ARRX Fall 2018

Fourth Quarter 2018 Award-Winning Quarterly Publication of the Arkansas Pharmacists Association

A Pharmacist's Role in

HEALTH LITERACY NOW WHAT? PBM Legislation Update

AR-Rx_Fall 2018.indd 1

11/1/18 12:14 PM

AR-Rx_Fall 2018.indd 2

11/1/18 12:14 PM

APA Staff

7

8

14

22

John Vinson, Pharm.D. Chief Operating Officer John@arrx.org Jordan Foster Director of Communications Jordan@arrx.org Susannah Fuquay Director of Membership & Meetings Susannah@arrx.org Lauren Jimerson, Pharm.D. Executive Fellow Lauren@arrx.org Celeste Reid Director of Administrative Services Celeste@arrx.org Debra Wolfe Director of Government Affairs Debra@arrx.org Office E-mail Address Support@arrx.org Publisher: John Vinson Editor: Jordan Foster Design: Gwen Canfield - Creative Instinct Arkansas Pharmacists Association 417 South Victory Street Little Rock, AR 72201-2923 Phone 501-372-5250 Fax 501-372-0546 AR•Rx The Arkansas Pharmacist © (ISSN 0199-3763) is published quarterly by the Arkansas Pharmacists Association, Inc. It is distributed to members as a regular service paid for through allocation of membership dues ($5.00). Non-members subscription rate is $30.00 annually. Periodical rate postage paid at Little Rock, AR 72201. Current edition issue number 84. © 2016 Arkansas Pharmacists Association.

POSTMASTER: Send address changes to AR•Rx The Arkansas Pharmacist 417 South Victory Little Rock, AR 72201 Opinions and statements made by contributors, cartoonists or columnists do not necessarily reflect the attitude of the Association, nor is it responsible for them. All advertisements placed in this publication are subject to the approval of the APA Executive Committee. Visit us on the web at www.arrx.org.

CONTENTS 4 Inside APA: Arkansas Pharmacists Have

22 Legislator Profile: Representative

5 From the President: Creating Innovative

23 AAHP: Resilience

Resilience

Practice Settings is Essential to the Growth of Pharmacy

7 Member Spotlight: Andrew Mize,

Pharm.D., Pharmacist, Collier Drug Compounding

8 FEATURE: Now What?

10 Farewell Letter from Scott Pace

26 Consulting Academy: Thinking Outside

the Script

27 Compounding Academy Report:

FDA Releases New Draft MOU Proposing Rules on the Interstate Shipment of Compounded Medications

28 2018 APA Regional Meetings

13 Safety Nets: Ketorolac

35 USPS Statement of Ownership

14 FEATURE: A Pharmacist's Role in

Health Literacy

17 New Drugs: A Fast-Track Quarter at

the FDA

18 UAMS: Practice-Ready 20 Harding University: 2018 HUCOP 21 Calendar of Events

AR-Rx_Fall 2018.indd 3

24 AAHP 2018 Fall Seminar

12 Rx & the Law: Marijuana Development

Annual Report

WWW.ARRX.ORG

Dan Douglas, Bentonville, District 91

ADVERTISERS 2 Pharmacists Mutual 6 Retail Designs, Incorporated 6 Arkansas Pharmacy Support Group 11 EPN 19 UAMS College of Pharmacy 21 Law Offices of Darren O'Quinn 26 EPIC Pharmacies 34 Pharmacy Quality Commitment Back Cover: Pharmacy Partners of America /

Compliant Pharmacy Alliance

3

2

11/1/18 12:14 PM

APA Board of Directors

INSIDE APA

2018 - 2019 Officers

President – Stephen Carroll, Pharm.D., Benton

Arkansas Pharmacists Have Resilience

President-Elect – Dean Watts, P.D., DeWitt Vice President – Kristen Riddle, Pharm.D., Greenbrier Past President – Lynn Crouse, Pharm.D., Lake Village

Regional Representatives Region 1 Representatives Dylan Jones, Pharm.D., Fayetteville Spencer Mabry, Pharm.D., Berryville Lacey Parker, Pharm.D., Charleston Region 2 Representatives Greta Ishmael, Pharm.D., Cherokee Village Region 3 Representatives Brandon Achor, Pharm.D., Sherwood Clint Boone, Pharm.D., Little Rock Lanita White, Pharm.D., Little Rock Region 4 Representative Betsy Tuberville, Pharm.D., Camden Region 5 Representative James Bethea, Pharm.D., Stuttgart At Large Representatives Yanci Walker, Pharm.D., Russellville Stacy Boeckmann, Pharm.D., Wynne Arkansas Association of Health-System Pharmacists David Fortner, Pharm.D., Rogers Academy of Consultant Pharmacists Larry McGinnis, Pharm.D., Searcy Academy of Compounding Pharmacists Tyler Shinabery, Pharm.D., Sherwood

Ex-Officio APA Chief Operating Officer John Vinson, Pharm.D., Benton AR State Board of Pharmacy Representative John Kirtley, Pharm.D., Little Rock UAMS College of Pharmacy Representative (Dean) Keith Olsen, Pharm.D., Little Rock Harding College of Pharmacy Representative (Dean) Jeff Mercer, Pharm.D., Searcy Legal Counsel Harold Simpson, J.D., Little Rock Treasurer Richard Hanry, P.D., El Dorado UAMS COP Student Cortni Hicks, Little Rock Harding COP Student Jacilyn 4 McNulty, Searcy

AR-Rx_Fall 2018.indd 4

John Vinson, Pharm.D. APA Chief Operating Officer

A

rkansas pharmacists have resilience.”

This quote from a professional colleague stood out to me from our district meetings this fall. Resilience accurately describes the toughness needed to survive and recover. 2018 has been a tough year for Arkansas community pharmacists. The challenges have been immense, including a broken healthcare market for pharmacy benefits. There have also have been other major challenges across all practice settings. However, I’d like to take a moment to reflect on some positive news in Arkansas pharmacy despite the challenges because of your incredible resilience.

• Arkansas pharmacists across many practice settings including ambulatory, academic, health systems, compounding, consulting and community pharmacy stood united this year in support of pharmacy benefit manager reform.

• The Arkansas legislature and Governor passed and signed pharmacy benefit manager licensure legislation during a special legislative session. This legislation, sponsored by Representative Michelle Gray and Senator Ron Caldwell, is leading the nation by creating oversight for the pharmacy benefits market in fully insured health plans.

• Senator Jason Rapert served as the President for NCOIL (National Council of Insurance Legislators) this year and introduced the Arkansas PBM Licensure Act as model legislation that other states should adopt.

• Arkansas Attorney General Leslie Rutledge held town hall meetings in all 75 counties, invited pharmacists to these discussions, and articulated to business and community leaders about the threat to healthcare and Arkansas communities that poorly designed pharmacy benefits can create.

• Arkansas pharmacists answered the call to the Arkansas Department of Health and administered thousands of Hepatitis A vaccine to adults in Northeast Arkansas "

and the Greater Fort Smith area in Western Arkansas during the Hepatitis A outbreak.

This response without a doubt helped to slow the outbreak and save lives.

• Arkansas pharmacists began prescribing naloxone under a statewide protocol and provided nearly 75% of all prescribed naloxone according to data from a major Arkansas health plan in 2018.

This is also an example of our profession responding to a public health emergency quickly to save lives.

• Arkansas pharmacists are now able to administer any medication that they are trained to administer. Pharmacists have administered infertility medications, hormones, emergency medications during cardiac arrest in the hospital, osteoporosis medications, antipsychotics and others.

• 110 Arkansas community-based pharmacies officially launched a clinical integrated network named Arkansas CPESN in collaboration with CPESN USA. This network signed its first contract and now has 95% network adequacy for population and 90% network adequacy for geography.

• The ambulatory pharmacy job market continues to grow in Arkansas. Physician practices and health systems participating in value based alternative payment models are hiring pharmacists to collaborate with primary care physicians to improve patient outcomes and collect bonus payments because of their good work.

• A major self-insured employer in Northeast Arkansas made a strategic decision to part ways with its current health insurance carrier and PBM and implement a transparent pharmacy benefit model. This new model will be implemented in 2019 and it eliminates traditional spread pricing, clawbacks, and below cost generic drug reimbursement.

The savings to the plan will be generated through better formulary design and 100% rebate pass through to the plan, rather than paying healthcare providers below cost.

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

• The Arkansas Pharmacists Association has continued its role as an owner and voting member for a new providerled insurance company named Forevercare. In this role, the pharmacy profession has a seat at the table to engage in fair benefit design that encourages both provider engagement and improved patient outcomes in the Arkansas Medicaid behavioral health, developmental disability, and substance abuse patient population.

2019 promises to be an exciting year for Arkansas pharmacy with the 92nd Arkansas General Assembly set to convene with the regular legislative session. In addition, we will work closely with the legislature, the Insurance Commissioner and community pharmacists to ensure that the PBM Licensure Act is working correctly. We also will be challenging pharmacists to identify additional locally owned self-insured employers to discuss fair pharmacy benefit design that encourages

competition and access to high quality community-based care rather than discouraging it. Through his extraordinary leadership, Dr. Scott Pace leaves the Arkansas Pharmacists Association in a strong position with a veteran staff, healthy finances, a modernized business structure and most importantly an engaged membership. With these strengths, anything is possible for 2019.

As your new leader for the Arkansas Pharmacists Association, I want to encourage you to continue to embrace the theme of resilience through 2019. Senator Ron Caldwell shared words of wisdom with us at the Little Rock meeting in September that “the fight has just begun.” We must continue to fight for our patients and our profession. We must continue the positive momentum to ensure that pharmacists are successful in their professional, clinical and business endeavors. §

FROM THE PRESIDENT

Creating Innovative Practice Settings is Essential to the Growth of Pharmacy

I

have spent many nights during September attending APA Regional Meetings around our great state. I had the opportunity to meet so many colleagues and connect with so many friends. Each meeting seemed to grow on the previous meeting in content and crowd size. I was excited to share information about specialty pharmacy practice and its importance to the citizens of Arkansas. I also was able to speak about my vision for APA. Specialty pharmacy is a growing, yet unique practice in pharmacy. I define specialty pharmacy as the management of complex disease states through high touch patient care and special handling of medication. Some of the specialty disease states that I encounter in my specialty pharmacy practice include oncology, neurological disorders including multiple sclerosis, rheumatology, dermatology, and gastroenterology.

I have also learned about the state licensing processes of all 50 states as well as the accreditation processes for multiple independent national accrediting organizations. These accreditations ensure that policies and procedures are in place to maintain a high level of patient care for pharmacies that care for patients who are prescribed specialty medications. As I mentioned in my address at the APA Regional Meetings, most specialty pharmacy prescriptions are filled by out of state mail order pharmacies. Our pharmacy hears more often than not that Arkansas citizens and patients of Arkansas community retail pharmacies prefer to receive their medications from Arkansas specialty pharmacists. This allows the patient to receive the same personal level of care that they receive from their community pharmacist.

I continue to be excited about the opportunities that exist in pharmacy in Arkansas and the way that APA members are WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 5

working to create new programs to demonstrate our value as a Stephen Carroll, Pharm.D. part of the healthcare team. We President must remember that we are the medication experts and we are making a difference in the health of our patients. Creating innovative practice settings will be essential to the growth of pharmacy.

I believe that the membership of APA has a strong message that is built on facts. With the passing of the PBM Licensure Act during the 2018 special session of the Arkansas Legislature called by Governor Asa Hutchison, APA members now have an avenue to push back on the predatory practices of PBMs when they are not following Arkansas law. I encourage you to use this law by following the processes created by the Arkansas Insurance Department. These processes include filing a complaint on behalf of your pharmacy or encouraging your patients to file a complaint if they feel that their access to care is being affected.

Lastly, I encourage you to get to know your legislators. Invite them to your pharmacy and show them how you provide care to the citizens of Arkansas and your community. It is very important that we thank them for their help on legislation such as the PBM Licensure Act, but also establish relationships that go beyond asking for help in a crisis. This will continue to help APA’s grass roots advocacy grow and allow our legislative leaders to have a better understanding of our practice settings.

2019 is likely to be another great opportunity for pharmacists in Arkansas. We must continue to stand up for our patients and our profession. §

5

11/1/18 12:14 PM

6

AR-Rx_Fall 2018.indd 6

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

MEMBER SPOTLIGHT

Andrew Mize, Pharm.D. Pharmacist, Collier Drug Compounding Springdale

Pharmacy School and Graduation Year: UAMS 2011 Years in Business: I was fortunate enough to start with

Collier's right out of school and have been managing the compounding location since we opened it in July 2012.

Favorite part of the job and why: The ability to problem

solve. In compounding, we are presented daily with unique questions and challenges from patients, prescribers, regulatory guidelines, and our marketing efforts that stretch our ability to find a solution that will be beneficial and costeffective. These challenges provide opportunities to improve personally, professionally, and hopefully make a lasting impact on others.

Least favorite part of the job and why: Reading regulatory

guidelines, a necessary evil. Reading USP guidelines, FDA rules, reviewing SOPs, etc. are a critical component of a compounding pharmacy, but it's certainly not the most enjoyable part for me.

What do you think will be the biggest challenges for pharmacists in the next 5 years?

With the push to control healthcare spending, pharmacists must work to show our value to the health system (if you didn't document it, you didn't do it) by reducing costs and improving patient outcomes. Simultaneously, we must develop additional billable services (outside of dispensing) that achieve these objectives. We must make our case to patients, payers, and legislators that pharmacists are in a unique position to directly affect healthcare savings and improve the lives of patients.

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 7

Oddest request from a patient/customer: There's so many,

how do you choose? There was a mom who asked for a certain flavor for their child's medicine. I added it. Then she changes her mind and asks me to take that flavor out and put in a different one. I had to calmly explain that I was unable to remove the previous flavoring because it was already mixed in but would be happy to change it on the next refill.

Recent reads: Business Secrets from the Bible, What You Must Know About Thyroid Disorders, and Good to Great Favorite activities/hobbies: Coaching my son's T-ball team, golf, and game night

Ideal dinner guests: George Washington, Benjamin Franklin, the Apostle John

If not a pharmacist then...: A lawyer - I enjoy debating, having to defend my position, and challenging others to defend theirs.

Why should a pharmacist in Arkansas be a member of the Arkansas Pharmacists Association: The APA staff is

made up of an extremely dedicated and talented group of individuals whose sole purpose is to promote the profession of pharmacy in Arkansas. Let me say that again. You have an entire group of people working to make your life better!

Why wouldn't you support that?! ยง

7

11/1/18 12:14 PM

NOW WHAT?

By Jordan Foster APA Director of Communications

Y

ou were there. When the bottom dropped out on PBM reimbursements at the beginning of the year and pharmacies across the state faced dire consequences, you were there. When APA called out to its members to make a statement and attend the Arkansas Health Insurance Marketplace Committee meeting resulting in a record-breaking crowd, you showed up. When pharmacists united to educate their patients, their legislators, and the general public about what the PBMs were doing to take away patient choice, you fought the fight. Throughout the year, APA members called, emailed, discussed, engaged, and banded together to stand up to the Goliath of the PBM industry and fight back against unfair practices. Legislation was filed, laws were passed, rules were approved, and starting January 1, 2019, PBMs will be required to be licensed with the Arkansas Insurance Department (AID) to do business in the state.

So…now what?

Begin at the Beginning

It’s a bit naive to think that with laws and rules now in place, the PBM issue has been completely solved. However, this new setup does provide some structure and guidelines to report specific instances of bad practices by the PBMs. With a referee established (AID) and the rules in place, it will be critical to submit complaints any time a PBM starts to fall

8

AR-Rx_Fall 2018.indd 8

back into their old ways. So where to begin?

First, a refresher on Arkansas Act 900 of 2015, sometimes referred to as the MAC Law: In 2015, APA teamed up with legislators to craft legislation that would amend the laws regarding maximum allowable cost lists and would create accountability in the establishment of prescription drug pricing. The result was a law that: • requires a PBM to provide access to its MAC list to each pharmacy subject to the list, • allows either a pharmacy or a pharmacy service administration organization (PSAO) to file an appeal to the PBM if a pharmacy was reimbursed for a prescription at an amount lower than the invoice acquisition cost, • prevents the PBM from paying an in-state provider less than they pay their own affiliate pharmacy (themselves), • and allows a pharmacist to decline to provide the service to a patient if the MAC price paid to the pharmacy is below the pharmacy invoice acquisition cost.

PSAO – pharmacy services administrative organization – a pharmacy contracts with a PSAO, that then contracts with PBMs to provide their client negotiating representation, payment reconciliation, and administrative efficiencies.

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

NOW WHAT?

Though the victory was well fought, the PBM industry soon struck back with a lawsuit to invalidate Act 900, leading to appeals and counterappeals until June 2018 when the U.S. Eighth Circuit Court of Appeals issued its ruling in PCMA v. Rutledge. The court ruled that when it comes to Act 900 and PBM MAC pricing, self-insured plans in Arkansas are preempted by ERISA (the Employee Retirement Income Security Act), a sweeping federal law that was designed to allow larger employers and unions to have a uniform employee benefit plan that stretches across multiple states, without having to be subject to 50 state laws regarding employee benefits. As a result of the appeal ruling, the Arkansas Insurance Department cannot enforce complaints about self-insured plans involving PBMs not responding to appeals on below-cost generic drug reimbursement or PBMs paying themselves more than a non-PBM owned pharmacy.

In addition, Medicare Part D drug plans were alse ruled to be pre-empted from state law.

Legislation was filed, laws were passed, rules were approved, and starting January 1, 2019, PBMs will be required to be licensed with the Arkansas Insurance Department (AID) to do business in the state.

Preemption – rule of law stating that federally enacted legislation through Congress shall displace or preclude a state from enacting laws on the same subject

Self-Insured vs Fully-Insured

Before you can make a complaint, you must verify that the claim is from a fully-insured commercial plan. A fully-insured health plan is described as a more traditionally structured employer-sponsored health plan.1 With a fully-insured commercial health plan: • the company pays a premium to the insurance carrier, • the premium rates are fixed for a year, unless the number of employees enrolled in the plan changes, • the insurance carrier collects the premiums and pays the health care claims, • and the covered employee pays any deductibles or copayments outlined under the policy.

With a self-insured (or self-funded) plan, larger employers are able to operate their own health plans instead of purchasing a plan from an insurance carrier, allowing the employers to save the money the insurance carrier would charge to administer the plan. However, the employer also takes on the risk of large claims having to be paid.

If the employer is less than 100 employees, it is unlikely to be self-insured. If the employer has greater than 500 employees, it is 80% likely to be self-insured rather than fully-insured.

The employee’s human resources department can verify if a plan is fully or self-insured. The Arkansas Insurance Commissioner’s staff should also be able to assist if you cannot determine from the employer. Some examples of selfinsured plans include Arkansas State University, Walmart, Tyson, and Dillard’s.

Generic vs Brand Name

Another factor to consider before you file your complaint with

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 9

the Insurance Commissioner is whether the drug in question is generic or brand name. Act 900 of 2015 provides an appeal process for below cost generic drugs; however, there is not a corresponding Arkansas law that does the same for brand name drugs. With brand name drugs, the reimbursement has historically been determined by average wholesale price (AWP) formulas which are published standards and readily available for contracting purposes. In general, it is more predictable for a pharmacy or PSAO to review these AWP standards and determine whether or not a contract is viable for the year.

However, if you are seeing reimbursement with brand name drugs in contracts that put you well underwater financially through take it or leave it contract terms, these should be tracked and discussed with your PSAO and the PBM. The insurance commissioner might be interested to see examples of reimbursement methodologies that are designed to drive business to mail order pharmacies that are owned and operated by the PBM designing the benefit and disrupting the Arkansas based local provider networks.

Rarity vs Trend

The final factor to consider before filing a complaint is whether the reimbursement is a rare blip for a specific plan or part of an unsustainable pattern. A basic financial analysis can help determine this. Look at several claims (at least 12) of prescriptions filled with the same BIN and Group for the last three months, including the current month. What do the trends look like?

In addition, run a report of the financials for the last three months on the BIN and Group. Overall, what is the gross profit per prescription?

9

11/1/18 12:14 PM

GROSS PROFIT

=

total PBM reimbursements for all claims total number of claims

(—)

total invoice acquisition cost

been determined (fully insured plan, generic drug, low reimbursement trend) and you have not reached a resolution with the PBM, it’s time to file a complaint with the Insurance Department.

total number of claims

www.arrx.org/pbm-complaints

Cost Recovery Benchmark – CMS has determined that cost recovery for a pharmacy in Arkansas is invoice acquisition cost + $10.50 per prescription filled. This figure was determined by a national accounting firm (Myers & Stauffer) and can be used to compare to your gross profit to determine if the plan has sustainable payment rates for operations plus drug costs.

BIN – Banking Identification Number – an acronym originally established in the banking industry and carried over to the health insurance industry when cards were first issued, the BIN number identifies which health insurance provider or PBM receives the claim for your prescription and will reimburse the pharmacy Group – a number that designates the employer that has purchased the health plan and identifies the specific benefits associated with the plan

Filing a Claim

As a general rule, pharmacists should attempt to resolve any potential violations of state law by PBMs and/or insurance carriers either directly with the PBM/insurance carrier or through their PSAO prior to submitting complaints to the Insurance Department. Once the above factors have

On APA’s website, you will find the above PBM Complaints page.

From here, you’ll find a few options to register your complaint through the AID website at the link provided on the page or by mailing the form to AID. You’ll need information about the claim (patient information, policy number, claim number, etc.) and will need to provide a summary of the situation.

As an alternative, the APA has provided its own complaint form that can be completed and submitted to AID. The form is somewhat similar but has the advantage of giving the commissioner’s office a more complete picture of the situation by allowing pharmacists to choose from specific indicators regarding network adequacy, prohibited practices of compensation, and use of prohibited gag clauses.

While the APA is offering this enhanced form as an alternative way to submit a complaint, it is crucial that you DO NOT send these completed forms to the Arkansas Pharmacists Association. The completed form will have patient information that could violate HIPAA laws if sent to APA. § https://www.peoplekeep.com/blog/fully-insured-vs-self-insured-selffunded-health-plans 1

A Special Message from Former APA CEO Scott Pace Dear APA Members, I want to thank each of you for the amazing support and encouragement over the past 12.5 years while I served as your Chief Operating Officer and Chief Executive Officer. It was a pleasure to be your voice and your advocate. The work that each of you do for your patients and your communities is simply invaluable. You are on the front line of healthcare and I encourage you to embrace and own your professional role as the medication expert in the healthcare team.

As healthcare evolves, your collaboration with your patients and the other providers in the healthcare team will be more important than ever. You must strive to maintain and grow your professional autonomy in a manner that supports the needs of your patients and your other provider colleagues.

You also must not back down from the political fights that need to be fought. Continue to fight for fairness and to ensure that you control your destiny, not a middleman. You must also continue to lock arms as brethren in pharmacy, regardless of practice setting. Care about one another, support one another, and ensure that pharmacy is strong for the next generation of

10

AR-Rx_Fall 2018.indd 10

our colleagues. I will be there with you as a fellow APA member and pharmacy owner.

Finally, I want each of you to take a moment to be thankful to be in Arkansas.

We say it a lot, but only because it is a fact - Arkansas has one of, if not the, best pharmacist association in the country. That’s not hyperbole, it is true.

It is one of the strongest because of you - your membership, your support, and your commitment to making Arkansas a better place by preserving a business and professional climate for pharmacists to be able to be successful in taking care of their patients.

Please don’t lose this. It is virtually impossible to rebuild, so support and grow the amazing organization that you have.

I wish you all the best and I am excited to see the next chapter in the history of APA! Warmest regards, Scott Pace, Pharm.D., J.D.

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 11

11

11/1/18 12:14 PM

Marijuana Development This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and the Arkansas Pharmacists Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

B

ack in 2014, this series explored the legality of marijuana, medical and otherwise, as state laws diverged from Federal law. This divergence started with California in 1996.

Two concepts discussed in that article have not changed; the Supremacy Clause and Enforcement Discretion.

The Supremacy Clause is a provision in the United States Constitution and it states that federal law is supreme to state law.1 Generally, states may enact laws that are more stringent than Federal laws, but not more lenient. For example, a state can move a Schedule III up to a Schedule II or move a noncontrolled drug into Schedule IV within their borders. But a state is unable to move a Schedule II down to Schedule III. This is a basic tenet in the relationship between federal and state laws. However, this tenet seems to have been forgotten as states moved to legalize marijuana and associated products within their borders.

One reason that this has occurred is another concept known as Enforcement Discretion. This occurs when an agency responsible for the enforcement of a law decides to not enforce that law. An earlier example of this concept was the importation of prescription drugs from Canada. The Food & Drug Administration (FDA) stated that all importation was illegal, but they exercised their discretion and would not prosecute those bringing in these drugs for their own use. In essence, the activity is still illegal, but the agency chooses to do nothing about it. The Drug Enforcement Administration (DEA) has been following this course since at least the publication of the Ogden memo in 2009.

The caveat here is that the agencies always have the ability to change their minds. Two recent developments have the potential to radically change the marijuana discussion. The first is the publication of a DEA internal directive on May 22, 2018.2 The clarification provided in this directive is that products and materials made from the parts of the marijuana plant that are not included in the definition of marijuana under the Controlled Substances Act (CSA) are not themselves controlled under the CSA. The directive goes on to say, “the mere presence of cannabinoids is not itself dispositive as to whether a substance is within the scope of the CSA . . .” This is a reversal from the position taken by DEA in a news release in 2001 that stated that any product that causes THC to enter the human body is a Schedule I substance. Essentially they were saying at that time was that any product that has any THC in it is a controlled substance. What this change in direction might mean for future enforcement actions by DEA is uncertain at this time.

1 Article 6 - This Constitution, and the Laws of the United States which shall be

made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.

12

AR-Rx_Fall 2018.indd 12

The second recent development was the introduction of a bill

by Senator Charles Schumer of New York on June 28, 2018.3 This bill may render the previous discussions moot. The main objective of the bill is the removal of marijuana and THC from Schedule I of the CSA. The bill also amends a number of U.S. Code sections to remove marijuana and THC from them.

Examples of these include removing them from the definition of felony drug offense and from the mandatory sentencing guidelines. If marijuana and THC are no longer Schedule I substances, there is no longer any disconnect between state and federal law. The states would clearly be free to regulate marijuana as they see fit.

The law also creates some other related funds and requirements.

First, the bill creates a fund to provide small business loans to women and socially and economically disadvantaged people who want to operate a marijuana business. It also directs the National Highway Traffic Safety Administration to study the impact of driving under the influence of THC on highway safety. The bill goes on to direct the Secretary of Health and Human Services to conduct research on various health issues involving marijuana, such as the effects of THC on the brain, efficacy of marijuana as treatment for specific conditions, and the identification of additional medical uses for marijuana.

The bill would also restrict advertising of marijuana products if needed for the protection of the public health, especially for individuals who are 18 years old or younger. Lastly, the bill would provide funds for grants to states to allow them to set up programs to expunge previous marijuana convictions.

If passed, this bill would completely change the conversation on marijuana in the United States. There has been a huge shift in public opinion on this issue, especially in the last 20 years or so. It is too early to tell if the bill has enough support in Congress to get passed. If anything gets in the way, it may be the additional requirements and studies that are created in the bill. Each of them comes with their own appropriations, so the fight may come down to the budget. Stay alert for new developments – there will almost assuredly be more coming! § ________________________________________________________________ © Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company.

This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accordingly.

2 https://www.deadiversion.usdoj.gov/schedules/marijuana/dea_internal_directive_

cannabinoids_05222018.html

3 Marijuana Freedom and Opportunity Act - https://www.congress.gov/bill/115th-

congress/senate-bill/3174/text?q=%7B%22search%22%3A%5B%22schumer+ marijuana%22%5D%7D&r=1

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES COLLEGE OF PHARMACY

Melanie Reinhardt, P.D. Eddie Dunn, Pharm.D.

Ketorolac This issue of Safety Nets once again examines the potential hazards associated with electronic prescriptions. Thank you for your continued support of this column.

T

he prescription illustrated in Figure 1 was electronically transmitted from a prescriber's office to a community pharmacy. The pharmacist verified the prescription information as ketorolac 10 mg tablets, quantity 90, with directions of "take one tablet every eight hours as needed." The pharmacist also verified the prescriber had authorized two additional refills.

The prescription was filled by a technician and placed in line for final pharmacist verification. During this final verification, a second pharmacist realized the ketorolac order contained three significant errors including the quantity prescribed, days supply, and authorized refills. The pharmacist immediately telephoned the prescriber's office and expressed her concerns to a nurse. The nurse replied, "That's what the doctor wants."

The pharmacist informed the nurse she would not fill the prescription as written because it did not conform to ketorolac prescribing guidelines. The nurse placed the pharmacist on hold. When she returned, she instructed the pharmacist to change the prescription to conform with ketorolac prescribing guidelines. After this, the pharmacist entered the prescription information into the computer as ketorolac 10 mg tablets, quantity 20, with directions of "take one tablet every four to six hours as needed - do not exceed four tablets in 24 hours". No refills were authorized. After this, the prescription was correctly filled and the patient appropriately counseled.

Figure 1

Ketorolac is an NSAID indicated for short-term management of moderately severe acute pain. Every ketorolac tablet prescription must be written using the following guidelines: • Tablets are continuation therapy following parenteral ketorolac • Combined parenteral and oral ketorolac therapy should not exceed five days • Recommended oral dose is 10 mg every four to six hours not to exceed 40 mg/day • A maximum of 20 tablets should be dispensed The prescription illustrated in this case clearly does not follow these guidelines. The two most dangerous errors

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 13

are the ketorolac quantity (90) and two authorized refills.

If this prescription had been dispensed as transmitted and administered for longer than five days - serious and/ or catastrophic gastrointestinal effects such as bleeding, ulceration, or even perforation could have occurred. Fortunately for this patient, the errors were discovered before the medication was dispensed.

STUDENT SPOTLIGHT

Pyxis - Be Picky - Maggie Thannisch Originally developed in 1987 as an automated drug distribution technology for the safe delivery of narcotics, Pyxis proved so effective it was expanded to distribution of medications of all kinds.

The implementation of the Pyxis Medstation provided nurses and clinicians with a streamlined workflow reducing manual error, time, and cost. In institutions that implemented Pyxis, medication errors were reduced by approximately 33%, and up to 93% in some facilities. Computerized physician order entry (CPOE) also allowed the integration of automated drug distribution to flourish. CPOE is designed to prevent mistakes at the prescribing step (wrong drug/dosage form, dose calculation, adjustments for renal or hepatic dysfunction, etc..

Like any technology, accuracy is determined by the user inputting the information. No system is perfect.

For example, pharmacy technicians and other healthcare workers refill Pyxis Medstations containing sometimes over 300 different medications. The technician/healthcare worker pulls medications from stock, a pharmacist gives a final check off, then the medications are added to the Pyxis. Mistakes can be made in loading the Pyxis or selecting medications to dispense. Pharmacists, technicians, and nurses can fall victim to inattentional blindness. Inattentional blindness is when a person selects a small amount of information to process – the rest of the information does not reach consciousness resulting in the person failing to perform a task.

Pyxis has multiple safeguards to decrease medication and user error. For example, when technicians fill the Pyxis, a scanner can be attached to the machine to scan the barcode assigned to each drug and the compartment where it will be stocked to ensure accuracy.

13

11/1/18 12:14 PM

A PHARMACIST'S ROLE IN

HEALTH LITERACY

By Lauren Jimerson, Pharm.D., APA Executive Fellow

From the time a patient makes an appointment with their doctor to the time they get home and take a medication, many important health decisions have already been made. Many times, the last healthcare professional to interact with the patient is the pharmacist.

14

AR-Rx_Fall 2018.indd 14

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

A PHARMACIST'S ROLE IN HEALTH LITERACY

T

here are three main components of communication: the sender, the message, and the receiver. During an encounter, the message is not always delivered or received in the same way it was originally intended. One potential reason for the disconnect in the healthcare setting between professionals and their patients is limited health literacy, which may be more common than one might think.

The term health literacy, as defined by the Patient Protection and Affordable Care Act — Title V., is the degree to which an individual has the capacity to obtain, communicate, process, and understand health information and services in order to make appropriate health decisions.1 Health literacy is not only comprised of the patient’s understanding, assimilation of information, and wise decision making about their health; it is associated with patient safety, healthcare costs, and chronic disease prevention and treatment amongst many other problems that healthcare professionals are focused on today.

Studies have shown that 40% to 80% of medical information provided by healthcare practitioners is forgotten immediately, with almost half of the information that is recalled being incorrect. considered to have Basic health literacy, with 14 percent of adults having Below Basic health literacy. The majority of adults, 53 percent, were found to be at an Intermediate level.

An example of a health task that maps to the Intermediate level is listed as determining what time a person can take a prescription medication, based on information on the prescription drug label that relates the timing of medication to eating. Only the remaining 12 percent of adults had Proficient health literacy.3

From the time a patient makes an appointment with their doctor to the time they get home and take a medication, many important health decisions have already been made.

Many times, the last healthcare professional to interact with the patient is the pharmacist. Therefore, as pharmacists, we must provide clear instructions when interacting with our patients such as how to administer each medication, as well as when to follow up with their pharmacist or primary care provider. By presuming patients may not understand how to take their medications without our guidance, we can aid in decreasing medical errors and increasing patient compliance.

Healthcare information can be very complex and daunting, even for those who are well educated. Studies have shown that 40% to 80% of medical information provided by healthcare practitioners is forgotten immediately, with almost half of the information that is recalled being incorrect.2 As healthcare providers, it is crucial that we are able to acknowledge both existing and potential communication barriers which may occur with our patients.

The 2003 National Assessment of Adult Literacy (NAAL) is the nation’s most comprehensive measure of adult literacy (since the 1992 National Adult Literacy Survey) and provides information on the status of health literacy of American adults age 16 and older.3 The NAAL was administered to over 19,000 adults in households and prisons and measured literacy directly through tasks completed by adults. The results from this report divide health literacy into four distinct levels — Below Basic, Basic, Intermediate, and Proficient — along with providing examples of the types of health literacy tasks that adults at each level may be able to perform.

Figure 2-1 from the NAAL displays the percentage of adults in each health literacy level from the findings of this study.

The NAAL concluded that 22 percent of American adults were

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 15

Identifying patients who have limited health literacy is important to providing optimal patient-centered care, as these patients may require additional time and more interventions with their pharmacist. A study published in 2008 evaluated and compared the performance of three health literacy screening questions for detecting patients with inadequate or marginal health literacy in a large Veteran Affairs (VA) outpatient population. 1,796 patients completed interviews which included three health literacy screening questions and two validated health literacy measures. The results of this study suggest that a single question may be useful for detecting patients with inadequate health literacy in a VA population.4 Additionally, the UAMS Center for Health Literacy has developed a resource to aid providers in selecting a tool to screen patients for health literacy.

This resource includes the single health literacy screening question used in the VA study: "How confident are you filling out medical forms by yourself?" This screening question takes approximately one minute to administer and is currently being implemented in large health systems, including UAMS, where over 40,000 patients have been screened.5 A good

15

11/1/18 12:14 PM

A PHARMACIST'S ROLE IN HEALTH LITERACY

community pharmacy research project would be to test the application of this screening question when utilized in Arkansas pharmacies and may serve as a beneficial routine patient intake question across many practice settings.

Once identified, there are various ways pharmacists can serve patients who have limited health literacy and bridge these potential gaps. A key way to do this is by using simplified language when providing patient education. To explain, plain terms such as “high blood pressure,” “blood sugar,” and “check” can be substituted rather than “hypertension,” “blood glucose,” and “monitor.”

Many prescriptions can have complicated administration directions and related information, therefore, another valuable technique for assisting in patient understanding is the teach-back method. The teach-back method is a beneficial way to ensure that the sender has adequately communicated the message to the receiver. To use the teach-back method, ask the patient an open-ended question after discussing an important concept. For example, you could ask “Now that we’ve discussed this medication, how will you use this medication when you get home?” This allows patients to respond candidly and helps the pharmacist facilitate feedback.

A simple way to assist patients with the names, doses, and scheduling of their medications, as well as reinforce trust between patients and pharmacists, is by providing a pocket medication card. This allows a patient to have a concise list of current medications. Many pocket medication cards have a designated area for a patient’s drug allergies, recent vaccinations, blood type, a place to list questions or concerns, etc. This is a great resource patients can present to all of their healthcare providers in order to facilitate optimal patient outcomes and decrease drug interactions and duplications of therapy.

Other health literacy barriers in the pharmacy setting include prescription labels and printed healthcare materials. Choosing a proper font, an adequate font size, simple layouts, and appropriate reading levels for a specific audience are all imperative in providing comprehensible information.

If you are interested in conducting a health literacy assessment of your pharmacy, the Agency for Healthcare Research and Quality (AHRQ) has a Pharmacy Health Literacy Center which provides a tool to assess the pharmacy’s ability to meet patient needs, detect potential barriers for patients with limited health literacy skills, and identify opportunities to improve customer service.6 It is imperative to not assume a physician has previously discussed a medication with the patient. While prompt and accurate order fulfillment are vital in any practice setting, of equal importance is the opportunity to ensure patients are properly educated about their medications. §

16

AR-Rx_Fall 2018.indd 16

If you would like to find out more information on health literacy and how you can get involved, please visit the resources listed below: Agency for Healthcare Research and Quality: Pharmacy Health Literacy Center: www.ahrq.gov/professionals/quality-patient-safety/ pharmhealthlit/index.html Arkansas’s Big Health Problems and How We Plan to Solve Them: State Health Assessment and Improvement Plan 2013 by the Arkansas Department of Health: www.healthy.arkansas.gov/images/uploads/pdf/ ARHealthReportHealthProblems.pdf Arkansas Foundation for Medical Care: Health Literacy: Increasing Pharmacological Compliance afmc.org/wpfd_file/201502-feb-health-literacy Centers for Disease Control and Prevention (CDC): Health Literacy: www.cdc.gov/healthliteracy/learn/index.html Institute for Healthcare Advancement: 18th Annual Health Literacy Conference: Held May 1-3, 2019 in Costa Mesa, CA hlc.iha4health.org/ University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy: healthliteracy.uams.edu/ U.S. National Library of Medicine: MedlinePlus Easyto-Read Health Materials: medlineplus.gov/all_easytoread.html

Sources 1. www.hhs.gov/sites/default/files/v-healthcareworkforce.pdf 2. www.ncbi.nlm.nih.gov/pmc/articles/PMC539473/ 3. nces.ed.gov/naal/ Kutner, M., Greenberg, E., Jin, Y., and Paulsen, C. (2006). The Health Literacy of America’s Adults: Results From the 2003 National Assessment of Adult Literacy (NCES 2006–483). U.S. Department of Education.

Washington, DC: National Center for Education Statistics.

4. www.ncbi.nlm.nih.gov/pmc/articles/ PMC2324160/#CR18 5. afmc.org/wp-content/uploads/2017/01/ Literacy-Tools-UAMS-CHL-DHS-2017.pdf 6. www.ahrq.gov/professionals/quality-patientsafety/pharmhealthlit/tools.html#tool AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

A Fast-Track Quarter at the FDA By guest author Mary Ann McAllen, Pharm.D. Candidate This column, presented by the Harding University College of Pharmacy, aims to briefly highlight information on new molecular or biological entities, new indications, or significant new dosage forms recently approved by the FDA.

I

t seems things were on the fast-track this past quarter at the FDA as many drugs received priority review, greatly expediting the drug approval process.

Chronic Care: A variety of chronic care products received the green light this past quarter. Annovera™ (segesterone/ ethinyl estradiol) became the first vaginal contraceptive ring that can be used for an entire year; Diacomit® (stiripentol) was approved for treating seizures associated with the rare genetic Dravet syndrome; Epidiolex® (cannabidiol) became the first cannabis drug approved for rare forms of epilepsy (Lennox-Gastaut and Dravet syndromes), but it should be noted cannabidiol is currently classified as a Schedule I controlled-substance and will need to be reclassified before it is available for distribution; Galafold™ (migalastat) received priority review as an orphan drug for patients with a certain genetically mutated form of Fabry disease; Jivi® (antihemophilic factor [recombinant] PEGylated–acul) was approved for three indications including routine prophylaxis, on-demand treatment, and perioperative management of bleeding in patients with hemophilia A; Mulpleta® (lustromnopag), a thrombopoietin receptor agonist, received fast-track priority review to treat thrombocytopenia in adults with chronic liver disease prior to undergoing a medical/dental procedure; Onpattro™ (patisiran) received fast-track priority approval as a breakthrough orphan drug as the first drug to treat polyneuropathy caused by hereditary transthyretinmediated amyloidosis; Orilissa™ (elagolix) became the first oral gonadotropin-releasing hormone antagonist developed for endometriosis pain; Oxervate™ (cenegermin-bkbj), a recombinant human nerve growth factor, got the nod to treat neurotrophic keratitis; and Takhyzyro™ (lanadelumab) received priority approval and breakthrough orphan drug designation as the first monoclonal antibody to help prevent attacks of hereditary angioedema.

Oncology: This market continues to expand as six drugs

received approval this quarter. Azedra® (iobenguane I 131), a radioactive agent, was granted fast-track priority review with orphan drug designation for rare unresectable adrenal tumors (pheotchromocytoma or paraganglioma); Lenvima™ (lenvatenib) a first-line kinase inhibitor was approved to treat unresectable hepatocellular carcinoma; Poteligeo® (mogamulizumab-kpkc) received priority review as a breakthrough orphan drug for treating mycosis fungoides and Sezary syndrome, two types of cutaneous T-cell lymphomas; Tibsovo® (ivisidenib) received fast-track priority review and orphan drug designation as treatment for IDH1-mutated WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 17

acute myeloid leukemia; and Braftovi™ (encorafenib) and Mektovi® (binimetinib), two kinase inhibitors approved for combination use in patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

Infectious Disease: Anti-infectives made a resurgence this quarter with several new drug approvals as follow: Krintafel (tafenoquine) as the first new antimalarial in >60 years and the first single-dose drug to prevent relapse of P. vivax malaria; Moxidectin, an anthelmintic previously used in animal health, for use in humans to treat onchoceriasis (river blindness); TPOXX® (tecovirimat) received fast-track priority review and orphan drug status under the ‘animal rule’ as the first drug indicated for smallpox; Zemdri™ (plazomicin) an aminoglycoside approved only for complicated urinary tract infections including pyelonephritis; and doravirine, a new non-nucleoside reverse transcriptase inhibitor available in the single-entity product Pifeltro™ and also in the combination product Delstringo™ (doravirine/lamivudine/ tenofovir) for treating HIV. Refusing to fit into a category, Omegaven® (fish oil triglycerides) received orphan drug approval as an IV emulsion source of calories/fatty acids for pediatric patients with parenteral nutrition-associated cholestasis.

New Dosage Forms: New dosage forms approved this

quarter include: Altreno™ (tretinoin, lotion) the first tretinoin lotion formulation for acne; Arakoda™ (tafenoquine, tablet) low-dose formulation for malaria prophylaxis; Aristada™ Initio (aripiprazole, extended release IM suspension) for day-one initiation in schizophrenia; Cassipa (buprenorphine/ naloxone, SL film) for maintenance treatment of opioid dependence; Cequa™ (cyclosporine A, ophthalmic solution) to promote tear production in dry eye; Consensi™ (amlodipine/celecoxib) new combination for hypertension/ osteoarthritis; Epinephrine SQ as the first generic version of EpiPen®; Inveltys™ (loteprednol, ophthalmic suspension) as first BID-dosed post-operative ocular steroid; Jornay PM™ (methylphenidate, ER tablet) for evening treatment of ADHD; Nocdurna® (desmopressin, SL tablet) for nocturia; Perseris™ (risperidone, extended-release SQ suspension) for schizophrenia; Qbrexza™ (glycopyrronium) underarm application for excess sweating; Symtuza™ (darunavir/ Cobicistat/emtricitabine/tenofovir) new combination for HIV; Tiglutik™ (riluzole, oral suspension) for amyotrophic lateral sclerosis; and Yonsa® (abiraterone, tablet) lower strength for metastatic castration-resistant prostate cancer. § 17

11/1/18 12:14 PM

UAMS SCHOOL OF PHARMACY

Practice-Ready Keith Olsen Pharm.D., FCCP, FCCM Dean and Professor

David Caldwell, Pharm.D. AAHIVE, UAMS Associate Professor (Co-Author)

I

t seems the pharmacy profession has more opportunities In recent years, this has included adjustments to ensure and challenges at this time than I can remember in my our graduates are able to provide direct patient care in a 37 years as a licensed pharmacist. These are not limited variety of healthcare settings through such services as to, but include, shrinking reimbursements, the Affordable immunizations, medication therapy management, point-ofCare Act (ACA), direct and indirect remuneration (DIR) fees, care testing, and others. But the ideal approach is one in pharmacy benefit managers (PBMs), specialty pharmacy, which we cultivate a mindset of lifelong learning within our 797 application to community pharmacies, medication students. Pharmacists graduating today need the tools that therapy management (MTM), 503 A/B, Community Pharmacy will enable them to practice successfully for the full length Enhanced Service Network (CPESN), opioid crisis, and of a career and to respond to change in a self-directed way. pharmacy manpower. Academia is also confronting other In addition, all colleges and schools of pharmacy need to issues as we prepare pharmacy demonstrate the practic-readiness of students prior to beginning their graduates for the NAPLEX and entry into the workforce as practice4th year clinical clerkships.

Practice-readiness is a guiding ready pharmacists. Colleges and principle to which we constantly In order to ensure that every schools of pharmacy are dealing UAMS College of Pharmacy pre with evolution in expectations refer as we make decisions and post graduate continues to for pharmacy practice, the new that affect the education of our be practice ready, we have begun NAPLEX exam format, curricular students, but it is a concept that is the process of evaluating our change to meet new practice difficult to define. current curriculum and developing models, change in learning styles improvements that will place an of current students, a smaller emphasis on such key areas as applicant pool, and pharmacy manpower issues. knowledge application, critical thinking, leadership, and innovation, while maintaining the commitment to excellence As you all know from first-hand experience, the practice of pharmacy is changing both here in Arkansas and nationwide. in the foundational sciences and medication expertise for These changes bring with them new opportunities as well which our program is well-known. The faculty is working hard to systemically build a curriculum that will prepare our as new challenges for our profession, from the expansion students for practice not just as it stands now, but also for of our scope of practice in various ways to the adaptation the life of their careers. We call this plan Curriculum 2025, required by new influences on reimbursement. Many of us and we hope to implement these changes for students probably did not foresee the differences that were to come entering the program in the year 2021. to our profession as we were graduating and entering the workforce. This climate of change will likely continue, and In addition to a renewed curriculum, we consider practiceit is something of which we must be very mindful as we readiness as we develop methods to evaluate our students. prepare the next generation of pharmacists to join our ranks.

With that in mind, I would like to share with you the ways in As many of you know from your experiences in the program, which our state’s College of Pharmacy develops its students the College utilizes many types of evaluation in addition to into graduates who are ready to enter a practice that is not traditional testing to ensure our students are capable of the types of higher-order thinking and decision-making that only in the midst of significant change right now, but which are such an integral part of our profession--the Objective will also continue to evolve throughout their careers.

Structured Clinical Examination, or OSCE, is one example Practice-readiness is a guiding principle to which we of this. Through the use of a variety of evaluation types, we constantly refer as we make decisions that affect the can build a better picture of our students’ knowledge, skills, education of our students, but it is a concept that is difficult and learning needs, and then respond with personalized to define. As practice develops, sometimes in ways we academic support. The result is a program in which we not anticipate and sometimes in ways we do not, we adjust our only measure what students know, but also how well they educational program to meet the needs of the profession. can apply what they know and synthesize new information

18

AR-Rx_Fall 2018.indd 18

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:14 PM

UAMS: PRACTICE-READY

to succeed in novel situations. This helps us bridge the sometimes formidable gap between the classroom and practice.

These are just some of the ways the UAMS College of Pharmacy is actively working to graduate students who are relevant today as well as equipped to respond to changes in practice throughout their careers. And we know the work does not end on our campus. You all, as members of the profession and preceptors of our students, also play a critical part in their education and preparedness for practice. We and our students thank you for your support in this process, and we ask for your continued partnership as we all commit to the fostering practice-readiness in every student. §

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 19

We have begun the process of evaluating our current curriculum and developing improvements that will place an emphasis on key areas of practice-readiness, such as: • knowledge application • critical thinking • leadership • innovation • We hope to implement these changes for students entering the program in the year 2021.

19

11/1/18 12:15 PM

` HARDING UNIVERSITY REPORT

2018 HUCOP Annual Report

F

all marks a busy time of year for faculty, staff, and students at the Harding University College Jeff Mercer, Pharm.D. of Pharmacy (HUCOP). It’s a joyous Dean time when we welcome both new and returning students to campus. It’s also a time when several of our administrators have the opportunity to attend the APA Regional Meetings and visit with pharmacists, preceptors, and alumni throughout the state of Arkansas.

The following is a portion of our HUCOP report for this new academic year:

• Delivering a contemporary didactic curriculum • Designing more immersive and meaningful pharmacy practice experiences • Incorporating interprofessional education opportunities for students to learn about, from, and with other healthcare professionals and their students • Implementing a formal co-curriculum that tracks alongside and enhances the didactic/experiential curricula • Promoting the Pharmacists Patient Care Process as the preferred practice model for pharmacists (see https:// jcpp.net/patient-care-process)

We were delighted to welcome our eleventh class of pharmacy The College is wrapping up the students this year – the class of last phases of our current Strategic The admissions cycle for the next 2022! This class is smaller than Plan while putting the finishing academic year (2019-20) has any of our previous classes with a touches on our new 2019 – 2023 already begun, and we are actively total of 35 students from locations Strategic Plan that will begin in taking applications and scheduling throughout Arkansas and several January. We appreciate all of the other states. In a challenging feedback and input from our many interviews on a rolling basis. We constituents. Soon we’ll share the admissions environment, the class are seeking outstanding students was chosen based on quality details of our vision for the next five with a mission-centered mindset indicators and a holistic assessment years. that want to serve others through process designed to identify the noble profession of pharmacy. students capable of succeeding in I’m pleased to share a great new opportunity for pharmacy our rigorous academic environment in Arkansas. The Arkansas while also meeting our serviceDepartment of Health and the Arkansas Pharmacists based mission. We are excited for this new group of students and hope you get the opportunity to meet them soon.

Association have joined with the chair of our department of pharmacy practice, Dr. Julie Kissack, to develop and The admissions cycle for the next academic year (2019-20) implement a pharmacist-administered tobacco prevention has already begun, and we are actively taking applications and cessation program. Funded through an initial $200,000 and scheduling interviews on a rolling basis. We are grant, the project is underway with a two-year pilot project to seeking outstanding students with a mission-centered investigate the feasibility of paying up to 30 Arkansas-based mindset that want to serve others through the noble independent pharmacies to provide tobacco prevention/ profession of pharmacy. We recently reduced our tuition cessation services. Surveys were administered at both the APA Regional meetings and via electronic means to and offer scholarship opportunities for both financial need gather perceptions and interest in this program. We are and high academic performance. In addition, we offer an early assurance program for exceptional undergraduate confident this program will support a healthier community students. If you know of students who want to become great for all Arkansans while helping Arkansas pharmacists find pharmacists, please consider having them contact us. successful new revenue streams.

You may recall my mentioning a time of self-study last year in anticipation of a visit by the Accreditation Council for Pharmacy Education (ACPE). In October of 2017, a fivemember team evaluated our self-study and completed a comprehensive on-site review of our program. I’m pleased to report that our accreditation status was affirmed through June of 2020. Our next accreditation visit will occur during the spring of that year and will focus on several key initiatives that we have identified for ensuring our students are “practice ready” upon graduation. Specifically, we have committed to the intentional incorporation of the following components in our program: 20

AR-Rx_Fall 2018.indd 20

In closing, I would like to express appreciation to all of you who serve as preceptors, mentors, advocates and encouragers to our students. Many of you support our students and program in so many ways, and we simply could not do what we do without you.

That’s a bit about what’s going on at Harding University College of Pharmacy. If you have any questions or interest in our program, please visit us at www.harding.edu or give us a call at 501-279-5528. §

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

`

2018-2019 Calendar of Events

DECEMBER ———————— December 2-6, 2018 American Society of HealthSystem Pharmacists Midyear Clinical Meeting Anaheim, CA December 9, 2018 APA Board Meeting Airport Holiday Inn Little Rock, AR

FEBRUARY ———————— February 12, 2019 APA Legislative Day/Reception Little Rock, AR February 22, 2019 CE at the Races Oaklawn Racing and Gaming Hot Springs, AR

December 9, 2018 APA Committee Forum Airport Holiday Inn Little Rock, AR December 24-25, 2018 APA Office Closed Little Rock, AR

JANUARY 2019 —————— January 1, 2019 APA Office Closed Little Rock, AR

January 14, 2019 92nd Arkansas General Assembly Little Rock, AR

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 21

21

11/1/18 12:15 PM

LEGISLATOR PROFILE

Representative Dan Douglas BENTONVILLE, DISTRICT 91

Represents (Counties): Part of Benton County Years in Office: 6 Occupation: Farmer, real estate What do you like most about being a legislator? I like solving problems. As a legislator, I get to help people in my district with problems and concerns they have. It’s rewarding when we can work together to find solutions.

What do you like least about being a legislator? Our

political climate has become extremely polarized. Sometimes we have trouble coming together across the aisle and working toward the common good.

Most important lesson learned as a legislator: There are many sides to an issue.

Your fantasy political gathering would be: If I had a chance to sit down with any political figure from history, it would be my great great-grandfather, Marshal Douglas. I have the honor of being named after him. He served in the Arkansas Senate from 1861-62 which was in the middle of secession. I am sure he would have great insight into navigating turbulent and divisive political times.

Hobbies: Working on my cattle farm, spending time with my grandkids, and traveling

Why did you run for office? I have been blessed in my life and was raised to give back (to whom much has been given...). My hope is to leave my grandkids a state that is better and more prosperous than when I was their age. I love Arkansas, and I want to help ensure her continued success for future generations. §

Most admired politician: Harry S. Truman. He was plainspoken, humble, and believed in taking personal responsibility.

Advice for pharmacists about the political process and working with the Arkansas Legislature: Don’t be afraid to reach out and communicate with legislators. Build relationships with them. Educate them about critical issues.

22

AR-Rx_Fall 2018.indd 22

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

ARKANSAS ACADEMY OF HEALTH-SYSTEM PHARMACISTS

Resilience

O

nce again, AAHP had a tremendously successful Fall David Fortner, Pharm.D., Seminar. Events like this do not President happen without the dedication of our membership. The planning committee did an exceptional job and we thank you for your efforts! I want to especially thank Kim Young, Amber Powell, and Joy Brock who served as cochairs for this year’s event.

The successful conference was a reminder of all of the great parts of the profession of pharmacy and a chance to discuss our shared challenges. We do practice in a different time, and for this reason, I believe, as a profession, we must continue to strive to be the very best at the things that are unique to pharmacy. Additionally, we need to continue to look for opportunities to expand our profession and find innovative ways to impact our patients.

Impact is a key word and one that we should all take some time to consider. Each of us has an opportunity to impact the people we interact with each day. When we think about patients that we see as pharmacists, it is fairly easy to identify our impact.

You could potentially improve medication adherence through counseling efforts. A pharmacist can manage kinetic consults to ensure appropriate antimicrobial therapy. However, we need to consider the impact and the influence that we can have on each other. Many of you probably know of Stephen Covey, the author of many leadership books. He once said, “in order to have influence, you have to be influenced.” Take some time to consider those that influenced your own career. Take Fall Seminar was also a forum for pharmacists to meet with some time to think about colleagues that you’ve been able to industry vendors and students to learn influence in your career. AAHP Fall about residency programs, while the Seminar was another example of poster session was an opportunity for the positive impact, and influence, This year’s seminar was entitled students and pharmacists to share the our membership has on patients, great work they’ve done over the past providers, and peers across our Resilience – Survive to Thrive year. Over 200 attendees came to the state. § event. We had 28 vendors, 28 posters attendees presented during our networking vendors session, and 14 residency programs recruiting during the showcase. posters presented during The theme for Fall Seminar 2018 was Resilience – Survive to Thrive. We heard from keynote speaker Jillanne Shulte Wall who serves as Director of Federal Regulatory Affairs for ASHP. She discussed some of the significant challenges we currently face in pharmacy practice. These include constant drug shortages, the continued fight for provider status, and drug pricing changes that continue to impact hospital finances, such as decreases to the 340b program, just to name a few.

Additionally, we heard speakers discuss clinician well-being, the continued opioid crisis, and transitions of care.

200 28 28

our networking session

14 residency programs

recruiting during the showcase

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 23

23

11/1/18 12:15 PM

AAHP 2018 Fall Seminar

Clinician of the Year – Dr. Karen King UAMS Medical Center

2018-2019 AAHP President David Fortner

New Practitioner of the Year – Dr. Meagan Doyle CHI St. Vincent

24

AR-Rx_Fall 2018.indd 24

Residency Preceptor of the Year – Dr. Gabriella Douglass, ARcare / Harding University CoP

Staff Pharmacist of the Year – Dr. Annie Lockhart CHI St. Vincent

Student Poster Session

Technician of the Year – Donna Young CHI St. Vincent

Student of the Year - Josh Park Pharm.D Candidate 2019, Harding University

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

Manager of the Year – Dr. Maggie Williams White River Medical Center

Louise Pope Lifetime Achievement Award – David Cobb Baptist Health Systems

Exhibitors Showcase

Louise Pope Lifetime Achievement Award – Dr. Mike Parr UAMS Medical Center

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 25

Student Poster Session

25

11/1/18 12:15 PM

CONSULTING ACADEMY

Thinking Outside the Script

H

ow many times in your career as a pharmacist have you been asked “what do you do”, “where do you work”, or “what is it you do there”? How many times have you been asked those same questions from another pharmacist?

Larry McGinnis, Pharm.D. President

I have been a nursing home consultant pharmacist for as long as I was a hospital pharmacist, doing both simultaneously for over 35 years in Arkansas. I retired from practicing as a hospital pharmacist two years ago and have since been focused on growing my nursing home consulting business.

The most difficult part for me has been recruiting and finding young pharmacists that are looking to work in a seemingly “secret practice” of pharmacy.

I often ask students and recent grads from both HUCOP and UAMS, “did they teach you anything about consulting in nursing homes,” to which the answer is most often “no, I’ve never heard of consulting pharmacy, what is it you do there?”

Nursing home consulting has been a very rewarding venture for myself and many other pharmacists I have known and

26

AR-Rx_Fall 2018.indd 26

worked with over the years. As the need for more young pharmacists to work in this area of practice continues to grow, so does the need to recruit and train young pharmacists in this “secret practice” of pharmacy.

HUCOP and UAMS both invite consultant pharmacists to come speak to their P1 career orientation classes each year, but often by the time the students are in their P4 year, nursing home consulting has become just another distant blur on the way to graduation and thoughts of other jobs and/or residency programs.

I was invited to speak to UAMS College of Pharmacy P3’s last year in Lisa Hutchison’s Geriatrics Class. I feel very fortunate to have been invited back again this year. I certainly appreciate the opportunity to share this area of pharmacy practice to a young group of students studying geriatrics and asking them to consider “thinking outside the script.”

I’ve already hired one from that class and more have reached out to me about consulting after graduation. Hopefully, an introduction to consulting in the P3 year will provide more career opportunities at a time when jobs in pharmacy seem to be at a premium. §

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

COMPOUNDING ACADEMY REPORT

Tyler Shinabery, Pharm.D. President

FDA Releases New Draft MOU Proposing Rules on the Interstate Shipment of Compounded Medications

A

s I start my tenure as the newest member in a longline of wonderful pharmacists to serve as the APA Compounding Academy President, I would like to take some time to introduce myself to the academy. As some of you may recognize my unique last name, there happen to be a few Shinaberys running around the pharmacy world in Arkansas. I am the second 3rd generation pharmacist in my family, and I currently work at Custom Compounding Center in Little Rock with my father Mark. He has managed Custom Compounding for 20 years now, and I joined his practice in 2013 after graduating from UAMS. We are a 503a facility focused primarily on non-sterile compounding. I am a native of Little Rock and proud Catholic High graduate. I received a BS in Psychology from Loyola University New Orleans in 2009 prior to entering pharmacy school. I currently live in Sherwood with my wife Megan.

I wanted to take time in my first article to go over some recent revisions to a draft guidance document released by the FDA on September 7th 2018 highlighting some changes the agency has made to the Draft Memorandum of Understanding (MOU) between the FDA and State Boards of Pharmacy that could potentially regulate the volume of interstate shipping of compounded medications. This has been a very hot topic nationally among many compounders, and revisions have been made based on comments from stakeholders on the original draft guidance released in 2015.

The new draft guidance would expand the amount of prescription volume that a traditional 503a pharmacy can distribute via interstate commerce from 30% to 50% of the pharmacy’s prescription drug volume. Prescription drug volume was also more clearly defined as the number of prescription drug orders the pharmacy receives. The FDA

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 27

draft guidance also loosens restrictions on the state with regard to how to collect such information from its pharmacies as well as not requiring the state to take action against said pharmacies based on risk. There is also language in the MOU that directs the states to report information based on complaints about compounded medications distributed out of state. This language would include collecting data on sterile compounds distributed interstate, due to inherently higher risk associated with these products.

If the guidance were to be finalized and the state did not enter into the MOU, according to section 503a of the Food, Drug and Cosmetic Act (FDC), traditional compounding pharmacies would be limited to shipping only five percent of prescription drug volume over state lines. This obviously could affect many businesses that work in border towns across Arkansas and well beyond. Since this is still a draft guidance, there will be an open comment period for at least 90 days for stakeholders to voice their concerns. If the MOU is finalized, there would be a 180-day grace period for individual states to review the document and decide whether or not to sign before the FDA would enforce the prescription limits on an inspection. It is important to note that the draft guidance does not apply to 503b facilities or to prescription drug orders for animal patients due to definitions defined in the FDC. In closing, I would be remiss if I did not mention the two compounders who ran against me for the current Academy President position, Andrew Mize and Kent Vinson. I know both will serve the academy well in years to come after my tenure is up. Please feel free to contact me with any concerns regarding the compounding academy that you feel need addressed. I will do whatever possible to bring your concerns to the APA Board as you see fit. Oh, and Go Hogs! §

27

11/1/18 12:15 PM

2018 Arkansas Pharmacists Association REGIONAL MEETINGS The Arkansas Pharmacists Association held its 2018 Regional Meetings in 11 cities across the state during the months of August and September. Members were able to engage with Arkansas pharmacy leaders, get updates from the colleges of pharmacy, AAHP, the State Board, and APA, and enjoy camaraderie and fellowship with fellow pharmacists in the area. APA member participation is integral to the success of the association. Thank you to all who attended!

Camden – Casey de Yampert, Jennifer Davis

Camden – Scott Harper, Tami Murphy, Eric Poole

Camden – Scott Pace presents Sen. Bruce Maloch with the APA Legislative Champion Award Camden – Betsy Tuberville, Rebecca Totty, Teresa McCann

Fort Smith – Dana Harrington, Hope Akins

28

AR-Rx_Fall 2018.indd 28

Fort Smith – Mark Manes, Amy Gibbons, Robert Woolsey, Courtney Langley, Elizabeth Woolsey

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

Hot Springs – John Vinson, Carissa Specht, Ashley Paul, Josh Paul

Hot Springs – Janice Beene, Rob Evans, Jodi Troutt

Hot Springs – Evelyn Johnson, Deborah Hobson, Rayanne Story

APA wishes to thank our Regional Meeting Sponsors: AmerisourceBergen, Ashford Advisers, Cardinal Health, Harding College of Pharmacy, McKesson, Smith Drug, and UAMS College of Pharmacy.

Hot Springs – William Wallace, Shelyn Davis, Samantha Pennington, Sheila Collins

Jonesboro – Reed Peavy, Amy Peavy, Phil Wilson, Emily Wilson

Jonesboro – Charlie Cain, Connie Bennett

Jonesboro – Kenny Lomax, Stephen Hill

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 29

Jonesboro – Harding University College of Pharmacy Dean Jeff Mercer

29

11/1/18 12:15 PM

Little Rock – Larry Franklin, Russell Sharp, Gabriella Nepomuceno

Little Rock – Brett Bailey, Will Arnold, Eric Hamilton

Little Rock – Larinda Floyd, Tamara Havner

Little Rock – Rick Rogers, Myka Tabor

Little Rock – Megan Smith, Rachel Stafford, Lindsey Dayer, DeMee Williams

30

AR-Rx_Fall 2018.indd 30

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

Little Rock – Scott Pace presents Sen. Jason Rapert with the APA Legislative Champion

Little Rock - Scott Pace presents Sen. Ron Caldwell with the APA Legislative Champion Award

Little Rock – Scott Pace presents Rep. Michelle Gray with the APA Legislative Champion Award

Monticello – Billy Gammel, Ben Johnson, Olivia Long, Jessica Long

Monticello – Mike Hollis, Jill Pippen

Monticello – Olivia Livingston, Lani Gabin, Brandy Bowen

Mountain Home – UAMS Dean Keith Olsen

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 31

Monticello – Scott Pace

31

11/1/18 12:15 PM

Mountain Home

Mountain Home

Russellville – Brenda McCrady, Stephen Carroll, Scott Pace

Russellville – Will Walker, Yanci Walker, RD Walker

Russellville

Russellville – Steve Stroud, Ive Lovett

32

AR-Rx_Fall 2018.indd 32

Searcy – Kelly Curd, Scott Curd, William Hamill

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

Searcy – Jeanie Horton, Jenny Treece

Searcy – Stephen Carroll, Dennis Moore, Tommy Johnson, Teri McKay

Searcy – Nancy Showalter, Stacy Featherston, Peyton Harvey

Stuttgart – James Bethea

Springdale – Kelsey Spire, Julie Stewart, Casey Rissinger

Springdale – Charles Shuster, Mark Silvers, Bill Graves, Carroll Barham, Gary Grammer WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 33

Stuttgart – Scott Pace presents Rep. Reginald Murdock with the APA Legislative Champion Award alongside his wife Willie Murdock 33

11/1/18 12:15 PM

34

AR-Rx_Fall 2018.indd 34

AR•Rx

|

THE ARKANSAS PHARMACIST

11/1/18 12:15 PM

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 35

35

11/1/18 12:15 PM

WWW.ARRX.ORG

AR-Rx_Fall 2018.indd 36

36

11/1/18 12:15 PM