The Kentucky Pharmacist May/June 2018

Vol. 13 No. 3 May/June 2018

THE KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

INSIDE: Legislative Session Summary 2018 Farewell to President Christopher Harlow

TABLE OF CONTENTS FEATURES Session Summary |8|

Mission Statement: The mission of KPhA is to advocate for and advance the profession through an engaged membership.

On the Cover 

Pictured left to right: Matt Carrico, Jaclyn Ochsner, Senator Ralph Alvarado, MD, (RDistrict 28), Richard Slone, Chris Palutis, Nathan Hughes and Sam Willett attend a legislative fundraising event.

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Kentucky Delegation at the U.S. Capitol for NCPA fly-in with U.S. Congressman James Comer (R-First District).

Editorial Office: ©Copyright 2018 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association.

Publisher: Mark Glasper Managing Editor: Sarah Franklin Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601.

Phone: 502.227.2303 Fax: 502.227.2258.

Email: info@kphanet.org.

Website: www.kphanet.org.

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IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |6| Advocacy Matters |13| Continuing Pharmacy Education |15| Campus Corner |29| Pharmacy Law Brief |32| Pharmacy Policy Issues | 34|

ADVERTISERS APSC|5| PTCB |22| EPIC |4 & 33 | Cardinal |37| Pharmacists Mutual |36|

PRESIDENT’S PERSPECTIVE This is my final message to you as President of the Kentucky Pharmacists Association. As we look to the future of our profession and association, I am hopeful of the advances we will make over the coming years. KPhA has a bold strategic plan that we implemented in 2016, and we are making satisfactory progress toward its goals.

We are more engaged with our membership than ever with the involvement of committee membership in our strategic plan, surveying our members to determine the value that KPhA can provide, disseminating key messages to all pharmacy stakeholders, enhancing recruitment strategies such as Christopher Harlow the ambassador program, and developing ad hoc committees to President, KPhA address the educational needs and leadership opportunities for our members. KPhA is demonstrating that it is the organization to support you in your professional development and continuing education requirements with our robust annual meeting and educational programming.

Through collaborative efforts with other state organizations and pharmacy leaders, we are advancing pharmacy practice. We recognize the need to modernize the pharmacy practice act and optimize the role of all pharmacy personnel, and we are progressing toward new models of success. The Board authorized protocols are a great achievement this year and we will continue to build on the momentum to advance pharmacists’ role as a valued member of the healthcare team.

The advancement continues with KPhA’s role in demonstrating pharmacists’ value in the area of public health. I am so proud of the response by pharmacists this past year in opioid overdose prevention through the distribution of naloxone, and their immediate availability to administer Hepatitis A vaccine during a serious outbreak in the Commonwealth. I personally thank all pharmacists for their contributions.

“I look forward to being a part of the continued growth of our wonderful profession.“

And lastly, KPhA continues to be the advocate for you. We are a unified profession and will always be the voice for all pharmacists regardless of your practice setting. It is KPhA that guides the policy to move our profession forward, and I believe the value is apparent in the daily work of our association.

It has truly been a pleasure and an honor to serve this association and the membership. From the time I entered the profession of pharmacy, I knew I found my passion and “professional home.” This past year has allowed me to work with pharmacists and other healthcare stakeholders in advancing the practice of pharmacy and addressing the difficult challenges we face. I am confident in the next generation of pharmacists and leaders. I look forward to being a part of the continued growth of our wonderful profession.

Thank you for allowing me to serve.

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to info@kphanet.org to get on the list. |3| www.KPHANET.org

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MY KPhA Rx Congratulations Pharmacy Graduates!

By Mark Glasper KPhA Executive Director/CEO I had the pleasure of attending for the first time the University of Kentucky College of Pharmacy and Sullivan University College of Pharmacy graduations this year. I was impressed with the programs orchestrated by UKCOP Dean Kip Guy and SUCOP Dean Cindy Stowe.

What made these graduations different, at least for me, was how all the graduates became united with each other and with those professionals in the audience over the reciting of the Oath of the Pharmacist. What a grand way to remind graduates of the Like any graduation, the graduates appeared digniimportance of the profession they were about to enfied in their caps and gowns. Doting parents ter. dodged in and out of the shadows craning their For those who haven’t had the opportunity for necks to get the perfect photos of their children.

And, yes, there were the occasional outbursts from some time to recite the oath, gaze upon the followsmall children that were quickly silenced by morti- ing words. fied parents, whisking them through the nearest doorways and into adjacent hallways.

The Oath of a Pharmacist "I promise to devote myself to a lifetime of service to others through the profession of pharmacy. In fulfilling this vow: I will consider the welfare of humanity and relief of suffering my primary concerns.

I will apply my knowledge, experience, and skills to the best of my ability to assure optimal outcomes for my patients.

I will respect and protect all personal and health information entrusted to me.

I will accept the lifelong obligation to improve my professional knowledge and competence.

Kentucky Board of Pharmacy Executive Director Larry Hadley leads SUCOP graduates in the Oath of a Pharmacist with assistance from Dean Cindy Stowe and Daniel Malcom, Associate Professor and Vice Chair, Department of Clinical and Administrative Sciences. |6| Kentucky Pharmacists Association | May/June 2018

I will hold myself and my colleagues to the highest principles of our profession’s moral, ethical and legal conduct.

I will embrace and advocate changes that improve patient care.

I will utilize my knowledge, skills, experiences, and values

to prepare the next generation of pharmacists.

I take these vows voluntarily with the full realization of the responsibility with which I am entrusted by the public.”

I have to be honest. I had chills as these solemn words were uttered. I know I saw a number of audience members dabbing at their eyes.

how important they are to the future of pharmacy.

We also provide graduates with complimentary membership as a first-year practitioner because we see them as influential future leaders, not only of KPhA, but also in the communities where they will practice.

Best wishes Class of 2018!

Words of Advice I was honored to address the UKCOP students minutes prior to their graduation. I told them, among other things, to pause for a moment during the ceremony and take a mental picture of their surroundings – their fellow classmates, their friends and families assembled in the audience, and file those images away for safe keeping. Graduation day, like so many of the important days of our lives, flies by at warp speed. I let them know that doing this had helped me many times in my own life when I wanted to remember a special moment.

I also had a similar opportunity to talk with SUCOP students at a lunch the week before graduation. I asked them how many came from “pharmacy” families. A few raised their hands.

Then I asked how many had a mentor steer them toward the pharmacy profession. A few more raised their hands. And then I asked how many just knew that being a pharmacist was what they wanted to do from the very beginning. More hands were extended.

No matter how they came upon the pharmacy profession or where they may practice their craft, I told them KPhA will be there for them. For their continuing education requirements, their networking needs or as their government affairs voice in Frankfort, KPhA will be their lifelong resource – just as they are the lifeblood for the association.

The Future of Pharmacy KPhA provides students with free membership while they are in school because we recognize just

KPhA President Chris Harlow helps lead UKCOP graduates in the Oath of the Pharmacist.

KPhA Executive Director Mark Glasper presents the KPhA Outstanding Graduating Man Award to pharmacy graduate, Thomas Lowell Platt at the University of Kentucky College of Pharmacy graduation pictured with KPhA President Chris Harlow and UKCOP Dean Kip Guy. |7| www.KPHANET.org

SESSION SUMMARY Session Summary Regarding Pharmacy Legislation 2018 Kentucky General Assembly By: Shannon Stiglitz, KPhA Lobbyist Carve out of Medicaid Pharmacy Benefits: Senator Max Wise (R-Campbellsville) once again championed legislation on behalf of community pharmacies. Pharmacies across the commonwealth have experienced dramatic drops in reimbursements from the Medicaid Managed Care Organizations (MCOs) and their contracted Pharmacy Benefit Managers (PBMs). These cuts coincided with four of the five MCOs contracting with one PBM—CVS/Caremark. This drop was, in many instances, significantly below the drug acquisition costs of most community pharmacies. KRF’s government affairs team met with the staff in the Kentucky Cabinet for Health and Family Services and its Kentucky Department for Medicaid (DMS) as well as legislators prior to the start of the session to try and reach a resolution to the problem but no such consensus could be reached.

That is why on September 24, Wise pre-filed legislation that would carve out the Medicaid outpatient pharmacy benefits from the managed care system and require DMS to administer it. Immediately, the MCOs called fouled and opposed what would become SB 5. Subsequently, the Kentucky hospitals came out in opposition to SB 5 because it would eliminate the generous spread pricing contained in the federal 340B program. In order to address the concerns raised by the hospitals, language was added to SB 5 that would allow 340B pharmacies to continue to bill MCOs. Other changes were made at the request of Medicaid Commissioner Steve Miller including to allow DMS to hire a third party to administer pharmacy benefits. The amended bill passed the Senate 32-4 on March 1.

It was assigned to the Banking and Insurance Committee when it reached the House and it became clear that the MCOs and PBMs had been working the House overtime and the CHFS officials were pushing hard against the legislation as well. A compromise was eventually proposed to make SB 5 a transparency bill that would make certain key pieces of information available. First, it requires the PBM contracting with a MCO to provide to the state Medicaid program administrators, by August 15, the total amount of Medicaid dollars paid out to pharmacies licensed in Kentucky as well as the total paid to pharmacies or other entities affiliated with the PBM. It also requires the PBM to report the average reimbursement to pharmacies with more than 10 locations and to those pharmacies with 10 or fewer locations. The reim|8| Kentucky Pharmacists Association | May/June 2018

bursement rate includes the dispensing fee that, on average, is currently 85 cents. The PBM must also report any fees directly or indirectly charged to a pharmacy.

For contracts entered into or renewed after the effective date of the bill, DMS shall set, create or approve the dispensing fee. The PBM must also give DMS 30 days advance notice of any change in reimbursement rates that exceed 5 percent. The agency can then decide whether or not to stop the reimbursement rate change.

Finally, DMS is required to approve all contracts between the MCO and PBM. The legislation included an emergency clause so that it takes effect for upcoming contract extensions and the new MCO contracts that star on January 1, 2019. Governor Bevin signed the legislation so it took effect on April 13.

Representative Danny Bentley (R– District 98), Representative Addia Wuchner (R-District 66), KPhA President Chris Harlow and KPhA Executive Director Mark Glasper connect during the Legislative Conference.

Increased Dispensing Fees: Because of the low dispensing fees paid to pharmacists by the Medicaid Managed Care Organizations through their Pharmacy Benefit Managers (PBMs), the Senate earmarked $12 million dollars of the Medicaid appropriations contained in the budget (HB 200) for increased dispensing fees for pharmacies during the first year of the biennium. This equates to about a two-dollar increase per prescription.

The House version of the budget did not include the increased dispensing fee requirement so it was a point of discussion in the budget conference committee. In the

end, the agreed-upon budget included the increased dispensing fee language. Although the governor vetoed HB 200, the General Assembly overrode his veto and the budget goes into effect for the new fiscal year which starts July 1.

only go into the General Fund. House Bill 366 passed the House, with bipartisan support, by a vote of 68-25.

The Senate reviewed the proposal and chose not to include an opioid tax in their version of the bill. When both chambers went to conference and the final conference committee report was released, it did not include an opioid tax. This doesn’t mean that this issue is dead forever, it is likely to be part of the conversation in the

Safe Disposal of Controlled Substances: Legislation filed by Senator Alice Forgy Kerr (R-Lexington) would have required pharmacists to provide all patients receiving a controlled substance with a safe disposal mechanism that deactivates or sequesters the active ingredients in the drug. Senate Bill 6 was intended to make sure that drugs are not diverted from patients’ medicine cabinets.

The Federation opposed the legislation and worked to get it changed in the Senate. The legislation was modified before it passed the Senate Health and Welfare committee but still required a pharmacist to offer to sell the patient one of these safe disposal products. KRF staff succeeded in the House to get SB 6 further amended to make it permissive for pharmacists to offer to sell patients these safe disposal mechanisms and increased the options to include drug takeback disposal boxes. The final version of SB 6 requires the pharmacy to inform patients about safe disposal of medications but this can Representative Melinda Gibbons Prunty (R– District 15) be done by posting a sign or by written or verbal communication. The governor let it become law without his along with Shannon Stiglitz, KPhA lobbyist, addresses Legislative Conference attendees. signature and it will take effect on July 14, 2018.

Medication-Assisted Therapy: Representative Danny Bentley (R-Russell) sponsored HB 246 to create a pilot project where a pharmacist, under a prescriber-approved protocol can administer medication-assisted therapy treatment for opioid abuse such as Vivitrol. Kentucky received funding through a KORE grant to increase treatment options for opioid-abuse disorder. The Kentucky Board of Pharmacy also promulgated a regulation that will allow pharmacists to enter into prescriberapproved protocols to treat patients with opioid-abuse disorders. House Bill 246 also removes some barriers to get patients in pharmacist-administered treatment programs by prohibiting prior authorizations and requires Medicaid Managed Care Organizations to reimburse pharmacies for the services without requiring the patient to use a specialty or mail order pharmacy. It was signed by the governor and will take effect in mid-July.

future as some legislators see it as a deterrent for opioid overprescribing and misuse.

Medical Malpractice Reform: In 2017, for the first time in nearly 100 years, Republicans controlled the House, the Senate and the governor’s mansion. This allowed Republicans to pursue bold policy changes they have long sought, but couldn’t accomplish with a Democratcontrolled House. One of the first policy changes they successfully pushed for and passed was legislation to make medical malpractice review panels the law of the land in Kentucky. This session, the Senate and House continued to push policy changes to reform Kentucky’s tort system.

After the successful passage of medical review panels, legislation that would have further improved Kentucky’s medical malpractice climate and made it more friendly to the medical provider, was introduced by Senator Opioid Tax: In 2017, a bill was filed for the first time to Ralph Alvarado (R-Winchester) who is a practicing phylevy a one-dollar tax on opioids at the wholesale level sician. Senate Bill 20 would have made comprehensive and on mail-order prescriptions. This year, HB 337 was changes to reform Kentucky’s medical malpractice sysintroduced to put a $1 tax on opioids and use the protem, by limiting attorney fees, requiring an affidavit to ceeds would help fund a permanent fix for the state’s be filed attesting to an expert witnesses’ credentials and pension obligations. This bill did not advance but an making peer review findings confidential. The Senate opioid tax did pass out of the House in somewhat of a passed the legislation with three amendments added to surprise move. The House included a 25-cent tax on opiit—removal of the peer review language, an increase in oids in their revenue package (HB 366) that was passed the cap on attorney fees to 33 percent and an exemption to finance the House’s proposed budget. The revenue from copying fees for pro- bono cases. It passed the Senwas not specifically allocated, meaning that it would ate by a vote of 20-16 but died in the House Judiciary |9| www.KPHANET.org

Committee.

picking up a controlled-substance prescription. The Federation worked with the sponsor to explain our concerns Peer review: House Health and Family Services Chair that HB 231 would require pharmacies to purchase new Addia Wuchner (R- Florence) introduced HB 4 to make point-of-sale systems to record the information. We findings of peer review organizations confidential and asked that the legislation not move forward and that is not subject to discovery in medical malpractice cases. what happened since HB 231 died in the House Health Hospitals and physicians argued that the peer review and Family Services Committee. process cannot operate if their findings could be used against the healthcare provider. Trial attorneys objected Prescription Co-Pays: Representative Michael Mereto HB 4, and language was added to the legislation to dith (R-Brownsville) successfully shepherded HB 463 make it clear that the peer review process had to be a through to its final passage. This legislation prohibits legitimate, nationally recognized peer review process.

Pharmacy Benefit Managers (PBMs) from putting gag Similar legislation was introduced in the Senate (SB 49) orders in their contracts to prohibit a pharmacist from but it was ultimately HB 4 that was enacted, signed by telling the patient that they could get a prescription drug the governor and will take effect on July 14. cheaper if they paid cash. It would also mean that if the cash price was cheaper, the patient won’t pay more than Major Tort Reform: Republicans have long wanted the cash price. A PBM couldn’t penalize the pharmacy comprehensive tort reform, which in Kentucky requires for charging the patient the cash price or for telling them a constitutional amendment, but this year, once again, that they could get the drug for less than their co-pay if this prize eluded them. Senate Bill 2 would have put a they paid cash. It was publically stated that the PBMs constitutional amendment on the 2018 ballot asking vothad no concerns over HB 463. It was signed by the govers to give the General Assembly the authority to limit ernor and takes effect in mid-July. civil damages for pain and suffering. The legislation passed out of the Senate State and Local Government Telehealth: The issue of payment for telehealth services Committee, but when it became clear that SB 2 did not was discussed in the interim and legislation was filed in have the votes to pass off the floor, Senate leadership the Senate and in the House (SB 112 and HB 12, respecreferred it back to the committee where it died. tively) that would require all health insurance plans, including Medicaid, to reimburse providers using teleMedical Review Panels: Legislation was filed to make health at the same reimbursement rates that they pay for changes to Kentucky’s new medical malpractice review face-to-face medical visits. Senate Bill 112 was the legispanels. Senate Bill 141 would have established a ninelation that was on the move and it passed the Senate by month extension for the panel when the court issues a a vote of 36-0, even after an amendment was added to stay, waived the fees for indigent plaintiffs and estabrequire face-to-face visits prior to a woman having an lished a process for out-of-state plaintiffs to access the abortion. Once it was received in the House, it was asreview panel. The legislation was withdrawn by the signed to the House Health and Family Services Comsponsor so it was never considered. mittee where it passed the committee and was sent to Prescription Drug Monitoring: Once again, there were the floor. A floor amendment was filed to remove the multiple bills filed regarding Kentucky’s prescription payment parity language but it was not called by its drug monitoring system—KASPER. Only the bill spon- sponsor. The legislation passed and was signed by the sored by Representative Danny Bentley (R-Russell)— governor.

HB 213— was enacted. It allows Kentucky to share preMedicaid Credentialing: Representative Ken Fleming scription drug monitoring data with cities and counties (R-Louisville) introduced HB 69 to reform the Medicaid of other states. Missouri is the only state without a credentialing process. Each Medicaid Managed Care statewide prescription drug monitoring system but the Organization has its own credentialing process and it city of St. Louis has its own system and now Kentucky can take months for the process to be completed, keepwill be allowed to share data with the city. The governor ing healthcare providers on the sidelines as they wait for signed the legislation so it will become law on July 14. their credentials. The enacted bill requires fewer credenA bill that did not pass this session was SB 94 would tialing processes and reduces the credentialing timeline have allowed employers of prescribers and pharmacists from 90 days to 45 days. It has been signed by the goverto have access to KASPER to monitor prescribing and nor. dispensing patterns of their employees. The legislation Cannabis: Medical marijuana was once again a topic was assigned to the Senate Health and Welfare Commitduring the session but none of the six measures filed betee, but it did not receive a hearing. came law. There were hearings in the House Judiciary APRISS, a Louisville-based company, pushed HB 231 Committee on HB 166 that would have legalized medithat would have required pharmacies to collect the driv- cal marijuana for treatment of certain medical condier’s license identification information of all non-patients tions, established a taxing structure and allowed em|10| Kentucky Pharmacists Association | May/June 2018

ployers to discipline employees for workplace impairment. The committee held multiple hearings but never voted on HB 166. A companion bill filed in the Senate (SB 118) also died.

Legislation filed by Senate Majority Caucus Chair Dan Seum (R-Louisville) proposed to legalize recreational marijuana but it never received a hearing in the Senate panel to which it was referred. Also filed in the Senate was SB 23 that would have allowed physicians to recommend and sell cannabidiol to patients but it too died without a hearing. In contrast, Representative Danny Bentley (R-Russell) filed HCR 34 to encourage the federal government to research medical marijuana for safety and effectiveness for the treatment of employees. The legislation was assigned to the Senate Health and Welfare Committee, but it did not receive a hearing.

APRISS, a Louisville-based company, pushed HB 231 that would have required pharmacies to collect the driver’s license identification information of all non-patients picking up a controlled-substance prescription. The Federation worked with the sponsor to explain our concerns that HB 231 would require pharmacies to purchase new point-of-sale systems to record the information. We asked that the legislation not move forward and that is what happened since HB 231 died in the House Health and Family Services Committee.

payment parity language but it was not called by its sponsor. The legislation passed and was signed by the governor.

In contrast, Representative Danny Bentley (R-Russell) filed HCR 34 to encourage the federal government to research medical marijuana for safety and effectiveness for the treatment of certain health conditions. The resolution passed the House and was assigned to the Senate Health and Welfare Committee where it died.

Senator Ralph Alvarado, MD ( R-District 28) addresses Legislative Conference attendees.

Prescription Co-Pays: Representative Michael Meredith (R-Brownsville) successfully shepherded HB 463 through to its final passage. This legislation prohibits Pharmacy Benefit Managers (PBMs) from putting gag orders in their contracts to prohibit a pharmacist from telling the patient that they could get a prescription drug cheaper if they paid cash. It would also mean that if the cash price was cheaper, the patient won’t pay more than the cash price. A PBM couldn’t penalize the pharmacy for charging the patient the cash price or for telling them that they could get the drug for less than their co-pay if they paid cash. It was publically stated that the PBMs had no concerns over HB 463. It was signed by the governor and takes effect in mid-July.

Occupational Licensing Board Reorganization: Public Protection Cabinet Secretary David Dickerson testified before the Interim Joint Committee on Licensing, Occupations and Administrative Regulations about the need to reform the structure of all occupation licensing boards. Governor Bevin had planned to do an executive order reorganizing all the boards, but that plan was delayed after legislators and board licensees raised questions about the reorganization plans. The cabinet argued that certain precautions need to be taken when marketbased participants are regulating themselves citing the U.S. Supreme Court decision in the Federal Trade Commission vs. N.C. Dental Board case that held that board members don’t have the protections of sovereign Telehealth: The issue of payment for telehealth services immunity when they are self-regulating without certain was discussed in the interim and legislation was filed in parameters being put in place. the Senate and in the House (SB 112 and HB 12, respec- The cabinet worked over the interim with KRF and othtively) that would require all health insurance plans, in- er groups interested in the licensing boards and made cluding Medicaid, to reimburse providers using telesignificant changes based on KRF comments and othhealth at the same reimbursement rates that they pay for ers. The board reorganization proposal was introduced face-to-face medical visits. Senate Bill 112 was the legis- as HB 465. The legislation would have required all lilation that was on the move and it passed the Senate by censing boards to go under the authority and jurisdica vote of 36-0, even after an amendment was added to tion of the Public Protection Cabinet. The Board of require face-to-face visits prior to a woman having an Pharmacy would be a stand-alone board as would some abortion. Once it was received in the House, it was asother medical boards. The executive director would still signed to the House Health and Family Services Combe required to be a pharmacist. House Bill 465 passed mittee where it passed the committee and was sent to the House but stalled in the Senate Licensing, Occupathe floor. A floor amendment was filed to remove the |11| www.KPHANET.org

tions and Administration Regulations Committee. Its chair said the issue would be discussed over the interim but before that discussion begins, Governor Bevin could issue an executive order reorganizing these boards, The General Assembly would have to codify it in the next session.

Reimbursement for Medical Claims: House Bill 506 died in the House Banking and Insurance Committee.

The legislation would have required health insurance companies to pay interest on late payments to providers and pay for damages that occurred as a result of the delayed payments. Healthcare providers have complained about delayed reimbursements, particularly by the Medicaid Managed Care Organizations.

the prior authorization process for prescription drugs.

Senate Bill 143 would have required the creation of an electronic prior authorization process and mandated that the authorization stay in place for one year. The concept of the legislation is to establish a uniform prior authorization process. While the legislation did not advance, Alvarado plans to continue discussions about the legislation and try to move it forward next session.

Scope of Practice Expansions for PAs and APRNs: For the last few sessions, advanced practice registered nurses (APRNs) and physician assistants (PAs) have pushed for an expansion of their scope of practices. This year, HB 228 was introduced to allow PAs to prescribe and administer controlled substances. Senate Bill 89 would have allowed APRNs with four years of experience to In-Home Dialysis: Baxter Healthcare pushed HB 509 sign collaborative agreements with other APRNs to althis session that would have exempted in-home dialysis low them to prescribe controlled substances. Similar legtreatment from the practice of pharmacy. They argued islation (HB 445) was filed in the House. Current law that the dialysate solutions cannot be dispensed through only allows APRNs to sign collaborative agreements a retail pharmacy and, therefore, they should not have with physicians. None of these bills advanced. Neither to have a licensed pharmacist on site at its warehouse did SB 260 that would have increased the requirements facilities in Tennessee and Ohio from which the product for collaborative agreements between APRNs and physiis shipped. Tennessee recently passed similar legislation cians. The bill was filed by Senator Ralph Alvarado (Rbut Kentucky law requires a pharmacist to be present Winchester) who has long opposed eliminating requirewhen prescriptions are dispensed. House Bill 509 died in ment for a collaborative agreement between APRNs and the House committee to which it was assigned but Baxphysicians. ter Healthcare plans to present the issue to the Kentucky Board of Pharmacy in the interim in hopes to reach a Medicaid Appeals: Legislation that would have allowed compromise on the legislation. healthcare providers to submit a single appeal (SB 259) when filing a complaint against a MCO for multiple Reduction in Number of Medicaid MCOs: Senator Steclaims was filed but did not pass this session. phen Meredith (R-Leitchfield) has long been concerned about the conduct of the Medicaid Managed Care Organizations (MCOs) and his solution was to reduce the number of MCOs. Meredith filed SB 53 that would have reduced the number of MCOs to two from five and established specific criteria for selecting the MCOs. The legislation did receive a hearing in the Senate Health and Welfare Committee but it was not considered for a committee vote.

Prior Authorization Reform: Senator Ralph Alvarado (R-Winchester) filed legislation calling for changes in

Donate online to the Kentucky Pharmacists Political Advocacy Council Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form. |12| Kentucky Pharmacists Association | May/June 2018

Advocacy Matters Ways you can support KPhA’s Advocacy efforts today! 

Participate in grassroots advocacy efforts

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Get to know your legislators—they should know your name

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Donate to the Political Advocacy Council and the Government Affairs Fund

Photo by: Matt Turner

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org form. |13| www.KPHANET.org

Sam Willett, RPh, Capital Campaign Donor

“

KPhA has always been devoted to its mission of advocating for and advancing the profession of pharmacy, a profession that has been very rewarding to me personally and financially. Donating to the capital campaign is just a small token of appreciation to the professional organization that supports all pharmacists.�

Leave a legacy by making a tax-deductible donation online at www.kypharmacyfuture.net |14| Kentucky Pharmacists Association | May/June 2018

May CPE Article Let’s Shake Things Up: A Review of the 2017 NICE Guidelines and New Parkinson’s Disease Medications By: Logan Roberts PharmD., PGY-1 Pharmacy Resident, Baptist Health Louisville, Krista Best, PharmD., BCPS The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest.

KPERF offers all CE articles to members online at www.kphanet.org

Universal Activity # 0143-0000-18-009-H01-P & T 1.5 Contact Hours (0.15 CEU) Expires 06/28/21

Goals: To educate pharmacists on new guidelines for treatment of Parkinson’s disease and new therapies to treat Parkinson’s disease and related complications.

Learning Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: 1. Describe basic epidemiology and risk factors of Parkinson’s disease.

2. Review pathophysiology and diagnosis of Parkinson’s disease.

3. Summarize new recommendations for treatment of Parkinson’s disease from the 2017 National Institute for Health and Care Excellence (NICE) guidelines 4. List two recently approved medications for Parkinson’s disease and the related complications these medications treat.

Figure 1: Parkinson’s Disease Pathophysiology Introduction Parkinson’s disease (PD) is a chronic neurological disorder that affects movement and continues to progress over time. Motor symptoms associated with PD include tremor, bradykinesia, limb rigidity, and balance problems. These motor symptoms are often described in periods of “on” periods, when motor symptoms are adequately treated, and “off” periods, when motor symptoms are not adequately treated. Patients with PD may also present with non-motor symptoms that may include, but is not limited to, depression, sleep behavior disorders, loss of sense of smell, and cognitive impairment. There is currently no known cure for PD while treatment of PD focuses on repletion of dopamine in the central nervous system of individuals with PD. According to the Parkinson’s disease foundation, around 60,000 Americans are diagnosed with PD each year; a majority of diagnoses occurring in older individuals in which males are one and one-half times more likely to develop PD than females.1,2 In addition, the combined direct and indirect cost of PD is estimated to be almost twenty-five billion dollars each year.2 Hence, as one may tell, PD is a prevalent issue from both the incidence, mortality, and cost of this disease state.

Although the cause of PD has not yet been definitively determined, researchers have found patients with Parkinson’s disease have concentrated dopamine depletion in the substantia nigra (SN) and the nigrostriatal pathway that ultimately lead to reduced excitatory input to the motor cortex, manifesting in PD symptoms such as bradykinesia.3,4 This general neurotransmitter pathway may be seen is illustrated in figure 1.5 Often, the brain compensates for this dopamine depletion, via several mechanisms including increased tyrosine hydroxylase, the enzyme catalyzing the rate limiting step in dopamine synthesis.6 As the brain becomes unable to continually compensate for this disparity and this increased compensatory mechanism causes increased dopamine outside of the basal ganglia, leading to changes in motor function.7,8

Similar to the cause of PD, protective factors and risk factors are ambiguous in their mechanism and have only been pinpointed through epidemiologic studies. One such study is a meta-analysis performed by Noyce and colleagues in 2012. Some of the risk factors of PD include a first degree relative with PD, history of anxiety or depression, head injury, living in a rural area, drinking from well water, exposure to pesticides, and beta-blockers. Protective factors included coffee intake (at least one cup daily), hypertension, calcium

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channel blockers, nonsteroidal anti-inflammatory drug (NSAID) use, UPDRS III accounting for most of the total points. The lower the alcohol use, and smoking. Smoking was found to be the most indica- score, the better the patient is with a score of 199 being the maximum tive protective factor when people who did not smoke were found to score a patient may get.11,12 be twice as likely to have Parkinson’s disease compared to those indi- Table 2: Parkinson’s Disease Severity11 viduals that do smoke.9 However, like all medications, it is important to weigh the risk versus the benefits these offer and although smoking may help prevent PD, the added risks of other more harmful disease Stage Symptoms states definitely outweigh any benefits. In addition, the hypothesized mechanism behind decreased incidence of PD in smoking is primariStage One Mild symptoms that do not interfere with activly associated with actions of nicotine on the reward pathway rather ities of daily living than other components of tobacco.10 The Movement Disorder Society (MDS) and the UK Parkinson’s Disease Society (PDS) each have different methods of diagnosis that are mentioned in the 2017 NICE guidelines. For the definitive diagnosis of PD per the MDS, patients are required to have the symptoms of bradykinesia along with tremor or rigidity. In addition, patients must not exhibit any absolute exclusion symptoms, such as Parkonsinsonian features restricted to the lower limbs or lack of response to high doses of levodopa therapy, and “red flags,” such as rapid progression or absence of motor symptoms after being diagnosed with PD for greater than 5 years.

However, patients may have probable PD if the patients have one to two red flags and at least one to two supportive criterion, such as dramatic benefit from dopaminergic therapy initiation. The UK PDS Brain Bank Criteria is mentioned in the NICE guidelines and is extremely similar to the MDS criteria for diagnosis and also include that patients must be evaluated for possible causes of tremor and other causes of PD. The primary difference between the MDS and UK PDS criteria is absence of “red flags” seen in the MDS diagnostic criteria. Hence, the external validity of the diagnosis of PD using the UK PDS trail may not be as applicable to the United States, but does not affect the overlying recommendations made in the 2017 NICE guidelines.

One part of pathology that many researchers believe is definitive toward PD is the presence round, intracytoplasmic proteins known as Lewy Bodies. These are a form of a mutated proteins that that arise specifically from the SN and locus ceruleus in the brain.8 However, it is also important to note that Lewy Bodies are not indicative for PD as these are often present in other disorders. When reviewing possible imaging to help diagnosis PD, the NICE guidelines recommends only using single photon emission computed tomography (SPECT) to aid in the diagnosis of Parkinson’s disease due to the fact that other imaging may aid in exclusion of other diseases, but does not lead to more accurate diagnosis of Parkinson’s disease.

Table 1: UPDRS Scoring Unified Parkinson’s Disease Rating Scale (UPDRS) UPDRS I

Mentation, Behavior and Mood

UPDRS II

Activities of Daily Living

UPDRS III

Motor Examination

UPDRS IV

Complications of Therapy (dyskinesias, clinical fluctuations, other complications)

After diagnosis of PD, it is now important to recognize the severity of the disease and subsequent progression of PD. The unified Parkinson’s disease rating scale (UPDRS) is one of the main tools used by healthcare providers to determine the severity of PD and to determine how quickly the disease may be progressing. The UPDRS is divided into four different sections that may be seen in Table 1. Each section of the UPDRS has a total score patients may have with the

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Tremor is mild and may only be associated with one side of the body Changes in posture, walking and facial expression

Stage Two

Tremor and other movement symptoms affect both sides of the body Daily tasks are more difficult and lengthy

Stage Three

Loss of balance and slowness of movements; falls are common Symptoms significantly impair activities of daily living such as eating

Stage Four

Possible to stand without assistance but require a walker for movement Unable to perform activities of daily living without help

Stage Five

Stiffness of the leg make it impossible to walk More non-motor symptoms occur such as hallucinations and delusions

In addition to determining severity it is also important to recognize how the disease is progressing. PD has been split into five specific stages based on severity with stage one being the least severe stage and stage five being the most severe. The severity of these stages may be seen in table 2.14 As Parkinson’s disease progresses, patient’s often have increased “off” time due to degeneration of the neuron’s ability to store dopamine and this translates to decreased activities of daily living (ADL). Thus, it is important to recognize the severity of Parkinson’s disease to also determine how well a patient may be able to function individually without any caretaker.

Review of Therapies Seeing as the pathophysiology of PD is based on depletion of dopamine, the therapies for PD primarily focus on repletion of dopamine via addition of dopamine to the central nervous system, agonizing dopamine receptors, and preventing dopamine break down. First, levodopa/carbidopa (SinemetTM, Sinemet CRTM) act to replete dopamine via dopamine addition. Dopamine cannot cross the blood brain barrier (BBB) as free dopamine, however, levodopa is able to cross the BBB and is subsequently into dopamine. In addition, to inhibit levodopa breakdown in the periphery, carbidopa prevents decarboxylation of Levodopa to allow for more availability in the brain.15 Medications that agonize the dopamine receptors are broadly separated into ergot alkaloids and non-ergot alkaloids. Ergot alkaloids are generally less preferable due to their association with valvular heart disease from past studies performed specifically with the dopamine agonist, pergolide. The primary ergot alkaloid approved in the United States is bromocriptine (CyclosetTM, ParlodelTM), but cabergo-

line has also been used outside of the United States as well.14 Thus, due to the possible cardiovascular side effects of ergot alkaloids, nonergot alkaloids are used more often and these include pramipexole (MirapexTM), ropinirole (RequipTM, Requip XLTM), and rotigotine (NeuproTM). Apomorphine (ApokynTM) is also used in PD as a dopamine agonist, but is specifically for “off” episodes in which patients experience enhanced symptoms of PD.16 There are also two classes of medications that are used to prevent breakdown of dopamine via two different mechanisms of action.

First, catechol-O-methyl transferase (COMT) Inhibitors work to inhibit the breakdown of catecholamines, such as dopamine, through suppressing the action COMT. COMT inhibitors are taken with each dose of levodopa/carbidopa and include tolcapone (TasmarTM) and entacapone (ComtanTM).17,18 However, it is important to note that tolcapone is rarely used due to the black box warning of increased incidence of hepatotoxicity. Second, monoamine oxidase B (MAOB) inhibitors work to inhibit the action of MAO-B; which is active in breaking down monoamines, such as dopamine, in the CNS. The MAO-B inhibitors currently used for PD are rasagiline (AzilectTM), selegeline (EldeprylTM, ZelaparTM), and most recently, safinamide (XadagoTM).

Finally, in addition to all of the previously reviewed therapies, there is one medication that also may be used to treat PD: amantadine.

Amantadine was first marketed for the treatment and prophylaxis of Influenza A. The exact mechanism of action for the treatment of PD is unknown, but has been hypothesized to act as noncompetitive NMDA receptor antagonist and may also have indirect effects on dopamine neurons. Some alleviation of PD symptoms have been noted with the addition of amantadine to conventional therapy but it is important to note the anticholinergic-like side effects that may occur with giving this medication.19,20

and were evaluated based on the 39-item patient rated Parkinson’s disease questionnaire (PDQ-39) to evaluate mobility and a general quality of life scale (EQ-5D). Levodopa/carbidopa was found to be superior to levodopa/carbidopa sparing therapies in both quality of life and mobility; p = 0.0002 and p = 0.05, respectively. In addition, it is important to note that 28% of patients taking dopamine agonists and 23% of patient taking MAO-B inhibitors discontinued treatment due to side effects compared to only 2% of patients taking levodopa/carbidopa (p < 0.0001).25 Hence, the NICE guidelines recommends using levodopa/carbidopa especially in treatment naive patients whose ADL are affected by their motor symptoms associated with PD due to the improvement in UPDRS II and III scores seen with levodopa/carbidopa when compared to dopamine agonists and MAO-B inhibitors. In addition, the NICE guidelines recommend using levodopa/carbidopa due to the long-term improved outcomes and health-related quality of life seen in several RCTs. Yet, dopamine agonists may be the best first line therapy for younger patients since they are at increased risk of dyskinesias and less wearing off seen with dopamine agonists.26,27 However, it is important to note increase edema, somnolence, constipation, dizziness, hallucinations, and nausea that are more associated with dopamine agonists compared to levodopa/carbidopa.28 Table 3: Levodopa/Carbidopa Immediate Release to Extended Release Capsule 13

Immediate Release Levodopa Dose (mg) 400 to 549

3 capsules of carbidopa 23.75 mg/levodopa 95 mg 3 times daily (levodopa total daily dose: 855 mg).

550 to 749

4 capsules of carbidopa 23.75 mg/levodopa 95 mg 3 times daily (levodopa total daily dose: 1,140 mg).

750 to 949

3 capsules of carbidopa 36.25 mg/levodopa 145 mg 3 times daily (levodopa total daily dose: 1,305 mg).

950 to 1249

3 capsules of carbidopa 48.75 mg/levodopa 195 mg 3 times daily (levodopa total daily dose: 1,755 mg).

>1250

4 capsules of carbidopa 48.75 mg/levodopa 195 mg 3 times daily (levodopa total daily dose: 2,340 mg) or 3 capsules of carbidopa 61.25/levodopa 245 mg 3 times daily (levodopa total daily dose: 2,205 mg).

First Line Treatment of Motor Symptoms Previous guidelines by the American Academy of Neurology, published in 2006, and the Canadian Neurological Sciences Federation, published in 2012, do not list any single preferred agent in the treatment of PD.21, 22 The 2017 NICE guidelines recommend using levodopa/carbidopa to be used as first line agents for the treatment of PD in treatment naive patients whose motor symptoms affect quality of life.23 The NICE guidelines support this particular recommendation from the results of several randomized trials and a network meta-analysis of 4 randomized controlled trials (RCTs) in which levodopa/carbidopa had the largest effect on improving UPDRS II compared to MAO-B inhibitors and dopamine agonists.23 In one study by Holloway et al., 301 patients with PD from 22 sites across the United States and Canada were randomized to receive pramipexole or levodopa/carbidopa. In this trial, patients were recently diagnosed (< 7 years of idiopathic parkinson’s disease history) and researchers examined side effects, change in UPDRS, quality of life scales, and general wearing off of the medications. Researchers followed patients for four years and found an early and sustained mean increase in UPDRS score in those patients taking levodopa/carbidopa compared to those patients taking pramipexole (p = 0.003). However, it is important to note that higher doses of levodopa/carbidopa are often associated with an increased involuntary, dystonic movements; also called dyskinesias. This is seen in the trial as there were reduced incidences of dyskinesia in the pramipexole group compared to the levodopa/carbidopa (p < 0.0001). In addition, pramipexole had less wearing off than levodopa/carbidopa (p = 0.2) and this has been hypothesized to be a result of pramipexole’s longer half-life in comparison to levodopa/carbidopa.24 In another open-label trial performed cited by the NICE guidelines

by Gray and colleagues, 1620 patient were assigned randomly to receive levodopa/carbidopa, a dopamine agonist, or MAO-B inhibitor in a 1:1:1 ratio. Patients were followed over a period of 6 years

Extended Release Dose (mg)

Adjuvant Treatment of Motor Symptoms Due to the short half-life of levodopa/carbidopa, patients often experiences a peak in drug level that may cause dyskinesias. In addition, protein consumption may also alter levodopa/carbidopa absorption, requiring higher doses for the same effect. One option to help increase doses of levodopa/carbidopa and prevent large peaks of dopamine release is to switch to an extended release version of levodopa/carbidopa. To convert to the controlled release tablets, one would just use an initial dosage that would provide approximately 10% more levodopa per day and divide this dose to be given to three times daily. Converting to extended release capsules is a little more complex and depends on current total dose of levodopa. This conversion may be seen in table 3. However, these medications do have a

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noted increased time of onset which is important for patients to understand when first starting these different levodopa/carbidopa formulations.13 Increasing levodopa/carbidopa doses is not always possible; even when switching to a controlled or extended release formulation. One other option that may be considered when needing additional control of motor symptoms without increasing the dose of levodopa/carbidopa is to use another medication in conjunction with levodopa/carbidopa to improve symptoms of PD. Per the NICE guidelines, COMT inhibitors, MAO-B inhibitors, dopamine agonists, and amantadine are all possible options to use as adjunctive therapy.

Unfortunately, there is not a much good data comparing agents in conjunction. In one RCT, it was found that pergolide was associated lower rates of dyskinesia and higher rates of adverse events requiring discontinuation than tolcapone. Comparing agents across the same class, the NICE guidelines found no difference between COMT inhibitors, and minimal differences between dopamine agonists. Some evidence from two RCTs cited by the NICE guidelines show that pramipexole may be associated with significantly decreased rates of dyskinesia compared to bromocriptine. However, besides possible difference in dyskinesia and valvular heart disease, there was no difference found between ergot dopamine agonists and non-ergot dopamine agonists.

Looking at dopamine agonists and MAO-B inhibitors as individual agents without levodopa/carbidopa, a network meta-analysis of 4 RCTs found that dopamine agonists were only second to high dose levodopa/carbidopa in improving UPDRS III scores. In addition, this same meta-analysis found that MAO-B inhibitors (selegiline) performed the worst in improving UPDRS II and III scores when compared with dopamine agonists and levodopa/carbidopa. Yet, another RCT did not see any significant difference between dopamine agonists and MOA-B inhibitors in long term mobility and ADLs. In the case of amantadine, the NICE guidelines found that there was no evidence supporting the benefits of amantadine except for reduction in dyskinesia.

minimal to no effects on the dopamine receptors to minimize any EPS. The two medications found to have the best effect in treatment of psychotic symptoms in patients with PD are quetiapine and clozapine. Clozapine and quetiapine have the least effect on the D2 receptor and thus do not affect the treatment of PD as much as other antipsychotics.29,30 In addition, both of these medications are dosed much lower than in treatment of other psychotic disorders. Quetiapine for PD psychotic symptoms is dosed at 25 to 150 mg daily or twice daily and clozapine is dosed at 6.25 to 50 mg daily. The NICE guidelines site that evidence from several RCT show that clozapine and quetiapine improved motor symptoms contrary to the minimal action they have on the D2 receptors.31,32 Yet, it is important to consider the negative side effects of clozapine including excessive weight gain and severe neutropenia that may be life threatening, while quetiapine has been known to increased somonlence. Due to these side effects, quetiapine recommended to be used as a first line agent for PD psychotic symptoms with clozapine to be used as a second line agent. When examining other antipsychotics, the NICE guidelines recommend against the use of olanzapine due to its lack of efficacy in improving psychotic symptoms and olanzapine should not be considered to use for psychotic symptoms in PD. New Medications Although the incidence of PD has continued to increase each year, breakthroughs in PD treatment and research have not grown as quickly. However, in the past couple of years two new agents have been released: pimavanserin (NuplazidTM) for PD psychotic symptoms and safinamide (XadagoTM), an MAO-B inhibitor. With the emergence of these medications, future research shows promise in the development of more medications to treat this disease.

First, safinamide is an MAO-B inhibitor that acts much like selegeline or rasagiline. Through decreasing breakdown of dopamine via MAO-B, safinamide increases the amount of dopamine available in the CNS to thus decrease PD symptoms. However, it is important to Thus, the NICE guidelines recommend using dopamine agonists, note like selegeline and rasagiline, safinamide was seen to have an MAO-B inhibitors, or COMT inhibitors with levodopa/carbidopa increase in dyskinesias and falls that may have contributed to infor those patients who continue to have persistent PD symptoms or dyskinesias due to levodopa/carbidopa therapy. However, due to the creased discontinuation of the medication compared with placebo.

Hence, until further research is performed, it is likely selegeline and possible harm associated with ergot-derived dopamine agonists, errasagiline will be used more often than safinamide. 33 got-derived agonists should only be used when symptoms are not controlled by a non-ergot derived dopamine agonist. Amantadine Lastly, pimavenserin is a new antipsychotic that was developed spemay be added on if dyskinesias are not controlled adequately. Specifcifically for use in PD psychotic symptoms. This is a novel antipsyics for slight differences in these treatments may also be seen in table ochitic in that it does not act on dopamine receptors and rather acts 4. primarily on serotonin receptors; specifically 5-HT2A. Hence, there is much less risk in regards to possibly blocking too much dopamine Management of Non-motor symptoms in the CNS and resurfacing of previously controlled PD symptoms.

Due to the nature of PD and treatment modalities, patients with PD This may be seen in trial results that showed no effect on UPDRS are at risk for several non-motor symptoms. These include hyperscores and thus no effect on motors symptoms. In addition, this medsomnolence, psychotic symptoms, dementia, REM sleep behavior ication has been shown to have a 37% improvement in hallucinations disorders, orthostatic hypotension, nocturnal akinesia, and excessive and delusions as measured by the scale for assessment of positive salivation. However, it is important to note that many of the nonsymptoms-Parkinsonâ&#x20AC;&#x2122;s disease (SAPS-PD). Hence, this may allow motor symptoms are treated similarly in other patient populations for a completely new and better method to treat PD related psychotic suffering from the same conditions with the exception of psychotic symptoms than has ever been available before.34 conditions.

Conclusion As previously mentioned, patients with PD often lack dopamine and As PD continue to grow in prevalence with better diagnostic tools therapies aim to replete dopamine in the CNS. Over repletion may and awareness of the signs and symptoms, guidelines and therapies lead to excessive amounts of dopamine circulating in the brain and will need to continue to be developed to better care for these patients. may lead to psychotic symptoms.29 To further complicate this probPer the NICE guidelines, all newly diagnosed patients should initiallem, many of the antipsychotic agents used to help treat psychotic ly be given levodopa/carbidopa when patients are experiencing mosymptoms tend to block dopamine in the CNS which may cause tor symptoms that are interfering with their ADL. After which, therincreased motor symptoms of PD. In particular, the first generation apy should be individualized to incorporate COMT inhibitors, antipsychotic medications tend to cause extrapyramidal symptoms (EPS) similar to those seen in PD. Hence, the ideal agent would have MAO-B inhibitors, dopamine agonists, or amantadine. However,

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Table 4: Adjuvant Therapy

Dopamine agonists

MAO-B inhibitors

COMT inhibitors

(Ropinirole, Pramipexole, Rotigotine, Bromocriptine)

(Selegeline, Rasagiline, Safinamide)

(Entacapone, Tolcapone)

Motor Symptoms

Improvement in motor symptoms

Improvement in motor symptoms

Improvement in motor symptoms

Activities of Daily Living

Improvement in activities of daily living

Improvement in activities of daily living

Improvement in activities of daily living

Off time

More off-time reduction

Off-time reduction

Off-time reduction

Adverse events

Intermediate risk

Fewer events

More events

Hallucinations

More risk

Lower risk

Lower risk

Clinical Pearls

Non-ergot > ergot

Entacapone > Tolcapone

Take with each dose of levodopa/carbidopa looking forward to further production of guidelines and studies, studies need to compare classes of agents to one another to definitively determine the best second line therapy to add to levodopa/carbidopa. In addition, it may be pertinent to look at combination therapies of more than two agents.

When treating psychotic symptoms in patients with PD, it’s important to consider the delicate balance of decreasing dopamine to prevent psychotic symptoms but not so much as to decrease dopamine to the point of increasing symptoms of PD. Quetiapine should be used first in the treatment of PD psychotic symptoms with clozapine used when quetiapine is not sufficient. In addition, per the NICE guidelines, it is important to avoid use of olanzapine seeing as the medication is not effective in treating PD psychotic symptoms.

However, when looking at treatment of PD psychotic symptoms, the development of pimavanserin may lead to a different first line agent and this medication may be able to replace first line agents in the near future. As illustrated by the development of pimavanserin, agents will continue to evolve for treatment of PD motor and nonmotor symptoms, treatment guidelines will also continue to evolve.

It is important for the pharmacy profession to also continue to recognize pearls of these medications and apply treatment guidelines to best serve our patients.

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2. Statistics on Parkinson’s. Parkinson’s disease foundation. http://www.pdf.org/parkinson_statistics. Accessed 2017 Aug 22.

3. Gerfen CR. Molecular effects of dopamine on striatal-projection pathways. Trends

Neurosci. 2000;23(10 Suppl):S64.

4. Ryoo HL, Pierrotti D, Joyce JN. Dopamine D3 receptor is decreased and D2 receptor is elevated in the striatum of Parkinson’s disease. Mov Disord. 1998;13(5):788.

5. Parkinson’s disease. MedicaLook. http://www.medicalook.com/Neurological_disorders/Parkinsons_disease.html. Accessed 2017 Oct 10.

6. Huot P, Parent A. Dopaminergic neurons intrinsic to the striatum. J Neurochem.

2007;101(6):1441.

7. Bezard E, Gross CE, Brotchie JM. Presymptomatic compensation in Parkinson’s disease is not dopamine-mediated. Trends Neurosci. 2003;26(4):215.

8. Noyce AJ, Bestwick JP, Silveira-Moriyama L, et al. Meta-Analysis of early nonmotor features and risk factors for Parkinson disease. Ann Neurol. 2012 Dec;72(6):893-901.

9. Jankovic J, Sherer T. The future of research in Parkinson disease. JAMA Neurol.

2014 Nov;71(11):1351-2.

10. Quik M, Perez XA, Bordia T. Nicotine as a potential neuroprotective agent for Parkinson’s disease. Movement Disorders. 2012 Jul;27(8):947-957.

11. Goetz CG, Tilley BC, Shaftman SR, et al. Movment disorder society-sponsored revision of the unified Parkinon’s disease rating scale (MDS-UPDRS): Scale presentation and cilnimetric testing results. Movement Disorders. 2008;23(15):2129-2170.

12. Postuma RB, Berg D, Stern M, et al. MDS clinical diagnostic criteria for Parkinson’s disease. Mov Disord. 2015 Oct;30(12):1591-601.

13. Stages of Parkinson’s. Parkinson’s foundation. http://parkinson.org/UnderstandingParkinsons/What-is-Parkinsons/Stages-of-Parkinsons. Accessed 2017 Nov 19.

14. Carbidopa-Levodopa. In: Lexi-Drugs [online database]. Hudson, OH. Accessed 2017 Oct 4.

15. Reichmann H, Bilsing A, Ehret R. Ergoline and non-ergoline derivatives in the treatment of Parkinson’s disease. J Neurol. 2006 Aug;253 Suppl 4:IV36-8.

16. Apomorphine. In: Lexi-Drugs [online database]. Hudson, OH. Accessed 2017 Oct 4.

17. Entacapone. In: Lexi-Drugs [online database]. Hudson, OH. Accessed 2017 Oct 4.

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18. Tolcapone. In: Lexi-Drugs [online database]. Hudson, OH. Accessed 2017 Oct 4.

by age of Parkinson’s disease onset. Mov Disord. 2005 Mar;20(3):342-4.

19. Amantadine. In: Lexi-Drugs [online database]. Hudson, OH. Accessed 2017 Oct 4.

27. Parkinson’s disease medications. Parkinson’s disease clinic and research center. http://pdcenter.neurology.ucsf.edu/patients-guide/parkinson%E2%80%99s-diseasemedications. Published 2014. Accessed 2017 Nov 19.

20. Crosby NJ, Deane KH, Clarke CE. Amantadine for dyskinesia in Parkinson’s disease. Cochrane Database Syst Rev. 2003;(2):CD003467.

21. Young BG, Findlay MJ, Benstead TJ, et al. Canadian guidelines on Parkinson’s disease. Canadian Journal of Neurological Sciences. 2012 July; 39(4): Suppl.4 S10-15.

22. Pahwa R, FActor SA, Lyons KE, et al. Practice parameter: treatment of parkinson disease with motor fluctuations and dyskinesia (an evidence-based review). Neurology.

2006 April;66(7):983-95.

28. Stowe RL, Ives NJ, Clarke C. Dopamine agonist therapy in early Parkinson’s disease. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD006564.

29. Tost H, Alam T, Meyer-Lindenberg A. Dopamine and psychosis: theory, pathomechanisms and intermediate phenotypes. Neurosci Biobehav Rev. 2010 Apr; 34 (5):689-700.

23. Cooper P, Barnes J, Bennett I, et al. Parkinson’s disease in adults: diagnosis and management. Circulation. Published online 2017 Jul.

30. Receptor binding profiles of atypical antipsychotics: Mechanism of therapeutic actions and adverse side effects. Presented at the 2012 NEI Global Psychopharmacology Congress.San 2012; Diego, California.

24. Holloway RG, Shoulson I, Fahn S, et al. Pramipexole vs. levodopa as initial treatment for parkinson’s disease: a 4-year randomized controlled trial. Arch Neurol. 2004 Jul;61(7): 1044-53.

31. Friedman J, Lannon M, Comella C, et al. Low-dose clozapine for the treatment of drug-induced psychosis in Parkinson’s disease. N Engl J Med. 1999 Mar; 340:757-763.

25. Gray R, Ives N, Rick C, et al. Long-term effectiveness of dopamine agonists and monoamine oxidase B inhibitors compared with levodopa as initial treatment for Parkinson’s disease (PD ME): a large, open-label, pragamatic randomised trial. Lancet. 2014 Sep 27;384(9949): 1196-205.

26. Kumar N, Van Gerpen JA, Bower JH, Ahlskog JE. Levodopa-dyskeinesia incidence

32. Ondo WG, Tintner R, Voung KD, Lai D, Ringholz G. Double-blind, placebocontrolled, unforced titration parallel trial of quetiapine for dopaminergic induced hallucinations in Parkinson’s disease. Mov Disord. 2005 Aug;20(8)958-63.

33. Safinamide [package insert]. Louisville, KY: Newron Pharmaceuticals SpA; 2017 May.

May 2018 — Let’s Shake Things Up: A Review of the 2017 NICE Guidelines and New Parkinson’s Disease Medications 1. Which of the following is true in regards to pathophysiology of Parkinson’s disease? Select all that apply.

A. Parkinson’s disease is primarily due to a depletion in dopamine B. Parkinson’s disease is primarily due to a depletion in serotonin C. Parkinson’s disease is primarily due to a depletion in norepinephrine D. “On” periods are when symptoms of Parkinson’s disease are most prominent E. “Off” periods are when symptoms of Parkinson’s disease are most prominent 2. RW is a 64 y/o WM with PMH significant for COPD, HFrEF, HLD, and BMI = 24 kg/m2. His SH is significant for tobacco use (1 ppy). His FH is significant for a father who has Parkinson’s disease. He currently lives on a farm in eastern Kentucky with his wife and confesses to feeling worried about his chances of having Parkinson’s. How many risk factors does he have for Parkinson’s disease?

A. 2 B. 3 C. 4 D. 5 E. 6 3. MK is a 72 y/o WF who is referred to you for further education on her Parkinson’s disease. The patient is concerned that she is having tremors affecting both sides of her body that cause daily tasks to be more difficult. Which stages of Parkinson’s disease most accurately matches MK’s symptoms?

A. Stage 1 B. Stage 2 C. Stage 3 D. Stage 4 E. Stage 5 4. Which of the following is NOT a risk factor for Parkinson’s Disease(PD)?

A. Head injury B. Living in a rural area C. History of schizophrenia D. First degree relative with PD E. Drinking well water 5. JP is a 77 y/o AAM who presents to your clinic complaining of side effects from his Parkinson’s disease medications. He reports increased dyskinesias with his newly started pramipexole and wishes to try a different therapy in addition to the levodopa/ carbidopa he is already taking. He says he wants to take a medication that has the “absolute least amount of adverse effects.” Which of the following would be most appropriate to start for JP? A. Start Ropinirole 0.25 mg PO TID B. Start Bromocriptine 1.25 mg PO BID C. Start Tolcapone 100 mg PO TID D. Start Apomorphine 2 mg Daily PRN E. Start Selegeline 5 mg PO BID 6. DM is a 50 y/o AAF with PMH significant for Type II Diabetes, HTN, HLD, PAD, and Parkinson’s disease. DM reports would like to add an additional agent to her current regimen of levodopa/carbidopa to help provide the largest decrease in off time. Which of the follow would provide the most appropriate to give the largest decrease in off time?

A. Start Amantadine 100 mg PO BID B. Start Entacapone 200 mg PO with each dose of levodopa/carbidopa

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C. Start Selegeline 5 mg PO BID D. Start Pramipexole 0.125 mg PO TID E. Start Bromocriptine 1.25 mg PO BID 7. JT is a 50 y/o WM with PMH significant for Depression, HTN, Type II DM, and Parkinson’s disease who presents to the outpatient clinic you staff. The patient reports increased tremors and loss of balance that interfere with his activities of daily living. The patient is subsequently diagnosed with Parkinson’s disease after meeting with his PCP a month later. Which of the following medications should be started for JT? A. Tolcapone 100 mg PO TID B. Selegeline 5 mg PO BID C. Carbidopa/Levodopa 25/100 mg PO TID D. Safinamide 50 mg PO Daily E. Rasagiline 0.5 mg PO Daily 8. RB is a 73 y/o WF with PMH significant for HTN, HLD, Osteoporosis, and Parkinson’s disease who is currently being treated at the long term care facility you staff.

RB begins to having psychotic symptoms such as hallucinations and delusions. Which of the following treatments is most appropriate for RB? A. Clozapine 6.25 mg PO Daily B. Quetiapine 25 mg PO BID C. Olanzapine 5 mg PO Daily D. Apomorphine 2 mg SC PRN E. Fluphenazine 1 mg PO Daily 9. LG is a 82 y/o AAM with PMH significant for HTN and Parkinson’s disease. He reports he has had an increase in motor symptoms when trying to take quetiapine for hallucinations and has a history of severe neutropenia with clozapine. Which of the following medications is most appropriate to treat LG’s Parkinson’s disease psychotic symptoms?

A. Safinamide B. Olanzapine C. Haloperidol D. Chlorpromazine E. Pimavanserin 10. MM is a 62 y/o WM who is currently taking SinemetTM 25/100 mg one tablet by mouth in the morning and at bed time, two tablets by mouth at noon, and two tablets by mouth before dinner. MM’s PCP wishes to switch MM to extended release levodopa/carbidopa capsules. Which of the following extended release levodopa/carbidopa doses is the correct choice to switch MM to?

A. 3 capsules of carbidopa 23.75 mg/levodopa 95 mg 3 times daily B. 4 capsules of carbidopa 23.75 mg/levodopa 95 mg 3 times daily C. 3 capsules of carbidopa 36.25 mg/levodopa 145 mg 3 times daily D. 3 capsules of carbidopa 48.75 mg/levodopa 195 mg 3 times daily E. 4 capsules of carbidopa 48.75 mg/levodopa 195 mg 3 times daily

CPE Quiz Online www.surveymonkey.com/r/CEQuizMay18

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

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 06/28/2021 Successful Completion: Score of 80% will result in 1.5 contact hour or .15 CEUs. TECHNICIANS ANSWER SHEET May 2018 — Let’s Shake Things Up: A Review of the 2017 NICE Guidelines and New Parkinson’s Disease Medications (1.5 contact hours) Universal Activity # 0143-0000-18-009-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 9. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E 10. A B C D E Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #__________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET May 2018 — Let’s Shake Things Up: A Review of the 2017 NICE Guidelines and New Parkinson’s Disease Medications (1.5 contact hours) Universal Activity # 0143-0000-18-009-H01-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 3. A B C D E 5. A B C D E 7. A B C D E 2. A B C D E 4. A B C D E 6. A B C D E 8. A B C D E

9. A B C D E 10. A B C D E

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |21| www.KPHANET.org

Have an idea for a continuing education article? WRITE IT! Continuing Education Article Guidelines The following broad guidelines should guide an author to  completing a continuing education article for publication in The Kentucky Pharmacist.  



Average length is 4-10 typed pages in a word processing document (Microsoft Word is preferred).



Articles are generally written so that they are pertinent to both pharmacists and pharmacy technicians. If the subject matter absolutely is not  pertinent to technicians, that needs to be stated clearly at the beginning of the article.



Article should begin with the goal or goals of the overall program – usually a few sentences.



Include 3 to 5 objectives using SMART and measurable verbs.



Feel free to include graphs or charts, but please submit them separately, not embedded in the text of the article.

|22| Kentucky Pharmacists Association | May/June 2018



Include a quiz over the material. Usually between 10 to 12 multiple choice questions.

Articles are reviewed for commercial bias, etc. by at least one (normally two) pharmacist reviewers.

When submitting the article, you also will be asked to fill out a financial disclosure statement to identify any financial considerations connected to your article.

Articles should address topics designed to narrow gaps between actual practice and ideal practice in pharmacy. Please see the KPhA website (www.kphanet.org) under the Education link to see previously published articles.

Articles must be submitted electronically to the KPhA director of communications and continuing education (info@kphanet.org) by the first of the month preceding publication.

June CPE Article Evolution and Current Status of Ethical Standards for Pharmacists By: Joseph L. Fink III, B.S.Pharm., J.D., D.Sc. (Hon.), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington The author declares there are no financial relationships that could be perceived as real or apparent conflicts of interest. He does report that he chaired the group that created the latest version of the APhA Code of Ethics for Pharmacists.

Universal Activity # 0143-0000-18-010-H03-P &T 1.5 Contact Hour (0.15 CEU) Expires 6/28/21

KPERF offers all CE articles to members online at www.kphanet.org

Goal: To educate pharmacists and pharmacy technicians about the evolution of pharmacy’s code of ethics and describe the background of the current version of the code, thereby enhancing the readers’ understanding of the ethical environment for contemporary professional practice.

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

Understand the history of timing of updates to pharmacy’s code of ethics;

2.

Describe the approach used for the most recent revision of the Code;

3.

Describe the legal impediment to enforcement provisions of the code in effect during the 1960’s – 1970’s.

4.

Describe the process for approval of changes in the Code.

Introduction One of the hallmarks of a profession is that it has ethical standards with which the practitioner should strive to comply. Pharmacy has a long history of formulating and communicating ethical standards for practitioners. The set of professional practice standards was developed in 1821 concurrently with the founding of the first college of pharmacy in the U.S., the Philadelphia College of Pharmacy.1 The code of ethics that guides professional decision-making by pharmacists is prepared and adopted by the American Pharmacists Association (APhA).2 In fact, it requires an affirmative vote of two-thirds of the active members of APhA to adopt changes in the Code.3 In the nearly two centuries since that innovation in professional standards, the code of ethics has been revised and updated seven times: 1821, 1852, 1922, 1952, 1969, 1975, 1981, 1994 It is noteworthy that the intervals between revisions grew shorter and shorter as the profession advanced in response to changes in the health care system and practitioners undertook new roles. At the time of revision it was note that the project that led to the 1994 version of the Code “was the first major overhaul of the document since 1969. Although changing legal standards caused Code modifications to be adopted in 1975 and 1981, the new version (adopted in 1994) was the first complete reconsideration of the Code in 25 years.”4

sibilities in patient care” while at the same time “burgeoning technological innovations have materialized to make possible treatment of disease or prolongation of life in situations where there was little hope in the past.” Additionally, “financing health care in general and pharmacy services in particular had experienced a metamorphosis.”5 As was noted earlier, examples of ethical quandaries for pharmacists were identified as associated with a variety of practice settings: “A community pharmacist is torn between his/her obligation to the patient and the restrictions on reimbursement for products and services imposed by the firm that provides health insurance for the patient’s health care costs.

A pharmacist in hospital practice is debating whether to dispense the ‘morning after pill’ to a patient seen at the emergency room.

A pharmacist who serves patients in extended care facilities is concerned about overuse of certain medications as ‘chemical restraints’ for patients.

A pharmacist in industry is wondering what ethical obligation there is to call to the attention of company executives his/her One publication emphasized the changes that had occurred in concerns that an immediate supervisor may be down-playing the interim. Pharmacists had “assumed new roles and respon- serious side effects of a new medication that is undergoing |23| www.KPHANET.org

clinical trials.”5 

The contemporary Code of Ethics for Pharmacists was adopted by the members of APhA during 1994 so it is now closing in on a quarter century of providing guidance for pharmacy practitioners.6 However, what is a code of ethics? Such a collection of standards can be defined as a set of principles that all members of a profession must work to comply with to ensure ethical decision making even in difficult situations. Another definition is that the code is a “formal statement by a group that establishes and prescribes moral and non-moral standards and behaviors for members of that group.”7



ceutical manufacturing firm One pharmacist serving as a state pharmacy association executive One pharmacy journal editor renowned for thought provoking editorial positions

Once identified and assembled, the group undertook its work using a stepwise process that focused on: 1.

2.

3.

4.

Agreeing on the roles of a code Agreeing on the purpose of a code Agreeing on the key values to be incorporated in a code Drafting the code and soliciting comments

Roles of a Code There are some core ethical principles that usually undergird a code of ethics. These over-arching principles are incorporated Following extensive discussion, the members of the Task one way or another in the ethical standards for many profesForce on Pharmacy’s Code of Ethics agreed on the following sions.8 roles for the code to guides the decisions and actions of pharmacists: Autonomy – Respecting the patient’s desires and thoughts; patients have the right to make independent judgments about  The code should be aspirational. The guidelines should their affairs strive to take pharmacists and the profession to a higher level.

Beneficence – Beneficial outcomes are valued; decisions must  The code should be standard setting, with the hallmarks be in the best interest of the patient. or benchmarks identified to enable the practitioner to gauge his or her position and to facilitate adjustments.

Fidelity – Being faithful, keeping promises to ensure confi The code should facilitate and encourage communication dence; professional integrity and honesty in patient relationwithin the profession. It should enable pharmacists to ships communicate with student pharmacists and pharmacy technicians about issues that arise in the course of patient Human Dignity –Respect for the inherent worth of each pacare. tient  The code should be useful for communication with external constituencies. A pharmacist should be able to use it Justice – Fair allocation of goods and services; fairness and as a resource when speaking with patient groups or other equality in the way patients are treated and decisions made gatherings in his or her community Non-maleficence – Avoidance of harm; avoiding bad outcomes is desirable Veracity – Truthful and accurate reporting of proper information to patients

Purpose of a Code Extensive discussion also centered around securing agreement on the purposes of a code. In the end the group agreed on the following purposes.

Irrespective of practice site or even profession, those principles  are hallmarks of sound ethical decision-making that can take one a long way when confronted with a challenging, or even  problematic, situation.

Approach Used for the Latest Revision

 

The code should explain the training, duties and responsibilities of pharmacists to the public.

The code should provide guidance to practitioners on ethical and moral dilemmas.

The code should lead to professional accountability.

The code should facilitate education of practitioners and students.

The code should authorize a structure for enforcing or interpreting the code.

To begin the process of updating the APhA Code of Ethics,  the organization assembled a diverse group from those affiliated with the profession. The members of the group included: The last purpose has never been effected due to resource con Three professors with specialties in pharmacy law and straints. Enforcement of the code also was hampered by the ethics fact that an earlier version had been challenged in court by a  One pharmacy student in her senior year of schooling disgruntled APhA member who held a managerial position  One community pharmacy owner with a divinity degree with a pharmacy chain that advertised prescription prices. The  One pharmacist enrolled in a bioethics PhD degree proAssociation took steps to revoke their memberships and the gram U.S. Department of Justice got involved to pursue allegations  One pharmacist working in pharmacy affairs at a pharma- of antitrust violations against APhA.9 Advertising prices for |24| Kentucky Pharmacists Association | May/June 2018

prescription medications was not permitted under the earlier version of the APhA Code of Ethics pursuant to a provision with this wording: “A pharmacist should not solicit professional practice by means of advertising or by methods inconsistent with his opportunity to advance his professional reputation through service to patients and to society.”10 Key Values to be Incorporated Protracted consideration of the values to be included in the code, either directly or by implication or inference, led to a rather lengthy list.                   

Caring as well as curing (continuity of care) Compassion Competence Concern for the patient’s welfare Confidentiality Cooperation with other health professions Dignity Distributive justice when resources are limited Fairness Faithfulness Honesty and integrity Nondiscrimination Professional autonomy of the pharmacist Protection of the patient Respect for patient autonomy Self-determination or empowerment Social responsibility Stewardship (managing resources in a responsible way) Trust

The challenge for the members of the Task Force was to “weave these values of the profession and individual professionals into a coherent whole.”4 The Result The Task Force prepared a draft of the wording of the Code that was distributed to APhA members for comment as well as to other national pharmacy and health organizations, state pharmacy associations, other health professionals, state boards of pharmacy and schools and colleges of pharmacy. It was circulated to national thought leaders in the fields of bioethics and professional ethics. Finally, the Task Force conducted an open hearing during the 1993 APhA Annual Meeting in Dallas.4

The structure of the body of the Code has eight key principles indicated with Roman numerals. Under each principle printed in bold face type is a paragraph designed to expand upon or explain how the item may be effected in practice.

I. A pharmacist respects the covenantal relationship between the patient and pharmacist.

Considering the patient-pharmacist relationship as a covenant means that a pharmacist has moral obligations in response to the gift of trust received from society. In return for this gift, a pharmacist promises to help individuals achieve optimum benefit from their medications, to be committed to their welfare, and to maintain their trust.

II. A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner.

A pharmacist places concern for the well-being of the patient at the center of professional practice. In doing so, a pharmacist considers needs stated by the patient as well as those defined by health science. A pharmacist is dedicated to protecting the dignity of the patient. With a caring attitude and a compassionate spirit, a pharmacist focuses on serving the patient in a private and confidential manner.

III. A pharmacist respects the autonomy and dignity of each patient.

A pharmacist promotes the right of self-determination and recognizes individual self-worth by encouraging patients to participate in decisions about their health. A pharmacist communicates with patients in terms that are understandable. In all cases, a pharmacist respects personal and cultural differences among patients.

IV. A pharmacist acts with honesty and integrity in professional relationships.

A pharmacist has a duty to tell the truth and to act with conviction of conscience. A pharmacist avoids discriminatory practices, behavior or work conditions that impair professional judgment, and actions that compromise dedication to the best interests of patients.

V. A pharmacist maintains professional competence.

A pharmacist has a duty to maintain knowledge and abilities as new medications, devices, and technologies become available and as health information advances.

VI. A pharmacist respects the values and abilities of colleagues and other health professionals.

When appropriate, a pharmacist asks for the consultation of colleagues or other health professionals or refers the patient.

A pharmacist acknowledges that colleagues and other health The result of the process that occurred over a number of years professionals may differ in the beliefs and values they apply to was the current version of the APhA Code of Ethics for Phar- the care of the patient. macists. A preamble “sets the stage” by identifying the key role of pharmacists as “health professionals who assist indiVII. A pharmacist serves individual, community, and socieviduals in making the best use of medications.” With empha- tal needs. sis on the “principles that form the fundamental basis of the The primary obligation of a pharmacist is to individual paroles and responsibilities of pharmacists”, the Code was tients. However, the obligations of a pharmacist may at times “established to guide pharmacists in relationships with paextend beyond the individual to the community and society. tients, health professionals and society.”

In these situations, the pharmacist recognizes the responsibilities that accompany these obligations and acts accordingly. |25| www.KPHANET.org

VIII. A pharmacist seeks justice in the distribution of health resources.

When health resources are allocated, a pharmacist is fair and equitable, balancing the needs of patients and society.

Disclaimer

The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educaApproval and Adoption tional or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in Once the Code of Ethics for Pharmacists had been drafted the course of professional practice. It is always the best advice and approved by the Task Force it was sent to the APhA for a pharmacist to seek counsel from an attorney who can Board of Trustees for review and approval. Concurrence at become thoroughly familiar with the intricacies of a specific that level was secured and, as required by APhA bylaws, the situation, and render advice in accordance with the full inforrevised Code was sent to the membership for a vote.11 It was mation. approved by at least a two-thirds majority vote that was confirmed on October 27, 1994.

References 1. Sonnedecker G. Kremers and Urdang’s History of Pharmacy (4th ed.). Philadelphia: J.B. Lippincott Co.;1976, p. 192.

2. Fink III JL. Ethics and a code of ethics in pharmacy practice.

Special Additional Introduction in White BD. Drugs, Ethics and Quality of Life: Cases and Materials on Ethical, Legal, and Public Policy Dilemmas in Medicine and Pharmacy Practice. Binghamton, NY: The Haworth Press; 2007, p.7-12.

3.American Pharmacists Association Bylaws (as amended through April 22, 2014), Article XIV. Amendments. Section 2. Code of Ethics. Available at http://pharmacist.com/sites/default/files/files/ Attachment%20D%20-%20APhA%20BYLAWS%20-%20Revised% 20April%202014.pdf 4.Fink III JL. Updating the code of ethics. Am Pharm. 1994 (Aug);NS34:80.

5. Fink III JL. Updating pharmacy's code of ethics. U.S. Pharm.

1992(Feb);17:53-4.

6.Code of Ethics for Pharmacists, Adopted by the APhA Membership, October 27, 1994. Available at http://www.pharmacist.com/ code-ethics.

7.Buerki RA, Vottero LD. Ethical Responsibility in Pharmacy Practice (2nd ed.). Madison, WI: American Institute of the History of Pharmacy (2002), p. 233.

8.Fink III JL. Developing ethical standards: The role of people, the role of codes. Int J Pharm Educ & Pract. 2011 (Spring);7:1-7, available at http://www4.samford.edu/schools/pharmacy/ijpe/011/ heal2010.pdf 9.American Pharmaceutical Ass’n v. U.S. Department of Justice, 344 F.Supp. 9 (E.D.Mich. 1971); aff’d 467 F.2d 1290 (6th Cir. 1972).

10.Section 8, APhA Code of Ethics (1969 version).

11.American Pharmacists Association Bylaws (as amended through April 22, 2014), Article XIV. Amendments. Section 2. Code of Ethics. Available at http://pharmacist.com/sites/default/files/files/Attachment% 20D%20-%20APhA%20BYLAWS%20-%20Revised%20April% 202014.pdf

|26| Kentucky Pharmacists Association | May/June 2018

CPE Quiz Online www.surveymonkey.com/r/CEQuizJune18

June 2018 — Evolution and Current Status of Ethical Standards for Pharmacists 1. The first pharmacy code of ethics in the U.S. was developed contemporaneously with what event?

A. Founding of the American Pharmacists Association B. Founding of the first college of pharmacy C. Granting of the first state-issued license to practice pharmacy D. None of the above 2. APhA has adopted a practice of having the wording of the Code of Ethics reviewed every ten years to assess whether the provisions still reflect current practice.

A. True B. False 3. The Task Force on Pharmacy’s Code of Ethics included members from all categories except: A. Community pharmacy owners B. Student pharmacists C. Military pharmacists D. Pharmacists in industry 4. Adoption of changes in the code requires approval of all except: A. Task Force on Revision B. U.S. Department of Justice C. APhA Board of Trustees D. APhA members 5. Enforcement of these provisions in the version of the code in use during the 1960’s – 1970’s ran afoul of the U.S. Department of Justice.

A. Mandate of extending the offer for patient counseling B. Prohibition on price advertising C. Mandate of completion of continuing education for renewal of licensure D. Prohibition on practicing in both community pharmacy and institutional pharmacy practice settings.

7. A principal source of interest in or pressure for revision of the Code in the past fifty years has been practitioners of pharmacy undertaking new roles in patient care.

A. True B. False 8. A key component of the vetting process for the code in effect now was conducting an open hearing at an APhA Annual Meeting.

A. True B. False 9. Which of the following agreed upon purposes of a code has yet to materialize for the current version of the APhA Code of Ethics for Pharmacists?

A. Provide guidance on ethical and moral dilemmas B. Explain the training, duties and responsibilities of a pharmacist to the public.

C. Authorize a structure for interpreting or enforcing the Code.

D. Facilitate education of students and practitioners.

10. During the revision process comments were solicited from all except: A. Other national pharmacy organizations B. The federal government C. State boards of pharmacy D. Schools and colleges of pharmacy

6. Over the existence of an APhA Code of Ethics, the intervals between revisions have been getting: A. Longer B. Shorter

|27| www.KPHANET.org

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

The fee for non-members is $30. Mail completed forms to: KPERF, 96 C Michael Davenport Blvd., Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: 6/28/21 Successful Completion: Score of 80% will result in 1.5 contact hours or .15 CEUs. TECHNICIANS ANSWER SHEET. June 2018 â&#x20AC;&#x201D; Evolution and Current Status of Ethical Standards for Pharmacists (1.5 contact hours) Universal Activity # 0143-0000-18-010-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 2. A B 4. A B C D

5. A B C D 6. A B

7. A B 8. A B

9. A B C D 10. A B C D

Information presented in the activity:

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

PHARMACISTS ANSWER SHEET June 2018 â&#x20AC;&#x201D; Evolution and Current Status of Ethical Standards for Pharmacists (1.5 contact hours) Universal Activity # 0143-0000-18-010-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B 4. A B C D 6. A B

7. A B 8. A B

9. A B C D 10. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet.

Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation |28| Kentucky Pharmacists Association | May/June 2018

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted.

Campus Corner 2018 Preceptor of the Year Dr. Kelly Walsh Davis has been named the UK College of Pharmacy Preceptor of the Year. Davis has been precepting pharmacy students and residents since 2011 and has left a lasting impact on those she has mentored. One student noted, “There are few people in my life that I have said I want to be like them in one way or another. I am honored to add Dr. Davis to that list.” Davis was nominated as our preceptor of the year due to her dedication to the profession, her teaching and mentorship, and her integral part as a professional role model in the lives of our students.

Davis grew up in White Plains, New York. She received a Bachelor of Science degree in Biology from Fairfield University in Fairfield, Connecticut and a Master of Science in Teaching degree from Iona College in New Rochelle, New York.

In 2009, she received her PharmD from Southern Nevada and completed specialty residency in Internal Medicine at the UK Medical Center, where she also served as the Chief Resident. She was a High School science teacher in New York, Connecticut, and California for six years prior to pursuing pharmacy training. She was also named Kentucky Society of Health-System Pharmacists Resident of the Year in 2010.

Following her residency, Davis worked at the University of Louisville Hospital as a Clinical Pharmacist before assuming her current role as a Clinical Pharmacy Specialist in Critical Care at the Lexington Veterans Affairs Medical Center. In addition to her Critical Care role, Davis also provides clinical services to the Internal Medicine teams and is involved with antimicrobial stewardship efforts at the facility.

Upon receiving this award, Davis said, “I have been blessed with dedicated preceptors and mentors throughout my career. So, it is my pleasure to return the favor to the next generation of pharmacists.”

Meet our Experiential Ed Team We’re excited to introduce the team working in our Office of Experiential Education. They coordinate the pharmacy practice experience components of the curriculum, including the Introductory Pharmacy Practice Experience (IPPE) and the Advanced Pharmacy Practice Experience (APPE).

Holly Divine, PharmD, BCACP, BCGP, CDE, FAPhA Clinical Associate Professor, Interim Director of Experiential Education/IPPE Coordinator I have 20 years of experience in community and ambulatory practice with my current practice site at Bluegrass Community Health Center where I provide medication management and diabetes management via collaborative care with our primary care providers. I’ve precepted student pharmacists since 2000 and community-based pharmacy residents since 2001. Nothing compares to that “light bulb” that illuminates when a student or resident uses their classroom-based skills in a real-world environment for the first time.

I love educating future pharmacists and networking with our site-based faculty.

Tera McIntosh, PharmD, BCACP Course Coordinator, Advanced Community and Advanced Ambulatory APPE and Longitudinal Experiential Education in Pharmacy |29| www.KPHANET.org

I have 17 years of experience in community and ambulatory practice. My current practice sites are Capital Pharmacy and Bluegrass Community Health Center where I provide medication therapy management, medication assisted treatment education for opioid use disorder and diabetes management via collaborative care with our primary care providers. What I most enjoy about precepting students is seeing their excitement when they connect what they have learned in the classroom to assist a real patient. I think real world learning is crucial to student education, so I am very excited to be in experiential education. I look forward to getting to know our community-based faculty.

Chris Miller

ble. Clinical pharmacist positions have included cardiology, critical care, and emergency medicine. Administrative roles have included pharmacy clinical manager and director of pharmacy. My most recent clinical work has been providing evidence-based medicine support in the form of white papers and therapeutic drug class comparisons for Vizient, a national healthcare performance improvement company. I believe learning is accelerated in clinical settings. I'm excited to partner with site-based faculty to create new and exciting educational opportunities for our students.

Kendra Harvey Data Management Specialist

The College of Pharmacy has been my home for the last 14 years and I recently started a new endeavor within the Office of EducaI have over 20 years of experience in nu- tion. My previous experience has been in the areas of trition support pharmacy in both the home healthcare administration and data management in the Department and hospital-based settings. My current practice is at of Pharmaceutical Sciences and the Dean’s Office. It’s Norton Hospital in Louisville, Kentucky where I am exciting to be part of such a wonderful team and to have involved in the clinical management of patients requir- the opportunity to watch the students contribute and ing specialized parenteral nutrition support. I have pre- learn throughout their experiential education opportunicepted student pharmacists and residents at this site and ties. it brings me great joy to see them become independent Mike Richardson, MS in managing patients. In my experiential education role, Program Coordinator I am the Clinical Training Coordinator for the College’s Louisville based Clinical Education Center (CEC) proI have over 19 years of experience in expegram. The CEC was developed as an academic partnerriential education with the College of Pharship between the UK College of Pharmacy and Norton macy. I enjoy working for a high performing, nationally Healthcare. The Louisville CEC program has been in ranked organization that continually looks for ways to existence since 2007 and was designed to support the improve and innovate. I really like developing new skills Louisville area preceptors, and to enhance the student sets, and especially enjoy working with and assisting the APPE experience through rotation expansion and devel- program’s pharmacy preceptors and students. opment of educational programing. Since inception of Autumn Rice the CEC program, we have had an approximate 200% growth in APPE experiences, and over 275 students parAdministrative Support ticipate in this program with approximately 42% pursuAs the Administrative Assistant for the Ofing post-graduate training. fice of Experiential Education, my responStacy Taylor, PharmD, MHA, BCPS sibilities include serving as the primary contact for our team, managing resources for our preceptors, and assistClinical Assistant Professor, Longitudinal Exing with the scheduling of student rotations. I enjoy the periential Education in Pharmacy "LEEP" Coopportunity to communicate with preceptors throughout Coordinator the state and to contribute to the experiential education Since completing residency training, I have served in of our students here at the College of Pharmacy. almost every hospital pharmacist role imaginaClinical Training Coordinator and Assistant Clinical Professor

|30| Kentucky Pharmacists Association | May/June 2018

Campus Corner Class of 2018 Awards Ceremony & Graduation In an accelerated program, the ends and beginnings are very, very close together… In June of each year we gather together to celebrate and recognize student pharmacists from each class that have excelled in leadership, scholarship, service, and professionalism.

The SU College of Pharmacy and Health Sciences Honors and Awards Ceremony was held on June 8. We are happy to announce that we recognized nine P1, nine P2, and 35 P3 student pharmacists. Additionally, three faculty members were selected by the students as faculty preceptor, Clinical and Administrative Sciences faculty member, and Pharmaceutical Sciences faculty member of the year.

The SU College of Pharmacy and Health Sciences 2018 Graduation Ceremony was held on June 9 and leadership from the Kentucky Pharmacists Association, Kentucky Society of Health-System Pharmacists, and the Kentucky Board of Pharmacy were in attendance to share in this celebration. There were 83 graduates in the Class of 2018 with 11 graduating with an MBA as well as their PharmD. Eleven graduates of the Class of 2018 will be entering postgraduate residency education in Kentucky.

Photos from the SUCOP Award Ceremony & Graduation

SUCOP RESIDENCY CLASS OF 2018 Sullivan University is proud to partner with other local organizations to provide five residency programs.

This year we are excited to graduate seven PGY1 residents from the following programs: Talya Burnett (SUCOP Center for Health and Wellness/St. Matthew’s Community Pharmacy PGY1 Pharmacy Residency);Christina Ciccone (SUCOP/Walgreens PGY1 Community Residency); Madison Conrad (SUCOP/Frankfort Regional Medical Center PGY1 Pharmacy Residency); Ethan Kuszmaul (SUCOP/Center for Health and Wellness PGY1 Pharmacy Residency); Amanda Miller (SUCOP/ Center for Health and Wellness PGY1 Pharmacy Residency); Cavan O’Reilly (SUCOP/Passport Health Plan PGY1 Managed Care Residency); Emily O’Reilly (SUCOP/Center for Health and Wellness PGY1 Pharmacy Residency) The Pass the Torch graduation ceremony was held on June 26 at Sullivan University.

SUCOP is proud of these graduates and looks forward to the wonderful places they will go. Congratulations!

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Pharmacy Law Brief Duties of a Corporate Board Member Author: Joseph L. Fink III, BSPharm, JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I have been approached about serving on the Board of Directors of a local nonprofit organization. I mentioned this to a friend and received some response that led me to believe that there are unusual legal expectations associated with that role. What are those?

conflict.

are two general fiduciary duties: The duty of care and the duty of loyalty. If the organization one is serving is operated as a non-profit basis then there is a third duty that comes into play, the duty of obedience. This means board members and officers must have a commitment to the corporationâ&#x20AC;&#x2122;s purpose or mission as stated in its governing documents.

Considering assuming such a role? You may also wish to read: Fink III JL. Pharmacy Law Brief: Potential Legal Exposure with Community Service as a Board Member of a Non-Profit Organization. Kentucky Pharm. 2008(Nov);3:1415.

The duty of obedience is unique to non-profit organizations and means that the director must work to assure that the purposes of the organization are adhered to and that charitable assets are not redirected to non-charitable purposes. Assuring compliance with all regulatory and reporting requirements, of Response: There are quite a few legal expectations that flow which there can be quite a few in order to retain non-profit from such an appointment and it does not matter whether the status, is also an expectation. board of directors/board of trustees is for an organization operated on a for-profit basis or has a non-profit orientation. Service as a board member, be it for a for-profit entity or a non-profit organization, can be very rewarding and even eduThe majority of these expectations fall under something cational. But one who assumes such responsibilities should known generally as â&#x20AC;&#x153;fiduciary duties.â&#x20AC;? A fiduciary duty is be aware of the legal context and expectations that come with one derived from being in a position of trust and confidence the role. and the scrupulous good faith and candor it requires. There

Turning first to the duty of care, this is the expectation that a leader of the organization, officer of member of the board, will act in an informed and deliberate manner when deciding matters related to the entity. The individual will avail himself or herself of all available reasonably related information about the matter under consideration. Was the process used to make the decision an appropriate one? Directors should understand the focus of the organization, avoid hasty decision making, review the relevant information that is available, consult appropriate advisors and consultants, consider the advice of relevant corporate officers and other employees, be alert to potential conflicts of interests for those advising the board, and generate an appropriate record of deliberations leading up to the decision.

The duty of loyalty is an expectation that the director will make decisions in the best interests of the organization, ignoring his or her own personal interests. One goal here is to prevent self-dealing by members of the board; board members should have no personal financial interest in a matter under consideration by the board. Should that occur, recusal would be appropriate following an open disclosure of the potential |32| Kentucky Pharmacists Association | May/June 2018

Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

Submit Questions: jfink@uky.edu

Welcome to KPhA! We’re so happy to have you!

The list reflects new memberships received from March 1, 2018— April 30, 2018 David Barhorst Louisville

Stephanie Fricks Tompkinsville

Azadeh Sarafraz Louisville

Donovan Bentley Pikeville

Sydney Haubner Seminole

Cassandra Silkowski Louisville

Sara Busse Springboro

Michael Kellihan Louisville

Regina Upchurch Corbin

Matthew Fricks Tompkinsville

Emmanuel Owusu-Amankwah Lexington

Debora Walls Lancaster

MEMBERSHIP MATTERS: To YOU, To YOUR Patients To YOUR Profession!

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

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Pharmacy Policy Issues FDA’s Attempts to Protect Patients Through Use of Printed Words Author: Rebekah Wahking is 2018 PharmD graduate of the UK College of Pharmacy as well as an MBA graduate of the UK Gatton College of Business and Economics. A native of Lexington, KY, she completed her pre-professional education at the University of Kentucky with a major in psychology. patients about safe and effective use of these products. Other medications may come with a PPI; however, this information is voluntarily provided by the manufacturer. Whether PPIs are mandatory or voluntary, all have wording that has been reviewed and approved by the FDA.4 PPIs for oral contraceptive products and estrogen products must be dispensed at every dispensing (or at least every Discussion: Pharmaceutical manufacturers are thirty days in an inpatient setting). Additionally, constantly advancing medical practice by developthey must contain specific information, such as ing sophisticated medications. While these medicarisks of the medication, benefits of the prescription, tions can be beneficial in treating highly complex and use of the product.2,3 Voluntary PPIs do not disease states, they are not without their adverse have to meet the same criteria.1 reactions. To educate and protect patients from poMedGuides are mandatory for a gamut of medicatential side effects, the FDA has intensified required documentation to be dispensed with several tions, ranging from antidepressants, oral diabetes medications, and even inhalers.5 MedGuide direcmedications. Currently, there are three levels of tives started in the 1990s.1 The FDA deems patient information that the FDA mandates: paMedGuides are suitable for products meeting at tient package inserts (PPIs), Medication Guides (MedGuides), and Risk Evaluation and Mitigation least one of the following criteria: “…patient labelStrategies (REMS). Frequently, the differences be- ing could help prevent serious adverse effects, the drug product is one that has serious risk(s) (relative tween these are misunderstood by prescribers, to benefits) of which patients should be made pharmacists and patients. To help clarify, the difference between these mandates are described be- aware because information concerning the risk(s) could affect patients' decision to use, or to continue low. to use…” and/or “the drug product is important to PPIs must be distributed with two classes of medihealth and patient adherence to directions for use cations: oral contraceptives and estrogen products. is crucial to the drug's effectiveness.”6 Typically, Additionally, if progestational product are being MedGuides are viewed as a step-up from PPIs. distributed for to achieve contraception a PPI is Again, the FDA approves all MedGuides and lists required then as well. The FDA started this dispecific criteria that they must meet.6 Notably, the rective in the 1960s and 1970s1 and it is still a relaw does allow prescribers the latitude to request a quirement today.2,3 The goal of PPIs is to educate MedGuide not be dispensed to a patient if they Issue: Ever since patient package inserts were mandated to be distributed with oral contraceptives the FDA has been ratcheting up expectations in this area with mandates related to MedGuides and REMS. What’s the difference in those three and some examples in each category as things stand today?

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deem it is not in the patient’s best interest. Howev- References: er, if a patient requests a copy of the MedGuide, it 1. “Prescription Drug Information for Patients: History.” must be provided.6 US Food and Drug Administration. Accessed November Most recently for the three required documents, the 14, 2017. https://www.fda.gov/downloads/ FDA began the REMS program in 2007. The pur- AdvisoryCommittees/CommitteesMeetingMaterials/ pose of REMS is to make certain that the benefits of RiskCommunicationAdvisoryCommittee/ therapy outweigh the risks.7 Generally, this is con- UCM150262.pdf sidered the highest-level FDA mandate. Unlike 2. Patient package inserts for oral contraceptives. 21 CFR PPIs and MedGuides, a REMS medication, may be § 310.501 (2012). required to meet one or more of the following crite3. Patient package inserts for estrogens. 21 CFR § 310.515 ria: PPI or MedGuide, communication plan, ele(2012). ments to assure safe use (ETASU), and/or implementation system. The communication plan is used 4. Office of the Commissioner. “For Patients – Learn mainly as an additional education tool for the prod- About Your Medicines” US Food and Drug Administrauct. ETSAU can vary between products, but intion Home Page. Accessed November 14, 2017. https:// clude elements such as ensuring prescribers, pharwww.fda.gov/ForPatients/ucm412663.htm macies, and infusion centers must be specially certi5. Center for Drug Evaluation and Research. “Drug Safefied to order, dispense, or administer the medicaty and Availability – Medication Guides. US Food and tion.7 Currently, the FDA has seventy-five medicaDrug Administration Home Page. Accessed November 14, tions as part of the REMS program and they consist 2017. https://www.fda.gov/Drugs/DrugSafety/ of products from several classes of medications, inucm085729.htm cluding, but not limited to, anti-psychotics and chemotherapies.8 Overall, the FDA aims to contin- 6. Medication Guides for Prescription Drug Products. 21 CFR § 20 (2010). ue to use REMS to keep more medications on the market, products that otherwise would have not 7. “A Brief Overview of Risk Evaluation &Mitigation been approved due to dangers associated with unin- Strategies (REMS).” US Food and Drug Administration. formed use. The goal is to diminish serious risks Accessed November 14, 2017. https://www.fda.gov/ with these medications such as infection, organ downloads/aboutfda/transparency/basics/ damage, and even birth defects.7 ucm328784.pdf Ultimately, the FDA is attempting to increase access to risky medications while executing their responsibility to protect patients. As more hazardous medications are studied and approved, the FDA is likely to expand these mandates further. While this may seem a nuisance with extra paperwork and requirements for dispensing, patient safety should be a top priority. In addition, health care professionals should take responsibility to understand the differences in these mandates and why they are important.

8. “Approved Risk Evaluation &Mitigation Strategies (REMS).” US Food and Drug Administration Home Page. Accessed November 14, 2017. https:// www.accessdata.fda.gov/scripts/cder/rems/index.cfm Have an Idea?: This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome.

Please send them to jfink@uky.edu.

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2017â&#x20AC;&#x201D;2018 KPhA BOARD OF DIRECTORS Trish Freeman, Lexington trish.freeman@uky.edu

Chair

Tyler Stephens, Lexington Vice Speaker of the House stevens.tyler@uky.edu

Chris Harlow, Louisville cpharlow@gmail.com

President

KPERF BOARD OF DIRECTORS Chair

Chris Palutis, Lexington chris@candcrx.com

President-Elect

Bob Oakley, Louisville rsoakley21@gmail.com

Secretary

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Treasurer

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Duane Parsons, Richmond dandlparsons@roadrunner.com

President. KPhA

Jessika Chinn, Beaver Dam jessikachilton@ymail.com

Past President Representative

Chris Harlow, Louisville cpharlow@gmail.com

Directors

Paul Easley, Louisville rpeasley@bellsouth.net

Angela Brunemann, Union Angbrunie@gmail.com

Sarah Lawrence, Louisville slawrence@sullivan.edu

Matt Carrico, Louisville matt@boonevilledrugs.com

Kelly Smith, Lexington ksmit1@email.uky.edu

Jaclyn Ochsner, Lexington jaclyn.Ochsner@uky.edu

University of Kentucky Student Representative

Chad Corum, Manchester pharmdky21@gmail.com

Matt Carrico, Louisville matt@boonevilledrugs.com Kim Croley, Corbin kscroley@yahoo.com

Cassy Hobbs, Louisville cbeyerle01@gmail.com Nathan Hughes, Louisville nhughe1030@my.sullivan.edu

KPERF ADVISORY COUNCIL

Sullivan University Student Representative

Chris Killmeier, Louisville cdkillmeier@hotmail.com Don Kupper, Louisville donku.ulh@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield* willettsam@bellsouth.net *At-Large Member to Executive Committee

HOUSE OF DELEGATES Amanda Jett, Louisville Speaker of the House ajett@sullivan.edu |38| Kentucky Pharmacists Association | May/June 2018

Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Mary Thacker, Louisville mary.thacker@att.net

KPhA/KPERF HEADQUARTERS 96 C Michael Davenport Blvd., Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) info@kphanet.org www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc

â&#x20AC;&#x153;With the need for Continuing Education increasing more and more each day in all fields of endeavor, your Association is devoting one entire session at the 1968 convention to the role Pharmacy and the Pharmacist must face in the changing world.â&#x20AC;?

- From The Kentucky Pharmacist, June 1968, Volume XXXI, Number 6

Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd.

Frankfort, KY 40601 (502) 227-2303 info@kphanet.org www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org Drug Information Center SUCOP 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org.

Deceased members for each year will be honored permanently at the KPhA office.

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THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd.

Frankfort, KY 40601

We welcome our new Board of Directors 2018-2019 Jessika Chinn: served as Past President Representative for the past 2 years and has been re-elected to a 3-year term.

Matt Carrico: re-elected for another 3-year term.

Chad Corum: re-elected to another 3-year term.

New Officers and Members of the KPhA Board of Directors installed at the closing session of the 140th KPhA Annual Meeting and Convention June 16, 2018 included: Chris Harlow, Chair Chris Palutis, President Don Kupper, President-Elect Tyler Stevens, House of Delegates Speaker Ben Mudd, House of Delegates Vice Speaker Stephen Drog, SUCOP Student Representative Dharti Patel, UKCOP Student Representative New Officers and Members of the KPhA Board of Directors to be installed at the July 26, 2018 Board meeting include: Brooke Hudspeth, Secretary Joel Thornbury, Past President James â&#x20AC;&#x153;Blakeâ&#x20AC;? Wiseman, Board of Directors Both Joel Thornbury and Blake Wiseman were appointed by President Chris Palutis. Wiseman will serve out the remaining term (one year) of Don Kupper who was elected President-Elect.

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