The Kentucky Pharmacist - July/August 2021

TABLE OF CONTENTS FEATURES Professional Awards |8| House of Delegates Summary |10| Commercial Insurance to Reimburse for PharmacistProvided Services in Kentucky |44|

On the Cover Mission Statement: To advocate and advance the pharmacy profession to improve the health of Kentuckians.

Editorial Office: ©Copyright 2021 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.

President Cathy Hanna and her husband Tom at the KPhA Annual Meeting & Convention

IN EVERY ISSUE President’s Perspective |3| My Rx |5| July CE Article |17| July CE Quiz |22| July CE Answer Sheet |23| August CE Article |24| August CE Quiz |31| August CE Answer Sheet |32| Pharmacy Law Update |36| New KPhA Members |38| Pharmacy Policy Issues |39| Campus Corner |42|

Publisher: Ben Mudd Managing Editor: Sarah Franklin 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.

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ADVERTISERS APSC |16| PTCB |33| APMS |47| |Back Cover| EPIC |38| Pharmacists Mutual |41| Cardinal |46| Safe Medicines |51|

PRESIDENT’S PERSPECTIVE President Cathy Hanna’s speech at the 2021 Ray Wirth Banquet on Saturday, June 5.

Good evening. I am deeply honored and humbled to be here tonight.

I wish to also thank colleagues who encouraged me and have continually provided counsel -- Thank you! I would like to thank my family – including four adult children scattered around the eastern part of the country tonight -- for their continued support throughout the years. My husband, Tom, is here this evening.

I am so glad we could all be here together – in person! To be able to meet and network is something we once took for granted! Although there are some advantages to attending zoom meetings - such as a casual wardrobe -- I miss networking and meeting with others in person -- even if we have to dress up and put on lipstick!

What a great evening!

I’d like to thank outgoing Chairman Don Kupper for his encourAlthough the last year has been full of agement and support. challenges, there have been many positive things we should recognize. Communities I also want to thank have come together to help each other. immediate Past President Joel Thornbury. Pharmacists and stakeholders in all areas Joel did many things to show his support of practice have risen to the occasion to for me as his successor, and I thank him, promote health and wellness in our comand caution him that I will be depending munities. As I look out at everyone this on his continued support throughout the evening, I think of all the contributions year. Joel will be a hard act to follow espe- each of you have made and I am grateful. cially on the social media front- I will need As I asked myself what message to share to drastically up my game! this evening, I decided to focus on the misI also thank our new Executive Director sion of KPhA- to advocate and advance the Ben Mudd, the KPHA Board of Directors, pharmacy profession to improve the health Membership, staff, distinguished guests – of Kentuckians. I know you all share -- and including students! -- and our sponsors. are as passionate about -- this mission with me -- just ask my students! We have I would also like to congratulate each of and continue - to make a profound impact the new Board members. Our members on the health and wellbeing of Kentuckihave shown their confidence in you and ans by focusing on this mission. me by electing us to our respective positions, and I look forward to serving with you.

Advocacy can mean something different for each of us. |3| www.KPHANET.org

When asking students about the importance of advocacy, I generally ask them the following questions:

To address the challenges we face, pharmacists from all areas of the profession must join in solidarity and speak with one unified voice. If we recognize the chal“What role do you think you can play in lenges and achievements of all pharmathe advancement of pharmacy practice?” cists -- regardless of practice site – we can stand together to advocate for our profes“If you do not advocate for the profession sion more effectively. Rather than remain of pharmacy, then who will?” in our individual silos of practice, our unique skills and knowledge can contrib“Who is going to act on your behalf?” “If ute to solving challenges and expanding someone is acting on your behalf, will they our opportunities for our vital profession. have the same vision as you?

Who can lead this change? We can, These are all questions we should be ask- through KPhA. I like what William Zellmer with ASHP said, “We can lead the change ing ourselves as we strive to improve the that we believe in, or we can just position profession and mentor students and other ourselves to be forced to accept the pharmacists. change being put on us by others. The choice is quite clear…We’re going to lead Each of us has a responsibility to promote the change.” our profession, daily, in what we do and We must advocate for effective public polihow we interact with our peers and pacy that allows us to fully care for our patients. As members of KPhA we all undertients and communities. We must work tostand the importance of this commitment, gether to create sustainable pharmacy however, engaging others has and contin- practice models that include proper reimbursement for services and promote pharues to be our biggest challenge as an ormacists’ overall health and well-being in ganization. Though KPhA represents all areas of pharmacy, many of our colleagues the workplace. do not feel that they belong here. We should work to change that.

We have accomplished a lot this year, but we cannot attain future goals by only convincing each other of the importance of our work. We must reach out, to our colleagues, our patients, our legislators, and fellow healthcare providers. We must ensure that the laws, policies, infrastructure, and financial decisions take proper account of the value, benefits and role of pharmacists in the overall wellness of our communities. This is the role that KPhA plays through our ongoing efforts in Government Affairs. |4| Kentucky Pharmacists Association | July/august 2021

I look forward to this next year and with the help and support of the Board members and KPhA membership, I will do my best to lead. I will close tonight with a request: Think about how YOU can best advocate for our profession. How you can form connections with pharmacists in other areas of practice, with other health care providers, and with our communities. Then turn that thought into action. Together, we can make this year truly fulfilling for the profession and our patients. Thank you!

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Martika Martin receives the Young Pharmacist of the Year Award pictured with Joel Thornbury and Don Kupper

Peter Cohron receives the Distinguished Service Award pictured with Joel Thornbury and Don Kupper

Rep. Danny Bentley receives the Professional Promotion Award pictured with Ben Mudd, Rep. Steve Sheldon, Joel Thornbury & Shannon Stigltiz

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Brooke Strong receives the Technician of the Year Award pictured with Cory Smith and staff from Knox Professional Pharmacy.

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Annual Meeting House of Delegates June 4-5, 2021 Marriott Downtown Louisville Speaker Martika Martin opened the meeting with an Invocation led by Board Member Kyle Harris, followed by the Pledge of Allegiance and the Oath of a Pharmacist.

KPhA Board Secretary Brooke Hudspeth gave the credential report as follows: 51 Total Delegates attending the meeting today. Votes needed for 1/2 = 26, 2/3= 34 and 3/4 = 39.

Reference Committee was held on Saturday, June 5, 2021 beginning at 7:00 a.m. Speaker Martika Martin appointed the following individuals to the 2021 Reference Committee: Nathan Hughes, Vice Speaker of the House of Delegates Kim Croley, Parliamentarian Joe Carr Misty Stutz Cathy Hanna Taylor Williams Rodrick Millner Including all Vice Speaker Nominees Motion by Joe Carr to approve the June 26, 2020 and November 13, 2020 House of Delegates minutes as presented, seconded by Trish Freeman. Motion carried. |10| Kentucky Pharmacists Association | July/august 2021

Speaker Martin opened the floor to nominations for the 2021-2022 Vice Speaker of the House. Motion was made by Trish Freeman for Kyle Bryan as the Vice Speaker of the House of Delegates. Kyle accepted the nomination and addressed the House of Delegates briefly.

KPhA members recite the Oath of a Pharmacist during the House of Delegates meeting.

The Organizational Affairs Committee chaired

by Sam Willett. The committee submitted the following addition to the Bylaws: 5.23 No individual shall serve more than three (3) successive full terms as an Elected Director. Nothing in this Article shall prevent a director who has served three (3) full terms from being elected as President, President Elect, Treasurer or Secretary nor does it prohibit any member from serving on a KPhA committee or participating in a KPhA volunteer activity.

Once a director has served three (3) successive terms, they are eligible to run for a director seat again after sitting out for at least one year. In the event that an insufficient number of nominations are received to fill all available director seats for an election cycle, the membership will be re-petitioned and individuals who were previously ineligible to serve based upon the above stipulations would now be considered eligible to serve based upon KPhA Organizational Affairs Committee ap proval.

This Bylaw recommendation will go to the Reference Committee.

The Government Affairs Committee chaired by Trish Freeman. The committee submitted the following Legislative Priorities for 2022: The action item for the 2021 House of Delegates is to confirm the legislative priorities for 2022. The committee is presenting two items to the House as the primary focus of the Association’s legislative agenda for 2022. It should be noted that as in any legislative session, unanticipated issues may arise that could result in changes in position and priorities. While these are recommendations from GAC, members are reminded that KPhA House of Delegates has the ultimate decision-making power in terms of agenda setting and can add or subtract items from the recommended agenda at will. In addition to legislative priorities, the GAC is presenting, for the first time, a regulatory priority for the association.

Legislative Priority 1: Comprehensive PBM Reform Work with Representative Sheldon to reintroduce HB532 comprehensive PBM reform.

Legislative Priority 2: Extend immunization authority to age 3 Statutory changes needed so that the immunization authority down to age 3 granted under emergency regulations can be continued permanently.

Regulatory Priority 1: Emergency Regulation Conversion Work with the Board of Pharmacy to ensure COVID-19 related emergency regulations for COVID-19 testing and others are appropriately converted to regular regulations as needed.

Past President Trish Freeman addresses the House of Delegates.

Clark Kebodeaux. The committee submitted the five names below to be submitted to the Governor’s Office for consideration to the Kentucky Board of Pharmacy by Alphabetical Order: Chris Clifton Pete Cohron Meredith Figg Jill Rhodes Anthony Tagavi President Joel Thornbury addressed the House of Delegates as the Ex Officio Member of the Professional Affairs Committee, since the committee’s last meeting, Jill Rhodes has asked that her name be removed from the list of candidates. President Thornbury asked that Mark Taylor be amended to the list in Jill Rhodes place, as he was the next candidate in line of nominations by the committee.

List of Candidates as Amended: Chris Clifton Pete Cohron Meredith Figg Anthony Tagavi

The 2022 Legislative Priorities will be sent to the Reference Committee.

The Professional Affairs Committee chaired by

Mark Taylor The amended list will be sent to the Reference |11| www.KPHANET.org

Committee.

guished service to KPhA as he stepped up and was the Interim Executive Director from November 2020- February 2021.

Chair Don Kupper made the motion to adopt the Resolution to Member Sam Willett, seconded by Treasurer Chris Killmeier. Motion carried.

President Thornbury made the motion to Recess the House of Delegates meeting until 2:00 p.m. on Saturday, June 5, 2021, seconded by Chair Don Kupper. Motion carried.

Speaker Martika Martin presents the House of Delegate reports.

The House of Delegates recessed at 11:28 a.m.

June 4, 2021.

The Public Health Committee co-chaired by JoAnne Taheri and Jessika Chilton. The committee submitted the following Position State- The Closing House of Delegates began with the Executive Director’s Report from Ben ment for KPhA: Mudd. Ben began his leadership with KPhA in There should be a requirement that pharmaFebruary 2021 and came in to work immediatecist be registered with KYIR and submit their ly with the Government Affairs Committee advaccination data to KYIR. vocating for the Profession of Pharmacy. With This position statement will be sent to the Ref- the leadership of the Government Affairs Committee and Shannon Stiglitz, the Profession erence Committee. had a great win with HB48 this year. Ben continues to work to Advocate for the Profession.

President Joel Thornbury gave his President’s Report from over the last 8 months as your KPhA President. This has been a great year for Executive Director Mudd gave the Treasurer’s the Association and the Profession. Thank you Report for the 2020 Year. KPhA has completed their 2020 Agreed Upon Procedure which Auto all the Committee Chairs. Thank you to Shannon Stiglitz and all her work towards the dited the financial position of the Association.

All reports came back position for the 2020 profession. The KPhA Staff have worked hard to do their daily work and to put on this meet- year. The Association continues to grow their investment funds with Berthel Fisher. ing. We have continued to work towards the goals of the Strategic Plan through Covid-19.

President Thornbury worked with the ExecuExecutive Director Mudd spoke about the tive Director Hiring Committee and the KPhA Board of Directors to hire Dr. Ben Mudd in Feb- KPhA Ambassador Program that will be led by Chad Corum to help promote growth and reruary and they have worked together daily to tention in the KPhA Membership. advance the Association and the Profession.

Chair Don Kupper made the motion to suspend House Rules, seconded by Lewis Wilkerson. Motion carried. Secretary Brooke Hudspeth read a resolution from the KPhA Board of Directors honoring Sam Willett’s distin|12| Kentucky Pharmacists Association | July/august 2021

The Credentials Committee gave the following report of the Delegates attending: 35 Total Delegates. Totals needed for Votes: 1/2= 18, 2/3= 23 and 3/4= 26 Clark Kebodeaux gave a brief report from the

KPERF Board of Directors. Dr. Kebodeaux is the current KPERF Chair. KPERF continues to raise funds for the Center of Excellence to continue to build the future of KPERF in advancing the role of the Pharmacist. Stay tuned for more opportunities to be involved with KPERF through professional development, endowments, and scholarships. All gifts given to KPERF are tax deductible in accordance with IRS regulations.

Vice Speaker of the House of Delegates was unable to be with us this weekend as Nathan Hughes and his wife welcomed their son Friday, June 4, 2021. Congratulations to the Hughes family! The Reference Committee report was given by acting Chair Joe Carr.

The Bylaw addition presented by the Organizational Affairs Committee was motioned to approve the amendment to add the Speaker and Vice Speaker of the House of Delegates, seconded by President Thornbury. Motion passed for the amended language.

5.23 No individual shall serve more than three (3) successive full terms as an Elected Director. Nothing in this Article shall prevent a director who has served three (3) full successive terms from being elected as President, President Elect, Treasurer, Secretary, Speaker or Vice Speaker of the House of Delegates nor does it prohibit any member from serving on a KPhA committee or participating in a KPhA volunteer activity. Once a director has served three (3) successive terms, they are eligible to run for a director seat again after sitting out for at least one year.

Motion was made by the Reference Committee to approve the Bylaw Addition, seconded

by President Thornbury. Motion passed.

Joel Thornbury presents the President’s report.

Legislative Priority 1: Comprehensive PBM Reform Work with Representative Sheldon to reintroduce HB532 comprehensive PBM reform.

Legislative Priority 2: Extend immunization authority to age 3 Statutory changes needed so that the immunization authority down to age 3 granted under emergency regulations can be continued permanently.

Regulatory Priority 1: Emergency Regulation Conversion Work with the Board of Pharmacy to ensure COVID-19 related emergency regulations for COVID-19 testing and others are appropriately converted to regular regulations as needed.

The Reference Committee makes the motion to adopt the list of names to be sent to the Governor for the Kentucky Board of Pharmacy as presented in alphabetical order, seconded

by President Thornbury. Motion passes.

Chris Clifton Pete Cohron

The Reference Committee makes the motion to adopt the Government Affairs Committee 2022 Legislative Priorities as presented, seconded by Trish Freeman. Motion passed.

Meredith Figg Anthony Tagavi Mark Taylor |13| www.KPHANET.org

Speaker Martin announced Kyle Bryan as the 2021-2022 Vice Speaker of the House of Delegates. Congratulations Kyle!

Chair Don Kupper, Secretary Brooke Hudspeth and President Joel Thornbury at the House of Delegates

The Reference Committee recommends adopting the position statement supporting utilization of the Kentucky Registry from the Public Health Committee as amended below: KPhA supports utilization of the Kentucky Immunization Registry, herein refereed to as “the registry”, and encourages immunizing pharmacists to register with the registry and submit all vaccination data to the registry.

The motion for amendment from the Reference Committee, seconded by Cassy Hobbs.

Motion passes.

The motion for adoption as amendment from the Reference Committee, seconded by Kyle Harris. Motion passes.

Chair Don Kupper and President Thornbury recognized the outgoing KPhA Board of Directors for their service to the Board. Those Board Members recognized were Chris Killmeier, Treasurer; Jessika Chilton, Director; Chad Corum, Director; Trevor Ray, Director; Lewis Wilkerson, Past President Representative; Thao Batovsky, Sullivan College of Pharmacy and Health Sciences Student Director; and Jacob Barnett, University of Kentucky College of Pharmacy Director. Again, thank you to all of our outgoing KPhA Board of Directors for their service!

Chair Kupper and President Thornbury recognized the new KPhA Board of Directors for the coming year. Those Board Members were as follows Steve Hart, Lakin Mills, Emma Sapp as Board of Directors, Taylor Williams, University of Kentucky College of Pharmacy Director, and Roderick Millner Sullivan College of Pharmacy and Health Sciences Director. *Board members Hart, Mills and Sapp were not present for the installation. They will be installed at the next KPhA Board Meeting.

This concludes the Reference Committee Report. Thank you to all who served on the Refer- Bryan was installed as the 2021-2022 Vice Speaker of the House of Delegates by Chair ence Committee today.

Kupper and President Thornbury.

Speaker Martin called for any further nominations of Vice Speaker, seeing none, she called for a motion to close the 2021-2022 Nominations for Vice Speaker of the House of Delegates. Trish Freeman made the motion to close nominations, seconded by Jessika Chilton. Motion carried.

*Vice Speaker Hughes was not able to be at the meeting. He will be installed as the 20212022 Speaker of the House at the next KPhA Board Meeting.

President- Elect Stutz was installed as the 2021-2022 KPhA President Elect by Chair KupPresident Thornbury presented the 2020 Tech- per and President Thornbury. nician of the Year, Brooke Strong. Congratula- Congratulations to the 2021-2022 KPhA Board tions Brooke! of Directors. |14| Kentucky Pharmacists Association | July/august 2021

Kentucky Congressional Leaders at this time.

Please write your congressional leader to support and sponsor HR2759!

Don Kupper and Joel Thornbury presented Speaker Martika Martin with a plaque for her leadership over the last year with the House of Delegates!

Members of the House of Delegates.

Speaker Martin called for any new Business to come before the House of Delegates.

The KPhA Board of Directors brought forth the access issue of buprenorphine to the house.

There are variety of reasons for the shortage to Pharmacies throughout the state of Kentucky.

The Physician Assistants are proposing a Regulation change to allow the PA to dispense buprenorphine. The KPhA Board would like to discuss how the KPhA Membership feels on Physician Assistants having the ability to dispense buprenorphine products?

After much discussion, motion was made by Ben Mudd to oppose the Physician Assistant dispensing privileges of any medication at this time, seconded by Jessika Chilton. Motion carried.

Ben Mudd made the motion to refer the topic of buprenorphine to the Public Health Committee to address the access issue of buprenorphine as a position statement and bring back to the House of Delegates, seconded by Trish Freeman. Motion carried.

Trish Freeman asked that all in the room reach out to their Congressional Leaders in support of HR2759, this is Federal Bill to add Pharmacists as Providers to the Social Security Act, this bill currently has 30 co-sponsors, none are

As always, the KPhA House of Delegates is a time to come together as a Profession and to debate and come together on many issues and topics facing the profession. Thank you to all Members who have participated in this meeting.

Motion was made by Joel Thornbury to adjourn the meeting, seconded by Lewis Wilkerson. Motion carried.

jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.

Kentucky Professionals Recovery Network (KYPRN) is a free-standing organization that provides confidential monitoring of licensed professionals struggling with the disease of addiction.

www.kyprn.com |15| www.KPHANET.org

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july CPE Article Kratom: An Emerging Herbal Supplement with Opioidlike Properties Authors: Anisa Moore, PharmD and Karen Blumenschein, PharmD, MS The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity #0143-0000-21-007-H08-P &T Contact Hour 1.0

KPERF offers all CE articles to members online at

Expires:8/05/2024

www.kphanet.org

Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1.

Describe kratom and its origins of use

2. Identify kratom use patterns in the United States 3. List adverse health effects that may result from kratom use 4. Review the current regulatory challenges posed by kratom 5. Identify the pharmacist’s role in caring for patients who use kratom

Introduction Kratom is an herbal supplement with growing popularity in the United States due to its unique pharmacologic activity with both stimulant and opioid-like properties. The broad range of activity for this natural product is largely due to the compound mitragynine and the analog 7-hydroxymitragynine[1]. These compounds are indole alkaloids that are partial agonists for mu-opioid receptors, competitive antagonists at kappa- and delta-opioid receptors, and have activity on the adrenergic, serotonergic, and dopaminergic receptors [2,3,4]. Kratom comes from leaves of Mitragyna speciosa, a tree a native to Southeast Asia [1]. It has been consumed medicinally in Indonesia, Malaysia, and Thailand for hundreds of years, where kratom leaves were chewed by labor workers for the stimulant effects to combat fatigue and brewed into tea for the relaxing effects [1]. There is also documented use of this herbal product in Malaysia and Thailand as an opioid alternative [2]. Given the current opioid epidemic, the opioid-like activity of kratom creates a valid concern for the potential of abuse liability.

In addition to its stimulant and analgesic properties, kratom is thought to have antidepressant, antidiarrheal, euphoriant, antispasmodic, and muscle relaxant activity [2,3]. The effects of kratom largely depend on the dose that is ingested and can vary from one person to another. At low to moderate doses of 1-5 grams, kratom produces mild stimulant effects [1]. At higher doses of 5-15 grams, kratom produces opioid-like effects including analgesia, constipation, euphoria, and sedation [1].

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In the United States, kratom is used for selftreatment of pain, mood disorders, fatigue, and mitigation of opioid withdrawal symptoms, despite the fact that there is minimal empiric evidence to support such use, and growing concern about the safety of this product. While kratom is currently legal in most of the United States, there is great debate around whether or not this product should be controlled due to its opioid-like properties.

Kratom Use in the U.S. In the United States, kratom is sold in a variety of products including raw leaves, powders, capsules, tablets, and concentrated extracts [1]. These products can easily be purchased via the Internet, in herbal stores, or in specialty stores known as “head shops” or “smoke shops” [1,2]. Kratom is most commonly consumed as a liquid, by brewing as a tea or mixing in juice, but the use of tablets and capsules is growing [3].

Over the last two decades, kratom has become widely available in America and its use has increased significantly as well. It is estimated that the number of individuals using kratom in America ranges from 3 to 5 million people [2]. Voluntary surveys have been conducted to collect demographic and kratom-surveys had a mean age of around 40 years old, usually more than half were male, and a majority were Caucasian and non-Hispanic with varying education and income levels [4,5]. These surveys indicate that current kratom users commonly ingest muluse information from current and previous users with over 11,000 total responses [4,5].

Overall, respondents for these tiple doses on a daily basis [4,5]. In a voluntary survey done by Nicewonder et al., a majority of kratom users consumed between 1 to 5 grams up to three times per day [6].

Kratom is primarily used in America to self-manage chronic pain, mood disorders, and opioid, alcohol, or other drug withdrawal symptoms [2]. Kratom use has also been promoted as a “legal” or “natural” high, but few survey respondents indicated that this was their reason for use [2].

The most common reported reason for selftreatment using kratom is chronic pain [4]. While there is limited clinical data supporting the use of kratom products for pain management, various animal models have shown evidence for pain alleviation with this compound [1]. Kratom’s opioid-like analgesic effects can be explained by the partial agonist activity on the mu-opioid receptor by mitragynine and 7-hydroxymitragynine [1, 7]. The most commonly reported reasons for using kratom for pain include relief of spine or back pain, fibromyalgia, injury-related pain, and osteoarthritis [4]. A majority of current and previous users state that kratom is “very” or “somewhat” useful in their pain management [4], and that prior to kratom use, other pain relief therapies were unsuccessful, including prescription medications, over-the-counter medications, physical therapy, and chiropractic adjustments [4]. Anecdotal data combined with evidence from animal models suggest that kratom could potentially be an alternative for pain relief, but further research is necessary before this product can be recommended for managing painful conditions.

Kratom for Mental Health and Focus The second most common reason for kratom use relates to its psychoactive properties that may aid in anxiety, post-traumatic stress disorder, depression, and combatting fatigue [4, 8]. Mitragynine and its analogs have activity on the serotonin and dopamine signaling pathways which suggest kratom could potentially help with depression or mood disorders [9]. There is little clinical data regarding the use of kratom for mood disorders, but several animal studies have demonstrated that mitragynine administration produces similar results when compared to atypical antipsychotics and antidepressants [9].

In addition to the potential antidepressant and antipsychotic properties, kratom has also been reported to alleviate anxiety and post-traumatic stress disorder (PTSD), as well as boost energy [9]. Several surveys highlight that a number of kratom users experienced an enhanced sense of wellbeing, relaxCommon Reasons for Kratom Self-Administration ation, reduced anxiety, and increased energy following kratom administration [8]. One study also Kratom is not classified as a prescription or overnoted that a portion of respondents experienced the-counter medication so there are no Food and enhanced sociability and/or empathy after kratom Drug Administration (FDA) approved indications for ingestion [8]. A majority of kratom users who use it its use. However, anecdotal reports indicate that for increased energy, focus, and motivation state kratom is used as a natural alternative for selfthat the stimulant effect is not as intense as other treatment of a wide variety of maladies. amphetamine-like substances [1]. Although anecdotal reports suggests that kratom’s psychoactive properties may enhance mood and combat fatigue, Kratom for Pain empiric evidence from randomized controlled trials |18| Kentucky Pharmacists Association | July/august 2021

to support these claims is lacking [8].

2018 [10]. A 2016 report evaluated 660 kratomrelated calls made to United States Poison Control Kratom for Opioid and Other Substance Use DisorCenters from 2010-2015 [11]. The authors found that ders most calls were from health care providers, with Kratom formulations are also used to decrease or about 25% of cases classified as minor (symptoms discontinue the use of opioids, alcohol, and other resolved rapidly with no residual disability), and drugs, combat withdrawal symptoms, and sustain roughly 42% of cases classified as moderate (some opioid abstinence [4, 8]. This activity can be exform of treatment was required but there was no plained by mitragynine being a partial mu-opioid residual disability) [11]. Reports that were classified receptor agonist and a kappa- and delta-opioid re- as major and life-threatening consisted of about 7% ceptor antagonist [4]. Animal models have shown of exposures, with one death in a person who was that pretreatment with mitragynine resulted in de- exposed to paroxetine and lamotrigine in addition creased self-administration of heroin and morphine to kratom [11]. The remaining reports either had no suggesting that kratom may reduce cravings for effects reported or the Poison Control Center staff these substances[4]. Survey respondents currently members were unable to follow-up on the report using kratom reported significantly less opioid use [11]. Many of these reports included the use of multiand an overwhelming majority of current and previ- ple substances in addition to kratom so it is difficult ous kratom users reported that this supplement to determine if kratom was the sole cause of these was either “very” or “somewhat” helpful in decreas- reactions [11]. ing or stopping prescription opioid or heroin use Serious adverse effects associated with kratom use, [4]. Kratom has also been reported to relieve withincluding seizures, hallucinations, respiratory dedrawal symptoms associated with excessive opioid pression, coma, and cardiac or respiratory arrest, and alcohol use [4]. Most survey respondents who have been documented [10]. In a small sample of report using kratom to reduce withdrawal sympcase studies, kratom was determined to be the toms indicated that the supplement was “very” or cause of hepatotoxicity and death, but these in“somewhat” helpful [4]. Anecdotal and animal data stances were rare and further research is needed to suggest that kratom could be used as a potential determine if kratom was the primary reason for opioid alternative or to relieve opioid withdrawal these outcomes [12]. Despite kratom’s opioid recepsymptoms, but once again, additional data from tor activity, it does not appear to result in signifirobust clinical trials is needed before kratom is concant respiratory depression and is far less likely to sidered safe and effective for these conditions. cause fatal overdose when compared to opioids [7].

Risks of Kratom Use While kratom-use has been promoted for the selftreatment of several maladies as described above, this herbal supplement is associated with several risks.

Kratom Dependence and Withdrawal

Although kratom use has been reported to ease opioid-withdrawal symptoms, current literature and case reports suggest that kratom use can also cause dependence and withdrawal [13]. Kratom users who consume larger doses multiple times a day for an extended period of time are more likely to Kratom Adverse Reactions become dependent [1]. Several case reports have Survey responses from current and previous kratdocumented withdrawal symptoms upon abrupt om users document adverse effects associated with discontinuation of kratom [10,13]. Withdrawal sympkratom exposure. The most common adverse eftoms typically present within 12-24 hours of kratom fects include agitation, tachycardia, hypertension, cessation and can last up to seven days [13]. The sedation, gastrointestinal problems, headaches, physical symptoms of kratom withdrawal manifest sweating, and confusion [4,10]. The online survey as muscle spasms, diarrhea, nausea, tremors, anoconducted by Coe and colleagues (2019) found that rexia, fever, pain, and lacrimation [1,10,13]. The psy13% of respondents reported experiencing “bad re- chological symptoms of kratom withdrawal include actions” while using kratom [4]. insomnia, restlessness, irritability, fatigue, anxiety, and mood disturbances [1,10,13]. When compared to As Kratom use has increased over the last decade, opioids, kratom’s dependence syndrome appears so have kratom-related calls to Poison Control Cento be mild in its psychosocial and physiological efters [10]. When looking at exposures reported from fects [8]. There are no specific guidelines on how to 2011 to 2018, there is a considerable increase in casmanage kratom withdrawal, but it is commonly es over time with 18 exposures reported in 2011 and treated using similar strategies that are used with 357 exposures reported during the first 7 months of opioid withdrawal [13]. |19| www.KPHANET.org

Schedule I compounds, but this action was delayed due to an outcry from the public, researchers, and Kratom-Drug Interactions legislators [10]. Kratom advocates filed comments As with any medication or herbal supplement, krat- to the DEA protesting the Scheduling of this comom has the potential to interact with other medica- pound and on October 13th 2016 the DEA antions or products that are concurrently adminisnounced its intent to withdraw the Scheduling of tered. In vitro, kratom demonstrated inhibition of kratom components and instead placed kratom on cytochrome P-450 (CYP) isozymes 2C9, 2D6, 1A2, the “Drugs of Concern” list [16]. While kratom is not and 3A4 which can impact the metabolism, effica- federally controlled in the United States, it is curcy, and safety of commonly prescribed medicarently classified as a Schedule 1 narcotic in Alations, including warfarin, phenytoin, and several bama, Arkansas, Indiana, Tennessee, Vermont, and antiarrhythmics, and opioids [10]. This is especially Wisconsin, as well as a few municipalities [10]. Floriimportant to consider because kratom may be da attempted to move kratom’s classification to a used concurrently with illicit substances that are Schedule I narcotic, but this proposal was rejected also substrates for these enzymes, including opiin May of 2017 [17]. Further research regarding oids, methylenedioxymethamphetamine (MDMA), kratom’s pharmacologic effects and potential for and synthetic cannabinoids. Thus, coabuse could help create a better understanding of administration of kratom with both licit medicawhether or not this product should be classified as tions and illicit substances can increase the risk of a controlled substance serious adverse effects [10].

Inconsistent Dosing and Impurities Kratom is currently classified as a dietary supplement, thus, there is potential for inconsistent dosing and impurities because supplements do not undergo extensive testing for purity and safety.

Furthermore, the amount of psychoactive compounds in different kratom plants can vary depending on where the plants were grown [14]. Inconsistent dosing among kratom products can put users at risk for adverse effects because they may unintentionally consume larger quantities than anticipated.

The potential for contamination is also a concern relating to the use of natural products. A major Salmonella outbreak related to kratom products occurred in 2018 with 41 states reporting a total of 199 cases and 50 hospitalizations [15]. The product was recalled but the investigation was not able to identify a single, common source of contaminated kratom, potentially resulting in contaminated products still being available for distribution and infecting more kratom-users [15].

Pharmacist’s Role With the growing availability and popularity of kratom in the United States, it is imperative that pharmacists and other healthcare providers are aware of the reasons that patients may be selfmedicating with this supplement, as well as the risks associated with its use. When conducting a patient medication review, pharmacists need to thoroughly investigate dietary supplementation in addition to prescribed and over-the-counter medications. Pharmacists should ensure that patients who use kratom are knowledgeable about adverse reactions that may accompany kratom use, and that they are aware of the potential risk of dependence and withdrawal symptoms when kratom use is discontinued. Patients taking warfarin, celecoxib, or glipizide should be especially cautious when using kratom because of the drug-drug interactions caused by CYP 2C9 inhibition. Kratom is not detected in a urine drug screen so healthcare professionals must be cognizant of the potential involvement of kratom in overdose situations, including events of multi-substance exposure. Healthcare providers should also be familiar with how to identify and manage kratom withdrawal.

Kratom Regulation Overview Kratom is banned in several countries including Australia, Malaysia, New Zealand, Romania, South Korea, and the United Kingdom due to its activity on the opioid receptor [6]. In the United States, kratom is currently classified as a dietary supplement but there is great debate about whether or not this natural product should be controlled because of its opioid-like effects. In August 2016, the Drug Enforcement Administration (DEA) proposed to make mitragynine and 7-hydroxymitragynine |20| Kentucky Pharmacists Association | July/august 2021

Conclusion The use of kratom products is increasing throughout the United States as a method of selfmedication for a variety of maladies including chronic pain, mood disorders, opioid mitigation, and opioid withdrawal. While a majority of kratom respondents in voluntary online surveys suggest that this supplement is a natural alternative to current medical treatments, further research is need-

ed before it can be considered a safe and effective an atypical molecular framework for opioid reform of treatment for any condition. The similarities ceptor modulators. Journal of the American between kratom and opioids raise valid concern for Chemical Society, 138(21), 6754-6764. potentially inappropriate kratom use. Pharmacists 8. Swogger, Marc T, & Walsh, Zach. (2018). Kratom and other healthcare providers should stay up-touse and mental health: A systematic review. date with federal and state regulations pertaining Drug and Alcohol Dependence, 183, 134-140. to kratom. Pharmacists can play a crucial role in 9. Johnson, Lindsay E, Balyan, Lillian, Magdalany, enhancing the safety of patients who use kratom Amy, Saeed, Fizza, Salinas, Robert, Wallace, Starby performing thorough medication reviews and la, Veltri, Charles A, Swogger, Marc T, Walsh, counseling patients on the adverse effects, potenZach, Grundmann Oliver. (2020). The potential tial herb-drug interactions, withdrawal symptoms, for kratom as an antidepressant and antipsyimpurities, and inconsistent dosing associated with chotic. The Yale Journal of Biology & Medicine, kratom.

93(2), 283-289.

References 1.

10. White, Michael C. (2018). Pharmacologic and clinical assessment of kratom. American Journal of Health-system Pharmacy, 75(5), 261-267.

Prozialeck, Walter C, Jivan, Jateen K, & Andurkar, Shridhar V. (2012). Pharmacology of kratom: 11. Anwar, Mehruba, Law, Royal, & Schier, Josh.

An emerging botanical agent with stimulant, (2016). Notes from the Field : Kratom (Mitragyna analgesic and opioid-like effects. The Journal of speciosa) exposures reported to Poison Centers the American Osteopathic Association, 112(12), — United States, 2010–2015. MMWR. Morbidity 792-799. and Mortality Weekly Report, 65(29), 748-749.

2. Veltri, Charles, & Grundmann, Oliver. (2019). Cur12. Schimmel, Jonathan, & Dart, Richard C. (2020). rent perspectives on the impact of Kratom use.

Kratom (Mitragyna Speciosa) liver injury: A comSubstance Abuse and Rehabilitation, 10, 23-31. prehensive review. Drugs (New York, N.Y.), 80(3), 3. Fox L.M. (2019). Plant- and animal-derived die263-283. tary supplements. Nelson L.S., & Howland M, & 13. Stanciu, Cornel N, Gnanasegaram, Samantha A, Lewin N.A., & Smith S.W., & Goldfrank L.R., & Ahmed, Saeed, & Penders, Thomas. (2019). KratHoffman R.S.(Eds.), Goldfrank's Toxicologic om withdrawal: A systematic review with case Emergencies, 11e. McGraw-Hill. series. Journal of Psychoactive Drugs, 51(1), 12-18. https://accesspharmacy.mhmedical.com/conte 14. Griffin III OH, Daniels JA, Gardner EA. (2016). Do nt.aspx?bookid=2569&sectionid=210271724 you get what you paid for? An examination of 4. Coe, Marion A, Pillitteri, Janine L, Sembower, products advertised as kratom. Journal of psyMark A, Gerlach, Karen K, & Henningfield, Jack choactive drugs, 48(5), 330 -335.

E. (2019). Kratom as a substitute for opioids: Re15. Multistate outbreak of Salmonella I 4,[5],12:b:sults from an online survey. Drug and Alcohol Infections linked to kratom products. (2018, FebDependence, 202, 24-32. ruary 20). Retrieved December 16, 2020, from 5. Bath, Rhiannon, Bucholz, Tanner, Buros, Amy F, https://www.cdc.gov/salmonella/kratom-02-18/ Singh, Darshan, Smith, Kirsten E, Veltri, Charles 16. Novel psychoactive substances and analogues: A, & Grundmann, Oliver. (2020). Self-reported 2017 Legislative Session Bill Status Update. health diagnoses and demographic correlates (2017, July 5). Retrieved December 15, 2020, from with kratom use: Results from an online survey.

National Alliance for Model State Drug Laws.

Journal of Addiction Medicine, 14(3), 244-252.

6. Nicewonder, Jessica A, Buros, Amy F, Veltri, Charles A, & Grundmann, Oliver. (2019). Distinct kratom user populations across the United States: A regional analysis based on an online survey. Human Psychopharmacology, 34(5), E2709-N/a.

17. Gerald Gianutsos, P. (2017). The DEA changes its mind on kratom. Retrieved December 16, 2020, from https://www.uspharmacist.com/article/the-deachanges-its-mind-on-kratom

7. Kruegel, Andrew C, Gassaway, Madalee M, Kapoor, Abhijeet, Váradi, András, Majumdar, Susruta, Filizola, Marta, . . . Sames, Dalibor.

(2016). Synthetic and receptor signaling explorations of the mitragyna alkaloids: Mitragynine as |21| www.KPHANET.org

July 2021—Kratom: An Emerging Herbal Supplement with Opioid-like Properties 1. What is the current federal status of kratom?

A. Schedule I substance B. Schedule II substance C. Dietary supplement D. Prescription medication 2. How is kratom consumed?

A. Brewed as a tea B. In capsule form C. In tablet form D. All of the above 3. Which of the following is true regarding kratom products?

A. Kratom products are extensively tested for purity B. Kratom products always contain consistent doses C. The purity and dose of kratom can vary from batch to batch D. Kratom is a natural product and does not need to be tested for safety 4. Which of the following are FDA-approved indications for kratom use?

A. Pain B. Depression C. Fatigue D. None of the above 5. In which of the following states is kratom able to be legally purchased?

A. Kentucky B. Tennessee C. Alabama D. Indiana 6. Which of the following is NOT a common reason for kratom self-administration?

A. Fatigue B. Pain C. Hypertension D. Opioid withdrawal

|22| Kentucky Pharmacists Association | July/august 2021

7. Why did the DEA withdraw its proposal to make kratom a Schedule I substance?

A. Kratom use was proven to be safe B. Kratom received FDA-approval for chronic pain C. The proposal received backlash from the public D. The proposal was rejected 8. What is the most common reason for kratom selfadministration?

A. Chronic Pain B. Sedation C. Depression D. Anxiety 9. Which of the following is NOT part of the pharmacist’s role for patients who use kratom?

A. Educating patients on the potential interactions with medications B. Encouraging patients to use kratom as an opioid alternative C. Performing thorough medication reviews to obtain a comprehensive list of all medications or supplements a patient is using D. Staying up to date with kratom regulations 10. Which of the following is not a common method for obtaining kratom?

A. Online B. “Smoke shops” C. Herbal stores D. Behind the counter at pharmacies

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

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PHARMACISTS ANSWER SHEET July 2021—Kratom: An Emerging Herbal Supplement with Opioid-like Properties Universal Activity #0143-0000-21-007-H08-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 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. 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.

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The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |23| www.KPHANET.org

August CPE Article Review of Long-Acting Injectable Antipsychotics Authors: Houston T. Williams, PharmD Candidate 2022; Hannah E. Johnson, PharmD, BCPS, BCPP; Kenneth E. Record, PharmD The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

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Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1.

Describe the mechanism of action and adverse drug effect profiles of first- and secondgeneration antipsychotics

2. Discuss the indications and place for long-acting injectable antipsychotics in therapy 3. Review the administration and storage of long-acting injectable antipsychotics 4. Identify the pharmacists’ role in access and administration of long-acting antipsychotics Introduction of Antipsychotics Since the early 1950’s, antipsychotics have played an important role in treating patients with mental health disorders. After the discovery of oral first-generation antipsychotics, such as chlorpromazine, a decline in hospitalizations and an increase in long-term psychiatric facility discharges was observed [1].

Soon after, long-acting injectable antipsychotics were being developed to help patients with adherence and reduce relapse from medication discontinuation [2]. In the 1980’s, oral second-generation antipsychotics emerged and long-acting injectable formulations of these were created shortly after [3].

Today, antipsychotics are used to help treat a variety of conditions including schizophrenia spectrum disorders, psychotic disorders, bipolar disorder, major depressive disorder, tic disorders, and autism spectrum disorder [4]. In the treatment of schizophrenia, both oral and long-acting injectable antipsychotics have shown efficacy, tolerability, and safety [5].

Schizophrenia Schizophrenia is a chronic disease that impacts the brain by affecting how a person feels, thinks, and behaves [6]. Chronic disease often requires medical assistance and is defined as a condition that persists long-term, may inhibit the ability to do everyday activities, and impact one’s quality of life (QOL) [7]. The median lifelong prevalence of schizophrenia is around 0.72%. The incidence of schizophrenia is higher in males with a ratio for males-to-females of 1.4:1. Males also develop symptoms earlier than females. Schizophrenia reduces life expectancy and increases the risk of mortality 2-3-fold [8]. In the United States, the total economic burden of schizophrenia is estimated to be 155.7 billion dollars annually. Patients who suffer from schizophrenia have an average cost of $44,773 per year [9]. |24| Kentucky Pharmacists Association | July/august 2021

Table 1: LAIs [23-29] Drug (Brand)

Generation

Dosing Regimen

Overlap of oral therapy?

PO to injectable conversion

Fluphenazine decanoate (Prolixin D®)

1st

6.25 - 25 mg every 2 weeks until steady state, then up to a max dose of 100 mg every 4-6 weeks

Yes, at least until the 2nd injection

No data

Haloperidol decanoate (Haldol®)

1st

10-20 times daily oral dose.

If the initial dose requires more than 100 mg of injection, administer in 2 injections with a max dose of 100 mg for the first injection with remaining given 3-7 days later.

Yes, for 2-3 months

Adjust oral dose and rate of tapering based on clinical response and tolerability

Max: 450 mg every month Aripiprazole (Abilify Maintena®)

2nd

400 mg every 4 weeks. Can consider 300 mg every 4 weeks if adverse events occur

Yes, for 14 days

No data

Aripiprazole lauroxil (Aristada®)

2nd

441-1,064 mg every 4-8 weeks

Yes, for 21 days

10 mg/day = 441 mg per month 15 mg/day = 662 mg per month or 882 mg every 6 weeks or 1,064 mg every 2 months >/= 20 mg/day = 882 mg per month

Olanzapine pamoate (Zyprexa® Relprevv™)

2nd

Up to 300mg every 2 weeks OR Up to 405 mg every 4 weeks 3

No

10 mg daily = Initial 210 mg every 2 weeks for 4 doses or 405 mg every 4 weeks for 2 doses 15 mg daily = Initial 300 mg every 2 weeks for 4 doses

Paliperidone palmitate (Invega Sustenna®)

Paliperidone palmitate (Invega Trinza®)

2nd

2nd

234 mg on the first day of treatment, then 156mg IM 1 week later. 5 weeks after initiation dose, start maintenance dose of 39-234 mg every month

No

Calculate every 3 months based on previous dose 2

No

3 mg/day = 39-78 mg every month 6 mg/day = 117 mg every month 9 mg/day = 156 mg every month 12 mg/day = 234 mg every month 3 mg/day = 273 mg every 3 months 6 mg/day = 410 mg every 3 months 9 mg/day = 546 mg every 3 months 12 mg/day = 819 mg every 3 months

Risperidone (Risperdal Consta®)

2nd

25mg-50mg every 2 weeks

Yes, for the first 3 weeks

</= 3mg/day = 25 mg IM ER Q2 weeks >3 to </= 5 mg/day oral = 37.5 mg IM extended release every 2 weeks >5 mg/day = 50 mg IM ER every 2 weeks.1

Risperidone (Perseris™)

2nd

90mg-120mg once a month

No

Oral dose of 3mg/day is = to SQ injection of 90 mg once a month Oral dose of 4 mg/day is = SQ of 120 mg once a month

Continued on next page |25| www.KPHANET.org

Table 1 shows LAIs and their dosing regimens, overlap requirements, and conversions [23-29] 1.

Manufacturer does not provide conversions. Recommendations are as listed [34]

2.

To be used only after monthly IM injection has been established as adequate treatment for 4 months

Table 2 : Administration and Storage of LAIs [21, 23-29] Abbreviations: IM, Intramuscularly; SQ, Subcutaneously. Table 2 represents the administration location and storage recommendations Drug (Brand)

Administration (Location)

Storage

Protect from Light?

Fluphenazine decanoate (Prolixin D®)

IM (gluteal) or SQ

Store at a temperature between 68-77° F; do not freeze or refrigerate

Yes

Haloperidol decanoate (Haldol®)

IM (gluteal)

Store at a temperature between 59-86°F; do not freeze or refrigerate

No

Aripiprazole (Abilify Maintena®)

IM (gluteal or deltoid

Store prefilled syringe below 86° F; do not freeze

Prefilled syringes: Yes

Store unused vial at 77° F Aripiprazole lauroxil (Aristada®)

IM (gluteal or deltoid)

Store at a temperature between 68-77° F

No

Olanzapine pamoate (Zyprexa® Relprevv™)

IM (gluteal)

Store in a room temperature controlled area; do not exceed 86° F

No

Paliperidone palmitate (Invega

IM (deltoid)

Store at 77° F

No

Paliperidone palmitate (Invega Trinza®)

IM (gluteal or deltoid)

Store at a temperature between 68-77°F

No

Risperidone (Risperdal Consta®)

IM (gluteal or deltoid)

Store at a temperature between 36-46°F

Yes

Risperidone (Perseris™)

SC (abdomen)

Store at a temperature between 36-46°F

No

Unopened product may be stored at a temperature between 68-77° F, up to 7 days before administration; after removed from refrigeration use within 7 days

The symptoms of schizophrenia are characterized into two main groups: positive and negative. Positive symptoms include alterations in the way a person thinks or acts, such as hallucinations and delusions [3, 10]. Negative symptoms cause a person to withdraw from everyday activities, lose interest, |26| Kentucky Pharmacists Association | July/august 2021

and appear to have no emotions [10]. Specific negative symptoms include social withdrawal, blunted affect, preoccupation, lack of insight, and motor retardation. There are also cognitive symptoms which impair memory, concentration, and attention [6]. Diagnosis of schizophrenia requires a men-

tal health professional to determine if the criteria is met in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) [11]. For some patients, symptoms can begin years before they have their first episode of schizophrenia [10].

some effect on the positive symptoms and limited to no effect on the negative symptoms [16].

Second-generation antipsychotics have varying degrees of D2-antagonism, with some having partial D2 agonism, and typically exhibit high 5-HT2A anThe exact cause of schizophrenia is still unknown. It tagonism [17]. Because of the lower affinity for the is thought to be a combination of multiple factors D2 receptors and higher affinity for the 5-HT2A reincluding genetics, environment, and brain develceptors, the SGAs are less likely to cause EPS and opment [11]. Schizophrenia is an intricate disease tardive dyskinesia [18]. However, the SGAs have the that involves dysregulation among different neuro- potential to cause metabolic syndrome, including transmitter pathways. Dopaminergic, glutaminerthe side effects of increased blood pressure, low gic, GABAergic, and cholinergic systems have all high-density lipoprotein (HDL) cholesterol, elevated been shown to play a role [12]. Treatment of schizo- blood sugar, central obesity, and hypertriglycerphrenia must be individualized for each patient and idemia [1, 4]. focuses on optimizing the patient’s quality of life and adaptive functionality [13]. Treatment courses Long-Acting Injectable Antipsychotics can include medications, psychotherapy (individual, While they are under-utilized in real life practice, group, or cognitive behavioral approaches), treatlong-acting injectable antipsychotics (LAIs) have ment programs that involve family support, and vocational rehabilitation [14]. A variety of members the potential to be one of the most effective treatassist in the process, including the multidisciplinary ments in psychiatry [19]. In the United States, there are a variety of LAIs that are used, including formuhealthcare team, case management, family/ lations of the FGAs haloperidol and fluphenazine caregivers, and the patient [13]. and the SGAs aripiprazole, olanzapine, risperidone, and paliperidone [19, 20].

First-Generation vs Second-Generation AntipsychotOne-third of patients with schizophrenia report beics ing non-adherent to their oral antipsychotics Antipsychotics are first-line treatment for schizo(OAPs). Medication non-adherence can lead to phrenia and are divided into two categories: firstworsening function, progression of disease, ingeneration antipsychotics (FGAs) and secondcreased cost, and hospitalizations. LAIs have been generation antipsychotics (SGAs). The primary shown to improve adherence and help patients mechanism of action for both FGAs and SGAs is domaintain their course of treatment for both acute pamine (D2) antagonism. However, they differ in and chronic schizophrenia [2, 19]. Research, includD2-receptor binding affinity. Each antipsychotic ing a meta-analysis of mirror studies, has shown within both classes has varying degrees of receptor that compared to OAPs, LAIs improve medication binding including serotonin 5-HT1A and 5-HT2A, doadherence and QOL, reduce adverse drug reactions pamine D1 and D2, histamine H1, adrenergic alpha1 and financial burden, and are superior for preventand alpha2, and muscarinic M1 and M4, which lead ing hospitalizations/rehospitalizations [2, 5, 19,]. to their differing adverse effect profiles.

There is limited literature comparing the efficacy of First-generation antipsychotics typically have individual LAIs to each other. strong D2-antagonism and weak serotonin (5LAIs are administered either intramuscularly or HT2A) antagonism [14]. Extrapyramidal symptoms subcutaneously and slowly absorbed systemically.

(EPS), including pseudoparkinsonism, dystonia, and The frequency of administration varies by formulaakathisia, are side effects that arise due to the tion, ranging from every two weeks to every three strong D2-receptor blockade. After taking medicamonths. The absorption of LAIs can be impacted by tion in this class for an extended period, patients drug properties including water solubility and pacan also experience tardive dyskinesia [15]. In retient-specific factors, including body habitus. LAIs gard to schizophrenia, the FGAs are known to have have “flip-flop” kinetics due to absorption being |27| www.KPHANET.org

slower than elimination rates, thereby causing time to steady-state to be a function of absorption and concentration at steady-state to be a function of elimination. The extended half-lives of LAIs result from the very slow absorption and the prolonged duration of blood concentration. The LAIs avoid first-pass metabolism, leading to an increase in bioavailability. Fewer side effects and better tolerability can be seen with LAIs compared to OAPs due to slower absorption rate causing less variations in the peak to trough plasma concentration levels. [21].

age and plasma levels correlations are more predictable when a patient is on a LAI. However, LAIs take longer to reach steady state levels, have a higher potential for injection site irritation, and are more difficult to titrate [22]. Additionally, stigma surrounding injection medications still exists for both healthcare providers and patients. Patients potentially receive the LAI recommendation poorly and see it as a form of punishment, a sign of progression of disease, or that the patient is severely ill.

By making the recommendation in a way in which is not blaming the patient for the non-adherence Before starting an LAI, it is recommended to ensure but as a lifestyle benefit can potentially reduce the tolerability to the oral formulation of that antipsystigma [19]. chotic. Many LAIs then require a period of overlap with the oral formulation after the initial injection of the LAI. This data is summarized in Table 1.

Administration of LAIs Safety and Tolerability of LAIs in the Literature Safety and tolerability appear similar between LAIs and OAPs. A meta-analysis of randomized controlled trials (RCTs) comparing LAIs and OAPs showed no differences in adverse drug events [2].

However, there were differences seen among individual agents including risperidone and paliperidone LAI formulations with increased akinesia and weight gain, decreased prolactin changes, and other metabolic events observed with LAIs [2, 19]. Another study found that SGA LAIs and OAPs had similar occurrences of EPS and that the pharmacokinetic (PK) profiles are irrelevant to the side effects experienced [2]. However, potential dosage adjustments are warranted based on the drug-drug interactions, food-drug interactions, and type of metabolizer a patient is (i.e., a poor metabolizer) [21]. Some of the differences between the rates of akinesia, weight gain, EPS, anxiety, dosing interval, requirement for overlap with OAPs, and other differences can help guide the selection of the LAI [2, 19].

The administration of long-acting antipsychotics varies for each specific agent (Table 2). Multiple LAIs can be administered via a gluteal or deltoid intramuscular injection, including fluphenazine, haloperidol, aripiprazole, olanzapine, paliperidone palmitate, and risperidone (Risperdal Consta®). In addition, both fluphenazine and risperidone (Perseris™) can be given in the abdomen via the subcutaneous route [23-29].

Pharmacists’ Role with LAIs With limited access for patients to mental health services in the state of Kentucky, pharmacists have the unique ability to help improve access to care for people with serious and persistent mental illness (SPMI). In the state of Kentucky, pharmacists are able to administer medications such as LAIs based on Kentucky law, which authorizes “administration of medications or biologics in the course of dispensing or maintaining a prescription drug order” [30].

Pharmacists administering LAIs in the community pharmacy setting may also help reduce stigma surAdvantages and Disadvantages of LAIs rounding mental health. According to an observaThe use of LAIs provides health care professionals tional study in the community pharmacy setting, the ability to manage non-adherence and allows patients were pleased with pharmacist administraprovider involvement to correct the issue. There is a tion of LAIs[31]. Pharmacists can also assist with aslower risk of accidental or intentional overdose with sessing drug interactions, counseling on important LAIs compared to OAPs, as well as improved paaspects of the medications, assisting with insurtient adherence, transparency, and confidence that ance coverage and patient assistance, and monithe patient is receiving the dose. In addition, dos|28| Kentucky Pharmacists Association | July/august 2021

toring for adverse effects, as well as providing missed dose recommendations to healthcare providers [32].

Navigating LAIs during COVID-19 During the global COVID-19 pandemic, many clinics transitioned from face-to-face interactions to virtual or telehealth appointments. Although many facilities have continued to allow in-person visits due to uncertainty of how to transition patients from their LAI back to an oral antipsychotic and desire to prevent patients from potentially discontinuing their medications, some have not [20,33]. It is imperative to continue providing access to administration of LAIs in medical facilities or expand LAI administration to community pharmacies to avoid potential hazards that could arise from missed doses or patient self-injection [20].

2.

Miyamoto, S., & Wolfgang Fleischhacker, W. (2017). The Use of Long-Acting Injectable Antipsychotics in Schizophrenia.

Current treatment options in psychiatry, 4(2), 117–126. https://doi.org/10.1007/s40501-017-0115-z

3.

Abou-Setta A.M., Mousavi S.S., Spooner C, Schouten J.R., Pasichnyk D, Armijo-Olivo S, Beaith A, Seida J.C., Dursun S, Newton A.S., Hartling L. (2012). First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness. Comparative Effectiveness Review (No. 63).

Available at:https://effectivehealthcare.ahrq.gov/products/ antipsychotics-adults/research

4.

Chokhawala K, Stevens L. (2020). Antipsychotic Medications.

StatPearls. StatPearls Publishing. Retrieved June 12th, 2021.

Available from: https://www.ncbi.nlm.nih.gov/books/ NBK519503/

5.

Olivares, J. M., Pinal, B., & Cinos, C. (2011). Comparison of long -acting antipsychotic injection and oral antipsychotics in schizophrenia. Neuropsychiatry, 1(3), 275–289. https:// doi.org/10.2217/npy.11.24

6.

National Institute of Mental Health (2020). Schizophrenia.

Retrieved June 12, 2021, Available at: https:// www.nimh.nih.gov/health/topics/schizophrenia/

7.

Centers for Disease Control and Prevention. (2021). About Chronic Diseases. National Center for Chronic Disease Prevention and Health Promotion. Available at: https:// www.cdc.gov/chronicdisease/about/index.htm

8.

McGrath, J., Saha, S., Chant, D., & Welham, J. (2008). Schizophrenia: a concise overview of incidence, prevalence, and mortality. Epidemiologic reviews, 30, 67–76. https:// doi.org/10.1093/epirev/mxn001

9.

Wander, C. (2020). Schizophrenia: opportunities to improve outcomes and reduce economic burden through managed care. The American Journal of Managed Care, 26(Suppl 3). https://doi.org/10.37765/ajmc.2020.43013

The Future of LAIs In the future, it would be beneficial to conduct more pragmatic studies that closely mimic clinical practice and look deeper into the efficacy of LAIs compared to the OAPs [2]. Head-to-head research studies between a variety of LAI formulations are needed to help ease the selection of LAIs in clinical practice. An increase in availability of the LAIs, utilization of home health, or assertive community treatments for antipsychotics would increase the likelihood for LAIs to be utilized. Pharmacists can play a crucial role by educating the public and healthcare providers, advocating for the use of LAIs and their role in treatment, and putting a focus on patient-centered care to maximize therapy. For LAIs to be optimized, there are some barriers that need to be addressed including the lack of provider knowledge, overall negative attitudes toward LAIs, resources, and cost [19].

References:

1.

Solmi, Marco, Murru, Andrea, Pacchiarotti, Isabella, Undurraga, Juan, Veronese, Nicola, Fornaro, Michele, Stubbs, Brendon, Monaco, Francesco, Vieta, Eduard, Seeman, Mary V, Correll, Christoph U, & Carvalho, André F. (2017). Safety, tolerability, and risks associated with first- and secondgeneration antipsychotics: a state-of-the-art clinical review.

Therapeutics and Clinical Risk Management, 13, 757–777. https://doi.org/10.2147/TCRM.S117321

10. National Health Service (2019) Schizophrenia. Available from: https://www.nhs.uk/mental-health/conditions/ schizophrenia/ (Accessed: 12th June 2021).

11.

Mayo Clinic Staff. (2020, January 7th). Diseases and Conditions: Schizophrenia. Available from: https:// www.mayoclinic.org/diseases-conditions/schizophrenia

12.

Deng C and Dean B. (2013). Mapping the pathophysiology of schizophrenia: interactions between multiple cellular pathways. Front. Cell. Neurosci. 7:238. doi: 10.3389/ fncel.2013.00238

13.

Pietrini, F., Albert, U., Ballerini, A., Calò, P., Maina, G., Pinna, F., Vaggi, M., Boggian, I., Fontana, M., Moro, C., & Carpiniello, B. (2019). The modern perspective for long-acting injectables antipsychotics in the patient-centered care of schizophrenia. Neuropsychiatric disease and treatment, 15, 1045–1060. https://doi.org/10.2147/NDT.S199048

14. Patel, K. R., Cherian, J., Gohil, K., & Atkinson, D. (2014). Schizophrenia: overview and treatment options. P & T : a peerreviewed journal for formulary management, 39(9), 638– 645.

15.

Campbell, M., Young, P. I., Bateman, D. N., Smith, J. M., & Thomas, S. H. (1999). The use of atypical antipsychotics in the management of schizophrenia. British journal of clinical pharmacology, 47(1), 13–22. https://doi.org/10.1046/j.1365-

|29| www.KPHANET.org

cited 12 June 2021]. Available from: https://online.lexi.com.

Subscription required to view

2125.1999.00849.x

16. Fleischhacker W. W. (1995). New drugs for the treatment of

schizophrenic patients. Acta psychiatrica Scandinavica. Supplementum, 388, 24–30. https://doi.org/10.1111/j.16000447.1995.tb05941.x

17.

Mailman, R. B., & Murthy, V. (2010). Third generation antipsychotic drugs: partial agonism or receptor functional selectivity?. Current pharmaceutical design, 16(5), 488–501. doi.org/10.2174/138161210790361461

18. Miyamoto, S., Duncan, G., Marx, C., Lieberman, J. A. (2005).

Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs.

Molecular Psychiatry, 10, 79-1004. https://doi.org/10.1038/ sj.mp.4001556

19. Correll, C. U., Citrome, L., Haddad, P. M., Lauriello, J., Olfson,

M., Calloway, S. M., & Kane, J. M. (2016). The Use of LongActing Injectable Antipsychotics in Schizophrenia: Evaluating the Evidence. The Journal of clinical psychiatry, 77(suppl 3), 1–24. https://doi.org/10.4088/JCP.15032su1

20. Gannon, Jessica M, Conlogue, Judith, Sherwood, Robin,

Nichols, Jessica, Ballough, Juliette R, Fredrick, Noreen M, & Chengappa, K.N. Roy. (2020). Long acting injectable antipsychotic medications: Ensuring care continuity during the COVID-19 pandemic restrictions. Schizophrenia Research, 222, 532–533. https://doi.org/10.1016/j.schres.2020.05.001

21.

Correll, C. U., Kim, E., Sliwa, J. K., Hamm, W., Gopal, S., Mathews, M., Venkatasubramanian, R., & Saklad, S. R. (2021).

Pharmacokinetic Characteristics of Long-Acting Injectable Antipsychotics for Schizophrenia: An Overview. CNS drugs, 35(1), 39–59. https://doi.org/10.1007/s40263-020-00779-5

22. Brissos, S., Veguilla, M. R., Taylor, D., & Balanzá-Martinez, V.

(2014). The role of long-acting injectable antipsychotics in schizophrenia: a critical appraisal. Therapeutic advances in psychopharmacology, 4(5), 198–219. https:// doi.org/10.1177/2045125314540297

23. Fluphenazine. In: Lexi-drugs online [database on the internet]. Hudson (OH). LexiComp, Inc.; 2021 [updated 10 June 2021; cited 12 June 2021]. Available from: https:// online.lexi.com. Subscription required to view

24. Haloperidol. In: Lexi-drugs online [database on the internet].

Hudson (OH). LexiComp, Inc.; 2021 [updated 9 June 2021; cited 12 June 2021]. Available from: https://online.lexi.com.

Subscription required to view

25. Aripiprazole. In: Lexi-drugs online [database on the internet].

Hudson (OH). LexiComp, Inc.; 2021 [updated 9 June 2021;

|30| Kentucky Pharmacists Association | July/august 2021

26. Aripiprazole Lauroxil. In: Lexi-drugs online [database on the internet]. Hudson (OH). LexiComp, Inc.; 2021 [updated 4 June 2021; cited 12 June 2021]. Available from: https:// online.lexi.com. Subscription required to view

27. Olanzapine. In: Lexi-drugs online [database on the internet].

Hudson (OH). LexiComp, Inc.; 2021 [updated 10 June 2021; cited 12 June 2021]. Available from: https://online.lexi.com.

Subscription required to view

28. Paliperidone. In: Lexi-drugs online [database on the internet]. Hudson (OH). LexiComp, Inc.; 2021 [updated 5 June 2021; cited 12 June 2021]. Available from: https:// online.lexi.com. Subscription required to view

29. Risperidone. In: Lexi-drugs online [database on the internet].

Hudson (OH). LexiComp, Inc.; 2021 [updated 12 June 2021; cited 12 June 2021]. Available from: https://online.lexi.com.

Subscription required to view

30. Kentucky Revised Statutes 315.010(22). Available from: https://pharmacy.ky.gov/statutesandregulations/ Documents/KENTUCKY%20PHARMACY%20LAWS% 20FEBRUARY%202021.pdf

31.

Mooney, E. V., Hamper, J. G., Willis, R. T., Farinha, T. L., & Ricchetti, C. A. (2018). Evaluating patient satisfaction with pharmacist-administered long-acting injectable antipsychotics in the community pharmacy. Journal of the American Pharmacists Association, 58(4). https://doi.org/10.1016/ j.japh.2018.04.035

32. Miller, L., & Melody, K. (2019). New Frontiers for Pharmacists: Administration of Long-Acting Injectable Antipsychotics.

Specialty Pharmacy Times, 10(4). Available from: https:// www.pharmacytimes.com/view/new-frontiers-forpharmacists-administration-of-long-acting-injectableantipsychotics

33. Nystazaki, M., & Karanikola, M. (2021). Long acting injectable

antipsychotics: Uninterrupted use during the COVID‐19 pandemic. Journal of Psychiatric and Mental Health Nursing. https://doi.org/10.1111/jpm.12750

34. Bai, Y. M., Ting Chen, T., Chen, J. Y., Chang, W. H., Wu, B., Hung, C. H., & Kuo Lin, W. (2007). Equivalent switching dose from oral risperidone to risperidone long-acting injection: a 48-week randomized, prospective, single-blind pharmacokinetic study. The Journal of clinical psychiatry, 68(8), 1218– 1225. https://doi.org/10.4088/jcp.v68n0808

August 2021—Review of Long-Acting Injectable Antipsychotics 1. All

of the following are second generation longacting antipsychotic except?

D. Both A & B

A. Aripiprazole lauroxil (Aristada®)

6. What is the primary mechanism of action of firstgeneration antipsychotics?

B. Haloperidol decanoate (Haldol®)

A. Binding to opioid receptors

C. Olanzapine pamoate (Zyprexa® Relprevv™)

B. Blocking of D2 receptors in the brain

D. Risperidone (Risperdal Consta®)

C. Dual inhibition of norepinephrine and dopamine reuptake

2. Long-acting antipsychotics can be administered in which way?

D. Stimulating serotonin receptor antagonists

A. Intramuscularly or Subcutaneously

7. What is the definite cause of schizophrenia?

B. Intrathecal or Intravenous

A. Brain development

C. Orally or Sublingual

B. Environmental factors

D. None of the above

C. Genetics D. Unknown, could be a combination of all three

3. In which of the following mental health disorders are antipsychotics used?

a. Bipolar disorder b. Major depressive disorder c. Schizophrenia d. All of the above

8.Which of the following is a positive symptom of schizophrenia?

A. Hallucinations B. Lack of attention C. Loss of Interest D. Memory loss

4. A patient has been taking oral aripiprazole and is being transitioned to the long-acting injectable aripiprazole (Abilify Maintena®) . How long should the patient overlap with their oral agent?

9. All of the following are potential benefits of longacting antipsychotics except?

A. 14 days

B. Decreased hospitalizations

B. 3 weeks

C. Improved adherence

C. 3 months

D. Improved quality of life

A. Cure for schizophrenia

D. No oral overlap is necessary 10. Which long-acting antipsychotic is superior to other long-acting antipsychotics?

5. Pharmacists…

A. Aripiprazole lauroxil

A. Can administer long-acting antipsychotics in Kentucky

B. Fluphenazine decanoate

B. Can help fight the stigma that surrounds mental health disorders

D. No LAI has shown superiority over another

C. Paliperidone palmitate

C. Prescribe long-acting antipsychotics in every clinical practice setting |31| www.KPHANET.org

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: 8/5/2024 Successful Completion: Score of 80% will result in 1.0 contact hours TECHNICIANS ANSWER SHEET. August 2021—Review of Long-Acting Injectable Antipsychotics Universal Activity # 0143-0000-21-008-H08-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

3. A B C D 4. A B C D

5. 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 August 2021—Review of Long-Acting Injectable Antipsychotics Universal Activity #0143-0000-21-008-H08-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 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. 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. |32| Kentucky Pharmacists Association | July/august 2021

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.

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Welcome new Members

We’re so happy to have you!

The list reflects new memberships received from May 1, 2021— June 30, 2021.

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

Brittany Bennett, Liberty Township New Practitioner Todd Carter, Hazard Pharmacist Sheila Franklin, Barbourville Technician Gadeer Hanbali, Louisville New Practitioner

Kerri Johnson, Louisville Pharmacist

Payton Waltz, Louisville New Practitioner

Kimberly Mansfield, Elkton Technician

Jenny Wright, Elizabethtown Pharmacist

Nathan Mills, Pikeville Pharmacist Whitney Russell, Louisville New Practitioner

|38| Kentucky Pharmacists Association | July/august 2021

|39| www.KPHANET.org

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|41| www.KPHANET.org

Campus Corner

communication as they spend more time in my clinic. It brings me pleasure to watch them flourish and hone their skills through patient interactions, documentation and interprofessional collaboration,” said Huffmyer. “I like to think the bonds formed between preceptors and students are lifelong and unbreakable. I enjoy seeing my previous students go on to have bright careers in pharmacy and interacting with them as colleagues.”

One piece of advice that Huffmyer has for students is for those having trouble determining the path they want to take in practicing pharmacy. “There are so many options and fields within pharmacy to specialize in, which can be daunting,” Huffmyer said. “My advice is to get as many different experiences as you can now, even ones you may not be By: Caitlyn Romanski sure about. You never know what you may enjoy or When it comes to dis- what passions you may find if you take the opporplaying leadership in a tunity to seek them out.” pharmacy career, In honor of the hard work and dedication of its preMark Huffmyer excels. ceptors, the UK College of Pharmacy is recognizing Huffmyer, a 2014 preceptors throughout the month of June. A virtual graduate of the Uniappreciation event is scheduled for June 24, 2021, at versity of Kentucky 7:00 p.m. EDT. For more information about the College of Pharmacy, event or information on becoming a College of is the UK College of Pharmacy preceptor, Pharmacy 2021 Preemail copexperiential@uky.edu. ceptor of the Year ____________________________________________ award recipient and works as a Clinical Continued from pg. 39 Staff Pharmacist in the Anticoagulation Clinic at Sources: the UK HealthCare Gill Heart and Vascular Institute.

1. Feola, DJ. Antimicrobial Stewardship. The University of He helps patients taking high-risk blood thinning Kentucky College of Pharmacy. Accessed January 22, 2020. medications and adjusts their medication doses based on laboratory monitoring, goals of care, pro- 2. Antimicrobial stewardship. APIC. https://apic.org/ Professional-Practice/Practice-Resources/Antimicrobialvider recommendations and duration of therapy.

Stewardship/. Accessed December 5, 2020.

A Dedicated Leader in the Clinic and Classroom

On top of his clinical duties, Huffmyer has also held 3. a 5-year-long position as a preceptor for UK College of Pharmacy students. His desire to become a preceptor originated from his personal experience as a pharmacy student and the mentorship his preceptors provided him. He wants to give back to stu4. dents the same way his preceptors invested in his education.

“I knew from an early age that I enjoyed teaching and educating. Before finding pharmacy, I had originally planned to become a teacher,” Huffmyer said. “My experiences in pharmacy school showed me how pivotal preceptors are for their students.

Precepting is one of my favorite methods for teaching and learning because it is so hands on and impactful for both the learner and the teacher.”

Huffmyer shared that forming bonds with students that are eager to learn is the most rewarding aspect of being a preceptor. “I love watching the students’ confidence grow in decision making and |42| Kentucky Pharmacists Association | July/august 2021

Sanchez, Guillermo V., et al. “Core Elements of Outpatient Antibiotic Stewardship.” Morbidity and Mortality Weekly Report: Recommendations and Reports, vol. 65, no. 6, 2016, pp. 1– 12. JSTOR, www.jstor.org/stable/24904408. Accessed December 5, 2020.

Lesprit, Philippea; Brun-Buisson, Christian. Hospital antibiotic stewardship, Current Opinion in Infectious Diseases: Volume 21 - Issue 4 - p 344-349 doi: 10.1097/ QCO.0b013e3283013959

Campus Corner

to witness firsthand our ability to be the forerunner in delivering patient care amongst what seemed like insurmountable obstacles and students witnessed firsthand the thought process we used to solve problems, prioritize need, and execute.

And yet even in this crazy year, the profession was able to accomplish something we have been trying to achieve for over a decade: reimbursement for the services of a pharmacist. By unanimous vote, legislators in Kentucky recognized the value of the pharmacist by mandating reimbursement for our knowledge, our skill, and our ability to take care of patients. If you are reading this article, you probably know this. But there are many pharmacists in this state that not only don’t know but have no idea the impact this will have on our profession. Our profession is on the precipice of moving into a world where script count will no longer dictate the number of technicians or our percent raise. Pharmacists will now be paid to do what they have been trained to do, improve patient care and safety, while improving quality of life through the management of By: Misty M Stutz PharmD, Dean, Sullivan University medications.

College of Pharmacy and Health Sciences Ten years ago, I was able to speak to the class of 2011, promising them a day when counting and pouring would not be their main job. And here we are. This year, the Advancing Pharmacy Practice in Kentucky Coalition (APPKC) has made it a priority to begin implementation of HB-48, reimbursement On June 26th, Sullivan University College of Pharof pharmacy services. This coalition includes SU, UK, macy and Health Sciences welcomed 63 new gradKSHP, KPhA, KY BoP, and APSC. The University of uates to the profession of pharmacy, celebrating 10 Kentucky has also hired a Practice Implement years of graduating pharmacists at Sullivan. And Pharmacist to help lead these efforts. Yes, the state what a year it has been. This year’s graduating class is uniting to bring about change. If you are a prachas had a crash course in flexibility and resilience. ticing pharmacist or a student graduate, make sure The pandemic experience has sent us all scramyou are a member of a KY professional organizabling to rethink our situations and our paths fortion. You will want to be in this new decade of pharward. Students of this year’s class have had to macists. adapt and change like none other. The events of Congratulations to the class of 2021, and to all the this past year have challenged us to rethink our alumni of Sullivan University. This is a great time to purpose and role within the healthcare team. The be a pharmacist, and I can’t wait to hear about how profession of pharmacy has been highlighted and appreciated in the media, within communities, and you are using your education to advance practice. by government officials. Our role has shown not only to be essential, but worthy of the national recognition we received. The class of 2021 was able

Sullivan Celebrates Ten Years of Graduating Pharmacists

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Feature article

Commercial Insurance to Reimburse for PharmacistProvided Services in Kentucky

surgical, dental, and health service corporation.”

An insurer shall provide reimbursement if the service or procedure “is within the scope of practice of pharmacy; would otherwise be covered under the policy, plan, or contract if the service or procedure were provided by a physician, APRN, or PA; and is performed by the pharmacist in strict compliance with laws and administrative regulations related to the pharmacist’s license.” In

addition, the reimbursement will be at a rate not By: Sara Hart, PharmD Candidate 2022 and Kyle Bry- less than that provided to other nonphysician an, PharmD practitioners.

On March 18th 2021, Kentucky House Bill 48: An Act relating to reimbursement of pharmacist services sponsored by pharmacist and Representative Danny Bentley1, was signed by Governor Beshear. The passage of this bill followed three years of legislative advocacy by the Kentucky Pharmacists Association and the Advancing Pharmacy Practice in Kentucky Coalition (APPKC), an

Why is this important?

In 2017, regulation 201 KAR 2:380 established procedures by which pharmacists, acting in collaboration with a prescriber, can provide mutually agreed-upon services as outlined in a specific care protocol. At the time, the hope was that this new regulation would help address limited access to care across Kentucky. It was estimated that Kentucky would experience close to a 30% shortfall

advocacy group of pharmacy stakeholder organizain primary care provider adequacy by 2025. In additions in Kentucky, including the Kentucky tion, evidence has shown that pharmacists Pharmacists Association, the Kentucky Society of providing protocol-driven direct patient care can Health System Pharmacists, the Kentucky Board of improve both patient and public health. As of July Pharmacy, the American Pharmacy Services Corpo1, 2021, sixteen protocols have been approved by ration, the Sullivan University College of the Kentucky Board of Pharmacy; however, many Pharmacy, and the University of Kentucky College pharmacies still have not implemented these proof Pharmacy’s Center for the Advancement of tocols in their practices.

Pharmacy Practice.

How does this bill help?

What does the bill do?

A major barrier to widespread implementation of care has been a lack of

The bill amended KRS Chapter 304 to establish when an insurer or third-party administrator for an

reimbursement. HB 48 addresses this issue by requiring commercial insurances to reimburse

insurer will provide reimbursement to a pharmacist pharmacists for theprotocol-driven services they for a service or procedure they provided. For provide. With this statute in place, pharmacies have one less barrier to offering protocol-driven patient this statute, an insurer is defined as “any insurer, care. More pharmacists offering protocol-driven self-insurer, self-insured plan, or self-insured care will group and shall include any health maintenance help further address limited access to care and imorganization, provider-sponsored integrated health prove both patient and public health throughout delivery network, or nonprofit hospital, medical-

|44| Kentucky Pharmacists Association | July/august 2021

Kentucky. This is a positive first step towards getting pharmacists reimbursement for their services.

However, additional work is needed to ensure full access for all patients, as HB 48 applies only to

care is paramount. The Pharmacy and Medically Underserved Areas Enhancement Act (S 1362 and HR 2759) is bipartisan legislation that will amend

section 1861 (s) (2) of the Social Security Act to allow commercial insurances and does not apply to Medi- pharmacists to receive reimbursement for care and Medicaid. services provided to patients within Medicare Part What are the first steps in implementation?

B. This bill was first introduced in the 113th To prepare for reimbursement for pharmacy services, there are important steps that your

Congress in the House and has been refiled this year in the 117th Congress. For this bill to pass,

pharmacy must complete:

pharmacists across the state and nation need to speak out. One way to do this is by sending an

• Examine the current services provided by your pharmacy and identify those that are eligible for billing.

email asking your legislators to cosponsor S. 1362/H.R. 27593. Personalize the provided email with

descriptions of your role on the healthcare team • Each pharmacist should obtain a National Provider that demonstrate the importance of giving Identifier (NPI) number.

Medicare patients access to pharmacists’ services.

• Pharmacists must become credentialed and contracted with health payers. It is important Sources: to specify that you are enrolling as a pharmacist for the purpose of providing care.

Keep in mind that to date, few states have required insurers to credential and contract with pharmacists; therefore, persistence is key. Many health plans utilize the Council for Affordable Quality Healthcare (CAQH) ProView2 service for their credentialing process. More information on

1 Available at: https://apps.legislature.ky.gov/recorddocuments/bil l/21RS/hb48/bill.pdf 2 https://www.caqh.org/solutions/caqh-proviewproviders-and-practice-managers 3 https://ashsp.ac360.aristotleactioncenter.com/#/ale rtId/7a08b943-77c9-4b09-b500-17f965bbf41c/

credentialing and contracting will be forthcoming from the APPKC and its stakeholder organizations.

It is paramount that we work together to support profession-wide implementation of this important legislation across all practice settings. On behalf of its stakeholder organizations, the APPKC is establishing a work group focused on implementation and the University of Kentucky College of Pharmacy has hired a practice implementation pharmacist to lead implementation efforts. While this progress is game-changing for Kentucky pharmacists, it is new legislation with little precedent and will require much time and effort to completely and successfully implement. If you are interested in assisting APPKC with HB 48 implementation efforts, please contact Kyle Bryan at kyle.bryan@uky.edu.

Call to Action To ensure full access to pharmacist-provided services for ALL patients, federal authority for reimbursement of pharmacist services within Medi|45| www.KPHANET.org

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A good financial professional helps an investor commit to staying on track. Through subtle or overt coaching, the investor learns to take short-term ups and downs in stride and focus on the long term. A strategy is put in place, based on a defined investment policy and target asset allocations with an eye on major financial goals. The client’s best interest is paramount. As the investor-professional relationship unfolds, the investor begins to notice the intangible ways the professional provides valA good professional provides important guidance ue. Insight and knowledge inform investment seand insight through the years. lection and portfolio construction. The professional explains the subtleties of investment classes and how potential risk often relates to potential reThis series, Financial Forum, is presented by PRISM ward. Perhaps most importantly, the professional Wealth Advisors, LLC and your State Pharmacy Ashelps the client get past the “noise” and “buzz” of sociation through Pharmacy Marketing Group, Inc., the financial markets to see what is really ima company dedicated to providing quality prodportant to his or her financial life. The investor ucts and services to the pharmacy community. gains a new level of understanding, a context for all the investing and saving. The effort to build wealth and retire well is not merely focused on What kind of role can a financial professional play “success,” but also on significance. This is the valfor an investor? The answer: a very important one. ue a financial professional brings to the table. You While the value of such a relationship is hard to cannot quantify it in dollar terms, but you can cerquantify, the intangible benefits may be signifitainly appreciate it over time. cant and long-lasting. There are certain investors who turn to a financial professional with one goal in mind: the “alpha” objective of beating the marCitations. ket, quarter after quarter. Even Wall Street money managers fail at that task – and they fail routinely. 1 - cnbc.com/2019/07/31/youre-making-bigfinancial-mistakes-and-its-your-brains-fault.html At some point, these investors realize that their financial professional has no control over what hap- [7/31/2019] pens in the market. They come to understand the real value of the relationship, which is about stratPat Reding and Bo Schnurr may be reached at egy, coaching, and understanding. A good finan800-288-6669 or pbh@berthelrep.com. cial professional can help an investor interpret today’s financial climate, determine objectives, and Registered Representative of and securities and assess progress toward those goals. Alone, an ininvestment advisory services offered through vestor may be challenged to do any of this effecBerthel Fisher & Company Financial Services, Inc. tively. Moreover, an uncoached investor may make Member FINRA/SIPC. PRISM Wealth Advisors LLC is self-defeating decisions. Today’s steady stream of independent of Berthel Fisher & Company Finaninstant information can prompt emotional behavcial Services Inc. ior and blunders.

Financial Forum Why Having a Financial Professional Matters

No investor is infallible. Investors can feel that way during a great market year, when every decision seems to work out well. Overconfidence can set in, and the reality that the market has occasional bad years can be forgotten. This is when irrational exuberance creeps in. A sudden Wall Street shock may lead an investor to sell low today, buy high tomorrow, and attempt to time the market. Market timing may be a factor in the following divergence: according to investment research firm DALBAR, U.S. stocks gained 10% a year on average from 1988-2018, yet the average equity investor’s portfolio returned just 4.1% annually in that period.1

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This material was prepared by MarketingPro, Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. This information has been derived from sources believed to be accurate. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment.

RX & the Law Drug Recalls

patients contact you with a question about a recall.

FDA recommends patients talk to their pharmacists about recalled medications. Class I recalls generally provide information specifically for patients, but other Class recalls do not. Being informed about current recalls will assist you in helping your patients get replacement therapies.

The ranitidine recall applied to both prescription and over-the-counter (OTC) versions of the drug.

The recall notice advised patients to stop taking OTC ranitidine immediately, but to consult with their health care professional about other treatment options before discontinuing prescription ranitidine. These types of instruction will generate As a young pharmacist, I experienced my first recall questions from your patients. Besides being aware when the drug Oraflex (benoxaprofen) was taken of the recommendations for your patients, the reoff the market in 1982. The drug was effective in call notice will advise the pharmacy on the removal treating arthritis, but had some serious side effects. of the drug from stock and the return procedures.

What I remember were patients telling us this was From a liability perspective, you should follow the the only drug that worked for them and asking us procedures outlined in the recall notice. Remove to sell it to them rather than returning the drug to items from stock as instructed. Some recalls will the manufacturer. Ultimately, we decided to send advise you to contact patients currently taking a it back to the manufacturer. The recent recall of prescription product. Verify that you have or had ranitidine and other products for nitrosamine imthe affected lots and notify your patients who repurities caused me to reflect on how little I underceived the affected lots as soon as practical. Keepstood recalls in 1982. ing your computer system updated with current lot Drug recalls are voluntary actions taken by a manunumbers and expiration dates of prescription prodfacturer to remove a defective product from the ucts is crucial to being able to identify those who marketplace. A recall can be initiated by the manuhave received the recalled product. If you receive a facturer or the Food and Drug Administration (FDA) new prescription after the recall notice, use the opcan request a recall. Recalls are almost always volportunity to help educate prescribers in your area. untary by the manufacturer and FDA rarely reBe ready to suggest alternatives that are not affectquests a recall. FDA's role in a drug recall is the ed by the recall. Needless to say, it is not a good same as in the recall of other FDA regulated prodidea to sell or dispense recalled products at the paucts; e.g. medical devices, cosmetics, food, etc. The tient's request instead of following the return proagency's role is to classify the recall, to oversee the cess in the recall notice. Another bad idea is commanufacturer's strategy, and assess the adequacy pounding the recalled medication when the manuof the recall. factured product isn't available due to a recall.

Recalls are classified by their severity. Class I recalls Rather than being a passive recipient of inforinvolve a dangerous or defective product that could mation, going online to regularly review recall nocause serious health problems or death. Class II tices will allow you to be proactive with you parecalls involve products that could cause a tempotients' therapies. Your patients will see you as a rary health problem or a slight threat of serious trusted partner in their healthcare. Follow the reharm. Products involved in Class III recalls are uncall procedures, make sound professional judglikely to cause adverse health reactions, but the ments when necessary, and your patients will value products violate labeling or manufacturing laws. your services even more.

You will not hear about every recall on the news.

Public notification of a recall usually occurs when the product has been widely distributed or poses a © Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice serious health hazard, such as in a Class I recall.

President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

However, all recalls are posted weekly on the FDA website through their Enforcement Reports page.

This article discusses general principles of law and risk manage(https://www.fda.gov/safety/recalls-marketment. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for spewithdrawals-safety-alerts/enforcement-reports) cific advice. Pharmacists should be familiar with policies and You can also register to receive email notifications procedures of their employers and insurance companies, and of new and updated recalls. Familiarizing yourself act accordingly. with current recalls will be beneficial when your This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

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Feature article

Frequently Asked Questions About Origin Codes When processing a prescription, the pharmacy is required to assign an origin code to the claim. PAAS National® continues to see audit results for invalid origin codes. These discrepancies can range from $5 fees to full recoupments. The proper use of the origin code field is to record how the pharmacy originally received the prescription order from the prescriber. Below are two of the most common questions PAAS receives related to origin codes.

Does the origin code change if you need to call the prescriber to clarify a prescription and make a clinical note?

Answer: No, NCPDP states that any clarifications or modifications to the original prescription [after receiving it at the pharmacy] do not change the origin code. The origin codes stays the same throughout the life of that prescription.

What origin code is used for a standing order or protocol?

Answer: Origin code 5 – Pharmacy (some software systems label as Transfer instead of Pharmacy). A standing order or protocol would be designated as origin code 5 because it is being created by the pharmacy. Two examples of a standing order or protocol commonly used are for administering immunizations and dispensing Narcan.

Here are the NCPDP Definitions: 0 – Not Known 1 – Written – Prescription obtained via paper.

2 – Telephone – Prescription obtained via oral instructions or interactive voice response using a phone.

3 – Electronic – Prescription obtained via SCRIPT or HL7 Standard transactions, or electronically within closed systems.

4 – Facsimile – Prescription obtained via transmission using a fax machine.

5 – Pharmacy – This value is used to cover any situations where a new Rx number needs to be created from an existing valid prescription such as traditional transfers, intrachain transfers, file buys, software upgrades/migrations, and any reason necessary to “give it a new number.” This value is also the appropriate value for “Pharmacy Dispensing” when applicable such as behind the counter (BTC), Plan B, established protocols, pharmacist’s authority to prescriber, etc.

You can find a link to the NCPDP February 2021, Telecommunication Version D and Above Questions, Answers and Editorial Updates document here: ncpdp.org/NCPDP/media/pdf/VersionD-Questions.pdf (see section 3.1.4 on origin codes).

PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact us today at (608) 873-1342 or info@paasnational.com to see why membership might be right for you.

By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit assistance and FWA/HIPAA compliance. ©2021 PAAS National® LLC All Rights Reserved

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KPhA BOARD OF DIRECTORS

KPERF BOARD OF DIRECTORS

Joel Thornbury, Pikeville jthorn6@gmail.com

Chair

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Chair

Cathy Hanna, Lexington channa@apscnet.com

President

Treasurer

Misty Stutz, Crestwood mstutz@sullivan.edu

President-Elect

Chris Killmeier, Louisville cdkillmeier@hotmail.com

President, KPhA

Brooke Hudspeth, Lexington brooke.hudspeth@uky.edu

Secretary

Cathy Hanna, Lexington channa@apscnet.com

Chris Killmeier, Louisville cdkillmeier@hotmail.com

Treasurer

Kevin Lamping, Lexington kevin.lamping@twc.com

Ron Poole, Central City

Past President Representative

Paul Easley, Louisville rpeasley@bellsouth.net

ron@poolespharmacycare.com

Pat Mattingly, Lebanon pat@patspharmacy.com

Directors Ronnah Alexander, Providence ralexander@hfchc.net

Sam Willett, Mayfield willettsam@bellsouth.net

Kyle Harris, London kyleharrispharmd@yahoo.com

Adrienne Matson, Lexington Adrienne.matson@uky.edu

Taylor Williams, Lexington taylorjwilliams17@gmail.com

University of Kentucky Student Representative

Cassy Hobbs, Louisville cbeyerle01@gmail.com Rodrick Millner, Louisville rodrickmillner@gmail.com

Sullivan University Student Representative

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Martika Martin, Owensboro 12marmar@gmail.com Nathan Hughes, Louisville njhughes1980@gmail.com Kyle Bryan, Lebanon kyle.bryan2@outlook.com Cory Smith, Barbourville corysmith6155@gmail.com

Secretary

Speaker of the House

KPhA Staff Ben Mudd Executive Director bmudd@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org

Vice-Speaker of the House Kristen Blankenbecler, PharmD Director of Clinical Outreach kristen@kphanet.org

Emma Sapp, Alexandria emma.hatfield@stelizabeth.com Steve Hart, Frankfort Steve.hartrph@gmail.com Lakin Mills, Lexington lakinrachelle@gmail.com

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Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org

“Leon Claywell, Columbia, a recent graduate of Samford University's School of Pharmacy in Birmingham, has accepted a position at Crume-Reed Drug in Bardstown.”

-From The Kentucky Pharmacist, August 1971, XXXIV, Number 8

Frequently Called and Contacted Kentucky Board of Pharmacy

Kentucky Society of Health-System Pharmacists

National Community Pharmacists Association (NCPA)

P.O. Box 4961

100 Daingerfield Road Alexandria, VA 22314

(502) 564-7910

Louisville, KY 40204 (502) 456-1851 x2 www.kshp.org info@kshp.org

www.pharmacy.ky.gov

Kentucky Regional Poison Center

Pharmacy Technician Certification Board (PTCB)

(800) 222-1222

State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601

2215 Constitution Avenue

American Pharmacists Association (APhA)

Washington, DC 20037-2985

2215 Constitution Avenue NW

(800) 363-8012

Washington, DC 20037-2985

www.ptcb.org

(800) 237-2742

(703) 683-8200 www.ncpanet.org info@ncpanet.org National Association of Chain Drug Stores (NACDS) 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001

www.aphanet.org

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd.

Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.youtube.com/KyPharmAssoc |53| www.KPHANET.org