• 23 May 2018 12:11 PM | MSHP Office (Administrator)

    Spring Tenet-Respect the Past

    I have great respect for the past. If you don't know where you've come from, you don't know where you're going. I have respect for the past, but I'm a person of the moment. I'm here, and I do my best to be completely centered at the place I'm at, then I go forward to the next place.

    -Maya Angelou


    As mentioned in my remarks at our Society’s recent Spring Meeting, I have had the pleasure of serving on the MSHP board for the last six years. I have been able to witness leaders in our profession guide our Society through times of trouble, times of change and times of success. Working on this Board with past Presidents Daniel Good, Andy Smith, Diane McClaskey, Sarah Boyd, Laura Butkievich, and Jeremy Hampton have given me the blueprint for a successful year as President. Having additional past Presidents in my professional network like Brad Cook, Joel Hennenfent, Greg Teale, Amy Sipe, Mark Woods and others will allow me to tap their combined wisdom in order to lead our Society for the next 12 months.

    My personal journey with MSHP has been an interesting one. It began with committee service in 2012 on both the Annual Meeting Planning Committee and the Pre-Meeting Workshop Planning Committee. I served as the Greater Kansas City Society of Health Systems Pharmacists President in 2013 and was a voting MSHP board member in that role. I then served as Treasure Elect/Treasure for 2 years in 2014-2015, chaired the Transitions Committee in 2016 and was elected to the presidential cycle last year. These past experiences have helped me understand the unique challenges that come with the operations of our Society and I hope they will form a foundation that will allow me to lead the MSHP Board for the next year.

    Moving forward I hope to improve our operational efficiencies as an organization and push forward with the regulatory and public policy momentum we have created over the past 18 months. I would also like to engage you, the MSHP membership, to continue to refine the role MSHP plays in your career, looking for more of what you want from your Society.

    It is truly an honor to be elected into the Presidency of MSHP. I will do my best to honor the strong tradition that has been set before I arrived in this role, push our Society forward in the present and hope to set us all up for success in the future.


    Respectfully
    Tony Huke, PharmD, BCPS


  • 21 May 2018 12:36 PM | MSHP Office (Administrator)

    Authors: Angela Brownfield, PharmD: UMKC School of Pharmacy at MU and Barb Kasper, PharmD, BCACP: UMKC School of Pharmacy at MU


    Background

    With the experiential program comprising at least 30% of the pharmacy curriculum, pharmacy preceptors may make use of the layered learning model (LLM) as an effective tool to juggle the demands of experiential instruction and patient care responsibilities at clinical sites.1 At its most basic level, the LLM allows learners at varying levels of instruction to educate and learn from each other.  LLMs include various combinations of the following participants:  attending pharmacist (i.e. pharmacy preceptor), postgraduate year 1 (PGY-1) or postgraduate year 2 (PGY-2) pharmacy resident, Advanced Pharmacy Practice Experience (APPE) students, and Introductory Pharmacy Practice Experience (IPPE) students.2-9 

    Across settings, the pharmacy preceptor oversees all teaching and patient care responsibilities of the learners.  Senior learners assume increased teaching and patient care oversight of the junior learners, depending on their place in the hierarchy of the LLM.  Senior learners also assume an increased volume of direct patient care responsibilities, up to the entire workload of the preceptor.  However, individual direct patient care tasks may differ between acute and ambulatory care practice settings.  Differences in responsibilities may include the type of task and manner of delivery.  Table 1 outlines the potential learners and responsibilities involved in LLM.

    Table 1

    Learner

    Acute Care Responsibilities

    Ambulatory Care Responsibilities

    PGY-2 Resident

    • Responsibility for all aspects of patient care and oversight/teaching of learners listed below
    • Responsibility for all patients on service
    • Responsibility for all aspects of patient care and oversight/teaching of learners listed below
    • Responsibility for all patients on service

    PGY-1 Resident

    • Responsibility for all aspects of patient care listed for APPE and IPPE students
    • Oversight/teaching of APPE and IPPE students
    • Responsibility for a greater number of patients than APPE or IPPE students
    • Responsibility for all aspects of patient care listed for APPE and IPPE students
    • Oversight/teaching of APPE and IPPE students
    • Responsibility for a greater number of patients than APPE or IPPE students
    APPE
    • Responsibility for all aspects of patient care listed for IPPE students
    • Oversight/teaching of IPPE students
    • Clinical consultation to rounding teams
    • Pharmacokinetic monitoring
    • Responsibility for a greater number of patients than IPPE students
    • Responsibility for all aspects of patient care listed for IPPE students
    • Oversight/teaching of IPPE students
    • Clinical decision-making
    • Responsibility for a greater number of patients than IPPE students

    IPPE

    • Completion of medication histories/medication reconciliation
    • Provide patient education
    • Documentation in EMR
    • Responsibility for a limited number of patients
    • Assess patient vital signs
    • Completion of medication histories/medication reconciliation
    • Provide patient education
    • Documentation in EMR
    • Responsibility for a limited number of patients

    Benefits

    The benefits of the LLM are quite extensive.  A few highlights of the advantages of LLM include: 

    • Enhanced Patient Care and Learning
    When multiple learners are in the same environment, a combined effort toward effective patient care may produce a sum greater than its parts.  By working together, the quality of patient care, as well as learning, may be augmented as different learners approach a situation from varying angles yet work collaboratively toward the same endpoint.  In the process, learners have the opportunity to process, explain, and/or discuss approaches with each other.  This, in turn, could lead to opportunities to adopt new approaches to patient care and/or increase comprehension of drug/disease state knowledge and patient care skills.  In addition, through modeling by senior learners, junior learners are able to observe expectations for future patient encounters and learning experiences.10
    • Increased Availability of Patient Care Experiences for Learners

    In order to provide optimal learning experiences for pharmacy learners, the LLM allows for increased availability of patient care experiences by overlapping learners at the clinical site.2-5, 9, 11-13  Both time and energy are maximized when junior and senior learners appropriately share patient care responsibilities (Table 1).  The LLM affords learners the ability to apply didactic knowledge and learned skills in a dynamic environment within the construct of existing patient workload.

    • Extension of Patient Care Activities for Clinical Institutions

    “Win-Win” is the overall goal for both the academic and medical institutions involved in the LLM.  Preceptors optimally use learners as extenders of patient care and thus, increase services that were once not possible with existing manpower.2, 3, 5, 6, 11, 14  This may include such services as medication reconciliation and high-risk patient counseling for a greater patient population than was previously possible. 

    • Increased Efficiency for Pharmacy Preceptors

    The LLM allows for improved balance of student learning and clinical site responsibilities for pharmacy preceptors.  By concurrently placing varying levels of learners at a site, preceptors may maintain an appropriate level of experiential oversight while addressing demanding patient care responsibilities.  Senior learners are able to provide higher-level patient care while modeling and coaching junior learners in the process.  This allows the preceptor to still engage in the LLM as the primary educator while allowing greater flexibility in ensuring clinical responsibilities are met.10  

    Potential Barriers and Mitigation Strategies

    While the LLM can provide a number of benefits to preceptors, barriers to successful implementation are also important to address.  Below are some common barriers to LLMs and opportunities to overcome them:

    • Inadequate Space and Resources  for Increased Learners
    Having limited numbers of computer stations could be overcome by providing learners with remote computer access.  Learners are able to access electronic medical records on personal devices, allowing for greater flexibility in the physical location needed to complete this task.  Within the ambulatory care setting, exam room space limits the number of learners who can see a patient at one time.  Pairing learners for complementary components of the patient encounter can serve several purposes. Pairing learners allows for modeling and coaching to occur.  Additionally, this strategy can minimize redundancies in the patient interviewing process when each learner needs the information gathered to make clinical decisions.
    • Complexities of Coordinating Multiple Learner Schedules
    Coordinating each learner’s schedule can be a complicated task and is best completed in a systematic manner.  Although scheduling requires time and advance planning, mapping each learner’s schedule will ensure learner overlap occurs in a logical sequence and aligns with direct patient care opportunities.  Preceptors should consider the amount of time needed for senior learners to orient to the rotation before assuming teaching responsibilities.  Additionally, preceptors should allow for flexibility in scheduling, based on individual learner needs.
    • Inconsistent Availability of Direct Patient Care Opportunities

    Despite advanced planning and scheduling, unpredictable situations may not afford equitable distribution of direct patient care opportunities across learners.  For example, a hospital may have an unusually low census or patients may not show for clinic appointments.  Having a contingency plan will be important in these situations to maintain quality learning experiences.  Some examples of contingency plans could include the following:

    • Convert clinic appointments to phone appointments if a patient does not show
    • Utilize senior learners to lead topic discussions with junior learners
    • Utilize senior learners to guide junior learners in population health management initiatives or other projects
    • Assist colleagues with direct patient care responsibilities

    Conclusion

    As pharmacists continue to engage in experiential learning, the LLM offers one approach to help maximize student learning while balancing patient care responsibilities.  Its design is flexible as it offers numerous approaches to the inclusion of various, overlapping learners where instruction and learning can coexist.  As with any pedagogical design, the LLM comes with both benefits and limitations that every preceptor must consider.  Yet, in order to increase learners’ knowledge, skills, and abilities, the LLM can serve as an effective mechanism for instruction as well as the delivery of patient care.2-14  

    References

    1. Accreditation Council for Pharmacy Education: Accreditation Standards and Key Elements for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree ("Standards 2016"). Available from: 〈https://www.acpe-accredit.org/pharmd-program-accreditation/〉; 2015. Accessed 7 February, 2018.
    2. Bates JS, Buie LW, Amerine LB, et al. Expanding care through a layered learning practice model. Am J Health-Syst Pharm. 2016;73:e603–e609.
    3. Delgado O, Kernan WP, Knoer SJ. Advancing the pharmacy practice model in a community teaching hospital by expanding student rotations. Am J Health-Syst Pharm. 2014;71(21):1871–1876.
    4. Bates JS, Buie LW, Lyons K, et al. A study of layered learning in oncology. Am J Pharm Educ. 2016;80(4) 68.
    5. Soric MM, Glowczewski JE, Lerman RM. Economic and patient satisfaction outcomes of a layered learning model in a small community hospital. Am J Health-Syst Pharm. 2016;73(7):456–462.
    6. Kalich BA, Cicci JD, Shah S, Reed BN. From pilot to practice: feasibility & impact of a layered learning practice model experience in cardiology [abstract]. Pharmacotherapy. 2013;33(10):e250.
    7. Leong C, Battistella M, Austin Z. Implementation of a near-peer teaching model in pharmacy education: experiences and challenges. Can J Hosp Pharm. 2012;65(5):394–398.
    8. Cameron K, Fernandes O, Musing ELS, Raymond C. Increasing capacity for experiential rotations for pharmacy learners: lessons learned from a multisite teaching hospital. Can J Hosp Pharm. 2016;69(1):23–29.
    9. Loy BM, Yang S, Moss JM, Kemp DW, Brown JN. Application of the layered learning practice model in an academic medical center. Hosp Pharm. 2017;52(4):266–272.
    10. Kasper B, Brownfield A. Evaluation of a Newly Established Layered Learning Model in an Ambulatory Care Setting.  Curr Pharm Teach Learn. (In Press).
    11. Masterson J, Rafferty A, Michalets E. The Clinical Training Center: a layered-learning rotation model to meet hospital goals and standards of practice [abstract]. Pharmacotherapy. 2016;36(12):e287.
    12. Smith WJ, Bird ML, Vesta KS, Harrison DL, Dennis VC. Integration of an introductory pharmacy practice experience with an advanced pharmacy practice experience in adult internal medicine. Am J Pharm Educ. 2012;76(3) Article 52.
    13. Kessler TL, Vesta KS, Smith WJ, Dennis VC, Bird ML, Harrison DL. Students' attitudes and perceptions of a structured longitudinal introductory pharmacy practice experience (IPPE) medicine rotation. Curr Pharm Teach Learn. 2011;3(1):2–8.
    14. Cobaugh DJ. Layered learning: the confluence of pharmacy education and practice. Am J Health-Sys Pharm. 2016;73(24):2035.


  • 18 May 2018 11:53 AM | MSHP Office (Administrator)

    Author: Amy Benson, PharmD, MHA
    MSHP Public Policy Committee Chair / Director of Pharmacy at Liberty Hospital


    The MSHP Public Policy Committee discussed the work the Hospital Advisory committee (HAC) has been completing with the Board of Pharmacy, Department of Health and Senior Services and Missouri Hospital Association (MHA). Senate bill 501 required the removal of duplicative language from the DHSS regulations. The HAC submitted its recommendations in December to remove several sections that are covered by CMS language and also provided additional language for expanded pharmacy technician roles. The HAC continues to have conversations with the Board of Pharmacy to assist in moving this language through the regulation process.

    Another group is working with the Board of Pharmacy on revising the rules related to sterile compounding for pharmacies licensed under a Class H license. A recommendation has been provided to the board to clarify the steps to take if/when compounding should cease based upon CFU counts exceeding USP 797 action levels. The group will continue to work with the board to ensure public safety is improved while limiting the potential delays to patient care.

    Several bills have been introduced in both the House and Senate that apply to pharmacy practice in the state.

    SB 1068 – Establishes regulations for the duties of pharmacy technicians in a hospital setting. The sponsor is Senator Sater and had the first read on 2/28/18. (http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=76743872)

    HB 1618 – Disposal of unused controlled substances. The sponsor is Representative Barnes and is awaiting a 3rd reading. https://house.mo.gov/bill.aspx?bill=HB1618&year=2018&code=R)

    SB 826 – Modifies provisions relating to pharmacy, including drug disposal, prescription limitations for controlled substance, and vaccine protocols. The sponsor is Senator Sater and has passed. http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=70365560)

    HB 1870 – Allows certain medications in multidose containers used by a patient during a hospital stay to be sent with the patient at discharge. The sponsor is Representative Barnes and has passed. https://house.mo.gov/bill.aspx?bill=HB1870&year=2018&code=R)

    HB 1542 – Prohibits certain actions by pharmacy benefits managers. Sponsor is Representative Morris and a public hearing has been completed. https://house.mo.gov/bill.aspx?bill=HB1542&year=2018&code=R)


  • 18 May 2018 11:44 AM | MSHP Office (Administrator)

    A Farewell Address from Immediate Past-President Jeremy Hampton

    I wanted to take a moment to thank everyone for helping to make this such a great year. I am extraordinarily thankful to have had the opportunity to represent such an amazing membership base and to have served alongside such an amazing Board of Directors throughout this last year. I don’t think I have the literary skills to appropriately express my gratitude, so I thought the best way to thank these exceptionally hard working volunteers would be to list their myriad accomplishments throughout the year.

    Introduction of a new local affiliate membership option – This year marked the introduction of a new membership option wherein a member of any ASHP-accredited state affiliate could join one of Missouri’s four (more on that number) local affiliates without requiring concurrent MSHP membership. The thought behind this initiative was that by growing the membership roster of our local affiliates to include out-of-state members, we could expand our reach as a state-level affiliate and demonstrate firsthand the benefits of MSHP membership. We believe this will lead to an increase in our membership and a commensurate enhancement of our ability to lobby for the expansion of pharmacist roles beginning at the state level.

    ASHP re-accreditation granted – In 2017 we began the process of applying for re-accreditation with ASHP. We are pleased to announce that in February of this year our application was unanimously approved by the ASHP re-accreditation board and our state affiliate status is secured for the next seven years!

    Introduction of a new local affiliate for Southeast Missouri – We are very pleased to announce that, due to the very hard work of a group of pharmacists in the southeast region of the state, the Southeast Missouri Society of Health-System Pharmacists (SEMSHP) has received recognition as a Board-approved local affiliate of MSHP. If you are a pharmacist practicing in the southeast portion of Missouri, rejoice! You now have your own affiliate!

    Joint Fall Conference with Missouri Pharmacy Association – We are very pleased to have the opportunity to collaborate with MPA to bring you the 2018 MPA/MSHP Fall Conference being held September 6-9 at the Hilton Branson Convention Center. Don’t miss this fantastic opportunity, register now! https://www.morx.com/conference


    From our Communications Committee (Chair: Elaine Ogden)

    We spent extensive time reformatting and updating the strategic plan

    • Created annual calendar to enhance organizational efficiency
    • Created a dashboard to track various metrics and provide baseline comparisons
    • Added more structure to communication committee which meets monthly. A large focus has been placed on spreading awareness around pharmacy via social media with the hope of expanding to additional social media platforms
    • eBlasts have been reformatted and the distribution frequency has been optimized in order to maximize information dissemination while minimizing email overload
    • Participated in the website committee to assist with updating our website


    From our Public Policy Committee (Chair: Amy Benson)

    The MSHP Public Policy Committee discussed the work the Hospital Advisory committee (HAC) has been completing with the Board of Pharmacy, Department of Health and Senior Services and Missouri Hospital Association (MHA). Senate bill 501 required the removal of duplicative language from the DHSS regulations. The HAC submitted its recommendations in December to remove several sections that are covered by CMS language and also provided additional language for expanded pharmacy technician roles. The HAC continues to have conversations with the Board of Pharmacy to assist in moving this language through the regulation process.

    Another group is working with the Board of Pharmacy on revising the rules related to sterile compounding for pharmacies licensed under a Class H license. A recommendation has been provided to the board to clarify the steps to take if/when compounding should cease based upon CFU counts exceeding USP 797 action levels. The group will continue to work with the board to ensure public safety is improved while limiting the potential delays to patient care.

    Several bills have been introduced in both the House and Senate that apply to pharmacy practice in the state.

    SB 1068 – Establishes regulations for the duties of pharmacy technicians in a hospital setting. The sponsor is Senator Sater and had the first read on 2/28/18. (http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=76743872)

    HB 1618 – Disposal of unused controlled substances. The sponsor is Representative Barnes and is awaiting a 3rd reading. https://house.mo.gov/bill.aspx?bill=HB1618&year=2018&code=R)

    SB 826 – Modifies provisions relating to pharmacy, including drug disposal, prescription limitations for controlled substance, and vaccine protocols. The sponsor is Senator Sater and has passed. http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=70365560)

    HB 1870 – Allows certain medications in multidose containers used by a patient during a hospital stay to be sent with the patient at discharge. The sponsor is Representative Barnes and has passed. https://house.mo.gov/bill.aspx?bill=HB1870&year=2018&code=R)

    HB 1542 – Prohibits certain actions by pharmacy benefits managers. Sponsor is Representative Morris and a public hearing has been completed. https://house.mo.gov/bill.aspx?bill=HB1542&year=2018&code=R)


    From our Membership Committee (Chair: Heather Taylor)

    • Published the MSHP Membership Survey results in the MSHP Newsletter
    • Cleaned up and updated the MSHP online membership database which, as many of you know has historically been suboptimal.
    • Introduced the online membership directory and a tips sheet to MSHP members
    • Offered membership discounts for new graduates/residents for a limited time to increase membership
    • Highlighted committees on the MSHP Facebook page to engage members and promote involvement in MSHP
    • Implemented monthly welcome emails to all new MSHP members by a current MSHP Membership Committee member to extend a warm welcome and invite them to get involved in a committee
    • Created new and updated membership benefit materials and distributed them to health systems and affiliates
    • Implemented a booth at MSHP Spring Meeting to highlight each committee and encourage member involvement


    From our Newsletter Committee (Chair: Barb Kasper)

    The MSHP Newsletter Committee worked closely with Q&A to enhance the aesthetics and publication process of the MSHP Newsletter. The newsletter now utilizes a template compatible with both desktop and mobile devices. Additionally, all newsletter articles are linked to the MSHP website. Linking past articles to the MSHP website allows for past publications to be retrieved more easily and identified on search engines. Lastly, a formal process was developed to solicit, organize, and proof newsletter drafts. These changes increased on-time distribution of the newsletter.

    The MSHP Newsletter Committee also sought to increase publication opportunities for students and residents across the state of Missouri. The response to these efforts has been substantial, with three of the last five issues reaching maximum capacity for submissions in the “Featured Clinical Topic” category. In total, 35 students/residents have authored/will author 31 articles between July 2017 and June 2018! Additionally, through collaboration with residency programs across the state, six of these articles provided/will provide MSHP members with six hours of pharmacist continuing education credit. Providing MSHP membership with CE opportunities in the newsletter fulfilled a significant strategic planning initiative this year.

    The MSHP Newsletter Committee would like to thank all who contributed content to the MSHP Newsletter over the last year. Additionally, none of this year’s success could have happened without the following Newsletter Committee members: Sarah Cook (vice-chair), Hannah Pope, and Laura Challen. Their hard work and dedication to producing a high-quality MSHP Newsletter is much appreciated!

    Again, I want to thank everyone for all of their hard work in making this past year a success. Without you, nothing would have been possible!!

    Jeremy Hampton
    Immediate Past-President MSHP


  • 28 Mar 2018 9:16 AM | MSHP Office (Administrator)

    Author: Amy Benson, PharmD, MHA
    MSHP Public Policy Committee Chair / Director of Pharmacy at Liberty Hospital


    The MSHP Public Policy Committee discussed the work the Hospital Advisory committee (HAC) has been completing with the Board of Pharmacy, Department of Health and Senior Services and Missouri Hospital Association (MHA).  Senate bill 501 required the removal of duplicative language from the DHSS regulations.  The HAC submitted its recommendations in December to remove several sections that are covered by CMS language and also provided additional language for expanded pharmacy technician roles.  The HAC continues to have conversations with the Board of Pharmacy to assist in moving this language through the regulation process.

    Another group is working with the Board of Pharmacy on revising the rules related to sterile compounding for pharmacies licensed under a Class H license.  A recommendation has been provided to the board to clarify the steps to take if/when compounding should cease based upon CFU counts exceeding USP 797 action levels.  The group will continue to work with the board to ensure public safety is improved while limiting the potential delays to patient care.

    Several bills have been introduced in both the House and Senate that apply to pharmacy practice in the state.

    SB 1068 – Establishes regulations for the duties of pharmacy technicians in a hospital setting.  The sponsor is Senator Sater and had the first read on 2/28/18.  (http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=76743872)

    HB 1618 – Disposal of unused controlled substances.  The sponsor is Representative Barnes and is awaiting a 3rd reading.  https://house.mo.gov/bill.aspx?bill=HB1618&year=2018&code=R)

    SB 826 – Modifies provisions relating to pharmacy, including drug disposal, prescription limitations for controlled substance, and vaccine protocols.  The sponsor is Senator Sater and has passed.  http://www.senate.mo.gov/18info/BTS_Web/Bill.aspx?SessionType=R&BillID=70365560)

    HB 1870 – Allows certain medications in multidose containers used by a patient during a hospital stay to be sent with the patient at discharge.  The sponsor is Representative Barnes and has passed.  https://house.mo.gov/bill.aspx?bill=HB1870&year=2018&code=R)

    HB 1542 – Prohibits certain actions by pharmacy benefits managers.  Sponsor is Representative Morris and a public hearing has been completed.  https://house.mo.gov/bill.aspx?bill=HB1542&year=2018&code=R)


  • 22 Mar 2018 11:20 AM | MSHP Office (Administrator)

    Welcome to Spring of 2018, known throughout the world as the season of drug shortages.  In this same spirit of shortages, I’ll keep my comments very brief in this issue.  In fact, I’d like to use this as an opportunity to ask questions.  We all know that recent drug and fluid shortages have made it extraordinarily difficult to provide optimal patient care in every situation.  In large part, our role as pharmacists is to get creative in these difficult times and to find unique solutions in the face of shortages.  The problem that we now see, however, is that as one drug is added to the shortage list there is an increased utilization of alternative agents which leads to that agent being added in turn.  It’s this problem that’s led me to sit in the corner, quietly rocking back and forth while mumbling incoherently as ketamine has now been added to this infernal list due to increased utilization stemming from the opioid shortage.  And I’m not even going to get started on the impact that the fluid shortages have had on our ability to practice.  What I want to do, however, is to tap into the collective brilliance of Missouri pharmacists to find out how you’re managing your practice in this challenging time.  So my questions to you are:

    Which shortage(s) have impacted your practice most profoundly?
    How have you changed your practice in light of shortage(s)?
    Are there any unique steps you or your institution have taken to mitigate the impact of shortages?
    What have you learned and what advice would you offer to others that could help navigate this problem?

    I would love to hear about the challenges you’ve faced, the lessons you’ve learned, and the successes you’ve realized and would really like to showcase what you’ve done to manage this growing problem.  Please don’t hesitate to email me at hamptonjp@umkc.edu to let me know!  Although we may not be able to directly solve the problem (unless one of you is getting ready to cut the ribbon on a new drug manufacturing facility), we can work together to share our knowledge and collectively try to minimize the impact of drug shortages.  When we work together there’s really no problem we can’t solve…except maybe finding the solution to creating an effective single stage to orbit, boost glide, sustained hypersonic platform (sorry, I have to release my inner aviation dork at least once per article).

    Thanks and stay strong!

    Jeremy P. Hampton, PharmD, BCPS
    President – Missouri Society of Health-System Pharmacists

    Clinical Associate Professor
    University of Missouri- Kansas City School of Pharmacy

    Clinical Specialist - Emergency Medicine
    Truman Medical Center

    ----

    As a side note, it feels like this is the worst that shortage problem has ever been.  I was very interested to learn, however, that from a numbers standpoint the problem of drug shortages has actually improved since 2009.  And here we thought we had it bad back in 2006…

    Source: University of Utah Drug Information Service
    Contact: Erin.Fox@hsc.utah.edu, @foxerinr for more information.

  • 22 Mar 2018 10:44 AM | MSHP Office (Administrator)

    Authors:
    Sara Schenkelberg, PharmD: PGY-1 Walgreens Community Resident-Kansas City, MO
    Chad Cadwell, PharmD, AAHIVP: Walgreens Health System-Truman Medical Center-Kansas City, MO

    Program Number: 2018-03-01
    Approval Dates: 4/4/18-7/6/18
    Approved Contact Hours: One (1) CE(s) per LIVE session.
    Submit for CE: Click Here

    Objectives

    1. Review background and prevalence of Obsessive Compulsive Disorder
    2. Recognize obsession and compulsion behavior
    3. Understand diagnostic criteria set by DSM-V
    4. Identify place in therapy for CBT and SSRIs
    5. Identify place in therapy for alternative therapies


    Introduction
    Obsessive Compulsive Disorder, also known as OCD, is an anxiety disorder in which people have recurring, unwanted thoughts and behaviors that one feels the need to repeat repetitively. Many people have intrusive thoughts, and/or repetitive behaviors, but usually do not act on them. People with OCD have thoughts that are persistent, undesirable, and cause unwanted distress. Behaviors are visible or mental and interact with one’s daily activities and social interactions.

    Current estimates state this condition affects approximately 1 in 40 adults in the United States, affecting roughly 2.2 million adults or 1.0% of the adult population, and 1 in 100 children.22 It equally affects men, women, and children of all races and socioeconomic status.20,22 The average age of onset is 19, with 25% of cases occurring before age 14. OCD is not only common in the United States, but also worldwide. The World Health Organization ranks OCD as one of the top 20 causes of illness-related disability worldwide between ages 15-44.11 Despite OCD being a common mental illness, most only seek treatment after several years of suffering. Those who suffer from OCD tend to be secretive about their symptoms and suffer from shame and embarrassment, which can lead to a delay in treatment. Less than one-third of OCD sufferers receive appropriate pharmacotherapy and even less receive evidence-based psychotherapy.11

    Obsessions vs. Compulsions
    Obsessions are repeated, persistent, unwanted thoughts and urges that are intrusive and cause distress or anxiety. These thoughts are hard to ignore and typically intrude on daily thoughts. Obsessions often have themes to them, such as, fear of contamination, needing things orderly and symmetrical, aggressive or horrific thoughts about harming yourself or others.15,16

    Compulsions are repetitive behaviors that one feels driven to perform. These repetitive behaviors or mental acts are meant to prevent or reduce anxiety related to the obsessions. However, engaging in the compulsions brings no pleasure and may offer only a temporary relief from anxiety. As with obsessions, compulsions typically have themes. Examples of these themes include constantly washing and cleaning, checking, counting, following a strict routine, and demanding reassurance.15, 16

    Diagnosis
    Many people experience intrusive thoughts and exhibit repetitive behaviors. A diagnosis of OCD is made only if symptoms are time consuming (i.e. more than an hour per day), distressing and cause significant interference in functioning.14 Unlike physical diseases and illnesses, no specific laboratory tests are available to diagnose mental illness. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) acts as a manual for mental health professionals in giving an OCD diagnosis. Although not all experts agree on the definitions and criteria set forth in the DSM-5, it is considered the gold standard by most mental health professionals in the United States.2,3 In order to determine if a patient meets DSM-5 diagnostic criteria for OCD, the patient must experience the presence of recurrent, unwanted, and intrusive thoughts and/or repetitive behaviors or rituals intended to relieve the fear, anxiety, and/or distress associated with obsessions. Additionally, obsessions and compulsions must cause significant distress and impairment in social, academic, and/or family functioning. The exclusion clause is that the obsessions or compulsions are not best explained by another mental disorder (table 1).12 Further diagnostic criteria include the addition of a “with tics” specifier and specifier distinguishing one’s insight: “with good or fair insight,” “with poor insight,” or “with absent insight/delusional beliefs.”2,3

    In the early 1990s, investigators identified a subgroup of children who developed a sudden onset of OCD symptoms following an active infection with beta-hemolytic Streptococcus.21 This was later identified as PANDAS, an acronym for “pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections.” Newer research has shown that strep is not the only infection that can cause these sudden-onset symptoms. In a condition known as Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS), similar OCD symptoms are observed following a wide variety of infections, such as mycoplasma, mononucleosis, Lyme disease, influenza, and auto-inflammatory diseases.21,23 PANDAS/PANS is a rare condition that affects roughly 1 in 2,000 children.2,3 Both conditions should be managed with antibiotic treatment followed by standard OCD treatments for continued symptoms.

    Risk Factors
    There are no clearly established environmental risk factors for OCD. However, some patients describe the onset of symptoms after a biologically or emotionally stressful event.1 There have been components of genetic factors contributing to an increased risk for developing OCD. Twin and family studies have shown that people with first-degree relatives who have OCD are at a higher risk for developing OCD themselves. The risk is higher if the first-degree relative developed OCD as a child or a teen.22 Ongoing research continues to explore the connection between genetics and OCD, which may help improve OCD diagnosis and treatment.

    Treatment
    First-line treatments for OCD are cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs).2 The U.S. Food and Drug Administration approved clomipramine, fluoxetine, fluvoxamine, paroxetine, and sertraline for treatment of OCD in adults. Sertraline, fluoxetine, and fluvoxamine have also been approved for use in children six, seven, and eight years of age and above, respectively.5,6,7,12 Although meta-analyses of placebo-controlled trials suggest greater efficacy and superiority for clomipramine than for fluoxetine, fluvoxamine, paroxetine and sertraline, the results of head-to-head trials comparing clomipramine and SSRIs does not support clomipramine as a first line agent.14,16 SSRIs are considered first line because the agents have less side effects and are better tolerated than clomipramine (table 2).12 Unlike the SSRIs, clomipramine also blocks norepinephrine reuptake, muscarinic cholinergic receptors, H1 histamine receptors, and alpha1-adrenergic receptors. Thus, clomipramine is more likely to induce anticholinergic effects, weight gain, sedation, orthostatic hypotension, and cardiac arrhythmias.16 In choosing among the SSRIs, the prescriber should consider the safety and acceptability of particular side effects for the patient, including any applicable FDA warnings, potential drug interactions, past treatment response, and the presence of co-occurring general medical conditions.

    Cognitive Behavioral Therapy (CBT) alone is recommended for a patient who is not too depressed, anxious, or severely ill to cooperate with this treatment modality, or who prefers not to take medications. CBT is the only form of psychotherapy for OCD whose effectiveness is supported by controlled trials.16 Compared to traditional psychotherapy, in which sessions are spent merely discussing the client’s problems, CBT treatment for OCD is far more proactive.8 Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a common assessment tool therapists use to help the client create a detailed list of his or her symptoms.18 Y-BOCS is considered the gold standard assessment tool for OCD symptom severity. Y-BOCS is a 10-item, clinician-administered scale designed to rate symptom severity, not to establish a diagnosis.18

    This list of symptoms is then used as the primary tool in a form of CBT treatment called Exposure and Response Prevention (ERP). The CBT variant that relies primarily on behavioral techniques, such as Exposure and Response Prevention (ERP), has the strongest evidence base. In CBT consisting of ERP, patients are taught to confront feared situations and objects (i.e. exposure) and to refrain from performing rituals (i.e. response prevention). Literature and expert opinion suggest providing CBT at least once weekly for 13-20 weeks.16

    An SSRI alone is recommended for a patient who has previously responded well to a given drug, prefers treatment with an SSRI alone, or when CBT is not accessible. Starting with an SSRI alone may enhance cooperation with treatment by diminishing symptom severity.1,16 Combined treatment with SSRI and CBT is more effective than monotherapy for some patients, but is not always necessary. Combined treatment should be considered for patients who have had an unsatisfactory response to monotherapy, who have occurring psychiatric conditions for which SSRIs are effective, or have severe OCD. Most patients will not experience substantial improvement until 4-6 weeks after starting medication, and some who will ultimately respond will experience little improvement for as many as 10-12 weeks.1,16

    Changing Treatment
    Initial treatments rarely produce freedom from all OCD symptoms and there is typically opportunity for improvement.2 If the patient continues to have an inadequate response to treatment, there are second-line options to consider. Examples include augmenting an SSRI with an antipsychotic medication, switching to a different SSRI, or switching to venlafaxine. Venlafaxine, a serotonin-norepinephrine reuptake inhibitor with preferential serotonergic action, has been studied in comparison to paroxetine in a double blinded study and clomipramine in a single blinded study.1,16 The studies found no difference in the efficacy between venlafaxine and the comparator agents in acute control of OCD. Given the absence of evidence from placebo-controlled trials, venlafaxine is not the first-line treatment for OCD.2 Hence, the guidelines consider venlafaxine as a second-line monotherapy agent in the treatment of OCD. In 2006, the National Institute of Clinical and Health Excellence (NICE) guidelines for Obsessive Compulsive Disorder (OCD) recommended anti-psychotics as a class for SSRI treatment resistant OCD.2 The article aimed to systematically review a meta-analysis on the clinical effectiveness of atypical anti-psychotics augmenting an SSRI. Risperidone and aripiprazole can be used cautiously at a low dose as an augmentation agent in non-responders to SSRIs and CBT. However, these agents should be monitored at four weeks to determine efficacy.2

    If those options have been exhausted, consider less well supported strategies such as augmentation of SSRIs with clomipramine, buspirone, pindolol, or once-weekly morphine sulfate.2,12 Morphine sulfate should be avoided in patients with contraindications to opiate administration. Last resort therapies include monotherapy with dextroamphetamine, tramadol, monoamine oxidase inhibitors, ondansetron, transcranial magnetic stimulation, or deep brain stimulation.2,12 These options may be considered in selected circumstances.

    Relapse is common in OCD patients, so it’s important to continue some form of treatment. Patients should continue successful medication treatment for 1-2 years before considering a gradual taper by decrements of 10%-25% every 1-2 months while observing for symptom return or exacerbation.10

    Conclusion
    Obsessive Compulsive Disorder is an anxiety disorder that traps people in endless cycles of repetitive thoughts and behaviors. There has been research done that suggests genetics are a factor for developing OCD. However, more research needs to be conducted on the environmental reasons a person has OCD. Studies show OCD affects gender, race, and socioeconomic status equally. DSM-V is the current diagnostic tool used by clinicians. If a patient is diagnosed, there are treatment options with CBT and/or pharmacologic options. Choice of initial treatment modality is individualized and depends on factors such as the nature and severity of the patient’s symptoms, co-occurring psychiatric and medical conditions, availability of CBT, the patient’s past treatment history, current medications, and preferences.


    References:

    1. Abramowitz, J. Effectiveness of psychological and pharmacological treatments for obsessive-compulsive disorder: a quantitative review. Journal of Consult Clinical Psychology. 1997; 65(1): 44-52.

    2. American Psychiatric Association: Clinical Guidance on Obsessive Compulsive Disorder. Arlington, VA, American Psychiatric Association, 2013.

    3. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th Edition. Arlington, VA, American Psychiatric Association, 2013.

    4. Bokor, G., Anderson, PD. Obsessive-Compulsive Disorder. Journal of Pharmacy Practice. 2014 April; 27 (2): 116-130.

    5. Clomipramine [package insert]. Hazelwood, MO: Mallinckrodt Inc.; Revised October 2012. Accessed 14 January 2018.

    6. Fluoxetine [package insert]. Indianapolis, IN: Eli Lilly and Company Inc.; 1987. Accessed 15 Jan 2018.

    7. Fluvoxamine [package insert]. Palo Alto, CA: Jazz Pharmaceuticals Inc.; 2008. Accessed 15 Jan 2018.

    8. Goodman, W, Lydiard, R. Recognition and Treatment of Obsessive-Compulsive Disorder. Journal of Clinical Psychiatry. 2007 December; 68 (12): e38.

    9. Keeley, M., Storch, E., Dhungana, P., et al. Pediatric Obsessive-Compulsive Disorder: A Guide to Assessment and Treatment. 2007 June; 28(6): 555-74.

    10. Koran, Lorrin M., M.D.; Simpson, Blair H., M.D., Ph.D. Guideline Watch (March 2013): Practice Guideline for the Treatment of Patients with Obsessive-Compulsive Disorder. www.psychiatryonline.org. March 2013.

    11. Lexi-Comp, Inc. (Lexi-DrugsTM). Accessed 12 Jan 2018.

    12. Mcintrye, John S., M.D.; Charles, Sara C.; et al. Treating Obsessive-Compulsive Disorder: A Quick Reference Guide. American Psychiatric Association. July 2007.

    13. Paroxetine [package insert]. Research Triangle Park, NC: GlaxoSmithKline Inc.; December 2012. Accessed 15 Jan 2018.

    14. Reddy, J., Sundar, A., Narayanaswamy, J.; et al. Clinical practice guidelines for Obsessive-Compulsive Disorder. 2017. 59(5): 74-90.

    15. Seibell, Phillip J.; Hollander, Eric. Management of Obsessive-Compulsive Disorder. 2014; 6: 68.

    16. Sousa, MB, et al. A randomized clinical trial of cognitive-behavioral therapy and sertraline in the treatment of obsessive-compulsive disorder. Journal of Clinical Psychiatry. 2006; 67 (7): 1133.

    17. Stewart, Evelyn S. Obsessive Compulsive Disorder. Psychiatric Neurotherapeutics. 2016; 2: 23-50.

    18. Storch E., Larson M., Price L., et al. Development and psychometric evaluation of the Yale-Brown Obsessive-Compulsive Scale-Second Edition. Psychological Assess 2010a; 22(2): 223-232.

    19. Sertraline [package insert]. New York, New York: Pfizer Inc.; Revised January 2018. Accessed 14 January 2018.

    20. Swedo S., Leckman J., Rose N. From research subgroup to clinical syndrome: Modifying the PANDAS criteria to describe PANS (Pediatric Acute-onset Neuropsychiatric Syndrome). Pediatric Therapeutics 2012, 2:2.

    21. Swedo SE, Leonard HL, Garvey M.; et al. Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections: Clinical description of the first 50 cases. American Journal of Psychiatry 144:2, February 1998; pp 265-271.

    22. UpToDate Inc. Accessed 14 Jan 2018.

    23. What are PANS/PANDAS? American Psychiatric Association. September 7, 2017.

    Appendix

    Table 1. Symptoms of Other Psychiatric Disorders to be Differentiated From the Obsessions, Compulsions, and Rituals of Obsessive-Compulsive Disorder (OCD). 12


    Table 2. Dosing of Serotonin Reuptake Inhibitors (SSRIs) in Obsessive-Compulsive Disorder.12

    Click Here for a Self Assessment

  • 22 Mar 2018 10:34 AM | MSHP Office (Administrator)

    Authors:
    Kim Ehrhard, PharmD Candidate 2019: UMKC School of Pharmacy
    Ben Miskle, PharmD Candidate 2018: UMKC School of Pharmacy
    Steve Stoner, PharmD, BCPP: UMKC School of Pharmacy

    It is estimated that there are about five million people currently taking antipsychotic medications and that number is continuing to rise as the use of antipsychotics has expanded beyond use for schizophrenia and are now used in bipolar disorder and major depression.1 Adherence is critically important with antipsychotic treatment and a consistent barrier to medication adherence has been some concern over long-term consequences of side effects. One of those concerns has been the potential for developing tardive dyskinesia (TD), which can be described as an involuntary, repetitive, purposeless movement, typically of the tongue, jaw, lips, face, trunk, or upper extremities.2 This side effect is thought to be caused by medications that work through dopamine receptor blockade, which include antipsychotic medications and gastrointestinal medications, such as metoclopramide.2,3 It is estimated that at least 1 in 10 patients exposed to antipsychotics has TD.1 A common assessment tool for TD is the 12-item Abnormal Involuntary Movement Scale (AIMS). Administration of this scale helps to identify the level of severity of the involuntary movements. An AIMS score of at least two, in two or more body regions, or a score of three to four, in at least one body region, in a patient with at least three months of cumulative antipsychotic drug exposure, equates to a probable diagnosis of TD.4 Until recently, if TD was not caught and addressed early it was thought to be irreversible. However, in 2017 the FDA approved two new medications indicated for the treatment of TD. These two medications, deutetrabenazine (Austedo™) and valbenazine (Ingrezza™) are similar in their primary mechanisms of action, but also possess distinct differences that should be considered.

    Mechanism of Action
    The exact mechanism of deutetrabenazine and valbenazine is unknown, though they likely exhibit their effects through reversible vesicular monoamine transporter 2 (VMAT2) inhibition.7,9 VMAT2 plays a key role in dopamine signaling as it is a transporter protein found in the presynaptic neurons of the CNS and helps package monoamines into synaptic vesicles for release within the synaptic cleft. TD is thought to be associated with prolonged exposure to dopamine receptor blocking agents and subsequent hyperactive dopamine signaling. This is thought to cause upregulation and hypersensitivity in postsynaptic dopamine D2 receptors in one of the areas of the brain that controls motor function.5,6 With deutetrabenazine and valbenazine selectively inhibiting the VMAT2 receptor, these medications are thought to provide reversible reductions of dopamine reuptake within the vesicle leading to a reduced number of monoamines available to bind hypersensitive postsynaptic dopamine D2 receptors.7,9

    Dosing/Drug Interactions
    Deutetrabenazine – The initial dose of deutetrabenazine is 6 mg twice daily for tardive dyskinesia. The dose may be increased weekly based on response and tolerability in increments of 6mg/day to a maximum of 48mg/day. With a total daily dose ≥12mg, administer in two divided doses and give with food. There are potential drug interactions to consider with deutetrabenazine. Deutetrabenazine is a substrate of CYP1A2, CYP2D6, and CYP3A4. In combination with strong CYP2D6 inhibitors like paroxetine, fluoxetine, bupropion, and quinidine, as well as poor CYP2D6 metabolizers, a maximum dose of 18mg/dose or 36mg/day should be utilized.8 Deutetrabenazine use should also be avoided with MAOIs.

    Valbenazine - The initial dose for valbenazine is 40 mg once daily. After one week, the dose should be increased to the recommended dose of 80mg once daily. Continuation of 40mg once daily may be considered for some patients. Valbenazine may be taken with or without food. There are important considerations to make when putting a patient on valbenazine including drug interactions. Valbenazine and its active metabolite are metabolized via CYP3A4 and CYP2D6. It is recommended that valbenazine be avoided in use with CYP3A4 inducers as concomitant may decrease the exposure of valbenazine and its active metabolite. Some examples of CYP3A4 inducers are rifampin, carbamazepine, and phenytoin. Dose reductions are also recommended during concomitant use with CYP2D6 and CYP3A4 inhibitors. Valbenazine should also not be used with any MAOIs.10

    There are some major warnings that come with each medication that need to be taken into account. Deutetrabenazine has the potential adverse effect of QT prolongation and should be adjusted with patients taking strong CYP2D6 inhibitors as well as those who are poor CYP2D6 metabolizers. Somnolence, diarrhea, fatigue, and xerostomia have shown to be the most prolific adverse effects associated with deutetrabenazine. One particular important side effect with deutetrabenazine is the black box warning for depression and suicidality in patients with Huntington’s Disease. Caution should be used in treating patients with a history of depression or prior suicide ideation. Deutetrabenazine is contraindicated in patients with untreated or inadequately treated depression.7-10

    With valbenazine, the major adverse effects include somnolence and QT prolongation. Due to somnolence, it is important that the patient avoids operating heavy machinery or activities that require them to be alert while taking this medication. Even though QT prolongation is a precaution to look at, the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing.10 Dose adjustments should be made in the situation of patients with congenital long QT syndrome, patients with arrhythmias, as well as patients on strong CYP3A4 or CYP2D6 inhibitors and poor CYP2D6 metabolizers.

    Clinical Significance
    Deutetrabenazine – The ARM-TD study was a randomized, double-blind, placebo-controlled, parallel group study designed to assess the safety and efficacy of deutetrabenazine over the course of 12-weeks. This trial included patients who had been diagnosed with TD for ≥3 months before screening and an AIMS motor score ≥6 (using a modified AIMS scale) at both screening and baseline, verified by a blinded central rater, with the baseline AIMS score of 9.6. The primary efficacy endpoint was the change in AIMS dyskinesia total score from baseline to week 12 as assessed by two blinded central video raters. Patients were randomized to deutetrabenazine 6mg twice daily or matching placebo with alpha set at 0.05. Deutetrabenazine was titrated weekly by 6mg until adequate dyskinesia control was achieved, a significant adverse effect occurred, or the maximal allowable dose of 48mg/day was achieved. Deutetrabenazine was found to be superior to placebo with a reduction of 3.4 points in the AIMS score for deutetrabenazine (p=0.027).11

    Valbenazine - The KINECT 3 study was a randomized, double-blind, placebo-controlled trial designed to assess the safety and efficacy of valbenazine. This trial included patients with moderate to severe tardive dyskinesia as determined by clinical observation and an underlying diagnosis of schizophrenia, schizoaffective disorder, or a mood disorder, with a baseline AIMS score of 10. The primary efficacy endpoint was the mean change from baseline in the AIMS dyskinesia total score at the end of Week 6 when patients were given fixed doses of valbenazine 40 mg, valbenazine 80 mg, or placebo with alpha set at 0.05.


    The valbenazine 80 mg group was found to be statistically significant with a 3.2 point reduction in the total AIMS score compared to placebo (P<0.001).12 These results are also found to be clinically significant as a change of 3 in the AIMS score can significantly improve a patient’s quality of life.13 It is important to note that longer trials are necessary to understand the long-term effects of deutetrabenazine and valbenazine in patients with tardive dyskinesia, as well as trials comparing the efficacy of deutetrabenazine in comparison with valbenazine for treatment of TD.

    Role in Therapy
    Both deutetrabenazine and valbenazine have been shown to be effective in treating TD, a once thought incurable side-effect of antipsychotic therapy. For patients whose TD is not improved by a reduced dosage of antipsychotic medication or a change in antipsychotic therapy, the VMAT2 inhibitors provide a potential treatment option for TD.


    References:

    1. Cloud LJ, Zutshi D, Factor SA. Tardive dyskinesia: therapeutic options for an increasingly common disorder. Neurotherapeutics. 2014;11(1):166-176

    2. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013:712

    3. Kenney C, Hunter C, Davidson A, et al. Metoclopramide, an increasingly recognized cause of tardive dyskinesia. J Clin Pharmacol. 2008;48(3):379-384.

    4. Guy W. ECDEU Assessment Manual for Psychopharmacology. Washington DC: US Department of Health, Education and Welfare; 1976. pp. 534–7.

    5. Stahl SM. Essential Psychopharmacology Online. Based on: Stahl SM. Stahl’s Essential Psychopharmacology. 4th ed. Cambridge, UK: Cambridge University Press; 2013. http://stahlonline.cambridge.org/essential_4th_chapter.jsf?page=chapter5_introduction.htm&name=Chapter%205&title=Conventional%20antipsychotics#c02598-5-1. Accessed January 2nd, 2018

    6. Sayers AC, Bürki HR, Ruch W, et al. Neuroleptic-induced hypersensitivity of striatal dopamine receptors in the rat as a model of tardive dyskinesias: effects of clozapine, haloperidol, loxapine and chlorpromazine. Psychopharmacologia. 1975;41(2):97-104.

    7. Deutetrabenazine. Lexi-Drugs Online. Hudson (OH): Lexi-Comp, Inc. 1978-2015 [cited 2018 Jan 4]. Available from: https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6454757

    8. Austedo (deutetrabenazine)[package insert]. Teva Pharmaceuticals USA, Inc., North Wales, PA;2017.

    9. Valbenazine. Lexi-Drugs Online. Hudson (OH): Lexi-Comp, Inc. 1978-2015 [cited 2018 Jan 4]. Available from: https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/6463109

    10. Ingrezza (valbenazine)[package insert]. Neurocrine Biosciences, Inc,, San Diego, CA;2017.

    11. Fernandez H, Factor S, Hauser R, et al. Randomized Controlled Trial of Deutetrabenazine for Tardive Dyskinesia. Am J Neurol. 2017;88:2003-2010.

    12. Hauser R, Factor S, Marder S, et al. KINECT 3: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Valbenazine for Tardive Dyskinesia. Am J Psychiatry. 2017;174:476-484.

    13. Stacy M, Kurlan R, Burke J, Siegert S, Liang G, O’Brien C. An MCID for AIMS Dyskinesia Total Score Change in Subjects with Tardive Dyskinesia. Mov Disord. 2017; 32 (suppl 2).

  • 22 Mar 2018 10:33 AM | MSHP Office (Administrator)

    Authors:
    Thi Dang, PharmD Candidate 2019: UMKC School of Pharmacy
    Leigh Anne Nelson, PharmD, BCPP: UMKC School of Pharmacy

    Alcohol Use Disorder (AUD) is a pattern of alcohol use that includes compulsive alcohol use, loss of control over alcohol intake, and having withdrawal symptoms when decreasing or ceasing alcohol intake. Alcohol effects on physical, psychological, and mental health can lead to many diseases and injury-related health conditions. In the United States, AUD is most common between ages 18 through 29 and overall, the rate of AUD is increasing. The Amercian Psychiatric Association (APA) developed a new practice guideline in 2018, which provides recommendations regarding appropriate use of medications for treatment of AUD, assessment to reduce the psychological and public health consequences from problematic alcohol use and guidelines to enhance the effectiveness of treatment. APA recommends appropriate pharmacotherapy to patients with AUD, including naltrexone, acamprosate, disulfiram, topiramate, and gabapentin. Additionally, the guideline cautions against use of certain medications, such as antidepressants and benzodiazepines.

    Naltrexone is offered to patients with moderate to severe AUD or opioid use disorder to reduce alcohol consumption and help decrease cravings. The recommended starting dose of oral naltrexone is 50 mg daily and maximum is 100 mg daily. Common adverse events from oral naltrexone include abdominal pain, nausea, diarrhea, vomiting and dizziness. Overall, it is well tolerated. For long acting naltrexone, patients may consider naltrexone intramuscular (IM) injection. The recommended dose is 380 mg IM every 4 weeks. Associated side effects of intramuscular naltrexone include pain or induration at the injection site and increased potential for bleeding in patients who take anticoagulants. Because naltrexone reduces the efficacy of opioids for analgesia and elevates hepatic enzymes, APA recommends against using naltrexone as a treatment for AUD if patients also use opioids or anticipate the need for opioids in the near future. Naltrexone should also be avoided in patients with acute hepatitis or liver failure.

    Acamprosate is recommended to treat patients with moderate to severe AUD and helps to reduce alcohol consumption. The recommended starting dose is 666mg three times daily. A common side effect is diarrhea. Overall, it is well tolerated. Acamprosate is excreted through kidneys, hence, serum creatine should be measured at baseline. Acamprosate is not recommended for patients who have severe renal impairment or when CrCl is less than 30 mL/min. In patients with mild to moderate renal impairment with CrCl between 30-50 mL/min, the acamprosate dose should be reduced. The main barrier of using acamprosate is the medication needs to be dosed three times a day.

    Disulfiram is offered to patients with moderate to severe AUD, who are intolerant to naltrexone and acamprosate. It is not the first line of treatment. Disulfiram is appropriate only for patients who seek abstinence and are actively using alcohol or products containing alcohol. The usual recommended dose of disulfiram is 250 mg daily and common side effects include liver toxicity, tachycardia and QTC prolongation. Disulfiram is associated with several drug interactions that may limit its use and is not recommended in patients with seizure disorders. Ritonavir and other antiretroviral medications increase disulfiram levels through CYP450 3A4 and metronidazole can cause psychosis and confusion when combined with disulfiram. To help avoid possible drug interactions with disulfiram, patients should let healthcare providers or emergency personnel know that they are taking disulfiram.

    Topiramate is recommended for patients with moderate to severe AUD, who are intolerant to naltrexone and acamprosate. The recommended starting dose is 200-300 mg daily. Common adverse events include weight loss, sedation, cognitive dysfunction and dizziness. Before starting topiramate as an initial treatment for AUD, it is appropriate to assess the patient’s cognitive status and renal function. In patients with renal impairment, the topiramate dose should be reduced.

    Gabapentin helps to reduce the alcohol consumption and increases the rate of abstinence in patients with AUD. The recommened starting dose is between 900 to 1800 mg/day and associates with common adverse events include fatigue, insomina, and headache. In patients with renal impairment, the dose of gabapentin should be adjusted.

    APA recommends against use of specific medications, including antidepressants and benzodiazepines. Antidepressant medications should not be used for treating AUD unless the patient has comorbid conditions, such as depression or anxiety disorder. Before starting pharmacotherapy for patients with AUD, the initial evaluation should include the assessment for comorbid psychiatric disorders. Benzodiazepines are not the primary treatment of AUD, except for alcohol detoxification or the treatment of alcohol withdrawal. Because of the risk for sedation, behavioral impairment, respiratory depression, benzodiazepines or other sedative-hypnotic agents should be limited.

    To improve the quality of care and treatment outcomes for patients with AUD, APA developed this updated practice guideline to provide information on the comparative effectiveness of naltrexone, acamprosate, topiramate, gabapentin, and disulfiram. Additionally, the practice guideline includes recommendations and sugesstions related to the psychiatric evaluation of patients with AUD.


    Reference:

    American Psychiatric Association (2018, January 19). The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. Retrieved Feburary 19, 2018, from https://psychiatryonline.org/doi/pdf/10.1176/appi.books.9781615371969


  • 22 Mar 2018 10:27 AM | MSHP Office (Administrator)

    Author: Nicole Burns, PharmD; PGY-1 Pharmacy Resident: Christian Hospital

    Adherence is just one of many potential barriers that may prevent patients from reaping the benefits of their prescribed therapies. Fortunately, there are a number of tools available to assist them with the task of remembering to take their medication. Many patients utilize applications on their smart phone as well as alarms, calendars, pill boxes, and various other reminders. Although non adherence is common across all areas of medicine, patients with psychiatric disorders may possess additional barriers to adherence.  

    Abilify MyCite®, aripiprazole with an Ingestible Event Marker (IEM), was approved by the Food and Drug Administration in November of 2017. This is the first approved medication in the United States with a digital ingestion tracking system. If your first thought was that this technology could potentially bring a schizophrenic patient’s delusion to life, you aren’t alone. It is rather ironic that the first roll-out of an ingestible medication tracking system is in a medication used for patients with psychiatric disorders.

    The Abilify MyCite® system is composed of three main components: an oral tablet with a built-in IEM, a patch, and a smart phone application. The Abilify MyCite® Patch should be applied to the left side of the body just above the lower edge of the rib cage. After ingestion, the IEM in the Abilify MyCite® tablet will become activated upon interaction with gastric fluid and will then send a signal to the patch that the medication has been taken. Patients must also download the MyCite® application to their phone and have Bluetooth enabled in order for the data to be recorded. Of note, it may take up to two hours for the system to detect ingestion although most ingestions are detected within 30 minutes.

    Patients may take this medication with or without food. The MyCite® Patch should remain on the individual during activities such as showering, swimming, and exercising. The MyCite® Patch should be replaced at least one weekly. Otherwise, the phone application will conveniently prompt patients to change their patch when needed.

    This technology serves additional purposes other than tracking ingestion. Abilify MyCite® also has the capability to measure a patient’s physical activity via step counting and detect sleep duration and disruptions by recording changes in posture. This information may be incredibly helpful to healthcare providers, as sleep disturbances and abrupt changes in amount of physical activity may serve as markers of a worsening psychological condition that could require immediate intervention.

    During a small four-week observational pilot study in 12 patients with bipolar and 16 patients with schizophrenia, feasibility and patient acceptance of the digital ingestion tracking technology was evaluated. Patients included in the pilot were required to be on a stable regimen of oral mood stabilizers or antipsychotics for at least 14 days with no anticipation of changes being made during the study.

    Candidates were excluded if they scored a three or higher on the suspiciousness/paranoia section of the Brief Psychiatric Rating Scale (BPRS). This tool is utilized to assess the severity of a patient’s psychiatric symptoms with a score from 1-7, with 1 being not present, 3 being mild, and 7 being extremely severe. Patients were also excluded if they had diagnoses or symptoms of substance use disorder, unstable medical illnesses, implanted electrical devices, or were pregnant.

    In this particular patient population, Abilify MyCite® did not lead to worsened psychosis. In fact, 70% of the patients in this pilot found the concept of the digital tracker easy to understand. A total of 89% thought the digital tracker could be useful to them and 78% wanted reminders sent to them if they forgot to take their medication.

    The most common adverse effect in this study was skin irritation at the patch site (occurred in 18% of participants). One patient was withdrawn from the study due to worsening paranoia and development of a BPRS score of >3. The patient was known to have a prior history of paranoia, but did not express any concerns related to the ingestible tracker or study staff. It was determined that the exacerbation was unrelated to the patient’s participation in the study.

    Although the first medication to be marketed with this digital tracking technology was tested in a clinically stable patient population with psychiatric ailments, the clinical utility of the tracking device itself is limitless. There are many ongoing studies pertaining to application of this technology to medications for cardiovascular diseases, Hepatitis C, and tuberculosis with promising preliminary results in hundreds of patients. Additionally, future generations of patients will be excellent candidates for digital tracking of medication adherence for a wide variety of medical conditions, as more advanced technology is already largely present and welcomed in their daily lives.

    References:

    1. Abilify MyCite® (aripiprazole tablets with sensor) [package insert]. Otsuka America Pharmaceutical Inc., Rockville, MD; 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207202lbl.pdf. Accessed February 15, 2018.

    2. Rosenbaum L. Swallowing a spy- The potential uses of digital adherence tracking. N Engl J Med. 2018;378(2):101-103.

    3. Kane JM, Perlis RH, DiCarlo LA, Au-Yeung K, Duong J, and Petrides G. First experience with a wireless system incorporating physiologic assessments and direct confirmation of digital tablet ingestions in ambulatory patients with schizophrenia or bipolar disorder. J Clin Psychiatry. 2013;74(6):e533-540.

    4. Proteus Digital Health, Inc. Proteus Digital Health website. https://www.proteus.com. Accessed February 20, 2018.


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