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VSHP January 2020 Newsletter 
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VSHP Spring Seminar 2020
Virginia Crossings Hotel
Richmond, VA

March 6-7, 2020

12 hours of live CE available

For agenda, registration and other details, visit: http://vshp.org/page-1075368



 
ELECTION OF VIRGINIA DELEGATES TO THE ASHP HOUSE OF DELEGATES
 
Lisa Hammond was elected to serve a three year term as a Virginia delegate to the ASHP House of Delegates.  She will join Natalie Nguyen, Craig Kirkwood and Katelyn Hipwell as delegates to the ASHP House of Delegates for 2020.
Kathy Koehl was elected to a one year term as an alternate delegate.
VSHP Grant Awards Announcement

This year $7,000 was set aside by VSHP for the grants program. This program allowed VSHP members to apply for a grant in order to fund a project which will improve health-system pharmacy services and patient care in Virginia.

We had 13 grant proposals submitted for consideration. We are excited that projects submitted from three VSHP members will be funded for the following year.

  • One proposal will be to support training for Hampton University faculty to become QPR instructors. QPR training for organizations will help learn how to question, persuade, and refer someone who may be suicidal. This would increase the number of trainers offered in Virginia. With approximately 90% of our 4th-year students engaging in APPE rotations in underserved areas where mental health is taboo but suicide rates are increasing, and with more than 75% of our recent graduates going on to practice in similar communities, this training is important. This training will be hosted at a state level to include other VSHP members to provide an even greater benefit for our pharmacists, students and patients.
  • Another project will be to improve pediatric medication safety with OTC medications for refugee patients. Since 1998, Charlottesville, Virginia has become home to over 3,000 refugees from over 32 countries. The International Family Medicine Clinic (IFMC) at the UVA provides comprehensive, culturally sensitive care to the refugee population. There are many barriers that may impact the quality of care provided including language differences. This project will develop patient education materials for two of the most common over-the-counter medications, acetaminophen and ibuprofen, in the native language of many of our refugee patients.
    After creation of translated patient education materials, we would then reproduce these and begin giving these during scheduled office visits for our pediatric patients. These education materials will be available to all VSHP members.
  • VSHP will also support a Pharmacy Technician Enrichment Series once every quarter. This will also be offered to the entire VSHP membership via on site and distance education options.
Thank you for all of the interest for the VSHP grant submission process. We are interested in hearing your feedback and are working to streamline the submission and review process moving forward. We will send out communication on the submission period soon for next year!
 
Catherine Floroff, PharmD
cfloroff@gmail.com

Interested in presenting a Poster at the 2020 VSHP Spring Seminar in Richmond, VA, Saturday, March 7, 2020 
  • The deadline for all abstract submission is Friday, February 14, 2020.
  • All submissions must have results at the time of submission.  The ASHP Midyear Clinical Meeting Student Poster Submission Rules and Format Guidelines offer formatting suggestions.
  • IMPORTANT: The Primary Author must be the person submitting the abstract. Primary Authors can only submit ONE abstract, however, a primary author can be an additional author on other abstracts. Submitting an abstract on behalf of someone else is prohibited.
  • Poster session is Saturday, March 7, 2020
  • Questions and poster submissions should be emailed to contact@vshp.org

ASHP Information

Comments to CMS on the Scope of Practice

ASHP, in collaboration with other national pharmacy groups and our affiliates including VSHP, has submitted extensive recommendations to CMS regarding the elimination of regulations that limit pharmacists from practicing at the top of their license. CMS requested additional input and recommendations under the Oct. 3, 2019, Executive Order "Protecting and Improving Medicare for Our Nation's Seniors."   
 

 
New Year, New Requirements: PTCB Launches New Certification Requirements and Updated Exam

Applicants must complete education and training or work experience to be eligible in 2020
 
WASHINGTON, DC -- With the start of the new year, the Pharmacy Technician Certification Board® (PTCB®), the nation's leading certifying organization for pharmacy technicians, has implemented new eligibility requirements and an updated Pharmacy Technician Certification Exam® (PTCE®) for its Certified Pharmacy Technician (CPhT) Program. The 2020 changes are based on data generated by PTCB's most recent pharmacy Job Task Analysis, reflecting input from more than 40,000 technicians across practice settings, and guidance from the pharmacy community, including employers, educators, and organizations.
 
"PTCB is focused solely on advancing medication safety, and we rely on data and input from pharmacy professionals to guide the direction of our program updates," said PTCB Executive Director and CEO William Schimmel. "With the 2020 changes, PTCB reaffirms our commitment to ensuring that PTCB's CPhT Program advances patient care. Pharmacists can trust that technicians who earn PTCB credentials have demonstrated current knowledge that is critical to performing their jobs safely in today's pharmacy workplace."


Review of Position Statement on Integrating New Migraine Treatments into Clinical Practice
Francine Kim, PharmD Candidate 2020, Kayla Ryan, PharmD, University of Virginia Health
 
Background
     Migraine is a chronic or episodic headache disorder associated with intense pain that is often unilateral in nature, accompanied by symptoms such as nausea and vomiting, photosensitivity, and phonosensitivity.1 About one-third of individuals experience an aura prior to an attack, which can be characterized by seeing flashing lights, experiencing numbness or tingling in the face or extremities, or increased sensitivity to odors.1 Around 1 out of every 7 Americans is affected by migraines annually, with an increased prevalence in women especially during their reproductive years.2 Symptoms of migraine cause an average of 50% loss in productivity leading to a substantial economic burden. 2 Treatment options for migraine aim to abort a current migraine, prevent future migraines, or both.3 Severity and frequency of migraine vary both between patients and over time for individual patients. Thus, treatments must be individualized and modified to optimize efficacy. Current migraine treatment options include acetaminophen, NSAIDs, triptans (sumatriptan, frovatriptan, zolmitriptan, etc), ergot derivatives, select beta blockers (propranolol, metoprolol), and select anticonvulsants (topiramate, divalproex). Recent advent of novel medications, device technologies, new formulations of established drug therapies, and biologics have added new treatment options. To address the integration of these novel treatments with current clinical practice, the American Headache Society released a position statement updating guidance on preventive and acute treatment of migraine. This article will address indications for acute and preventive treatments, guideline-based recommendations for the use of novel agents, and data supporting use of new agents.
 
Preventive Treatment
     The indications for preventive treatment remain unchanged from previous guidelines. Preventive treatment should be considered for patients in whom attacks significantly interfere with their daily lives, experience frequent attacks, experience adverse effects with acute treatments, possess contraindication to, failure of, or overuse with acute treatments, or have migraine of uncommon subtypes (hemiplegic migraine, migraine with brainstem aura, migraine with prolonged aura, and those who have previously experienced a migrainous infraction).4 Prior to starting preventive therapy, ensure that acute treatments have been optimized by finding the most appropriate drug type, route and timing of administration, and frequency of use. Additionally, acute treatments should be accompanied by education and lifestyle modifications (e.g. massage therapy, limiting dietary triggers, aromatherapy).4 Agents chosen for preventive treatments should have established evidence supporting their use.4 The guidelines classify preventive agents as those that have established efficacy, are probably effective, and are possibly effective. Oral agents with established efficacy include antiepileptic drugs (divalproex, valproate, topiramate) and beta-blockers (metoprolol, propranolol, timolol).4 In the setting of short-term preventive use for menstrual migraine, frovatriptan has established efficacy. For short-term prophylaxis frovatriptan dosing is 2.5 mg twice daily starting two days prior to menstrual onset and continued for a total of six days, which is different from acute treatment dosing.5 Treatment options that are probably effective and should be considered for migraine prevention are: antidepressants (amitriptyline, venlafaxine), beta-blockers (atenolol, nadolol), and angiotensin receptor blockers (candesartan).4
     The principles guiding use of preventive migraine agents are consistent with previous recommendations. Oral treatments should be initiated at low doses and titrated slowly. Dose titration should continue until one of the following occurs: desired response is achieved, maximum or target dose is reached, or once a patient is unable to tolerate adverse effects (AEs). Combination drug therapy may be beneficial when a partial response is achieved or AEs are dose-limiting.4 Prior to changing therapy, ensure patients are given an adequate trial of oral therapy. Adherence to preventive therapy may be difficult to achieve due to results that do not meet patients' expectations and AEs, thus patient education and shared decision making are crucial in improving adherence. Given the dynamic nature of the quality and frequency of migraine, it is important to reevaluate therapeutic response every six to eight weeks.
     Since publication of previous migraine guidelines, four injectable preventive therapies have been FDA approved for migraine prophylaxis. The injectable therapy options include: onabotulinumtoxinA and three calcitonin gene-related peptide (CGRP) antagonist monoclonal antibodies (mAbs). OnabotulinumtoxinA is approved for chronic migraine, while the mAbs are approved for episodic and chronic migraine. There are several differences with injectable treatment compared to oral: dose titration is not required, therapeutic benefits are observed early, and agents are generally well tolerated. Similar to oral agents, patient centered and validated outcome measures should be used to guide clinical decision making in regard to efficacy and decisions to escalate dose or switch treatment agents.4
     OnabotulinumtoxinA is the only botulinum toxin on the market that is approved for chronic migraine prophylaxis. The agent is delivered as 155 units divided between 31 sites across 7 specific head and neck muscle areas, and is administered every 12 weeks.5 OnabotulinumtoxinA inhibits the release of acetylcholine at the neuromuscular junction thereby inhibiting striated muscle contraction and peripheral sensitization.6 Adverse reactions associated with onabotulinumtoxinA include musculoskeletal/connective disorders, headache, and eyelid ptosis. Additionally, a boxed warning for distant spread of toxin effect is included in the labeling. Support for the efficacy of onabotulinumtoxinA as prophylactic treatment for chronic migraine comes from the results of the PREEMPT study. The PREEMPT study investigated onabotulinumtoxinA's effect on mean change from baseline in frequency of headache days at 24 weeks compared to placebo. Pooled analyses revealed a statistically significant greater decrease in number of headache days in patients treated with onabotulinumtoxinA compared to placebo (-8.4 vs -6.6; p < 0.01). 7 Most study participants reported mild to moderate adverse events, with more patients in the onabotulinumtoxinA treatment arm discontinuing therapy compared to placebo (3.8% vs 1.2%).7
     If patients are unable to tolerate oral agents or onabotulinumtoxinA therapy, calcitonin-gene related peptide (CGRP) antagonists may be indicated.4 CGRP is a neuropeptide released from activated trigeminal sensory nerves and leads to intracranial and extracranial vessel dilation. CGRP also centrally modulates vascular nociception.16 Thus, CGRP plays an important role in the pathophysiology of migraine. Currently, erenumab, fremanezumab, and galcanezumab are the three CGRP antagonists that are FDA approved for prophylaxis. These monoclonal antibodies are the first drugs specifically created to prevent migraine and have fewer adverse drug reactions than previous medications used (i.e. beta-blockers, antiepileptics, and antidepressants). Erenumab is a CGRP receptor blocker, while fremanezumab and galcanezumab target the CGRP ligand. CGRP antagonists avoid hepatic metabolism and renal clearance, thus do not require dose adjustments and avoid possible drug interactions, making them ideal candidates for combination therapy with oral agents. 4 Given the very low/nonexistent risk of drug-mAb interactions, it is reasonable to add a mAb to an existing regimen without other therapeutic changes until effectiveness of the mAb is determined. 5 Principles guiding evaluation of outcomes of treatment are consistent with those mentioned previously; however, evaluation of efficacy of mAb treatment requires 3 or 6 months of outcome data in patients receiving monthly or quarterly injections respectively. 4 Information regarding the dosing, criteria for use, and efficacy data for the CGRP antagonists are summarized in tables 1-4.
 
Table 1. Monoclonal Antibody Summary8-12
Monoclonal Antibody
Route
Dose
Frequency
Mechanism of Action
Erenumab
SQ
70 mg or 140 mg
monthly
IgG2 CGRP receptor blocker
Fremanezumab
SQ
225 mg or 675 mg*
monthly or every 3 months*
IgG2 CGRP ligand antagonist
Galcanezumab
SQ
240 mg LD then 120 mg MD
monthly
IgG4 CGRP ligand antagonist
 
Table 2. Indications for Monoclonal Antibody Prophylaxis4

A. Age ≥ 18 years

 

 

B. ICDH-3 diagnosis of migraine with or without aura (4-7 monthly headache days), plus: 

  • MIDAS score > 11 or HIT-6 score >50
  • Unable to tolerate or inadequate response to at least 2 other oral prophylactic regimens with a 6-week trial

C. Migraine with or without aura (8-14 monthly headache days), plus:

Unable to tolerate or inadequate response to at least 2 other oral prophylactic regimens with a 6-week trial

D. Chronic migraine diagnosis, plus one of the following:

  • Unable to tolerate or inadequate response to at least 2 other oral prophylactic regimens with a 6-week trial
  • Unable to tolerate or inadequate response to 2 quarterly injections of onabotulinomtoxinA
 
Table 3. Criteria for Continuing Biologic Therapy4

A. Reduction in average headache days by ≥ 50% from pretreatment baseline

 

 

B. Clinically meaningful improvement in one of the following measures

  • MIDAS: reduction of ≥ 5 with baseline score 11-20 or 30% reduction with baseline score >20
  • MPFID: reduction ≥ 5 points
  • HIT-6: reduction ≥ 5 points
 
Table 4. Summary of Clinical Trials Supporting Efficacy of Monoclonal Antibodies8-12
Monoclonal Antibody
Trial (Year)
Outcome Measured
Efficacy
Erenumab
ARISE (2018)
Change in MMD* from baseline during 3rd month of therapy
Reduction in MMD* by 2.9 days in episodic migraine vs 1.8 in placebo
Erenumab
STRIVE (2017)
Change in MIDAS score from baseline
Dose dependent MIDAS score improvement
Fremanezumab
Dodick et al. (2018)
Change in mean MMD* at 12 weeks after first dose
1.3 to 1.5-day reduction in mean MMD over 12-week period
Galcanezumab
REGAIN (2018)
Change in MMD* from baseline over 3 months in chronic migraine
120 mg and 240 mg monthly resulted in          ≥ 50% decrease in MMD
Galcanezumab
EVOLVE-2 (2018)
Change in mean MMD* from baseline in episodic migraine
MMD* reduction:
120 mg: 4.3 days
240 mg: 4.2 days
Placebo: 2.3 days
Monthly migraine days*
Migraine Disability Assessment (MIDAS) score: a questionnaire used to measure impact of headaches on daily life
Headache Impact Test (HIT-6): measures adverse impact of headache on social functioning, role functioning, vitality, cognitive functioning and psychological stress
Migraine Physical Function Impact Diary (MPFID): capture experiences on days with migraine as well as the days in-between migraines
 
Acute Treatment
     The guidelines state that all patients with migraine should be offered a trial of acute treatment. For mild-to-moderate attacks, treatment options include NSAIDs, acetaminophen, and combination analgesic + caffeine.4 Moderate or severe attacks or mild-to-moderate attacks with suboptimal response to nonopioid analgesics or caffeinated combos should be treated with triptans or a dihydroergotamine.4 Choosing the appropriate route of administration given symptoms of migraine are also emphasized i.e. sublingual, subcutaneous, and intramuscular administration of abortive therapy in the setting of nausea and vomiting.4 Consideration of side effects and safety issues remains important to ensure treatment use. A key point in acute treatment is to avoid medication overuse as it may lead to medication overuse headache. It is suggested that patients overusing abortive therapy in the setting of preventive treatment may need dose escalation, modification of preventive therapy, or addition of another preventive agent.4
     Novel acute migraine treatment options have also recently emerged. When acute treatment with triptan fails, defined as trial of at least two triptans, clinicians may consider ubrogepant, rimegpant, lasmiditan, or a neuromodulation device.4 Patients should try novel agents for at least two attacks in order to evaluate efficacy and tolerability.4 Guidelines suggest that patients who prefer non pharmacologic options may try neuromodulation therapy. Additionally, evidence supporting biobehavioral therapies is growing. Studies have shown improved patient response to pharmacologic therapy when combined with biobehavioral therapy.4
 
Table 5. Monoclonal Antibodies for Acute Treatment13-15  
Novel Agent
Drug Class
Trial (Year)
Outcome Measured
Efficacy
Common Side Effects
Ubrogepant+
CGRP receptor antagonist
ACHIEVE II (2019)
Headache pain freedom and absence of MBS* 2 hours after initial dose
Significantly greater proportion of patients achieved 2-hour pain freedom and 2-hour absence of MBS*
Nausea, somnolence, dry mouth
Rimegpant+
CGRP receptor antagonist
Croop et al. (2019)
Headache pain freedom and absence of MBS* 2 hours after initial dose
Significantly greater proportion of patients achieved 2-hour pain freedom and 2-hour absence of MBS*
Nausea and urinary tract infection
Lasmiditan++
Serotonin 5-HT1F receptor agonist
Goadsby et al. (2019)
Headache pain freedom and absence of MBS* 2 hours after initial dose
Significantly greater proportion of patients achieved 2-hour pain freedom and 2-hour absence of MBS*
Dizziness, somnolence, paresthesia
+Currently in pipeline for treatment of acute migraine, not FDA approved
*Most bothersome migraine-associated symptom
++FDA approved for acute migraine treatment
 
Conclusion
     The American Headache Society's Position Statement provides guidance for clinicians on integrating new treatment options in their approach to migraine therapy. OnabotulinumtoxinA is a second line agent for prophylaxis in those that qualify for prophylactic treatment. The mAbs (erunumab, fremanezumab, and galcanezumab) are well-tolerated prophylactic treatment options for those meeting criteria previously mentioned. Notable advantages of injectable therapies are quick onset and the lack of dose titration. Lasmiditan became the first FDA approved mAb within this past year. The updated position statement does not go into detail about these treatment options; however, they are options for individuals who have failed therapy with two different triptans.
 
1)      Hilldrew CJ, Lynm C, Glass RM. Migraine headache. JAMA. Jun 2009; 301(24):2608. DOI: 10.1001/jama.301.24.2608.
2)      Bruch RC, Loder S, Loder E, Smitherman TA. The Prevalence and Burden of Migraine and Severe Headache in the United States: Updated Statistics from Government Health Surveillance Studies. Headache. Jan 2015; 55(1):21-34. DOI: 10.1111/head.12482.
3)      Burch R, Rizzoli P, Loder E. The Prevalence and Impact of Migraine and Severe Headache in the United States. Headache. Apr 2018; 58(4):496-505. DOI: 10.1111/head.13281. Epub 2018 Mar 12.
4)      Hu Y, Guan X, Fan L. Triptans in Prevention of Menstrual Migraine: a Systematic Review with Meta-Analysis. J Headache Pain. Jan 2013; 14:7. DOI: 10.1186/1129-2377-14-7.
5)      Durham PL, Cady R. Insights into the Mechanism of OnabotulinumtoxinA in Chronic Migraine. Headache. Nov-Dec 2011; 51(10):1573-7. DOI: 10.1111/j.1526-4610.2011.02022.x.
6)      Ranoux D, Martine G, Espagne-Dubreulih G. et al. OnabotulinumtoxinA Injections in Chronic Migraine, Targeted to Sites of Pericranial Myofascial Pain: An Observational, Open Label, Real-Life Cohort Study. J Headache Pain. Dec 2017;18(1):75. DOI: 10.1186/s10194-017-0781-7. Epub 2017 Jul 21.
7)      Dodick DW, Turkel CC, DeGryse RE. OnabotulinumtoxinA for treatment of chronic migraine: pooled results from the double-blind randomized, placebo-controlled phases of the PREEMPT clinical program. Headache. Jun 2010 ;50(6):921-36. doi: 10.1111/j.1526-4610.2010.01678.x. Epub 2010 May 7.
8)      Dodick DW, Ashina M, Brandes JL, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalagia. May 2018; 38(6):1026-1037. DOI: 10.1177/0333102418759786. Epub 2018 Feb 22.
9)      Goadsby PJ, Reuter U, Hallstrom Y, et al. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. Nov 2017; 377(22):2123-2132. DOI: 10.1056/NEJMoa1705848.
10)  Dodick DW, Silberstein SD, Bigal ME, et al. Effect of Fremanezumab Compared with Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. May 2018; 319(19):1999-2008. DOI: 10.1001/jama.2018.4853.
11)  Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: The randomized, double-blind placebo-controlled REGAIN study. Neurology. Dec 2018; 91(24):e2211-e2221. DOI: 10.1212/WNL.0000000000006640. Epub 2018 Nov 16.
12)  Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial. Cephalagia. Jul 2018; 38(8):1442-1454. doi: 10.1177/0333102418779543. Epub 2018 May 31.
13)  Trugman JM, Dodick DW, Ailani J, et al. Efficacy, Safety, and Tolerability of Ubrogepant for the Acute Treatment of Migraine: Results From a Single-Attack Phase 3 Study, ACHIEVE II. Neurology. Apr 2019;
14)  Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. Aug 2019; 394(10200):737-745. DOI: 10.1016/S0140-6736(19)31606-X. Epub 2019 Jul 13.
15)  Goadsby PJ, Wietecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. Jul 2019; 142(7): 1894-1904. DOI: 10.1093/brain/awz134. Epub 2019 May 27.
16)  Villalon CM, Olesen J. The role of CGRP in the pathophysiology of migraine and efficacy of CGRP receptor antagonists as acute antimigraine drugs. Pharmacol Ther. Dec 2009; 124(3): 309-23. DOI: 10.1016/j.pharmthera.2009.09.003. Epub 2009 Sep 29.


Members in Spotlight

Bill Lee and Michael Czar-2019 Literature Award Recipients from the ASHP Foundation.

Joe Dipiro-Named Editor of ASHP Foundation 2021 Pharmacy Forecast Report
 
Van Tran, PharmD, BCPPS, BCPS, MBA-Thank you for presenting the January webinar to VSHP members

Did You Know...

If you were unable to attend our live webinars, you can view them at http://vshp.org/Webinars
 
There are 2 options for viewing-one with one hour of pharmacist or pharmacy technician CE credit ($10 CE processing fee) and one without CE.

Clinical Writing Opportunities for APPE Students

As a new year of APPE rotations begin, writing a clinical article for the VSHP newsletter is a great way for students to get publication experience. As preceptors we can co-author these articles with our students, engage them in the writing process, and enhance their rotation experiences. Topics can be anything related to hospital-system pharmacy. Examples include (but are not limited to): new drug updates, national policy updates for hospital pharmacy, guideline updates, therapeutics reviews, and clinical controversies. Articles are generally 1-3 pages in length, and can include tables and figures. Interested member and students should email Steve Glass, contact@vshp.org for more details.

 
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