The Kentucky Pharmacist Vol. 12 No. 5

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Vol. 12, No. 5 September/October 2017

KENTUCKY

PHARMACIST Official Journal of the Kentucky Pharmacists Association

2017 Legislative Conference Hyatt Regency Lexington November 17 Registration Open

INSIDE: 2017 Legislative Conference Continuing Pharmacy Education Articles


TABLE OF CONTENTS FEATURES 2017 Graduates |4| Legislative Conference |5|

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

Editorial Office: ©Copyright 2017 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.

IN EVERY ISSUE President’s Perspective |3| My KPhA Rx |6| Advocacy Matters |10| Member News |34| Continuing Pharmacy Education |12| Pharmacy Law Brief |30| Pharmacy Policy Issues | 32|

Publisher: Mark Glasper Managing Editor: Sarah Brandenburg Editorial, advertising and executive offices at 96 C Michael Davenport Blvd., Frankfort, KY 40601. Phone: 502.227.2303 Fax: 502.227.2258. Email: info@kphanet.org. Website: www.kphanet.org.

ADVERTISERS APSC|8| PTCB |20| EPIC |37| Pharmacists Mutual |38| Cardinal |39|

|2| Kentucky Pharmacists Association | September/October 2017


PRESIDENT’S PERSPECTIVE October is American Pharmacists Month. Let us celebrate. Pharmacists are an integral part of health care teams, regardless of your practice setting. We face challenges in our profession, whether it is increased regulation or not being recognized as billable providers, but we have many opportunities for professional advancement. I am confident that the profession is moving forward in a positive direction. I believe the role of the pharmacist is continuing to evolve in Kentucky. Pharmacists are an asset to their patients, and they will continue to seek health care guidance from their pharmacist. We see this with immunizations, and this is the perfect time of year to discuss immunization outreach. The CDC continues to rely on pharmacists to lead the way in immunizations, and we are not disappointing. As we assess our patients for vaccine preventable illnesses, there are also opportunities to reach out to your community for immunization needs. And, KPhA is here for you for your practicerelated needs for vaccine-related training. As we talk about professional promotion, I encourage pharmacists to talk about what they can do for public health while they are with their friends, family, or out in the community. The more we talk about what we do, the more the public will know about the role that pharmacists serve in patient and public health. The best way to promote ourselves as individual pharmacists is by promoting the profession itself.

“I encourage pharmacists to talk about what they can do for public health while they are with their friends, family, or out in the community. “

One way to promote the profession is by purchasing an American Pharmacists Month yard sign for $25 to be placed outside the KPhA office in Frankfort. These can be to honor a pharmacist, a pharmacy, or be in memory of a pharmacist. All proceeds will go to the Kentucky Pharmacy Education & Research Foundation (KPERF). We also have a legislative conference on November 17th. This one day is filled with important information to move your profession forward. We hope to see you there.

Donate online to the Kentucky Pharmacists Political Advocacy Council Go to www.kphanet.org and click on the Advocacy tab for more information about KPPAC and the donation form. |3| www.KPHANET.org


Class of 2017

Congrats Grads!

OUR KPhA welcomes the newest members of the profession in Kentucky and wishes all graduates success in their chosen pursuits.

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Legislative Conference Register Online www.kphanet.org

November 17 | Hyatt Regency | Lexington The Kentucky Pharmacists Association supports the pharmacists and pharmacy technicians of Kentucky by providing programming on up-to-date topics faced in pharmacy practice. Pharmacists and pharmacy technicians who practice in hospital/health systems, community, retail, consultant, long-term care and insurance industries are the targeted audience for this meeting. This conference targets topics such as grassroots legislative advocacy, prescription drug abuse, and the future of health care in Kentucky.

Agenda Highlights 

House of Delegates Meeting

Advocacy 101

Panel Discussion with Legislators

Networking with Colleagues

Shape KPhA’s Legislative Agenda CPE credits (pending approval)

Accommodations You may contact the Hyatt Regency Lexington at (859) 253-1234 and note KPhA for the group rate of $135+ taxes/fees. The group rate is available until October 26, 2017.

The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education. |5| www.KPHANET.org


MY KPhA Rx Drinking from the Firehose By Mark Glasper KPhA Executive Director/CEO I’ve more or less worn out this phrase during my first two months as your Executive Director/CEO. The acronyms seem like alphabet soup and the issues are mired in complexity. However, it’s my business as an association management professional to learn your business and profession. I will prevail thanks in large part to your great Officers, Board Members and Committee Chairs who indulge me with the many questions I have about pharmacy related topics and jargon. KPhA President Chris Harlow, Chair Trish Freeman and President-Elect Chris Palutis have fielded the bulk of my queries. I’d be remiss if I didn’t thank our lobbyist, Shannon Stiglitz, and the talented KPhA staff, including Interim Executive Director/CEO Sam Willet, for their help in making me feel at home.

Hit the Ground Running Burning up I-64 between Louisville and Lexington has become the norm for me with all of the meetings and legislative fundraisers I’ve attended thus far. This is where I also have to thank Kentucky Pharmacists Political Action Committee (KPPAC) Chair and KPhA Director Matt Carrico for introducing me to so many of our Commonwealth’s legislators. I finally found the Capitol Annex parking lot, too, and just in time for all of the committee meetings that I’ve attended. A highlight for me in my short tenure has been a trip to Washington D.C. where I met with Senator Rand Paul and the staff of Senator Mitch McConnell as part of a legislative fly-in for the American Pharmacists Association and my peers at the National Alliance of State Pharmacy Associations (NASPA). I found Sen. Paul to be quite engaging and totally understood our position on provider status and the need for action on Medicaid reimbursements.

Take Action & Celebrate Please take note of the many newsworthy e-blasts that we send your way. Whether it’s writing letters and/or making calls to legislators or addressing important regulatory issues with your Board of Pharmacy, make your voice heard. I promise to make these requests only when your input is needed in a timely manner.

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Some of our e-blasts will be less serious in nature and we hope you take us up on fun events such as American Pharmacists Month this October. What a great time to show your community how important pharmacy is and what pharmacists do to help serve and protect the public. And, when you do great things in your community, please send us photos and/or videos of you and your colleagues in action. You just might see yourself in a future issue of The Kentucky Pharmacist!

See you at Legislative Conference I can’t wait to attend my first Legislative Conference November 17, 2017 at the Hyatt Regency in Lexington. I understand these are can’t-miss events if you enjoy learning about the behind-the-scenes legislative process and hearing about the issues affecting pharmacists. Plus, you can earn CEs by attending. I hope to see you there!

Upcoming Naloxone Training November 2, 2017

November 17, 2017

December 8, 2017

801 Westlake Dr

Jackson County Board

368 Penny Ln

Columbia, KY 42728

of Education

Williamsburg, KY 40769

1pm-5pm

12pm – 5pm

1pm – 4pm

November 9, 2017

December 8, 2017

Maysville Loin’s Club

805 S Main St #106

1403 E. 2nd Street

Corbin, KY 40701

Board of Pharmacy Naloxone Certified Pharmacists Needed -

Maysville, KY 41056

10am – 12pm

11am-3pm

contact Jody Jaggers (jjaggers@kphanet.org) to volunteer today! |7| www.KPHANET.org


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#NatlPrep #PlanAhead

Did you know that September was National Preparedness Month (NPM)? Each year the goal of NPM is to increase the overall number of individuals, families, and communities that engage in preparedness actions at home, work, business, school, and place of worship. It is easy to fall into complacency thinking a disaster will never happen to me or my family. However, now more than ever we need to prepare for the unexpected. Being prepared doesn’t have to be complicated or expensive. In fact it all starts at home with a conversation.

Volunteer Today

Pharmacist, pharmacy technician and student pharmacist recruitment is still underway for the Kentucky Pharmacists Association emergency preparedness program! Pharmacy professionals play a critical part in responding to emergency events such as a natural disaster or infectious disease outbreak.

For more information on how you can be involved in the KPhA Pharmacy Emergency Preparedness Initiative, contact KPhA 502-227-2303 or by email at jjaggers@kphanet.org.

|9| www.KPHANET.org


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

Participate in grassroots advocacy efforts

Get to know your legislators—they should know your name

Donate to the Political Advocacy Council and the Government Affairs Fund

Photo by: Matt Turner

Donate online to the KPhA Government Affairs Fund Funds contributed to KPhA Government Affairs are applied directly to our lobbying efforts in terms of staffing and contracted lobbying services. Company donations are acceptable for Government Affairs contributions, unlike contributions to Political Advocacy Funds, like KPPAC. Go to www.kphanet.org form. |10| Kentucky Pharmacists Association | September/October 2017


Sam Willett, RPh, Capital Campaign Donor

“

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

Leave a legacy by making a tax-deductible donation online at www.kypharmacyfuture.net |11| www.KPHANET.org


September CPE Article Emergency Preparedness in Kentucky: Both Physical and Mental Relief By: Brittany N. Galop, PharmD Candidate, and Joseph L. Fink III, BSPharm, JD, DSc (Hon.), FAPhA The authors declare that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-17-009-H04-P & T 1 Contact Hours (0.1 CEU) Expires 10/10/2020

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

Goals: This review will discuss pertinent information on how to accurately assess a disaster of any type. Additionally, it will discuss potential relief efforts each pharmacy operation should implement during a disaster, as well as providing information on existing volunteer opportunities for pharmacy personnel. Finally, it will include educational resources that may help pharmacists be better prepared to meet both the mental and physical health needs of patients during a disaster situation. Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: A. Define how a population is affected by a disaster (survivor classifications, types of injuries and losses, etc.); B. Understand how to compose an accurate emergency plan; and C. Analyze and utilize the education information options provided to prepare as a responder in the face of a disaster.

Natural disasters and public health emergencies affect lives, properties and governments in uncontrollable ways. They are unable to be planned for specifically because of their variation and their effects are felt by the devastated community for years to come. This is primarily seen as they can consume budgets, homes, valuables, and most importantly, lives. One of the most recent disasters, Hurricane Harvey, has caused roughly $190 billion of damages, almost four times as much as Hurricane Katrina ($49.8 billion).1 The best way to prepare for a disaster is through implementing preventive measures to limit potential damages, and to understand how to respond once in a disaster scenario. These preparations include understanding what a disaster could entail, what the survivors may deal with and how healthcare representatives can best prepare for these traumatic events. Although proactive preparation cannot prevent emergencies from arising, it enables the community to be more adequately equipped to handle these situations, which in turn, enables the community to return more rapidly to its

state of normality in the aftermath. Being able to assist patients, with both their physical and mental needs, will also help the community to readjust and become stronger despite the damage. Disasters can be defined as uncontrollable circumstances resulting in major loss.2 These disasters can be further broken down to include: terror attacks, natural disasters like hurricanes and tsunamis, man-made disasters, and public health emergencies like infectious disease outbreaks. These cases generally begin with a response from local authorities. Once local resources are overwhelmed, however, the governor can request federal assistance either through a presidential disaster request or by declaring a state of emergency.3 Before reaching such a declaration, however, a state will follow the appropriate policies that were formulated in preparation for a disaster. For decades, the United States has enacted policies, reviewed previous strategies and implemented protocols in order to be more prepared for disasters. In 2002, pharmacists were recruited to become a part of a national organization called the

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National Pharmacy Response Team (NPRT) to assist physicians with meeting requirements during the first response to disasters.4 This initiative was started in the wake of the attacks on September 11th. During a similar timeframe, many federal and state governments updated emergency preparedness operations and policies in order to be more capable at accurately assessing the needs following a disaster. For Kentucky specifically, this process has included updating the appropriate policies for emergency preparedness including the Kentucky Emergency Operations Plan (KYEOP). This plan includes all overview policies for each type of disaster as well as details the specific operational roles and responsibilities each government and some nongovernment agencies will fulfill in each situation.5 The goal of this plan is that agencies will be aware of their present duties prior to an emergency, and therefore strive to minimize the overwhelming burden of responsibilities that generally accompanies the distress of a traumatic event. Appropriate policies like the KYEOP also review previous patterns of traumatic events and natural disasters in order to pinpoint where another outbreak or casualty may occur. Policies are helpful in preparing for disasters, but understanding the affected population will enable responders to more effectively help individuals in need. There are five main categories of survivors: primary, secondary, third-level, fourth-level and fifth-level.2 With each increasing level, the personal impact of the disaster slightly decreases. This fact, however, does not mean that the upper level survivors should be overlooked and not assisted as thoroughly as the lower categories. Primary survivors will be those who experience the maximum exposure to the traumatic event. Secondary survivors will include grieving first-order relatives of the primary survivors, while third-level survivors include rescue personnel including medical, clergy, and local governmental responders. The fourth level will include local government officials and reporters. Fifth-level survivors include anyone experiencing

disturbances due to the visual or audio reports of the event.2 These levels are extremely pertinent in determining the order in which to attend to the victims, as well as being useful when triaging supplies. In addition to understanding patient subgroups, being able to dissect a disaster timeframe will help assess how damage has already affected the area and what can be expected in the future. The aftermath of disasters can be broken up into three main categories: acute phase, short-term phase and long-term phase. These phases emphasize the burden both locally and nationally, while still accounting for the effects on the community, both physically and mentally. The acute phase is the first few days following the original trauma. The primary focus during this time includes assessing physical injuries and triaging supplies, as well as providing shelter, food and water to those in need. The short-term phase, or post-disaster phase, may last up to weeks as the initial clean up begins. This period will include adjusting to the damage, burying the dead and dealing with long-term or underlying illnesses that may not have been originally assessed. These would primarily include behavioral conditions due to the event—namely anxiety, fear, depression and in some cases, post-traumatic stress disorder (PTSD). The final phase, known as the long-term phase, may continue on for months and years as reconstruction takes place and the community adjusts to post-disaster life.2,6 During the short- and long-term phases, health professionals need to assess and treat behavioral illnesses in addition to treating physical conditions. Following traumatic events, mental health conditions become more common. Failure to provide timely behavioral health treatment can delay a community’s ability to start over. In light of this information, the World Health Organization has emphasized the importance of behavioral health by recommending that at least one healthcare professional at each health facility during humanitarian disasters be able to assess and manage mental health problems.7 |13| www.KPHANET.org


Additionally, another way communities and health care professionals can prepare to effectively address the rise in mental health problems during an emergency state is through completing a Mental Health First Aid class facilitated by the National Council of Behavioral Health.8 These classes are conducted monthly and are open to any individual who is interested in becoming trained in metal health first aid. During an emergency state, moreover, if a behavioral healthcare professional is not available, the Substance Abuse and Mental Health Services Administration (SAMHSA) provides a disaster stress helpline. This helpline provides counseling to those experiencing anxiety, stress and depression-like symptoms.9 Healthcare professionals can make information regarding this helpline available to patients, or specifically refer patients who exhibit symptoms to the helpline, when treating physical needs. Following a disaster, people respond in a variety of ways. Being able to provide individuals with adequate healthcare to meet both their physical and mental needs will help to achieve long-term goals of both personal and community health. These services need to be provided to all classifications of survivors. It is important to note that responders are included in a survivor classification. Despite being listed as a “rescuer,� they will also need assistance and support. Even if these responders routinely deal with death and extreme situations, a large disaster will be roughly 100 times more impactful on the individual compared to the normal exposure in their career. Some ways to assist such responders is by clearly listing objectives, setting up a specific timeline and shift for responders to be on duty, providing resources (beds, food, clothes) to each responder, and creating inter-professional teams to assist in diversity and multiple skill sets.2 Responders are commonly thought of as being strong, brave and heroic. Although these qualities are true, they do not exempt responders from being deeply affected by the events, and from physical and behavioral care. Understanding the functionality of a disaster highlights the need for, and better enables us, to create emergency plans to assist our communities in the future. This process of preparation includes educating

ourselves and our staff about emergencies, creating an appropriate plan of action to address an emergency situation and finally, testing the plan. A thorough plan should include how team members will respond at work or home, where their services will be best utilized, and ensuring that they have the appropriate certifications and training for volunteering.10 For healthcare professionals specifically, this preparation should also include having the appropriate liability insurance for treating patients outside of their scope of practice and ensuring all HIPAA regulations are followed as best as possible within the HIPAA Compliance and Disaster Recovery Statute. 1 In response to a state of emergency, pharmacists and additional pharmacy personnel play a specific and vital role not only through their actions, but also by what they represent. Pharmacists hold a sense of trust as they are highly visible within their community and work to put the patient first.12 This trust factor is crucial during traumatic events as patients will be more willing to talk with local pharmacists and more readily trust their advice during high stress situations. Beyond their community influence, pharmacy personnel will also be responsible for preparing prescriptions and assisting clinicians in medical emergencies.12 The mathematical skills and resourcefulness of a pharmacist will be vital in medication therapy management for patients needing multiple medications, as well as potential triaging of supplies. During emergency situations, the volume of injuries will be increased causing the resources to be more sparse, requiring all trained health personnel -- including pharmacy professionals -- to be pushed into non-routine scenarios. In Kentucky specifically, pharmacy professionals will be needed in order to dispense medications from the Strategic National Stockpile (SNS). The SNS provides medications to secondary locations, like mobile pharmacies and communitybased dispensing sites that will provide the most direct aid to patients throughout the area of con-

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cern.12 Pharmacists may also be asked to assist in mass vaccinations in the event of a pandemic.13 Depending on an individual’s background, pharmacy professionals can also be utilized in ambulatory based sites or pharmacotherapy locations. Those who are accustomed to community-centered care may function at an ambulatory site that is focused more on dispensing medications to meet patients’ needs whereas other pharmacists may be more pharmacotherapy based. These two diverse fields provide pharmacists a way to volunteer in an environment similar to their normal practice, enabling them to be more impactful within their specialty while providing the necessary resources to patients. There are many opportunities for involvement. Kentucky pharmacy professionals are able to participate in KPhA’s emergency preparedness seminars, study the resources for emergency preparedness on KPhA’s website or volunteer at the KPhA mobile pharmacy which can be equipped for use in emergencies. Additionally, health professionals can be volunteer members on the Kentucky Community Crisis Response Board which rapidly responds to specific crises and disasters within the state.14 Following a disaster, of any type, it requires months of hard work from members of diverse fields and backgrounds. Although disasters cannot normally be anticipated, its overall devastation can be minimized through adequate preparation— correct contingency plans and education. Being able to assess patient’s needs, both physically and mentally, will not only save lives but also potentially speed up the rebuilding phase. For pharmacy professionals specifically, it will require personal care and understanding to effectively assist patients in a crucial situation.

References: 1.

hurricane-harveys-jaw-dropping-size-anddestruction/617923001/>. 2.

Cohen, Raquel E. “Mental Health Services for Victims of Disasters.” World Psychiatry, Masson Italy, Oct. 2002, <www.ncbi.nlm.nih.gov/pmc/articles/PMC1489840/>.

3.

Emergency and Disaster Preparedness and Response Planning: A Guide for Boards of Pharmacy. National Association of Boards of Pharmacy, Nov. 2006,<http:// nabp.pharmacy/wp content uploads/2016/07/06Emergency_Preparedness_Guide.pdf>.

4.

Vecchione, Anthony. “Pharmacists Play Key Role in Emergency Preparedness.” Drug Topics, Advanstar Communications Inc, 16 Dec. 2002, <drugtopics.modernmedicine.com/drug-topics/content/ pharmacists-play-key-role-emergency-preparedness>.

5.

“Kentucky Emergency Operations Plan.” State EOP, Commonwealth of Kentucky, Aug. 2014, <http:// kyem.ky.gov/sitecontacts/Documents/State% 20EOP.pdf>.

6.

Rosenbaum, Sara. “Law and the Public’s Health.” Public Health Reports 126.1 (2011): 130. Print.

7.

“Mental Health in Emergencies.” World Health Organization, World Health Organization, Mar. 2017, <www.who.int/mediacentre/factsheets/fs383/en/>.

8.

“Mental Health First Aid USA.” Mental Health First Aid, National Council of Behavioral Health, 10 Oct. 2013, <www.mentalhealthfirstaid.org/>.

9.

“Disaster Preparedness, Response, and Recovery.” SAMHSA, Substance Abuse and Mental Health Services Administration (SAMHSA), 19 Jan. 2017, <www.samhsa.gov/disaster- preparedness>.

10. “Emergency Preparedness: 3 Steps to Prepare Your Pharmacy.” Elements Magazine, PBA Health, 28 July 2016, <www.pbahealth.com/emergency-preparedness-3-stepsto-prepare-your-pharmacy/>. 11. Cohen, Richard. When Disaster Strikes: Emergency Preparedness for the Community Pharmacy. NCPA, 10 Oct. 2006, <www.ncpanet.org/pdf ed/06conv_disaster.pdf>.

Sergent, Jim, et al. “Charting Hurricane Harvey's JawDropping Size and Destruction.” USA Today, Gannett 12. “Resolve to Be Ready: KPhA Pharmacy Emergency PreSatellite Information Network, 1 Sept. 2017, paredness.” Kentucky Pharmacists Association, KPhA, <www.usatoday.com/story/news/2017/08/30/charting-

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2017, <www.kphanet.org/emergency-preparedness>. 13. “Emergency Preparedness.” Michigan Pharmacists Association, MPA, 2015, <www.michiganpharmacists.org/ resources/emergency>. 14. “Crisis Response Team.” Kentucky Community Crisis Response Board, Ky.gov, 2016, <https://kccrb.ky.gov/ crt/Pages/overview.aspx>.

CPE Quiz Online www.surveymonkey.com/r/SepCE2017

September 2017 — Emergency Preparedness in Kentucky: Both Physical and Mental Relief 1. A disaster will include which of the following: A Terror attack B. Natural C. Public Health Emergency D. All of the Above 2. Who has the authority to declare a state of emergency once local resources are overwhelmed? A. Governor of the state responding to a disaster B. Vice President of the United States C. Mayor of the county/city responding to a disaster D. Secretary of the Cabinet of Health and Family Services 3. Which of the following is not a primary category of the disaster response timeframe? A. Acute Phase B. Short-Term Phase C. Primary Phase D. Long-Term Phase

6. Who provides Mental Health First Aid Training? A. Centers for Disease Control and Prevention (CDC) B. Substance Abuse and Mental Health Services Administration (SAMHSA) C. Red Cross D. National Council of Behavioral Health 7. Who has a Disaster Distress Helpline specific to behavioral health needs? A. Substance Abuse and Mental Health Services Administration (SAMHSA) B. Centers for Disease Control and Prevention (CDC) C. National Council of Behavioral Health D. Red Cross 8. HIPAA compliance is not necessary in a state of emergency because of the extreme circumstance. A. True B. False

4. At which phase will mental illness begin to be seen in patients and affect society from moving forward? A. Acute Phase B. Short-Term Phase C. Long-Term Phase D. Primary Phase

9. What is the abbreviation of the location that pharmacists will acquire medications from during a state of emergency? A. BDS B. SNS C. KYEOP D. CDC

5. Which level is a responder listed in within the survivor classifications? A. Secondary B. Primary C. Fifth D. Third

10. Which organizational website provides pharmacyspecific emergency preparedness information for the state of Kentucky? A. KSHP B. KPhA C. CDC D. SAMHSA

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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: 10/10/2020 Successful Completion: Score of 80% will result in 1.0 contact hour or .1 CEUs. TECHNICIANS ANSWER SHEET September 2017 — Emergency Preparedness in Kentucky: Both Physical and Mental Relief (1.0 contact hour) Universal Activity # 0143-0000-17-009-H04-T Name _______________________________________________KY Cert. # __________________________________ 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 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 September 2017 — Emergency Preparedness in Kentucky: Both Physical and Mental Relief (1.0 contact hour) Universal Activity # 0143-0000-17-009-H04-P Name _______________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B C D

7. A B C D 8. A B

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

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieved the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________ Personal NABP eProfile ID #_____________________________ Birthdate _______ (MM)_______(DD)

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

Quizzes submitted without NABP eProfile ID # and Birthdate cannot be accepted. |17| www.KPHANET.org


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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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October CPE Article Legal Issues with Counseling By: Peter P. Cohron is a pharmacist working in retail in Henderson, KY, an attorney whose practice represents pharmacists, interns, techs and pharmacies, and the owner operator of Pharmacy Law Source, PLLC. He is a former part-time associate professor at the University of Kentucky College of Pharmacy. His email is pharmacylawsource@gmail.com. The author declares that there are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-17-010-H03-P & T 1 Contact Hours (0.1 CEU) Expires 10/10/2020

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

Objectives: At the conclusion of this Knowledge-based article, the reader should be able to: A. Define legal issues with counseling patients B. Apply the required topics for counseling per Kentucky law C. Define and understand the common bases for counseling lawsuits against pharmacists

Back in the 1990s when OBRA ’90 became law, I predicted that lawsuits about failure to counsel or failing to fully counsel would soon be a primary basis for lawsuits against pharmacists. For several years, failure to counsel is the number two reason for lawsuits against pharmacists and pharmacies (number one remains misfilling a prescription).

vides the areas that must be covered (a) The name and description of the drug; (b) The dosage form, dose, route of administration, and duration of therapy; (c) Special directions and precautions; (d) Common and clinically significant adverse effects, interactions, or contraindications that may be encountered, including their avoidance and the action required should they occur;

Let us start off by reviewing Kentucky law. 201 KAR 2:210 if you want to follow along with the actual regulation. Counseling is not required in (e) Techniques for self-monitoring of drug therapy; Kentucky. What is required is an OFFER to coun(f) Proper storage; sel on all new prescriptions and on refills where professional judgment dictates. Only by an ac(g) Refill information; ceptance of the offer does the duty to counsel arise. (h) Action to be taken in event of a missed dose; Before we look at what counseling requires, (i) His comments relevant to the individual’s therawhat about if counseling is refused? Kentucky repy; and quires documentation of the refusal. There is no (j) Any other information peculiar to the specific requirement to obtain an acknowledgement that counseling was done. If such documentation is not patient or drug. present, a legal presumption exists that states counLegal issues arise from several areas. First seling was offered, the offer was accepted, and rea- and foremost are a failure to offer to counsel and sonable counseling was provided. providing insufficient counseling. With the failure Once counseling is accepted, the regulation pro-

to offer, it is most often an absolute failure to make

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any kind of inquiry to the patient about counseling. No one in the pharmacy asks “Do you have any questions about your prescription?” or a similar phrase that would invite the patient to request counseling.

tion states that things like patient instruction sheets and auxiliary labels are supplemental to counseling and are not counseling in and of themselves. The presence of these where there was a failure to counsel is not going to be very helpful in your defense.

Insufficient counseling is providing counseling but failing to reasonably cover any of the above required criteria. Talking about all of the above except for “action to be taken in the event of a missed dose” is not acceptable to state boards of pharmacy. Omitting any provision, deliberately or inadvertently, in required counseling points does not mean that a patient was partially counseled—the patient was not counseled. Period.

Example: At a dinner party, patient approaches Joe Pharmacist and asks if she can get a little advice on her medication, as she did not speak to her pharmacist when she first picked it up. Pharmacist agrees though she is not really desirable of doing so, and her responses are short and abrupt. Relying on the “advice,” patient ends up injured.

The example above is more often seen where a patient does a “corner consult” with a physician Example: Patient presents a prescription for acetaminoand is injured relying on that advice, but it has happhen with codeine and accepts the offer to counsel. All the pened to a couple of pharmacists. Yes, the pharmapoints are covered but the pharmacist fails to warn against cist is liable here. The location of the counseling is mixing the medication with alcohol. Patient does so and not important; neither is the fact that this is not at falls down a staircase. Pharmacist is liable for failing to the pharmacy but at a dinner party. Legal cases counsel on a common and clinically significant adverse hold that when a professional accepts a duty, no effect. matter where, the duty must be fulfilled as if the pharmacist were behind the prescription counter. The common and clinically significant adverse effect provision has been the basis for several Example: Patient presents a prescription for acetaminolawsuits (in other states, not KY). However, most phen with codeine and accepts the offer to counsel. Paof these lawsuits have resulted in no pharmacist lia- tient is warned not to mix the medication with alcohol but bility as the patients were found to have counseled does so anyway and is injured. At trial pharmacist shows reasonably. In one matter, the family sued because that he warned against mixing the two but patient is able the patient was not warned of the possibility of de- to prove the pharmacist did not cover other provisions of veloping Stevens-Johnson syndrome. In another, the counseling criteria. the male plaintiff contended he should have been I bring this example up to show you a twist warned of the possibility of priapism from trazoon the situation. Here, the pharmacist is not liadone. Both courts, through the use of expert witble. The court would hold that the failure to fully nesses, found for the pharmacist as these adverse counsel is “harmless error” or “no harm, no foul” effects, though clinically significant, were uncomas the lack to fully counsel has no effect on the issue mon to the point that they would not be included in before the court. However, a complaint to the reasonable counseling. board of pharmacy could still see the pharmacist Special directions is another leading factor sanctioned for failing to fulfill a duty, the court’s or common basis for lawsuits. With these, liability holding notwithstanding. is pretty clear cut where a pharmacist fails to tell the Some states considered the concept of prepatient to refrigerate or not refrigerate, shake well emptive counseling, where a pharmacist would reor shake gently, etc. A note here. The KY regulalate an important fact about a drug and then offer |21| www.KPHANET.org


counseling. “Sir, you will be taking metronidazole. You should avoid all forms of alcohol while taking this. Now, do you have any questions about your medication?” “Your prescription today is for amoxicillin. Make sure to take it until it is all gone. Now, do you have any questions about your medication?” Phrased as above, this meets the legal requirement, as the pre-emptive statement is followed by the offer to counsel. However, if there is no offer included, the pharmacist has pre-emptively assumed the duty to counsel and must do so fully, covering all the required criteria. Pre-emptive counseling is not followed in any state, as I understand it, though some legal commentators continue to support the idea. Counseling on prescriptions is an important duty for pharmacists, and this importance has not shrunk even though many pharmacists today have problems finding the time to adequately counsel those patients who request such. Pharmacists should keep in mind that boards do not consider being busy as an excuse for failing to offer or to counsel. There are as many pitfalls to this duty as there are rewards.

CPE Quiz Online www.surveymonkey.com/r/OctCE2017 October 2017 — Legal Issues with Counseling 1. Failure to counsel is the _____ most often basis used for suing pharmacists. A. First B. Second C. Third D. Fourth 2. If no counseling documentation exists, the legal presumption is A. The patient was not counseled B. The patient received no offer to counsel C. The patient was reasonably counseled D. The prescription was a refill 3. Which of the following is NOT a topic to be discussed in counseling? A. Proper storage

B. Common or clinically significant adverse effects C. Name and description of the drug D. Refill information 4. The two most common legal issues from counseling are A. Failure to counsel and failure to fully counsel B. Failure to offer to counsel and failure to document this failure C. Failure to counsel and failure to counsel in a private setting D. Failure to offer counseling and failure to fully counsel 5. Insufficient counseling is A. Failure to include all required counseling topics B. Not putting auxiliary labels on the prescription bottle C. Not telling the patient to read all enclosed materials D. Permitting a pharmacy intern to perform counseling 6. Counseling on adverse effects must be A. According to the latest literature on the medication B. On all common or clinically significant adverse effects C. Based on personal experience by the pharmacist or intern D. On all common and clinically significant adverse effects 7. Another leading factor or common basis for lawsuits in counseling arises from A. Special instructions B. Storage requirements C. Action to be taken in event of a missed dose D. Techniques for self-monitoring 8. Joe Pharmacist is approached at his favorite bookstore by a patient customer who wants to ask questions about a prescription she picked up three days ago. A. Joe can answer her questions without fear of liability B. Joe should fully counsel her as if she and he were at the pharmacy C. Joe has no liability since this is a social setting D. Joe should refuse to discuss this 9. Pre-emptive counseling would require a pharmacist to A. Offer counseling on all new and refill prescriptions B. Reduce counseling topics to those the pharmacist feels are the most important C. Refer the patient back to her physician D. State an important fact about the medication and then make the offer to counsel 10. Pam Pharmacist warns a patient about operating heavy machinery while taking a benzodiazepine. The patient is injured while driving a riding lawnmower later that afternoon. The patient is able to prove other counseling topics were not included during the counseling session. The doctrine that protects the pharmacist from liability is: A. “You should have paid attention” B. “Res ipsa loquitor” C. “Harmless error” D. “Essential element”

|22| Kentucky Pharmacists Association | September/October 2017


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: 10/10/2020 Successful Completion: Score of 80% will result in 1.0 contact hours or .1 CEUs. TECHNICIANS ANSWER SHEET. October 2017 — Legal Issues with Counseling (1 contact hour) Universal Activity # 0143-0000-17-010-H03-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. 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 October 2017 — Legal Issues with Counseling (1 contact hour) Universal Activity # 0143-0000-17-010-H03-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________

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

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

Quizzes submitted without NABP eProfile ID # and Birthdate will not be accepted. |23| www.KPHANET.org


Rx and the Law Insurance Coverage for New Advances Author: Don McGuire. Don McGuire, R.Ph., J.D., General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company This series, Pharmacy and the Law, is presented by Pharmacists Mutual Insurance Company and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

An earlier article in this series talked about preparing to enter the exciting period of change that is occurring in the pharmacy profession. Recent changes in a number of states have broadened the clinical and patient care activities that can be undertaken by pharmacists. These changes take many different forms. Ohio passed a bill that authorizes pharmacists to provide a large number of patient care activities, including ordering and analyzing the results of blood and urine tests, ordering up to a 30 day supply of life saving medication when a physician is unavailable, and modifying drug therapy (including ordering new drugs). Many other states also allow pharmacists to order and interpret laboratory tests. Most states allow pharmacists to participate in Collaborative Practice Agreements (CPA). The activities allowed under a CPA vary tremendously from state to state. These can include initiation of drug therapy, modification of drug therapy and/or discontinuation of drug therapy. Another development is the use of statewide protocols to allow pharmacists to prescribe certain medications. The leaders in this area are New Mexico, Idaho, California, and Oregon, but other states are beginning to follow their lead. Among the medications that pharmacists are allowed to prescribe are emergency contraception, smoking cessation, oral hormonal contraceptives, and preventative prescription medications recommended by the CDC for people traveling outside the US.

cover in a policy, regardless of what constitutes your state’s scope of practice. For example, there are policies available in the marketplace that exclude damages resulting from patient counseling – whether or not the counseling is required by law. Whether the services you provide are required or optional, you will want to be sure you are adequately protected. It is never safe to assume that you have coverage for something that you cannot find in your policy without first asking and validating it with your insurance company. So how do you go about examining your insurance coverage? Remember that under the law, insurance is a contract. The terms of that contract or agreement are spelled out in the insurance policy. While every provision is important, three parts of the policy are key to our question. They are the definitions, the insuring agreement, and exclusions. Make sure that the activity in question is included in the definitions and/or the insuring agreement of the policy and that it is not included in the exclusions.

In a situation like we have in these states, new activities recently authorized likely will not be found in the policy yet. There is a time lag due to the requirement that insurance policies be approved A question that should come to mind for by the Department of Insurance in each state. Beevery pharmacist involved is whether they are cov- cause of this lag, coverage will depend on the insurered by their insurance policy for these activities. ance company’s interpretation of its existing policy This is a very important and challenging question language. Some policies carry a broad definition of because the coverage provided by each insurance what activities are covered. For example, the policompany is different. You cannot just assume that cy may say that you are covered for your acts as a new practices are covered. Each insurance compa- pharmacist or for your acts within the profession of ny can determine what they do and do not want to |24| Kentucky Pharmacists Association | September/October 2017


pharmacy. For cutting edge advances, you may not know how your insurance company will interpret what acts they are intending to cover. Another insurance company includes the phrase, “and other services of a professional nature legally performed by “you””. This phrase picks up newly authorized activities until policies can be rewritten to specifically include them in the policy language. It is important to note that the phrase also includes the words “legally performed”. The pharmacist would need to complete any required training program or certifications prior to providing these services for the coverage to apply. It is also important to comply with all procedures and recordkeeping required by the law. Pharmacists will need to verify what activities they are legally allowed to provide in their state. Once they have chosen the activities that they wish to add to their practice, pharmacists need to verify coverage with their insurance company because every insurance company is different. © Don R. McGuire Jr., R.Ph., J.D., is General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company. This article discusses general principles of law and risk management. It is not intended as legal advice. Pharmacists should consult their own attorneys and insurance companies for specific advice. Pharmacists should be familiar with policies and procedures of their employers and insurance companies, and act accTake Action

Celebrate American Pharmacists Month in October! APhA and KPhA want to help you promote the profession and get the attention you deserve among your peers, patients and community this October during American Pharmacists Month. Check out the APhA website on ways to celebrate. Use the hashtag #APhMKY2017 to share with us how you're celebrating across The Commonwealth! Thank you to those who supported KPERF by purchasing a sign that was displayed at headquarters throughout the month of October.

Signs outside KPhA headquarters celebrating American Pharmacists Month. |25| www.KPHANET.org


Financial Forum How much will you spend when you retire? Author: Don McGuire. Don McGuire, R.Ph., J.D., General Counsel, Senior Vice President, Risk Management & Compliance at Pharmacists Mutual Insurance Company This series, Financial Forum, is presented by PRISM Wealth Advisors, LLC and your State Pharmacy Association through Pharmacy Marketing Group, Inc., a company dedicated to providing quality products and services to the pharmacy community.

You may have heard that people spend less once they are retired. Statistically, that is true. The question is whether a retiree has enough income to meet his or her expenses. Ideally, retirees should be able to live comfortably on 70-85% of their end salaries and draw their retirement fund down no more than 4-5% per year during a 30-year retirement. Are these two objectives realistic for the average retiree household?1,2 According to the most recently published Bureau of Labor Statistics data, a household maintained by someone 65 or older had a mean income of $46,627 in 2015 and a disposable income of $42,959 after taxes. That average retiree household spent an average of $44,664 in 2015. So, on average, seniors spent more than they had on hand.2,3 Basic math tells us that 46,627 is roughly 70% of 66,500 and roughly 85% of 55,000. So, a retirement income of $46,627 would correspond to about 70-85% of a typical middle-class salary in 2015. In other words, it appears all too easy for the middle-class worker to transform into the financially challenged retiree.

that went to health insurance, $672 for medicines). Another $1,298 went for mortgage costs.2,3 When you spend more than you make in retirement, you dip into your savings. That fact takes us straight toward a larger problem.

Most baby boomers are approaching retirement with a savings shortfall. The 2016 Employee Financial Wellness Survey from PwC (PriceWaterhouseCoopers) found that 50% of baby boomers had less than $100,000 in a workplace retirement plan. So, drawing down that amount by 4% a year would bring them less than $4,000 in annual retirement income. Of course, some of these employees will be able to tap IRAs, brokerage accounts, or income streams from other sources – but when your workplace retirement plan savings are that scant after age 50, other sources must compensate mightily. For many retirees, Social Security will not take up the slack. The average projected monthly Social Security benefit for 2017 is just $1,360.2 From the numbers in this article, you can glean that the average American retiree faces more Why is the average retiree household spending than a little financial pressure. If you are a baby more than its net income? Three possible reasons boomer who has saved and invested for decades come to mind. One, the cost of living may be rising and wants to work longer to give your invested asfaster for retirees than some assume. Social Securi- sets a few more years of growth and compounding, ty bases its cost-of-living adjustments to retiree ben- you may have above-average prospects for a comefits on changes in the CPI-W (Consumer Price In- fortable retirement. dex for Urban Wage Earners and Clerical Workers). Some economists think Social Security should 1 - cbsnews.com/news/how-much-retirementuse a different yardstick. Two, annual health care costs may suddenly jump for some seniors. Three, income-do-you-really-need/ [3/3/16] it is not unusual for new retirees to spend more 2 - fool.com/retirement/2016/12/18/how-muchthan they anticipate as they travel and enjoy life.4 money-does-the-average-baby-boomer-need-i.aspx [12/18/16] How do average retiree expenses break down? Housing costs accounted for $15,529 of that afore- 3 - bls.gov/cex/2015/combined/sage.pdf [8/16] mentioned $44,664 in 2015 household expenses. 4 - fool.com/retirement/2016/09/24/heres-whyTransportation costs took another $6,846. Health your-social-security-check-is-hardly-goi.aspx care costs made up $5,756 of the total ($3,900 of [9/24/16] |26| Kentucky Pharmacists Association | September/October 2017


Pat Reding and Bo Schnurr may be reached at 800-288-6669 or pbh@berthelrep.com. Registered Representative of and securities and investment advisory services offered through Berthel Fisher & Company Financial Services, Inc. Member FINRA/SIPC. PRISM Wealth Advisors LLC is independent of Berthel Fisher & Company Financial Services Inc. This material was prepared by MarketingLibrary.Net Inc., and does not necessarily represent the views of the presenting party, nor their affiliates. All information is believed to be from reliable sources; however we make no representation as to its completeness or accuracy. Please note - investing involves risk, and past performance is no guarantee of future results. The publisher is not engaged in rendering legal, accounting or other professional services. If assistance is needed, the reader is advised to engage the services of a competent professional. This information should not be construed as investment, tax or legal advice and may not be relied on for the purpose of avoiding any Federal tax penalty. This is neither a solicitation nor recommendation to purchase or sell any investment or insurance product or service, and should not be relied upon as such. All indices are unmanaged and are not illustrative of any particular investment.

in drug stores in the area and eventually became a sales representative for Merrell Dow Pharmaceuticals.

In Loving Memory Senator Richard Roeding 1930-2017

When asked to become a lobbyist, he met the challenge with confidence and conviction. When approached to run for the Senate at age 60 he did not waver. Dick served 18 years as a KenFormer Kentucky Senator and KPhA tucky State Senator, 1991-2009.

DirectorSen. Richard ‘Dick’ RoedHe held several leadership positions, Senate ing Passed Away President Pro Tem, 2000-2004; Senate RepubliFormer state senator Richard L. “Dick” Roed- can Whip, 1995-1996; Chair, Senate Minority, ing, 86, of Lakeside Park, passed away Friday Republican Caucus, 1997-1998; Chair, Northern October 6, surrounded by his family. Kentucky Legislative Caucus, 1995-1996. RegisDick will be remembered for his love of family tered Pharmacist, 1952- 2017, Merrell Dow and his moral fortitude. He spent his life making Pharmaceuticals, Incorporated Sales Executive sure his family was well cared for, that his chil- and Corporate Lobbyist, 1956-1990.

dren were provided opportunities to make sure He served in the United States Army, Korean they experienced success and had a foundation War, 1952-1954. for the future. He spent his early years as a pharmacist working

|27| www.KPHANET.org


Pharmacy Law Brief Malpractice Claim Screening Panels in Kentucky Author: Joseph L. Fink III, BSPharm., JD, DSc (Hon), FAPhA, Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Disclaimer: The information in this column is intended for educational use Question: I’ve seen a good bit of publicity about and to stimulate professional discussion among colleagues. It should not be changes in Kentucky law addressing how malprac- construed as legal advice. There is no way such a brief discussion of an issue tice claims against physicians are to be handled. or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of I’ve concluded that the legislature has put in place professional practice. It is always the best advice for a pharmacist to seek a requirement that before such a claim can go to counsel from an attorney who can become thoroughly familiar with the intricourt it must pass through a screening panel. How cacies of a specific situation, and render advice in accordance with the full is that supposed to work and are there any implica- information. tions for pharmacists or pharmacies in that new approach? serve as a panel member. If so selected, the panel Response: Most of the publicity and discussion in member must comply with the expectations outnews media about this development has focused on lined in the statute –KRS Chapter 216C.

the impact of this on claims against physicians and hospitals. However, the reach of this statute, known as Senate Bill 4, is much more broad. It covers pharmacists and pharmacies as well as other health professionals and health care facilities. The legislation bears a list of covered professions by referring to the portion of Kentucky Revised Statutes that govern the field. Chapter 315, the statutes governing pharmacists and pharmacies, is listed in the statute. At its core, this legislation requires peer review of malpractice complaints before they can go to court.

Having constituted the panel, the parties may submit potential evidence identified in the statute for review. The panel members determine (1) whether the evidence supports the claim that the practitioner or provider deviated from the expected standard of care, and (2) whether this shortcoming was a substantial factor in the adverse outcome the patient experienced. Agreement of two of the three panel members is needed for that conclusion, with the chairperson not participating in the voting.

If, upon receiving the decision of the review panel, the potential plaintiff decides to pursue the matter The panel to conduct the pre-trial review is comin court, the opinion of the review panel may be posed to the chairperson, who shall be an attorney, introduced into evidence and members of the panel and three health professionals. Each party to the may be called to testify about their review. claim selects one panel member and then those two In response to this provision in the law going into agree on the third member. The panel members effect July1, 2017, there were 111 medical malpracmay be from the same specialty as the health protice lawsuits filed in circuit courts around the state fessional proposed to be the target of the suit, i.e., just before that implementation deadline. the three panel members could be pharmacists if the suit is against a pharmacist or a pharmacy. The This development in public policy has its advocates and critics. Those who support the legislation see it statute notes that all health professionals licensed in the Commonwealth are eligible for selection to as an approach to earlier resolution of frivolous |28| Kentucky Pharmacists Association | September/October 2017


claims. The opponents view it as placing a barrier between potential claimants and the court system created to provide redress for aggrieved citizens. This entire legislative approach may not withstand judicial scrutiny as a result of at least one lawsuit filed to challenge it. The basic objection is that it places a hurdle in front of citizens seeking access to the courts for redress of grievances. As a practical matter, pharmacies and pharmacy owners should be alert for a certified or registered letter for which a signature is needed coming from the Kentucky Cabinet for Health and Family Services. This may bear a copy of a “Proposed Complaint” that launches this entire process. Should such a notification arrive, one should alert his or her professional liability insurance underwriter immediately. Additional Information: National Conference of State Legislatures-Medical Liability/Malpractice ADR and Screening Panel Statutes. http://www.ncsl.org/research/financial-servicesand-commerce/medical-liability-malpractice-adrand-screening-panels-statutes.aspx

Submit Questions: jfink@uky.edu

National Check Your Meds Day! October 21 With 90% of the country’s population within five miles of a pharmacy, you’re the community’s most accessible health care provider. Demonstrate your expertise and value on October 21 for the inaugural National Check Your Meds Day. Patients are encouraged to bring their prescription medications and supplements to their local pharmacy for a brown bag medication review. |29| www.KPHANET.org


Pharmacy Policy Issues How to Handle Hazardous Medications: Revisions in the USP-NF General Chapter 800 Hazardous Drugs – Handling in Healthcare Settings Author: Rebecca Seagraves, a native of Grayson, KY, is a third professional year student at the UK College of Pharmacy. She completed her pre-professional education at Morehead State University as a chemistry major. Issue: There seems to have been a flurry of activity recently with the USP updating, revising and expanding their standards related to compounding pharmaceutical dosage forms for patient use. What’s the latest on their expectations about handling potentially hazardous medications, those posing a potential threat to the pharmacist handling them?

person. This does not have to be a pharmacist but they need to understand the guidelines from the chapter and make sure the pharmacy is compliant. They will oversee all the monitoring, documentation, and reporting.3

There are some main changes to understand as a community or compounding pharmacy. First is that there will need to be a designated USP 800

tion. There will be no low volume exemptions like the ones outlined in USP 797.4 Personal protective equipment must include two pair of special gloves

All pharmacies must keep an inventory list of any hazardous drug in the pharmacy. This will need to be updated annually or on the receipt of any new Discussion: The US Pharmacopeia is in the pro- hazardous drug entity. Also, antineoplastic agents will not be allowed in an automated machine.3 cess of being revised by the USP Compounding Expert Committee. The official implementation A major implication will be risk assessment. This and compliance date will be December 1, 2019 in means that for each hazardous drug on inventory the next publication of the USP-NF. 1This will al- the category of hazardous drug that it is, the doslow time to adjust workplaces to these changes be- age form, the risk of exposure, the packaging, and fore they would be considered noncompliant. the manipulation to be done must be documented. There is a GAP analysis tool available to check This assessment will guide the containment recompliance. 2The new chapter will include ninequirement which will vary greatly. Any bulk agent teen sections and is aimed at protecting the such as a powder or any antineoplastic agent needhealthcare worker and the environment as well as ing manipulation must follow all containment rethe patient from hazardous drugs.3Previously, the quirements. These include facility implications as focus was on patient safety only. A hazardous drug well as personal protective equipment. These will is considered any drug included on the NIOSH list require a designated area to receive and unpack which is updated on even years. There are three hazardous drugs, separate storage from the noncategories of hazardous drugs including antineohazardous drugs in a negative pressure room, a plastic, non-antineoplastic, and reproductive toxici- designated area and set of equipment for comty only agents. These exhibit things like carcinopounding including a hood to work in with ventilagenicity and teratogenicity.3 tion, a sink for handwashing, and an eye wash sta-

|30| Kentucky Pharmacists Association | September/October 2017


This assessment will guide the containment requirement which will vary greatly. Any bulk agent such as a powder or any antineoplastic agent needing manipulation must follow all containment requirements. These include facility implications as well as personal protective equipment. These will require a designated area to receive and unpack hazardous drugs, separate storage from the non-hazardous drugs in a negative pressure room, a designated area and set of equipment for compounding including a hood to work in with ventilation, a sink for handwashing, and an eye wash station. There will be no low volume exemptions like the ones outlined in USP 797.4 Personal protective equipment must include two pair of special gloves changed at least every thirty minutes, a gown that closes in the back changed every 2-3 hours, and head, hair, and shoe covers. There are other requirements if there is a spill and something is being done out of the hood.3 If there are no bulk powders or antineoplastic agents needing manipulation then the pharmacy does not need to follow all containment requirements. They must, however, have an alternate strategy to minimize risk. For example, birth control is considered a hazardous drug but since it is not a bulk powder or an antineoplastic requiring manipulation the risk assessment could be “none� if the containment strategy is that the tablets will not be removed from the package. This assessment and plan will need to be done for every hazardous agent. Other alternative strategies may include designating a counting try, washing hands before and after counting, cleaning the counter, or wearing gloves. 3 There are other important points covered in the chapter that will be important to read, understand, and implement before compliance is required on December 1, 2019.

References: 1. 800 Hazardous Drugs - Handling in Healthcare Settings intent to revise. US Pharmacopeial Con-

vention, 15 Apr. 2016. Web. 21 Dec. 2016. <http://www.usp.org/uspnf/notices/hazardous-drugs-handlinghealthcare-settings> 2. Massoomi, F. USP 800 Safe Handling of Hazardous Drugs. Visante, Inc., 19 Apr. 2016. Web. 21 Dec. 2016. <http://visanteinc.com/wpcontent/uploads/2016/04/Visante-USP-800Webinar-Slides.pdf>. 3. Proposed <800> Hazardous Drugs - Handling in Healthcare Settings. US Pharmacopeial Convention, 1 Dec. 2014. Web. 21 Dec. 2016. <http:// www.usp.org/sites/default/files/usp_pdf/EN/ m7808_pre-post.pdf>. 4. <797> Pharmaceutical Compounding- Sterile Preparations proposed revisions. US Pharmacopeial Convention, 2 Nov. 2015. Web. 22 Dec. 2016. <http://www.usp.org/sites/default/files/ usp_pdf/EN/USPNF/usp-gc-797-proposedrevisions-sep-2015.pdf>.

Have an Idea? This column is designed to address timely and practical issues of interest to pharmacists, pharmacy interns and pharmacy technicians with the goal being to encourage thought, reflection and exchange among practitioners. Suggestions regarding topics for consideration are welcome. Please send them to jfink@uky.edu.

KPhA sends email announcements weekly. If you aren’t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to info@kphanet.org to get on the list. |31| www.KPHANET.org


6. See It All KPhA is the only statewide pharmacy organization that represents all pharmacists in all practice settings—you can learn about all the opportunities available within pharmacy and gain insights from pharmacists representing a variety of practice settings.

7. Develop Your Leadership Skills Participate as an active leader in a variety of committees and volunteer leadership positions that will develop your skills as you give back to your profession.

1. Strengthen Your Career KPhA members enjoy educational opportunities designed to increase knowledge and keep up with the latest information.

2. Advance Patient Care

8. Make a Positive Impact By joining KPhA, you are taking a step to ensure the future of the profession in Kentucky. We can’t do this important work without YOU.

The more you learn about drug and treatment updates through our publication, The Kentucky Pharmacist, as well as through attending OUR KPhA meetings, the better equipped you are to help your patients.

9. Make the Connection

3. Network with Others in Your Field

KPhA partners with many industry partners that offer discounts or important expertise that can positively impact your pharmacy.

KPhA members are invited to join their colleagues at the KPhA Annual Meeting & Convention and the Legislative Conference.

4. Advocate for Your Profession By joining KPhA, you are supporting the only organization representing the unified voice of all pharmacists. During the past year, KPhA’s work on health care legislation and regulation increased policy makers’ awareness of the pharmacist’s role in health care. KPhA continues to work on YOUR behalf.

10. Gain the Competitive Edge KPhA gives you exclusive access to unique experiences, career information, and resources designed to meet your needs and provide support as you advance in your career.

5. Proclaim Your Professionalism Adding your name to the ranks of your colleagues who are members declares your pride in the profession. Support KPhA’s advocacy efforts as we work with policy makers to implement health care reform legislation and as we continue to advocate for regulations that positively impact the profession. |32| Kentucky Pharmacists Association | September/October 2017

JOIN TODAY WWW.KPHANET.ORG


Welcome to KPhA! We’re so happy to have you! The list reflects new memberships received from July 1, 2017— August 31, 2017 Majaz Ahmed Elizabethtown

James Jasis Shelbyville

Tyler Sanders Bowling Green

Elizabeth Berryman Wilder

Ethan Kuszmaul Louisville

Claire Stall Lexington

Jeffery Bray North Salt Lake, Utah

Sarah Lisenby Crestwood

Jeb Stewart Madisonville

Amanda Brenske Louisville

Andrew McKinney Allensville

Samantha Winebarger Dixon

Talya Burnett Louisville

Amanda Miller Louisville

Andrea Carter Memphis, Tennessee

Byran Murphy Lexington

Sela Cathright Lexington

Courtney Pence Louisville

Allison Dixon Louisville

Mary Pummer Louisville

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

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

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Member News Hello Muddah, Hello Faddah: A Pharmacist’s Letter from Diabetes Camp Author: Andrea Carter is a PGY2 in ambulatory care at University of Louisville Hospital. Her practice interests: diabetes, transitions of care and infectious disease. Unlike the popular song about Camp Grenada filled with complaints of camp life, my experience at diabetes camp exceeded expectations. As a PGY-2 pharmacy resident in ambulatory care, I set off for camp excited to get out of the office, work with children, and serve in a nontraditional practice setting. I anticipated the most impactful part of camp would be learning about various insulin dosing strategies for type 1 diabetes and insulin pump technology, but I was surprised to learn many other more valuable lessons.

on staff gives parents the peace of mind that their child will be properly assisted in managing diabetes during their week away from home. It also provides parents a much-needed break from the stress of managing diabetes.

As members of the medical staff, my coresident and I managed insulin therapy for ten adolescent boys all of whom were on insulin pumps. We were initially nervous due to limited experience with both type 1 insulin management and insulin pumps themselves. However, we received camp medical training that reviewed dosing strategies, various pump models, and camp procedures including those for medical emergencies. Additionally, many of the medical-pediatric residents had no more experience than we did. This similarity Camp Korelitz is a week-long residential encouraged us to collaborate to discuss new techcamp held at Camp Joy in Clarksville, Ohio, for niques we identified or seek advice on campers that children/adolescents ages 8 to 15 with type 1 dia- were difficult to manage. We also were blessed to betes. When I told most of my friends and family I work under the guidance of outstanding pediatric was going to a diabetes camp, they assumed that it endocrinologists. They not only provided great inwas primarily an educational experience for the struction but also the autonomy to apply various campers. While campers do attend sessions on management strategies. healthy lifestyle modifications, medication educaEach day we were responsible for assessing tion, and advocacy, the primary objective of the our campers’ blood glucose values to make necescamp is to provide a safe environment for children sary changes to their insulin regimens. At a minito have a traditional camp experience. I enjoyed mum, the campers are required to check eight watching our campers challenge themselves on times a day including midnight and 3 am readings. high-ropes courses, participate in team-building Being with the campers all day and knowing their activities, and show off their best dance moves at exact carbohydrate intake and activity level alour space-themed dance party. Having physicians, lowed us to witness first-hand the effects of exernurses, pharmacists, dieticians, psychiatrists, and cise and dietary changes on blood glucose values. counselors (many of whom have type 1 diabetes) However, it was often impossible to maintain sta|34| Kentucky Pharmacists Association | September/October 2017


ble blood glucose values even accounting for all these factors in our insulin adjustments. At the start of camp, I anticipated making some significant changes to my campers’ regimens; however, I was not prepared for how frustrating it was to do all the “right” things and still fight uncontrolled blood glucose values. When practicing in an outpatient clinic, it is easy to view uncontrolled blood glucose values as a failure of the patient to follow a diet, monitoring plan, insulin regimen, etc. Although many excursions are due to non-compliance, camp has taught me that often these episodes are unpredictable. Moreover, they are even more frustrating and discouraging to the patient than they are to us as practitioners. Throughout my time at camp, the most rewarding experience wasn’t learning how manage insulin therapy, becoming familiar with various insulin pumps, collaborating with other health care professionals, or participating as a first responder for a camper who had a seizure from severe hypoglycemia. Although all of these experiences made me a more competent pharmacist, it was my interactions with the campers that have made me a more empathetic pharmacist. As healthcare professionals, we all intellectually know that it is difficult to live with type 1 diabetes. But it was eye-opening to witness the time and foresight required for blood glucose monitoring and insulin pump maintenance. It was difficult to sit on the sidelines with campers having hypoglycemia episodes while others campers got to participate in group activities. It was depressing to wake campers up at 3 am every night to check blood glucose then potentially have to eat a snack or test for urine ketones. And it was frustrating to listen to them talk about discrimination they face in classrooms and on athletic teams concerning diabetes self-care. Through these moments, I learned the importance of acknowledging the difficulty living with diabetes when practicing in a culture driven by core measures and therapeutic outcomes. Camp reminded me that our patients are

people, not projects. The highlight of diabetes camp was listening to campers share how camp has changed their lives. Most of the fifteen-year-old campers have attended Camp Korelitz for multiple years. Several of them said that their camp friendships grew and continued outside of camp. They felt like these friends are the only ones who truly understand them despite having excellent support from family and friends at home. Other campers discussed looking forward to camp every year because it was the only time that having diabetes is the norm and not the exception. To the campers, it is almost as if they have a break from worrying about their diabetes. Medical staff manage their insulin regimens, and the camp staff structure activity and meal schedules with diabetes self-care in mind. For example, the camp dance party turned off all the music half-way through the evening to allow for blood glucose checks and snack time so that no one has to miss out on dancing. Finally, the campers discussed learning how to become the best versions of themselves. One of my boys broke down in tears saying that his camp friends and mentors were responsible for his transformation from a kid who was mean and bitter to an adolescent who is kind and wants to be a positive role model for younger kids with diabetes. Several of our campers commented that if a cure for diabetes became available, they would not choose it. Diabetes is such a large part of their identity and overcoming the struggles with associated with diabetes has built their character and changed them for the better. During my week at camp Korelitz, I learned everything I had anticipated and more. I realized that the most rewarding part of camp was being part of the team that allowed these campers a safe space to experience the personal growth and empowerment that come from camp friendship and mentorship. Have content to share in “Member News”? Email us info@kphanet.org.

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KPhA BOARD OF DIRECTORS Trish Freeman, Lexington trish.freeman@uky.edu

Chair

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

Chris Harlow, Louisville cpharlow@gmail.com

President

KPERF BOARD OF DIRECTORS

Chris Palutis, Lexington chris@candcrx.com

President-Elect

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Jessika Chinn, Beaver Dam jessikachilton@ymail.com

Past President Representative

Directors

Clark Kebodeaux, Lexington clark.kebodeaux@uky.edu

Secretary

Duane Parsons, Richmond dandlparsons@roadrunner.com

Treasurer

Chris Harlow, Louisville cpharlow@gmail.com

President

Paul Easley, Louisville rpeasley@bellsouth.net

Sarah Lawrence, Louisville slawrence@sullivan.edu

Matt Carrico, Louisville* matt@boonevilledrugs.com University of Kentucky Student Representative

Kelly Smith, Lexington ksmit1@email.uky.edu

KPERF ADVISORY COUNCIL

Chad Corum, Manchester pharmdky21@gmail.com

Matt Carrico, Louisville matt@boonevilledrugs.com

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

Chair

Melinda Joyce, Bowling Green MBJoyce@chc.net

Angela Brunemann, Union Angbrunie@gmail.com

Jaclyn Ochsner, Lexington jaclyn.Ochsner@uky.edu

Bob Oakley, Louisville rsoakley21@gmail.com

Sullivan University Student Representative

Chris Killmeier, Louisville cdkillmeier@hotmail.com Don Kupper, Louisville donku.ulh@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield willettsam@bellsouth.net

Kim Croley, Corbin kscroley@yahoo.com Kimberly Daugherty, Louisville kdaugherty@sullivan.edu Mary Thacker, Louisville mary.thacker@att.net

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

*At-Large Member to Executive Committee

HOUSE OF DELEGATES Amanda Jett, Louisville Speaker of the House ajett@sullivan.edu

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K.PH.A. BREAKS GROUND FOR BUILDING The official ground-breaking ceremonies for the new building to house the Kentucky Pharmaceutical Association and the Kentucky Board of Pharmacy were held at 12:00 Noon E.S.T. October, 2, 1967, with an estimated crowd of some seventy-five persons representing pharmacy from the various sections of the state. - From The Kentucky Pharmacist, October 1967, Volume XXX, Number 10

Frequently Called and Contacted Kentucky Pharmacists Association 96 C Michael Davenport Blvd. Frankfort, KY 40601 (502) 227-2303 www.kphanet.org Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov Pharmacy Technician Certification Board (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

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

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

KPhA Staff Mark Glasper Executive Director mglasper@kphanet.org Sarah Brandenburg Director of Communications & Continuing Education sbrandenburg@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Jody Jaggers, PharmD Director of Pharmacy Emergency Preparedness jjaggers@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org

KPhA Remembers KPhA desires to honor members who are no longer with us. Please keep KPhA informed by sending this information to eramey@kphanet.org. Deceased members for each year will be honored permanently at the KPhA office.

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THE

Kentucky PHARMACIST 96 C Michael Davenport Blvd. Frankfort, KY 40601

Legislative Conference Friday, November 17 Register Online www.kphanet.org

www.kphanet.org |40| Kentucky Pharmacists Association | September/October 2017


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