TABLE OF CONTENTS FEATURES Welcome new Board of Directors |4| Legislative Session Summary |7| 340B Third Party Administrator Data Breach of 1.6 Million Patients – Would You Be Prepared? |41|
On the Cover Mission Statement: To advocate and advance the pharmacy profession to improve the health of Kentuckians.
Editorial Office: ©Copyright 2021 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.
President Joel Thornbury and family at the KPhA Annual Meeting & Convention (look for more photos from the Annual Meeting n the July/August issue)
IN EVERY ISSUE President’s Perspective |3| My Rx |5| May/June CE Article |15| May/June CE Quiz |29| May/June CE Answer Sheet |30| Pharmacy Law Update |32| New KPhA Members |34| Pharmacy Policy Issues |35| Campus Corner |37|
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PRESIDENT’S PERSPECTIVE
ary of 2020.
My unwavering love for not only this organization but our profession has only been fortified and added to substantially during this term as President. The Kentucky Pharmacist Association continues to push and protect the envelope for every pharmacist in Kentucky. Over the last 18 months, if you're a practicing pharmacist in the state of Kentucky and you do not belong to this Association then I'm not For the second time quite sure you really grasp how unfortunate you I have been granted are if you fail to take advantage of the Kentucky a gracious gift to Pharmacists’ Association. There is so much that represent you as goes on within the profession and within society surrounding the practice of pharmacy on a moPresident. With 15 mentary basis that simply taking a day, week, or years between opmonth snapshot during any given time is worth portunities, this the value of the membership. No, you do not get a time has been even shirt or a sticker, but what you do get is to be part sweeter than the of an organization that helps you to help yourself first. I will be forever nurture the profession at which you fought to earn gracious to The As- and develop during college. Becoming a pharmacist is not a job! Becoming a pharmacist is becomsociation and YOU ing a professional! for allowing me this opportunity. I have given this I grew up surrounded by extraordinarily strong my all and will leave this knowing that everything goal oriented and generally decisive individuals. I was left on the playing field. THANK YOU from the continue to be thankfully to the guidance of my bottom of my heart! siblings, my colleagues, and specifically my mother and father (May they Rest in Peace). I speak often Where has the time gone? It just seems like yesterof them because they are the ones that I must conday when we were starting the year 2020 and I was sider and directly answer to when making decigetting news of a possible worldwide pandemic. I sions. They are the ones that give you an underwas in the middle of my preparatory year as presistanding of who I am. I was always shown to give dent elect of this grand Association and faced with back to your community and your profession. Bea once in a lifetime occurrence. Trying to increase coming a pharmacist was the right choice for me membership, The Organization itself, and the life of because it directly connects me with the masses pharmacist in pharmacy were all issues on the forethat I try to care and nurture for daily. No one perfront when the beginning of 2020 started. From son can say their life is typically one, two, or maybe that moment until today everything seems a blur. even three simple emotions. Daily, I have quesThe newscast that a new virus strain was sweeping tions, anxieties, determination, happiness, tears, across China causing havoc only culminated with etc. what I warily theorized would happen. The rapid and widespread infiltration of the world by COVID- As I look back and try to place a synopsis on this 19. Within weeks, we were shutting things down year as your president, I feel confident the 2020/21 and dealing with a worldwide pandemic because year could be called the Year of the Pharmacist. No of the unknown complexity of this virus. At the be- time at any other in my professional career have ginning of 2020, the Association brought together we had this much focus, success, and optimism a collaboration of all the statewide organizations’ surrounding our practice/profession. Many brain trust to create a couple of items that would things are moving in rapid motion to not only supbe pushed out to membership to help educate port but confirm our status as providers! We have around and how to handle the reality of COVID-19. pharmacists working in areas that were not Battles were being fought on many fronts at this thought of 20 years ago. Providing care and serpoint but in my mind the honor, protection, and vices outside the basic medication dispensing. All education of the Association and its’ members rein all, being reimbursed and recognized as a true mained pure. We fought to maintain our Mission provider of service. We are not simply putting pills statement to advocate and advance the profession in a bottle as most misrepresent us as doing. Your to improve the health of Kentuckians. I am proud brain is your brawn, and more and more we are beto say that we all have come a long way since Janu- ing properly engaged and reimbursed for this |3| www.KPHANET.org
heavy lifting. Forces outside of our profession are finally seeing the path of care we have always known we are qualified to provide and accompanying us on it. This increased value from pharmacists and technicians within the practice of pharmacy will only return a tremendous bounty to patient care and public health. To see these forces and our actions, not only a professional on the inside but as the Association's President, has been rewarding and inspiring. I have never bought in to the fact or reports that we are in a pharmacist abundancy. If we are to fulfill our oaths and strive for optimal quality patient care within the modern healthcare scheme, then more pharmacists are needed. Pharmacists have to get out from behind the counter and bring our assistants and technicians along as qualified support to make these things happen. We can no longer do everything ourselves! I would be ultimately remiss if I did not take a moment and thank a few people: Ben Mudd, Sam Willet, Lisa Atha, Angela Gibson, Sarah Franklin, Kristen Blankenbecler, Jody Jaggers, and Michelle Pinkston! These individuals do more for every pharmacist, technician, and pharmacy in Kentucky than anyone will ever see. They deserve our utmost appreciation. I need to thank my committee chairs who pushed through some great issues and managed some wonderful debates this year for the betterment of the profession. Their work is only beginning for there are influences and pressures facing The Association and Profession daily. The paths appear long, but they have worked hard to help get us information along it to make improved decisions, as well as lead the membership’s voices from within. These Chairs and Co-Chairs are the ones that provide our member a voice. KPhA is a membership organization structured to maximize as many members willing to participate actively as possible. The KPhA Board needs and starves for the input from our committees. Because pharmacy is so much like a family, these people do so much more to cover everyone. Thank you all for your devotion to the Association, its members, all the other potential members, and myself. Your actions do not go unnoticed! I must thank my staff at NOVA Pharmacy in Pikeville along with several students who luckily precepted with me during this term. They are owed a tremendous debt by me for the success this year. These ladies and gentlemen are the best and are real heroes! Finally, I cannot go any further without thanking my loving wife, Sandy, and my girls, Phoebe and Jade! They have to deal with me every day, whether it was a good day or a bad day. They get my crazy ideas, rough drafts for my articles and papers, and eternal LOVE! I give to our Profession and |4| Kentucky Pharmacists Association | May/June 2021
to you all only because they allow me and fully support me in these endeavors. They all helped during a tough few months last fall when my father passed. However, life must continue to move forward and push on. Again, I love my family and I hope it shows! As I come to the end, I admit my heart is full! I love you all and am extremely proud of the way everyone has stepped up over the past year! We have more great days ahead and I am excited to step into the next exciting role to continue supporting President Hanna and The Association! May God bless The Kentucky Pharmacists’ Association, you, your family, and our Profession. GO FUN!!! GO RUN!!! GO I’M OUT!!!
KPhA Welcomes the 2021-2022 Board of Directors Joel Thornbury, Chair Cathy Hanna, President Misty Stutz, President-Elect Brooke Hudspeth, Secretary Chris Killmeier, Treasurer Nathan Hughes, Speaker of the House Kyle Bryan, Vice-Speaker of the House Ron Poole, Past-President Representative Ronnah Alexander, Director Emma Sapp, Director Kyle Harris, Director Steve Hart, Director Lakin Mills, Director Cassy Hobbs, Director Jeff Mills, Director Cory Smith, Director Taylor Williams, UK College of Pharmacy Student Representative Rodrick Millner, SUCOPHS Student Representative
jobs.kphanet.org THE location for pharmacy job seekers + employers for targeted positions.
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Legislative session summary 2020
macists to be sued by whistleblowers for Medicaid fraud. The measure had the potential to dramatically increase liability costs for pharmacists and pharmacies and we worked to make sure it did not advance this session.
Oftentimes KPhA’s government affairs team achieve success, by opposing certain bills. This session was no different, as KPhA worked to stop a bill that would have expanded opportunities for phar-
the Pharmacy Benefit Managers (PBMs), but after passing the House Health & Welfare Committee, HB 532 failed to receive a vote on the House floor and was referred back to the House Appropriations
The following narrative summary is arranged alphabetically by issue area and highlights some of the key issues affecting KPhA and its members that were debated during the 2021 Session. The The 2021 session of the General Assembly forced lobbyists and advocacy organizations to rethink the electronic version of our 2021 Session Summary includes links to the legislature’s website so you can work of government affairs. Visitors to the legislaeasily access additional information on specific tive annex were limited to either schedule private bills, including the full text of the legislation as it meetings or committee testimony. It left advowas introduced along with changes made or procates, including pharmacists, forced to write letters, call, text, or email legislators to have their voic- posed as it moved through the process. es heard; with the rare exception of an in-person All legislation with an emergency clause took effect meeting. At the outset of the session many specu- upon the governor’s signature and those statutory lated that the focus would be on passing a onechanges without an emergency clause takes effect year budget and curtailing Gov. Beshear’s emerJune 29, 2021. Please note some bills take effect on gency executive power; with the understanding dates specified in the legislation. that in a short session, there may not be time to address many other issues. As the session wore on Reimbursement for Pharmacist Services: Rep. Bentley filed HB 48 and as introduced the bill would reit became increasingly clear that the scope of the session would not be limited to these topics. While quire health insurers to reimburse pharmacists for healthcare services within their scope of practice a budget was passed and the governor’s power and establish a clean claims process for pharmawas restricted, the General Assembly addressed numerous issues by filing 880 bills and resolutions cists to utilize. Pharmacists would be reimbursed at the non-physician rate, and it is important to note in both chambers. The KPhA government affairs that nothing in the legislation expands the scope of team identified several measures that would dipractice of a pharmacist. Pharmacist advocates rectly impact pharmacists and pharmacies. and Bentley worked together to get more than 50 Even with all the challenges facing constituents cosponsors on the legislation—signaling that the and lobbyists alike, KPhA was successful in passing bill could easily pass the House if it was called to legislation to require commercial health insurers to the floor. It was this effort that pushed the bill reimburse pharmacists for healthcare services in across the finish line and ensured that the measure their scope of practice, if they provide reimbursepassed. After unanimously passing the House ment for other healthcare providers for the service. Banking & Insurance Committee, HB 48 unaniPharmacists will be reimbursed at the nonmously passed the House. It moved to the Senate physician reimbursement rate. It is a huge step for- where it was heard in the Senate Health & Welfare ward for pharmacists. Committee. There was some griping from physicians concerned about the bill leading to scope of In addition to passing legislation to reimburse practice expansion, but there were also physicians pharmacists for healthcare services, comprehenasking the committee to hear HB 48 because it sive pharmacy benefit manager reform moved a would increase opportunities for pharmacists and few steps forward. Legislation was passed by the physicians to work together and improve patient House Health & Family Services Committee that outcomes. The bill unanimously passed the comwould prohibit PBMs from reducing reimbursemittee and the Senate and was signed by the govments, mandating the use of mail-order pharmacies, requiring patients to use pharmacies in which ernor. The bill goes into effect June 29, 2021. they have ownership, and many other provisions regulating PBMs. The bill passed the committee Comprehensive Pharmacy Benefit Manager Reform: but it did not get called for a vote before the full Legislation introduced by Rep. Steve Sheldon (RHouse. It is expected that the legislation will return Bowling Green) would have made comprehensive next year. changes by prohibiting the negative practices of
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& Revenue Committee. Sheldon had secured 28 cosponsors on the legislation, but the bill was opposed by health insurers and PBMs who argue that they control prescription drug prices and keep costs to patients low. The bill would have made significant changes to the PBM industry requiring more accountability, transparency and prohibitions on the practices that negatively impact community pharmacies. The bill would have applied to commercial health insurance plans. The comprehensive changes would have included prohibiting PBMs from requiring pharmacies to receive accreditations beyond that which is required by the Board of Pharmacy. It would have also prohibited any retroactive reduction in reimbursements of any kind except the actual overpayment of a claim, including prohibitions on effective rates, clawbacks, and preor post-adjudication fees. It would have also prohibited PBMs from reimbursing pharmacies in which they have an affiliation higher rates than they reimburse other contracted pharmacies. Another provision would have prohibited a PBM from requiring a patient to use a pharmacy with which they have an affiliation, and it would have prohibited the practice of mandating patients use a mail order pharmacy and from incentivizing patients to use pharmacies in which they have an ownership in. The PBMs would be required to disclose the health insurer rebates received from pharmaceutical companies and the amount of reimbursement actually paid to the pharmacies. Finally, PBMs would be prohibited from using patient data it obtains through its PBM for the purpose of marketing pharmacies services in which they have ownership.
macies argued that without making this permanent, 1,000s of Kentucky jobs would be lost because they would relocate to other states where remote work is legal.
Syringes and Remote Order Entry: House Bill 219, also sponsored by Rep. Bentley, started as legislation that would remove the logbook requirement for retailers selling syringes without a prescription. It would also require pharmacies selling syringes without a prescription to provide written or electronic information about substance use disorder and a prescription for Naloxone, but there would be no limit on the number of syringes that could be sold to a person when they don’t have a prescription. Pharmacies selling syringes would not be subject to the drug paraphernalia laws.
Insulin co-pay cap: The cost of insulin has been greatly discussed during the last two legislative sessions, and a measure that would cap the cost of a 30-day supply of insulin to $35 passed the General Assembly and was signed by the governor. House Bill 95 will take effect Jan. 1, 2022. Pharmacist and legislator Rep. Danny Bentley (R-Russell) was the sponsor of the bill. Two other measures did not pass this session that would have impacted the copay cost of a monthly supply of insulin as well. Senate Bill 110 would have created an emergency insulin program funded by insulin manufacturers and cap the cost of insulin to $35 for a monthly supply. Additionally, HB 123 would have eliminated co-pay requirement for insulin all together. Neither of these measures were heard in committee.
In the House Health & Family Services Committee, an amendment was added that would allow for closed-door pharmacies – those those not open for walk-in patients at retail – to have pharmacy personnel work remotely for the purpose of order data entry and verification. The Kentucky Board of Pharmacy during the COVID-19 pandemic allowed pharmacy personnel to work remotely to ensure social distancing and to protect vulnerable personnel. Some large mail-order and patient assistance phar|8| Kentucky Pharmacists Association | May/June 2021
The committee adopted language that would allow closed door pharmacies located and permitted in Kentucky to allow licensed pharmacists, registered technicians and pharmacy interns to work remotely for the purpose of remotely entering orders and conducting drug regimen reviews. The legislation clearly states that no prescription could be dispensed remotely. The Kentucky Board of Pharmacy raised concerns in the committee meeting about the bill adding remote order entry, and Rep. Sheldon stated that he would work with them to address their concerns. As a result, a floor amendment was filed to make changes requested by the Kentucky Board of Pharmacy. The personnel could be located anywhere in Kentucky or within 100 miles of the pharmacy. No paper prescriptions could be handled outside of the permitted pharmacy. The bill passed the Senate and Beshear has signed the measure, meaning it will take effect June 29, 2021.
Co-prescribing of Naloxone: Two bills filed – HB 94 HB 94 and SB 277 – would would have required that when a healthcare practitioner prescribes an opioid that they must simultaneously prescribe Naloxone and provide education to the patient on opioid overdose and the appropriate use of Naloxone. Neither bill advanced in their respective chambers, and died in the Committee on Committees.
Emergency Insulin Program: Two bills introduced this session, one by a Republican Senator and one by a Democratic House member, would have created an emergency insulin program for those without health insurance coverage or those on Medicare who have spent $1,000. An eligible patient would
take the prescription to a pharmacy along with evidence that they are a candidate for the program and the pharmacist would fill the prescription. The pharmacist could then submit a claim to the drug manufacturer for reimbursement that would be capped at the acquisition cost. Emergency insulin program legislation was advancing in the 2020 session and it was funded through a wholesale tax on prescription drugs, which appears to require the manufacturer to reimburse a pharmacist for the acquisition cost. One bill, HB 122 would have required the Board of Pharmacy to implement the program; in contrast, SB 110 requires the Cabinet for Health and Family Services to implement the program. Unlike the 2020 session, there was no movement on an emergency insulin program bill.
Telehealth: House Bill 140, sponsored by Rep. Deanne Frazier (R-Richmond), makes permanent some of the telehealth measures put in place during the declared emergency related to COVID-19 that allowed patients to access healthcare services through telehealth. Healthcare providers would be reimbursed according to in-person reimbursement rates for an array of healthcare visits. The bill passed both chambers, even with some opposition from health insurers, and was signed by the governor.
Payment of Health Insurance Costs: Some nonprofits provide financial assistance to patients to ensure continuation of health insurance coverage allowing patients to afford to receive medical care by allowing non-profits or state and federal governReady Recovery Communities: House Bill 7, sponment to pay for services on behalf of the insured. sored by Rep. Adam Bowling (R-Middlesboro), Health insurers argued that providers were using would establish a Ready Recovery Community cer- this as an inducement to get care from a specific tification program. The program would be manprovider, but the advocates of the measure said it aged by the Advisory Council on Ready Recovery was not true and some health insurers had stopped Communities, which would be responsible for esallowing these non-profit organizations to pay pretablishing quality metrics for determining commu- miums on their behalf, leaving some without nities with high-quality recovery programs; and of- health insurance coverage. Sen. Alvarado successfering communities resources for managing the fully passed SB 44 and it was signed by Gov. drug addiction crisis. A pharmacist will serve on the Beshear and allows non-profits and other specified advisory council. The bill moved quickly through entities the ability to pay on behalf of the insured both chambers and was signed by the governor health insurance premiums, co-pay, or coand will take effect June 29. insurance. Incentivized Lower-Cost Healthcare Services: Sponsored by Senate Health & Welfare Committee Chair Ralph Alvarado (R-Winchester), SB 119 would require health insurers to develop an incentive program for patients willing to seek non-emergency care from a healthcare provider willing to receive lower reimbursements than other providers. The bill was referred to the Senate Banking & Insurance Committee, but never received a hearing.
Prescription drug coupons: Senate Bill 45 and its House companion bill, HB 114, would require commercial health insurers to accept prescription drug co-pay assistance cards to count towards deductibles, co-insurance, co-pays and out-of-pocket costs. Some health insurers implemented policies that prohibited co-pay assistance from pharmaceutical manufacturers or non-profits from counting towards a patient’s deductible. Many of these medications are high-cost prescription drugs and the Balance Billing: Sometimes referred to as surprise patient cannot afford them without the help. Senbilling or out-of-network billing, the concept is ate Bill 45 would only apply to commercial plans where a patient goes to a non-participating provid- and if there was not a generic equivalent drug on er to receive care and then gets a ‘surprise bill’ the market available. It passed the Senate and the when the non-participating provider bills for the House and was signed by the governor. It will take usual and customary charge for the service. It has effect Jan. 1, 2022. been a topic of discussion in the Commonwealth and across the country. Sen. Alvarado has led the Prior authorizations – Substance Use Disorder: Medicharge on the issue and was expected to push the cation-assisted treatment for substance use disormeasure in the 2021 session, but the federal govder has been touted as a vital outpatient healthcare ernment passed legislation addressing the issue option for those suffering from substance use disand Alvarado agreed to wait and see the progress order. Some health insurance plans require prior and implementation of the federal bill. Senate Bill authorization, utilization reviews or step-therapy 19 was referred to the Senate Banking & Insurance before a patient can receive coverage for medicaCommittee, but it did not receive a committee tion-assisted treatment therapies. To address this, hearing. SB 51 and HB 102 were introduced, but it was SB 51 that made it through to the end. The bill would pro|9| www.KPHANET.org
hibit health insurers, including Medicaid managed care organizations, from requiring prior authorizations for medication-assisted treatment services. Advocates argued that the utilization review requirements delayed care that forced patients back to using. The bill delays the effective date of the legislation until Jan. 1, 2022.
tions, to include conscientious objections. Wilson amended the legislation to narrow the new exemption of “conscientious objection” to only those vaccines that may be required because of a declared emergency. The House did pass the legislation and the governor let it become law without his signature.
Mandated Health Insurance Benefits: There were many health insurance mandates filed that did not advance. This includes health insurance benefit mandates – coverage of preexisting conditions and other Affordable Care Act mandates (HB 11), requirements that health insurers cover the cost of mailing or delivering prescriptions (HB 117), alternative treatments of chronic pain (HB 119), birth control (HB 201), breast feeding equipment (HB 296), and prosthetics and orthotics (HB 530). All of these bills were sponsored by one or more members of the Democratic minority, making them even less likely to move.
Other bills introduced would have much more significant changes. House Bill 101 would have prohibited any private or public university from requiring a student get vaccinated as a condition of attending schools. In the Senate, SB 37 would have prohibited any state agency, local government or employer from mandating any vaccinations. And, SB 98 would have prohibited employers from discriminating against any employee refusing a vaccination and prohibited employers from requiring them, but none of these measures passed this session.
Medicaid Co-Pays: Sen. Stephen Meredith (RLeitchfield) has lamented the statutory provision that allows the Department for Medicaid Services to implement copays for prescription drugs and other healthcare services. Former Gov. Matt Bevin expanded the use of copays in Medicaid and navigating copays in Medicaid managed care quickly become cumbersome due to federal requirements surrounding the issue, where a patient at or below the federal poverty level could not pay a certain percentage of their income out-of-pocket in a quarter. The bureaucratic nightmare of administering the copays led to healthcare practitioners comCannabidiol Labeling: House Agriculture Commitplaining that it wasn’t worth it. Meredith filed the tee Chair Rep. Richard Heath, (R-Mayfield) success- bill for two years during the Bevin administration fully passed House Bill 325, which was signed by and when the Beshear administration came in they the governor in late March. Any CBD product sold decided to eliminate all copays, but the price tag in Kentucky will now require product labeling that appeared to be too great. In the 2021 legislative will allow the consumer to access the certificate of session, even though DMS had eliminated Medianalysis from an accredited laboratory attesting to caid copays, SB 55 finally passed meaning that no the product composition. The label could use a bar future DMS administration could use the permiscode, QR code or website on the label to provide sive statute to establish copays. The governor the full certificate of analysis. No product label signed the bill, and it takes effect on June 29, 2021. would be allowed to state any claims that a product can diagnose, treat, cure or prevent any disMedical Marijuana: Rep. Jason Nemes (R-Louisville) ease. once again pushed legislation that would legalize marijuana for medical use. But unlike the 2020 legVaccinations: Senate Bill 8, sponsored by Sen. Mike islative session where there was a lot of discussion Wilson (R-Bowling Green), was the only legislation regarding medical marijuana; the bill did not even that passed addressing vaccinations, particularly get a hearing this session. As introduced this year, those developed in response to a declared public HB 136 would make non-combustible medical mahealth emergency, even though there were several rijuana legal for patients with a valid identification measures introduced that would have made dras- card showing they have a legitimate recommendatic changes to Kentucky’s mandatory vaccination tion from a healthcare provider. A patient would be laws. Senate Bill 8, as adopted, expands the rearequired to consult with a pharmacist on the initial sons for citizens to object to any mandatory vacvisit to go over potential harmful medical interaccination requirements, including school vaccinations. A pharmacist could enter into a collaborative Bridge Insurance Task Force: Sponsored by House Speaker Pro Tem David Meade (R-Stanford), HJR 57 requires the Cabinet for Health & Family Services to create a task force to study the feasibility of implementing a bridge insurance program through the Medicaid managed care organizations as allowed in the Affordable Care Act, to cover those not eligible for Medicaid but unable to afford health insurance on the private market. The Federation will have a seat on the Task Force, which starts meeting in July and will conclude in December of 2021.
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agreement with a dispensary, who furnishes the final product. Senate Bill 92, filed once again by Sen. Steve West (R-Paris), would legalize medical marijuana and it would allow for the smoking of marijuana. The bill doesn’t require consultation with a pharmacist prior to the product being furnished to the patient. It suffered the same fate as HB 136.
creating a committee to review scope of practices of healthcare providers and their prescribing practices. Ultimately the bill did not pass as it was never called for a floor vote.
American-made PPE: After healthcare providers were scrambling in the early days of the COVID-19 pandemic to find enough of the right personal protective equipment (PPE), House Bill 214 would have Inhalers in Schools: Senate Bill 127, sponsored by required state agencies to purchase PPE made in Senate Education Chair Max Wise (Rthe United State of America. The exception would Campbellsville) and as enacted, will allow schools to be if no American company made the specific PPE keep bronchodilator rescue inhalers on school or no PPE could be purchased at that time. Origigrounds for use when a child may be in duress due nally, the legislation would have required all to an asthmatic attack. The school would also be healthcare companies to purchase American-made eligible to receive a prescription in the name of the PPE as well, but it was changed to limit it to only school, and a pharmacist would be allowed to disstate agencies, not including state universities, buypense a prescription to the school. This is similar to ing PPE. It specifically does not apply to licensed the current law allowing Epi-pens to be prescribed health care providers in Kentucky, including state and dispensed in the name of the school, which and university-affiliated hospitals. The bill passed passed several years ago. The bill will take effect out of the House Economic Development CommitJune 29, 2021. tee. Sponsor Rep. Matthew Koch (R-Paris) said his hope is that the legislation would encourage companies to get up and running, hopefully in KenMedicaid Pharmacy Reimbursement: Rep. Sheldon tucky, to produce the PPE and agencies would not filed HB 177 that would require the Medicaid Dehave to scramble to find it the next time there is a partment to implement all provisions of SB 50 (RS demand for it. The bill died awaiting action in the 2020) starting Jan. 1, 2021. If reimbursements are Senate Economic Development Committee. established after this date, pharmacies would need to be retroactively reimbursed for all claims back to Jan. 1. The legislation is meant to correct the delay Medicaid Prescription Claims Monitoring: Rep. Shelin implementation of SB 50 that required the imdon sponsored HB 222 that would have required plementation of a state single PBM for the Medithe Department for Medicaid Services to contract caid managed care organizations. Medicaid has yet with an entity that monitors all Medicaid pharmacy to implement the required reimbursement methreimbursements to ensure that they are reimodology for pharmacies. The bill passed the House bursed properly. It also establishes selection criteria Health & Family Services Committee, but it failed to for the contractor providing the prescription claim get a vote by the full House. reimbursement monitoring. The bill was amended in the House Health & Family Services Committee to sunset the requirement for such a contract after Scope of Practice APRNS: Advanced Practice Regis- two years and the contracted entity would be paid tered Nurses (APRN) continue to push for legisla30% of what they recover. The bill passed the House tion that would allow any APRN with three years or easily, but hit snags in the Senate when some more experience dispensing opioid medications, raised concerns that the legislation was too narrowunder a collaborative practice agreement for conly focused on one contractor and would need to be trolled substances with a physician, to continue to amended. The bill will be discussed in the interim in be able to prescribe opioids without operating unpreparation for the 2022 legislative session. der a collaborative practice agreement. Senate Bill 78, sponsored by Sen. Majority Caucus Chair Julie Raque Adams (R-Louisville) filed the bill this sesGender Identity Treatment: Under a proposed sion. Physicians adamantly oppose these changes measure that did not advance, healthcare providarguing that opioid prescribing needs to be more ers, including pharmacists, would have been procontrolled. Senate Bill 78 passed the Senate Licens- hibited from providing healthcare to minors wishing & Occupations Committee but Sen. and physiing to express a different gender that the one ascian Ralph Alvarado (R-Winchester) filed several signed at birth (HB336). It would also allow parents floor amendments including enhancing collabora- to refuse to provide consent for a child wishing to tive requirements for controlled substances and engage in therapy or treatments for gender reas|11| www.KPHANET.org
signment surgery. Finally, any employer would be prohibited from discriminating against an employee who expresses a negative opinion of transgender persons. The bill died in the Committee on Committees meetings, but other states have passed similar measures, so it is likely the legislation will return next session. Medicaid False Claims Act: House Bill 553, sponsored by House Judiciary Chair Ed Massey (RHebron), would have expanded the Federal False Claims Act to state courts. Currently, whistleblowers filing claims of Medicaid fraud in federal court can receive a percentage of the fraud the federal government recovers as a part of prosecuting the case. Attorney General Daniel Cameron’s office asked the General Assembly to add whistleblowers incentives to fraud claims filed in state court as well. Opponents of the legislation, including healthcare providers organizations, argue that the legislation is unnecessary and redundant since there is a Federal False Claims Act. Cameron’s office argued that the passage of such legislation would allow the state to keep a higher percentage of money recovered in fraud cases if it adopted legislation that allowed these cases to go through state courts as well.
directive in an emergency. Hospital emergency rooms would be allowed to exercise judgement in emergency situations. If a pharmacist receives a prescription for an opioid for a patient with a directive on file, the pharmacist is to presume that the prescription is valid and should fill the prescription. The bill was filed late in the session, so it did not advance to any committee for a hearing. Vaccine Distribution: House Bill 590, sponsored by Rep. Josh Bray (R-Mt. Vernon), would have required any pharmacy, hospital, medical clinic or other healthcare provider to be treated as a vaccine site and required to receive vaccines, including COVID19 vaccines, to administer to patients, so long as they met certain criteria including being enrolled as a qualified provider with the U.S. Center for Disease Control, have the appropriate storage for the vaccine, and the ability to report vaccinations to the Kentucky Immunization Registry. The bill was introduced very late in the legislative session and it died in the House Committee on Committees.
Severe Mental Illness Task Force: A resolution was introduced that would have established a Severe Mental Health Task Force to study the physical and mental healthcare challenges those with severe The bill passed out of the House Judiciary Commitmental illness face (HCR 7). As proposed, the bill tee with the exact number of ‘yes’ votes required to would include a psychiatric pharmacist nominated move legislation. Massey said that he would work by the Kentucky Pharmacists Association on the with healthcare provider groups concerned about task force. It passed the House, but it never adthe legislation, especially since so many committee vanced in the Senate. members expressed concerns about increased tort actions against healthcare providers. Pharmacists raised concerns about the timing of this legislation Infants Born Alive: Senate Bill 9, sponsored by Sen. during the COVID-19 pandemic when pharmacists Whitney Westerfield (R-Crofton), did become law are billing COVID testing under Medicaid DME and after it passed the General Assembly and the govermany other practices of pharmacy rules have been nor let the bill become law without his signature. relaxed. The bill did advance to the House Floor, The bill requires any healthcare provider, including where an amendment was adopted that removed a pharmacist, in the presence of an infant born alive the Medicaid False Claims Act and only made to provide medical care and nourishment to keep changes relating to unemployment fraud a Class D them alive. The bill allows parents of infants where Felony. It passed the House, but the Senate never care is not provided to sue healthcare providers for took up HB 553. compensatory and punitive damages. The bill contains an emergency clause, so it is in effect now. Voluntary Non-opioid Directive: Legislators continue to have concerns about high opioid overdose rates in Kentucky, and HB 584, sponsored by House Health & Welfare Chair Kim Moser (R-Taylor Mill), would allow a patient to sign a voluntary nonopioid directive that would be on file in the KASPER. The form would be developed by the Cabinet for Health and Family Services, and the healthcare provider would need to verify whether or not there was such a directive on file and the patient would select individuals who could revoke the |12| Kentucky Pharmacists Association | May/June 2021
Medicaid Managed Care Contracts: Sen. Stephen Meredith (R-Leitchfield) once again filed legislation that would limit the number of Medicaid managed contracts that could be issued by the Kentucky Department of Medicaid to no more than three (SB 56). Currently there are six Medicaid managed care organizations providing healthcare coverage to Medicaid recipients. Senate Bill 56 passed the Senate and was referred to the House Health & Family
Services Committee, but it was never called for a hearing. Meredith believes that if the state had fewer Medicaid managed care contractors, the state would be better able to manage the MCOs. If it had passed, the bill contained an emergency clause and would have taken effect immediately. This would have further complicated the tangled web of Medicaid managed care contracts since recently Franklin Circuit Court Judge Philip Shepherd ruled that the state must rebid the Medicaid managed care contracts that were issued in January of 2020. Medical Conscience: Legislation filed in the Senate and passed in the Senate Judiciary Committee would allow a healthcare provider to refuse to provide a medical treatment, including dispensing a prescription drug, if the healthcare services would violate their conscience. The employer would be prohibited from discriminating against an employee for making decisions based on conscience or moral or ethical beliefs. Senate Judiciary Chair Whitney Westerfield (R-Crofton)filed floor amendments to SB 83 that would have given any healthcare facility where a person made this decision immunity from being sued. Originally, the bill allowed for a healthcare provider to refuse to provide healthcare on the initial visit, but since this was considered discriminatory it was removed. It would still allow healthcare practitioners to refuse to provide a referral for any healthcare service they have a medical objection with. The ethical objection would have to be in relation to a specific medical service and could not be related to the patient. The legislation did not pass the Senate, as several healthcare provider groups and others raised concerns about the legislation. Limited Legal Liability Protections: Senate Bill 5, as it passed the Senate, provided legal liability protections for businesses and healthcare providers operating during the declared emergency and for one year after the declaration ends. The legislation does this in two ways – first, it would create a gross negligence standard for premise liability and secondly, it would extend governmental immunity to essential service providers that would include pharmacies and pharmacists. This would protect pharmacies and pharmacists from frivolous lawsuits, especially while they were operating under legal flexibilities. The House Judiciary Committee passed an amended version of SB 5 that would limit the premise liability to only protect businesses in claims where a plaintiff argues they contracted COVID-19 from the premise. Additionally, the immunity and premise liability protections would only last until the declared emergency ends. The legislation passed out
of the House Judiciary Committee, but it passed with the bare minimum votes. The measure did not receive a vote before the full House and a floor amendment was filed that would further weaken the bill. Rep. Kim Banta (R-Ft. Mitchell) filed the amendment, and it would have changed the standard to ordinary negligence and only what a reasonable, prudent person would do. The amendment if adopted would render the legislation useless. House Judiciary Chair Ed Massey filed a floor amendment on the last day that expanded the legal liability protections for non-essential employers, and this is the measure that passed the House. The Senate concurred in the legislation stating that the House only made ‘technical or stylistic’ changes to the bill. Finally, Gov. Beshear let the measure become law without the governor’s signature. House Bill 10 would have provided employers with a defense of rebuttable presumption for businesses operating during COVID-19, and it passed the House early in the session, but the Senate never took up the measure. Legal liability reform advocates continue to push for a constitutional amendment that would allow the General Assembly to limit noneconomic or punitive damages in lawsuits. Given that any attempts of limiting legal liability would be challenged in the courts and continually the courts reaffirm a right to access the courts, the only way to have meaningful reform is through a constitutional amendment. That is why Senate Bill 17 was introduced. It was referred to the Senate State & Local Government Committee, but it never received a hearing.
Kentucky Professionals Recovery Network (KYPRN) is a free-standing organization that provides confidential monitoring of licensed professionals struggling with the disease of addiction.
www.kyprn.com |13| www.KPHANET.org
|14| Kentucky Pharmacists Association | May/June 2021
May/june CPE Article Pharmacists’ Contributions to the U.S. Legal System: The Role of the Pharmacist as an Expert Witness Authors: 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 declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Goal: To educate pharmacists and pharmacy technicians about the role of an expert witness in U.S. court processes and discuss some situations where pharmacists have served in such roles to assist those assigned to decide a case. Universal Activity #0143-0000-21-005-H03-P & T Contact Hour 2.5 Expires:6/29/2024
KPERF offers all CE articles to members online at www.kphanet.org
Learning Objectives: At the conclusion of this knowledge-based article, the reader should be able to: 1]
Describe several ways an expert witness can contribute to legal proceedings such as a trial;
2]
Differentiate the roles of a fact witness and an expert witness;
3] Identify who makes the decision whether a proposed expert witness is qualified to participate in the trial in that role; and 4] Identify the expectation in the APhA Code of Ethics for Pharmacists that Pharmacists support the legal system through such a role. Introduction An expert witness is a witness, who by virtue of education, training, knowledge, profession, or experience, is believed to have special knowledge of some subject beyond that of the average person, sufficiently so that others may officially and legally rely upon his or her informed opinion. Expert witnesses have increasingly been used in court cases and other proceedings to assist the jury or the judge with insights to help appropriately decide the matter. Expert witnesses are given special latitude in court proceedings because of their expertise – they are permitted to state their opinion concerning technical aspects of the situation under consideration even though they were not present at the event. Being designated an expert witness entitles the individual to testify about his or her opinion on the meaning of the facts. Several television shows such as “Law and Order” and its progeny, “CSI: Crime Scene Investigation” and its spin-offs, or “NCIS” about the Naval Criminal Investigative Service, have served to heighten the awareness of the public about the role of experts, their technical abilities, and their information during trials. An expert witness has several potential ways to contribute to a fact-finding effort such as a trial. During |15| www.KPHANET.org
pre-trial evaluation the expert sometimes may
the other side as “work papers.” As a result, veteran
more properly be designated a consultant, perhaps experts tend to avoid doing research that could limiting involvement to case evaluation or assess-
lead to an incorrect answer, lest this information
ment and contributing to the attorney’s decision
fall into the wrong hands.1
whether to accept the case. As long as the work is done in the role of consultant it will not be subject to the pre-trial process of discovery whereby one party has a variety of means to attempt to learn about the other side’s case and how strong it is. This protection from discovery, also known as privilege, is similar to the attorney’s work product being protected by attorney-client privilege. At this stage the expert may want to be careful about putting preliminary opinions, impressions, or thoughts in writing. Doing so can make those items subject to
Fact Witnesses versus Expert Witnesses “Fact witnesses” testify regarding facts that are within their knowledge. Typically, such a witness observed something directly or participated in the transaction about which he or she will testify. On the other hand, expert witnesses are permitted to testify regarding their opinions, their testimony not being limited only to facts directly observed, and they may even be permitted to respond to hypothetical situations posed in questioning by one of the attorneys.
discovery later should the consultant become an expert witness expected to testify during the proceeding.
The question of whether an individual has the appropriate background to be considered an expert witness is a question of law for the judge to decide.
If the consultant is classified as a potential expert witness the prior work will become subject to discovery. If the expert will testify in court, the information will no longer be protected from discovery. The identity of the expert witness, along with nearly all documents used to prepare the testimony, will be considered subject to discovery. It has been pointed out that: All of an expert’s research in a case is subject to “discovery”, even equations scribbled on a napkin in preparation for testimony must be offered up to |16| Kentucky Pharmacists Association | May/June 2021
In typical court cases, judges answer questions of law, e.g., is this evidence admissible under applicable legal rules, does this person’s background qualify him or her to be an expert witness, while the jury answers questions of fact, e.g., was an error made when the medication was dispensed, was the traffic light green or red when the car entered the intersection. Expert witness testimony is normally required in claims against health care professionals for alleged
negligence in the practice of their profession. This
credentials could qualify as an expert, leaving the
is so because the laymen serving on the jury do not admission of such testimony almost entirely to the have the qualifications for professional practice and what constitutes reasonable conduct for a professional person is not ordinarily within the knowledge of the usual juror individually or the jury collectively. However, an exception to the normal rule exists where the alleged misconduct is within the common knowledge of a layman.2 Consequently, pharmacists may be asked to serve as expert witnesses in cases involving the practice of pharmacy or use of medications. History
discretion of the trial judge. The Frye Case Rule The decision in the case of Frye v. United States during 1923 stands for the rule that a scientific principle or discovery must achieve sufficient general acceptance in the relevant field to warrant the admission of expert testimony based on the principle.5 As a result of this case an expert’s reputation and achievements in his or her specialty became central to the question of admissibility.1 This was sometimes referred to as the “general acceptance”
The earliest known use of an expert witness in An-
or “relevancy test.” This rule was in place for over
glo-American law came in 1782, when a court that
fifty years until 1975 when Congress and the U.S.
was hearing litigation relating to the silting-up of a
Supreme Court promulgated and adopted Federal
harbor. The judge accepted evidence from a lead-
Rule of Evidence (F.R.E.) 702 which provided a new
ing civil engineer, John Smeaton, widely regarded
standard for the admissibility of expert testimony.6
as the father of modern civil engineering. The court’s acceptance of Smeaton's evidence based on his expertise is widely regarded as the origin of modern court rules on expert evidence.3 The first U.S. Supreme Court ruling on the use of expert witnesses came during 1855 in the case of The Schooner Catharine v. Dickinson.4 The decision created a vague standard to be applied by judges when deciding the “reliability” criterion established in the case. Almost any witness with professional
The Daubert Case Rule In the case of Daubert v. Merrell Dow Pharmaceuticals, Inc., the highest federal court addressed an issue presented in a case brought by children born with severe birth defects allegedly caused by Bendectin®, a combination product used for “morning sickness” containing doxylamine succinate, dicyclomine, and pyridoxine.7 The plaintiffs presented expert testimony in eight affidavits about the alleged causal link between the medication and the
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deformities based on newly developed information from test-tube and live animal studies and statistical reevaluation of pre-existing data. Under the trial court’s approach, since human data were available, animal studies alone were not deemed sufficient. Moreover, the statistical reconsiderations of data published in journal articles were neither published nor subject to the peer review process, rendering their conclusions not acceptable according to the court. The federal trial court excluded this expert testimony, relying on the “general acceptance” standard outlined in the Frye case. On appeal this exclusion was upheld by the U.S. Court of Appeals for the Ninth Circuit in California, which focused on the fact that the experts based their conclusions on science not generally accepted within the epidemiological community. The U.S. Supreme Court took the opposite position, ruling that F.R.E. 702 superseded the “general acceptance” standard from the Frye decision. The
applied in federal trials.8 The approach outlined by the Supreme Court includes the trial court holding a preliminary hearing (sometimes referred to as a hearing in limine, meaning at the outset) to determine whether the individual proposed to be used as an expert witness by one of the parties and challenged by the other side in fact qualifies as an expert and will testify as to scientific knowledge that will assist the trier of fact to understand and determine a fact in issue.9 The Supreme Court decided that answering the question of whether the “scientific knowledge will assist the trier of fact” requires a two-pronged approach: 1. The processes and techniques underlying the expert analysis must be reliable, with these factors taken into account to assess reliability: A. Whether the theory or technique can be (and has been) tested;
Court pointed out that neither the actual wording of Rule 702 nor the Notes of the Advisory Committee on the Rules of Evidence incorporated the Frye test in their “permissive” approach to use of expert testimony: Frye made “general acceptance” the exclusive test for admitting expert scientific testimony. That austere standard, both absent from and incompatible with the Federal Rules of Evidence, should not be |18| Kentucky Pharmacists Association | May/June 2021
B. Whether the theory or technique has been subjected to peer review and publication; C. The known or potential rate of error; and General acceptance of the approach. 2. The evidence or testimony must assist the
trier of fact to understand the evidence
Court emphasized the difficulty of crafting a set of
or to determine a fact in issue., i.e., it
standards for admissibility of expert testimony ap-
must be relevant.
plicable to the myriad cases that come before
In sum, the expert testimony must satisfy the re-
courts:
quired level of reliability and must also pertain to
The conclusion, in our view, is that we can neither
the issue in question. It is noteworthy that the im-
rule out, nor rule in, for all cases and for all time
portance of these issues has led to creation of a
the applicability of the factors mentioned in Daub-
website devoted exclusively to issues arising under
ert, nor can we now do so for subsets of cases cate-
the Daubert decision www.daubertontheweb.com. gorized by category of expert or by kind of eviFine Tuning the Daubert Approach Four years later, in the case of General Electric Co. v. Joiner, the U.S. Supreme Court ruled that the decisions of a judge on admissibility of scientific evidence are subject to review on appeal and that the standard used for such reviews will be an abuse of discretion standard, i.e., did the judge abuse his or her discretion in admitting or rejecting the evi-
dence. Too much depends upon the particular circumstances of the particular case at issue.13 Thus, following this decision federal courts are not bound by the factors set forth in the Daubert decision and are not precluded from addressing other factors that more adequately address the reliability and relevance of the proposed testimony of the expert witness.
dence.10 This approach invests the trial court judge The Federal Courts with broad latitude to accept or reject such offered evidence.11
The U.S. has multiple court systems, with the federal system covering the entire country. Federal
In the 1999 case of Kumho Tire Co. v. Carmichael,
courts have jurisdiction over cases arising under
the Supreme Court extended the Daubert stand-
the laws of the federal government or between citi-
ards to cases beyond those using scientific evi-
zens of different states. State court systems have
dence to those involving expert testimony based
authority over certain cases within the confines of
on technical or specialized knowledge.12 This differ- their jurisdictional boundaries. ent approach was adopted because factors such as peer review and general acceptance serve a much more limited role in non-scientific contexts. The
The federal courts have adopted the Federal Rules of Evidence referred to above so that standards governing what evidence will be considered admis|19| www.KPHANET.org
sible and what will not admitted will be uniform
ably applied the principles and methods to the
throughout the country. A brief glimpse at some
facts of the case.15
relevant rules will make this clearer.
The role of the expert witness is to assist the “trier
Rule 701 of the Federal Rules of Evidence addresses of fact”, the entity that will answer questions of fact the issue of a non-expert witness testifying about
presented in the case. While this is usually the jury,
their opinions, imposing strict limits:
it is possible to have the right to a jury trial waived,
Rule 701. Opinion Testimony by Lay Witnesses If the witness is not testifying as an expert, the witness' testimony in the form of opinions or inferences is limited to those opinions or inferences which are (a) rationally based on the perception of the witness, and (b) helpful to a clear understanding of the witness' testimony or the determination of a fact in issue, and (c) not based on scientific, technical, or other specialized knowledge within the scope of Rule 702.14 The federal courts also have a specific rule of evidence governing testimony by expert witnesses: Rule 702. Testimony by Expert Witnesses A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expert’s scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based upon sufficient facts or data; (c) the testimony is the product of reliable
in which case the judge would become the trier of fact. Is it permissible for an expert witness to express an opinion on the ultimate issue in the case, e.g., who ran the red light and did that cause the accident, did the dispensing of the incorrect medication cause the severe damages suffered by the patient? If the witness does so will that not usurp the responsibility of the trier of fact? The Federal Rules of Evidence provide that such testimony is permissible: Rule 704. Opinion on an Ultimate Issue (a) An opinion is not objectionable just because it embraces an ultimate issue. (b) In a criminal case, an expert witness must not state an opinion about whether the defendant did or did not have a mental state or condition that constitutes an element of the crime charged or of a defense. Those matters are for the trier of fact alone.16 What if the witness is basing the expert opinion on
principles and methods, and (d) the expert has reli- information that itself would not be admissible at |20| Kentucky Pharmacists Association | May/June 2021
trial? Should that bar the expert witness from expressing an informed opinion in the case? The Federal Rules of Evidence say no. Rule 703. Bases of an Expert An expert may base an opinion on facts or data in the case the expert has been made aware of or personally observed. If experts in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject, they need not be admissible for the opinion to be admitted. But if the facts or data would otherwise be inadmissible, the proponent of the opinion may disclose them to the jury only if their probative value in helping the jury evaluate the opinion substantially outweighs their prejudicial effect.17 Another example of the courts deferring to the expertise of the expert witness appears with regard to whether the witness must lay some
The State Courts Each state is its own sovereign jurisdiction with ability to adopt its own rules of evidence to be followed in its court system. This is typically done either in the process of reviewing the rules of evidence applicable in the courts of that state or through deciding a case on appeal through the state court system. It has been reported that at least fourteen states have expressly rejected the older (1923) Frye test of “general acceptance” in favor of using the approach outlined in the Supreme Court’s Daubert decision of 1993. On the other hand, some sixteen states have continued to use the approach from the Frye case, with some of the most active jurisdiction for criminal law proceedings included – California, Florida, Illinois, New York, and Pennsylvania.11 Depositions
groundwork for the expert opinion by providing to
One serving as an expert witness can expect to be
the trier of fact that data or facts leading to that
called for a deposition prior to the start of trial. A
opinion.
deposition is an interview conducted under oath
Rule 705. Disclosure of Facts or Data Underlying Expert Opinion Unless the court orders otherwise, an expert may state an opinion - and give reasons for it - without first testifying to the underlying facts or data. But the expert may be required to disclose those facts or data on cross-examination.18
just as it would be in court. However, depositions are typically less formal than court proceedings in that they are often conducted in a law office conference room or hotel meeting room, not in a courtroom. No judge is present for the testimony, but a court reporter will be there to take down what is said. The absence of a judge can make a
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deposition most unpleasant for the party being de-
portant to the jury than the credentials or
posed because there is no higher authority present
knowledge of the witness.21
to make sure the attorney is asking questions that are proper and not outrageous. While the attorney for your side likely will be present, his or her ability to object to outlandish or irrelevant questions is greatly limited compared with the ability to do that in a courtroom proceeding.19 The transcript of the deposition may play several important roles because it represents a faithful rendering of what was said. If a witness is unable to appear at trial, the deposition transcript may possibly be admitted in place of the live testimony of the witness. Should witnesses alter their testimony while in court, the deposition may be introduced to highlight the different responses of the witnesses at different times, thereby impeaching their credibility.20 Testifying The expert opinions and any highly technical information must flow together in a manner that is cohesive and credible, being presented in a fashion
Charging The expert’s professional fees should not be linked to the outcome of the case; to do so creates the appearance of “buying” testimony. Questions about the expert’s charges for activity on the case are fair game for the attorney representing the other side. The attorney may ask the hourly rate being charged or the total billed to date, attempting to paint a picture for the jury that the expert is a mere “hired gun” or is avaricious. Such questions should be answered directly, leaving it up to the attorney on whose side your testimony falls to decide whether to pursue that on cross examination to clarify matters for the jury. Such questions can also be motivated by a desire on the part of the attorney for the other side to get the witness flustered. Some activities for which differential charges might be considered are: Reviewing materials Writing reports
that does not talk down to the jury but does explain the matter in a comprehensible fashion. Details of the case and large themes of the testimony must come together to create a complete picture for the jury. Thus, the ability of the expert to communicate
Travel time Waiting time Deposition time Court testimony time
his or her expertise well may be even more imThe first four activities listed here tend to be much |22| Kentucky Pharmacists Association | May/June 2021
less stressful than the last two, so a differential rate
the individual’s expertise and experience in the
might well be appropriate. Use of a retainer fee at
field of specialty. Sometimes these hourly rates ap-
the outset has been recommended.22
pear to be astoundingly high, but it should be
A written agreement should be executed between the witness and the attorney or firm retaining the expert. Provisions should include travel-related expenses being reimbursed in full and the witness/consultant should specify mileage reimbursement rate, usually the I.R.S. allowable rate. Provision should be made for submitting a billing statement on a monthly basis, with the voucher specifying both hourly charges plus expenses to be reimbursed. Submitting such statements on a monthly basis will enable the expert to ascertain whether timely payment will follow before getting too far into the case. It is also recommended that a provision be included specifying that expenses and fees will be paid within three weeks of final activity by the expert, e.g., deposition, testimony, or report. This proviso should specify that this will be so irrespective of outcome, e.g., payment should occur even if the attorney or law firm still has some payment or settlement check outstanding. It could also be that the proceeding will continue on long after the expert’s contributions have been completed. The hourly rate charged by an expert witness may be quite substantial, running in the hundreds of
borne in mind that for most witnesses this activity is taking them away from their normal occupation or practice and they may even be using vacation or other leave time to serve as the witness or consultant. Typically, these hourly rates greatly exceed the hourly rate such an individual would receive in the normal course of professional activities and it should be borne in mind that this is a sporadic activity, not typically something done on a full-time basis. Illustrative Cases from Pharmacy A number of cases from around the country have presented judges with opportunities to rule on whether pharmacists may serve as expert witnesses. In some cases, courts have ruled that pharmacists are not qualified as experts to testify on the standard of care for a physician when prescribing medications.23-26 On the other hand, in a 1987 Mississippi case the court ruled that an expert with an M.S. in pharmacology/ toxicology could testify about the medical standard of care27 as did a Louisiana court with a pharmacologist.28 It has been reported that a court also ruled that a physician may not testify as an expert witness about practice of pharmacy.29
dollars per hour depending on the uniqueness of |23| www.KPHANET.org
In another Louisiana case the expert testimony
sota the patient questioned the pharmacist when
served to exonerate the pharmacist who was sued
the medication label differed from what she had
for compounding a preparation of phenylpropano-
received before, the medication had a different ap-
lamine that allegedly caused a hypertensive crisis.
pearance, and the indicated name of the medica-
The expert witnesses for the defendant pharmacist
tion was different from her past medication. The
identified an alternative, plausible explanation for
prescribing physician moved to be dismissed from
the patient’s health problems that gave the jury
the case, presenting an expert witness who testi-
legitimate reason to question whether the com-
fied that the inaction of the pharmacy staff in re-
pounded product caused the crisis.30
sponse to the patient’s concerns superseded any
In a 1993 case, a patient was suffering rapidly progressive glomerulonephritis (RPGN), a rare and serious disease that leads to end-stage renal disease.
arguable negligence by the physician. The physician was granted summary judgment and got out of the case.32
He filed suit against manufacturers of ibuprophen
In a Virginia case, no expert testimony was required
claiming that his consumption of their products
to supplement that of the patient’s personal physi-
had created the condition. His burden of proof was
cian along with that of the injured patient and her
that he must establish a causal connection be-
son that a super-potent corticosteroid dispensed in
tween ingestion of ibuprophen and his acute renal
place of the one requested by the prescriber
failure. The role of the expert testimony was ex-
caused injuries to the patient.33
plained this way:
Failure to produce an expert witness led to an Ohio
In order to shed light upon a controverted fact, the
appellate court affirming the trial court’s dismissal
expert must compare data from the case at hand
of a negligence case based on mislabeling a pre-
with known scientific relationships and then state
scription. This was the appropriate result, the court
a conclusion about that data based on the compar- reasoned, because the plaintiff failed to produce ison. If an opinion lacks foundation and would not actually assist the jury in arriving at an intelligent sound verdict, then it is inadmissible. An expert’s mere guess or conjecture must be excluded.31 In a misinterpreted handwriting case from Minne-
|24| Kentucky Pharmacists Association | May/June 2021
expert testimony to support her claim.34 Some lawsuits where the use or appropriate role of an expert witness became a central issue have been discussed in the literature of pharmacy. During 2006 a U.S. District Court judge in North Caroli-
na ruled that a pharmacist could not offer a rele-
On occasion, the individual whose performance is
vant or reliable expert opinion related to pharma-
being critiqued by an expert witness, perhaps in a
cology.35
professional negligence case, will feel the witness
In a 2007 state court case in Texas, an appellate court ruled that the trial court judge had made an
went too far. What recourse exists in such a situation?
error when ruling on the testimony of a physician
In a Michigan case one physician filed a lawsuit al-
expert witness. The case involved a dispensing er-
leging defamation, negligence, and fraud by anoth-
ror and the physician testified that the damages
er practitioner who gave testimony during a depo-
suffered by the plaintiff were “consistent with” the
sition as an expert witness in a malpractice action.
dispensing error. The trial court judge ruled that
The court ruled that the deposition testimony was
such testimony was sufficient to support the claim
considered subject to an absolute privilege and, as
for damages. The appellate court ruled that
a result, could not be basis for the civil lawsuit.39
it was not, resulting in dismissal of the lawsuit.36
A number of physician organizations have ad-
A 2008 case handled by the New Jersey court system also involved misdispensing an incorrect medication based on misinterpretation of the prescriber’s handwriting. The state appellate court ruled that members of the jury would not need expert
dressed their member’s service as expert witnesses, including: American Academy of Orthopaedic Surgeons American Academic of Pediatrics American Association of Neurological Surgeons
testimony to determine whether a pharmacist who dispensed an incorrect medication had deviated from acceptable professional standards.37 During 2011 a California Court of Appeals ruled that it was acceptable for a pharmacist to testify with a reasonable degree of medical certainty about an OTC product causing a death, not the prescription
American Board of Plastic Surgery American College of Obstetricians and Gynecologists American College of Radiology American College of Surgeons American Society of General Surgeons
medications the patient had consumed.38 Society for Vascular Surgery Possible Recourse When the Expert Witness Goes Too Far with Criticism
Society of Interventional Radiology
|25| www.KPHANET.org
For example, the American College of Surgeons ad- chologist in the state of Washington who was subdresses both recommended qualifications for the
ject to sanctions by the Examining Board of Psy-
physician who acts as an expert witness and guide- chology for failing to meet ethical standards while lines for behavior while in that important role.40
offering expert testimony in child custody suits. The
These organizations have an interest in this topic
Supreme Court of Washington stated:
because membership in their groups is often used to demonstrate the witness’ experience and knowledge of the standard of care in the field. Membership in the organization gives the potential witness a “cloak of credibility.”41 Professional societies must report to the National Practitioner Data Bank when a physician or dentist is subject to a professional review action, based on reasons related to professional competence or conduct that adversely affects the person’s membership status, such as suspension or expulsion from membership. For other health professions such reports are voluntary.42 A lesser sanction such as a reprimand or censure would not be reported.43 Licensure boards may also have a role to play.44 In a 1991 decision, the ruling of the District of Columbia Board of Medicine that providing expert testimony constituted engaging in the practice of medicine was upheld by the District of Columbia Court of Appeals. False statements made regarding his professional qualifications during a case in South Carolina subjected a DC-licensed physician to a reprimand and a civil fine.45 A similar result was reached in the case of a psy|26| Kentucky Pharmacists Association | May/June 2021
Permitting a professional to be subject to discipline for unprofessional conduct…serves to advance the court’s goal of accurate testimony from expert witnesses, and furthers the disciplinary board’s goal of protecting the public.46 Conclusion The court system faces many challenges, not the least of which is dealing effectively with ever more complex issues during trials. Jurors and judges turn to those with scientific, technical, and professional expertise to help them see that justice is done by arriving at appropriate decisions based on wellfounded information. Pharmacists have both a professional and civic duty to provide their expertise to the court system. The current version of the APhA Code of Ethics for Pharmacists makes this clear in its Provision VII that “A pharmacist serves individual, community, and societal needs.” The background to this statement provided by the drafters states: The primary obligation of a pharmacist is to individual patients. However, the obligations of a pharmacist may at times extend beyond the individual to
the community and society. In these situations, the
Boon or bust? FDLI Update. 2005(May/June);3:30-32.
pharmacist recognizes the responsibilities that ac-
22] Fraser GL, Davis TD. The pharmacist as an expert witness. Am
company these obligations and acts accordingly.47
J Hosp Pharm. 1990;47:2082-85.
References
23] Bell v. Hart, 516 So.2d 562 (Ala. 1987). 24] McMickens v, Callahan, 533 So.2d 579 (Ala. 1988).
1] Moss S. Opinion for sale: Confessions of an expert witness. Legal Affairs. 2003(Mar/Apr);2:52-5. 2] Vivian JC. Experts and evidence. U.S. Pharm. 2002(3);27:86-88.
25] Young v. Key Pharmaceuticals, 770 P.2d. 182 ( Wash. 1989). 26] See also, Brushwood DB. Pharmacist’s qualifications as an expert witness on a
3] Expert Witness. https://en.wikipedia.org/wiki/Expert_witness. physician’s standard of care. Am J Hosp Pharm. 1990;47:2078-80. 4] 58 U.S. (17 How.) 170 (1855). 5] 293 F. 1013 (D.C. Cir. 1923). 6] Fed. R. Evid. 702. 7] 509 U.S. 579 (1993). 8] 509 U.S. 579, 589 (1993).
27] Thompson v. Carter, 518 So.2d 609 (Miss. 1987). 28] Cagnolatti v. United Medical Center of New Orleans, et al., No. 95-CA-2599, La.Ct.App., 4th Cir., December 11, 1996; cited in Rx Ipsa Loquitur 1997(Jan);24:2. 29] Fink III JL. May a physician testify as a pharmacy expert witness? Pham Times 2008(Mar);74:70.
9] 509 U.S. 579, 592 (1993). 30] Jeans v. Caraway, 649 So.2d 1141 (La. App 1995). 10] 522 U.S. 136 (1997). 31] Porter v. Whitehall Laboratories, Inc., 9 F.3d 607 (7th Cir. 1993). 11] Hansen M. The uncertain science of evidence. Am Bar Assoc J. 2005(July);91:48-53. 12] 526 U.S. 137 (1999). 13] 526 U.S. 137, 150 (1999). 14 Fed. R. Evid. 701. 15] Fed. R. Evid. 702.
Quotation from Simonsmeier LM. Expert testimony. Rx Ipsa Loquitur 1995(Nov);22:3-4. 32] Shultz v. Group Health Plan, Inc., et al. Fourth Judicial District PI 94-3715, Hennepin County Minn., April 13, 1995. Cited in Rx Ipsa Loquitur 1995(Jun):22:3-4. 33] Nichols v. Kaiser Foundation Health Plan of the Mid-Atlantic States, 514 S.E.2d 608 (Va. 1999).
16] Fed. R. Evid. 704. 34] Clodgo v. Kroger Pharmacy, Franklin (OH) App. No. 98AP17] Fed. R. Evid. 703. 18] Fed. R. Evid. 705. 19] Vivian JC. How to prepare for a deposition. Am J Hosp Pharm.1992;49:818,820,822. 20] Fink III JL, Vivian JC, Bernstein IG. Pharmacy Law Digest. 39th ed. St. Louis, MO: Facts & Comparisons; 2004:10. 21] Tiedt TN. Expert witnesses in product liability litigations:
569, March 18, 1999. 35] Fink III JL. Can a pharmacist be an expert witness on pharmacology? Pharm Times 2008(Aug);74:54. 36] Fink III JL. Role of an expert witness in a pharmacy lawsuit. Pharm Times 2009((Dec);75:80. 37] Fink III JL. Expert witness needed for misdispensing case? Pharm Times 2009(Aug);75:74.
|27| www.KPHANET.org
38] Fink III JL. Pharmacist testifies as an expert witness on medical certainty. Pharm Times 2011(Aug);77:68. 39] Kahn v. Burnam, 674 F.Supp. 210 (E.D. Mich. 1987), aff’d 878 F.2d 1436 (6th Cir. 1989). 40] American College of Surgeons. Statement on the physician acting as an expert witness. [Homepage on the Internet] Chicago: The College (2004), available at https://www.facs.org/aboutacs/statements/8-expert-witness. 41] Sacopulos MJ. Addressing false expert witness testimony in medical malpractice litigation. Health Lawyer News 2005(May);9:24. 42) Anon. Fact sheet on the National Practitioner Data Bank. Chantilly, VA: National Practitioner Data Bank (available at https://www.npdb.hrsa.gov/resources/whatIsThe NPDB.jsp). 43] Pelton RN. Medical society self-policing of unprofessional expert testimony. Annals of Health Law. 2004;13:557. 44] Wenner, WJ. The role of licensing boards in the evaluation and discipline of the expert witness. J Med Licensure and Discipline 2004;90:16-20. 45] Joseph v. District of Columbia Board of Medicine, 587 A.2d 1085 (D.C. 1991). 46] Deatherage v. State of Washington, Examining Board of Psychology, 948 P.2d 828, 832 (Wash. 1991). 47] Code of Ethics for Pharmacists. Washington, DC: American Pharmacists Association, adopted by the Association Spring, 1995, available at https://aphanet. pharmacist.com/codeethics?is_sso_called=1.
|28| Kentucky Pharmacists Association | May/June 2021
May/June 2021—Pharmacists’ Contributions to the U.S. Legal System: The Role of the Pharmacist as an Expert Witness 1] One can be qualified to serve as an expert witness 6] A pretrial process wherein an attorney gets to based on: interview potential witnesses for the “other side” is known as: A] Education B] Professional role A] Pretrial conference C] Experience B] Deposition D] All the above C] Declination D] Discharge 2] When testifying expert witnesses are given: 7] The rule that pretrial work done by a consultA] Less leeway that fact witnesses ant for an attorney is private is known as: B] More leeway than fact witnesses C] The same degree of leeway as fact witnesses A] Confidential D] Latitude to use slides or other audiovisuals B] Privileged which fact witnesses cannot C] Secret use D] Discoverable 3] Who is allowed to render an opinion during a court proceeding?
8] Supportive roles for an expert witness working with an attorney preparing for trial include all except:
A] Fact witnesses B] Expert witnesses C] Law enforcement officials serving as a witness D] Other governmental representatives serving as a witness
A] B] C] side” D]
4] Who makes the ultimate decision regarding whether an individual is qualified to serve as an expert witness? A] B] C] D]
The judge The attorney whop presents the witness The attorney for the other side The jury
5] A provision addressing the expectation that pharmacists will strive to support their community and society at large is found in: A] ASHP Code of Professional Conduct B] APhA Code of Ethics for Pharmacists C] The Oath of a Pharmacist one takes upon graduating D] Board of Pharmacy regulations
Reviewing case materials Drafting reports Interview potential witnesses for the “other Participating in a deposition
9] In the federal court system judges are to follow a set of standards known as: A] B] C] D]
Federal Rules of Expectations Final Rules of Evidence Federal Requirements for Trials Federal Rules of Evidence
10]
State court rules of evidence are:
A] Uniform across the U.S. B] Adopted by each state’s court system C] Fixed and cannot be modified or updated D] Private and accessible only to judges and attorneys
|29| 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: 6/29/2024 Successful Completion: Score of 80% will result in 2.5 contact hours TECHNICIANS ANSWER SHEET. May/June 2021—Pharmacists’ Contributions to the U.S. Legal System: The Role of the Pharmacist as an Expert Witness Universal Activity # 0143-0000-21-005-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D
3. A B C D 4. A B C D
5. A B C D 6. A B C D
7. A B C D 8. A B C D
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 May/June 2021—Pharmacists’ Contributions to the U.S. Legal System: The Role of the Pharmacist as an Expert Witness Universal Activity #0143-0000-21-005-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 7. A B C D 9. A B C D 2. A B C D 4. A B C D 6. A B C D 8. 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 Council for Pharmacy Education as a provider of continuing Pharmacy education. |30| Kentucky Pharmacists Association | May/June 2021
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.
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.
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|32| Kentucky Pharmacists Association | May/June 2021
|33| www.KPHANET.org
Welcome new Members
We’re so happy to have you!
The list reflects new memberships received from March 1, 2021— April 30, 2021.
If you see one of these new members, please welcome them to the KPhA family! Megan Lowe, Bowling Green Pharmacist
Teanna Nixon, Florence New Practitioner 1st Year
Erin Bookman, Lexington Pharmacist
Clinton Bybee, Tompkinsville Pharmacist
Cayla Pelle, Melbourne New Practitioner 1st Year
Scott Yates, Auburn Pharmacist
Brittney Engle, Vicco Pharmacist
Elizabeth Eveland, Georgetown Technician
Brooke Strong, Barbourville Technician
Will Osborn, Trenton Pharmacist
Angela Kamer-Lay, LaGrange Pharmacist
Shelby Benson, Dixon Pharmacist
|34| Kentucky Pharmacists Association | May/June 2021
|35| www.KPHANET.org
|36| Kentucky Pharmacists Association | May/June 2021
Campus Corner
Pinning Ceremony By: Duy Tran, Doctor of Pharmacy Candidate, Class of 2022 Thao Batovsky, Doctor of Pharmacy Candidate, Class of 2022
years ago, Dr. Hartlage provided the students with firsthand knowledge of what their rotations would be like and encouraged them to embrace the year ahead. In her remarks, she took the students down memory lane, telling of her own journey. She said, “Accept your lack of knowledge and find a way to use your inexperience as an asset. Reach out to mentors and preceptors for guidance, maintain a positive attitude at all times, and most importantly, enjoy your last year of pharmacy school.” In addition to the remarks and presentation of pins by SUCOPHS faculty, Dr. Daniel Malcom, students were also recognized for their outstanding achievements during their time at SUCOPHS. The Pinning Ceremony was a wonderful event that marked the pharmacy students’ lives as they move on to the next phase of learning and start their clinical rotations next year. Special thanks to Dr. Ben Mudd for his time and encouragement at the SUCOPHS Pinning Ceremony. It’s good to know KPhA is always there to cheer us on. It was truly an honor to have you at the ceremony.
On April 23, Sullivan University College of Pharmacy and Health Sciences (SUCOPHS) hosted its first inperson ceremony since the onset of COVID-19, honoring its second-year Doctor of Pharmacy students at the traditional Professional Pinning Ceremony. With students, family and friends in attendance (following strict Covid 19 protocols) — the annual event recognized members of the Class of 2022 as they prepare to make the transition from a predominately classroom environment to advanced pharmacy practice experiences. “I am so proud of our students as they transition from the didactic curriculum to the experiential one,” said Dr. Misty Stutz, Dean of SUCOPHS. “This past year has certainly been a real challenge and they have stepped up to the plate, showing the dedication needed to be ready to take care of patients. In just a few short weeks they will rise to the occasion and put their hard work into action with their APPE.” During the pandemic SUCOPHS second-year students were given the opportunity to learn through a real-world lens by administering thousands of COVID-19 vaccines to the community. In the upcoming year, the Class of 2022 will receive hands-on experience from various types of patient care while applying skills and knowledge they’ve gained during their two years of didactic coursework.
Above: Duy Tran and Dr. Wasana Sumanasekera Left: Dr. Ben Mudd, KPhA Executive Director & KPhA Award Recipient Katie Ritchie
The ceremony’s keynote guest speaker, Dr. Whitney Hartlage, is currently a PGY1 pharmacy resident at Baptist Health Louisville as well as an alumnus of SUCOPHS. Having been in their shoes just a couple |37| www.KPHANET.org
|38| Kentucky Pharmacists Association | May/June 2021
|39| www.KPHANET.org
Feature article
340B Third Party Administrator Data Breach of 1.6 Million Patients – Would You Be Prepared? On February 19, 2021, a 340B Third Party Administrator (TPA) became aware of unusual activity within their system and discovered unauthorized access had occurred on February 6, 2021. The 340B TPA’s investigation of the breach completed around March 19, 2021, and they determined the following types of information had been accessed: first name, last name, date of birth, prescription information, and medical record number. As a Business Associate (BA) of the pharmacy, the 340B TPA has an obligation to notify the affected pharmacies per the HITECH Act of 20091 42 USC 17932 sec 13402(b). Ultimately, it is the pharmacy’s responsibility (as the Covered Entity [CE]) to ensure all notifications are made as required under the HITECH Act. The CE also carries the burden of maintaining proof as per section 13402(d)(2). PAAS National® has seen these breaches affect anywhere from 15, to over 700, patients, per pharmacy. It is imperative that pharmacies are aware that the proper response entails far more than sending out notification letters. While providing guidance to our FWA/HIPAA Compliance Program members, numerous questions must first be answered, to ensure the appropriate actions are taken. Would your pharmacy know how to answer these important questions? 1. How long do I have to report the breach to the patient, HHS Secretary and media (if applicable)? 2. What must be done if one or more of the notification letters were undeliverable? What about ten or more? 3. What happens if a breach exceeds 500 patients? 4. Is the Business Associate acting as an agent of the Covered Entity? Why does that matter? 5. What is considered a “prominent media outlet”
per section 13402(e)(2) of the HITECH Act? Having a HIPAA expert on your side to navigate through the turbulent waters of a data breach can help ensure that all appropriate steps are taken, and deadlines are not missed. Utilize your HIPAA/FWA Compliance membership and reach out to PAAS for additional guidance by calling 608873-1342 or emailing info@paasnational.com. Additional HIPAA/FWAC benefits include a customized policy and procedure manual (with breach-related guidance in section 10.14), online HIPAA/FWA training, daily OIG/GSA checks and much more. PAAS National® is committed to serving community pharmacies and helping keep hard-earned money where it belongs. Contact us today at (608) 8731342 or info@paasnational.com to see why membership might be right for you. By Trenton Thiede, PharmD, MBA, President at PAAS National®, expert third party audit assistance and FWA/HIPAA compliance. ©2021 PAAS National® LLC All Rights Reserved Reference: https://www.hhs.gov/sites/default/files/ocr/privacy/ hipaa/understanding/coveredentities/hitechact.pdf
KPhA BOARD OF DIRECTORS
KPERF BOARD OF DIRECTORS
Joel Thornbury, Pikeville jthorn6@gmail.com
Chair
Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu
Chair
Cathy Hanna, Lexington channa@apscnet.com
President
Treasurer
Misty Stutz, Crestwood mstutz@sullivan.edu
President-Elect
Chris Killmeier, Louisville cdkillmeier@hotmail.com
President, KPhA
Brooke Hudspeth, Lexington brooke.hudspeth@uky.edu
Secretary
Cathy Hanna, Lexington channa@apscnet.com
Chris Killmeier, Louisville cdkillmeier@hotmail.com
Treasurer
Kevin Lamping, Lexington kevin.lamping@twc.com
Ron Poole, Central City
Past President Representative
Paul Easley, Louisville rpeasley@bellsouth.net
ron@poolespharmacycare.com
Pat Mattingly, Lebanon pat@patspharmacy.com
Directors Ronnah Alexander, Providence ralexander@hfchc.net
Sam Willett, Mayfield willettsam@bellsouth.net
Kyle Harris, London kyleharrispharmd@yahoo.com
Adrienne Matson, Lexington Adrienne.matson@uky.edu
Taylor Williams, Lexington taylorjwilliams17@gmail.com
University of Kentucky Student Representative
Cassy Hobbs, Louisville cbeyerle01@gmail.com Rodrick Millner, Louisville rodrickmillner@gmail.com
Sullivan University Student Representative
Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Martika Martin, Owensboro 12marmar@gmail.com Nathan Hughes, Louisville njhughes1980@gmail.com Kyle Bryan, Lebanon kyle.bryan2@outlook.com Cory Smith, Barbourville corysmith6155@gmail.com
Secretary
Speaker of the House
KPhA Staff Ben Mudd Executive Director bmudd@kphanet.org Sarah Franklin Director of Communications & Continuing Education sarah@kphanet.org Angela Gibson Director of Finance & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Public Health jjaggers@kphanet.org
Vice-Speaker of the House Kristen Blankenbecler, PharmD Director of Clinical Outreach kristen@kphanet.org
Emma Sapp, Alexandria emma.hatfield@stelizabeth.com Steve Hart, Frankfort Steve.hartrph@gmail.com Lakin Mills, Lexington lakinrachelle@gmail.com
|42| Kentucky Pharmacists Association | May/June 2021
Michele Pinkston, PharmD, BCGP Director of Emergency Preparedness michele@kphanet.org Lisa Atha Office Assistant/Member Services Coordinator latha@kphanet.org
-From The Kentucky Pharmacist, May 1971 Volume XXXIV, Number 5
Frequently Called and Contacted Kentucky Board of Pharmacy
Kentucky Society of Health-System Pharmacists
National Community Pharmacists Association (NCPA)
P.O. Box 4961
100 Daingerfield Road Alexandria, VA 22314
(502) 564-7910
Louisville, KY 40204 (502) 456-1851 x2 www.kshp.org info@kshp.org
www.pharmacy.ky.gov
Kentucky Regional Poison Center
Pharmacy Technician Certification Board (PTCB)
(800) 222-1222
State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601
2215 Constitution Avenue
American Pharmacists Association (APhA)
Washington, DC 20037-2985
2215 Constitution Avenue NW
(800) 363-8012
Washington, DC 20037-2985
www.ptcb.org
(800) 237-2742
(703) 683-8200 www.ncpanet.org info@ncpanet.org National Association of Chain Drug Stores (NACDS) 1776 Wilson Blvd., Suite 200 Arlington, VA 22209 www.nacds.org 703-549-3001
www.aphanet.org
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.youtube.com/KyPharmAssoc |43| www.KPHANET.org
