AJP Winter 2017

ARIZONA JOURNAL OF PHARMACY Winter 2017 The Official Publication of the Arizona Pharmacy Association brought to you by the Pharmacy Network of Arizona

Lorri Walmsley, R.Ph. AzPA President 2016-2017

TABLE OF CONTENTS PAGE NUMBER

3

Board of Directors

4

President’s Message

5

Association News

7

PAPA Message

10

Legislative Update

11

2016 Annual Convention Recap

14

Technician Spotlight

15

Features “Provider Status”

18

“Common Sense Ways to Solve Our Medication Non-Adherence Conundrum”

20

“Electronic prescribing requirements for mid-level practitioners in the United States”

25

50th Southwestern Clinical Pharmacy Seminar Informational

30

Pharmacy Comics

32

Continuing Education: “The Pharmacology of Medical Marijuana”

Arizona Journal of Pharmacy THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION BROUGHT TO YOU BY THE PHARMACY NETWORK OF ARIZONA

Winter 2017

Vol. 8, No. 1

2016 - 2017 Board of Directors Executive Committee Betty Louton Past President

Keith Boesen President-Elect

Lorri Walmsley President

Lisa Tonrey Treasurer

Az-ACCP CHAPTER Michelle Baker, Chair Stacey Hollen, Chair Elect Community Pharmacy Academy Sophia Galloway, Chair Susana Horst, Chair-Elect Health-System Academy Nicole Murdock, Chair Jeannie Hong, Chair-Elect Managed Care Academy Darren Clonts, Chair

James Montague, Chair-Elect Student Pharmacist Academy Lacey Simpson, Chair, MWU Seth Anderson, Chair, U of A Brian Seigfried, Chair-Elect, MWU Candice Eastman, Chair-Elect, U of A Technician Academy Kayla Berry, Chair J.R. Gill, Chair-Elect District Directors Laura Moore, Northeast Lynette Wasson, Northwest Jacob Schwarz, Southwest

Jessica DiLeo Secretary

Industry Representative Lori Drea Dean of Colleges Phil Scheinder, The University of Arizona - Phoenix Mitch Emerson, Midwestern University - Glendale Legal Counsel Roger Morris, Quarles & Brady SPECIAL PROJECTS Katherine Murphy, Chair AzPA Staff Kelly Fine, Chief Executive Officer Cindy Younger, Accounting Deborah Marcum, PAPA Sarah Elenes, Membership Erin Roy, Legislative/Research Liaison Cindy Esquer, Operations Kathy Harty, Continuing Education

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 (Ridgway), R.Ph. Chief Executive Officer

Managing Editor Cindy Esquer

Editorial Board Whitney Rice, Pharm.D. Andrea Burns, Pharm.D. Christi Jen, Pharm.D. Jaime Bailey, Pharm.D. Kalani Anderson, C.Ph.T.

Winter 2017 • Arizona Journal of Pharmacy • 3

PRESIDENT MESSAGE Dear AzPA Members,

Let me begin by thanking you for the honor and privilege to serve as your President of our State Pharmacy Association. I am very proud of the work we accomplish as an association and look forward to another very successful year during my presidency. As we embark on a new year with our new Board of Directors, I think it is important that we reflect on the work that was accomplished by our organization last year.

Our association plays an important role in providing continuing education and professional development programs for the Pharmacists and Technicians in the state. In the past year we held the annual convention, two additional educational conferences and a number of certificate programs. We also added an additional education platform to our menu for members’ that is affectionately called “lunch and learn.” This platform allows pharmacists and technicians to participate in live learning webinars during the lunch hour and for those pharmacists that miss the session they are also available on demand on our continuing education site.

Our association had tremendous legislative success last year in both passing bills and preventing bills that would have negatively impacted pharmacy. SB1112 expanded the scope for pharmacists’ authority to provide immunizations in Arizona without a prescription order. Under this new law, pharmacists will be able to immunize children that are 3 years or older for flu, administer adolescent boosters to children 11-12, and administer all vaccines to children and adults 13 years and older. HB2109 is a great example of AzPA’s collaboration with the Board of Pharmacy. It removes the restriction for being licensed for 1 year prior to transferring a pharmacist license to Arizona allowing Arizona to expand our PGY-2 residency programs. This bill also addresses a challenge that has been encountered since the inception of the fingerprint requirement for licensure. As a result of the bill fingerprint clearance cards are now being utilized to fulfill this requirement and it is anticipated that the process to receive a license will be cut in half. HB2692 establishes ground rules for Pharmacy Benefits Managers with regards to audits to provide greater transparency and fairer practices for pharmacies. In addition to these AzPA run bills we also supported HB2355 which will allow pharmacists to prescribe opioid antagonists under a statewide protocol and will expand the access to this lifesaving medication to patients at risk for opioid overdose.

In my coming year as President we will continue to focus on similar activities to grow the voice of pharmacy in Arizona. My priorities are first, creating an additional education program for medication synchronization as our bill from 2015 goes into effect, second, increasing membership and reinventing the association to provide additional benefits to all stakeholders. Lastly, but most importantly, focusing on legislative priorities. AzPA will continue to be active on the political front by monitoring for bills that could negatively impact the profession of pharmacy and we will continue to strive to expand and improve the role of Pharmacies, Pharmacists and Technicians in our state. Our legislative priorities for the next year will include expanding scope of practice for pharmacists and continuing to focus on reform to the third party payment process.

With all of this activity, it should be apparent that every pharmacy professional, pharmacists and technicians alike have a place at AzPA. This is the reason that I chose “Creating the Path to our Future” for the theme of this year’s convention which was symbolized by a hiking trail. I am an avid hiker and it is one of the reasons why I enjoy living in Arizona. What I enjoy the most about hiking is the focus and dedication needed to reach your destination but along the way finding unexpected surprises. This applies to our professional careers and our involvement with AzPA. We all have professional goals, a destination if you will, but it is the activities along the way which help you to achieve your goals and help you to achieve personal fulfillment in your career. We have a lot of paths for involvement on the AzPA trailhead. I ask you, which path do you choose? I personally enjoy them all; education, networking and most importantly political advocacy for our profession. I joined AZPA because I wanted to have a voice for my profession, but along the way I have discovered so much more that has helped to shape my professional career. I would like to close my letter by asking for a Call to Action from each of you, please continue to be involved in our association and look for opportunities to be further engaged. Each of us has a role that we can play in the association to help to further our profession, but it will take all of us, actively engaged, to help AzPA create the path to our future.

Lorri Walmsley, RPh AzPA President 2016-2017 Winter 2017 • Arizona Journal of Pharmacy • 4

ASSOCIATION NEWS WELCOME NEW MEMBERS ASSOCIATES James Kotusky Deborah Profant Jill Sugg James Paxton NEW PRACTITIONERS Julia Lewis Travis Bastow Heejung Woo Fabrice Afanyu-Lorater Roger Beaudoin Kellie Busby Marshall De Groot May Nguyen Madeline Shurtleff Brian Bogdanowicz Danielle Dunlap PHARMACISTS Vinesh Soni Amir Akhlaghi Jeffrey Althoff Scott Black Katie Johnson Michael King

Debbie Laird Robert Andersen Alicia Castleman Marcella Chock Louis Feldman William Grimm Gary Gunderson Bailey McComb Cindi Nehrke Paul Wachter Jeanne Weir Venita Mishra Kam Gandhi Vina Whittington RESIDENTS Thien Tran Andrew Dwenger Patrick Galdun Anne Muhleisen Eric Oborn Alyssa Peckham Jenna Vaughn Samuel Assani Faren French Alexander Guimaraes

Chikezie Okoro Hiva Pourarsalan Neeketa Sheth Saad Tariq Helen Vu

Razelle Hernandez Seongeun Kim Thomas Richards David Romanet Amy Vanderpool

RETIRED Jim Ayers

TECHNICIAN Nancy Morris Van Cao Thai Huynh Daniel Sharpe

STUDENTS Dominick Grosso Hien Nguyen Shannon Sampley Kari Ehm Teresa Baker Aliaa Alhaddad Fatima Benhalima Vera Benson Katie Bratsch Julia Henson Kailee Morton William Nguyen Thomas Richards David Romanet Kari Ehm Amy Grant

TECH IN TRAINING Andre Adams Rocio Loya Linda Benson Siena Hetherington Vicki Mann Teresa Zenti Aseel Aywaz Patricia Enriquez Catherine Padilla

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

CHEERS FOR VOLUNTEERS!

MISSION STATEMENT

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.

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

David Kingsley Spencer Fosnot Ryan Gries Mark Boesen Seth Anderson Paris Cook Joshua Coulter Candice Eastman Samuel Felix Mika Jankowski Eric McCarthy Rianne Michael Thu Nguyen KoanHee Rim Isha Shah Aashish Sharma J.T. Simonsen Alisa Lee Charles Westfall

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

Cheryl Frush John Sears Mark Rhoads Mark Murphy Jim Brown Mark McKee Jerry Denny Rosalie Canaya Gina Gries John Glover Shannon Metzel Heather Linbach Jessica DiLeo Valerie Richards

VISION Empowering pharmacy professionals to provide optimal patient care.

Stay connected!

Special Thank You to the Supporters of the 2016 Masquerade Ball: Southwest Laboratories, Inc.

William Haztly, All State, Tempe Midwestern University College of Pharmacy University of Arizona College of Pharmacy

Fry’s Food and Drug Janssen Pharmaceutical Advancing Pharmacy to Improve Healthcare

Winter 2017 • Arizona Journal of Pharmacy • 5

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

AzPA MENTOR CONNECTION PROGRAM Build relationships, further professional networks, and strengthen continuous professional development!

Participation is open to all members.

Program runs from October - July, annually!

VISIT azpharmacy.org/mentor

Save The Date AzPA 2017 Events 50 Southwestern Clinical Pharmacy Seminar th

February 24 - 26, 2017 (Tucson)

Southwestern States Residency Conference June 9, 2017 (Tucson)

Annual Convention

June 8 - 11, 2017 (Tucson)

Fall Conference

September 9, 2017 (Phoenix Metro)

Certificate Programs AzPA Anticoagulation February 24, 2017 (Tucson) APhA Pharmacist & Patient-Centered Diabetes Care February 26, 2017 (Tucson) April 22, 2017 (Phoenix) AzPA Immunization Delivery Training Program February 24, 2017 (Tucson) April 8, 2017 (Glendale) April 28, 2017 (Phoenix) June 8, 2017 (Tucson) APhA Cardiovascular Disease Risk Management April 28, 2017 (Phoenix) AzPA Psychiatric June 8, 2017 (Tucson) APhA Delivering Medication Therapy Management Services September 10, 2017 (Scottsdale) Winter 2017 • Arizona Journal of Pharmacy • 6

YOU’RE INVITED

Join an AzPA Committee

Legislative Committee Co-Chairs : Mark Boesen & Ken Bykowski

Meetings held 1st Wednesday of the month at 12pm

Membership Committee Co-Chairs : Amy Leung & Kristyn Straw-Wilson

Meetings held 2nd Wednesday of the month at 12pm

Continuing Education Committee Co-Chairs : Nicole Scovis & Lindsay Davis Meetings held 2nd Thursday of the month at 3pm

Marketing/Social Media Committee Co-Chairs : Whitney Rice & Kate Murphy Meetings held 3rd Tuesday of the month at 3:30pm

VISIT

azpharmacy.org/committees

PHARMACISTS ASSISTING PHARMACISTS OF ARIZONA (PAPA) Bridges to Recovery – Understanding Addiction to Prescription Medication Triggered by Chronic Pain

By Michel Sucher, M.D., FASAM, FACEP

Addiction to painkillers as well as other prescription drugs is a national epidemic. The occurrences today are so prevalent they touch each of us in some form or another – whether through a loved one, our patients – or even ourselves. The growth in the use of prescribed pain relievers has resulted in a widespread epidemic of prescription drug misuse and addiction among people of all ages, posing an even larger addiction problem than their illegal counterparts.

As an emergency physician in Arizona for more than 20 years before specializing in the field of addiction medicine, I treated my share of critical incidents arising from drug-related trauma, drug interactions and overdoses. I now lecture extensively to medical groups across the country on how the addiction situation has evolved and where we are at today in the treatment of prescription medicine addiction, especially focusing on what many consider to be the most dangerous area -- narcotic painkillers.

Most physicians recognize that we have essentially become a society of painkillers-on-demand, and it’s resulted in unintentional addiction for people who have an underlying medical condition causing them chronic pain.

At Community Bridges, we have made significant advances in this area of treatment. We recognized a number of years ago that we were seeing an increase in prescription drug addiction where many people had some injury or illness that caused chronic pain, triggering their addiction disorder. CBI developed a comprehensive approach to unintentional addiction, recognizing that addiction is a primary disease and that all substances and behaviors associated with addiction are addressed in treatment.

Pain medication historically was prescribed to treat acute medical situations often resulting from some sort of trauma or medical condition. Early in my career as an emergency physician, if we prescribed 60 mg. per day of Oxycodone for a broken arm or sprained ankle, it was considered a very high dose.

The synthetic painkillers of today are much more potent than the formulations of several years ago.

There are many more options within the formulations, and there is a constant flood of newer drugs that are contributing to the increasing numbers of narcotics. Pharmaceutical companies are developing new variants all the time – long acting, slow acting, with or without acetaminophen, etc. In the past five to eight years, prescription painkiller medication has grown in strength If you or someone you care about and potency, and dosages once considered very high are now is suffering from an alcohol and/or a fraction of common current regimens. At today’s typically prescribed dosages, patients can easily become addicted in as chemical dependency problem... little as 10 days, all while following label directions. ...help is available.

Prevention is the key to combating substance abuse.

While patients are trained to trust that their physicians are fully informed about the impact of drugs we are prescribing, it’s often not the case. Once patients become addicted, they often seek continued or recurring prescriptions to ease their pain.

Many physicians, in an effort to relieve the symptoms, are persuaded to comply with these requests.

Even following medical guidelines, it’s often not physicians or even patients who first recognize that something is off. Very often it’s the families, especially children, who are most sensitive to odd behaviors in their parents, grandparents or even siblings.

Twenty years ago, 60 mg per day of Oxycodone was a high dose, but today we commonly see people who are on a 160 mg. of a long-acting Oxycodone dose three times a day, plus additional painkillers for breakthrough. Today, people are often taking 10 times the doses that we used to consider high

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

Winter 2017 • Arizona Journal of Pharmacy • 7

even a few years ago.

For many years, pain has been considered “the fifth vital sign” along with blood pressure, pulse, temperature and respiration. We ask patients to rate their pain from 1 to 10 and prescribe accordingly, but it’s still a very subjective scale.

Since physicians are now rated on patient satisfaction, it’s a common practice to want to write a pain med prescription with the advice that the patient shouldn’t take it unless the pain becomes severe.

Patients have come to expect getting a prescription when they visit a physician, and physicians have become accustomed to writing those prescriptions. Both patients and physicians are busy, so writing a prescription is sometimes quicker than looking into the underlying condition that’s causing the patient’s chronic pain.

When this fifth vital sign notion came along, the medications being promoted were prescribed in doses that were much safer and less often addictive. A wide range of medications today have addictive potential, but few are as lethal and dangerous over time as narcotics for pain, anxiety and sleep medications.

The rise of painkiller addiction has also led to a resurgence of street heroin. With skyrocketing street prices for prescription narcotics and physicians under pressure to be cautious in prescribing, heroin quickly becomes a viable alternative that is easy to obtain, inexpensive and very pure. We’ve seen a recent surge, corroborated by the Centers for Disease Control and Prevention, in heroin addicts who started out on legitimate prescription pain medications.

Addiction is almost impossible to understand without medical knowledge of how it affects the nervous system and functioning of the brain. It’s deeply hurtful and puzzling to family members who often mistake a loved one’s frightening transformation for a lack of willpower.

I explain the syndrome to families this way: “We all have the biological drives to eat, sleep, drink liquids, but they are conscious drives experienced as hunger, fatigue or thirst. The most primitive drive you have is the drive to breathe. With addiction, the unconscious “chemical” lie the body tells its victim is that, ‘You need this drug to stay alive.’ It’s not true, of course, but the addict can’t tell the difference, and that’s why people who are addicted often attempt such desperate acts as lying, stealing and engaging in criminal activity to obtain and use the drug.”

The strength of the “chemical lie” that accompanies addiction is largely misunderstood. When addiction takes hold, the brain chemistry changes and the addiction becomes as strong for the addict as the biological drive to breathe. Without treatment most addicts won’t quit using until they distance themselves from the drug for a sustained period of time and receive enough treatment and education to master the tools that will help them hold that unconscious chemical lie in check.

Unscript is a non-invasive integrated system of education and physician-monitored medical protocols specifically designed to treat unintentional physical dependence on prescription pain medication. There is no ‘blaming, shaming, guilting” or psychotherapy. Patients are treated as men and women who, while addressing a legitimate medical condition, became unintentionally dependent on increasing doses of prescription pain medication.

As with all addiction, this is a medical problem that must be dealt with using science, education and alternative forms of pain management to address the underlying chronic pain that triggered the addiction disorder.

People come to our program in all stages of acceptance of their condition. The program is voluntary, and there are varying degrees of awareness in dealing with the fact they are addicted. Many individuals don’t perceive the problem themselves, but it’s their family members who contacted us. We often are contacted by and meet with family members before patients come for treatment.

Complete discretion is important because no one should be labeled an addict, other than as having a medical condition. This fear of being found out or labeled often keeps individuals from seeking treatment they need. No one is immune to addiction. It’s not confined to the streets. It cuts across all socio-economic levels and all walks of life.

The truth is that addiction is a chronic, relapsing and treatable disease. Newer treatment modalities all but ensure that recovery is not just possible, but expected. As with most chronic medical conditions, the Winter 2017 • Arizona Journal of Pharmacy • 8

key is early diagnosis and treatment. For a list of community resources available in Arizona, please refer to the following link: http://communitybridgesaz.org/resource/

Michel A. Sucher, MD FASAM FACEP is Chief Medical Officer of Community Bridges, Inc. and also serves as the Medical Director of the Monitored Aftercare Programs for the Arizona Medical Board, the Arizona State Board of Dental Examiners, and the State Bar of Arizona. Dr. Sucher is a Fellow of the American College of Emergency Physicians and a Fellow of the American Society of Addiction Medicine (ASAM) and is the Immediate Past President of the Arizona Chapter of ASAM. He is a highly sought after nationally known speaker on addiction medicine.

Community Bridges is dedicated to providing outreach and education to the community at large. Our services reach the mainstream public through our education efforts and our clinical services provide quality treatment for substance use disorders for men and women. We believe addiction is a disease that carries tremendous consequences for individuals, families, the workplace, and the community as a whole.

Community Bridges, Inc. has more than 30 locations throughout Arizona that provide behavioral and primary healthcare treatment. Unscript, for the treatment of addiction, has offices in Scottsdale, with East Valley and West Valley locations opening soon. CBI is a community-based nonprofit that is funded primarily by state and federal sources, including AHCCCS and Medicaid types of programs. CBI has contracts with most commercial insurers and accepts private pay. For families and individuals in need, grants and donations are often available. No one is ever refused assistance because of a lack of funds. For more information, contact CommunityBridgesAZ.Org or Unscript.com, or call 480-502-7000 for 24/7 assistance.

Reprint/Permissions The Maricopa County Medical Society (MCMS) hereby grants permission to the Arizona Pharmacy Association to make a one-time reprint of the Round-up Magazine article titled, Bridges to Recovery: Understanding Addiction to Prescription Medication Triggered

by Chronic Pain, by Michel Sucher, MD. Originally published in Round-up Magazine, Volume 61, Issue Number 10, October 2015.

Permission for any subsequent or different uses of MCMS Materials must be separately applied for in writing.

This grant of permission to use the MCMS Round-up Magazine article does not include the right to syndicate, rent, loan, scan or digitize the article. You may not manipulate, modify or alter the article in any way and you must reproduce the article in its entirety.

As part of your use of the MCMS Round-up Magazine article, you agree to give MCMS proper and full credit for the article in the following form: The basic credit line is to include: Round-up Magazine October 2015 And the following permission statement: Used with permission from the Maricopa County Medical Society.

In authorizing the publication of the reprinted MCMS Round-up Magazine article, MCMS does not surrender its own right to publish the MCMS Round-up Magazine article or its right to grant permission for others to publish the MCMS Round-up Magazine article. You agree that MCMS owns all rights to the reprinted article.

Winter 2017 • Arizona Journal of Pharmacy • 9

LEGISLATIVE UPDATE 2017 LEGISLATIVE AGENDA

LEGISLATIVE WINS MEDICATION SYNCHRONIZATON: SB1288 is now in effect in AZ as of January 1st!

This bill mandates that prescription plans issued or renewed on or after January 1, 2017 allow medication synchronization services. It states that plans may not deny coverage and is required to prorate the cost sharing rate for a prescription drug that is dispensed by a network if certain criteria are met and if the insured requests enrollment into a medical synchronization program. In addition, requires acceptance of early and short refill requests for prescription drugs using the submission clarification and message codes as adopted by NCPDP. Refer to ARS 20-848 for more details.

FAIR AUDIT & GENERIC PRICING HB2692 is now in effect in AZ as of January 1st!

Arizona joins over 30 other states that have passed similar legislation to create standards for pharmacy audits. This bill creates, among other things: written notice requirements; establishes a periods of time such audits can go back in time; prohibits extrapolation and create an appeals process. Refer to ARS 20-3321 for more details.

Help support our Legislative Efforts by contributing to the Pharmacists Political Action Committee of Arizona (PharmPAC). www.azpharmacy.org/PharmPAC

Kelly L. Fine, R.Ph., FAzPA AzPA Chief Executive Officer

Jessie Armendt Axiom Public Affairs AzPA Contract Lobbyist

Erin Roy AzPA Legislative Liaison

Mark Boesen, Pharm.D., FAzPA, JD Ken Bykowski, BS Pharm, MSHSA AzPA Legislative Committee Chairs

Winter 2017 • Arizona Journal of Pharmacy • 10

SCOPE EXPANSION: TOBACCO CESSATION

Will allow Arizona pharmacists the ability to prescribe over the counter nicotine replacement products as well as presciption nicotine replacements products indicated to aid in smoking cessation treatment for eligible patients 18 and older, according to FDA recommendations and clinical guidelines.

SCOPE EXPANSION: EMERGENCY REFILLS

Will allow a pharmacist to dispense a one-time emergency refill of a prescription for a non-controlled medication for up to 14 days. This allows patients in an emergency situation, the flexibility needed to schedule an appointment with their doctor, without suffering from interrupted medication therapy.

SCOPE EXPANSION: ORAL HEALTH

This bill will allow Arizona pharmacists to administer Oral Fluoride Varnishes to eligible patients according to ADA guidelines. Pharmacists will perform a caries risk assessment on every patient, provide a fluoride record card to track treatments between providers, and make necessary referrals.

MEDICATION AFFORDABILITY & ACCESSIBILITY

This bill will mandate price updates every 7 days to accurately reflect the market price of acquiring the medication; allow retail pharmacies to fill 90 day prescriptions for the same co-pay & price as mail order pharmacies; allow retail pharmacies to continue to mail and deliver prescriptions to their patients; and prohibit contracts that prevent pharmacists from telling a patient there is a cheaper alternative medication compared to what the plan is offering.

LEGISLATIVE ALERT As a result of the passage of HB2355 pharmacists can now dispense Naloxone without a prescription!

Complete the AzPA training today to make an impact in your community!

All AzPA members are welcome to attend the monthly Legislative Affairs Committee meetings. If you are interested in joining the discussions, contact AzPA.

AzPA 2016 ANNUAL CONVENTION RECAP Over 400 pharmacists, technicians, residents and students from all over the state of Arizona, gathered for this year’s event.

Thank You to Our Convention Sponsors

EXHIBIT HALL Thank you to the following exhibitors for making it a successful trade show.

AbbVie Allergan Institutional Sales AmerisourceBergen Corp Arkray USA, Inc. AstraZeneca Diabetes AstraZeneca LLP Banner Health Baxalta US Boehringer Ingelheim Pharmaceuticals Cardinal Health Country Financial CSL Behring CSL Behring Freedom Pharmaceuticals Germfree Labs, Inc Grifols USA Humana Pharmacy Janssen (Johnson and Johnson) Janssen Pharmaceutical - CNS Division Johnson & Johnson Diabetes Care Liberty Software Lilly USA McKesson Corporation Meda Pharmaceuticals

Meda Pharmaceuticals Medistar Healthcare Connections Corp.

Merck & Co Midwestern University College of Pharmacy - Glendale Northern Arizona Healthcare Northern AZ Healthcare Novartis Novo Nordisk, Inc Pfizer Vaccines Pharmacists Mutual Companies Precision Diagnostics PRI Healthcare Solutions (Teva) Roche Diabetes Care Rx Relief RxPlus Pharmacies, Inc Sanofi Pharmaceutcials SigmaTau Pharmaceutical Teva Pharmaceuticals The Arizona Partnership for Immunization United States Air Force Health Professions University of Arizona College of Pharmacy Upsher-Smith Laboratories, Inc. Walgreens Winter 2017 • Arizona Journal of Pharmacy • 11

AzPA 2016 Annual Convention Recap

We bid on Silent Auction items and ran to support pharmacy education and raise money for the Foundation

OVER 40 CONTINUING EDUCATION SESSIONS

Together, we raised over $4,500 to support PharmPAC!

Winter 2017 • Arizona Journal of Pharmacy • 12

AzPA 2016 Annual Convention Award presentations

CONGRATULATIONS TO ALL AWARD RECIPIENTS 1. Distinguished Young Pharmacist of the Year Sophia Galloway, Pharm.D. 2. Generation Rx Champions Award Susan Wilson, R.Ph 3. AzPA Fellows Ann Sears, BS Pharm Martha Fankhauser, MS Pharm Ali McBride, MS Pharm 4. AzPA Exemplary Patient Care Award Maryam Fazel, Pharm.D. 5. Technician of the Year Award Kalani Anderson, CPhT 6. Bowl of Hygeia Carl Labbe, BS Pharm, R.Ph 7. Pharmacist of the Year Award Ann Sears, BS Pharm 8. Pharmacy Appreciation Awards Ryan Gries, Pharm.D. Lindsay Davis, Pharm.D. Virginia Boomershine, Pharm.D. 9. Corporate Appreciation Award: Banner Health 10. AzPA Hall of Fame Award Dean Wright, R.Ph. Erin Raney, Pharm.D. Vincent Angichiodo, RPh

Winter 2017 • Arizona Journal of Pharmacy • 13

TECHNICIAN SPOTLIGHT

Technician Spotlight: Tanya Ribald, CPhT

Submitted by: J.R.Gill, BS, CPhT, USN/Ret.

As a child, Tanya wanted to be a chemist. She originally studied to be a pharmacist at the University of Arizona but later decided on a career as a pharmacy technician, which she said was rewarding. She received onthe-job training at University Medical Center in Tucson and received her PT diploma from Penn-Foster. She became certified through PTCB in 1999 and worked in inpatient pharmacy as well as for a Pharmacy Benefits Manager for five years. She is IV certified through NPTA and received a certificate of training in Medication Therapy Management through Power-Pak. She is currently attending Pima Community College for an associates degree in Health Information Management and Business. Tanya has also worked in retail and trained as a surgical technician. She is currently working at Pharmerica and serves as an adjunct instructor for the Pharmacy Technician Program at Pima Medical Institute since 2012.

Assistant Professor David Lee, RPh, has worked with Tanya for over 15 years and states, “Tanya is a mature, intelligent, friendly, hard-working technician and under stressful situations, she always remains calm.” He also states, “by the end of the day, we will have given our best effort and attention to patient care and service to our colleagues.”

Michele McDermott, RPh of over 20 years and currently employed at Pharmerica, has worked with Tanya for 2 ½ years and states, “I have to say, she is the best technician I have EVER worked with!” She adds, “The nursing staff know her work ethic and know they are in good hands because Tanya cares!” Tanya was instrumental in developing a pull-back method in the IV room that was quickly approved by the Pharmacy Director. Michele states that Per Diem Pharmacists “know they can count on Tanya.”

Tanya has been married to her husband for 11 years and they have two sons together and a stepson that visits regularly. She says, “my family means the world to me.” She loves to camp, fish, hike, and kayak. She volunteers in her sons’ classroom and/or with the PTA at their elementary school.

Tanya joined AzPA in 1999. She enjoys the CE luncheons and networking at the conventions. She feels that teamwork and respect foster a strong working relationship between pharmacists and technicians. Tanya states that, “when I first started, the pharmacists were very patient and willing to educate me, which made a huge impact on my career to this day.”

Her advice to other technicians, “To be a chameleon, be able to multi-task and adapt to any situation. Don’t let the little things bother you. The stress level can get intense and people react differently under stress. Don’t take it personally. Remember that in the end, we are here for the patient.”

Tanya can be reached at: ribald@live.com or through LinkedIn: https//www.linkedin.com/in/tanya-ribald-780a0833

INNOVATION DRIVES OUR SCIENCE As a global biopharmaceutical company, we combine science, passion and expertise to improve health and health care in new ways. Making a remarkable impact is more than our promise, it’s our purpose. abbvie.com Winter 2017 • Arizona Journal of Pharmacy • 14

FEATURES Provider Status

We talk a lot about the idea of pharmacists having “provider status.” But what exactly does that mean?

Krystalyn Weaver, Pharm.D., the vice president of policy and operations for the National Alliance of State Pharmacy Associations, talks about that phrase — why provider status is important and why we’re working so hard to achieve it nationwide.

Across practice settings, provider status is seen as the great brass ring for pharmacists. So let’s start by defining the term: What is provider status, and why do we need it?

Today the federal government does not recognize pharmacists as medical “providers” — specifically in Part B of the Social Security Act. That means Medicare beneficiaries aren’t able to access pharmacists’ patient-care services such as diabetes management, smoking cessation assistance, and even simple wellness visits through their Medicare benefits.

Hence our goal of attaining federal “provider status." A major step of that would be passage of the Pharmacy and Medically Under-served Areas Enhancement Act, aka H.R. 592 or S.314. It would allow Medicare to pay for pharmacists' services in medically under-served areas.

But if you dig into the “why” of that objective, it's more than just about pharmacists. It's about the fact that patients benefit from the valuable services pharmacists can provide. We know that when pharmacists are on the healthcare team, outcomes improve and costs go down.

To sum it up, the goal is to ensure that patients’ have access to pharmacists’ brains — not just the products we dispense.

Back to the term provider status. Medicare access is a major step, but it's only the first step. The reality is that we need to approach ensuring patient access to pharmacists’ services from more than one angle. Though Medicare patients make up a huge population of those who would benefit from pharmacists knowledge and skills, there are many other patients who do not have Medicare coverage.

So "provider status" is broader. It encompasses any effort to get patients access to these services, which makes the meaning of that term somewhat complicated.

Add to that the fact that not every pharmacist wants to provide those services. Often when I'm talking about integrating more patient-care services into our practices I get the inevitable comment: “I’m too busy in the pharmacy as it is. There is no way I can add even more activities to my day-to-day operations and still get prescriptions filled.”

By Krystalyn Weaver, Pharm.D. Vice President, Policy’s Operations: NASPA

As a practicing community pharmacist myself (although it’s only moonlighting), I can relate. Any pharmacist (or consumer for that matter) knows how busy a community pharmacy can be. It is, in fact, difficult to add to that workload in the world we live in now.

But that's the key phrase: in the world we live in now. It doesn't have to be this way.

I challenge my peers not to think of the current practice environment. When we're talking about broadening pharmacists' services, think of the future. Remember that the reason we aren’t already doing this is because our payment system is broken — it doesn’t recognize the value pharmacists are capable of providing. A core premise of the provider status push is that we have to change our business model. We need to change the practice environment and make it feasible for our services to be delivered effectively.

We are talking about overhauling our work flow so patient-care services become a focus, not an add-on. And yes, we're talking about new streams of revenue.

I would also argue that considering the ever increasing pressures to decrease what Americans pay for prescription drugs, that a change in our business model is likely essential for pharmacies to survive. Any pharmacy owner can attest to the fact that margins are decreasing. In order to keep pharmacist jobs viable, we need to leverage our most valuable asset: our ability to optimize medication regimens, assist patients with disease management and prevention, and decrease overall health care costs — not just get the right drug to the right patient at the right time (although that will always be important).

If the case is so strong, what's keeping Congress?

That’s a great question, but it assumes that policy decisions are always made with 100 percent reliance on facts and data. The reality is that national policy is influenced by political pressures. And one of the biggest political pressures we're facing today is our national debt and the ever ballooning costs of entitlement programs. Adding pharmacists services to Medicare benefits will come at an added cost to the program, at least initially.

So rather than reflecting on why it hasn’t happened yet, I like to focus on why now is a good time.

There has never before been more of an awareness on health policy in the larger policy environment. Policy makers are realizing that saving money is more than simply cutting costs — it's also critical to get the most Winter 2017 • Arizona Journal of Pharmacy • 15

value.

healthcare in both the short and long term.

Pharmacists are pros at keeping people healthy and maximizing the utility of a critical healthcare resource: medications. We have plenty of data to show that. More people are realizing this, so not only do we have unprecedented collaboration among pharmacy associations, wholesalers, and national pharmacy chains, we are now seeing support from many outside organizations such as the Centers for Disease Control and Prevention, the National Governors Association, the Office of the Surgeon General, and others.

There are hard data showing that within one year, simply paying pharmacists to provide modest MTM services for Medicaid patients delivered a 4 to 1 return on investment. And data for the long term is even stronger — an average ROI as high as 12 to 1.

Okay, so Congress is concerned about the price tag. I get that. Isn’t there research, though, to demonstrate that the long-term savings from compensating pharmacists as providers is greater than the short-term costs? I can imagine healthier patients and reduced hospital admissions could save Medicaid and Medicare some real money.

Absolutely, there are plenty of data to show that pharmacists can save payers on the overall cost of

First Quarter 2017: Pharmacy Time Capsule POSTED ON January 16, 2017

Pharmacy Time Capsules are written by Dennis Worthen who makes them available for state pharmacy associations to share with their members. Appropriate attribution is at the bottom. If you are publishing, please leave us a comment below.

1992 The American Association of Colleges of Pharmacy (AACP) passed a resolution supporting a single entry level professional degree. Psychiatric pharmacy recognized as a specialty by the Board of Pharmacy Specialties (BPS).

1967 Donald Brodie articulated the concept of drug use control which would become the central precept of clinical pharmacy and later pharmaceutical care.

1942 American Foundation for Pharmaceutical Education incorporated in 1942 to provide financial support to colleges of pharmacy in need during World War II and later finance the Elliot Report.

1892 Original passage of Utah Pharmacy Practice Act. University of Minnesota College of Pharmacy founded

by Dean Wulling.

By: Dennis B. Worthen, Ph.D., 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. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

Winter 2017 • Arizona Journal of Pharmacy • 16

Unfortunately, the way new federal bills are analyzed doesn’t account for these savings. The Congressional Budget Office assigns a “score” to bills that estimates the cost of the bill to the federal budget over the next 10 years. But that score doesn’t take into account cost savings — which doesn’t help our cause one bit. We've heard that this process may be loosening a bit but the score of the federal bill will continue to be a challenge, especially in an election year.

You’ve mentioned that Congress would need to enact provider status at the federal level. But what about at the state level? Is there any benefit to asking the legislature to grant pharmacists provider status?

What would state provider status look like?

Absolutely, there is a lot states can do to ensure patients access to and coverage for pharmacists’ patient care services (which is really what we mean by “provider status,” remember). Unfortunately it isn’t as simple as a state legislature simple granting provider status. The state environment is different than the federal one. At the federal level, a somewhat simple change of definition in law results in a massive change in the payment structure for MANY patients across the country. At the state level this almost always isn’t the case.

There are often several places in state law and regulation where the term “provider status” is defined, each with a different degree of impact on patient access to pharmacists’ services. They may be important in their own way but are very unlikely to be the broader solution that a federal change would be.

Additionally, it's at the state level where scope of practice is defined, and that's an essential factor in pharmacists’ ability to provide the care they want to provide. In recent years states have made improvements to laws regulating pharmacists: broadening immunization and collaborative practice agreements, allowing pharmacists to prescribe travel medication, and promoting access to public health services through pharmacies, such as smoking cessation products and hormonal contraceptives.

Finally, states can influence local payers including Medicaid, state employee plans, and private payers through legislative or regulatory action, or by simply working with those payers directly and sharing the business case with them.

So are we talking about expanding pharmacists’ scope of practice? Providing services under collaborative practice agreements with physicians? Or simply doing stuff pharmacists can already do but currently can’t be compensated for?

All of the above. As we discussed before, state provider status efforts often include work to align pharmacists’ scope of practice with their clinical ability — so patients aren’t missing out on pharmacists’ care because of outdated laws. Collaborative practice agreements can allow for increased collaboration and efficiencies in care delivery — unless the state laws and regulations are so restrictive that entering into an agreement becomes a burden.

And finally there is “stuff” pharmacists can already do and already are doing that they aren't being compensated for. It won’t be as easy as just submitting a quick claim for services; we'll need to comply with the rules and regulations other providers comply with now — including credentialing, documentation, quality assurance, etc.

How do you think physicians will react to that?

Does it change the physician–pharmacist relationship?

The examples we currently have of physicianpharmacist collaborations are relatively few and far between because it requires great creativity to make the relationship financially viable. But when we are able to find sustainable revenue streams to take the strain off of the system, physicians often report favorably on working closely with pharmacists. I think physicians and other providers will embrace the presence of pharmacists on the health care team. Let’s face it — drugs are complicated and there are plenty of other things doctors, nurses, physician assistants, and nurse practitioners have to focus on. Having a medication expert on their side will make their job that much easier and allow them to provide care to more patients.

How do you see this new paradigm impacting the quality of patient care?

It’s been said many times before but I’ll say it again: When pharmacists are on the team, health outcomes improve and costs go down. I think it's a given that pharmacists’ services can improve quality. The impact pharmacists are already making, even in our broken system, is probably under-appreciated. But I think if we align the incentives appropriately — and build an infrastructure that allows pharmacists to access the patient health data they need — the system can be fixed to maximize pharmacists' skills and improve patient care.

Let’s talk about compensation. If, as providers, pharmacists could be compensated for a broader range of their services, what does that look like? What are the mechanics of it?

I don’t want it to sound like an easy, quick

transition. We'll need to adjust workflows, re-imagine how we use pharmacy technicians, implement infrastructure changes to allow pharmacists to plug into the information systems hospitals and doctors use, and learn how to do medical billing. And medical billing is VERY different than prescription billing, which is quick, automated and immediately tells you if a claim is covered.

In medical billing, a claim is submitted but the provider may not know for weeks if it will be paid by the insurer. Copays have to be collected at the time of service but are only estimates of what the patient’s cost share is — meaning you have to bill the patient after the fact as well. And if a claim isn’t covered, the dispute process can be lengthy and arduous. Obviously all of these challenges have been overcome by our colleagues in other health professions so they're not insurmountable, but they will be big changes for pharmacy.

Sounds like this is an issue pharmacists need to anticipate, so that when it’s enacted, our members are ready to take advantage of it on day one. What can pharmacists be doing now to prepare themselves, their practices, and their patients for provider status?

Pharmacists can get themselves ahead of the game by incorporating services into their current business model now. Start small. Consider incorporating medication synchronization into your pharmacy.

Incorporate other adherence interventions. Make sure to fulfill all of the Medicare Part D MTM opportunities that come your way. This will help you to get your workflow to a better place and start to change patient perceptions about the level of care pharmacists are capable of providing.

Build relationships in the community. Reach out to local physicians' offices, get to know the care managers in the local hospital and see if you can find a way to help them with medication reconciliation at discharge. Building relationships will also build a referral network. Yes, this will mean business when we are able to bill Medicare for medical services but it will also mean increased business now. If your local providers see you as the go-to pharmacy for optimal medication management, they will send their patients to you.

Try to understand the quality measurement landscape — and beyond Star Ratings. Physicians, ACOs, medical homes, and hospitals are all held to different quality metrics. Learn what they are, learn what the pressure points are and think of how pharmacists can help to achieve those metrics. Also get to know the billing codes that may be available to us through Medicare.

These include CPT codes, chronic care management codes, G-Codes and more. The Medicare Learning Network is a great resource. Sign up for their email list and get information sent to you regularly.

This interview first appeared in Georgia Pharmacy magazine.

Winter 2017 • Arizona Journal of Pharmacy • 17

Common Sense Ways to Solve Our Medication Non-Adherence Conundrum “Drugs don’t work in patients who don’t take them” C. Everett Koop, M.D.

Medications are dispensed with the expectation that patients will consume them as they are prescribed.

However, we all know that patients oftentimes are noncompliant with their medicines which commonly lead to poor medical and economic outcomes. In the U.S., nonadherence leads to wasted resources north of $200 billion annually in avoidable medical services and hospitalization and poor health outcomes for patients. To put this figure in context, the federal program, Medicare Part D is estimated to spend only $88 billion in 2016 according to Congressional Budget Office. In addition U.S. payers spend less for all of the oncology, respiratory, mental health and diabetes medicines combined than the resources we waste with not appropriately taking our medications.

The fact that non-compliance with medicines creates an inordinate amount of human and capital waste is not new to most pharmacists. Researchers have underscored this point for the past several decades. As a multitude of published research papers demonstrate the extent of poor medication adherence and potential consequences to patients and the healthcare system.

Supporting data show that 50% of patients are not taking their medicines as prescribed by their provider and that non-adherence drives up hospitalizations and emergency department visits. One study published in 2011 found that medication adherence was associated with significantly lower annual inpatient hospital days, ranging from 1.18 fewer days for patients with high cholesterol to 5.72 fewer days for congestive heart failure. There are also studies that highlight the impact of non-adherence on non-medical outcomes, such as worker productivity, in specific disease states like rheumatoid arthritis. Given the broad consensus around the benefits and consequences of medication adherence, building consensus for solutions should be achievable. What are the interventions that offer the best patient outcomes without burdening the individual, the provider or overwhelming the healthcare system?

One way to address non-adherence is to allow a pharmacist to synchronize a patient’s chronic medicines.

Medication synchronization is not a new concept; pharmacists across the country have synchronized refills for patients on multiple chronic medications for the past decade, ensuring that all a patient’s refills are ready to be picked up on the same day every month. They have also operationalized the concept of an appointment based model the practice by which a pharmacist makes an appointment with a patient once a month or more to pick up their medications and to discuss other issues pertinent to their care such as over the counter medicine usage, disease management like smoking cessation education or vaccinations. These practices have helped reduce the number of trips a patient has to take to the pharmacy and lessened the administrative burden on pharmacists and physicians who no longer have to accommodate last minute refill requests. Most importantly, it has led to better patient adherence. In a paper published last year in the Journal of the American Pharmacists Association, patients who used the appointment based synchronization Winter 2017 • Arizona Journal of Pharmacy • 18

model had a 70% better chance of staying adherent to their therapies than those who continued to pick up their medications whenever they ran out.

For synchronization services to become a broad reality, pharmacists have to be allowed to partially fill prescriptions to ensure that they can get all of the refills to align on the same pick-up day. In addition, to be fair to the patient, payers ought to allow pro-rated copays for the impacted prescriptions and thus avoid potentially putting too much financial burden on the patient all at once, paying the same amount for a smaller number of pills . The pharmacy should also not be penalized with a lower dispensing fee for dispensing pursuant to medication synchronization since the pharmacy overhead costs remain the same.

Support for medication synchronization is growing. In 2014, the Centers for Medicaid and Medicare Services (CMS) decided that patients enrolled in Medicare Part D plans should have the opportunity to synchronize their medications if they choose to and if it is deemed appropriate by their physician and pharmacist. The American Medical Association (AMA) House of Delegates has supported a resolution that implements prescription refill schedule strategies to reduce the burden on patients of having to travel numerous times to the pharmacy to pick up prescriptions. In addition AMA has created a physician education program that explains the benefits of synchronization from a practicing physician perspective.

For pharmacists and patients the American Pharmacists Association (APHA) has created an educational initiative which includes a zip code locator so patients who are interested in synchronizing their medicines can identify pharmacies that provide the service. Most importantly 15 states in the last 2 years through legislation or regulation allow pharmacists to synchronize medicines including state of Arizona which in 2015 passed Senate Bill 1288.

Ultimately, synchronization and the appointment-based model may also help address other issues beyond patient adherence such as a reduction in inappropriate use of medicines including opioid abuse and a reduction in pharmaceutical waste due to potential changes or discontinuation in therapy. Clearly, it is time for all public and private payers to take the lead from CMS, patients, pharmacists and physicians and promote policies, regulations and legislation that would allow synchronization which would support medication adherence for the benefit of patients and economics of the healthcare system overall. http://kff.org/medicare/fact-sheet/the-medicare-prescription-drug-benefitfact-sheet/ https://www.imshealth.com/files/web/IMSH%20Institute/Reports/The%20 Global%20Use%20of%20Medicines%20Outlook%20Through%202016/Medicines_Outlook_Through_2016_Report.pdf

Medication Synchronization is Easier in Arizona!

SB1288 in effect as of January 1st, 2017 Arizona pharmacists who perform Medication Synchronization services will have an easier time coordinating this service due to AzPA legislative efforts through mandated short fills through insurance and prorated copays.

The New Normal DSCSA Compliance Tips: Policy Matters

What is my new normal? The newly enforced Food and Drug Administration’s (FDA) Drug Supply Chain and Security Act (DSCSA) requires electronic tracking and tracing of all dispensed prescription drugs and requires a process for product verification in the event of a suspect product and mandatory reporting requirements. These latest regulations bring a new way of life and create a new normal when approaching compliance as a part of your day to day business practices. The best way to document standard operating procedures related to DSCSA is to adopt and document policies.

Developing your Policy and Procedure Manual for DSCSA compliance may seem like a daunting task, especially when considering all of the elements of the new law and what is required of you as a dispenser. A store policy clearly communicates to staff the standard operating procedures for any process, ensuring that all employees handle situations consistently. Adopting a policy is also an important risk management move because, if done properly, it verifies your standard business practices. Even if an employee makes mistakes, evidence of a clear policy and guidelines (which the employee may not have followed) will be helpful to lessen any potential fines or penalties. A clear policy combined with annual staff training is excellent protocol to show compliance with regulatory process requirements.

InfiniTrak, has been following the development of these DSCSA regulations since they began in 2013. When designing a software solution, they looked at the situation from the point of view of the dispenser - and independent pharmacies like yours, and created a tool to meet you needs. For example, InfiniTrak provides its customers with a template for a track and trace policy document to be created to meet each location’s requirements.

InfiniTrak is a cost-effective, easy to use software that will save you time and money, increase productivity, ensure full compliance, and provide the peace of mind that comes from knowing that all of your data is at your fingertips, when you need it. Contact us today to learn more about how you can electronically create and transmit FDA and other government reports as required, all in a cloud solution.

Questions regarding your store policy and your compliance plan? Contact info@infinitrak.us.

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Electronic prescribing requirements for mid-level practitioners in the United States Authors: Melissa Shreve, Pharm.D.; Tatiana Sawyer, Pharm.D.; Melissa Nelson, Pharm.D.; Terri Warholak, Ph.D., RPh, FAPhA ABSTRACT

INTRODUCTION

Specific Aims: To identify which types of mid-level practitioners have prescribing authority in each state in the United States (US), compare the types of prescriptive authority for scheduled medications for mid-level practitioners, and delineate differences between state and federal requirements for electronic prescribing (e-prescribing) for mid-level practitioners in each state.

With a rapidly growing and aging population, and a shortage of primary care practitioners, there has also become a greater opportunity and demand for midlevel practitioners to have prescriptive authority. On July 29, 1992 the DEA proposed creating a new classification for mid-level practitioners. It would require those wanting to dispense controlled medications to register with the DEA under the new classification of practitioners. On June 1, 1993 the DEA published the final rule for the new regulation of mid-level practitioners.1

Methods: A data extraction tool was developed and utilized to collect e-prescribing requirements and mid-level practitioner prescriptive authority from publically accessible state and federal websites.

Dependent variables were analyzed using frequencies and percentages. A comparison of regional midlevel practitioner prescriptive authority patterns was conducted.

Main Results: Mid-level practitioner prescriptive authority and e-prescribing requirements were collected from 50 states, the District of Columbia, and the Drug Enforcement Administration (DEA). For e-prescribing requirements, 19 (37%) states listed federal law requirements, 28 (55%) states listed requirements in addition to federal law, and 4 states (8%) did not specify requirements. Overall, over half of the US had more stringent e-prescribing requirements than federal law. States varied in which mid-level practitioners had authority to prescribe controlled substances: 98% of states allow nurse practitioners to prescribe; 96% allow physician assistants; 84% allow optometrists; 14% allow naturopathic doctors; 12% allow registered pharmacists; 8% allow certified nurse midwives, 4% allow homeopathic physicians, medical psychologists, and nursing homes; and 2% allow doctors of oriental medicine, certified chiropractors, clinical nurse specialists and/or advanced practice registered nurses.

Conclusions: There are differences in e-prescribing requirements and varying levels of prescriptive authority for mid-level practitioners between US states.

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In 2009 the Centers for Medicare and Medicaid Services (CMS) provided a monetary incentive program for eligible providers who implemented an e-prescribing program in their practice. Incentive eligibility ran from January 1, 2009 through June 30, 2013 as a monetary motivator to avoid a payment adjustment for those who did not register by 2014.2 In 2010, the DEA indicated that the number of authorized prescribers who would be affected by e-prescribing would be 328,772 for in-office physicians, 169,337 for in-hospital physicians, 82,579 for in-office mid-level practitioners, and 48,841 for inhospital mid-level practitioners.3 CMS stated that eligible providers of Medicare and Medicaid services who are not successful electronic prescribers would start to receive a payment adjustment beginning in 2012 through 2014.2 Subsequently in November 2014 CMS published a core measure addressing e-prescribing as one of their eligible professional meaningful use core measures (measure 2 of 17).4

The National Health Statistics report from 2007 to 2012 described trends in electronic health records (EHRs) use among non-federal office-based physicians.

In 2007, 34.8% of office-based physicians reported using some type of EHR system, and this increased to 71.8% in 2012. Of those physicians in 2012, 39.6% had an EHR system with features that met the criteria of a basic system, and 23.5% had an EHR system with features meeting the criteria of a fully functional system.5 For prescription orders, basic systems did not have warnings for drug interactions or contraindications, or a means to send prescriptions to pharmacies from the system electronically, whereas the fully functional systems did.

A study by Gabriel et al. looked at the total number of e-prescribing of controlled substances (EPCS’s) from July 2012 through December 2013. The number of EPCS’s increased from 1535 to 52,423, and the number and percentage of pharmacies across the US that were EPCS enabled increased from 8768 (13%) to 20,498 (30%) respectively. The proportion of all providers using EPCS during this period was 1%, but was increasing steadily each month.6

Winter 2017 • Arizona Journal of Pharmacy • 20

From 2011 to 2013 there was an 82 percent

increase in e-prescribing.

Data published by Surescripts showed that between 2010 and 2013 there was a 219 percent increase in prescriptions that were routed electronically in the US (326 million in 2010 to 1.04 billion in 2013).7,8,9 In February 2013, MediScripts, a company that provides prescription pads and electronic prescribing services, published a press release indicating the number of hand-written prescriptions from practitioners who use MediScript pads was almost one billion in 2012.7 In 2012, Surescripts reported its users electronically routed 788 million prescriptions.8 Due to the pay adjustments for authorized Medicare and Medicaid providers who do not have EHR technology with an electronic prescription component, the steady increases seen in EHR systems with an electronic prescription component, and a constant increase in the number electronic prescriptions transmitted annually, the probability that an e-prescription from a mid-level practitioner will be transmitted to an authorized pharmacy is expected.

The purpose of this study is to compare the prescribing authority and requirements of mid-level practitioners for each US state.

METHODS

Design This was a descriptive study evaluating information on state boards of pharmacy and the US federal government websites.

Subjects No human subjects were part of this study. The study obtained publicly accessible information from the DEA website and each state’s board of pharmacy website. Inclusion criteria included mid-level practitioners, their electronic prescription requirements and their prescriptive authority as defined by the corresponding state and/or federal requirements. Each US state statute on the corresponding Board of pharmacy website and DEA website were examined for authorized mid-level practitioners and e-prescribing requirements.

Measures Data were collected using publicly accessible information from the DEA website and each state’s board of pharmacy website. A data collection form was used to ensure all members of the research team performed data collection in a similar manner, and data collection methods were the same at each website.

For controlled substance prescriptive authority in each state, mid-level practitioners who had authority were noted on the data collection form, designated a number to delineate whether they had prescriptive authority for each controlled substance category, and any specific prescribing requirements for scheduled medications were recorded. For e-prescribing requirements in each state, mid-level practitioners were designated a number to delineate if the requirements were the same as federal requirements, had additional requirements, or if there were no specifications. A data dictionary was used to define common terms associated with our data extraction.

See Appendix A, B, and E for data extraction tool, data collection form and data dictionary, respectively.

Data collection A standardized data extraction tool and

data collection form were used to systematically collect and review state and federal websites. The form included directions for data collection from the US state boards of pharmacy and the US DEA websites. See Appendix B for the data collection form.

Data analysis Based on the number of state board of pharmacy websites and the federal law, we estimated a sample size of 52 for e-prescribing requirements and 51 for analysis of mid-level practitioner prescriptive authority. Dependent variables were analyzed using frequencies and percentages. Midlevel practitioners were separated by region according to the US Census Bureau to identify regional patterns in prescriptive authority of controlled substances.10 RESULTS

The variation in e-prescribing requirements in the US are shown in Table 1. Thirty-seven percent of states had listed the federal requirements, and 55% had listed requirements in addition to federal law. Eight percent of states (Florida, Hawaii, South Dakota, and Tennessee) did not specify their state requirements, which would default to the federal requirements. Overall, 45% of states had requirements that matched federal, and over half of the US had more stringent standards.

Table 1.

A comparison of US state and federal e-prescribing requirements

The variations in prescriptive authority for mid-level practitioners are shown in Tables 2 and 3.

The different schedules of controlled substances, and authorized medications within each schedule, varies for mid-level practitioners within and between states. For mid-level practitioner controlled substance prescriptive authority, physician assistants (PAs), nurse practitioners (NPs), and optometrists (ODs) are the most common.

Ninety percent of states (46 of 51) allow NPs and/or PAs, and 47% (24 of 51) allow ODs prescriptive authority for all controlled substances. Other mid-level practitioners with prescriptive authority for all controlled substances across the US are: 12% (6 of 51) allow registered pharmacists (RPHs); 6% (3 of 51) allow naturopathic physicians (NDs) and certified nurse midwives (CNMs); 4% (2 of 51) allow homeopathic physicians (HMDs), NDs, and nursing homes (NHs); and 2% (1 of 51) allow advanced practice registered nurses (APRNs). When considering Winter 2017 • Arizona Journal of Pharmacy • 21

Table 2.

Mid-level practitioner prescriptive authority by US region and state Northeast State Connecticut Maine Massachusetts New Hampshire

Prescriptive authority NP, OD, PA (SS2-5) NP, PA (SS2-5); OD (SS3-5) NP, PA, RPH (SS25) NP, PA (SS2-5)

South State

Prescriptive authority

Midwest State

Alabama

NP, PA (SS2-SS5)

Illinois

Arkansas

NP, OD, PA (SS2-5)

Indiana

Delaware

NP, PA (SS2-5)

Michigan

District of Columbia

NP, PA (SS2-5); ND (SS3-3N)

Ohio

NP, OD, PA (SS2-5) NP, PA (SS2-5); OD (SS4) NP, OD, PA (SS2-5)

West State Arizona Colorado Idaho

NP, PA (SS2-5)

Montana

NP, PA (SS2-5); OD (SS3-5)

Nevada

Prescriptive authority HMD, ND, NP, PA (SS2-SS5), OD (SS23N) NP, OD, PA (SS2-5) NP, OD, PA (SS2-5) NP, OD, PA, RPH (SS2-5) HMD, NP, OD, PA (SS2-5) MP, NP, OD, PA,RPH (SS2-5); DOM, CC (SS3N)

New Jersey

NP, OD, PA (SS2-5)

Florida

OD (SS3-4)

New York

CNM, NP, PA (SS25)

Georgia

NP, PA (SS3-5); OD (SS2-4)

Iowa

NP, PA (SS2-5)

Kentucky

NP,OD (SS2-5)

Kansas

NP, OD, PA (SS2-5)

Utah

NP, PA (SS2-5);ND (SS3N); OD (SS2-3, 4, 5)

Louisiana

MP, NP, OD, PA (SS2-5)

Minnesota

NP, PA (SS2-5); OD (SS4-5)

Wyoming

NP, PA (SS2-5); OD (SS3-5)

Maryland

NP, PA (SS2-5); OD (SS4-5)

Missouri

Mississippi

NP, PA (SS2-5); OD (SS4-5)

Nebraska

Pennsylvania

Rhode Island Vermont

CNM,NP, OD, PA(SS2-5); CNS (SS2, 2N, 4) ND, NP, OD, PA (SS2-5)

North Carolina Oklahoma South Carolina Tennessee Texas Virginia West Virginia

NP, OD, PA, RPH (SS2-5) OD, PA (SS2-5); NP (SS3-5) OD, PA(SS2-5); NP (SS3-5) NP, OD, PA (SS2-5) NP, PA (SS25);OD(SS3-5) NP, PA (SS2-5); OD (SS2-4) NP, OD, PA (SS35)

Table 3.

Wisconsin

Prescriptive authority

North Dakota South Dakota

NH, NP, OD, PA (SS25) NP, OD, PA (SS2-5); CNM (SS2-2N) APRN, NP,PA (SS2-5); OD (SS3) CNM,NP, OD, PA (SS25)

New Mexico

Alaska California Hawaii Oregon Washington

NP, PA (SS2-SS5); OD (SS3-SS5) NP, PA, RPH (SS25); ND (SS3-5); OD (SS2-3N) NH, NP (SS2-5); PA (SS3-5) ND, NP, PA (SS2-5); OD (SS2, 3-5) NP, PA, RPH (SS25); ND, OD (SS3-5)

Mid-level Practitioner Key: Advanced Practice Registered Nurse = APRN, CC = Certified Chiropractors, Certified Nurse Midwife = CNM, DOM = Doctors of Oriental Medicine, MP = Medical Psychologists, ND = Naturopathic Physicians, NH = Nursing Homes, NP = Nurse Practitioners, OD = Optometrists, PA = Physician Assistants, RPH = Pharmacists.

Controlled Substance Key: SS2 = schedule 2, narcotics; SS2N = schedule 2, non-narcotics; SS3 = schedule 3, narcotics; SS3N = schedule 3, non-narcotics; SS4 = schedule 4; SS5 = schedule 5.

NOTE: Restrictions may apply for day supply, authorized drugs within each schedule, or specific requirements for obtaining authorization. Refer to state law for specification(s).

US map of mid-level practitioners and their prescriptive authority

Winter 2017 • Arizona Journal of Pharmacy • 22

NP, OD, PA (SS2-5)

prescriptive authority for any controlled substance in the US, 98% of states (50 of 51) allow NPs; 96% (49 of 51) allow PAs; 84% (43 of 51) allow ODs; 14% (7 of 51) allow NDs; 12% (6 of 51) allow RPHs; 8% (4 of 51) allow CNMs; 4% (2 of 51) allow homeopathic physicians (HMDs), medical psychologists (MPs), and nursing homes (NHs); and 2% (1 of 51) allow doctors of oriental medicine (DOMs), certified chiropractors (CCs), clinical nurse specialists (CNSs) and APRNs. The western region of the US has 71% (15 of 21) of authorized HMDs, NDs, NHs, DOMs, CCs, RPHs, and MPs with controlled substance prescriptive authority.

DISCUSSION

Physician assistants, nurse practitioners, and optometrists are commonly known mid-level practitioners with controlled substance prescriptive authority in the US. However, there are other federally recognized midlevel practitioners with controlled substance prescriptive authority, such as: pharmacists, homeopathic physicians, naturopathic physicians, doctors of oriental medicine, certified chiropractors, medical psychologists, certified nurse midwives, and certified registered nurse anesthetists.

The primary finding of this study are that NPs and PAs are the largest groups of mid-level practitioners with prescriptive authority for controlled substances in most of the US, with the exception of Florida and Kentucky.

The third largest group of mid-level practitioners with controlled substance prescribing authority are ODs. A finding that was not commonly known is the prescriptive authority for controlled substances by other mid-level practitioners, such as HMDs, NDs, DOMs, CCs, and MPs, which have more authority in the western region of the US. Of the western region, the four corners area has the highest number of non-NP, PA, and OD mid-level practitioner groups: 7 of the 21 authorized groups (33%).

For e-prescribing, over half of US (28 of 51) states list requirements in addition to federal, which vary by state. Almost half of the US (23 of 51) states meet federal requirements. The most frequently occurring requirements that states list in addition to federal are the following: the identity of the pharmacy intended to receive the prescription, the age or date of birth for whom the prescription is being issued, the full name of the authorized practitioners agent transmitting the prescription (some states also require the title of the agent be listed), and the telephone number of the prescribing physician for verbal confirmation of the prescription. Another common requirement is for mid-level practitioners with a supervising physician list the physician’s name on prescriptions, while some states, such as Arizona, also require the supervising physician’s address and telephone number. A recent change in e-prescribing occurred in New York on March 27th, 2016, which requires all controlled substances to be submitted electronically. There are a few exceptions to the new rule which include veterinarians, Veterans Affairs prescribers, and prescribers with an EPCS approved waiver and designated waiver number. Another exception is a phoned in prescription of a controlled substance for a day supply of 5 or less followed by a hard copy sent by mail.

This may only be done if both the doctor and pharmacist agree that an electronic copy cannot be sent, and a delay in

getting the prescription would adversely impact the patient.11 These strict requirements for e-prescribing can help alleviate fraudulent prescriptions or alterations to prescriptions for controlled substances, and reflect an increase in EPCS.

To our knowledge there are no other studies to date that have analyzed requirements of electronic prescriptions for mid-level practitioners and compared the scope of their prescriptive authority for each US state. A study by the National Center for Health Statistics published a data report in the US from 2002 to 2012 on the variability in office-based primary care providers and an average of mid-level practitioners in their practice. The data showed the average number of primary care providers was fortysix per one hundred thousand members of the population, which remained relatively constant over ten years. Of the practitioners in the report, an average of fifty-three percent of office-based primary care providers worked with midlevel practitioners, such as nurse practitioners or physician assistants.12

The findings have implications for practicing pharmacists, interns and technicians in a community setting, as well as mid-level practitioners who practice in more than one US state. One of the implications is the final verification and validity of a prescription which pharmacy personnel are responsible for determining. The topic is also important for pharmacy interns that are completing rotations outside of their home state.

The southern states of the US experience an increase in temporary residents from other states during the winter. During this time pharmacies may experience an increase of out-of-state prescriptions. Pharmacy personnel may not be aware of which states’ mid-level practitioners possess prescriptive authority for controlled substances, or what each states’ additional requirements may be for electronic prescriptions (relative to federal requirements alone). The prescriptive authority of mid-level practitioners varies between states, particularly the western region of the US. These findings can help provide a comprehensive time effective guide in determining the specific requirements for each state, and to help clarify potential confusion of prescriptive authority for prescriptions being sent within and between states, as well as bring about awareness for potential additional requirements of electronic prescriptions.

The most recent change in mid-level practitioners have been an increase in pharmacists with prescriptive authority, particularly in the western region of the US. Similar to the relief that NPs and PAs have had for physicians, pharmacists can provide similar assistance to physician’s offices and their patients. As well as being an expert resource for drug information, drug safety, and medication counseling through a collaborative approach with other healthcare professionals in providing comprehensive patient care.

As with any study that utilizes website data there are limitations, such as websites are not required to update their information regularly. Instead, website updates are completed and updated as each organization requires. The date that the state and federal prescriptive authority was based on was November 2015. In addition, not all websites are created equal; some are less accessible than others Winter 2017• Arizona Journal of Pharmacy • 23

producing barriers to standardized data extraction methods which poses limitations. Furthermore, additional limitations of the study include the interpretation of the prescription requirements as listed by each state board of pharmacy and federal agency; and exclusion of city or company policies on electronic prescription requirements, which may be stringent relative to state and federal requirements.

CONCLUSIONS

There are differences in e-prescribing requirements between states, with over half of states listing requirements in addition to federal law. Additionally, there are varying levels of controlled substance prescriptive authority for mid-level practitioners between US states.

Almost all of the US allows NPs and PAs controlled substance prescriptive authority, and less than 5% of the US allow other federally recognized mid-level practitioners similar prescriptive authority. The western region of the US has the highest number of other federally recognized mid-level practitioners, which includes pharmacists, with controlled substance prescriptive authority.

Acknowledgements: We want to thank Ajit Dhavle for recommending a subject of research, as well as Yuze Yang for reviewing the proposal.

Disclosures: None.

REFERENCES 1. Blumenreich GA and Tobin MH. Drug Enforcement Administration mid-level practitioner regulation. AANA J. 1993;61(5):480-4.

2. Centers for Medicare & Medicaid Services. Electronic Prescribing (eRx) Incentive Program. Retrieved at: www. cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentI n st r u m e nt s / E R x I n ce nt i v e / i n d ex . ht m l ? r e d i r e c t = / erxincentive. Accessed 2015 Jan 11.

3. Drug Enforcement Administration Office of Diversion Control. Resources. Federal Register Notices. Rules-2010.

Electronic prescriptions for controlled substances.

FR31MR10-17. 2010 March 24. Volume 75, Number 61: 16235-319. Retrieved at: www.deadiversion.usdoj.gov/ fed_regs/rules/2010/fr0331_d.htm. Accessed 2015 Jan 18.

4. Centers for Medicare & Medicaid Services. Electronic Prescribing (eRx) Incentive Program, Stage 2. Retrieved at www.cms.gov/Regulations-andGuidance/Legislation/ EHRIncentivePrograms/downloads/Stage2_EPCore_2_ ePrescribing.pdf. Accessed 2015 Jan 18.

5. Hsiao C, Hing E, and Ashman J. Trends in Electronic Health Record System. Use Among Office-based Physicians: United

States, 2007–2012. Number 75, May 20, 2014. National Center for Health Statistics. Retrieved at: www.cdc.gov/ nchs/data/nhsr/nhsr075.pdf. Accessed 2015 Jan 18.

6. Gabriel MH, Yang Y, Vaidya V, et al. Adoption of Electronic Prescribing for Controlled Substances Among Providers and Pharmacies. Am J Manag Care. 2014;20(11 Spec No. 17):SP541-SP546. Retrieved at: http://www. ajmc.com/publications/issue/2014/2014-11-vol20sp/adoption-of-electronic-prescribing-for-controlledsubstances-among-providers-and-pharmacies.

Accessed 2015 Jan 23.

7. MediScripts. 2012 Year in Review Press Release.

Retrieved at: http://mediscripts.com/wp-content/ uploads/2013/09/20120Year-in-Review-FINAL_2.28.13. pdf. Accessed 2015 Jan 23.

8. Surescripts. 2013 National Progress Report and Safe-Rx Rankings. Retrieved at: http://Surescripts. com/docs/default-source/national-progress-reports/ Surescripts_2013_national_progress_report.pdf.

Accessed 2015 Jan 5.

9. Surescripts. 2012 National Progress Report on E-Prescribing and Safe-Rx Rankings. Retrieved at: http:// Surescripts.com/docs/default-source/national-progressreports/national-progress-report-on-e-prescribingyear-2012.pdf. Accessed 2015 Jan 5.

10. U.S. Census Bureau. Economic Planning and Coordination Division. Geography. Regions and Divisions.

Retrieved at: http://www.census.gov/econ/census/help/ geography/regions_and_divisions.html . Accessed 2016 Jan 19.

11. Myers B. E-prescribing mandate for controlled substances takes effect in New York. Pharmacy Times [serial online]. 2016 Mar 28.

12. Hing E and Hsiao CJ. State variability in supply of office-based primary care providers: United States, 2012.

NCHS Data Brief. 2014;151. Retrieved at: http://www. cdc.gov/nchs/data/databriefs/db151.htm.

Accessed 2015 Jan 19.

13. Drug Enforcement Administration- office of diversion control. Rules 2010- Electronic prescriptions for controlled substances. Retrieved at: http://www. deadiversion.usdoj.gov/fed_regs/rules/2010/fr0331. htm . Accessed 2015 Apr 24.

14. Drug Enforcement Administration- office of diversion control. Electronic prescriptions for controlled substances. Retrieved at: www.deadiversion.usdoj.gov/ ecomm/e_rx. Accessed 2015 Jan 28.

15. Abood RR. Pharmacy practice and the law. 7th ed.

Burlington: Jones & Bartlett Learning: 2014.

16. Drug Enforcement Administration. Drug info: drug scheduling. Retrieved at: http://www.dea.gov/druginfo/ ds.shtml. Accessed 2015 Apr 23.

2017 Masquerade Ball

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Coming Soon to a Castle Near You Winter 2017 • Arizona Journal of Pharmacy • 24

September 30, 2017

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PHARMACY COMICS Winter is coming...

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The Pharmacology of Medical Marijuana Author: Justin Lane, Pharm.D. Candidate, University of Nebraska Medical Center, College of Pharmacy Continuing Education for Pharmacists and Technicians

UAN: 0100-9999-17-003-H01-P/T

Objectives 1. Explain the mechanism of action of marijuana and relate it to conditions it may treat.

2. Identify general dosing guidelines and the different formulations of marijuana.

3. Define the possible indications (FDA approved and non-FDA approved) for the uses of medical marijuana.

4. Examine potential side effects from marijuana treatment.

5. Identify what key facts pharmacists should relay to patients in the traditional pharmacist-patient relationship.

Introduction

In the last several years the legalization of medical marijuana has been hotly debated.

As of July 2014, twenty-three states and the District of Columbia have introduced medical marijuana laws, and over half of these have enacted laws within the last five years.1 As a pharmacist, it is important to be knowledgeable

Mechanism of Action

about this medicinal agent in order to educate patients in the best way possible. Pharmacists may become responsible for the safe dispensing of marijuana should it ever become legal in Nebraska, and patients should feel comfortable discussing marijuana with health care providers.

CBD has been shown to be non-psychoactive and may reduce the psychotropic side effects of How marijuana effects the body is not 4 completely understood. Although the effects are THC. CBD has anticonvulsant properties in animal models, but data in human models is complex, several components have been sparse. CBD has shown both neuro-protective identified that have pharmacological activity. and anti-inflammatory properties. There have There are over 400 different compounds in been many case reports claiming that mixtures the Cannabis sativa plant, the plant from containing both CBD and THC are effective which marijuana is derived. Most drugs have in treating epilepsy, but randomized, doubleone chemical entity contributing to its effect; blinded, controlled trials are lacking. Spasticity however, marijuana has multiple chemical related to multiple sclerosis and cancer pain entities contributing to its effect. The group are two other indications pharmaceutical of compounds in marijuana thought to contribute to its mechanism of action are called companies are interested in utilizing mixtures of CBD and THC.5 cannabinoids. It is possible that approximately 60 to 70 cannabinoids are present in marijuana.

Like many other agents in medicine, Cannabinoids are extremely lipophilic and cannabinoids act through activation of produce a variety of pharmacological effects. receptors in both the central and peripheral The lipophilic property of cannabinoids allows them to cross the blood brain barrier and exert nervous system. These receptors are named CB1 and CB2. CB1 receptors are more prevalent their effects on the central nervous system (CNS). The three most abundant cannabinoids in the CNS, while CB2 receptors are more in marijuana are delta-9- tetrahydrocannabinol prevalent in the periphery. THC is a partial CB1 (THC), cannabidiol (CBD), and cannabiol. The agonist with limited CB2 activity. The resulting pharmacological action these receptors create concentration of THC is highest in the flowers and leaves of the plant, and lowest in the roots, depends on where they are located in the brain and how tightly the cannabinoids bind to the stems, and seeds.2 THC has been proven to receptor. Synthetic cannabinoids including be one of the constituents responsible for the 3 “K2” or “spice” can bind to CB1 receptors more psychoactive properties of marijuana. tightly than THC causing intense psychoactive Winter 2017 • Arizona Journal of Pharmacy • 32

effects. CB1 receptors in the basal ganglia of the brain are extremely dense and contribute to dyskinesia, while CB1 receptors in other locations of the brain can induce dopamine release. The release of dopamine is responsible for triggering the reward pathway in the human brain and may possibly contribute to marijuana addiction.3 According to the DSM-IV guidelines, 9% of those who use marijuana will become addicted. Thisnumber increases to 1 in 6 (16%) among those who begin smoking marijuana as teenagers and further increases to 25-50% in people who use marijuana daily.6 There is evidence of withdrawal syndrome in people who quit using marijuana. Symptoms of marijuana withdrawal include irritability, sleeping difficulties, dysphoria, craving, and anxiety.3 These withdrawal symptoms likely contribute to the addiction potential of marijuana.

There are various other mechanisms through which THC may exert effects on the human body. THC can interact with cell wall lipids and effect prostaglandin biosynthesis, decreasing inflammation. Reducing the production of prostaglandins may decrease pain in patients who se marijuana. Marijuana can also stimulate opiate receptors in the forebrain. These receptors may explain its effect on reducing chemotherapy-induced nausea and vomiting as stimulation of opiate receptors leads to direct inhibition of the emetic center in the brain.2

Potential Indications

Because marijuana is a Schedule I controlled substance, research on marijuana in the United States is challenging. There are various studies cited in the next few paragraphs; however, it should be noted that this lesson is not a complete review of all studies conducted on marijuana. The studies cited here were selected because their conclusions represent the majority of studies performed. With all of these indications, there are studies that both support and disprove the efficacy of marijuana.

Most indications do not have large, high-quality studies supporting marijuana’s safety and efficacy.

Cancer-induced nausea and vomiting

Dronabinol, which contains synthetic THC, is currently FDA approved for the treatment of chemotherapy-induced nausea and vomiting (CINV) refractory to other agents. The American Society of Clinical Oncologists recommends that cannabinoids should be reserved for patients ho are intolerant or refractory to first-line therapy.3 First-line therapy currently includes 5- HT3 serotonin receptor antagonists, NK1 inhibitors including aprepitant or fosaprepitant, and examethasone.7 A study published in 2001 concluded that dronabinol was more effective than conventional anti-emetics which included prochlorperazine, and metoclopramide at controlling acute CINV.8 In another study, dronabinol was found not to be superior to ondansetron in controlling chronic CINV following highly emetogenic chemotherapy.

Nausea intensity and vomiting/retching were actually lower in patients treated with dronabinol, but there was not a large enough difference for statistical significance.9 The study only included a small sample size of 61 patients making it underpowered to find any difference between the two treatments. Some evidence also suggests dronabinol may be more effective in treating nausea and vomiting in certain age populations including children.5 The inhaled form of marijuana has not been studied as in depth as the oral form for CINV. One open-label study from 1988 suggested inhaled cannabis was effective in 78% of 56 patients whose CINV could not be controlled by conventional measures.10 This study was conducted prior to the introduction of 5-HT3 antagonists in the last decade. Overall, the majority of evidence shows dronabinol is effective for treating nausea and vomiting associated with chemotherapy. The oral route is the formulation most studied and is a legitimate indication for the use of medical marijuana.

HIV/AIDS and cancer cachexia

Dronabinol is also FDA approved for cachexia associated with HIV/AIDS or cancer. Most of the positive data for this indication have been obtained from patient surveys. Increases in Winter 2017 • Arizona Journal of Pharmacy • 33

appetite are self-reported and have not been demonstrated in many clinical trials. One of the major clinical trials was done in 2006 by the Cannabis-In-Cachexia-Study-Group. This trial compared the effects of cannabis extract (2.5 mg of THC, 1 mg of cannabidiol), 2.5 mg of THC, and placebo on appetite and quality of life in patients demonstrating cachexia related to cancer. 243 patients were randomly assigned to the three arms and no statistically significant differences in patients’ appetite or quality of life were found between any of the arms. It is worth noting that there was a significant placebo effect that occurred during this study. 69% of patients reported an increase in appetite with placebo alone. This compared with 73% and 58% of patients reporting an increase in appetite with cannabis extract and THC, respectively.11

Chronic pain

Clinical trial data regarding the treatment of pain with medical marijuana are conflicting.

Since pain can be the result of several different disorders, it is difficult for studies to prove which kind of pain marijuana may be effective in treating. Patients can have pain due to multiple reasons, which adds complexity to this issue. For example, neuropathic pain, postoperative pain, chronic pain, and cancer pain are just a few different types of pain. It is estimated that 10 mg of THC is roughly equivalent to 60 mg of codeine with respect to analgesic effect.5

A study performed in 2003 reviewed THC use in postoperative pain. It was a double-blind, randomized, placebo-controlled study that investigated 40 women undergoing an elective There are a few clinical studies showing abdominal hysterectomy. Patients were given dronabinol is effective for cachexia. Beal et al either 5 mg of THC or placebo two days after performed a randomized clinical trial in 139 surgery when patient-controlled analgesia was patients comparing dronabinol 2.5 mg twice discontinued. The primary outcome was a daily vs. placebo. Dronabinol was associated summed pain intensity difference calculated by with an increased appetite over baseline vs. a visual analog scale six hours after the study placebo (38% vs. 8% P=0.015) and increased medication was given. The study concluded that weight gain vs. placebo (22% vs. 10.5% gained > there was no difference in the primary outcome 2 kg). This study concluded that dronabinol was between THC and placebo.13 Other studies have safe and effective for anorexia associated with shown a dose-dependent analgesic effect in weight loss in patients with AIDS.12 postoperative pain, suggesting the evidence is mixed.

The clinical trial data for weight loss in patients with AIDS are conflicting, but there seems to be Studies have also been conducted evaluating a connection between cannabinoid receptors cannabis use for chronic pain. Ware et al and appetite stimulation. A CB1 antagonist, concluded in 2010 that a single inhalation of 25 rimonabant, was available in Europe for mg of 9.4% THC three times daily for five days the treatment of obesity and type 2 diabetes reduced the intensity of pain, improved sleep, mellitus in 2006. Several studies confirmed and was well tolerated. It should be noted that the efficacy of rimonabant for both of these the study only included 24 patients indicating indications. Even though the agent appeared that the statistical significance is fairly weak.14 to have efficacy, the use of this agent was suspended in 2008 due to significant psychiatric One study looked at the use of marijuana in side effects. The fact that clinical studies conjunction with opioids for chronic pain. supported that the CB1 antagonist rimonabant A study in 2011 concluded that vaporized was efficacious for weight loss may suggest cannabis might augment the analgesic effects cannabinoid agonists are of value for appetite of opioids. This combination is thought to stimulation. Other CB1 antagonists have been allow lower dosing and decrease side effects tested in trials recently, but side effects limit associated with both agents.15 Cannabinoids their use. More CB1 antagonists are expected to have proven to have an analgesic effect, but be investigated in the upcoming years.5 both when and how to use them best has yet to be determined.

Winter 2017 • Arizona Journal of Pharmacy • 34

Spasticity – multiple sclerosis

pain. The results from this study were rather High-quality studies looking at cannabis use to encouraging. Relief from muscle stiffness occurred in twice as many patients taking the treat spasticity in multiple sclerosis have been cannabis extract compared to placebo (29.4% performed over the years. With the evidence vs. 15.7% P=0.004). The other outcomes being somewhat mixed, the FDA has not studied showed similar efficacy for cannabis. approved THC and/or CBD for this use. This Like the CAMS study, the drawback to using lesson will review two of the bigger studies cannabis for multiple sclerosis is the side effects examining cannabinoids in treating spasticity due to multiple sclerosis conducted over the last associated with its use. 30 patients (21%) withdrew from the cannabis arm due to adverse decade. effects, compared to nine patients (6.7%) in the placebo arm. The more common side effects The largest study conducted to evaluate seen in the cannabis extract group compared marijuana in treating spasticity is the to placebo were dizziness, disturbance in Cannabinoids in Multiple Sclerosis (CAMS) study. This study examined 630 patients from 33 attention, somnolence, dry mouth, GI effects, urinary tract infections, and falls. From the different centers in the United Kingdom. They were randomized to receive THC, oral cannabis data, it appears that cannabis can be efficacious for spasticity in multiple sclerosis, but the side extract, or placebo. The primary outcome effects can be dose-limiting in some patients.17 measured was the change in the Ashworth spasticity scale that looked at overall spasticity GM Pharmaceuticals produces a formulation scores. The study concluded that there was no statistically significant difference in the primary named Sativex® - a mucosal spray that contains an equal ratio of THC and CBD. The product outcome of spasticity. Although there was no has launched in 11 countries including Spain, difference in the primary outcome, patients tended to feel better. Patients stated an objective Italy, Germany, and the United Kingdom, and difference in mobility and improvement in their approved in another 13 countries. Sativex® is derived from the marijuana plant and is not pain in the treatment groups. Some of the side synthetically created like dronabinol. Sativex® effects associated with the treatment groups is currently conducting phase III studies in the included dizziness, light-headedness, dry United States for use with chronic cancer pain; mouth, diarrhea, constipation, and increased 16 is set to begin studies for use with multiple appetite. sclerosis, and has phase I and II studies Another large study examining cannabinoid use underway for other indications. The metered dose spray allows patients to titrate to desired in multiple sclerosis was performed in 2012. effects and could decrease the consequences After 2 patients withdrew from the study, 277 associated with smoking marijuana.18 There patients with stable multiple sclerosis were randomized to oral cannabis extract or placebo. is some concern regarding abuse with this formulation leading the FDA to include a dose Twenty-two different centers in the United counter to reduce abuse potential.

Kingdom were utilized during this study. The study was a double-blind, phase III study which included a two week titration phase from 5 mg Glaucoma of THC to a maximum 25 mg of THC daily, Most people are aware of marijuana use in followed by a 10-week maintenance phase. The treating glaucoma, but surprisingly, there are majority of patients could tolerate 10 mg to 15 few studies demonstrating the efficacy of such mg of THC daily, with only 24.5% of patients treatment. Most of these studies are extremely reaching and maintaining the maximum 25 mg small in sample size. One of the studies done dose. The study looked at four outcomes with was uncontrolled, unmasked, nonrandomized, the primary outcome measure being a category and only included nine patients. Participants rating scale. This scale measured patient were given oral THC capsules for 1 to 9 months reported change in muscle stiffness. The other in addition to their previous glaucoma regimen. three outcomes were category rating scales A decrease in intraocular pressure occurred in that assessed spasms, sleep quality, and body all nine patients at the onset of treatment, but Winter 2017 • Arizona Journal of Pharmacy • 35

by the end of treatment, the response was lost.

Patients seemed to develop tolerance and all subjects experienced toxic side effects to the treatment. Definite conclusions cannot be made from a study of this type, and more studies will be needed to conclude the benefit of treating glaucoma with marijuana.19

Dravet syndrome

Dravet syndrome is a severe myoclonic form of epilepsy that begins in infancy and is resistant to current treatment. Children diagnosed with this disorder have a poor prognosis, as they are at increased risk for sudden unexplained death in epilepsy and status epilepticus events.

Unfortunately, children do not outgrow this condition, making management of this condition vital.20

would be unethical and might not treat the patient’s pain adequately.

There is a silver lining with dosing medical marijuana. A few studies have concluded that the chance of overdosing on marijuana leading to death is extremely unlikely. A cohort of over 65,000 marijuana users was examined and there was no increase in mortality associated with cannabis use on an average 10-year follow-up.

This does not mean that marijuana intoxication cannot lead to death by driving under the influence or other mechanisms secondary to intoxication, but it is thought to be nearly impossible to die from a marijuana overdose.22

To further complicate the dosing of marijuana, there are multiple ways for administration.

Marijuana can be smoked, vaporized, eaten in various foods, applied topically or taken orally CBD has shown to produce anticonvulsant effects, and there have been case reports of CBD through oils and tinctures. Dosing can vary depending on the strain of marijuana used and being effective for Dravet syndrome. the route of administration. There have been Unfortunately, no high-quality studies attempts to standardize the dose of THC in evaluating pure CBD in epilepsy have been 21 different strains of marijuana. Low doses are completed. There are randomized, doubleconsidered below 7 mg, medium doses between blinded studies planned to assess CBD in 7 mg and 18 mg, and high doses over 18 mg. To treating Dravet syndrome. The FDA has get the same amount of drug absorbed orally recently granted Epidiolex© for fast track as through an inhalation formulation, a patient designation, which contains only CBD. This may need to ingest three to five times more designation facilitates the drug approval THC to receive the desired effects. This type process for drugs that can have an impact on of classification (low, medium, and high) may rare, serious disorders with few or no available work well for dosing THC, but sometimes THC treatments. The company that produces is not the main ingredient in a specific strain of Epidiolex©, GW Pharmaceuticals, is also interested in conducting a clinical development marijuana or may not be present at all.23 program for Lennox-Gastaut syndrome, another form of severe epilepsy.20 Dosing of marijuana derivatives Since there is significant inter-patient variability with response to cannabinoids, titration of Dosing Due to the multiple compounds contributing to dosing is critical for optimum response to marijuana. For chemotherapy-induced nausea/ marijuana’s pharmacological effect, dosing can vomiting, the dose should begin at 5 mg/m2 be challenging. A pharmacist should feel by mouth 1-3 hours before administration of comfortable dispensing medical marijuana chemotherapy, then every 2-4 hours afterwards only when they are certain the dose of for a total of 4-6 doses per day. If the initial dose marijuana is accurate and consistent every is not effective and side effects are not evident, time. For example, pharmacists would not feel the dose can be increased by increments of 2.5 comfortable dispensing 80 mg of lisinopril mg/m2 , up to a maximum of 15 mg/m2 not to when the ordered amount is 10 mg. Large exceed 6 doses per day. Side effects are more overdoses would lead to significant adverse common at higher dosages.3 events. Conversely, giving a patient 5 mg of oxycodone when they are prescribed 20 mg

Winter 2017 • Arizona Journal of Pharmacy • 36

As an appetite stimulant, dronabinol should

be dosed at 2.5 mg by mouth before lunch and dinner. Similar to CINV, the dose can be increased if more response is desired and side effects are absent. The dose can be titrated up to a maximum of 20 mg per day in divided doses for CINV.3

Side Effects

Short-term effects

Overall, marijuana is fairly well tolerated and has a positive side effect profile if administered in low doses. Finding the right dose with minimum side effects will be important if marijuana is to be used medically. In many scenarios, side effects might not allow patients to titrate up to sufficient dosages to make marijuana a useful agent. Mild side effects associated with marijuana include headache, dry eyes, dry mouth, dizziness, light- headedness, numbness, and cough.5 The psychoactive effects associated with THC may include anxiety, depression, drowsiness, fatigue, dysphoria, and reduced motor function.

Marijuana has an impact on the cardiovascular system as well. Within ten minutes of smoking a marijuana cigarette, heart rate and cardiac output will increase and may last for two to three hours.3

happen due to down-regulation or decreased sensitization of the CB1 receptor. Patients can also have withdrawal symptoms from marijuana if discontinued suddenly; however, due to marijuana’s fairly long half-life, withdrawal symptoms are usually not intense and do not require medical intervention.3 Along with tolerance and withdrawal, there is evidence that early and prolonged exposure to cannabinoids is associated with psychotic diseases including schizophrenia. Using marijuana during the adolescent stage increases the risk of inducing psychotic like effects in this population. There is a hypothesis stating that the brain is in a crucial time period during adolescence, since it is actively developing and maturing. This process may persist into one’s early 20’s. Cannabis may have the ability to disrupt these important development processes and cause significant harm during these years.24

Drug-Herb Interactions

As with other herbal medications, there are drug interactions with marijuana. THC is metabolized through CYP-450 enzymes, particularly the CYP2C9 and CYP3A4 pathways. Medications with narrow therapeutic Smoking marijuana can have adverse effects on windows that are metabolized through these pathways should be monitored closely for the lungs. Symptoms of chronic bronchitis are adverse events. Examples of these types of common with smoking marijuana including cough, wheezing, increased bronchial secretion, medication include anti-retrovirals including NRTIs, NNRTIs, and protease inhibitors. The exertional dyspnea, nocturnal awakening, and chest tightness. It has been shown that smoking metabolism of these agents may be decreased.

This interaction may lead to increased side marijuana can decrease the FEV1/FVC ratio in patients. Some studies suggest that while it may effects due to increased levels of drug with concurrent use of marijuana, however, the decrease the FEV1/FVC ratio, it does not impact the ratio as severely as tobacco does. efficacy of these compounds will not change. A pharmacist should be mindful of an increased Marijuana smoke has several known carincidence of side effects when these agents are cinogens and it is theorized that smoking used together.3

marijuana can cause secondary malignancies. More evidence is needed as no studies have proven that smoking marijuana causes cancer.3

Another class of agents with significant drug interactions with smoked marijuana includes antipsychotics. Like smoking cigarettes, there are components within the smoke of Long-term effects marijuana that can induce CYP1A2 enzymes.

The long-term effects that marijuana can have This pathway primarily metabolizes olanzapine on an individual are not as well documented as and clozapine. There will be a decrease in the short-term effects. Repeated use of THC can efficacy if a patient is on a combination of lead to tolerance in individuals. Tolerance can these agents. Marijuana may also interfere Winter 2017 • Arizona Journal of Pharmacy • 37

with anti-psychotics from a pharmacodynamic standpoint. Combining marijuana with benzodiazepines, alcohol, or other CNS depressants could lead to synergistic CNS depression, leading to respiratory depression.

THC has known psychoactive pharmacologic properties, which may complicate antipsychotic therapy and control of various psychological conditions.3 Do not initiate medical marijuana in a patient with known psychological conditions, especially anxiety, depression, bipolar disorder, and schizophrenia.

Marijuana has shown to exacerbate the symptoms associated with these conditions and there is a poor risk to benefit ratio in these patients.25 INR should be closely monitored if a patient is taking warfarin and using medical marijuana.

There is no experimental evidence examining the interaction between warfarin and marijuana. The perceived interaction is mostly theoretical and should not cause great concern. A pharmacist should be aware of the possibility of this interaction and monitor INR accordingly. 26

Patient Counseling

Explaining to patients how to titrate marijuana to their desired effects is extremely important.

When marijuana is inhaled, it takes 2 - 30 minutes to take effect. This differs substantially from when marijuana is administered orally.

Marijuana that is ingested orally usually takes 2 - 3 hours to take effect. An uninformed marijuana user may eat one brownie or cookie with marijuana in it and not feel any immediate effect. This could lead the user to ingest multiple doses in a row, leading to unnecessary adverse effects if they are not aware of the delayed absorption properties with the oral formulation.23 Pharmacists should also be aware of the euphoric effects marijuana can cause. A patient in chronic pain may actually prefer to be in a euphoric state to alleviate pain, but a pharmacist must counsel on the safe use of such a drug. Detecting marijuana in drivers in car accidents is increasing at an alarming rate.

Patients should never drive or operate heavy machinery while using any formulation of Winter 2017 • Arizona Journal of Pharmacy • 38

marijuana. From 2005 to 2009, almost a third of drivers killed in accidents tested positive for non-alcoholic drugs. The number one nonalcoholic drug in their system was cannabinol, a metabolite of THC. From 1999 to 2010, the prevalence of cannabinol in drivers killed in car accidents increased from 4.2% to 12.2%.27 Since marijuana has psychoactive properties, patients with schizophrenia or bipolar disorder should never use marijuana. Even if a patient is in relapse, marijuana is unsafe and may have negative consequences on the course of the illness.24 This is a situation where pharmacists could be the last barrier between a patient receiving medical marijuana and exacerbating a serious mental condition.

Pharmacists should be aware that for most indications, marijuana may not be as efficacious as drugs already on the market. This is not saying that marijuana has no place in the medical field, but patients should be informed that there is not sufficient evidence to indicate its effectiveness over other available agents.

Marijuana may work well in some patients, but may cause significant side effects in others.

Regulations have been tight in the United States regarding research on marijuana, thereby limiting data. Recently, regulations for researching marijuana seem to be loosening, which will likely allow more studies to be performed in the future. Pharmacists need to stay informed with the current literature regarding the safety and efficacy of medical marijuana. This will allow pharmacists to continue to provide accurate and important information to their patients.

ACPE UAN: 0100-9999-17-003-H01-P/T Contact Hours: 1.0 (0.1 CEUs)/Activity Type: Knowledge-based Release Date: 1-20-17/Expiration Date: 1-20-20 To receive CE credit for this activity, participants must read the article in its entirety, complete an evaluation survey http:// www.azpharmacy.org/surveys/default.asp?id=932940, and earn a grade of 70% or higher on a short exam.

Reprinted with permission of the author and Nebraska Council for Continuing Pharmacy Education where this article originally appeared. This activity may appear in other state pharmacy association journals. This lesson does include a discussion of unlabeled or investigational use of a product(s) that has not yet been approved by the FDA for the use being presented.

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

References

1. National Conference of State Legislature. (2014).

State medical marijuana laws. Retrieved June 16, 2014, from http://www.ncsl.org/research/health/state-medicalmarijuana-laws.aspx 2. Natural Database Marijuana (2014). Stockton, California: Natural Medicines Comprehensives Database. Retrieved from http://naturaldatabase. therapeuticresearch.com/nd/PrintVersion. aspx?id=947&&AspxAutoDetectCookieSupport=1 3. Gold Standard, Inc. Medical Marijuana. Clinical Pharmacology [database online]. Available at: http://www.clinicalpharmacology.com. Accessed: July 2, 2014.

4. Wade, D. T., Makela, P., Robson, P., House, H., & Bateman, C. (2004). Do cannabis-based medicinal extracts have general or specific effects on symptoms in multiple sclerosis? A double-blind, randomized, placebo-controlled study on 160 patients. Multiple Sclerosis (Houndmills, Basingstoke, England), 10(4), 434-441.

5. Marijuana, Natural Products Database. Lexicomp. Wolters Kluwer Health, Inc. Hudson, OH. Available at: http://online. lexi.com. Accessed July 2, 2014.

6. Volkow, N. D., Baler, R. D., Compton, W. M., & Weiss, S. R. (2014). Adverse health effects of marijuana use. The New England Journal of Medicine, 370(23), 2219-2227.

7. American Society of Clinical Oncology, Kris, M. G., Hesketh, P. J., Somerfield, M. R., Feyer, P., ClarkSnow, R., et al. (2006). American society of clinical oncology guideline for antiemetics in oncology: Update 2006. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 24(18), 2932-2947.

8. Tramer, M. R., Carroll, D., Campbell, F. A., Reynolds, D. J., Moore, R. A., & McQuay, H. J. (2001). Cannabinoids for control of chemotherapy induced nausea and vomiting: Quantitative systematic review. BMJ (Clinical Research Ed.), 323(7303), 16-21.

9. Meiri, E., Jhangiani, H., Vredenburgh, J. J., Barbato, L. M., Carter, F. J., Yang, H. M., et al. (2007).

Efficacy of dronabinol alone and in combination with ondansetron versus ondansetron alone for delayed chemotherapy-induced nausea and vomiting. Current Medical Research and Opinion, 23(3), 533-543.

10. Vinciguerra, V., Moore, T., & Brennan, E. (1988).

Inhalation marijuana as an antiemetic for cancer chemotherapy. New York State Journal of Medicine, 88(10), 525-527.

11. Cannabis-In-Cachexia-Study-Group, Strasser, F., Luftner, D., Possinger, K., Ernst, G., Ruhstaller, T., et al. (2006).

Comparison of orally administered cannabis extract and delta-9-tetrahydrocannabinol in treating patients with cancer-related anorexia-cachexia syndrome: A multicenter, phase III, randomized, double-blind, placebo-controlled clinical trial from the cannabis-in-cachexia-study-group.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 24(21), 3394-3400.

12. Beal, J. E., Olson, R., Laubenstein, L., Morales, J. O., Bellman, P., Yangco, B., et al. (1995). Dronabinol as a treatment for anorexia associated with weight loss in patients with AIDS. Journal of Pain and Symptom Management, 10(2), 89-97.

13. Buggy, D. J., Toogood, L., Maric, S., Sharpe, P., Lambert,

D. G., & Rowbotham, D. J. (2003). Lack of analgesic efficacy of oral delta-9-tetrahydrocannabinol in postoperative pain.

Pain, 106(1-2), 169-172.

14. Ware, M. A., Wang, T., Shapiro, S., Robinson, A., Ducruet, T., Huynh, T., et al. (2010). Smoked cannabis for chronic neuropathic pain: A randomized controlled trial. CMAJ : Canadian Medical Association Journal = Journal De l’Association Medicale Canadienne, 182(14), E694-701.

15. Abrams, D. I., Couey, P., Shade, S. B., Kelly, M. E., & Benowitz, N. L. (2011). Cannabinoid-opioid interaction in chronic pain. Clinical Pharmacology and Therapeutics, 90(6), 844-851.

16. Zajicek, J., Fox, P., Sanders, H., Wright, D., Vickery, J., Nunn, A., et al. (2003). Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): Multicentre randomised placebo-controlled trial. Lancet, 362(9395), 1517-1526.

17. Zajicek, J. P., Hobart, J. C., Slade, A., Barnes, D., Mattison, P. G., & MUSEC Research Group. (2012). Multiple sclerosis and extract of cannabis: Results of the MUSEC trial.

Journal of Neurology, Neurosurgery, and Psychiatry, 83(11), 1125-1132.

18. GWPharma. GW Pharmaceuticals. June 2014. Available at http://www.gwpharm.com/default.aspx. Accessed July 2, 2014 19. Flach, A. J. (2002). Delta-9-tetrahydrocannabinol (THC) in the treatment of end-stage open-angle glaucoma.

Transactions of the American Ophthalmological Society, 100, 215-22; discussion 222-4.

20. GWPharma. GW Pharmaceuticals Announces Epidiolex Receives Fast Track Designation From FDA for the Treatment of Dravet Syndrome. June 6, 2014. Available at http://www.gwpharm.com/GW%20Pharmaceuticals%20 Announces%20Epidiolex%20Receives%20Fast%20 Track%20Designation%20from%20FDA%20for%20the%20 Treatment%20of%20Dravet%20Syndrome.a spx. Accessed July 2, 2014 21. Devinsky, O., Cilio, M. R., Cross, H., Fernandez-Ruiz, J., French, J., Hill, C., et al. (2014). Cannabidiol: Pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia, 55(6), 791-802.

22. Sidney, S. (2003). Comparing cannabis with tobacco-again. BMJ (Clinical Research Ed.), 327(7416), 635-636.

23. Sonya, C. (2014). How pharmacists can counsel patients on medical marijuana. Retrieved June 16, 2014, from http:// www.pharmacist.com/how-pharmacists-can-counselpatients-medical-marijuana 24. Radhakrishnan, R., Wilkinson, S. T., & D’Souza, D. C. (2014). Gone to pot - A review of the association between cannabis and psychosis. Frontiers in Psychiatry, 5, 54.

25. Duckworth, K., & Freedman, J. (2013). Marijuana and mental illness. Retrieved June 16, 2014, from http://www. nami.org/Content/NavigationMenu/Hearts_and_Minds/ Smoking_Cessation/Marijuana_an d_Mental_Illness.htm 26. Ge, B., Zhang, Z., & Zuo, Z. (2014). Updates on the clinical evidenced herb-warfarin interactions. EvidenceBased Complementary and Alternative Medicine: ECAM, 2014, 957362. 27. Brady, J. E., & Li, G. (2014). Trends in alcohol and other drugs detected in fatally injured drivers in the United States, 1999-2010. American Journal of Epidemiology, 179(6), 692-699.

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