NCAP E-News August 2020

E-News ENews

2020, Issue 7 of 12 August 15, 2020 ncpharmacists.org

Advancing Pharmacy. Improving Health.

General News NCAP 2020 Annual Convention To Be Virtual Our 2020 Convention originally scheduled to be held at the Benton Convention Center (BCC) in Winston-Salem on October 29th and 30th will be moved to a virtual environment. The NCAP Board of Directors voted at their July 29th meeting to change the format based on the safety of our members and their financial duty to the Association. We will renegotiate our contract with the BCC to host an event in their venue in 2022. Meanwhile, the NCAP Convention Planning Committee and the NCAP Staff are working diligently to produce a quality virtual convention. You can expect to see more hours of continuing education and greater flexibility in programming hours. In addition, the staff is currently working on new ways to bring residency showcase, exhibitor interaction, poster presentations, and roundtable topics, all for a lower price point than we could offer in a contracted venue. Registration is NOT yet open, but stay tuned for more details on our new format, programming, and how to register.

NCAP Partners with Vaccine Ambassadors and Letter to Governor Cooper

In an attempt to further emphasize the role of pharmacists in public health and immunizations, NCAP is working on some partnership opportunities with Vaccine Ambassadors, including a recent letter sent to Governor Cooper. In this letter, we provided data released by the Centers for Disease Control and Prevention (CDC) in early May that indicated the number of vaccinations administered to children has dropped sharply since the United States declared a national emergency in March. Many routine vaccination appointments have been missed or delayed because of coronavirus insecurities, increasing the risk for potentially fatal outbreaks of vaccine-preventable diseases. We emphasized our work to help increase parental confidence in the healthcare environment and importance of receiving recommended vaccines for children and adults. We also put a final focus on the upcoming flu season and ways in which pharmacists can help with influenza immunization. Vaccine Ambassadors and NCAP has a follow-up meeting set for August 24. We hope to be able to bring more news on specific engagement opportunities for our members based on this partnership.

We also hope to use these types of relationships and cooperative campaigns as a foundation to support NCAP advocacy work that would hopefully move our state toward pharmacist-authority to administer

any FDA approved vaccination. In closing if you are passionate about immunizations, consider volunteering to work on our immunization task force. You can submit your interest via email to penny@ncpharmacists.org.

NCAP Board of Directors Approves 2021 Election Slate and Selects Next NCAP Treasurer At the July 29th the Board of Directors (BOD) approved the slate of candidates for our upcoming ballot. Members should expect a link to a ballot to be received in their email by no later than August 31.

Academy members will also receive a ballot link to vote on candidates for specific academy positions. All elected individuals will begin their term of service January 1, 2021. The approved slate for BOD positions are as follows: President-elect (Matt Kelm, running unopposed); Secretary—2-year term (Paige Brown, running unopposed), and At-large Member—3-year term (Riley Bowers and John Stancil).

The Board of Directors selected, according to the Association’s Bylaws, our next Treasurer to serve a 3-year term. Ryan Mills, with Novant, provided a detailed letter of interest and the Board interviewed him on July 29th. NCAP is excited to announce that Ryan was approved by the Board, and he has graciously ac-

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cepted the appointment. He will begin his term as Treasurer on January 1, 2021. Meanwhile, he will spend time with our current Treasurer, Tom D’Andrea, reviewing our financial policies and learning the Association’s financial procedures. On December 31, Tom will conclude six years of service as NCAP Treasurer.

He has served the Association well during his tenure and has made a number of changes to improve our internal finance operations and securities. The staff and Board of Directors will be sad to see Tom go, but we look forward to welcoming Ryan as part of the Association’s Executive Committee.

NCAP Board of Directors Approves Establishing a Technician Work-Force Task Force As the NCAP Board of Directors continues its work in setting the Association’s 2021 Advocacy Agenda, they have determined there is a need to establish a task force that would help explore and research potential solutions to technician work force needs, including an examination of what is occurring in other states related training, certification for advanced roles, salaries and turnover.

NCAP President David Phillips will need to appoint members to serve on the task force. We need individuals well versed in technician needs in our state, who are willing to volunteer a few hours each month to working on the charges for this task force. If you are passionate about this issue and willing to serve, please email your name, position, and contact information to Rhonda Davis at rhonda@ncpharmacists.org.

Comment Period Open for Proposed DHHS Medicaid Policies

The law requires the Department to publish proposed new and amended clinical coverage policies on the DHHS website and accept oral and written comments. All consultations and comments are considered.

The Department has delegated to the Division of Health Benefits Division Director the authority to make the final decisions regarding clinical coverage policies. There are a number of proposed new or amended Medicaid and NC Health Choice clinical coverage policies, including ‘Outpatient Pharmacy Program’, can be accessed here, and open for comment until mid-September. NCAP members work in an array of diverse practice settings and care for many different subpopulations. You may find that some of the proposed changes could potentially impact your practice. The NCAP Policy and Advocacy Committee, as well as our Board of Directors, is reviewing this list and determining which items may warrant official comment letter from the Association on behalf of our members.

Management and the Managed Care Pharmacy Benefit. This position will also manage and oversee additional Medicaid Program Services (Pharmacy, Durable Medical Equipment and Supplies and Prosthetics and Orthotics, Specialized Therapies, Independent Practitioners and Local Education Agencies).

The link for the underlined here above is:

21ST Year of Residency Conference a Virtual Success

For more information, access the job posting at one of the following links: https://www.linkedin.com/jobs/ view/1924413698/ https://w w w.gover nmentj obs. com/careers/northcarolina/ jobs/2785194/pharmacy-directornc-medicaid Contact recruiter Roslynn Bartley roslynn.bartley@dhhs.nc.gov with any questions.

Event News

https://me dic aid.ncd h hs.gov/ On July 17th, NCAP hosted our 21st meetings-and-notices/proposed- Residency Conference in a virtual medicaid-and-nc-health-choice- environment. The webinar bepolicies gan with a welcome from Debra Kemp who spoke about NCAP and NC Medicaid Searches for Next the importance of our state asPharmacy Director sociation. Debra then introduced NCAP’s lobbyist, Tony Solari, who The Division of Health Benefits, spoke about the importance of adwith NC Department of Health and vocacy and how pharmacists can Human Services, is seeking a dy- get involved to help bring about namic Pharmacy Director who has a positive change in laws that effect strong business acumen, operations pharmacy. and clinical program. The Pharmacy Director provides oversight and The program continued with a management to the Medicaid Direct presentation by Suzanne Harris (Fee-for-Service) Pharmacy Benefit

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and Ina Liu entitled Resiliency in Residents: Gaining Strength from Adversity. The final segment, Zoom Into Virtual Precepting: Best Practices and Avoiding Pitfalls, was presented by Macary Weck Marciniak and Steven Johnson.

The event was viewed by 25 residency programs from around the state and included 35 residency program directors, 21 preceptors and 197 residents. NCAP wishes to thank our speakers and we extend a debt of gratitude to the planning committee chaired by Holly Canupp.

Although COVID-19 kept us from meeting in person, it was still exciting to host this annual event designed to kick-off the new residency year and welcome all the new residents.

Dog Days Of Summer Sunday CE Series

In our partnership with the Catawba Valley Society of Pharmacists, NCAP will host a summer Sunday CE series. Registration for the new webinar series of live CE programs will open soon. As the hot days of summer begin to wane and we prepare to welcome fall, we hope you will find time to join us for one or more of these virtual live CE programs. Stay tuned for more information on topics, speakers and how to register.

Dates Extended!

Due to our convention switching to a virtual event, we are extending the cutoff dates for Call for Posters, Call for Roundtables and Call for Pearls. The deadline

for each of these had been August 17th; however, we are extending the deadline to August 31st. Our planning committee is working hard to incorporate each of these sessions in new, engaging ways.

If you are interested in presenting for either of these sessions act now and submit your interest

by August 31st. Below are links detailing everything you need to know and do to be part of these awesome ways to present your work and practice your presentation skills. Just click on the one (below) you want to take part in to find out what you need to do and who the contact person is for each session.

Call for Posters

Call for Roundtables Call for Pearls

Partner News

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• RxRegulator® – Value-added prescription claims reconciliation program and automated reimbursements below cost system.

July 31st, 2020, marks the close of year one of the 2-year NCAP Cardinal Grant initiative “Practice Transformation for Appropriate and Safe Pain Man• PHARMCAP Web-based solu- agement.”

Throughout the tion for pharmacy regulatory and year, achievements ranged from NCAP’s development of training compliance management. and educational materials to • Clinical Programs – value-added support pharmacies in meeting consultation service to manage grant objectives, advertising, MTM outcomes. recruitment, onboarding, and finally, active launch and delivery • PrescribeWellness – patient en- of pharmacy interventions to gagement and patient care solu- high-risk patients. tions for CMS Star Ratings.

Baseline and quarterly popula• Legislature lobbyists for inde- tion reporting were challenges cited early in the initiative, as pendent pharmacy. many pharmacists reported time • Cyber liability insurance as a constraints with data collection.

In partnership with PioneerRx, an value-added service. independent pharmacy software It is the perfect time to work to- vendor with a large NC footprint, gether for the future of pharmacy. collaborative efforts resulted in Please visit us at www.epicrx.com the development of an Opioid Stato learn more or connect with our tistics Report to streamline data collection at the click of a butteam. ton, leading to an 82% pharmacy submission rate to date. This has Practice Advancement been one of the most notable partnerships driving progress in year one, allowing pharmacies to effectively identify their high-risk NCAP’s Cardinal Grant Initia- patients. Also, PioneerRx serves tive Ends Year One on a Posimore than 4000 pharmacies native Note tionwide, providing scalability beyond North Carolina.

Population reports in year one are not surprising either. For pharmacies submitting baseline data at years end, there were more than 3000 patients identified on opioids with approximately 10% on high dose (>90MME) with another 10% on concomitant Opioid/ BZD combinations. Representing we have no shortage of patients and much to do in closing care gaps associated with in-

appropriate prescribing and pain management.

In partnership with the four North Carolina schools of pharmacy, (Campbell, High Point, UNC and Wingate) efforts to train and prepare the next generation of pharmacists to work in the Opioid space were realized in early February 2020 with the launch of our first Student-Pharmacists Opioid Stewardship Certificate Training Program . Support from faculty and students has been overwhelming, with 226 students registered and now actively completing their Certificate training.

After a fantastic first year, we are excited for year two and continuing our work to show the value pharmacists bring to this highly vulnerable population. My sincerest gratitude to all those individuals working so hard behind the scenes to drive this initiative forward, and to those pharmacy teams and students working tirelessly to improve patient lives.

UNC Students Host Inaugural Opioid “Outreach Campaign” with a Presentation to The North Carolina National Guard Counterdrug Program

Student pharmacists actively seeking their Opioid Stewardship Certification as a part of NCAP’s Cardinal Grant initiative

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are charged with putting their learning into practice by designing and implementing an opioid “outreach campaign” to educate, improve, and or advance opioid safety practices.

NCAP would like to congratulate UNC PharmD Candidates Caroline Luther and Stephanie Hwang (Class of 2022) in hosting the initiatives first “outreach campaign” following their presentation to the NC National Guard’s Counterdrug Program Annual Training Event held August 10th, 2020 at the Ramada in Raleigh NC. To give you some background, the North Carolina National Guard Counterdrug Program comprises national guard members (military members) providing support to their communities by supporting law enforcement agencies and community coalitions against illegal drug trafficking organizations, substance abuse, and misuse. They do this by embedding national guard members within agencies and alliances across the state to enhance and support their efforts in combating the opioid epidemic.

This year they reached out to NCAP with interest in learning more regarding the pharmacist’s role, experiences, prevention efforts, and practices associated with combating the opioid crisis.

Both Caroline and Stephanie did a fabulous job sharing the historical perspective on “How healthcare found itself amid this epidemic!”

They spoke to pharmacist’s involvement with risk mitigation through education and awareness, non-discriminatory sale of syringes, Naloxone dispensing, and medication disposal. They highlighted practice transformation, including pharmacist’s roles

in implementing service interventions such as screenings, pain assessments, care planning, and use of SBIRT that help to bridge care gaps often associated with inappropriate pain management.

In recognition of their service, they received a Certificate of Appreciation from the National Guard thanking them for their time and invaluable contribution to their Counterdrug Program’s mission.

Hat’s off to Caroline and Stephanie for a job well done!

well as our conferences and conventions. We will definitely miss her youthful presence, enthusiasm, and especially her sense of humor. The NCAP staff and Board of Directors thank her for her contributions to the Association, and wish her the very best as she continues her studies in forensic science.

Member News

Past NCAP Board Member Makes Nation Cover Jennifer Burch was featured in this month's APhA issue of America's Pharmacist. Check out the story here.

Office Announcements NCAP Says Goodbye to Staff Member Madelyn Anhui has returned to college full time and unfortunately will no longer be able to work for NCAP. She had served as our Continuing Education Coordinator for two years and helped with a number of day-to-day office responsibilities. Madelyn also created and managed special website designs for our advocacy information, as

NCAP Member Reappointed to Medicaid Committee Casey Johnson, pharmacist with Carroll's Pharmacy in Johnston County, was reappointed to a 2-year term to serve on the Preferred Drug List Committee with NC Medicaid.

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NCAP Member To Share PBM Concerns with NCMedical Care Advisory Committee As NC Medicaid's managed care transformation is back on track for July 2021, Benjamin Smith, with Duke University Health System, and appointee to the NC Medical Care Advisory Committee (MCAC), will share pharmacists concerns regarding PBMs in managed care, at the September MCAC meeting.

FDA News

The following are select excerpts from FDA News covering the timeframe since our last E-news.

Keytruda Approved as FirstLine Treatment for Colorectal Cancer

Novartis has agreed to pay $729 million to settle kickback allegations made by the Department of Justice. The company will pay $678 million to settle allegations that it hosted sham speaker programs and other events to bribe doctors into prescribing its medicines; and $51.25 million to settle allegations that the company used charitable foundations to pay patient copays for specific medications.

Regeneron Begins Phase 3 Trial of Antibody Cocktail for COVID-19

Regeneron Pharmaceuticals has begun a phase 3 clinical trial in the U.S. of its antibody cocktail REGN-COV2 for the prevention of COVID-19 infections. The trial is being conducted with the National Institutes for Allergy and Infectious Diseases, and plans to enroll 2,000 patients across 100 sites.

The company has also launched two phase 2/3 trials evaluating the cocktail’s ability to treat patients already infected with COVID-19. Regeneron Pharmaceuticals has been granted a $450 million contract with HHS and the Department of Defense to manufacture and supply its antibody cocktail REGN-COV2 for the treatment of COVID-19 patients.

The FDA has approved Merck’s Keytruda (pembrolizumab) as a first-line immunotherapy for certain patients with colorectal cancer, specifically unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, which occur in approximately five percent of patients with metastatic colorectal cancer. The approval was based on trial results showing that patients treated Novavax Nabs $1.6 Billion with Keytruda demonstrated a Warp Speed Contract for COprogression-free survival of 16.5 VID-19 Vaccine months compared to 8.2 months for those who received chemoThe U.S. government has granted therapy.

Novavax $1.6 billion to support manufacturing and clinical develNovartis Pays DOJ $729 Million opment of its COVID-19 vaccine To Settle Kickback Allegations candidate NVX- CoV2373. Under

the agreement, Novavax will produce 100 million doses, which the government will make available for clinical trial use or will distribute to the public at no cost if it is approved or granted an Emergency Use Authorization by the FDA. The contract will also fund a phase 3 clinical trial of the vaccine in 30,000 participants, which is expected to begin in the fall.

New Data Shows Gilead’s Remdesivir Improves Recovery for COVID-19 Patients

New data on Gilead Sciences’ remdesivir showed a 62% reduction in the risk of mortality for severe COVID-19 patients. Gilead released the results of an analysis comparing patients treated in a phase 3 trial with a separate cohort of patients given standard of care. The analysis found that 74 percent of patients treated with remdesivir recovered by day 14 compared to 59 percent of those receiving standard of care alone.

Gilead’s analysis supports the findings in the National Institutes of Health’s trial of remdesivir, which showed the drug shortened time to recovery by four days compared to placebo.

Pfizer and BioNTech Given Fast Track Status for Two COVID-19 Vaccines

The FDA has granted Pfizer and BioNTech fast track designations for two messenger RNA-based COVID-19 vaccine candidates. The agency granted the designations for BNT162b1 and BNT162b2 based on promising early results from clinical trials in the U.S. and

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Germany, and on data from animal studies. HHS and the Department of Defense have a $1.95 billion agreement with Pfizer and BioNTech for large-scale production and nationwide delivery of 100 million doses of their COVID-19 vaccine. The contract is the largest to date under Operation Warp Speed and allows the government to acquire an additional 500 million doses.

patient population. Farxiga was approved by the agency in May for reducing the risk of hospitalization and cardiovascular death in adults with heart failure when their left ventricle is not pumping normally.

Separately, Indivior will pay $10 million to settle allegations by the Federal Trade Commission that it engaged in anticompetitive activities to block generic competition for Suboxone.

The FDA has approved Jazz Pharmaceuticals’ Xywav (calcium, FDA Adds Dexamethasone to magnesium, potassium and soCOVID-19 Temporary Comdium oxybates) oral solution for pounding Lists the treatment of cataplexy — a sudden, brief loss of voluntary The FDA has added dexametha- muscle tone — or excessive sone to the list of drugs that may daytime sleepiness in patients 7 be compounded under its tempo- years of age and older with narrary policy allowing compound- colepsy. The approval was based ers to produce the drug during on phase 3 clinical trial results in the COVID-19 pandemic. Demand which Xywav demonstrated stafor the anti-inflammatory drug tistically significant differences in surged in mid-June after UK re- the weekly number of cataplexy searchers reported that it reduced attacks and excessive sleepiness deaths in critically ill COVID-19 compared to a placebo. The FDA patients. Five suppliers of dexa- required a boxed warning for Xymethasone are currently on the wav because of its potential for FDA’s drug shortages list — Au- misuse and abuse. roMedics Pharma, Fresenius Kabi USA, Hikma Pharmaceuticals USA, Indivior Pays $600 Million to Mylan Institutional and Somerset Settle DOJ Probe Into Suboxone Therapeutics.

The FDA has approved Roche’s Tecentriq (atezolizumab) in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of BRAF V600 mutation-positive advanced melanoma. The approval was based on a phase 3 study, in which the combination treatment helped patients live longer without disease progression or death compared to a placebo plus Cotellic and Zelboraf. The FDA has granted the combination treatment a priority review and evaluated it under Project Orbis, in which the agency reviews oncology products developed with international partners.

AstraZeneca’s Farxiga Gets Fast Track Designation for Heart Failure

The FDA has granted a Fast Track designation to AstraZeneca’s Farxiga (dapagliflozin) for reducing the risk of hospitalization for heart failure or cardiovascular death in adults following a heart attack. AstraZeneca plans to conduct a phase 3 trial to study the drug’s safety and efficacy in that

Jazz Pharmaceuticals’ Xywav Approved for Narcolepsy

Roche’s Tecentriq, Cotellic and Zelboraf Combo Approved for Advanced Melanoma

Janssen’s Stelara Approved for Plaque Psoriasis in Children

The FDA has approved Janssen’s Indivior Solutions has agreed to Stelara (ustekinumab) for the pay $600 million to resolve crimi- treatment of children ages 6-11 nal and civil investigations into years old with skin lesions assoits marketing of the opioid ad- ciated with moderate to severe diction treatment Suboxone Film plaque psoriasis. Stelara targets (buprenorphine/naloxone). The interleukin (IL)-12 and IL-23, two company pleaded guilty to mak- inflammatory cytokines produced ing false statements about the by the immune system. product’s safety for children and agreed to pay $289 million. It Cannabis-Based Drug Apalso agreed to pay $300 million proved for Seizures in Rare to settle charges that its marketGenetic Condition ing of Suboxone led to false claims to public healthcare programs.

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The FDA has approved Greenwich Biosciences’ Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex is the only FDAapproved drug that contains a purified drug substance derived from cannabis. The drug was previously approved for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome.

FDA Expands Spravato Approval for Major Depressive Disorder

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The FDA has approved Janssen’s Spravato (esketamine) nasal spray along with an oral antidepressant for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. The approval was based on two phase 3 trials in which Spravato significantly reduced depressive symptoms within 24 hours, with some patients starting to respond after just four hours.

The FDA previously approved Spravato in March 2019 for adults with treatment-resistant depression (TRD), a subpopulation of MDD patients.

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