The Kentucky Pharmacist Vol 12 No. 6

Vol. 12, No. 6 November/December 2017

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE: Legislative Conference Recap Campus Corner Happy Holidays from KPhA

TABLE OF CONTENTS FEATURES Legislative Conference |4|

Risk-taking Healthcare Advocate Embodies Community Pharmacy Pillar in Albany, Kentucky |40| Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

Cover Photos Top: Rep. Danny Bentley, Rep. Addia Wuchner, Chris Harlow, President/KPhA, Mark Glasper, KPhA Executive Director/CEO Bottom: Attendees at the 2017 Legislative Conference

Editorial Office: ©Copyright 2017 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |6| Advocacy Matters |10| Continuing Pharmacy Education |12| Pharmacy Law Brief |34| Pharmacy Policy Issues | 36|

Publisher: Mark Glasper Managing Editor: Sarah Brandenburg Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601.

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

ADVERTISERS APSC|8| PTCB |18| EPIC |39| Cardinal |42| Pharmacists Mutual |43|

|2| Kentucky Pharmacists Association | November/December 2017

PRESIDENT’S PERSPECTIVE As we head into the 2018 legislative session, we have serious issues to overcome to make sure pharmacists remain as integral members of the healthcare team and receive appropriate payment for products and services provided. We need the engagement of our membership to accomplish these legislative priorities. We ask that you read our weekly grassroots update and ask your legislator for support of the KPhA. KPhA also is working on both the State and Federal levels to raise awareness of what pharmacists can do to help with the opioid epidemic. Pharmacists stand willing and ready to serve in a capacity on which our communities need and depend, whether this be through longacting injectable clinics, identifying and educating those at risk for addiction through appropriate screening tools, or prescriber education for appropriate medication selection. We realize barriers exist to get more pharmacists on board, such as payment for services provided. KPhA is working diligently with government leaders to overcome these barriers.

We know that pharmacists play an integral role as healthcare providers, especially when it comes to public health needs. Pharmacists demonstrate this in our commu- “We need the engagement of nities for vaccine awareness and administration, opioid our membership to overdose prevention with naloxone, and emergency preparaccomplish these legislative edness to name a few. As I’ve stated previously, KPhA can priorities.“ help you as a pharmacist with a future that can offer opportunities and exciting challenges. We are working hard to advance initiatives that will enable pharmacists to practice at the top of the profession. We developed a new Public Health Committee this year, and we are asking that you reach out to KPhA if you believe there is a need where pharmacists can help in your community. We are on the front lines daily, so we can provide support to those we serve.

KPhA will continue to advocate for and advance the profession of pharmacy. I believe in the future of our profession, and I look forward to the accomplishments we will achieve next year together as an association.

Donate online to the Kentucky Pharmacists Political Advocacy Council Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form. |3| www.KPHANET.org

Legislative Conference November 17 | Hyatt Regency | Lexington

More than 300 pharmacists, student pharmacists and technicians came together on November 17 to discuss issues the pharmacy profession could advance in the upcoming legislative session. The conference included a session on board authorized protocols and collaborative care agreements, a panel with current legislators and a panel on public health trends. The day rounded out with a lively roundtable discussion where legislators were invited to discuss topics impacting the pharmacy profession.

|4| Kentucky Pharmacists Association | November/December 2017

Greg Corby-Lee - HIV/AIDS Continuing Education Program Director, Public Health Trends Panel.

KPhA President Elect Chris Palutis (left) and KPhA board member Chad Corum (right) network during lunch.

(L-R) Nathan Hughes, Jaclyn Oschner, Megan Cummins and Kyle Bryan, pharmacy students assist at registration.

KPhA lobbyist, Shannon Stiglitz leads the advocacy panel with Rep. Danny Bentley, Rep. Addia Wuchner and KPhA President Chris Harlow.

Attendees network during the afternoon break.

Rep. Melinda Gibbons Prunty participates in the pharmacy topic roundtable discussion.

View more photos on

Sen. Max Wise engages with attendees during the pharmacy topic roundtable discussion.

Thank you to Kristie Colรณn for providing the photos. |5| www.KPHANET.org

MY KPhA Rx Annual Survey Results Drive KPhA Direction

By Mark Glasper KPhA Executive Director/CEO We conducted an online survey in October of all Kentucky pharmacists, technicians and students, including KPhA members and nonmembers. The results have been provided to members of your Board of Directors and committees for review and action as we plan for 2018 and beyond.

I want to thank everyone who responded to the survey - for the tremendous input you provided and for the many fine comments you directed our way. We also received comments that give us reason to pause and reflect, but all comments and suggestions provided will be useful for guiding our future direction.

Now for some statistics...

Of those responding, 80% were Pharmacist Members followed by 11% Student Members and 4% Technician Members.

Pharmacy employment was dispersed among practice settings with community independents leading the way at 29% followed by community chains at 17% and hospitals at 10%. A big group of “other” at 21% was comprised of consultants, ambulatory care and long-term care pharmacists among others. Female respondents led males 54% to 46%. Respondents between the ages of 25-29 led all other age groups with 20% responding. Coming in next were those aged 60-64 at 12% followed by ages 40-44 at 11% and 30-34 at 10%.

Your KPhA received strong marks with 86% of respondents either very or somewhat satisfied with membership and 90% indicated they would recommend KPhA to a friend or colleague. More than 93% of respondents said KPhA added value to their professional development and 97% said they read the KPhA weekly e-newsletter!

…Give us More When it comes to additional value for your KPhA membership, you were clear. Give us more member engagement/networking opportunities (84%), more job opportunities (76%) and more CE courses including online and webinars (61%). Among issues you want KPhA to address are in order: reimbursements, PBM clawbacks, provider status, MAC claim process, jobs, USP 795, 797 and 800, and the opioid crisis. |6| Kentucky Pharmacists Association | November/December 2017

‌Look out for us Survey results support our advocacy efforts as 88% of respondents believe KPhA delivers tremendous membership value as the voice of the profession in Kentucky legislative and regulatory affairs. A surprising 23% of respondents know their state legislators and all of you can expect a call from us soon. Connecting members with their state legislators is very important as we lobby and look out for your interests in Frankfort.

We drew one lucky winner during Facebook Live from those who participated in the survey. Congratulations to Jacob Wishnia and thanks again to all who provided feedback to the Annual Survey.

In summary, you told us about the issues that are important to you, your businesses and the profession. You told us how we can add value to your KPhA membership. We hear you and will continue to fight for your causes because it’s critical to your success. We will continue to work on a daily basis to do just that.

Time to start holiday shopping with AmazonSmile!

Did you know that Amazon donates 0.5% of the price of your eligible AmazonSmile purchases to the Kentucky Pharmacy Education and Research Foundation Inc.? This contribution supports our educational initiatives.

All you need to do is: Step One: Go to Smile.Amazon.com (https://smile.amazon.com/ch/31-1012133) Step Two: Choose the Kentucky Pharmacy Education and Research Foundation Inc. as your charity.

Step Three: Whenever you are shopping, start at Smile.Amazon.com Take advantage of this easy way to do your holiday shopping and help the KPERF! |7| www.KPHANET.org

|8| Kentucky Pharmacists Association | November/December 2017

At the holiday season, our thoughts turn gratefully to those who have made our progress possible. It is in this spirit that we say...Thank you and best wishes for the holidays and happy New Year.

In observance of the holidays KPhA headquarters will be closed on December 25, 26, 29 and January 1. The offices will resume regular business hours on January 2.

Volunteer Today Pharmacist, pharmacy technician and student pharmacist recruitment is still underway for the Kentucky Pharmacists Association emergency preparedness program! Pharmacy professionals play a critical part in responding to emergency events such as a natural disaster or infectious disease outbreak.

For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact KPhA 502-227-2303 or by email at jjaggers@kphanet.org.

|9| www.KPHANET.org

Advocacy Matters Ways you can support KPhA’s Advocacy efforts today! 

Participate in grassroots advocacy efforts



Get to know your legislators—they should know your name



Donate to the Political Advocacy Council and the Government Affairs Fund

Photo by: Matt Turner

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org form. |10| Kentucky Pharmacists Association | November/December 2017

Sam Willett, RPh, Capital Campaign Donor

“

KPhA has always been devoted to its mission of advocating for and advancing the profession of pharmacy, a profession that has been very rewarding to me personally and financially. Donating to the capital campaign is just a small token of appreciation to the professional organization that supports all pharmacists.�

Leave a legacy by making a tax-deductible donation online at www.kypharmacyfuture.net |11| www.KPHANET.org

November CPE Article Policy Primer: Regulating Gabapentin in Kentucky By: James S. Blackmer, PharmD, MPA and Patricia R. Freeman, RPh, PhD, FAPHA, University of Kentucky College of Pharmacy The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

The work reported here was completed in partial fulfillment of the requirements for the Master of Public Administration degree program at the James W. Martin School of Public Administration, University of Kentucky. Dr. Blackmer completed this project while also pursuing the PharmD degree at UK. Universal Activity # 0143-0000-17-011-H03-P & T 1.5 Contact Hours (0.15 CEU) Expires 12/07/2020

KPERF offers all CE articles to members online at www.kphanet.org

Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: A. Discuss the evidence underlying gabapentin’s abuse liability.

B. Recognize factors used to determine the schedule of a controlled substance.

C. Identify the policy process to schedule a medication in the state of Kentucky.

Introduction Gabapentin, also known as Neurontin®, Gralise ®, Horizant ®, or Gabarone®, was first approved by the Food and Drug Administration (FDA) in 1993 as adjunctive therapy for partial seizures. Later, the anticonvulsant was approved for postherpetic neuralgia, also known as shinglesrelated nerve pain.1 Although currently these are the only two FDA-labeled indications, gabapentin is commonly used off-label for indications such as bipolar disorder, restless leg syndrome, multiple sclerosis, anxiety, various types of pain, and substance use disorders (SUD).2-5 The mechanism by which gabapentin produces its analgesic and antiepileptic effects are unknown; however, one theory is that it binds with high affinity to the α2δ subunit of voltage-activated calcium channels, which in turn causes the pharmacologic effects.1 The drug is structurally similar to the neurotransmitter gammaaminobutyric acid (GABA), but information provided by the manufacturer states that it does not have an effect on GABA binding, uptake, or degradation.1 Common adverse reactions are dizziness,

somnolence, ataxia, fatigue, and nystagmus.1 Gabapentin doses range from 100 to 3600 mg/day in divided doses, with higher doses usually being taken three to four times per day. The bioavailability of gabapentin is not dose proportional, meaning that the effect of the drug does not increase proportionally as the dose of the drug is increased.1 Pregabalin (Lyrica®) is a structurally similar drug in the same class as gabapentin and is classified as a Schedule V drug by the Drug Enforcement Administration (DEA). Gabapentin, however, is not a controlled substance under federal law, although there has been growing concern in the United States and other parts of the world that the drug is being misused. The focus of this article is to discuss the issues surrounding the potential misuse, abuse, and diversion of gabapentin and the policy process that led to its reclassification as a Schedule V controlled substance in Kentucky.

Problem Statement Prescription drug abuse has become a huge problem around the country with the number of

|12| Kentucky Pharmacists Association | November/December 2017

drug overdose deaths increasing every year. Opioids, both prescription and illicit, are the most common drugs found in overdose deaths. Opioid deaths have gone up by 400% since 1999 and continue to be a major issue around the country.6 Although new legislation continues to be introduced on the state and national level, the opioid epidemic continues to affect families across the country.

Review of Gabapentin Abuse Liability

gabapentin gives at high doses. In a study of a social network (cohort) of 503 nonmedical users of opioids in Appalachia, 15% reported using gabapentin to “get high” within the past 6 months.

12 This report, published in early 2015, brought attention to the issue of gabapentin abuse in Kentucky. Data from the study showed that people in Appalachian Kentucky were currently misusing gabapentin, and the number of individuals from the same social network reporting gabapentin misuse represented a nearly 3000% increase from 2008 .

When the respondents were asked how they obtained gabapentin, 52% of people in the social network reported getting it from a physician and 36% from a drug dealer.12 A recent systematic review by researchers at Kentucky’s Center for Drug and Alcohol Research suggests that gabapentin misuse/abuse occurs in a variety of contexts.13 The authors reviewed 23 case studies and 11 epidemiological reports and found a 1% prevalence of gabapentin misuse overall in the general population, with higher prevalence of misuse in persons with gabapentin prescriptions and an estimated 15-22% prevalence of misuse in populations with underlying opioid abuse. The authors conclude that: “Epidemiological and case report evidence suggests that the anti-epileptic and analgesic medication gabapentin is being misused internationally, with substance abuse populations at special risk for misuse/abuse.” 13

Since gabapentin was first approved, considerable evidence has emerged regarding its abuse potential. In early studies that looked at using gabapentin for the treatment of withdrawal syndromes, authors concluded the drug was effective and would be good to use because it had no potential for abuse, especially in those with substance use disorder.4,8 However, recent case studies have shown that there is a potential for gabapentin to be misused, particularly when combined with other medications such as opioids.3,5,9-11 The reason stated for this misuse is because of the “euphoric” feeling

It’s important to consider that prescribers may be using gabapentin to control patients’ chronic pain instead of using stronger medications like opioids. This aversion to opioids by prescribers may be due to the fact that the patients requiring pain treatment have a history of substance use disorder.

In a study of Oregon Medicaid members, 95% of people receiving gabapentin were using it for offlabel indications, with the most common use being chronic pain control.2 In this circumstance, use of gabapentin, which may have lower abuse potential than opioids, may be appropriate.

Kentucky, one of the states in which this epidemic is most visible, had the third highest rate of death due to drug overdose at 29.9 per 100,000 people/lives in 2016.6 Prescription opioids were the most common cause of overdose deaths in Kentucky in 2015, contributing to an estimated 30% of deaths combined; illicit opioids, including heroin and synthetic fentanyl, were also common contributors to drug overdose found in 24% and 19% of overdose deaths, respectively.7 While opioids are by far the most common, people who die from drug overdose are also using other medications, sometimes simultaneously, as shown by the fact that many deaths involved more than one drug. Following opioids, the next medications listed in the Kentucky Resident Drug Overdose Deaths, 2015 report are alprazolam (Xanax®) (15%) and gabapentin (14%).7 It is important to consider that increased findings of gabapentin in Kentucky overdose deaths could be due to the increase in testing for the drug in the year of the report.7

|13| www.KPHANET.org

Factors Used to Determine Scheduling To understand more about the issues surrounding gabapentin and what may be done to address them, it is first important to understand the characteristics of a controlled substance. The Food and Drug Administration (FDA) considers medications that have a high potential for abuse controlled substances under the Controlled Substance Act (CSA). Under the CSA, the factors necessary to qualify a drug as a controlled substance can be found in Table 1.14 These factors determine whether a drug or substance should be controlled or removed from the list of scheduled medications.

Table 1. FDA factors determinative of control or removal from schedules from the CSA

or taking it to avoid feeling bad. For example, dependence would be if someone who no longer needed the medication for a legitimate medical purpose continued taking it so they did not feel bad, or to get the good feeling the drug provides. If gabapentin were listed as a controlled substance there would be more oversight into the prescribing of the medication. Both pharmacies and prescribers must be registered with the DEA to prescribe or dispense controlled substances in order to maintain a closed system. Due to this additional monitoring and requirement of DEA registration, prescribers may be less likely to prescribe the medication.

The Policy Process

In Kentucky, the Cabinet for Health and Family Services (CHFS) has the authority to make Factors considered when making a drug controlled: changes to scheduling of substances under KRS Its actual or relative potential for abuse.

218A.020 by an administrative regulation change.

Scientific evidence of its pharmacological effect, if known.

The same factors used by the FDA to make this deThe state of current scientific knowledge regarding the drug or other substance. termination, found in Table 1, are used by the Its history and current pattern of abuse.

CHFS to make changes to Kentucky AdministraThe scope, duration, and significance of abuse. tive Regulations (KAR)15. In 2008, the medication tramadol (UltramÂŽ), which had been FDA apWhat, if any, risk there is to the public health. proved since 1994, went through this process to Its psychic or physiological dependence liability. move from a designation of non-controlled subWhether the substance is an immediate precursor of a substance already controlled under this subchapter. stance to Schedule IV in Kentucky.15 Following the move by the state, in 2014, tramadol moved to a While some factors listed are selfSchedule IV substance at the federal level. Kenexplanatory, others may be more challenging to untucky decided to treat this medication differently derstand. The scientific evidence of its pharmacothan it was federally due to evidence of tramadol logical effects allows the government to see if the misuse and diversion in the state. As an alternative drug has any similarities to other controlled subto this regulatory approach, a legislator could sponstances, which could involve using similar pathsor a bill to change KRS 218A, to include a new ways in the brain or having similar adverse effects. medication in the controlled substance listing.

The patterns, scope, duration, and significance of If the CHFS believes they have enough eviabuse are imperative because they provide infordence to move forward with regulatory changes to mation on the population the drug is affecting.

Risk to the public health takes into account the peo- make a medication a controlled substance, there are ple who are misusing the medication or the people a few steps they must follow. First, they must file the proposal with the Legislative Research Comwho are affected by the misusers, directly or indirectly. Another factor mentioned by the FDA is de- mission (LRC) where it will then be published in 16 pendence liability of the drug, which is the need for the Administrative Register of Kentucky. Next, the user to get a good feeling from taking the drug, there would be a time for a public hearing and com|14| Kentucky Pharmacists Association | November/December 2017

ment period, which would be held by the CHFS. If no letters of intent to attend are received, the agency may cancel the hearing. After the public comment period any submitted comments are gathered together into a Statement of Consideration, which will then be submitted to the LRC. The administrative regulation would then make its way into two legislative committee hearings where the regulations are reviewed. It would go into effect if neither committee “attaches” the administrative regulation, which means that it is “deficient” or “wrongfully declared”.16 Kentucky’s Office of the Inspector General in the CHFS filed amendments to 902 KAR 55:035 on September 15, 2016 that added gabapentin the Schedule V controlled substance list. Following the public comment period, the regulation was reviewed and approved at the January 17, 2017 meeting of the Administrative Regulation Review Subcommittee, and the regulation was finalized and adopted on March 3, 2017.

Kentucky’s administrative changes detailed above resulted in the reclassification of gabapentin as a Schedule V controlled substance. However, other states have taken different approaches. For example, changes have been made in Ohio to require submission of gabapentin dispensing to their Prescription Drug Monitoring Program, Ohio Automated Rx Reporting System (OARRS).17 To date, five additional states have taken this approach – making gabapentin a drug of concern reportable to the state’s respective prescription drug monitoring program – including Massachusetts, Minnesota, North Dakota, Virginia, and West Virginia.

Conclusion When first FDA approved, gabapentin was thought to have no potential for abuse. Since then, research has shown the medication has some abuse potential. The CHFS has determined that the factors used to schedule a medication in the state of Kentucky have been met; therefore, gabapentin was made a Schedule V controlled substance effective

July 1st, 2017. While this change may present some initial challenges for pharmacists, hopefully it will ultimately decrease the misuse, abuse, and diversion of gabapentin, and subsequently the contribution of gabapentin to drug overdose deaths in the Commonwealth.

References 1.

Pfizer, I., Neurontin® [package insert]. 2016.

2.

Hamer, A.M., et al., Gabapentin Use in a Managed Medicaid Population. Journal of Managed Care Pharmacy, 2002. 8(4): p. 266-71.

3.

Markowitz, J.S., et al., Gabapentin abuse in a cocaine user: implications for treatment? J Clin Psychopharmacol, 1997. 17(5): p. 423-4.

4.

Bonnet, U., et al., Treatment of alcohol withdrawal syndrome with gabapentin. Pharmacopsychiatry, 1999. 32(3): p. 107-9.

5.

Satish, R., et al., Gabapentin dependence in a patient with opioid dependence syndrome. J Neuropsychiatry Clin Neurosci, 2015. 27(1): p. e64.

6.

Prevention, C.f.D.C.a. Drug Overdose Death Data.

2016 December 16, 2016 [cited 2017 January 17, 2017]; Available from: https://www.cdc.gov/drugoverdose/data/statedeaths.html.

7.

Slavova, S., D. Akers, and P. Rock. Kentucky Resident Drug Overdose Deaths, 2015. 2016 June 3, 2016 [cited 2017 January 17, 2017].

8.

Lavigne, J.E., et al., A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors.

Breast Cancer Res Treat, 2012. 136(2): p. 479-86.

9.

Kruszewski, S.P., R.P. Paczynski, and D.A. Kahn, Gabapentin-induced delirium and dependence. J Psychiatr Pract, 2009. 15(4): p. 314-9.

10.

Hellwig, T.R., R. Hammerquist, and J. Termaat, Withdrawal symptoms after gabapentin discontinuation. Am J Health Syst Pharm, 2010. 67(11): p. 910-2.

11.

Reccoppa, L., R. Malcolm, and M. Ware, Gabapentin abuse in inmates with prior history of cocaine dependence.

Am J Addict, 2004. 13(3): p. 321-3.

12.

Smith, R.V., M.R. Lofwall, and J.R. Havens, Abuse and diversion of gabapentin among nonmedical prescription opioid users in Appalachian Kentucky. Am J Psychiatry, 2015. 172(5): p. 487-8. |15| www.KPHANET.org

13.

Smith, R.V., JR Havens and SL Walsh, Gabapentin misuse, abuse and diversion: a systematic review. Addiction, 201. 111(7): p. 1160-74.

14.

United States. Food and Drug Administration., Federal food, drug, and cosmetic act, as amended. U.S. Dept. of Health, Education, and Welfare: Washington. p. v.

15.

Inciardi, J.A., et al., The Diversion of Ultram, Ultracet, and generic tramadol HCL. J Addict Dis, 2006. 25(2): p. 53-8.

16.

Robert S. Silverthorn, J. Kentucky Administrative Regulation Promulgation Process. [cited 2017 March 3, 2017]; Available from: http://water.ky.gov/Documents/Regulations/RegulationPro mulgationProcess.pdf.

17.

Schierholt, S.W. Reporting Gabapentin Products to OARRS. 2016 July 7, 2016 [cited 2017 Febuary 2, 2017].

CPE Quiz Online www.surveymonkey.com/r/NovCE2017

November 2017 — Policy Primer: Regulating Gabapentin in Kentucky 1. FDA-approved indications for gabapentin include: A Post-herpetic neuralgia B. Seizures C. Restless leg syndrome D. A & B only E. A, B & C 2. The maximum approved dose of gabapentin is: A. 1200 mg per day B. 2400 mg per day C. 3600 mg per day D. 4800 mg per day 3. Gabapentin is currently a Schedule V controlled substance at the Federal level.

A. True B. False

6. In Kentucky, proposed regulations can be approved by the Cabinet for Health and Family Services (CHFS) without any legislative committee oversight.

A. True B. False 7. Which of the following statement(s) regarding the abuse liability of gabapentin is (are) true?

A. Individuals misuse gabapentin to ‘get high’ B. Individuals misuse gabapentin to minimize opioid withdrawal symptoms C. In one cohort of drug-using subjects, gabapentin use has increased 3000-fold since 2008 D. All of the above are true statements

8. Which of the following is NOT a common adverse effect of gabapentin?

A. Insomnia 4. Which class of medications is responsible for the majority B. Dizziness of drug overdose deaths in Kentucky?

C. Ataxia A. Opioids D. Fatigue B. Benzodiazepines E. Nystagmus C. Amphetamines D. Gabapentinoids E. Cannabinoids 5. Which of the following factors are considered by the FDA when determining if a drug should be scheduled as a controlled substance?

A. Its actual or relative potential for abuse B. Its psychic or physiological dependence liability C. What, if any, risk there is to public health D. All of the above

|16| Kentucky Pharmacists Association | November/December 2017

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 12/07/2020 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEUs. TECHNICIANS ANSWER SHEET November 2017 — Policy Primer: Regulating Gabapentin in Kentucky (1.5 contact hour) Universal Activity # 0143-0000-17-011-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B 5. A B C D 7. A B C D 2. A B C D 4. A B C D E 6. A B 8. A B C D E Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET November 2017 — Policy Primer: Regulating Gabapentin in Kentucky (1.5 contact hour) Universal Activity # 0143-0000-17-011-H03-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: ABCDE 3. A B 5. A B C D 7. A B C D ABCD 4. A B C D E 6. A B 8. A B C D E Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |17| www.KPHANET.org

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.



Include a quiz over the material. Usually between 10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.

When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.

Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.

Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

|18| Kentucky Pharmacists Association | November/December 2017

December CPE Article Part 1: Review of Intravenous Lipid Emulsions (ILEs) Used in Specialized Parenteral Nutrition (PN) Support Therapy in the Adult Patient Population By: Christopher Miller, PharmD, MS, MBA, BCNSP, Clinical Assistant Professor, Department of Pharmacy Practice & Science, University of Kentucky College of Pharmacy; Jonathan Burdick, PharmD candidate 2018, University of Kentucky College of Pharmacy The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

This article represents part 1 of a two-part series that provides a comprehensive review of ILEs use in clinical practice. Part 2 in a forthcoming publication will focus on the complex stability and compatibility issues associated with the sterile compounding of these products.

Universal Activity # 0143-0000-17-012-H01-P & T 2 Contact Hours (0.2 CEU) Expires 12/07/2020

KPERF offers all CE articles to members online at www.kphanet.org

Goal: To provide insight and education on the historical development of the different generations of Intravenous lipid emulsion (ILE) formulations and review clinical applications and compare differences of the two primary formulations available for use in the United States.

Pharmacist Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: A. Describe the evolution and generation classification of intravenous lipid emulsions (ILE) used in parenteral nutrition therapy B. Discuss characteristics along with potential issues and benefits of the different ILEs being used in clinical practice C. Classify a fatty acid using the X: Y: Z classification system D. Compare the key differences between the newly approved four-oil ILE product versus the 100% soybean oil ILEs Technician Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: A. Describe the generation classification of ILEs B. Identify essential fatty acids (FAs) and differentiate between omega-3 and omega-6 FAs C. Understand the differences between the ILEs available for use in the U.S. market

ensure the delivery of adequate EFAs to prevent essential fatty acid deficiency (EFAD).1 A safe Intravenous lipid emulsions (ILEs) have source of ILE was not readily available in the early been a vital component of parenteral nutrition (PN) years of PN therapy in the U.S. during the early therapy as a means of providing a concentrated 60’s to the mid 70’s and a balanced NPC regimen source of calories and essential fatty acids (EFAs). was difficult to provide. This resulted in potentially ILEs are used as a complement to carbohydrates to feeding excessive carbohydrate (CHO) calories to provide a dense source of calories in the form of patients requiring PN therapy in order to provide non-protein energy when feeding patients via the adequate calories.2 Reported complications of overparenteral route. Lipids ideally should provide in feeding with CHO calories include hyperglycemia, the range of 15-30% of the non-protein calories hepatic steatosis (fatty liver), and increased carbon (NPC) for an optimal “mixed-fuel” system and to dioxide production placing stress on the pulmonary Introduction/Background:

|19| www.KPHANET.org

system.3,4 EFAD can arise when patients are fed di- duce the ω-6 content. ets with low amounts or devoid of EFAs. Primary Table 1. Frequently Used Abbreviations symptoms include growth impairment, renal and Many abbreviations are used throughout this paper and Table 1 provides a pulmonary abnormalities, scaly dermatitis, alopesummary of the abbreviations used to help the practitioner. cia, immune dysfunction, and thrombocytopenia. 5,6 AA: arachidonFO: fish oil SFA: Saturated fatty The EFAs that must be provided by ILEs to prevent EFAD are linoleic acid (LA), which is an omega-6 acid ic acid (20:4 ω6) (ω-6) FA and α-linolenic acid (ALA), which is an omega-3 (ω-3) FA. LA and ALA are considered FA: fatty acid SMOF: acronym for ALA: αessential in humans for normal cellular functions.6,7 the 4-oil combination linolenic acid EFAD from a biochemical perspective is a deficien(18:3 ω3) Smoflipid® cy of LA which results in a deficiency of arachidonALT: alanine HPN: home SFO: safflower oil ic acid (AA). Physiologically, LA is converted to parenteral nutriaminotransfertion AA, a tetraene. When LA is not present results in oleic acid being converted to 5,8,11 – ecosatrenoic ase acid, a triene of less physiologic integrity causing AP: alkaline IFALD: intestiSO: soybean oil EFAD.6,7 The triene: tetrene ratio is a unique moninal failuretoring marker for biochemical confirmation of phosphatase associated liver disease EFAD which is established as ≥ 0.2. However clinical manifestations of EFAD are often not observed ASPEN: Ameri- ILE: intraveTG: triglycerides can Society for nous lipid emuluntil a triene: tetrene ratio is ≥ 0.4.6,8 ILEs were introduced in the United States in 1956, as a cottonseed oil based emulsion Lipomul® with an extremely high ω-6:ω-3 ratio of 54:1. This product was withdrawn from the U.S. market in 1965 due to severe adverse reactions including fat overload syndrome which is primarily characterized by impaired immune, pulmonary, hepatic, and platelet function.2,5 Soybean oil-based (SO-based) ILEs have dominated the American market since their introduction in Europe in 1961 and subsequent approval in the United States in 1975.2,5 In the 1979, Liposyn® a 100 % safflower oil (SFO) based ILEs was approved for use in the United States with the speculated benefit of reducing the risk of fat overload syndrome.8,9 This product was later removed from the market because of its low ω3 ALA content causing concern for risk of deficiency of this EFA. Since SFO is richer in the ω-6 LA compared to SO (77% vs. 54%), a combination product of SO and SFO (50:50) Liposyn II® was developed to increase the ALA content. It was approved in 1984 but was removed from the market due to lack of supply of SFO.2,5 Liposyn III® was subsequently approved as a 100% soybean oil (SO) emulsion but is not currently being marketed and distributed. Over the past few decades, ILE emulsion development has gone from being almost solely made from SO to being composed of different fatty acid (FA) components with a strategy to re-

Parenteral and Enteral Nutrition

sion

AST: Aspartate Aminotransferase

LA: linoleic

CHO: carbohydrate

MCT: Mediumchain triglyceride

2-in-1: PN with the combination of macronutrients dextrose/ amino acids in the same IV container; ILE infused separately

DHA: Docosahexaenoic acid (22:6 ω3)

MUFA: monounsaturated fatty acids

3-in-1: PN with the combination of all macronutrients (dextrose/ amino acids/ILE) in the same IV container

EFA: essential

NPC: nonpro-

fatty acids

tein calories

ω-3: Omega-3 FA [i.e. α-linolenic (ALA) acid, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA)]

EFAD: essential fatty acid deficiency

PN: parenteral nutrition

ω-6: Omega-6 FA [(i.e. linoleic acid (LA])

EPA: Eicosapentaenoic acid (20:5 ω3)

PUFA: polyunsaturated fatty acids

ω-9: Omega-9 FA (i.e.

ESPEN: European Society for Parenteral and Enteral Nutrition

RES: reticuloendothelial system

|20| Kentucky Pharmacists Association | November/December 2017

acid (18:2 ω6)

TNA: total nutrient admixture (equivalent to a 3-in-1 PN)

oleic acid)

Such FA components include medium chain triglycerides (MCT) primarily from coconut oil, olive oil (OO) and most recently fish oil (FO). Since 1980, several combination oils have been developed and are currently being used in clinical practice outside the United States. These ILE formulations have been focusing on FA components with lower inflammatory characteristics and less potential for liver toxicity.2,8 These agents hold promise for their potential ability to mitigate notorious complications associated with SO-based ILEs.8 Recently a four-oil combination ILE called Smoflipid® (SMOF), which includes SO, MCT, OO, and FO was approved for use by the U.S. FDA in July of 2016.

ILE Generations and FA Nomenclature: The generation progression of ILE has been defined in a position paper of the American Society of Parenteral and Enteral Nutrition (ASPEN) published in 2012 and the primary classification is based on the fatty acid (FA) components of the ILE.2 Furthermore, the ILE generations can be differentiated by their inflammatory potential. Generally speaking, the first generation ILEs are considered pro-inflammatory, whereas the second and third generations are considered inflammatory neutral. Furthermore, the most current fourth generation are anti-inflammatory in comparison. Figure 1 below shows a visual depiction of the ILE generations with oil components and the inflammatory status of each of the generations, whereas Figure 2 shows the inflammatory spectrum with favorable progression of the FA oils used historically in ILE product development. The FA source in the ILE and the inflammatory profile has dictated the evolution and development of these emulsions over time. Thus, ILEs have evolved from being solely made from SO in the 1960’s to being combined with MCT in the 1980’s, OO in the 1990’s and most recently combinations with FO.5 When discussing ILE development, understanding the nomenclature of the FAs and their structure is important to gain an appreciation of the ILE generations. FAs have three classifications and labeled as X: Y: Z.2,6,10 The X classification refers to number of carbons in the molecule with short chain being 2-4, medium chain being 6-12 and long chain > 14. The Y designation is the number of double bonds in the FA structure, whereas zero double bonds are labeled as saturated FAs (SFA), 1 double

bond is labeled as monounsaturated FAs (MUFA) and ≥ 2 double bonds are polyunsaturated FAs (PUFA). The highly unsaturated FAs have > 3 double bonds and examples include the very long chain FAs docosahexaenoic acid (DHA; 20:5 ω3) and eicosapentaenoic acid (EPA; 20:5: ω3) which are found in fish oil and deemed to have beneficial attributes including lower inflammatory potential.

The Z designation is the distance that first double bond occurs within the FA carbon chain from the terminal methyl group and this determines the omega classification. For example the main members of the omega-6 (ω-6) and omega-3 (ω-3) families contained in ILE are the PUFAs LA (18:2: ω6) and ALA (18:3: ω3) respectively. These represent the two key fatty acids that must be provided to prevent EFAD in clinical practice.

First Generation ILEs: First generation lipids are pure SO-based ILEs and have been used extensively in the United States because of unavailability of alternative ILE formulations until most recently. The current marketed first generation ILEs available for use in this country are Intralipid® and Nutrilipid®. An important feature of these pure SO-based lipid emulsions is that they provide a rich source of essential fatty acids (EFA) being approximately 44% to 62% LA (ω-6) and 4% to 11% ALA (ω-3). Hence, these lipids are a very effective in preventing and treating EFAD. However, due to the metabolites that form from ω-6 fatty acid catabolism, such as the series 2prostanoids and the series 4-leukotrienes, first generation ILEs are considered pro-inflammatory.

Pure SO-based formulations lack EPA and DHA, beneficial ω-3 nutrients contained in fish oil. EPA is the precursor in FO that directs the metabolic pathway to produce series 3-prostanoids and series 5-leukotrienes that have anti-inflammatory properties.2,5 Moreover, SO-based ILEs are low in αtocopherol, a beneficial and powerful anti-oxidant, and rich in phytosterols, which are reported to decrease bile flow and cause liver injury.2 The characteristics of first generation ILEs make these formulations less than ideal for patients being parenterally fed, especially for the critically ill patient where a reduced ω-6 load is desirable. This has consequently led to the development of newer generations of ILEs to help mitigate liver, inflammatory and immunosuppressive complications. |21| www.KPHANET.org

Figure 1: IVE Generations with FA Components and Inflammatory Status11

Figure 1 adapted from: Biesboer AN, Stoehr NA. A Product Review of Alternative Oil-Based Intravenous Fat Emulsions. Nutri Clin Pract. 2016;3(5):1:610-618.

Figure 2: Relative Systemic Inflammatory Activity of FA Oils Used in ILE Development 2

Figure 2 adapted from: Vanek VW, Seidner DL, Allen P, et al. ASPEN position paper: clinical role for alternative intravenous fat emulsions. Nutr Clin Prac.2012;27(2):150-192.

Second Generation and Third Generation ILEs: The second generation of lipids emerged from a focus on developing a more ideal ILE with a lower ω-6 load and less inflammatory potential than the first generation ILEs. Second generation ILEs are a 50:50 mixture SO and MCT. The MCT component of these products is derived from coconut oil which is primarily made up of caprylic and capric acids. MCTs provide an advantage of more rapid oxidation resulting in a more immediate energy source as well as not impairing hepatic or immune function.8,11 One major downside to MCTs is that they do not supply the necessary EFA so they must be combined with other FAs such as SO. The combination SO and coconut oil based formulations are considered to be inflammatory neutral which represent a benefit over the first generation ILEs.5,11 Third generation products contain an 80/20 (4:1) split of OO and SO, respectively. This decreases the load of omega-6 FAs by approximately 75% of the original SO-based ILEs. This combination product contains a high amount of ω-9 MUFA (65%) primarily as oleic acid and 20% essential

PUFA, and 15% SFA; an attribute that differentiates them from previously developed ILEs.11,12 The high amount of MUFA content gives this ILE an advantage of being less prone to perioxidation than those primarily made from PUFA. Additionally, the olive oil component when compared to soybean oil has advantages of lower phytosterol and high α-tocopherol (active vitamin E content).

Moreover, because of the FA makeup of these ILEs they maintain an inflammatory neutral status like the second generation ILEs. Clinolipid® is a brand name, third generation ILE approved product in the United States as of 2013.9 However, the manufacturer has no plan to release this on a broad scale, presumably due to innovations brought forth by the newest fourth generation of ILEs made with the FO component.

Fourth Generation ILEs: The most recent generation of lipids distinctly differentiates itself from previous ILEs by containing fish oil; an attribute that provides supplementation of DHA and EPA to the patient. The rich ω-3 content of fish oil is the basis for the pro-

|22| Kentucky Pharmacists Association | November/December 2017

posed anti-inflammatory effect of this class of novel products. Furthermore, FO is rich in the beneficial active form of vitamin E (α-tocopherol) and only contains trace amounts of the harmful phytosterols.

Omegaven® is a 100 % FO product that is currently only available in the European, Canadian and Asian markets. It is approved for use outside the U.S. as a FO supplement to other ILEs that don’t contain it in their commercial form. Monotherapy with this product is considered an off-label use with the low content of EFAs, especially LA. The pure ω-3 FA content of Omegaven® provides a ω-6 to ω-3 ratio of 1:8, which is unique in comparison to other ILEs.11,13 Smoflipid®, a four-oil product produced by Fresenius Kabi, is the first of the fourth-generation products to be made available in the United States in July of 201614despite years of use in Europe.

SMOF is an acronym for the composition of the product, which contains SO (30%), MCT (30%), OO (25%) and FO (15%). This combination oil results in an ω6: ω-3 ratio of 2.5:1 which is reported to be an advantage over the current SO-based ω-6 products available.11,15 Additionally, with the FO and OO components, this novel product contains a high amount of α-tocopherol, a nutrient known to have antioxidant properties which is speculated to help prevent hepatic injury. The decreased amount of ω-6 content of SMOF compared to the first generation ILE’s has provided optimism for reducing liver, infectious and inflammatory complications.

Table 2. FDA Approved ILEs for use in the U.S. market1

a

30% lipid is only approved for compounding and not for direct infusion ω-6 essential fatty acid linoleic acid c ω-3 essential fatty acid α-linolenic acid d Status of Liposyn III current unavailable in the United States e Not on the market at the time of this publication f Olive oil is a ω-9 fatty acid and contains significant amounts of α-tocopherol (Vit E) g A mixture of four fatty acids including fish oil and recently approved for use in the United States h Medium chain fatty acids consisting primarily of Caprylic (13-24%) and Capric (5-15%) fatty acids i Fish oil which contains a valuable source of eicosapentaenoic acid (EPA; 1-3.5%) and docosahexaenoic acid (DHA; 1-3.5%) b

Adapted from: Derenski K, Catlin J, Allen L, Parenteral Nutrition Basics for the Clinician Caring for the Adult Patient. Nutr Clin Pract.

2016:31:578-59

|23| www.KPHANET.org

Comparison of the Two Primary ILEs Products available in the U.S: Prior to July 2016, only the 100% SO-based ILEs were available for use in the United States.

FDA approval of the new FO based ILEs have been anticipated in this country for some time and now with the availability of SMOF, its use is expanding in clinical practice. Meta-analysis and clinical studies have shown decreases in length of stay (LOS), lower rates of infection, improved fatty acid profiles, and reduced inflammatory makers.16-19 It is theorized that SMOF confers anti-inflammatory benefits due to the inclusion of ω-3 fatty acids as a portion of the delivered energy source. SMOF has become a viable therapeutic option in patients receiving nutritional supplementation with ILE while receiving PN therapy. Table 2 provides a comprehensive comparison of the two commonly used ILEs currently available in the U.S. Table 3. ILE Clinical Considerations with Smoflipid® and Intralipid® (SO-based) Comparisons1,2,5,7,8-10,11,14,15,20-27

Issue / topic

Discussion Points with Clinical Applications

Inflammation potential

SO-based ILEs are pro-inflammatory with reported negative effects on the immune system with increased infection risk.2,,8,11 SMOF is much less pro-inflammatory and immunosuppressive compared to SO-based ILEs, which is an often cited and recognized advantage.2,8,11

Phytosterol content

SO-based ILE’s have a higher content of phytosterols, which is approximately 439 mg/ L, whereas SMFO contains approximately 207 mg/L5,20 Administration of phytosterols IV contribute to an increased potential for liver toxicity and the development of intestinal failure-associated liver disease (IFALD).2,5

α-tocopherol content

The estimated amount of α-tocopherol in SO-based ILE is 3.8 mg/100ml, whereas SMOF contains approximately 16-23 mg/100ml.5 SMOF contains more active vitamin E (α-tocopherol), primarily from the OO and FO sources with the benefit of less potential oxidative stress damage.5,11

Essential fatty acid content

The approximate percentage of LA & ALA in the SO-based IVEs is 53% and 7.5% respectively2,5,15

Egg phospholipids

SMOF contains approximately 19.5% LA and 2.5% ALA2,5,14 The egg phospholipid emulsifier is the same concentration of 1.2% for the U.S. approved ILEs and is the ingredient that causes concern with egg allergies5,6,14,15

Glycerin Caloric contribution Role in EFAD

The glycerin concentration is 2.25% for Intralipid®, and 2.5% for SMOF; glycerin contributes to the caloric content of these products6,14,15,24 The SO-based and SMOF ILE 20% products are 2 Kcal’s/ml and contribute 10 Kcal’s/g of ILE14,15,20 SO-based ILEs have a much higher content of EFA’s (approximately 3 x’s more than SMOF) and less is needed in the treatment and prevention of EFAD.2,5,11 Prevention of EFAD with SO-based is accomplished by providing approximately 8-10 % 15 of the total calories or by giving 100 g weekly in two divided doses.1,3,7 Prevention of EFAD with SMOF can be accomplished by giving approximately 13-25% of the total calories.14

w

Omega-3 content

When reduced SMOF dosing is required, the target should be approximately 15% of the calories to prevent EFAD. SMOF contains ALA 1.5-3.5%, EPA 1-3.5%, and DHA 1-3.5%.14 Intralipid® contains ALA 4-11%.15 The increased ω-3 content of SMOF is expected to provide benefits of reduced inflammation.2,11,

|24| Kentucky Pharmacists Association | November/December 2017

Table 3. ILE Clinical Considerations with Smoflipid® and Intralipid® (SO-based) Comparisons1,2,5,7,8-10,11,14,15,20-27 ω-6: ω-3 ratio

Dosing

SMOF has a ω-6: ω-3 ratio of 2.5:1, whereas SO-based ILE is 7:1; expert recommendations is a ratio range of 2:1 – 4:1.11,14,15 SMOF is considered to have an improved ω-6: ω-3 ratio compared to SO-based ILEs with the expected benefit of less inflammatory impact.

Adult dosing for SMOF is 1-2 g/kg/day and should not exceed 2.5 g/kg/day.14 Intralipid® prescribing information gives a max dose of 2.5 g/kg/day.11 Published recommendations for ILE dosing in a PN regimen includes a maximum of 60% of total calories in addition to a maximum dose of 2.5 g/kg/day to prevent fat overload syndrome 1,7 The ASPEN PN handbook publication suggests a dose ≤ 1 g/kg/day for the hospitalized patient 6,17; this reference was published when only SO-based ILEs were available in the U.S. Derenski et al. establishes an appropriate ILE dose as 0.5 – 1 g/kg/day1; again this was before SMOF became available.

ESPEN guideline recommendations for long-term home parenteral nutrition patients (> 6 months) is an IVE dose not to exceed 1 g/kg/day2 Per current ASPEN guidelines, when dosing ILEs in the obese patient population, a hypocaloric nonprotein calorie regimen is recommended.18,19 When reducing the dose, consideration should be given to required amounts of EFA to prevent EFAD. Current ASPEN critical care guidelines recommend holding SO-based ILEs during the first week of therapy or reducing the dose to a maximum of 100 g if EFAD risk is a concern.2,5,11,22 This consensus recommendation is based on the immunosuppression and infection risk potential with SObased ILEs. This recommendation is supported by weak evidence and specifically applies to the first generation SO-based ILEs22

Administration

The 10 and 20% IVE products can be administered via either central or peripheral administration as these products are iso-osmotic.15,24 ILEs can also be administered as part of the PN feeding formula, which is defined as a 3-in-1 formula (amino acid/dextrose/ILE) or total nutrient admixture (TNA).

When ILE is administered separate from the parenteral nutrition feeding formula (2-in-1) it is usually infused via Y-connector into the same central line near the infusion site.14 ILE infused via TNAs are infused over a maximum of 24 hours with recommended change of the IV tubing with each change of the container2,26 ILE infused separately from the PN feeding formula is generally infused over 12-24 hours, with 12 hours recommended in the adult population since ILE is an excellent growth media for bacteria.

IV tubing should be replaced with each change of the container. 2,26 The ILE infusion rate should not exceed 0.11 g/kg/hour to prevent over burdening the reticuloendothelial system (RES) which causes immune system compromise and risk of fat overload. 2,4,6 The lower ω-6 load with SMOF should not be as problematic although the same restriction applies. 2,14 ESPEN guidelines specify that a rate of 0.7 – 1.5 g/kg can be safely infused over 12 – 24 hours. The 1.5 g/kg over 12 hours is considered aggressive especially with SO-based ILEs because lipid energy is provided in excess of the fat oxidation capacity.2 The concentrated 30% ILE products are not for direct administration and only used in compounding total nutrient admixtures (TNAs)7,24 A minimum pore size of 1.2 u filter must be used in the administration of ILE’s. The more optimal 0.22 u bacterial retentive filters should not be used for administering ILEs since clogging may occur with the size of the fat particles.7,14,15,25 The filters used in administering ILEs should never be removed for patient safety due to potential micro precipitates of calcium/phosphate or enlarged fat globules which can be lodged in the micro-vasculature of the lung or other organs14,15,25

|25| www.KPHANET.org

Table 3. ILE Clinical Considerations with Smoflipid® and Intralipid® (SO-based) Comparisons1,2,5,7,8-10,11,14,15,20-27 Allergy precautions

SMOF sensitivity precautions include soy, peanut, egg, and fish allergies per the package labeling. The peanut allergy is listed due to a potential cross-reactivity with soy.14 Intralipid® allergy precautions would include soy, peanut, and egg although these are not listed in the package insert.15 Nutrilipid®, a SO-based ILE equivalent to Intralipid®, lists precautions with egg and soy allergies in the package insert.27

Monitoring considerations

ILE should be held or reduced to prevent EFAD for TG levels ≥ 400 mg/dl1,4,14,26; ILE administration is contraindicated for TG levels ≥ 1000 mg/dl.4,14 The 20% SO product is preferred over the 10% due to a lower egg phospholipid: triglyceride ratio resulting in improved triglyceride clearance.1,5,6 Monitor liver enzymes AST, ALT, and AP along with bilirubin during ILE therapy. Increased levels of these lab parameters may warrant reduced dosing.14,15 Assess for signs and symptoms of EFAD when IVE dosing is reduced or held for over 2-4 weeks.6,7 Monitor for signs and symptoms of fat overload syndrome which is generally seen when the recommended ILE dose or infusion rate is exceeded.1,2,14,15

Conclusions:

References:

The ideal ILE is one that provides a concentrated source of nonprotein calories (NPC) as part of a PN regimen to facilitate growth and development along with preventing EFAD. Additionally, the ideal ILE would be free of complications in the normal dosage range. The current ILEs available in the U.S are effective and relatively safe products.

The first generation SO-based ILE products have historically been the only option in this country until 2016 when an alternative fourth generation ILE became available. The continued development of ILE products has primarily focused on decreasing the ω-6 content while still maintaining sufficient EFAs. Furthermore, the development of these novel products are making strides in reducing the complications of liver toxicity, immunosuppression, and enhancing antioxidant properties. Based on this, the new alternative ILEs containing FO appear to have theoretical benefits over the first-generation products. However, further large scale randomized prospective research studies are required to provide evidence of their superiority in improving patient outcomes.

1.

Derenski K, Catlin J, Allen L, Parenteral Nutrition Basics for the Clinician Caring for the Adult Patient. Nutr Clin Pract. 2016:31:578-595

2.

Vanek VW, Seidner DL, Allen P, et al. ASPEN position paper: clinical role for alternative intravenous fat emulsions. Nutr Clin Pract. 2012;27(2): 150-192.

3.

Kumpf VJ, Gervasio J. Complications of Parenteral Nutrition In: Mueller CM, Kovacevich DS, McClave SA, Miller SJ, Schwartz DB. Eds. The A.S.P.E.N. Adult Nutrition Support Core Curriculum. 2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2012:284-297

4.

Ch. 8 Complications of Parenteral Nutrition. In: Ayers P, Guenter P, Holcome B, Plogsted S. Eds. The A.S.P.E.N. Parenteral Nutrition Handbook. 2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2014:197-229

5.

Anez-Bustillos L, Dayo DT, Baker MA, et al. Intravenous Fat Emulsion Formulations for the Adult and Pediatric Patient: Understanding the Differences. Nutr Clin Pract. 2016;31(5): 596-609.

6.

Hise M, Brown JC. Lipids. In: Mueller CM, Kovacevich DS, McClave SA, Miller SJ, Schwartz DB. Eds. The A.S.P.E.N. Adult Nutrition Support Core Curriculum.

|26| Kentucky Pharmacists Association | November/December 2017

2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2012:63-82 7.

Mattox, TW, Crill CM, Parenteral Nutrition. In. DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM. Eds. Pharmacotherapy: A Pathophysiologic Approach, 10th Ed. New York, NY: McGraw-Hill, 2017: Pharmacy on-line secure access Ch. 142.

8.

Fell GL, Nandivida P, Gura KM, et al. Intravenous lipid emulsions in parenteral nutrition. Advances in Nutrition: An International Review Journal 2015;6: 600-610.

9.

Teitelbaum DH, Guenter P, Griebel D, et al. Proceeding from FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products, October 29, 2013. JPEN J Parenter Enteral Nutr. 2015;39(7):768786

10. Driscoll DF. Lipid injectable emulsions: 2006. Nutr Clin Pract. 2006;21(4):381-386 11. Biesboer AN, Stoehr NA. A Product Review of Alternative Oil-Based Intravenous Fat Emulsions. Nutri Clin Pract. 2016;31:610-618 12. Clinolipid (lipid injectable emulsion) for intravenous use [package insert]. Deerfield, IL: Baxter Healthcare Corp; 2013 13. Omegaven (emulsion for infusion) [package insert]. Bad Homburg, Germany: Fresenius Kabi; 2012 14.

15.

16.

17.

18.

21. Ch. 5 How to Prescribe Parenteral Nutrition Therapy. In: Ayers P, Guenter P, Holcome B, Plogsted S. Eds. The A.S.P.E.N. Parenteral Nutrition Handbook. 2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2014:111-134 22. McClave SA, Taylor BE, Martindale RG, et al. Guidelines for the Provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine (SCCM) and American Society of Parenteral and Enteral Nutrition (A.S.P.E.N.) JPEN J Parenter Entral Nutr. 2016;40(2):159-211 23. Dickerson RN. Hypocaloric, high-protein therapy for critically ill patients with obesity. Nutr Clin Pract.

(6):786-791 24. Ch. 4 Parenteral Nutrition Formulations and Managing Component Shortages. In: Ayers P, Guenter P, Holcome B, Plogsted S. Eds. The A.S.P.E.N. Parenteral Nutrition Handbook. 2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2014:87-109 25. Barber JR, Sacks GS. Parenteral Nutrition Formulations In: Mueller CM, Kovacevich DS, McClave SA, Miller SJ, Schwartz DB. Eds. The A.S.P.E.N. Adult Nutrition Support Core Curriculum. 2nd ed. Silver Springs, MD: American Society for Parenteral and Enteral Nutrition; 2012:245-264

26. Ch. 7 Parenteral Nutrition Administration and Monitoring. In: Ayers P, Guenter P, Holcome B, Plogsted S. Eds. Smoflipid® [package insert]. Bad Homburg vor der Höhe, The A.S.P.E.N. Parenteral Nutrition Handbook. 2nd ed.

Germany: Fresenius Kabi; 2016 Silver Springs, MD: American Society for Parenteral and Intralipid® 20% [package insert]. Bad Homburg vor der Enteral Nutrition; 2014:165-196 Höhe, Germany: Fresenius Kabi; 2017 27. Nutralipid [package insert]. Bethlehem, PA;B. Braun Bae HJ, Lee GY, Seong JM, Gwak HS. Outcomes with Medical; revised August 2014. perioperative fat emulsions containing omega-3 fatty acid: 28. Boulatta JI, Gilbert K, Sacks G, et al. A.S.P.E.N. clinical A meta-analysis of randomized controlled trials. Am J guidelines: parenteral nutrition ordering, order review, Health Syst. Pharm 2017; 74:904-18 compounding, labeling, and dispensing. JPEN J Parenter Grimm H, Mertes N, Goeters C, et al. Improved fatty Enteral Nutr. 2014;38(3):334-377 acid and leukotriene pattern with a novel lipid emulsion 29. Ayers P, Adams S, Boulatta J, et al. A.S.P.E.N. parenterin surgical patients. Eur J Nutr 2006;45:55-60 al nutrition safety consensus recommendations. JPEN J Klek S, Chambrier C, Singer P, et al. Four-week parenterParenter Enteral Nutr. 2014;38(3):296-333 al nutrition using a third generation lipid emulsion (SMOFlipid)—a double blind, randomized, multi-center study in adults. Clin Nutr 2013;32:224-31

CPE Quiz Online

19. Metry A, Abdelaal W, Ragaei M, et al. SMOFlipid versus Intralipid in postoperative ICU patients. Enliven: J Anesthesiol Crit Care Med 2014;1:1-8 20. Vanek, Vincent W., et al. "Update to ASPEN Position Paper Clinical Role for Alternative Intravenous Fat Emulsions." Nutrition in Clinical Practice 29.6 (2014): 841-841.

Pharmacist: www.surveymonkey.com/r/ DecCE2017 Technician: www.surveymonkey.com/r/ DecCE2017T |27| www.KPHANET.org

Technicians Quiz 1. Which of the following ILE products is for compounding only and should not be given by direct infusion?

A. Intralipid® 10% B. Clinolipid® 20% C. SMOFlipid® 20% D. Intralipid® 30%

6. What minimum pore size filter is used for the administration of ILE containing IV’s?

A. 0.22 u filter B. 1.2 u filter C. 5 u filter D. IFE should not be filtered

2. The listed packaging adult dosage for Smoflipid® is?

A. 0.5 – 1 g/kg/d B. 1 -2 g/kg/d C. ≤ 1 g/kg/d D. 2 – 2.5 g/kg/d

7. When administering ILE as part of a total nutrient admixture (TNA), the maximum time limit required for changing the IV tubing is: A. 12 hours B. 24 hours C. 48 hours D. 72 hours

3. Which of the following ILEs would be contraindicated for a patient with fish allergy?

A. Intralipid® B. Liposyn II® C. Clinolipid® D. Smoflipid®

8. What generation of ILE would Intralipid® be categorized as: A. First generation B. Second generation C. Third generation D. Fourth generation

4. Which unique fatty acid oil differentiates the fourth generation from others?

A. olive oil B. fish oil C. soybean oil D. coconut oil

9. How many Kcal’s is contained in 250 ml of 20% Smoflipid® A. 250 Kcal’s B. 500 Kcal’s C. 750 Kcal’s D. 1000 Kcal’s

5. Which of the following dosing strategies is used in practice with SO-based ILE to prevent EFAD when a minimum dose is desired?

A. 50 g per week in one dose B. 100 g per week in two divided doses C. 50 g given every other day D. 50 g given daily

10. A soybean allergy would be a contraindication for which of the following ILE’s: A. Intralipid® B. Smoflipid® C. Both a&b D. None of the above

Pharmacists Quiz 1. Which of the following would be deemed a benefit of the 3rd generation ILE OO:SO (4:1) versus the first generation SO-based emulsions?

A. Increased amount of linoleic acid B. Increased amount of vitamin E C. Increased amount of alpha-lenolenic acid D. Increase amount of DHA and EPA 2. The omega designation in the X:Y:Z format system would be represented by?

A. X B. Y C. Z D. None of the above 3. Which ILE has the highest content of phytosterols?

A. Intralipid® B. Clinolipid® C. SMOFlipid® D. Omegaven® 4. The reported ω-6:ω3 ratio for SMOFlipid® is?

A. 1:1 B. 2.5:1 C. 7.5:1 D. 1:8 5. Which of the following fatty acid oils would be the most proinflammatory?

A. Safflower oil B. Olive Oil C. Medium chain triglycerides D. Fish oil

6. Which of the following fatty acids oils would be most rapidly metabolized and a readily available source of energy?

A. Soybean oil B. Olive oil C. Coconut oil D. Safflower oil 7. Which of the following is deemed a benefit of SMOFlipid® over Intralipid®?

A. Increase amount of EFA’s B. Contains a source of EPA & DHA C. Increase amount of phytosterols D. The comparative 20% product is a higher concentrated source of calories 8. Which of the following ILE products contains only a minute trace of phytosterols?

A. Intralipid® B. Clinolipid® C. SMOFlipid® D. Omegaven® 9. Which of the following ILE products should not be given by direct infusion?

A. Intralipid® 10% B. Clinolipid® 20% C. SMOFlipid® 20% D. Intralipid® 30% 10. The listed packaging adult dosage for SMOFlipid® is?

A. 0.5 – 1 g/kg/d B. 1 -2 g/kg/d C. ≤ 1 g/kg/d D. 2 – 2.5 g/kg/d

This activity is a FREE service to members of the Kentucky Pharmacists Association.

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 12/07/2020 TECHNICIANS ANSWER SHEET. December 2017 — Part 1: Review of Intravenous Lipid Emulsions (ILEs) Used in Specialized Parenteral Nutrition (PN) Support Therapy in the Adult Patient Population (2 contact hours) Universal Activity # 0143-0000-17-012-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B C D

Information presented in the activity:

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET December 2017 — Part 1: Review of Intravenous Lipid Emulsions (ILEs) Used in Specialized Parenteral Nutrition (PN) Support Therapy in the Adult Patient Population (2 contact hours) Universal Activity # 0143-0000-17-012-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B C D

9. A B C D 10. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

Quizzes submitted without NABP eProfile ID # and Birthdate will not be accepted. |29| www.KPHANET.org

Campus Corner KPhA continues to shape the evolution of pharmacy practice and is active in the legislative process to positively affect change. This November, the Association hosted its annual Legislative Conference and invited pharmacists and future pharmacists from throughout Kentucky. University of Kentucky College of Pharmacy had over 130 students in attendance, with the entire third year class present, as well as a few first and second year students. We caught up with a few of our students after the event.

Megan Cummins (PY3) Legislative Co-Chair for KAPS & KPhA Student Engagement Committee Hometown: St. Charles, KY

Natalie Conley (PY3) Hometown: Ashland, KY

What I Learned

Why It Matters

What I Learned

Why It Matters

One of the largest takeaway from Legislative Day was that our legislators value our opinions and want to hear from us. I found a common theme among the legislators present and that was that they seek advice from people they trust when it comes to issues they are unfamiliar with. We, as future pharmacists, can be those trusted experts. I also left feeling confident in the future of our profession. Seeing so many students, pharmacists, and legislators work together was encouraging.

Legislative Day is important for future pharmacists because our voices are important. Students often believe their opinions won't matter until they graduate, but that's not the case. We are the future of this profession.

Showing how passionate we are and advocating for pharmacists is extremely important. Our opinions matter because they will affect how we practice in the future. We aren't just advocating for pharmacy, we are advocating for our future patients.

I learned the importance of advocating for the profession and having people in that legislature that advocate for you and care about your opinions.

Legislative Day is so important because future pharmacists need the interaction with legislatures.

It is the one time that students can see how their advocacy efforts positively impact the profession.

Kyle Bryan (PY3) Policy VP for UK Chapter APhA & Legislative Co-Chair for KAPS Hometown: Lebanon Junction, KY

Students network during the Legislative Conference.

What I Learned

Why It Matters

The one thing that really stuck out to me during the Legislative Day is how approachable our legislators are. From a student perspective, the thought of approaching or contacting legislators can be intimidating. Being able to see them up close, talk with them on an individual basis, and work with them at the roundtable discussions helped to humanize them and made me realize that they’re approachable and friendly.

Legislative Day is important for future pharmacists because it helps drive home the importance of advocating for the profession of pharmacy. So many people are content to sit back and do nothing regarding pharmacy, but that doesn’t allow pharmacists to be in control of our profession and future.

|30| Kentucky Pharmacists Association | November/December 2017

UK Celebrates American Pharmacists Month Throughout the month of October at the University of Kentucky College of Pharmacy, our APhA-ASP chapter members were busy celebrating American Pharmacists Month through patient care opportunities and advocacy efforts. We hosted a wide variety of events encompassing advocacy, outreach, and patient care activities. To increase awareness and participate in #APhMSelfieDay, a national campaign through APhA, two Snapchat filters were created which resulted in over 11,000 views from 269 uses. Student members participated in over 190 volunteer opportunities educating the public, providing patients with health screenings, and administering immunizations. Students also participated in a letter drive sending 420 letters to our senators and representatives to show support of federal bills for provider status.

A new partnership was initiated with Kentucky Clinic Pharmacy to host events every day during the week of October 23-27. Through this partnership, 59 patients participated in blood glucose screenings with Operation Diabetes and 35 patients participated in blood pressure screenings with Operation Heart. Our Legislative committee educated patients on services pharmacists can provide to the public and our OTC Medicine Safety committee informed patients about proper medication disposal. We look forward to continued screening and educational events for patients in collaboration with the Kentucky Clinic Pharmacy.

Outside of our events across the street from the college, Operation Immunization volunteers participated in four separate flu clinics in October along with immunizing 22 members of the University of Kentucky Board of Trustees. Our Generation Rx committee spoke with students through educa- Students snap a selfie. tional presentations at Jessie Clark Middle School and hosted an awareness event at the main library on UK’s campus.

In addition to patient care events in October, nine students attended the 2017 Region 4 Midyear Regional Meeting in Indianapolis, Indiana where our chapter was awarded a regional award for Operation Heart. These students also represented our chapter during the policy proposal process. Our policy proposal generated discussion around the utilization of pharmacy technicians to further support clinical service opportunities for pharmacists. The entire month would not have been a success without the APhA-ASP members at the University of Kentucky College of Pharmacy. We look forward to an exciting rest of the year for our chapter!

Students provide flu immunizations during American Pharmacists Month.

Students celebrate American Pharmacists Month. |31| www.KPHANET.org

Campus Corner By: Nathan Hughes, PharmD Candidate (2019) Sullivan University College of Pharmacy

"We make a living by what we get. We make a life by what we give." - Winston Churchill Many people in this country simply do not have access to health care. Currently, over 60% of counties in Kentucky are deemed medically underserved. Even in our local community here in Louisville, many people are without access to quality health care. The Family Community Clinic in Louisville is helping bridge this gap and provides all patients with free access to care.

Last year, our APhA-ASP chapter at Sullivan University began a partnership with the Family Community Clinic to help serve our own community of Louisville, KY. Our past-president, Katherine Keeney, spoke about how the volunteer program began and its impact. “I was approached by Dr. Chris Betz about the idea of having student volunteers in the free clinic to help the uninsured and underserved of Louisville – just the idea of the program and I was immediately hooked.” Katherine continued, “Setting up volunteers in the clinic was a breeze. The volunteer staff are extremely welcoming and kind and the whole experience is energizing and inspiring.”

Each quarter, 8 volunteers, all P2 students, sign up to manage four week shifts through the Family Community Clinic. The impact was very powerful for Tuba Parvez, a past volunteer and a current P2 student at Sullivan. “It was heartwarming to work with patients who are less fortunate than myself. It reminded me why I chose to be in the healthcare field in the first place.”

On Tuesday November 28, a very special celebration for all Family Community Clinic volunteers took place at St. Joseph's School. All of our student volunteers have had an integral part in helping grow this amazing clinic and Tuesday night was the beginning of a new chapter for the Family Community Clinic here in Louisville as an expansion project has begun. Mayor Greg Fischer and others were on hand to witness the outpouring of generosity by our community. However, the work now is only beginning. The clinic is tripling in size from 4,000 sq. ft. to 12,000 sq. ft. and the only thing limiting their growth is volunteers. If you are interested in helping out, please Mayor Greg Fischer addresses volunteers visit www.famcomclinic.org and fill out an application. Physicians, nurses, lab technicians, Spanish interpreters, and office help are all welcome to apply!

With this new expansion project, the clinic has begun their 2020 capital campaign. They are currently accepting new donations to help cover the renovation costs. At the celebration dinner, it was announced that an anonymous donor has decided to currently match donations dollar for dollar. With your donations, the clinic can help to reach the more than 90,000 families still uninsured in Louisville. |32| Kentucky Pharmacists Association | November/December 2017

We are thankful at Sullivan University to have this unique partnership with the Family Community Clinic in helping foster growth in our students to a life of serving others. To all of our Sullivan volunteers past and present who worked so hard to make this opportunity a reality, thank you for all of your hard work and selfless giving!

“In this life we cannot do great things. We can only do small things with great love.” - St. Teresa of Calcutta Donations can be mailed to:

Nathan Hughes poses with Juanita Richardson, Clinic Manager, Family Community Clinic Inc.

Family Community Clinic 1406 E Washington St Louisville KY 40206

KPERF Awarded KORE Grant The Kentucky Pharmacy Education and Research Foundation (KPERF) has undertaken a new grant opportunity to develop and implement a centralized naloxone distribution program in partnership with community pharmacies in Kentucky. The goals are to increase access to naloxone (in the form of Narcan®) and opioid prevention services as well as to ensure individuals leaving residential treatment programs have Narcan® to take with them at the time of discharge.

Participating pharmacies will be reimbursed with replacement inventory as well as $25 for education and dispensing per patient With more than 1,800 pharmacists certified by the Kentucky Board of Pharmacy to initiate the dispensing of naloxone via physician protocol, community pharmacists offer unparalleled access points for opioid overdose prevention and related harm reduction services with at least one community pharmacy located in 119 of Kentucky’s 120 counties.

“This is a great opportunity for pharmacists to further demonstrate the importance of the profession by collaboratively solving public health problems like the opioid epidemic, said Jody Jaggers, KPhA Director of Pharmacy Emergency Preparedness.

“Through my experiences with the mobile pharmacy naloxone training program, I’ve heard many stories from individuals about how thankful they are to have access to naloxone, whether for themselves or their loved ones,” Jaggers said. “I am convinced that pharmacists can make a huge difference, not only in the lives of those struggling with substance abuse but also for their friends and family who desperately want to help them.”

KPERF will work with the Cabinet for Health and Family Services, Department for Behavioral Health, Developmental and Intellectual Disabilities (CHFS:DBHDID) to meet the objectives of the grant.

Funding is through the Substance Abuse and Mental Health Services Administration (SAMHSA) as a part of the Kentucky Opioid Response Effort (KORE).

The cost of naloxone remains a significant barriIf you would like more information on the proer to patient access. This program will allow uninsured gram, contact Jody Jaggers at jjaggers@kphanet.org. patients or those whose insurance does not adequately cover the cost of naloxone to receive Narcan® at no charge to them from a state-purchased inventory that will be acquired and managed by KPERF.

|33| www.KPHANET.org

Pharmacy Law Brief Refusal of Treatment Based on Religious Beliefs Author: Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I have heard of cases in the past where parents refused treatments for critically ill children based on the parents’ religious beliefs. I believe there was such a high profile case in Tennessee several years ago. What’s Kentucky’s approach to handling such matters?

Response: The law on this topic varies greatly from state to state. The approach can be described generally as the law treating health care decisions based on religious beliefs as an exception to the overarching state laws, both civil and criminal, dealing with child abuse. Much of the activity in this area can be traced back to enactment of the Child Abuse Prevention and Treatment Act of 1974. That federal statute allocated a pool of funds for which states could apply for activities related to preventing child abuse but there was a proviso that for a state to qualify it had to enact a religious exemption statute. Eventually, all fifty states enacted such an exception to their general child abuse and neglect statutes.

The general thrust of these statutes is that a parent or guardian cannot be prosecuted for child neglect if the decision to withhold care was tied to legitimately practicing religious beliefs “for that reason alone.” Most states require it to be a “recognized religious denomination.” In about a third of the states a court may intervene even when the parents’ are tying their decision to withhold treatment to a religious precept.

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

fruit. The nurse informed them she was alerting the UT Medical Center about the child’s situation and that they should go there without delay. When they never arrived staff members at the hospital followed up and, upon her death, an investigation was commenced. The conclusion was that she’d received “treatment” from a friend of her mother.

The Tennessee Supreme Court did not view that individual as an “accredited practitioner of a recognized religious denomination so the exemption was inapplicable. The offshoot was that the state repealed its religious exemptions for medical neglect of children.

Kentucky currently has two statutes addressing civil law matters related to interplay of religious beliefs and health care for a child. The first appears in the “definitions” section of the Kentucky Revised Statutes dealing with child neglect: 600.020(1) “Abused or neglected child” means a child who whose health or welfare is harmed or threatened with harm when:

The Tennessee case of 2014 involved the (a) His or her parent or guardian, person in death of a 15 year old who died from Ewing’s sar- a position of authority or special trust, as defined in coma. Her mother had taken her to a walk-in clinic KRS 532.045, or other person exercising custodial with a tumor on her shoulder the size of a grape|34| Kentucky Pharmacists Association | November/December 2017

control or supervision of the child:

behalf of his or her county with the cabinet or the (8) Does not provide the child with adequate Department of Juvenile Justice for the furnishings of these services. care, supervision, food, clothing, shelter, and education or medical care necessary for the child’s (2) The court may order or consent to neceswell-being. A parent or other person with custodial sary medical treatment, including surgical procecontrol or supervision of the child legitimately prac- dures, except for the purpose of abortion, electroticing the person’s religious beliefs shall not be con- shock therapy or psychosurgery as provided in sidered a negligent parent solely because of failure KRS Chapter 645, or sterilization, after a hearing to provide specific medical treatment for a child for conducted to determine the necessity of such treatthat reason alone. This exception shall not preclude ment or procedure. In making the order, the court a court from order necessary medical services for a may take into consideration the religious beliefs and child. practices of the child and his parents or guardian.

Reasonable notice, taking into account any emerThe second statutory provision appears in gency circumstances, shall be provided to the parKRS 610.310: 610.310 Medical treatment for ents, guardian or person exercising custodial conchild. trol or supervision of the child to enable them to (1) When the mental or physical health of attend the hearing. any child before the juvenile court requires it, the These matters can be complex and thorny as court may order the child to be placed in a public or private hospital or institution for examination, eval- frequently seen with issues at the intersection of uation, treatment, or care by a health officer, com- public policy and religion. prehensive care center, children's clinic, or any reputable physician or psychologist who will conduct Submit Questions: jfink@uky.edu the examination. The cabinet and the Department of Juvenile Justice may furnish services under agreements with the individual juvenile courts. For this purpose, any county judge/executive or chief executive officer of an urban-county or charter county government may enter into a contract on

CPE Reminder: A pharmacist shall complete a minimum of one and five tenths (1.5) continuing education units (15 contact hours) annually between January 1 through December 31, pursuant to 201 KAR 2:015, Section 5(1). A pharmacist first licensed by the Board within 12 months immediately preceding the annual renewal date shall be exempt from the continuing pharmacy education provisions.

Still need hours? KPERF CPE articles are available to members online at www.kphanet.org under the Education tab.

|35| www.KPHANET.org

Pharmacy Policy Issues Pharmacists’ Roles in Pharmacy Deserts Author: Kirstyn M. Hill is a third year PharmD student at the UK College of Pharmacy and a second year student in the MPH degree program. A native of Sauk Village, IL, she completed her preprofessional education at the University of Illinois at Urbana-Champaign with a major in Interdisciplinary Health.

Issue: I have heard the phrase “pharmacy deserts” used and I think I know what’s being referred to but I’m not absolutely certain. What does that mean?

Discussion: Increasing the number of pharmacies and other sources of healthcare services in rural areas across the United States has been the driving force for many pharmacy programs throughout the years. Numerous initiates offer students specialized curricula, scholarships, and alternative loan repayment options if they commit to practicing in such an area. Other programs, such as the Public Service Loan Forgiveness Program, offer similar incentives for pharmacists that practice for non-profit or government organizations. However, the placement of pharmacies and resources for a similar collection of disadvantaged individuals in the United States is often overlooked. “Pharmacy deserts” are locations within major cities that lack adequate access to pharmacy services. These pharmacy deserts disproportionally affect the health and well-being of minorities throughout the country, causing an expansion of health disparities within large, resourceful cities.

Dr. Dima Qato, an assistant professor at the University of Illinois at Chicago College of Pharmacy, studied the prevalence of pharmacy deserts within Chicago from 2000 to 2012.1 While this study was published in late 2014, these deserts are still extremely prevalent in 2017. In the study, a community was labeled a “pharmacy desert” if it was considered both low access and low income.1 Researchers found that during the study period, the

number of pharmacies in segregated white communities increased by 30 percent, while they declined by 17 percent in segregated Hispanic communities and 11 percent in segregated African-American communities.1 Chain pharmacies accounted for 58.6 percent of the pharmacies located in segregated white areas, while they accounted for only 38 percent in segregated black communities.1 Most pharmacy deserts were found on the south and west sides of Chicago, which are predominately low income Hispanic and African-American communities.1 One mile pharmacy deserts were almost exclusively found within segregated AfricanAmerican communities throughout the city.1 Overall, the study found that the proportion of pharmacy deserts in low-income African American communities was 58 percent, compared to 30 percent in low-income white communities.

With no pharmacies nearby, affected individuals must find ways to travel further for their maintenance medications, acute prescriptions, over-thecounter products, vaccinations and pharmacist counseling. However, further travel is not always ideal or possible for many. Medications are often underused by minorities for numerous reasons, including cost, lack of understanding their medication regimen, and accessibility. By improving the accessibility to pharmacies, we may see an increase in medication adherence and the public health of our communities overall.

Although there is no simple solution for this issue, there are various strategies that may help eliminate these pharmacy deserts. One way would

|36| Kentucky Pharmacists Association | November/December 2017

be to increase the local government’s involvement in the placement of pharmacies. By doing so, representatives would be able to utilize population data to determine potential pharmacy locations to adequately meet the needs of the community. The government could also offer a tax incentive or increase reimbursement rates for chain and independent pharmacy owners to open their pharmacies within certain areas of the city. Another way to decrease the number of pharmacy deserts is to incorporate pharmacies within community health centers.

Federally qualified health centers (FQHCs) are centers that serve in medically underserved areas.

Dr. Qato’s study found that eighteen pharmacies in Chicago were within FQHCs, and nine of them were in black communities.1 By expanding the existence of FQHCs and incorporating pharmacy services into these centers, community members could have access to more resources.

Since many of these individuals lack medical resources in general, opening pharmacies that offer more preventive care services, such as urgent care clinics, immunization clinics and medication therapy management (MTM) opportunities, could contribute to improvements in the public health overall. Finally, it is important that we work toward placing more pharmacists in these medically underserved areas. Whether there are incentives offered or more pharmacy programs geared towards students interested in serving in urban areas, we must show students that pharmacists and the resources that we can offer are needed in numerous areas across the country.

References: 1. Qato, D.M., Daviglus, M.L., Wilder, J, Lee, T, Qato, D, Lambert, B. (2014) ‘Pharmacy Deserts’ Are Prevalent In Chicago’s Predominantly Minority Communities, Raising Medication Access Concerns. Health Affairs 2014(Nov.) 33:1958-65.

Have an Idea?

This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu.

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to info@kphanet.org to get on the list. |37| www.KPHANET.org

6. See It All KPhA is the only statewide pharmacy organization that represents all pharmacists in all practice settings—you can learn about all the opportunities available within pharmacy and gain insights from pharmacists representing a variety of practice settings.

7. Develop Your Leadership Skills Participate as an active leader in a variety of committees and volunteer leadership positions that will develop your skills as you give back to your profession.

1. Strengthen Your Career KPhA members enjoy educational opportunities designed to increase knowledge and keep up with the latest information.

2. Advance Patient Care

8. Make a Positive Impact By joining KPhA, you are taking a step to ensure the future of the profession in Kentucky. We can’t do this important work without YOU.

The more you learn about drug and treatment updates through our publication, The Kentucky Pharmacist, as well as through attending OUR KPhA meetings, the better equipped you are to help your patients.

9. Make the Connection

3. Network with Others in Your Field

KPhA partners with many industry partners that offer discounts or important expertise that can positively impact your pharmacy.

KPhA members are invited to join their colleagues at the KPhA Annual Meeting & Convention and the Legislative Conference.

4. Advocate for Your Profession By joining KPhA, you are supporting the only organization representing the unified voice of all pharmacists.

During the past year, KPhA’s work on health care legislation and regulation increased policy makers’ awareness of the pharmacist’s role in health care. KPhA continues to work on YOUR behalf.

10. Gain the Competitive Edge KPhA gives you exclusive access to unique experiences, career information, and resources designed to meet your needs and provide support as you advance in your career.

5. Proclaim Your Professionalism Adding your name to the ranks of your colleagues who are members declares your pride in the profession. Support KPhA’s advocacy efforts as we work with policy makers to implement health care reform legislation and as we continue to advocate for regulations that positively impact the profession. |38| Kentucky Pharmacists Association | November/December 2017

JOIN TODAY WWW.KPHANET.ORG

Welcome to KPhA! We’re so happy to have you!

The list reflects new memberships received from September 1, 2017— October 31, 2017 Kimberly Boothe Ft. Thomas

Michael Grace Barboursville, WV

Laura Carpenter Phoenix, AZ

James Nash Crestwood

Justina Egwuagu Owensboro

Michael Southall Louisville

Dale English Louisville

Devin Wallace Lexington

If you see one of these new members, please welcome them to the KPhA family!

MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession!

|39| www.KPHANET.org

Feature Article Risk-taking Healthcare Advocate Embodies Community Pharmacy Pillar in Albany, Kentucky Pharmacists play an essential role in our nation's health care delivery system – now more than ever.

Pharmacists are the most accessible healthcare provider for millions of patients, especially in very urban or rural communities, across the country. In fact, according to Gallup's annual poll, pharmacists rank as the most trusted of all professionals in all industries - second only to nurses.

consider buying the store. It was a priority for the former owners to transition ownership to someone local who would keep the culture they had worked so hard to establish for the community.

“Everyone that walks in our pharmacy door is a member of my family,” Collins said. “Our staff have pride in doing the best they can for patients every day. We work diligently to ensure patients are taken care of by maintaining communication with their physician, ensuring their medications are safe and refilled quickly, and striving to offer the best price possible. These are the characteristics that determine where someone goes to fill their prescription.”

was not something that was taught when she was in pharmacy school. In fact, she knew very little about independent pharmacy before purchasing her store. Any experience she had with an independent pharmacy business came from visiting the local, independent pharmacy in the small town she grew up in.

This family-owned independent pharmacy was owned by a couple, and the husband had recently passed away. The pharmacy had been in operation with the family, in the same location, since 1916. Collins was supporting this store as a relief pharmacist – while still working at the chain - to help during the challenging time.

She says developing a partnership to help manage the business is one of the most impactful ways Cardinal Health has helped her as a pharmacy owner. She relies on a team at Cardinal Health to provide industry expertise, efficient products and programs, and an option for how she can make those offerings work for her store.

“This pharmacy was – and is - a pillar of our community. I had really grown to admire what they built in that community pharmacy,” Collins This trust in a local healthcare professional said. “I always wanted to do the best job possible is a driving force for one independent pharmacist for my patients in the community, and I saw ownin Albany, Kentucky. Arica Collins, pharmacist ing this pharmacy - building relationships and servand owner at Dyer Drug, says that what sets inde- ing patients every day – as an ideal way to do just pendent pharmacies apart from others is something that.” you feel immediately when you walk in to an indeCollins admits that she had no education on pendent store. how to purchase and run a pharmacy – it simply

However, even as a very young professional, new in her career, Collins said ownership was an ideal fit for her. She continues to grow as an inCollins started her pharmacy career at a re- dependent owner by seeking new opportunities to tail chain in Kentucky in 2005 after graduating expand, develop and learn. Collins keeps an open from pharmacy school at Purdue University. A few mind about change, and relies on a strong network short years later, an opportunity presented itself for of people for support. One of the most important her to purchase a local, independent pharmacy in a learnings in ownership for Collins has been relying neighboring community. on partners when she doesn’t have the expertise.

Eventually, Collins was approached by the pharmacy owner/widow in 2008, asking her to

|40| Kentucky Pharmacists Association | November/December 2017

“You have to find the balance as a pharmacist business owner,” Collins said.

“We’re in a small town, we have a very communityfocused setting, and eveDyer Drug storefront. ryone wants to see you – you’re the face of business! It’s hard to step back and do those other (important) tasks to keep the business moving in the right direction. It’s reassuring to know we have Cardinal Health services in our back pocket to help us manage the daily pharmacy operations; it’s a good relationship to have.”

Collins says many programs from Cardinal Health have been an invaluable resource for her business: 





Cardinal Health’s reconciliation program to identify opportunities for reimbursement.

helped ensure proper inventory of the newest over-the-counter products, as well as the right supply of specialty products not found in chain pharmacies.

“The improved front end of our pharmacy really helped give us the ‘chain look,’ while keeping our small-town, community atmosphere,” Collins said.

“Arica and the entire staff at Dyer Drug are risk takers with their pulse on the needs of the Albany community,” said David Booth, pharmacy business consultant at Cardinal Health. “If we can help them manage the business of running a pharmacy, it allows them to focus on what matters most – their patients. You honestly feel like family coming in to Dyer Drug, and the generational business the pharmacy has garnered is something you simply can’t quantify.”

In addition to offering the right services, and finding the right support, Collins attributes a large part of the pharmacy’s success to the staff’s ability to really know their patients and welcome them in to the pharmacy.

Collins says the staff at Dyer Drug are very proactive thinkers, and constantly seeking to do “The customer service from this program is more in the community by identifying ways to supamazing; our representative is very helpful,” port patient needs. Some offerings in Dyer Drug are Collins said. “We really couldn’t realize the unique to the needs of the community: opportunities we were missing without that  Diabetes Center to meet a growing need in the program; we simply don’t have the time or community. It’s been quite successful and is resources.” growing daily.

Cardinal Health programs to quantify Direct  Pink Room for post-mastectomy supplies to and Indirect Remuneration (DIR) fees in an serve many patients in the area, and surroundeasy-to-access, real-time platform. ing areas, with no other options for finding care “The ability to have the DIR information easily or support after breast surgery. accessible and in a very straightforward forTo learn more about Dyer Drug, and its alwaysmat has been amazing for our business.” evolving offerings, visit www.dyerdrugky.com.

Cardinal Health Inventory Manager is a dailyuse platform that Collins says has been invaluable to limit excessive inventory and ensure medications or items are not expired or filling shelves.

“Any time we can limit inventory and increase cash, that’s a good day,” Collins said.



The front end program helped Dyer Drug “flip the pharmacy” to enhance the customer experience in the store. The improved structured

Inside Dyer Drug

|41| www.KPHANET.org

|42| Kentucky Pharmacists Association | November/December 2017

|43| www.KPHANET.org

KPhA BOARD OF DIRECTORS Trish Freeman, Lexington trish.freeman@uky.edu

Chair

Tyler Stephens, Lexington Vice Speaker of the House stevens.tyler@uky.edu

Chris Harlow, Louisville cpharlow@gmail.com

President

KPERF BOARD OF DIRECTORS

Chris Palutis, Lexington chris@candcrx.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Jessika Chinn, Beaver Dam jessikachilton@ymail.com

Past President Representative

Directors

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Chris Harlow, Louisville cpharlow@gmail.com

President

Paul Easley, Louisville rpeasley@bellsouth.net

Sarah Lawrence, Louisville slawrence@sullivan.edu

Matt Carrico, Louisville* matt@boonevilledrugs.com University of Kentucky Student Representative

Kelly Smith, Lexington ksmit1@email.uky.edu

KPERF ADVISORY COUNCIL

Chad Corum, Manchester pharmdky21@gmail.com

Matt Carrico, Louisville matt@boonevilledrugs.com

Cassy Hobbs, Louisville cbeyerle01@gmail.com Nathan Hughes, Louisville nhughe1030@my.sullivan.edu

Chair

Melinda Joyce, Bowling Green MBJoyce@chc.net

Angela Brunemann, Union Angbrunie@gmail.com

Jaclyn Ochsner, Lexington jaclyn.Ochsner@uky.edu

Bob Oakley, Louisville rsoakley21@gmail.com

Sullivan University Student Representative

Chris Killmeier, Louisville cdkillmeier@hotmail.com Don Kupper, Louisville donku.ulh@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield willettsam@bellsouth.net

Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Mary Thacker, Louisville mary.thacker@att.net

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

*At-Large Member to Executive Committee

HOUSE OF DELEGATES Amanda Jett, Louisville Speaker of the House ajett@sullivan.edu

|44| Kentucky Pharmacists Association | November/December 2017

K.PH.A. BREAKS GROUND FOR BUILDING Like it or not, pharmacists must recognize that their profession—like many other professions and industries—has been dragged into the political arena.

What happens now depends on how strenuously politically active R.Ph.’s are willing to fight at the hometown level where, as Newsweek’s Raymond Moley says, the lawmakers are created.

- From The Kentucky Pharmacist, December 1967, Volume XXX, Number 12

Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd.

Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center SUCOP 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Brandenburg Director of Communications & Continuing Education sbrandenburg@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org.

Deceased members for each year will be honored permanently at the KPhA office.

|45| www.KPHANET.org

THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601

www.kphanet.org |46| Kentucky Pharmacists Association | November/December 2017