for Cesarean Delivery. N Engl J Med. 2016;375(13):1231-41. DOI: 10.1056/NEJMoa1602044.

Balance of Benefits vs. Harms• Azithromycin is a widely used antibiotic for multiple infections and is generally well tolerated. This study demonstrated that adjunctive azithromycin for unscheduled cesarean delivery resulted in an absolute reduction in risk of overall postoperative infection rate (absolute risk reduction; ARR 5.9%), which is clinically as well as statistically significant (p <0.001).

• Azithromycin appears to have a good safety profile in both the mothers as well as the infants. The secondary composite outcome which included neonatal death and complications at 3 months was similar between the study groups azithromycin group (14.3%) versus placebo (13.6%) with an absolute risk difference of 0.7% (p=0.63). Further, the women receiving adjunctive azithromycin had fewer serious adverse events (1.5%) at 6 weeks compared to placebo (2.9%) with an absolute risk difference of 1.4% (p =0.03). However, since a large number of the mothers and infants did not follow up as directed, these secondary outcomes may be skewed.

• If 1000 patients undergoing non-elective cesarean delivery were treated with adjunctive azithromycin compared to placebo, there would be 17 fewer postoperative infections.

• The overall favorable outcome should be weighted with the cost-effectiveness of expanded use of azithromycin and the possibility of increasing antibiotic exposure.

Conclusion for Healthcare ProfessionalsIn this study, patients who received adjunctive intravenous azithromycin with the standard antibiotic prophylaxis for nonelective cesarean delivery had a relative risk reduction of 49% in postoperative infection rate (p<0.001) compared to those who received standard antibiotic prophylaxis alone. Azithromycin appeared to be well tolerated in the exposed mothers and infants. However, the two groups may not have been balanced, as standard antibiotic prophylaxis treatments may have differed between the groups, and smoking during pregnancy was higher in the placebo group than the azithromycin group. Also, a greater percentage of patients were lost to follow-up in comparison to the absolute risk differences of the secondary outcomes discussed herein, introducing a potential bias with unknown impact. Furthermore, since ureaplasma cultures were not reported, it is not definitive that ureaplasma was the causative organism for the development of the infections. Taking into consideration the above factors, azithromycin prophy-laxis may be beneficial for patients meeting the eligibility criteria and with high suspicion of acquiring postoperative infections.

Conclusion for PatientsAzithromycin is a commonly used antibiotic for a variety of infections and is relatively inexpensive. The study showed that women who underwent an unplanned cesarean section had a lower chance of contracting infections after surgery when given azithromycin in addition to standard antibiotics than with standard antibiotics alone. The mothers and their infants who were exposed to azithro-mycin appeared to have tolerated it well. A limitation to the study was that the placebo group had more smokers than the azithro-mycin group, possibly biasing the results. Further, it is not clear if the bacteria that azithromycin is thought to target caused the infections. Overall, the addition of azithromycin for unscheduled cesarean section may be beneficial for some patients at high risk for infections after surgery.


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background

According to the California State Board of Pharmacy’s website, “An advanced practice pharmacist is a licensed pharmacist

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what is an advanced practice pharmacist?

The new statute states that in order for a pharmacist to be recognized by the California Board of Pharmacy as an advanced

practice pharmacist, you must satisfy at least two of the following:

what are the requirements?

4210(a)(2)(A):

pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy,

pharmacotherapy, or psychiatric pharmacy, from an organization recognized by [ACPE] or another entity

recognized by the board.”

4210(a)(2)(B):

“Complete a postgraduate residency through an accredited postgraduate institution where at least 50 percent of

the experience includes the provision of direct patient care services with interdisciplinary teams.”

4210(a)(2)(C):

“Have provided clinical services to patients for at least one year under a collaborative practice agreement or

protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy

management, or health system”

1

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The California Pharmacists Association (CPhA)

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only recognizes pharmacists as health care providers,

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advanced practice pharmacist.

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• Refer patients to other health care providers

• Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers

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APP Flyer - Two Page Spread.pdf 1 11/22/2017 11:06:39 AM


background

According to the California State Board of Pharmacy’s website, “An advanced practice pharmacist is a licensed pharmacist

who has been recognized by the board, pursuant to Section 4210. A board-recognized advanced practice pharmacist is

entitled to practice advanced practice pharmacy, as described in Section 4052.6, within or outside of a licensed pharmacy.

The advanced practice pharmacist license shall be coterminous with the licensee’s pharmacist license.”

what is an advanced practice pharmacist?

The new statute states that in order for a pharmacist to be recognized by the California Board of Pharmacy as an advanced

practice pharmacist, you must satisfy at least two of the following:

what are the requirements?

4210(a)(2)(A):

pharmacy, nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pediatric pharmacy,

pharmacotherapy, or psychiatric pharmacy, from an organization recognized by [ACPE] or another entity

recognized by the board.”

4210(a)(2)(B):

“Complete a postgraduate residency through an accredited postgraduate institution where at least 50 percent of

the experience includes the provision of direct patient care services with interdisciplinary teams.”

4210(a)(2)(C):

“Have provided clinical services to patients for at least one year under a collaborative practice agreement or

protocol with a physician, advanced practice pharmacist, pharmacist practicing collaborative drug therapy

management, or health system”

1

2

3

Offered through CPhA!

The California Pharmacists Association (CPhA)

spearheaded a bill also known as SB 493 signed by

Governor Jerry Brown on October 1, 2013. This bill not

only recognizes pharmacists as health care providers,

but also develops a new classi�cation known as the

advanced practice pharmacist.

Certificate ProgramRegister for the new training program brought to you by CPhA & NACDS

CPhA partnered with the National Association of Chain Drug Stores (NACDS) to develop the Advanced Practice Pharmacist

provides pharmacists with the knowledge and skills to expand their scope of practice as an advanced practice pharmacist.

patient referral, drug therapy management, and documentation.

• 30 hours (3.0 CEU) self-study modules with assessment exam

• 8.0 hour (0.80 CEU) live seminar with interactive case studies and hands on assessment

one of two criteria required to become an advanced practice pharmacist (APh). Visit www.appharmacist.com to learn more!

what are the benefits of becoming an APh?Successful candidates who meet two of the three criteria and apply with the California State Board of Pharmacy to

become an APh are authorized to:

• Perform patient assessments

• Order and interpret drug therapy-related tests in coordination with a patient’s primary care provider or diagnosing prescriber to monitor patient progress

• Refer patients to other health care providers

• Participate in the evaluation and management of diseases and health conditions in collaboration with other health care providers

• In accordance with a protocol with a physician or facility, a pharmacist may initiate, adjust, and discontinue drug therapy upon referral from a patient’s treating prescriber when necessary and medically appropriate

learn more | appharmacist.com

upcoming dates & locationsFebruary 24, 2018 • Los Angeles, CA

March 24, 2018 • Stockton, CA

June 16, 2018 • Pasadena, CA

September 29, 2018 • Oakland, CA

December 8, 2018 • Los Angeles, CA

register early!This program has 30 hours (3.0 CEU) of self-study modules with an assessment exam to be completed prior to the live training program.

Visit appharmacist.com to register now!

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APP Flyer - Two Page Spread.pdf 1 11/22/2017 11:06:39 AM


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WPE - Two Page Spread.pdf 1 11/22/2017 11:44:49 AM


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A Guide to the California Immunization Registry and Its Use to Enhance the Delivery of Immunization Services

special article

AbstractPharmacists in California are assuming a greater role as independent providers of immunizations for children and adults under Senate Bill 493 (SB 493). One of the requirements for pharmacists as independent providers of immunizations in California is that they must report their administered doses to the California immunization registry system (CAIR). The National Vaccine Advisory Committee Standards for Immunization Practice also supports this practice by recommending that all immunizing providers report vaccinations to their local and state immunization information systems (IIS). This document presents background and specific features of CAIR; best practice recommendations for the use of IIS lookup, forecasting, follow-up, and recall; and documentation features to enhance the delivery of immunization services.

Background

Immunization Information Systems (IIS)

Vaccinations are among the most significant public health advancement in the prevention of many communicable diseases. However, there are st i l l gaps in care, as adu l t vacc ina t ion ra tes fo r rou t ine recommended vaccines in the United States are low and well below projected Healthy People 2020 targets. It is estimated that 40,000 to 50,000 adults st i l l die annual ly f rom vaccine-preventable disease in the United States.1,2

As recommended in the 2013 updated National Vaccine Advisory Committee (NVAC) Standards for Immunization Practice, one step toward improving immunization coverage in the United States is better collaboration among healthcare providers, healthcare systems and organizations, public health departments, and other stakeholders.3 Collaboration among such a large group of providers and stakeholders to increase immunization coverage depends on the ready availability of timely, complete, and accurate patient vaccination information.A tool that provides this information and has shown to enhance vaccine collaboration and communication among providers,

Albert Bach, PharmD; Jeffery Goad, PharmD, MPH; Steven P. Nickell, Ph.D.

facilitate public health monitoring, and increase immunization rates are immunization information systems (IISs), also known as immunization registries.4 The Centers for Disease Control and Prevention (CDC) defines IISs as “confidential, population-based, computerized databases that record all immunization doses administered by participating providers to persons residing within a given geopolitical area.” In addition to providing clinical, decision support, an IIS consolidates a patient’s immunization record from a variety of immunization providers with the goal of assembling a complete patient immunization record for continuity of care and public health assessment. Each state has its own state-based IIS program that is independent of other states but follows policies and recommendations made by the CDC, American Immunization Registry Association (AIRA), and other relevant public health agencies and organizations. Features that are available in most IISs are the ability to query patient vaccine records, receive up-to-date ACIP vaccine recommendations for specific patients, be notified of due or overdue vaccines for patients, and manage vaccine inventory.

A current limitation of IISs at this time is the variability that exists within and between states with regard to IIS reporting of administered vaccine doses. Some states require reporting, while others do not. States that require reporting vary in who is required to report, which age groups are required or even allowed to be reported, which vaccines are required to be entered, and which vaccines are allowed to be entered.

Although these limitations exist, they do not undermine the usefulness of IISs, which continue to benefit from ongoing reporting of childhood and adult doses that still add value.5

California Board of Pharmacy Immunization Documentation Requirements

Prior to 2013, pharmacists in California were only able to administer vaccinations under a signed protocol with a physician. With the passage of Senate Bill 493 (SB 493) in 2013, pharmacists in California are assuming a greater role as independent providers of vaccinations for children and adults.


Section 4052.8 of California Business and Professions code authorizes pharmacists with specified training to initiate and administer the CDC’s Advisory Committee on Immunization Practices (ACIP) routinely recommended vaccines independent of a physician signed protocol. The regulation also mandates that pharmacists in California who provide immunizations must report their administered immunizations into the California Immunization Registry (aka CAIR) and provide notif ication of vaccination to the patient’s primary care provider (PCP), if known. Pharmacists must also notify a pregnant patient’s prenatal provider in addition to their PCP. These reporting mandates must be completed within 14 days of administration of any vaccine. While the state law requirement is for pharmacists to report vaccine doses administered, it is the pharmacy that needs to be registered with CAIR. If the pharmacist wants to view immunization records or enter them manually, then they will need to be added as an individual user under the pharmacy that is registered with CAIR.

Pharmacies are also required to electronically or manually document and retain vaccine administration records for each vaccine administered in the pharmacy. This is often achieved by entering the vaccine like any other prescription medication, making sure to include all federally required elements. Vaccine administration records should include patient information, name of vaccine, vaccine manufacturer name and lot number, date of edition of the VIS and date the VIS was provided to the patient, office address and name and title of the person who administered the vaccine, and date of administration for each vaccine given.

Information on legislation regarding pharmacist-provided immunization and mandated reporting of immunizations to local/state IISs varies by state laws and is updated regularly on the APhA’s Immunization Center webpage (http://www.pharmacist.com/immunization-center) and on the CDC website (https://www2a.cdc.gov/vaccines/i is / i issurvey/ legis lat ion-survey.asp), respective ly.

California Immunization Registry (CAIR)

The IIS system in California is known as the California Immunization Registry (CAIR) System. The centralized CAIR2 regis t r y inc ludes pat ient data f rom the former Nor thern Cali fornia, Greater Sacramento, Bay Area, Central Valley, Central Coast, LA-Orange, and Inland Empire regional registries and is managed by the California Department of Public Health (CDPH).

California also has three non-CDPH CAIR regions (San Diego, Imperial County, and San Joaquin) that will begin sharing data with CAIR2 in the 2018. At that point, any CAIR user will be able to access statewide patient data.

CAIR Enrollment & Training

Instructions for enrolling in CAIR are provided on its website (cairweb.org). To enroll in CAIR2, the pharmacy facility (or any facility that needs access to CAIR2) is actually enrolled, and then individual users are assigned access through their enrolled facility. Information needed for enrolling in CAIR2 are name, address, city, zip code, phone, email, and fax number of the facility and the name and contact information for a main contact at the facility. The CAIR2 enrollment form also asks for a “CA Medical License,” but pharmacists should enter their Registered Pharmacist License number instead (of the PIC or the main contact, if they are a registered pharmacist). When registering in CAIR2, facilities and organizations are given the option of selecting CAIR Access Levels for their facility. These access levels are data exchange, clinical, limited clinical, and read-only. If not enrolling in data exchange (electronic submission), pharmacies should choose the “clinical” access level. This will allow them to manually create new patients, enter vaccine doses, and look up patient records. For pharmacies that would like to sign up for data exchange, they should consult with their pharmacy computer system vendor to see if their system has the capability to send immunization records to CAIR2 in HL7 format. If a pharmacy computer system does not have the capability to send records directly to CAIR2 in HL7 format, there are some health information exchanges and vendors that, for a subscription fee, are able to convert data from most pharmacy computer systems to HL7 so that it can be submitted electronically to CAIR2.

When adding users to a facility, the facility administrator can also assign user levels for each user. These user levels are “Power,” “Regular,” and “Read-Only.” Differences between these three user levels is shown in Table 1 below. Pharmacies that are manually submitting doses to CAIR2 should choose the “Regular” user type if they do not plan to manage inventory in CAIR or the “Power” user type if they would like to use the inventory feature.


Prior to 2013, pharmacists in California were only able to administer vaccinations under a signed protocol with a physician. With the passage of Senate Bill 493 (SB 493) in 2013, pharmacists in California are assuming a greater role as independent providers of vaccinations for children and adults. Pharmacists at sites that are enrolled in data exchange do not need to manually add/edit new doses or add/edit new patients, but they should enroll their vaccinating pharmacists as “Read-Only” so they can at least search patient records and run reports or as “Regular” users so they can search records, run repor ts, and enter historical vaccine doses. We will discuss the importance of pharmacists having access to these features later in this document.

After enrolling the pharmacy and users within the pharmacy, each user is emailed instructions to schedule and complete online training before they are granted access to CAIR2. “Power” users will be required to complete a 2-hour live training webinar, and “Regular” users will be required to complete a 1-1/2-hour live training webinar. “Read-Only” users are not required to complete training but will be referred to videos and quick guides for self-review.

Pharmacies in the San Joaquin, San Diego, or Imperial County have different enrollment procedures and should contact their local CAIR Representative listed on this page: http://cairweb.org/cair-regions/.

CAIR Disclosure/Sharing Policy

Before pharmacists can enter and submit patient information to CAIR, they are required per California law (Health and Safety Code, Section 120440) to provide patients/parents with a proper disclosure notice. Pharmacists must use the CAIR “Immunization Registry Notice to Patients and Parents” to provide disclosure; this CAIR Notice is available on the CAIR Forms webpage (ht tp://cairweb.org/forms/ ) in multiple languages. Pharmacists must give a copy of the CAIR Notice or post it and point it out to each patient/parent whose information will be entered into CAIR to read. If the patient is under the age of 18, the disclosure notice must be given to the parent or guardian. Patients or parents do not need to sign the disclosure. So as long as a patient/parent is given proper disclosure, the data can be shared with CAIR and the date of disclosure is documented in the patient’s profile in CAIR. This disclosure process only needs to be done once.

Once disclosure is performed, patient information that is entered into or shared with CAIR can include any and all vaccine doses or tuberculosis (Tb) testing results received by the patient, regardless of when those doses or Tb tests occurred relative to the date of disclosure.

If a patient or parent wishes to limit access to their immuniza-tion record in CAIR, they must complete and submit to the CAIR Help Desk a “Decline or Start Sharing Immunization Information Request Form,” which can also be found in mul-tiple languages on the CAIR Forms webpage. Upon receipt of this form as a fax or email, CAIR Help desk staff will “lock” the record so it cannot be access by other CAIR users.

Beyond Reporting: Use of CAIR to enhance the deliv-ery of immunization services

While the California Board of Pharmacy regulation current-ly only mandates reporting of vaccine doses adminis-tered to the IIS, CAIR offers many other features that can enhance and improve the delivery of immunization servic-es. CAIR and many other state IISs have the feature to look up patient immunizations, provide patient-specific vaccine recommendations, run patient follow-up reports, and pro-vide immunization record documentation. Pharmacists with access to CAIR are encouraged to incorporate these CAIR tools and features into their immunization practice and the Pharmacist’s Patient Care Process for immunization services.6,7

Lookup

Prior to providing immunizations, pharmacists should collect patient information to screen for vaccine precautions or contra-indications as well as indications for other vaccines. Information needed to screen for indications and precautions/contraindica-tions are gathered from multiple sources, including a patient’s personal immunization record, pharmacy dispensing system records, primary care providers, and patients’ verbal history. Access to CAIR provides another useful and reliable source of immunization information that can be used to determine vaccine status and needs. Pharmacists with access to their state immu-nization registry are encouraged to query and look up patients in the registry before vaccinating. This process also ensures that patients are not receiving duplicate vaccinations, spacing and sequencing of vaccines is appropriate, and due or overdue vaccines for the patient are identified and recommended during the encounter. CAIR also has the ability to document and record notes from other CAIR providers about previous vaccine reac-tions and adverse events to determine if it is appropriate for the patient to receive subsequent doses of a vaccine or a particular type of vaccine.


Currently, CAIR and many other IISs are not able to access IIS data from other states; users will not be able to see vac-cine records that were administered and entered in another state’s IIS. This limitation is not unique to IISs but related to the absence of a centralized data and electronic health record sys-tem.

Vaccine Schedule & Forecasting

When conducting a patient search and lookup in CAIR2 prior to vaccination, providers should view the “Vaccines Recommended by Selected Tracking Schedule” section listed in the patient’s “History/Recommend” page. This section notifies the user of overdue, due, and future vaccine dates to keep patients up-to-date and on schedule with current ACIP recommendations. Providers can use this registry-generated assessment section to determine if the next dose in a vaccine series is appropriate to be given, and, if not, when is the recommended date to give the dose. The schedule tool in CAIR2 is also able to inform the provider if a certain vaccine that was previously administered was considered an invalid dose if its administration did not follow ACIP recommendations. Clicking on the name of a vaccine listed under “Vaccines Recommended by Selected Tracking Schedule” for the patient will present the user with an explanation for the current status as well as what the recommended interval and age recommendations are for that vaccine. Similar to the benefits of a lookup, the vaccine schedule and forecasting tools in the CAIR IISs allows for determination of appropriate spacing and sequencing of vaccines and to identify due or overdue vaccines for the patient. The schedule and forecast tool in CAIR IISs can also save the pharmacist time by providing timely access to immunization records and recommendations without having to collect and review information from multiple sources. As more adult providers begin to document in CAIR the vaccines they administered, CAIR will become a complete immunization record.

A caveat to mention for the schedule and forecast tool is that CAIR only provides recommendations for routine ACIP recommended vaccines; therefore, travel vaccines or elective vaccines will not be included in the list of recommended vaccines for the patient. While such vaccinations will not show up in the recommendations section, all FDA-approved vaccines can be documented in CAIR. As with many clinical support tools, there may be a lag time in which new ACIP recommendations may appear in CAIR’s schedule and forecasting feature.

The forecast tool is not able to make recommendations that a re based of f of the ACIP recommended immunizations by health condition. For example, pneumococcal recommendations in CAIR are currently only based on the patient’s age and do not take into account high-risk conditions that may require a patient to receive pneumococcal vaccination before 65 years of age. Pharmacists must assess and use their clinical judgment to determine if vaccination is needed in these patient populations. Also, a listed recommendation in CAIR does not mean that the patient is medically clear to receive that vaccine—pharmacists should still conduct a thorough screening for precautions and contraindications to receiving vaccines before providing the recommended vaccine.

Follow-up & Recall Reminders

Pharmacists should have a plan to follow up with patients to provide additional doses needed to complete a vaccines series and/or booster doses. Follow-up ensures continuity of care, increases rates of immunizations and completion rates, and increases vaccine volume for your practice. Immunization registry reminder and recall systems have shown to boost immunization rates by up to 20%.8,9 CAIR has a patient “Reminder/Recall” report feature that can identify your pharmacy’s CAIR patients who are due for vaccines. Providers can run these reports to obtain a list of patients who they have provided vaccines for in CAIR and who have due or overdue vaccines and should be contacted for follow-up.

DocumentationIn addition to documenting vaccines administered by the pharmacy as required by law, pharmacists are also encouraged to update the patient’s historical records in CAIR. Situations that may require updating information in CAIR include the patient presenting with record of having received vaccine(s) that is not found in CAIR, a new Tb test or chest X-ray results, or a change in the patient’s information/demographics. CAIR users are able to enter historical doses into the patient’s record for vaccines that were administered by another healthcare provider. Entering historical doses will help complete the patient’s record, make that information available to all users of CAIR, and allow CAIR’s recommendation and forecasting tool to make more accurate recommendations for the patient that can avoid duplication and inappropriate spacing of vaccines. Pharmacists are only required to notify the primary care provider when they administer a vaccine but not when they update CAIR with historical immunization data.


CAIR is also able to produce and print a copy of the patient’s records in the “Immunization Yellow Card” format, which can be given to the patient as documentation for them to carry and share with other members of their healthcare team.

ConclusionAs California pharmacists independently initiate and administer more immunizations in the pharmacy setting, it is increasingly important for pharmacists to share those records with other healthcare providers in the “Immunization Neighborhood,” such as through IIS reporting. Reporting to the IIS assists in the public health efforts to improve immunization rates and reduce vaccine-preventable diseases. Access to an IIS like CAIR also provides the pharmacists with an additional clinical decision support tool that can reduce missed immunization opportunities by conducting vaccine assessment for patients based on their immunization record/history in accordance with ACIP recommendations. In addition to complying with Board of Pharmacy regulations for reporting to the IIS, pharmacists are encouraged to incorporate and utilize the lookup, forecasting, and recall reminder features within an IIS to enhance their delivery of immunization services.

About the Authors

Albert Bach, Pharm.D., Assistant Professor of Pharmacy Practice at the Chapman University School of Pharmacy, Bach has no conflicts of interest to report.

Jeffery Goad, Pharm.D., MPH, FAPhA, FCPhA, Professor and Chair of the Department of Pharmacy Practice at the Chapman University School of Pharmacy. Goad is a speaker for Merck Vaccine and a consultant for Travax.

Steven P. Nickell, Ph.D., Chief of Registry & Assessment Section for the Immunization Branch at the California Department of Public Health, Nickell is an employee of the California Department of Public Health and is responsible for oversight of the California Immunization Registry program planning and development.

References1. Robert Wood Johnson Foundation, Trust for America's Health, Infectious Disease Society of America. Adult Immunization: Shots to Save Lives. 2010.

2. Immunization and Infectious Diseases—Healthy People. 2010; http://www.healthypeople.gov/2020/topicsobjectives2020/overview.aspx?topicid=23. Accessed January 22, 2017.

3. National Vaccine Advisory Committee. Update on the National Vaccine Advisory Committee Standards for Adult Immunization Practice. In:2013.

4. Groom H, Hopkins DP, Pabst LJ, et al. Immunization information systems to increase vaccination rates: a community guide systematic review. J Public Health Manag Pract. 2015;21(3):227-248.

5. Progress in immunization information systems—United States, 2012. MMWR Morb Mortal Wkly Rep. 2013;62(49):1005-1008.

6. Bach AT, Goad JA. Applying the Pharmacists Patient Care Process to Immunization Services: A Resource Guide for Pharmacists. In: American Pharmacists Association; 2017.

7. Joint Commission of Pharmacy Practitioners. The Pharmacists' Patient Care Process—JCPP. 2017.

8. Briss PA, Rodewald LE, Hinman AR, et al. Reviews of evidence regarding interventions to improve vaccination coverage in children, adolescents, and adults. The Task Force on Community Preventive Services. Am J Prev Med. 2000;18(1 Suppl):97-140.

9. Jacobson Vann JC, Szilagyi P. Patient reminder and patient recall systems to improve immunization rates. Cochrane Database Syst Rev. 2005(3):Cd003941.

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New Doses

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New Patients

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Inventory

Power X X X X X X

Regular X X X X X

Read Only X X

Table 1. Comparison of the three different access levels within CAIR.

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