AJP Fall 2017

Arizona Journal of Pharmacy Fall 2017

The official publication of the Arizona Pharmacy Association brought to you by the Pharmacy Network of Arizona

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T N E M ANAGE

M N I A P

AzPA is proud to announce the launch of our

Pain Management Certificate Program (PMCP) The Pain Management Certificate Program was developed to provide pharmacists with education on the pharmacist’s role in chronic pain management and how to communicate with patients and providers about issues related to common pain syndromes, monitoring, and treatment approaches. This program will consist of a home study component and a virtual live webinar.

December 16, 2017

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Table of Contents Page Number

Journal Section

4

Board of Directors/ Editorial Board

5

President’s Message

6

Association News

9

Event Recaps (APF Masquerade Ball & Fall Conference)

11

PAPA Message

13

Legislative Update

15

Featured Highlights

32

Continuing Education

The Evolving Role of Pharmacists in Providing

Contraception: A Practical Guide to Contraceptive Products

Cover Art Credit: James and Danielle Montague “This drawing was inspired by the fact that not only does AZPA advocate for new initiates that advance the practice of pharmacy in Arizona, but a big part of its role in promoting the profession as a whole is protecting pharmacy from potentially harmful legislation and initiatives. The picture depicts various pharmacy professionals and technicians banding together to form a shield wall. The strength of this bulwark is the sum of its members; the darkly colored arrows deflected are symbolic of the negative initiatives which can seemingly come from anywhere.”

- James Montague, PharmD AzPA Managed Care Academy Chair

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Arizo na Pharmacy Association 2017-2018 Board of Directors Officers Lorri Walmsley

Past President

Jessica DiLeo

President-Elect

Keith Boesen

President

Az-ACCP Chapter

Jeannie Hong, Chair

Managed Care Academy James Montague, Chair

Jaime Von Glahn, Chair-Elect

Aimee (Keller) Itaaehau, Chair-Elect

Patrick Hryshko, Chair-Elect

District Directors

Laura Moore, Northeast Jacob Schwarz, Southwest

Dean of Colleges

Mitchell R. Emerson, Midwestern University CPG Rick G. Schnellmann, University of Arizona COP

Legal Counsel AzPA Staff

Kelly Fine, Chief Executive Officer Cindy Younger, Accounting Deborah Marcum, PAPA Sarah Elenes, Membership Erin Roy, Events/ Communication Cindy Esquer, Operations Kathy Harty, Continuing Education

Brian Seigfried, Chair, MWU Justin Spicer, Chair-Elect, MWU Candice Eastman, Chair, U of A Kassie Notbohm, Chair-Elect, U of A

J.R. Gill, Chair

Secretary

Roger Morris

Student Pharmacist Academy

Technician Academy

Whitney Rice

John Fezza

Community Pharmacy Academy Health-System Academy

Treasurer

Industry Representative

Stacey Hollen, Chair

Susana Horst, Chair

Lisa Tonrey

Kevin Reger, Chair-Elect

Lynette Wasson, Northwest

The interactive digital version of the Arizona Journal of Pharmacy is available for members only online at www.azpharmacy.org/ajp (480) 838-3385 web@azpharmacy.org EDITOR’S NOTE: Any personal opinions expressed in this magazine are not necessarily those held by the Arizona Pharmacy Association. “Arizona Journal of Pharmacy” (ISSN 1949-0941) is published quarterly by the Pharmacy Network of Arizona at: 1845 E. Southern Avenue, Tempe, AZ 85282-5831.

Editor

Kelly Fine, R.Ph., FAzPA

Managing Editor Cindy Esquer

Editorial Board Lindsay Davis, Pharm.D. Whitney Rice, Pharm.D. Andrea Burns, Pharm.D. Christi Jen, Pharm.D. Nicole Scovis, Pharm.D.

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Creative Coordinator Sarah Elenes

P r e s i d e n t ’s

M e s s a g e

Dear AzPA Members, Winter is coming! We must prepare our houses…

Speaking for the board of directors, we have much to do in preparation for winter. In my last message, we already had a list of tasks we must complete before and during the winter months.

One of those was to update our strategic plan, which includes our mission, vision, core values, and goals for the next few years. Your board of directors used the feedback from the annual convention to develop the framework at our summer retreat. We continued the planning during and after our second board meeting in September, and we plan to have it finalized at our third board meeting in November.

Another item on the list was to update our bylaws. This is critical and one of the most important tasks for the association. As many of you know, the bylaws are the blueprints for how the association operates.

Our bylaws have not been updated in many years and we plan to exit the winter as prepared as we can be to move the association forward.

I also mentioned a desire to improve the efficiency of the board. I feel the best way to do this is to both decrease the size of the board and adjust the terms of service. We have an incredibly large board that turns over pretty frequently making continuity of ideas and progress quite difficult. This is a pretty significant change and will require a great deal of planning. I welcome feedback from the members to help us shape the association for future generations.

Finally, I mentioned the need for advocacy. This is one of the more important roles the association provides to the profession. AzPA is there to help expand our profession as well as protect it from threats.

AzPA is the only group in the state capable and organized to speak on behalf of the profession. Having a large membership base increases the volume of the voice of the association.

The board is not the only group preparing for winter. Kelly Fine, AzPA CEO, the AzPA staff, and all of you who are volunteering on the various groups and committees necessary to plan for the next legislative session, the development and implementation of Naloxone training, an updated website, a corporate memberships structure, the next conference, and many other tasks are all hard at work. …So as you all prepare your houses for the winter, whether you are a Lannister, a Stark, or a Targaryen, the Board of Directors and the Central Office owe you all a tremendous thank you for your hard work and your support.

Keith Boesen, PharmD, CSPI AzPA President 2017-2018

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A s s o c i a t i o n

N e w s

MISSION STATEMENT

The Arizona Pharmacy Association is committed to serving and representing all pharmacy professionals in all practice settings.

AzPA will foster safe and effective medication therapy, promote innovative practice, and empower its members to serve the health care needs of the public.

VISION Empowering pharmacy professionals to provide optimal patient care.

Advancing Pharmacy to Improve Healthcare

WELCOME NEW MEMBERS ASSOCIATES Nathan Kofler Dawna Rinetti PHARMACISTS Dorian Foster Michael Licamele Kellie Goodlet Cynthia Gray Chawntel Hunt Symara Schmidt RESIDENT Ali Aldayyen Jonathan Enchinton Alex Hadesman Jeffrey He STUDENT Dylan Altstadt Alexandra Maga Kyle Miller Kelsey Spadafora

Donna Vo Andraea Aksentijevic Kalia Anderson Yaseen Arsalan Nicholas Averill Riham Awad Anna Karyl Bagsic Rita Bali Justin Bandy Jessica Barajas Linda Barakat Alanda Barash Jacob Bell Alexis Betancourt Maximilian Bini Natella Borukhova Misty Brannon Tanner Bucholz Casey Buckway Alicia Bylsma Sean Cahill Emily Cameron Sheridan Carson

Ryan Cohen Amanda Colistro Megan colvin Roberto Cortez Giselle Cuellar Colton Dabney Magy Eskander Adam Francis Amanda Haage Toktam Habibi Taylor Heintz Cameryn Hicks Meranda Hirmiz Van Anh Hoang Manuel Holguin Chavarria Andrew Jubala Brittany Kelly Grace Korames Maria Kovac Yasmeen Kronz Tanya Lasker Karen Le Joshua Lee

Khoa Ma Eden Malki Chase Markel Sema Masani Ann Mason Yeseniya Matatova Intesar Mohammed Kenneth Myers Jordan Ng Han Nguyen Nam Nguyen Van Nguyen Jana Olwine Melissa Reay Kelsey Rewinkel Crystal Rim Dustin Robinette Viola Rudolph Cindy Ryanto Mary Rzayev Stanislav Sazonov Himani Shah Shannon Somero

Alyssa Spavor Byron Stevenson Huy Tran Nathan Tran Anh-Thu Truong Curtis Wall Megan Werckmann Sydney Westergren Traditha Williams Nicholas Winter James Yee Nusem Yu Leila Zahedi TECHNICIAN Matthew Gordier Shannon Starr Jeffery Bray Sophia Chen Marcene Larson

NEW MEMBERS: Visit your Member Center to learn how to get more involved with AzPA. Located on www.azpharmacy.org homepage.

CHEERS FOR VOLUNTEERS! We acknowledge the contributions of the volunteers who have made a difference for our organization over the past quarter. Thank you for your continued support of the pharmacy profession.

Thomas Richards | Nathan Lazan | Andrew Chun

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See what our tomorrow looks like at: phmic.com/tomorrow2

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S A V E

T H E

D A T E

AZPA EVENTS Pharmacy Day at the Capitol April 19, 2018 (Phoenix, Az)

Southwestern Clinical Pharmacy Seminar April 27-29, 2018 (Tucson, Az)

AzPA 2018 Annual Convention June 14-17, 2018 (Chandler, Az)

AzPA LEARNING EXPERIENCES Pain Management Certificate Program December 16, 2017 (Virtual Program)

Anticoagulation Certificate Program January 19, 2018 (Phoenix, Az)

AzPA Psychiatric Certificate Program January 27, 2018 (Tucson, Az)

APhA Pharmacy-Based Cardiovascular Disease Risk Management Program February 16, 2018 (Phoenix, Az)

APhA Pharmacy-Based Medication Therapy Management Services in the Community February 24, 2018 (Phoenix, Az)

AzPA Career Center Check out the AzPA Career Center online.

Find the best pharmacy-related jobs in the state, or search through resumes of the most highly qualified pharmacists Arizona has to offer. Ask about our employer advertising. azpa.webscribble.com

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2017 Fall Conference The Arizona Pharmacy Association partnered with the Southwest Diabetes Symposium and the American Society for Medication Therapy Management to host our Annual Fall Conference on September 16, 2017. We had over 700 attendees ranging from physicians, nurses, dieticians, pharmacists, technicians and students. We plan to partner again next year so mark your calendars for September 15, 2018!

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2017 APF Masquerade Ball The Arizona Pharmacy Foundation is a charitable organization dedicated to supporting substance use disorders by administering the PAPA program as well as educating pharmacy professionals on proper medication use and disposal. Our goal is to partner with Arizona professionals to make a difference and positively impact our community.

On September 30, 2017 we hosted a Masquerade Ball to raise support for our mission. Thank you to all who joined us at the ball and in the fight for a healthier Arizona!

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Pharmacists Assisting Pharmacists of

Arizona (PAPA)

Not a Scary Movie Carl Labbe, RPh. Arizona Pharmacy Foundation - Director at Large He was always willing to help out, covering an extra shift here and there, offering to work till closing alone, and always just so darn helpful. It wasn’t long before I began to notice the dark side, however. The nervous reaction when a pharmacist or tech approached him while he was working alone, escalating offers that would allow him to be alone in the pharmacy, and an underlying sense of dishonesty, all led to suspicions of misbehavior. Then product started disappearing. When alerting management of my suspicions,I was advised not to schedule this pharmacist for coverage shifts any longer, effectively terminating his parttime employment with us. I know now that this was the wrong thing to do. He was never allowed back in that pharmacy.

Months later he started showing up at the clinic and the pharmacy. He brought treats for the nurses and the pharmacy staff. He tried so hard to ingratiate himself into our good graces. I could still see the dark side, however. The offers to send myself or the staff pharmacist home early and he would close up for us, resumed. Even off the clock!

I detected the furtive glances trying to see how much hydrocodone we had on the shelf.

I could feel the desperation.

Despite what management had told me, I felt that I must intervene, so I took this young pharmacist to my office and discussed his obvious substance problem. At first he denied it all, of course, but as I expressed empathy and pointed out the obvious addictive behaviors, he told me the whole story. Like many patients with substance abuse disorders, it began with a legitimate prescription for pain management of an acute injury. This pharmacist had be in a grievous accident, involving multiple fractures and significant pain. The slippery slope was too much for him to overcome. In a familiar progression of events, he started augmenting his regular prescriptions with Rxs from other prescribers, taking a tablet or two during his works shifts at one of his three part-time jobs, to eventually stealing entire stock bottles as his addiction took control of his life.

Fortunately, he was able to break the cycle of addiction and get the help he needed. He admitted his addiction to his parents and referred himself to the board of pharmacy and into the PAPA program. All of this happened over a decade ago and that pharmacist is now rehabilitated and working in the profession.

Over the years I have had more opportunities to see the scope of this problem. It has many different faces. A doctor friend whom I played racquetball with on a regular basis, had been ordering a hydrocodone cough syrup at increasing frequency from our pharmacy “for office use,” a former student was caught on tape accessing the narcotic

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Pharmacists Assisting Pharmacists of

Arizona (PAPA) cabinet during non-business hours and removing product, I was asked to go to a pharmacy as quickly as possible because there would be no pharmacist there and arrived in time to see the pharmacist being “perp walked” out of the facility, I was nearly physically assaulted when a call from a technician required me to go and ask the pharmacist for his keys and terminate his employment as he was obviously drunk, and belligerent, on duty. The scary stories are endless.

Most of us enjoy the thrills we get from a scary movie, whether it be an evil clown peeking out of a sewer or mysterious creatures from an upside-down world right next to ours. In real life, not only our patients are affected, the problems of substance abuse permeate our profession. Pharmacists are not unlike our patients and have substance abuse disorders at about the same rate as the general population, somewhere around 12%. The problem is scary and all too real.

This is why I became a part of the Arizona Pharmacy Foundation which provides critical support for the PAPA program as well as providing education for pharmacists and the community to prevent, recognize and understand treatments of substance abuse disorders. It’s rewarding to be a small part of an effective solution.

If you or someone you care about is suffering from an alcohol and/or chemical dependency problem...help is available.

Pharmacists Assisting Pharmacists of Arizona “A Partnership in Caring”

Contact the AzPA Office at 480.207.7869 or papa@azpharmacy.org All calls confidential. Caller remains anonymous.

PAPA is a program of the Arizona Pharmacy Foundation

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L e g i s l a t i v e

U p d a t e

ARIZONA STATE BOARD OF PHARMACY (ASBP) OCTOBER 4-5, 2017 MEETING HIGHLIGHTS Andrew Chun, University of Arizona - PharmD Candidate EXECUTIVE DIRECTOR’S REPORT (KAM GANDHI, PHARMD): ASBP Proposed Legislative Agenda: • Removal of the term “grad intern” from all statutes.

• Implementation of a deadline to open a pharmacy from when the approval for their permit is received.

• Institute a license reinstatement fee.

• Determine time frame one can ask for reinstatement after revocation.

Pharmacy Profiles are now active?

There is a new software available that allows licensees to update their contact and employment information. Update your profile on the Board of Pharmacy website. *Coming soon* an online profile for permit holders.

Can a pharmacy technician work under a physician or medical provider?

After discussion, the Board concluded that a pharmacy technician can only work as a technician under a pharmacist if performing duties that utilize their technician license.

There is nothing stopping a pharmacy technician from working under a physician or medical provider outside of their technician license.

Naloxone Rules: The Board decided that they need to update Naloxone dispensing rules R4-23-407.1 due to HB 2493 mandating the use of a standing order.

PAPA Committee Update: The PAPA committee met on August 15, 2017 and developed a new mission statement to help further patient care: “To protect the public by ensuring that individuals who are or may be suffering from a substance use disorder are actively engaged in participating in and being monitored by the Pharmacist Assisting Pharmacists of Arizona (PAPA) program with the ultimate goal of the PAPA participant achieving a full and lasting recovery.”

They also listed several topics that needed to be addressed such as communication between the Board and PAPA, developing criteria reporting to the Board, what is confidential and non-confidential.

CSPMP UPDATE (DOUG SKVARLA, RPH) As of October 16, 2017 prescribers must check the CSPMP prior to writing an initial prescription for an opioid or benzodiazepine and at least quarterly thereafter. Some exceptions to this check are patients in hospice/palliative care, patients with cancer or on dialysis treatment, inpatient facilities, assisted living or correctional facilities, prescribing less than a 10 day supply.

The director reported statewide integration is complete with the statewide health information exchange.

ASBP BOARD MEETING MINUTES: The Board voted to accept the video recording of the meetings in place of written minutes

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as the official record of the board meeting.

SUBSTANTIVE POLICY AROUND OTC PRODUCTS: The Board discussed the need to define “OTC” due to recent inspections of facilities that did not have a proper permit. They discussed adopting the FDA’s definition. Decision: Board staff will work on substantive policy to address this issue and rulemaking if necessary.

RECIPROCATED LICENSES & DISCIPLINE: The Board discussed whether staff should flag reciprocated licenses as having discipline if that licensee had discipline in another state. Decision: Tabled until the December meeting.

FAXING PRESCRIPTION TRANSFERS The Board decided to modify rules to allow pharmacists to fax prescription transfers to another pharmacy. Decision: Language will be presented at December meeting.

TECHNOLOGY ASSISTED VERIFICATION The Board submitted a rule package to the Governor’s regulating review council.

GRRC expressed concerns that the pharmacist was delegating their responsibilities to technicians. Decision: Board members decided to schedule a meeting to educate GRRC about the intentions of the rules.

RULEMAKING ON KIOSKS Request was made to write rules to allow the use of kiosks for automated dispensing of maintenance medications (non-refrigerated and non-controlled) without submitting a deviation request. A rule making exemption has already been approved by the Governor’s office. Decision: Board staff will work on rule language.

DEVIATION REQUESTS: • Walgreens: Obtained approval to allow immunization administration reports to be sent from a central location, bypassing the need for each pharmacy to manually fax and keep records in their pharmacy.

• St. Joseph’s Scriptcenter: Obtained approval to install a 2nd kiosk in their Chandler location to allow employees access to refills through the company benefits.

• Intern Ratio: The Arizona Pharmacy Association brought forth a request to examine the intern ratio. AzPA received reports from the colleges that pharmacies were being cited for having too many interns. Decision: The 2:1 ratio listed in rules applies to employed interns only and NOT those on experiential rotations.

• CVS health on medication return to mechanical storage: Obtained approval to allow medications to be returned to their mechanical filling device if the medication never left the pharmacy. The approval only applies to 1 specific store in Mesa, and other stores wanting approval will need to apply separately.

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F e a t u r e d

H i g h l i g h t s

PROVIDERSTATUS | PHARMACISTSPROVIDECARE.COM

The Latest on Provider Status at the Federal, State Levels APhA and its partners in the Patients’ Access to Pharmacist Care Coalition (PAPCC) remain focused on efforts to advance the Pharmacy and Medically Underserved Areas Enhancement Act (H.R. 592/S. 109) on Capitol Hill. While the exact future of the Affordable Care Act continues to evolve in Congress, APhA and PAPCC will continue to explore avenues to advance the provider status recognition bill and ensure that Medicare Part B beneficiaries in medically underserved communities have access to pharmacist-provided care. The bill is up to 206 cosponsors in the House and 43 cosponsors in the Senate.

Grassroots advocacy Pharmacists across the country used Congress’s August recess to push for provider status recognition by hosting elected officials to see the work they do for patients and their communities firsthand.

Historically, August is when legislators return to their districts or states, providing pharmacists and their allies an opening to advocate and make personal connections with decision makers as the constituents directly affected by the proposed policy.

Did you host a pharmacy visit in August? Send copies of any photos you took during a site visit directly to your legislators and to APhA

so we can recognize your advocacy efforts.

Stay on top of the latest news on federal provider status legislation and learn more about how to advocate for the issues that affect patients and pharmacists most by visiting www. pharmacistsprovidecare. com.

State action in MA and TN Meanwhile, states are pursuing provider status recognition in their own ways.

So far, 2017 has seen movement in Massachusetts, Indiana (see page 4 in the August 2017 issue), and Tennessee.

Massachusetts. In June, the Massachusetts

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Senate and House of Representatives health care committee held a hearing on legislation that would expand the scope of practice for pharmacists in the state.

Among those who testified on “An Act Recognizing Pharmacists as Healthcare Providers” (HB 1214/SB 1240) were the leadership of the Massachusetts Pharmacists Association (MPhA) and Massachusetts Independent Pharmacists Association (MIPA), pharmacists representing diverse practice settings, and physician supporters.

The bills would “increase access to care, optimize medication therapy, improve health outcomes, and minimize

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adverse drug reactions” and “allow clinical pharmacy programs to be sustainable and allow pharmacists to practice at the top of their license to provide comprehensive care as part of an integrated health care team, ”said MPhA president Alicia Mam daCunha, PharmD, AE-C, BCACP. The bills’ provisions would allow pharmacists with collaborative practice agreements to modify dosages of medications prescribed by the patient’s physician for any diagnosis and administer drugs and biological products ordered by the supervising physician. In addition, if the legislation becomes law, pharmacists would gain the authority to furnish selfadministered hormonal contraceptives and nicotine replacement products.

Also, it would allow pharmacists to negotiate with health plans to provide medication therapy management (MTM) services.

Tennessee. The Volunteer State saw major provider status legislation take

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effect on July 1.

“Pharmacists as Providers” (HB 405/SB 461) gives Tennessee pharmacists formal recognition as providers through managed health insurance issuers, including reimbursement and inclusion in medical networks, as providers of care.

The Tennessee Pharmacists Association (TPA) worked with legislators, managed health insurance issuers, and key pharmacy advocacy groups to introduce and pass the bill. “This legislation creates exciting new opportunities for pharmacists and also increases patient access to essential care and services,” said Micah Cost, PharmD, MS, TPA executive director.

This landmark legislation provides a pathway for pharmacists who are acting within the scope of their license or certification under state law to be credentialed with managed health insurance issuers and enable them to participate, receive referrals, and be reimbursed for covered services or

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indemnification. It also creates a mechanism for pharmacists to participate as members of the larger health care team, resulting in increased communication, collaboration, and patient referrals, as appropriate, to physicians and other health care providers for further assessment, management, and treatment.

“Through state-based provider laws passed in Washington and Tennessee, state associations are building the framework for implementation of H.R 592/S. 109 when it becomes law,” Cost added. “These statebased provider laws showcase the important synergy between state and national pharmacists associations.”

Rachel Balick, Reporter

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Lack of provider status for pharmacists is barrier to pain relief for patients The patient, “Neil,” was in the final stages of pancreatic cancer. His only wish was to be able to spend his last days with his family, preferably at home. But he was in too much pain to move from his hospital bed, much less interact with family. Opioids were not much use to him—the quantity needed to numb the pain rendered him incapable of communicating with his wife and children.

That’s when Jessica Geiger-Hayes, PharmD, clinical pharmacist on the palliative care team at Ohio Health Riverside Methodist Hospital, intervened. As a palliative care pharmacist, GeigerHayes’s focus is to help relieve the painful symptoms of end-stage, terminal illnesses.

She offers solutions to patients and their families and also physicians, who often feel they’ve used all the tools in their toolbox to treat their patients’ pain. She educates patients and providers on medication options, recommends medication and dose changes, and follows up with patients to ensure the regimen is having the intended effect.

“I help the team get very creative with therapy, and that doesn’t necessarily mean using opioids,” said Geiger-

Hayes.

Geiger-Hayes worked with the physician and suggested they treat Neil with ketamine—a medication the physician hadn’t considered at first and the patient knew little about. The physician was open to the suggestion, and both the patient and the physician accepted Geiger-Hayes’s recommendation.

“After two doses, he got out of bed and walked down the hall,” GeigerHayes said. “Shortly after that, he went home and was able to pass away comfortably and peacefully at home with his family rather than in a hospital.”

Geiger-Hayes wishes it were always that easy to help her patients get relief for their pain. But at times when the

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pharmacist cannot reach the physician immediately, patients and their families suffer unnecessarily.

Though physicians routinely seek GeigerHayes’s advice and frequently accept her recommendations, she is not authorized to change or initiate medication. Pharmacists, unlike other health professionals, are not recognized by CMS as health care providers.

The lack of recognition helps sustain antiquated pharmacy practice acts in many states, where pharmacists’ scope of practice lags far behind the current scope of their training and expertise. As a result, pharmacists cannot provide patients the level of care that aligns with their expertise, and it’s patients who suffer the consequences of the

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restrictions placed on pharmacists.

Geiger-Hayes recalls a patient writhing with pain in her hospital bed.

The patient’s husband sat by her bedside, crying helplessly. The patient cried. The nurses fought back tears. No one could do anything to relieve the patient’s pain.

Geiger-Hayes had several ideas, which she had discussed with the patient and her family, about how to relieve the pain. But she couldn’t reach the doctor— the only health care provider who had the authority to order a change in medication.

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The patient cried.

The nurses fought back tears. No one could do anything to relieve the patient’s pain.

“My hands are tied. I cannot give a nurse an order to administer an extra dose of any medication. I couldn’t adjust anything.

So, I just had to sit there with everybody else and wait for someone to call me back to get an order to treat this person’s pain,” GeigerHayes said. “That’s no way to treat a patient.”

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Pharmacists are often considered the most accessible, but also the most underutilized, providers in the health care system. But neither patients nor pharmacists’ health care colleagues can take full advantage of pharmacists without laws to facilitate access.

“That’s the biggest barrier,” GeigerHayes said. “I’m on a team of providers that trust me. Patients and their families trust me. But, legally, there is only so much that I can do.”

Sonya Collins, Contributing Writer

Provider status stories Pharmacists are health care providers. In a series of profiles appearing in Pharmacy Today and on pharmacist.com, pharmacists explain how their patients would benefit from provider status. And as part of our campaign for provider status, APhA has asked pharmacists to share their story of how they provide care to their patients and how provider status will improve health care. These stories are collected on the APhA YouTube channel at https:// www.youtube.com/user/aphapharmacists/playlists. If you would like to share your story, please visit PharmacistsProvideCare.com.

Reprinted with permission from the Provider Status column in the September 2017 issue of Pharmacy Today (www.pharmacytoday.org). For more information about ways for pharmacists and student pharmacists to follow and influence the profession’s efforts to achieve provider status, access the provider status recognition section of APhA’s website (www.pharmacist.com/providerstatusrecognition) and APhA’s Pharmacists Provide Care website (PharmacistsProvideCare.com). Copyright © 2017, American Pharmacists Association. All rights reserved.

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Gabapentin and the Opioid Epidemic: How Divergent State Policies May Affect Pharmacists Alyssa M. Peckham, PharmD, BCPP; Kathleen A. Fairman, MA; Urszula Lawrence, BA, PharmD Candidate; Jonah H. Rucker; David A. Sclar, BPharm, PhD The authors have no conflicts to disclose.

1. Introduction In recent years, the “epidemic” of opioid abuse in the United States (U.S.) has increasingly become a well-known source of adverse medical, social, and economic consequences.1 As the front-line “gatekeepers” in medication dispensing and counseling, pharmacists and pharmacy chains have responded to the public health crisis using a variety of policy approaches, such as enhanced patient education, workflow revisions, and “safe disposal” policies.2,3 The role of pharmacists in stemming the opioid crisis has been widely discussed.4 Less well known—but now emerging as a problem that may affect practicing pharmacists in the next few years—is evidence regarding the abuse of gabapentin.5 6 Recently published evidence suggests that utilization of gabapentin displays hallmark characteristics of medication misuse, and that this misuse results in medical harm. This evidence is consistent with a phenomenon anecdotally reported in the popular press, in which opioid-addicted patients misuse gabapentin in order to seek an enhanced state of euphoria (“high”) via potentiation.7 2. Gabapentin abuse: Evidence of daily dosage, prevalence, and medical harm One commonly used metric of medication abuse potential is the proportion of total medication supply used by the top 1% of medication consumers, known as “Lorenz-1” because it is derived from Lorenz curve (supply) analysis. The nation’s first assessment of gabapentin abuse prevalence found Lorenz-1 values of 19% for gabapentin, compared with, for example, 37% for opioids, 15% for pregabalin, and 14% for alprazolam.6 These findings indicate that utilization patterns for gabapentin are similar to those of medications known to be commonly abused. More troubling was the average daily dosage of gabapentin among the top 1% of patients 19 | Fall Journal 2017

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treated for 120 days or more, estimated at more than 11,000 milligrams daily (i.e., more than 3 times the labeled maximum dosage set by the Food and Drug Administration) over a 365-day observation period.5,6 In that study, sustained overuse of gabapentin increased the odds of a drug-related inpatient hospitalization (IPH) by 40%, and the odds of IPH or emergency department (ED) visit for altered mental status (e.g., euphoria or anxiety) by 86%.5 Perhaps more concerning is evidence of medical harm associated with sustained high-dose use of gabapentin and opioids concomitantly, which in one study quadrupled the odds of IPH/ ED use associated with respiratory depression5 and in another study increased the risk of opioid-related death by more than 80%.8 These findings are particularly troubling because opioid abuse increases the risk of respiratory depression, even in the absence of other agents, and respiratory depression is the most common cause of opioid overdoserelated mortality.

Prevalence and daily dosages for gabapentin/opioid co-prescription and co-misuse provide a good indication of the problem. Among patients with sustained (>120 days over a 365-day period) concomitant gabapentin/ opioid use who were identified in one study, sustained medication overuse was uncommon, occurring at a prevalence rate of 12%.5 Within this group, patients with sustained overuse of one medication (i.e., gabapentin or opioids, but not both) averaged daily dosages of 45 to 154 morphinemilligram equivalents (MMEs) opioids, coupled with 1,300 to 2,040 milligrams of gabapentin. Relative to the use of opioids at normal dosages, this combination more than doubled the odds of IPH/ED use associated with respiratory 3 depression. Those misusing both gabapentin and opioids constituted less than 1% of gabapentin/opioid-treated patients— but they filled prescriptions for averages of 262 MME opioids and 8,507 mg gabapentin daily over the course of a year.

Additional emerging evidence of potential harms associated with gabapentin/opioid co-prescription has come, notably, from a study of neonates born to mothers who used opioids during the 45 days prior to delivery.9 Neonatal drug withdrawal occurred in 1.0% of those exposed in utero to opioids alone, but in 11.4% of those exposed to concomitant gabapentin/opioids.

3. Summary of current legal action To determine how individual states are responding to emerging evidence regarding the problem of gabapentin misuse, we investigated state 20 | Fall Journal 2017

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policies, using Web searches coupled with follow-up telephone contacts.

Web searches were conducted using the name of each state coupled with the following search terms: PDMP, prescription monitoring program, gabapentin, controlled substance, schedule IV, schedule V, and schedule substance list. Telephone contacts were made to persons identified in the Web searches and followed up with additional persons as needed.

Results (Figure 1) suggest that states are beginning to take legal action.

Although gabapentin is not considered a controlled substance by the U.S. Drug Enforcement Agency, some states have opted to place more stringent criteria on its use. Among the most stringent are Kentucky and Washington DC,10,11 which have opted to reclassify gabapentin to a Schedule-V controlled substance, in addition to incorporating mandatory reporting and monitoring into their local Prescription Drug Monitoring Programs (PDMPs). Additional states taking action, though less stringent, include Massachusetts,12 Minnesota,13 Nebraska,14 North Dakota,15 Ohio,16 Virginia,17 West Virginia,18 and Wyoming.19 These states have implemented the latter policy of incorporation and monitoring into local PDMPs without reclassification of gabapentin as a controlled substance.

Additional regulatory action may be forthcoming. Local policymakers in several states, such as Hawaii,20 Kansas,21 New Hampshire,22 New Jersey,23 and Pennsylvania,24 have discussed gabapentin regulation at various levels, although they have yet to adopt regulatory changes as of July 2017. In Kansas, gabapentin has been deemed “a drug of concern,� and discussions of mandatory PDMP reporting are ongoing. In New Hampshire, preliminary data collection of gabapentin dispensing has begun, though PDMP reporting remains optional. In New Jersey, mandatory reporting is under current consideration and may come to fruition in early 2018.

These discussions may have important consequences for public health in these states, particularly in communities that have been disproportionately affected by the opioid abuse epidemic. For example, in Beaver County, Pennsylvania, which includes the Pittsburgh area, rates of hospitalizations related to opioid overuse increased by 159% from 2014 to 2016.25 From 2000 to 2016, the rates of drug-dependent newborns in that county increased by 388%, from 4.3 to 21 per 1,000 births.26 4. Practical ramifications for practicing pharmacists Pharmacists can expect several challenges as a result of this variation in state policies:27

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“Doctor shopping” and “pharmacy shopping.” Patients whose home state has adopted a stringent approach to gabapentin dispensing or reporting may seek medical providers in other, more lenient jurisdictions, potentially bringing with them the societal and criminal consequences known to result from drug abuse.1 Tough decisions. States that require reporting of gabapentin without actually restricting its use place decision-making responsibility in the hands of the dispensing pharmacist. When encountering a patient whose PDMP report suggests abuse of gabapentin, either alone or coupled with opioids, a pharmacist must decide from a variety of options—for example, contacting the prescriber, referring the patient to substance abuse services, or refusing to dispense the prescription. These decisions, which may literally have life-or-death consequences for the patient, pose potentially enormous legal and ethical challenges.

Legal ramifications. In some states, such as West Virginia, patients with addiction(s) have the right to sue healthcare professionals, including pharmacists, for contributing to their addiction and criminal activity, according to the West Virginia Supreme Court of Appeals.28 In that state, 29 plaintiffs with addictions filed eight separate lawsuits against three pharmacists and four physicians for causing their addictions, resulting in sentencing for one pharmacist and detention in federal prison for two physicians. The plaintiffs’ complaints against the pharmacists alleged that they had “refilled the controlled substances too early, refilled them for excessive periods of time, filled contraindicated controlled substances, and filled ‘synergistic’ controlled substances.”25 Strained customer relationships. Decisions about gabapentin dispensing touch on several factors that have been posited as key sources of consumer satisfaction with pharmacy services, such as perceived fairness, whether expectations are met, and fulfillment of health-related goals.29 Pharmacists who make the difficult choice to restrict gabapentin use may have to face disgruntled customers as a result of the decision, even if it was the most appropriate choice for the well-being of the patient.

5. Conclusion The U.S. is in the throes of an opioid epidemic. Although the national focus on opioids is important for public health, it has allowed some consumers to shift drugs of abuse to evade detection. Gabapentin presents itself as an opportunistic prescription drug of abuse, given its relatively low cost and relatively lax regulations due to lack of controlled substance status. It 22 | Fall Journal 2017

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is critical that all healthcare personnel become familiar with the prevalence of gabapentin abuse and the resulting potential for medical harm, which could result in both societal and economic consequences.

Although thwarting prescription drug abuse should be carried out across all levels of healthcare, pharmacists are often the last line of defense to identify those who may be drug seeking or using prescription drugs recreationally. With the information presented herein, we call for all pharmacists to have a heightened awareness and critical eye when encountering prescriptions for gabapentin.

Figure 1. Legal Actions Taken by States to Prevent Gabapentin Misuse: Updated July 2017

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References 1. Siemaszko C. (9 Jan 2017). Wilkes Barre faces heroin scourge turning it into “the most unhappy place in America.” NDC News. Retrieved from: https://www.nbcnews. com/news/us-news/wilkes-barre-faces-heroin-scourge-turning-it-most-unhappyplace-n699541 2. Shafer E, Bergeron N, Smith-Ray R, Robson C, O’Koren R. A nationwide pharmacy chain responds to the opioid epidemic. J Am Pharm Assoc (2003). 2017;57(2S):S123-129.

3. Reynolds V, Causey H, McKee J, Reinstein V, Muzyk A. The role of pharmacists in the opioid epidemic: an examination of pharmacist-focused initiatives across the United States and North Carolina. N C Med J. 2017;78(3):202-205.

4. No authors listed. Pharmacists’ role in addressing opioid abuse, addiction, and diversion. J Am Pharm Assoc (2003). 2014;54(1):e5-15.

5. Peckham AM, Fairman KA, Sclar DA. All-cause and drug-related medical events associated with overuse of gabapentin and/or opioid medications: a retrospective cohort analysis of a commercially insured US population. Drug Saf. 2017 Sep 27. [Epub ahead of print].

6. Peckham AM, Fairman KA, Sclar DA. Prevalence of gabapentin abuse: comparison with agents with known abuse potential in a commercially insured US population. Clin Drug 7. Investig. 2017;37(8):763-773.

Rodriguez CH. Gabapentin boosts high for opioid abusers. Pain News Network. July 6, 2017.

8. Gomes T, Juurlink DN, Antoniou T, Mamdani MM, Paterson JM, van den Brink W. Gabapentin, opioids, and the risk of opioid-related death: a population-based nested case-control study. PLOS Medicine. 2017 Oct 3. e1002396.

9. Huybrechts KF, Bateman BT, Desai R, et al. Risk of neonatal drug withdrawal after intrauterine co-exposure to opioids and psychotropic medications: cohort study. BMJ. 2017;358:j3326.

10. Important Notice: Gabapentin Becomes a Schedule 5 Controlled Substance in Kentucky [Internet]. Kentucky Cabinet for Health and Family Services; 2017 [cited 2017 Oct 18]. Available from: http://chfs.ky.gov/NR/rdonlyres/92D10F1A-8842-4E6D-B9D2935741E2926E/0/KentuckyGabapentinFactSheet.pdf.

11. Telephone conversation with Kofi Onumah, PharmD, RPh, Pharmacist Inspector, Government of the District of Columbia Department of Health. August 23, 2017.

12. Data Submission Dispenser Guide Massachusetts Prescription Monitoring Program (MA PMP) Version 3.0 [Internet]. Commonwealth of Massachusetts, Department of Public Health; 2017 May [cited 2017 Oct 18]. Available from: http://www.mass.gov/ eohhs/docs/dph/quality/boards/pharmacy/alerts/pmp-data-submission-guide.pdf.

13. Minnesota Board of Pharmacy News [Internet]. Minnesota Board of Pharmacy and the National Association of Boards of Pharmacy Foundation; 2016 Jul [cited 2017 Oct 18].

Available from: https://mn.gov/boards/assets/July-2016_tcm21-249637.pdf.

14. Telephone conversation with Kevin C. Borcher, PharmD, PDMP Program Director at Nebraska health Information Initiative. August 18, 2017.

15. North Dakota State Board of Pharmacy News [Internet]. North Dakota State Board of Pharmacy and the National Association of Boards of Pharmacy Foundation; 2017 Jun [cited 2017 Oct 18]. Available from: https://nabp.pharmacy/wp-content/ uploads/2016/06/ND062017.pdf.

16. Effective Dec 1, Pharmacies, Prescribers, and Wholesalers Must Report Gabapentin to Ohio Automated Rx Reporting System [Internet]. The National Law Review; 2016 Dec [cited 2017 Oct 18]. Available from: https://www.natlawreview.com/article/effectivedec-1-pharmaciesprescribers-and-wholesalers-must-report-gabapentin-to.

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17. Virginia Acts of Assembly – Chapter [Internet]. General Assembly of Virginia; 2017 [cited 2017 Oct 18]. Available from: http://leg1.state.va.us/cgibin/legp504. exe?171+ful+HB2164ER+pdf.

18. Telephone conversation with Michael Goff, West Virginia Prescription Drug MonitoringProgram, Administrator. August 23, 2017.

19. E-mail from Mary K. Walker, RPh, Executive Director, Wyoming State Board of Pharmacy. July 7, 2017.

20. Hawaii Board of Pharmacy [Internet]. Minutes of Meeting; 2017 Aug 17 [cited 2017 Oct 18]. Available from: https://cca.hawaii.gov/pvl/files/2013/06/170817-min.doc.pdf.

21. Telephone conversation with Reyne Kenton, Program Manager K-TRACS and PDMP. August 17, 2017.

22. Telephone conversation with Michelle Ricco-Jonas, New Hampshire PDMP Program Manager. August 23, 2017.

23. Telephone conversation with Jeffrey D. Laszczyk, Jr., PharmD, New Jersey PMP Administrator. August 18, 2017.

24. Telephone conversation with Jared M. Shinabery, MPH, Chief Technology Officer, Prescription Drug Monitoring Program Office, Pennsylvania Department of Health.

August 30, 2017.

25. Malongowski K. (28 Jun 2017) Report: Beaver County had highest opioid overdose hospitalization rates in western Pennsylvania. The Times. Retrieved from: http://www. timesonline.com/5b2d4e58-5b6e-11e7-bc5a-5b3ee63f5bdd.html 26. Malongowski K. (28 Sept 2016). Rate of drug-dependent newborns inBeaver County up nearly 400 percent since 2000. Ellwood City Ledger. Retrieved from: http://www. ellwoodcityledger.com/a75ac496-8594-11e6-8568-277922480bda.html 27. Peckham AM, Fairman KA, Sclar DA. Policies to mitigate nonmedical use of prescription medications: how should emerging evidence of gabapentin misuse be addressed?

Expert Opin Drug Saf. 2017 Oct 6. [Epub ahead of print].

28. Bonner L. (26 May 2015). West Virginia ruling: People with addictions can sue pharmacists. Pharmacy Today. Retrieved from: https://www.pharmacist.com/westvirginia-ruling-peopleaddictions-can-sue-pharmacists 29. Panvelkar PN, Saini B, Armour C. Measurement of patient satisfaction with community pharmacy services: a review. Pharm World Sci. 2009;31:525-537.

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Implementation of a Discharge Prescription Delivery Service: A Guide for Hospitals and Health Systems Ndidi Precious Alino, PharmD, MS Background: Primary medication noncompliance, defined as a situation whereby a patient does not fill an initial prescription written upon discharge from the hospital, has become a major challenge that not only results in suboptimal outcome, but could potentially lead to hospital readmission. Patients may not fill their prescription for several reasons; ranging from unwillingness to physical incapability. A study conducted by Fallis et al (2013) evaluated primary medication non-adherence of older patients (66 and older) who are discharged from a general internal medicine service to determine the prevalence of primary non-adherence and its associated characteristics. In this study, the investigators reviewed electronic prescriptions, electronic discharge summaries and pharmacy dispensing data from April to August 2010 for drugs listed on the public formulary. Out of 493 patients eligible for inclusion in the study, 232 were prescribed new medications. According to the result of their study, 66 (28%) exhibited primary non-adherence at 7 days after discharge and 55 (24%) at 30 days after discharge. Some of the medications to which patients were non-adherent included antibiotics, drugs for the management of coronary artery disease, heart failure, stroke, diabetes, and chronic obstructive pulmonary disease. Saunders, in 1987 also evaluated the prevalence of unfilled discharge prescriptions and the reasons given among patients discharged from the emergency room.

This study identified lack of transportation (14%), negligence (32%) among other reasons given by patients for not filling their discharge prescriptions.

Hospitals and health care systems with an outpatient pharmacy on site are therefore looking at discharge medication bedside delivery service as a way to reduce primary medication non-compliance related to negligence and physical incapability.

Purpose: The purpose of this article is to demonstrate the need for a bedside discharge prescription delivery service, recognize challenges associated with establishing such service and finally outline potential guide to implementing quality bedside discharge prescription delivery service.

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Introduction: Bedside discharge prescription delivery service provides the opportunity to build great relationships with patients through quality and coordinated care. It is more comforting and value-adding to patients when they know that they are going home with the correct medications and that discharge counseling is provided by a team of pharmacists who have access to their medical record and have been involved with the whole care process. By instituting this service, adverse drug events related to unclear instructions related to new or changed medication regimens upon discharge could be potentially eliminated. Secondly, this service could potentially be a way to improve patient satisfaction scores because of the convenience and seamless care transition that it provides. Especially if the pharmacist makes a lasting good impression on the patient during medication counseling.

More so, patients will have improved clinical outcomes due to enhanced compliance and patient engagement since counseling is provided in a relaxed environment and patients are more likely to listen and retain information. Lastly but not the least, most hospital outpatient pharmacies are not conveniently located, and are often competing unfavorably with big chain drug stores. Therefore this service will not only improve patient engagement, enhance compliance to prescribed medications, it actually has the potential to increase outpatient prescription capture rate, thereby increasing outpatient pharmacy revenue without any additional cost to patients.

Common Barriers and Challenges: One of the biggest barrier to providing a service such as this, is the availability of adequate human resources needed to run a smooth and consistent service. There is a need for dedicated staff in order to meet the expectations of the front counter patients as well as counseling expectations for discharge patients. Lack of adequate human resources could introduce some unwarranted inconsistency to the service and potential dissatisfaction on the side of the patient.

Another huge barrier is being able to manage patient expectations in terms of meeting target delivery times to ensure discharge times are not delayed.

Technical difficulties related to handheld point-of-sale devices, especially if network coverage is not consistent across the different floors/units in the hospital is another potential challenge that one may run into.

Guide to successful Implementation: Operational Actions While the service may sound exciting, especially considering the value and comfort it adds to patient care, the implementation process if not well planned out may jeopardize the entire service. The success of every 27 | Fall Journal 2017

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service hugely depends on how well the operational plan and actions are articulated prior to execution. Below are a list of operational actions that could help guide to a successful implementation: • Seek guidance and advise from other facilities who have tried to implement the same or similar service in the past and ask for lessons learned • Set expectations up front • Manage patient expectations in terms of meeting target delivery times. For instance, you may decide that discharge prescriptions should be received at least 2 hours prior to discharge target time • Determine appropriate service units and gradually introduce service one nursing unit at a time and then expand as necessary • Get buy-in from your multidisciplinary team (especially nursing staff) and discuss role out strategies with all stakeholders. Communication of service details and education of nursing staff and other care providers is important and could be challenging if not handled well.

Especially if they consider it an additional step in their workflow.

Therefore it may be wise to consider the following: • Interdisciplinary team meetings prior to implementation • Education of the admissions team and nursing on communication of service to patients and the target time to receive prescription orders prior to discharge • Hire and train Pharmacy staff that will provide the service • It may be more cost-effective to provide a technician driven service initially, while partnering with the inpatient pharmacy staff to provide discharge counseling upon delivery of medications • Determine when discharges occur to determine whether or not there is a need to modify the current hours of operation for the service pharmacy staff • Test network connections within all locations that the service will be provided prior to service implementation to ensure consistency in connection. Some handheld point-of-sale device lose network connection depending on your location within the hospital. It is advisable to test such connectivity prior to contract signing with the vendor.

• Determine how you will capture patient identification for patients that will be discharged with controlled substances. Certain devices can only process payments and do not have the capability to capture such identifications. A portable laptop or notepad have been used by some institutions and might be an option.

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• Determine methods of payment accepted (cash, credit card, check, etc.). Having a broad range of payment options contributes to customer satisfaction • If cash will be accepted, there is need to work out the logistics of how the cash will be handled throughout the day • Establish a tracking mechanism to collect and analyze data for performance measures. Having a tracking mechanism for performance measures helps to evaluate effectiveness and value of the service compared to non-service patients and justify need for service expansion if necessary. It may also help justify the need for additional human resources. Tracking mechanism may include collection of data and reports to evaluate: • Number of discharge prescriptions filled compared to total number of discharge prescriptions written • Wait times for discharge medication prescriptions of service patients • Number of refills captured from service patients • Readmission rates of service patients compared to non-service patients • Amount of revenue from discharge prescription delivery service For ease of data collection, it is reasonable to enable an automated track process within the outpatient pharmacy electronic medical record software that captures all discharge prescriptions that are delivered via this process.

Guide to successful Implementation: Financial Plan and Affordability Financial projections and the affordability of the service by the institution should be included in the initial business plan submitted. This should include the estimated number of pharmacy technicians and/or pharmacists needed, as well as the number of hours that will be dedicated to this service per work shift. This can be determined by calculating the average technician/pharmacist time (hours per month) per hourly rate, compared with the total revenue per month from discharge prescriptions in order to determine a break-even point.

Conclusion Discharge prescription room delivery service is a unique service that not only creates great value for our patients, but also has the added benefit of increasing revenue for the institution without any additional costs to the patient. As with every new service, there are quite a few challenges and barriers that one may encounter in the implementation process.

By following this guide, hopefully most of these barriers are proactively 29 | Fall Journal 2017

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identified and eliminated to ensure a smooth implementation process.

Lastly, performance evaluation is an important aspect of every service.

Hence, it is important to collect and analyze data to accurately access performance. There may be need to start this service initially without additional human resources, however, it is important to note that high performance and sustainability hugely relies on adequate resources.

References 1. Fallis BA, Dhalla IA, Klemensberg J, Bell CM. Primary Medication NonAdherence after Discharge from a General Internal Medicine Service.

PLoS ONE 2013; 8(5): e61735 2. Saunders C.E. Patient compliance in filling prescriptions after discharge from the emergency department. Am J Emerg Med. 1987 Jul; 5(4):283-6

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Fourth Quarter 2017: Pharmacy Time Capsule 1992 • For fiscal 1992, the total amount Medicaid spent on drugs in 1992 approached $6.8 • National health care spending was $854.1 billion or $3287/person • There were 75 accredited colleges of pharmacy (compared to 130 in 2015) 1967 • For fiscal year 1967, the total amount Medicaid spent on drugs exceeded $182 million.

• National health care spending was $51.6 billion or $253/person 1942 • Marijuana was removed from the US Pharmacopeia in 1942. It had been included since 1854.

• Premarin first marketed by Ayerst.

1917 • Dean Rufus Lyman of the University of Nebraska calls for the formation of a national pharmacy honor society that is eventually realized with the founding of the Rho Chi Society.

By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history.

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The Evolving Role of Pharmacists in Providing Contraception: A Practical Guide to Contraceptive Products ACPE UAN: 0100-0000-17-062-H01-P Authors: Kari Allan, Pharm.D. Candidate and Erin Raney, Pharm.D., BCPS, BC-ADM; Midwestern University College of Pharmacy – Glendale Objectives: At the completion of the CPE activity, participants should be able to: 1. Discuss recent changes in legislation that affect provision of contraceptives by pharmacists.

2. Identify current hormone-based products for contraception.

3. Choose safe products for women seeking contraception based on their individual medical history.

4. Include information about proper use of emergency contraception while counseling on contraceptive use.

Introduction: In light of recent legislation in various states allowing pharmacists to prescribe contraception, it is vital that those working in patient care environments optimize their working knowledge of available options.

This review discusses commonlyused contraceptive products, concentrating on the hormonal contraception options for which pharmacist prescribing has become permissible in some states. This discussion also includes precautions and contraindications to consider when selecting contraceptive products, the current role of longacting reversible contraception, and emergency contraception.

Background: Unplanned pregnancies in the United States remain high – up to 50% of all pregnancies.1 Improving access to effective birth control is a key component of reducing this statistic. In a recent national survey, 30% of women reported some level of difficulty with accessing contraception prescriptions or refills at some point.2 Removing the requirement for a physician’s order for contraception through legislation at the state level is a recent movement that aims to break down barriers between patients and direct access to birth control by allowing pharmacists to prescribe these medications. 1,3-4 Obtaining hormonal contraception directly

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from pharmacies facilitates improved access for women due to the high accessibility of pharmacists, and because pharmacies are typically numerous and central within communities.1

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pharmacist.

Since 2013, several states have introduced legislation allowing for pharmacists to prescribe contraception. As of June 2017, Oregon, California, Colorado, and New Mexico have passed and/or enacted laws, and several more including Maryland, Hawaii, Illinois, Minnesota, Missouri, and New Hampshire have proposed legislation pending approval.5 While these permissions are similar across states, they do vary in the types of products pharmacists can prescribe, the age of the patient to which they can be prescribed without a physician’s order, and the requirements for evidence of recent women’s health exams.1

Resources for Contraception Provision: Two clinical practice guidelines assist with the selection and provision of contraception. The U.S. Medical Eligibility Criteria for Contraceptive Use (US MEC) lists classes of available contraceptives and contraindications associated with each, thereby providing guidance for safe, patient-specific contraceptive selection. This document was most recently updated in 2016 and lists recommendations first by class of contraception, then by concurrent medical conditions, and then by classifications that indicate the relative risk associated with their use. These classifications range from 1 (the benefit of the contraceptive outweighs any risks associated with the medical condition) to 4 (unacceptable risk associated with use of the contraceptive).6

The majority of existing legislation includes procedures to ensure that pharmacists obtain sufficient patient information to safely forgo a visit to a physician prior to obtaining contraception. Pharmacists must complete a training program and obtain a medical and medication history (typically by questionnaire) for each patient, as well as perform a blood pressure screening.3 Pharmacists with prescribing privileges take on the responsibility of screening patients for contraindications to contraception use and counseling on alternative forms of contraception that are not available through the provision of a

The 2016 U.S. Selected Practice Recommendations for Contraceptive Use (US SPR) are intended to be used in conjunction with the US MEC and provide guidance for contraceptive selection, patient education, and monitoring parameters. Information includes appropriate timing of initiation/ placement of the contraceptive products and need for backup methods, among other guidance points. Both the US MEC and US SPR documents are foundational for any pharmacist involved in recommending contraception options and counseling on best use.

Table 1 outlines electronic access

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points to these resources.6-7 Oral Hormonal Contraception: Oral hormonal contraception remains one of the most popular forms of birth control among women in the United States, and stands to greatly increase in use as pharmacist provision of contraception expands.

In a survey of women currently not using any contraception, 41% stated that they would begin to use a hormonal contraceptive if it were to become available without physician prescription.2 There are both progestin-only and combination (estrogen plus progestin) products within this category – each have benefits and risks to different patient populations. Patient screening is necessary to conduct prior to provision of these products, to include an evaluation of current pregnancy status, current and past medical history, current medications (including herbal supplements and over-the-counter medications), and a blood pressure assessment.3 The National Association of State Pharmacy Associations along with state boards of pharmacy provide links to the state-specific screening procedures recommended in approved and pending legislation.2

Combination Oral Contraception (COC) Combination products include estrogen, most commonly as ethinyl estradiol, in conjunction with a progestin such as levonorgestrel, norethindrone acetate, desogestrel, drospirenone, and norgestrel.

There are many different available products that vary in the dose of

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ethinyl estradiol, the dose and type of progestin, and the cycle pattern.

Increasingly more of these products become available each year, and the sheer number can make it challenging to select an agent to use.

Product selection varies depending on characteristics of the individual patient.

COCs are typically packaged as a 21-day pack containing 3 weeks of active pills only, or as a 28-day pack that includes 21 or 24 days of active hormone pills followed by 4-7 days of placebo or supplements (such as iron or folic acid). If the active pills contain the same amount of estrogen and progestin each day, the product is considered “monophasic.”

If the amounts of active ingredients vary throughout the active portion of the cycle, it is considered “multiphasic.” The design of a singlecycle COC pack provides hormone for 3 weeks followed by a hormonefree period (usually 4-7 days) during which a withdrawal bleed occurs.

However, there are multiple options that provide several months of estrogen and progestin continuously, which allow for fewer withdrawal bleed periods per year (typically between 1-4). These are “continuous cycle” products.7 Patient screening processes for contraception provision focus on potential contraindications for use of estrogen and/or progestin.3 Table 2 displays select examples of common precautions and/or contraindications to the use of COCs.7 Interestingly, a recent study found that up to 23% of women using COCs prescribed by

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a physician were doing so despite a high-risk condition.2 Therefore, pharmacist-initiated screening for these high-risk conditions will be an important strategy to improve this finding moving forward. While studies have shown that self-screening by patients tends to be generally effective, aided screening by a health care professional results in the most accurate determination of genuine contraindications.8 While perfect use of COCs results in a pregnancy prevention rate of 99%, typical use of these medications has a lower efficacy rate of 91%. A crucial factor in their effectiveness lies in the proper timing of the doses, with consistent daily use required for maximum effectiveness.

These pills must be taken at the same time every day, and while one missed dose can be made up by taking it as soon as possible, 2 or more consecutive missed doses necessitates use of a backup method (BUM) or abstinence for at least 7 days of consistent COC use.

Depending on where the missed dose falls within the pill pack, emergency contraception (EC), other than ulipristal acetate, should also be considered. Detailed instructions regarding missed pills are provided in the product package insert as well as the US SPR.2,6 Also important to the efficacy of COCs is the appropriate use of a BUM, such as male or female condoms, during the initiation period. For example, if a woman begins a COC less than 5 days from the beginning of her menstrual

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bleed, no BUM is needed. If, however, a COC is initiated more than 5 days after menstruation begins, a BUM is needed for the first 7 days of COC use if a woman does not wish to abstain from sexual activity during that time. This 7-day cross-over period also applies if a woman has amenorrhea (no evidence of a menstrual bleed), is more than 21 days postpartum, or when switching from one oral product to another.6 Typical side effects of COCs can include weight gain, mood changes, headache, nausea, and abnormal menstrual bleeding patterns. While most of these symptoms are mild, occasionally an alternative product is required. For weight gain, mood changes, headache, and nausea, the type of progestin or the amount of estrogen in the product can be responsible. A common approach is to change to a product that contains a different dose of estrogen or form of progestin. On the other hand, if breakthrough bleeding (bleeding that occurs outside the expected withdrawal bleed interval) occurs and does not resolve within approximately 3 months of use, the dose of estrogen or progestin contained in the product may be too low. Changing to a product that contains a higher dose of hormone may help alleviate this issue.6,9

Progestin-Only Pills (POP) Among oral contraception users in the U.S., only about 4% use POPs.2 Also known as the “mini pill,� they are equally efficacious in pregnancy prevention under conditions of ideal

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use, although this is notably more difficult to achieve than with COCs. These options are an alternative for women who have contraindications to the estrogen component of COCs but who still desire a hormone-based oral option.

within the same day in order to take the next regularly-scheduled dose. When a dose is missed, a BUM is recommended until at least 2 consecutive doses have been taken properly to reduce the risk of unintended pregnancy.6

The progestin component of POPs has a shorter duration of action than the COC products, and therefore correctly timed doses is even more crucial. A dose of a POP is considered “missed� if it is taken more than 3 hours after it is due, and it is recommended to take a missed dose as soon as possible to allow the woman to quickly resume their normal schedule. This applies even if it is necessary to take 2 pills

Additional Hormonal Contraceptives: Multiple routes of administration are available for hormonal contraceptive products. In some states, pharmacists can prescribe transdermal patches, intravaginal rings, and/or intramuscular injections in addition to COCs and POPs. The transdermal patch contains estrogen and progestin and is applied to the skin (rotating placement) once

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Your patients.

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A 2016 survey* of the public found:

94% 85% 76%

say trust in their pharmacy would increase with standardized certification for technicians. believe it’s very important for pharmacy technicians to be certified. say they would change pharmacies if technicians were not certified.

SETTING THE STANDARD. ADVANCING PATIENT CARE. Learn more at www.ptcb.org. *KRC Research, 2016, ptcb.org/resources/research

weekly for 3 weeks, and then removed for 1 week to allow for the withdrawal bleed, similar to the placebo period in COCs. Alternatively, the vaginal ring is a combination product that is inserted by the patient once per month for 3 weeks, and then removed for one week to allow for the withdrawal bleed. These combined hormone products have the same contraindications and precautions listed in Table 2.

The depo medroxyprogesterone acetate intramuscular injection is administered once every 3 months, and can be an option for women with contraindications to the estrogen component of combined products.

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For women seeking a contraceptive option that is less dependent on the user for efficacy, long-acting reversible contraceptives (LARCs) are an excellent option. These products include copper and levonorgestrel intrauterine devices (IUDs) and the etonogestrel implant. Many experts recommend LARCs as firstline contraceptive options because they do not depend on patient adherence to a dosing regimen and are therefore less likely to fail under “typical� use.6 Because of these benefits, pharmacists should include information on LARCs when counseling women on individualized contraceptive choices.2 Emergency Contraception (EC): EC is intended to prevent a pregnancy in the event of unprotected sexual intercourse or failed contraception if administered within a short time afterwards. It is recommended to discuss EC with all women who are provided hormonal contraception, especially since missed doses are a common occurrence and greatly impact efficacy. There are multiple forms of EC. The copper IUD, if placed within 5 days (120 hours) of unprotected intercourse, has been shown to be a highly effective form of EC (especially for obese women for whom other options may not be as effective) but requires an appointment with a healthcare provider for insertion.6 Additionally, two oral products are available for EC: levonorgestrel and ulipristal acetate. Ulipristal is currently only available via prescription, and can be utilized

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up to 5 days from unprotected intercourse.

Levonorgestrel is available without a prescription and has maximum efficacy if taken within 72 hours of unprotected intercourse. These two products have largely replaced the traditional Yuzpe method (taking 2 doses of multiple COC pills, totaling 100 mcg of ethinyl estradiol and 0.5-1 mg of levonorgestrel, given 12 hours apart) due to the high risk of nausea and vomiting associated with its use. It is important to counsel women that EC is most effective the sooner it is used after unprotected intercourse, and is never a guarantee of pregnancy prevention.10 There are no medical contraindications to the use of oral EC products due to their short duration of use.7 However, if ulipristal is used by a woman who is breastfeeding, breast milk should be discarded for 24 hours after its use due to the potential for infant exposure.6 It is appropriate to counsel frequent users of EC to consider a LARC for routine contraception.

If a levonorgestrel product is used for EC, women can resume their hormonal contraception immediately following its use. If ulipristal acetate is used, it is recommended that a hormonal form of contraception should be resumed or initiated after a delay of at least 5 days to avoid interference between the two products.6 The copper IUD, if placed for the purposes of EC, provides contraception for up to 10 years.10 Conclusion: The recent expansion of pharmacist

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scopes of practice to allow for hormonal contraceptive provision in several states translates into a responsibility on the part of pharmacists practicing in patient care settings to effectively screen patients for safe and appropriate use of these methods. Hormonal contraception, especially combination estrogen/progestin products, is a relatively convenient and cost-effective method of contraception. Pharmacists must be familiar with contraindications to hormonal methods, and recommend

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individualized options based on a woman’s medical history and lifestyle preferences. Finally, counseling on emergency contraception and backup contraceptive methods is an essential component of contraception provision to maximize efficacy and further reduce unintended pregnancies. The 2016 US MEC and US SPR are essential references for pharmacists providing patient counseling or selection and monitoring of contraceptive methods.

Table 1. Select recommended contraceptive resources

Centers for Disease Control and Prevention US Medical Eligibility Criteria (US MEC) for Contraceptive Use, 2016

Full print version and a summary chart can be downloaded directly from the site

https://www.cdc.gov/ reproductivehealth/ contraception/mmwr/mec/ summary.html

US Selected Practice Recommendations (US SPR) for Contraceptive Use, 2016

Full print version and a summary chart can be downloaded directly from the site

https://www.cdc.gov/ reproductivehealth/ contraception/mmwr/spr/ summary.html

2016 US MEC and US SPR app

Mobile app available for Android and iOS; combines information from the both of the CDC guidelines listed above

Available at either of the two links listed above

Providing Quality Family Planning Services

Full print version can be downloaded directly from the site

https://www.cdc.gov/ reproductivehealth/ contraception/qfp.htm

Family Planning National Training Center The Quality Family Planning Services (QFP) Mobile App

Free mobile app on Android and iOS

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https://fpntc.org/trainingand-resources/qualityfamily-planning-servicesmobile-app

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Table 2. Select precautions and contraindications to the use of combination hormonal contraceptives Condition

Concerns/ Comments

<21 days postpartum

21-42 days postpartum with other VTE risk factors

Category 4

VTE risk factors = age ≥ 35, previous VTE, thrombophilia, immobility, transfusion at delivery, peripartum cardiomyopathy, BMI ≥ 30, postpartum hemorrhage, C-section, preeclampsia, smoking

3

21-30 days postpartum and breastfeeding without other VTE risk factors

3

Age ≥ 35 years smoking less than 15 cigarettes per day

3

Age ≥ 35 years smoking more than 15 cigarettes per day

4

Multiple risk factors for ASVCD

ASCVD risk factors = older age, smoking, diabetes, hypertension, low HDL, high LDL, high triglycerides

Hypertension adequately controlled

3 or 4

3

Elevated blood pressure

Systolic 140-159 mm Hg or diastolic 90-99 mm Hg

3

Elevated blood pressure

Systolic ≥ 160 mm Hg OR diastolic ≥ 100 mg Hg

4

4

Vascular disease Acute DVT/PE or history of DVT/PE with higher risk for recurrence (has risk factors)

DVT/PE risk factors = history of estrogendependent, pregnancy-associated, or idiopathic DVT/PE, known thrombophilia, active cancer, recurrent DVT/PE

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Table 2. Select precautions and contraindications to the use of combination hormonal contraceptives

Condition

Concerns/ Comments

Category

History of DVT/PE with lower risk for recurrence (no risk factors)

3

Major surgery with prolonged immobilization

4

Current/history of ischemic heart disease

Includes stroke or complicated valvular heart disease

4

Systemic lupus erythematosus

Positive or unknown antiphospholipid antibodies

4

Migraine with aura

4

Current breast cancer

4

Past breast cancer in remission for at least 5 years

3

Diabetes with nephropathy, retinopathy, Specific classification depends on severity neuropathy, other vascular of disease disease, or > 20 yearsâ&#x20AC;&#x2122; duration Concurrent use with certain anticonvulsants, rifampin, or rifabutin

Anticonvulsants include phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine

Severe (decompensated) cirrhosis, hepatocellular adenoma, or malignant hepatoma

3 or 4

3

4

3 = A condition for which the theoretical or proven risks usually outweigh the advantages of using the method.

4 = A condition that represents an unacceptable health risk if the contraceptive method is used.7

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REFERENCES 1. The PEW Charitable Trusts. States start to let pharmacists prescribe birth control (2016).http://www. pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/02/18/states-start-to-let-pharmacistsprescribe-birth-control-pills (accessed 2017 May 27).

2. Grossman D. Over-the-counter access to oral contraceptives. Obstet Gynecol Clin North Am 2015;42(4):619-629.

3. Vivian JC. Pharmacists prescribing birth control. US Pharm 2016;41(2):48-50.

4. Pharmacy Times. Colorado is third state allowing pharmacists to prescribe birth control (2017).http:// www.pharmacytimes.com/contributor/sally-rafie-pharmd/2017/02/colorado-is-third-state-allowingpharmacists-to-prescribe-birth-control (accessed 2017 May 27).

5. National Alliance of State Pharmacy Associations. Pharmacists authorized to prescribe birth control in more states(2017). https://naspa.us/2017/05/pharmacists-authorized-prescribe-birth-control-states/ (accessed 2017 July 11).

6. Centers for Disease Control. U.S. Selected Practice Recommendations for Contraceptive Use, 2016.http:// www.cdc.gov.mwu.idm.oclc.org/mmwr/preview/mmwrhtml/rr6205a1.htm. (accessed 2017 May 27).

7. Curtis KM, Tepper NK, Jatlaoui TC, et al. U.S. Medical Eligibility Criteria for Contraceptive Use, 2016.

MMWRRecomm Rep 2016; 65:1.

8. Grossman D, Fernandez L, Hopkins K et al. Accuracy of self-screening for contraindications to combined oralcontraceptive use. Obstet Gynecol 2008;112(3):572-8.

9. Lexicomp Online [online database]. Hudson, OH: Lexi-Comp (accessed 2017 May 27).

ACPE UAN: 0100-0000-17-062-H01-P Release date: 11-1-17 Expiration date: 11-1-20 CPE Hours: 1 (0.1 CEU) The author, the Arizona Pharmacy Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. This lesson is a knowledge-based CPE activity and is targeted to pharmacists in all practice settings. Disclosure: The AzPA and other individuals responsible for planning AzPA continuing pharmacy education activities have no relevant financial relationships to disclose.

10. Batur P, Kransdorf LN, Casey PM. Emergency contraception. Mayo Clin Proc 2016; 91(6):802-7.

The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

CONTINUING EDUCATION QUIZ QUESTIONS

The Evolving Role of Pharmacists in Providing Contraception: A Practical Guide to Contraceptive Products 1.How long should combination oral contraception be avoided after using ulipristal acetate foremergency contraception? a. 24 hours b. 2 days c. 5 days d. 1 week 2. A 30-year old woman requests a combination oral contraceptive. She says she has migraine headaches without aura, has been in remission from breast cancer for 6

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years, and smokes ½ pack of cigarettes per day. Her blood pressure is 126/84 mm Hg. Which of her medical conditions is/are classified as a category 3 or 4 precaution according to the U.S. Medical Eligibility Criteria for Contraceptive Use? a. migraine headache without aura b. remission from breast cancer c. tobacco use d. current blood pressure 3.Which of the following is NOT considered a long-acting reversible contraceptive? a. depo medroxyprogesterone intramuscular injection b. levonorgestrel IUD c. copper IUD d. etonogestrel implant 4. In states that allow pharmacists to provide hormonal contraception, which of the following must thepharmacist complete prior to prescribing in all situations? a. a patientâ&#x20AC;&#x2122;s medication history b. a training program c. a cholesterol screening d. both a and b 5.A woman is taking a progestin-only oral contraceptive and it has been 6 hours since she was supposedto take her pill today. What should she do to avoid an unintended pregnancy? a. take a dose as soon as possible and resume her regular schedule tomorrow b. take a dose as soon as possible and resume her regular schedule tomorrow; also use a backup methodfor 2 days c. skip todayâ&#x20AC;&#x2122;s dose and resume taking her pill tomorrow; also use a backup method for 2 days d. take 2 doses as soon as possible and resume her regular schedule tomorrow 6.Which of the following statements is correct regarding the copper intrauterine device? a. it can be used as emergency contraception if inserted within 10 days of unprotected intercourse b. it provides effective contraception for up to 5 years c. it is eligible for pharmacist prescribing as contraception under recent legislation d. it is the most effective emergency contraceptive option for obese women 7. A woman with type 2 diabetes for 5 years has evidence of nephropathy and is requesting a combinationoral contraceptive. Is she eligible for this contraceptive product according to the U.S. Medical Eligibility Criteria for Contraceptive Use? a. yes b. no To get credit for this CPE activity visit: azpa.learningexpressce.com and click on [On Demand] programs. AzPA members will receive FREE CPE credit. Use code: AJPFall17 (Please do not share this code-non-members must pay for this activity)

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