The Kentucky Pharmacist Vol. 8 #3

Y K C U T N E K E H T T S I C A M PHAR LEGISLATIVE Vol. 8, No. 3 May 2013

ROUNDUP 2013

Senate Bill 107 Passes with no dissenting votes!

Thanks to your calls, visits and testimony, KPhA’s top priority was approved!

Have you registered? www.kphanet.org

Don’t forget to vote for KPhA Board of Directors!

Deadline 5/21/13 www.kphanet.org

News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

May 2013

Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 135th KPhA Annual Meeting Message from Your Executive Director SUCOP student pharmacists in Costa Rica 2013 Legislative Wrapup Support the Bowl of Hygeia May 2013 CE: Nicotine Replacement Therapy May Pharmacist/Pharmacy Tech Quiz Drug Information Center at SUCOP

June 2013 CE: Testosterone Replacement June Pharmacist/Pharmacy Tech Quiz KPhA Emergency Preparedness KPhA New and Returning Members Pharmacy Law Brief Pharmacy Policy Issues Kentucky Renaissance Pharmacy Museum Pharmacists Mutual Senior Care Corner KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted

2 3 4 6 8 11 15 16 24 25

26 32 33 34 36 38 39 40 41 42 43

Oath of a Pharmacist At this time, I vow to devote my professional life to the service of all humankind through the profession of pharmacy.

I will consider the welfare of humanity and relief of human suffering my primary concerns.

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

I will keep abreast of developments and maintain professional competency in my profession of pharmacy.

I will embrace and advocate change in the profession of pharmacy that improves patient care.

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

Kentucky Pharmacists Association

The Kentucky Pharmacy Education and Research Foundation (KPERF), established in 1980 as a non-profit subsidiary corporation of the Kentucky Pharmacists Association (KPhA), fosters educational activities and research projects in the field of pharmacy including career counseling, student assistance, post-graduate education, continuing and professional development and public health education and assistance.

The mission of the Kentucky Pharmacists Association is to promote the profession of pharmacy, enhance the practice standards of the profession, and demonstrate the value of pharmacist services within the health care system.

Cover Photo: Special thanks to Gov. Beshear’s office for allowing the use of the photo documenting the signing of SB 107.

It is the goal of KPERF to ensure that pharmacy in Kentucky and throughout the nation may sustain the continuing need for sufficient and adequately trained pharmacists. KPERF will provide a minimum of 15 continuing pharmacy education hours. In addition, KPERF will provide at least three educational interventions through other mediums — such as webinars — to continuously improve healthcare for all. Programming will be determined by assessing the gaps between actual practice and ideal practice, with activities designed to narrow those gaps using interaction, learning assessment, and evaluation.

Additionally, feedback from learners will be used to improve the overall programming designed by KPERF.

Editorial Office: © Copyright 2013 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. 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.

Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org.

Website http://www.kphanet.org.

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President’s Perspective

May 2013

President’s Perspective

care?” I replied to him, we come to meetings and give up our free time to try and help our profession because we care about our profession. In fact, in my opinion, caring separates us from being workers into being professionals. I also hold to the truth that each of us have the ability to make a difference and that when we work together towards a common goal, we are a force with which to be reckoned!

Kimberly Sasser Croley

This brings me to my last paragraph of this amazing year!

When YOUR KPhA calls you to join a committee, or the Advancing Pharmacy Practice Coalition asks you to join the cause, or a student pharmacist group asks you to sponsor a health fair, please do it! When you see a legislator in your pharmacy, make sure to tell him or her who you are and what you do! Offer to speak to Chemistry students about Pharmacy as a career; volunteer to do a Brown Bag at a local Senior Citizen Center. These opportunities will build the Relationships we all desire and prove the Relevance we bring to our communities. They also will afford us professional and personal satisfaction and make every “pharmacy job” your “dream job.”

KPhA President 2012-2013

At the APhA Annual Meeting in Los Angeles in March, the House of Delegates passed the following Policy Statement without a dissenting vote, “Pharmacists are Providers which should be recognized/compensated by payers.”

YOUR KPhA, YOUR Profession, Needs YOU!

Oh, I told you that before you say! Guess what, you needed to hear it again.

The 2013 KPhA Board of Directors Election will be held online at www.kphanet.org.

This is the last issue of Relevance and Relationships because my year as President of YOUR KPhA is quickly (and sadly) coming to a close. Time passes by so quickly, and I find that my Mama was right: the older you get, the quicker the years fly away! I love my profession! I have the best job in the world, and I love going to work every day. I wish for all of you the same joy that I have! I worry so much about our young student pharmacists as they enter the profession for the first time. They graduate from our prestigious colleges of pharmacy with such high expectations, but I don’t think their expectations are always matched by their job choices (at least they don’t think they do).

You will need to log in to the site to cast your vote.

They think their first job as a pharmacist should be their dream job and are so disappointed when it doesn’t work that way.

Paper ballots will be available, but ONLY upon request.

I would like to offer in this column that, if you want satisfaction in your professional life, you must do more than show up to work on time. A dear friend of mine shared with me one time that a lot of his colleagues he worked with told him he was crazy to give up his days off from work to attend professional meetings. Their contention was that if he didn’t attend the meetings someone else would do that work and he could find something better to do with his time off. After one particularly long meeting, he shared this story with me and asked, “Am I an idiot for giving up some of my valuable free time to attend meetings; does anybody really

Call the KPhA Office at 502-227-2303 for more information.

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135th KPhA Annual Meeting

May 2013 Preconference events on June 6: 

 

Immunization Training (5 hour CE credit) CPR Recertification KPERF Golf Scramble

Register now at www.kphanet.org Friday, June 7, 2013 (up to 7.5 CE) 7 am Registration Opens 8 am-8:30 am Opening Breakfast 9 am Opening House of Delegates 9-10:15 am Immunization Update (1.25) Fraud Waste and Abuse (1.25) 10:15-10:30 am Break 10:15-Noon Board of Pharmacy Advisory Council 10:30-11:45 am Pharmacy’s role in Emergency Preparedness (1.25)* Documentation Requirements for Medicare DMEPOS Pharmacies (1.25) 10:30-noon Pharmacy Transitions Program (Non-CE) 12 noon KPhA Awards Luncheon 1:30-4 pm Finance 101 for Pharmacy (2.5) 1:30 -3:30 pm Accountable Care Organizations (2) 3:30-4 pm Break 4-5:30 pm Self-Care Championship CE Program (1.5) Diabetes Update (1.5) 5:30-7:30 pm Opening of Hall of Exhibits 8 pm Dessert Reception Financial Planning for Student/ New Practitioner 8 – 9 pm Electronic Health Information Exchange (1)

Saturday, June 8, 2013 (up to 5 CE) 7:30 am Registration/Continental Breakfast 7:30 am Reference Committee 8-10 am New Drugs CE Program (2)* 9-10 am Preceptor CE Program (1) 10 to noon Hall of Exhibits Open 12 noon Lunch (UK Preceptor Recognition) 1:30-2:30 pm Law Update CE Program (1)* 2:30-2:45 pm Break 2:45-3:45 pm Creating a Career Ladder for Pharmacy Technicians (1)* MTM CE program (1) 3:15-5pm House of Delegates Closing Session 4-5 pm Handling Complaints in the Community Pharmacy Part 1: Dermatology (1) 6 pm President’s Reception 7 pm Ray Wirth Banquet Sunday, June 9, 2013 (2 CE) 7:30 am Continental Breakfast 8 - 10 am Handling Complaints in the Community Pharmacy Part 2: Eye/Ear (2 hr) *Pharmacy Technician Track To book your hotel room online, visit YOUR www.kphanet.org and follow the link from the 135th Annual Meeting page. Or contact Louisville Marriott Downtown at 1-800-266-9432 and reference Group Code KY Pharmacists Association for the special rate of $119/night. Cut-off for this rate is May 14, 2013.

Lodging rate includes wireless internet access.

Accreditation is pending for these activities.

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

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135th KPhA Annual Meeting

May 2013

Support Pharmacy’s Future with a gift to the KPhA Annual Meeting As the 135th KPhA Annual Meeting approaches, student pharmacists at UK and Sullivan are getting excited about this opportunity. We are writing to ask for your financial support for student involvement at the KPhA Annual Meeting.

State-wide meetings offer student pharmacists a great opportunity to network with you, our colleagues. Student pharmacists bring energy to the meeting. We are eager to learn about the latest advances in the continuing education programs and to see how KPhA is governed in the House of Delegates. We support the work of the Association by assisting staff with speaker introductions, by collecting evaluation sheets in the CE programs, helping with registration and in completing other tasks.

If you remember when you were in our place, you know we don’t have the monetary resources to pay for hotel rooms and the meals at the annual meeting. KPhA solicits support to cover the majority of these costs for us, and that’s why we are asking for your assistance. Please consider sponsoring Pharmacy’s Future by donating to the KPhA Annual Meeting. You can submit a check to KPERF, which is tax deductible. Mail your check payable to KPERF to KPhA Annual Meeting, 1228 US 127 South, Frankfort, KY 40601, or make a donation online at www.kphanet.org under the Education tab.

Thank you for your assistance in opening this door for student pharmacists!

Heather Bryan SUCOP Class of 2015

Brooke Herndon UKCOP Class of 2015

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From Your Executive Director

May 2013

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR Robert “Bob” McFalls While there isn’t an "i" in team, there’s certainly one in WIN (Michael Jordan). If there was an advocacy theme for this year’s legislative session, it was all about the WIN in getting SB 107 passed. YOUR KPhA PHARMACIST TEAM spoke with one clear and consistent voice, and our legislators listened and voted their unanimous support.

Maintaining KPhA’s presence in the Capitol is a high priority for members of YOUR KPhA. Legislative advocacy for the profession of pharmacy is vital to preserve a favorable and progressive environment for the practice of pharmacy throughout the Commonwealth. To call again upon the illustration of tropical fishkeeping, good water quality is key to successful aquatic life. Broadly speaking, if you are a dedicated hobbyist and you look after the water quality, the fish will thrive. Can’t the same be said for the profession of pharmacy?

When I was in my early 30s, I relocated from Lexington to Memphis and sought an opportunity to connect with a new social team. I found that experience with a great group of fellow tropical fish hobbyists within the Mid-South Aquarium Society. It was a great experience — planning and participating in competitive fish shows, engaging in educational presentations, buying locally bred fish and the like. Our ranks included an editor of the Tropical Fish Hobbyist, who was an expert among experts invested and knowledgeable about the hobby. Over time, we witnessed a decline in attendance at our monthly meetings as we competed with the Internet.

What the new hobbyists did not fully appreciate was the value of being in community — being able to connect with the expert resource that was literally “in the room” at our meetings.

Are Kentucky pharmacists aware of their scope of practice? Do you think it could improve? Do you know how the scope of practice is determined? Or, are you like a tropical fish in cloudy water and willing to swim in the water where you are? As a member of YOUR KPhA, you know that the scope of practice for a Kentucky licensed pharmacist is not determined by your professional degree. You realize that the scope of practice is a function of the legislative process and intentional engagement. Who cleaned the water of pharmacy before you? Or who did not? That may well be the reason for much of the muddy water we are attempting to clean up today. How I would offer that this experience is about becoming aware of the proanalogous to engaging with YOUR fession's water status and encourKPhA and your colleagues — age others to join with you in taking responsibility for the pharmacists and pharmacy technicians alike “in the room” great opportunity you have to practice as trusted together in pushing the agenda forward. Kentucky was rechealthcare professionals? YOUR KPhA is the key to the ognized by NCPA as the first state to have passed a “MAC” continued expansion and updating of the "legal" practice of bill for PBM transparency. Throughout our history, YOUR the profession of pharmacy as we work with our partners KPhA has maintained a positive and respected position in and decision makers. At KPhA, we invest every day in adthe Commonwealth’s political arena. YOUR KPhA PHARvocacy for pharmacists. Our door is open to pharmacists MACIST TEAM’s success this year was built upon a twoand pharmacy technicians who identify issues that need to year educational effort, a commitment to advance the conbe addressed to improve the value of your license and your versation and need with our elected officials, a willingness career. Our pharmacist educators regularly communicate to work with pharmacists from all practice settings and a the expanded education of our graduates and how they collaborative team effort with our KPhA lobbyists and partcan provide new services in today's healthcare delivery. ners. At the end of the day, the one-on-one engagement by individual pharmacists was the critical ingredient in getting Will you consider making a water change? One of my fathis important legislation approved and signed by Governor vorite fish through the years was a scavenger that originatBeshear. ed from the Amazon River who I named Plecostomus 6

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From Your Executive Director Jones. Did you know that fish grow larger when given more space? P.J. certainly did, growing to 17” before I stunted her growth when I refused to move beyond a 110-gallon aquarium. This begs the question, “What could pharmacists and techs do with a larger scope of practice and expanded career opportunities?”

It is time for pharmacists and techs to step up and to take responsibility to change the water in which you swim. We

May 2013 know that pharmacists have the power to WIN by putting your “I” self forward. Abdicating one’s professional responsibility by not being actively engaged with your colleagues in your professional association only muddies the water for the profession's future. Engage and embrace the WIN that is yours for the taking by diving deep with YOUR KPhA to improve the practice of pharmacy and to advance the future of the profession.

KPhA Leaders Attend NASPA Leadership Conference KPhA President-Elect Duane Parsons and Executive Director Robert McFalls journeyed to Rockville, Maryland, Sunday through Tuesday of this week, to attend the annual National Alliance of State Pharmacy Associations Leadership Conference sponsored by Pharmacists Mutual Insurance Companies held at US Pharmacopea. This meeting included invited association executives and their president elects from nearly all states as well as the leadership of NCPA, APhA, NACDS and AACP. The conference focused on such things as board and officer liability, a review of the existing association model, membership trends and strategic thinking and visioning for the future. National executives shared their insight on the changes pending for pharmacy.

2013 KPERF Golf Scramble June 6, 2013 at Covered Bridge Golf Club 12510 Covered Bridge Road, Sellersburg, IN 47172

Register now at www.kphanet.org 7

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SUCOP Students in Costa Rica

May 2013

SUCOP students travel to Costa Rica By: Steven Jenkins, PharmD Candidate, Jenny Quinn, PharmD Candidate, Tram Thai, PharmD Candidate and Amber Riesselman, PharmD, Sullivan University College of Pharmacy Introduction Each year, thousands of students travel overseas to both developed and underdeveloped countries to study abroad.

Whether it is to learn a new language or cultural exposure, complete a degree or volunteer for community outreach, they all have a common goal: studying abroad remains a meaningful and invaluable experience that can be transferred to all aspects of one’s personal and professional life.

This Advanced Pharmacy Practice Experience (APPE) rotation takes place in Costa Rica, a middle-class, developing country and is considered one of the safest and most stable countries in Central America.1 In addition to cultural immersion, Costa Rica offers a plethora of learning experiences for students including community volunteerism, working in a pharmacy and hospital tours. and attending Spanish classes on an average of 20 hours per week. To assess common medical conditions in Costa Rica, pharmacy students are exposed to impoverished communities, as well as the healthcare system by working

The Costa Rica APPE is designed to completely immerse P3 (final year) pharmacy students into the Spanish culture.

Students are given many opportunities to improve their Spanish proficiency such as living with a “Tico” host family

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SUCOP Students in Costa Rica

May 2013

in a local community pharmacy and participating in hospital tours. Pharmacy students also attended dance classes, futbol games, cooking classes when available and traveled to unique destinations to experience the culture and natural beauty of Costa Rica.

Spanish Classes Spanish classes are taught at the Escuela de Lenguas y Experiencias Culturales (ELEC) on Monday through Friday approximately 20 hours per week for four weeks. The classes are designed in an original approach to expose students to everyday common Spanish conversation. Even though the professors are bilingual in Spanish and English, speaking in English is highly discouraged unless absolutely necessary. At ELEC, they believe it is very important to be able to communicate in Spanish daily; therefore, communication takes precedence over correct grammar. However, Spanish was not the only thing taught at ELEC; students also learned traditional Latino dances such as salsa and meringue, and discovered how to prepare typical Costa Rican food.

used the public transportation system to and from work. Pharmacy students were scheduled to work in the pharmacy for 2.5 hours for three days each week during weeks two and La Carpio three. Since most of the La Carpio is a poor, deprived community on the outskirts of pharmacy students were beginners in Spanish, working in San Jose. It is overpopulated with roughly 40,000 refugees the community pharmacy was more of an observational mainly from Nicaragua. Toxic living conditions can be con- experience. This time gave students the chance to comtributed to scrap metal housing, polluted rivers and the pare between U.S. and Costa Rican prescription laws, landfill that surrounds one side of La Carpio. Community common disease states and medications and pharmacy outreach work in La Carpio was organized through a non- school curriculum. Additionally, the pharmacy allowed stuprofit organization, the Costa Rican Humanitarian Founda- dents to practice their medical Spanish by listening to the tion (CRHF). Since 1997, the CRHF has been working in pharmacist counsel patients. Depending on the student’s impoverished communities to address an extensive array level of comfort and proficiency in Spanish over time, some of social problems in Costa Rica.2 The CRHF pre-identified pharmacists allowed the students to measure blood preshealth topics for students to present “charlas” or “talks” to sure and counsel patients on medications. community members in Spanish at the Guaderia la LiberHospital Tours tad. Students spent a few half days in La Carpio during Costa Rica currently has seven major National Hospitals, week 1 and 4 of their rotation. Sullivan students were responsible for presenting a total of four charlas during their three of which are located in San Jose. Students were able to take a tour of Hospital Mexico, which was the first hospitime in La Carpio. Some of the topics covered were exertal constructed in Costa Rica in 1969. Costa Rica decided cise, healthy foods, fresh rain water, relationships, hyperto name the hospital after Mexico due to receiving much tension, diabetes, antibiotics, fever reducers in children help from their northern neighbor. At the time, Costa Rica and dental care. The CRHF also invited a few women to did not have any resources to staff the hospital they were share stories of how the foundation has helped them planning on building. Mexico helped Costa Rica design the through their struggles and how they are now able to provide better opportunities for their family. Tours through the hospital and accepted Costa Rican students to their medical schools to staff the new hospital. Hospital Mexico is a neighborhood and by the river gave students exposure to public hospital, which means that it is operated by the Caja the harsh living conditions and pollution in La Carpio.

Costarricense de Seguro Social (CCSS) which is commonLa Farmacia ly called the CAJA. The objective of the hospital tour was Pharmacy students worked in a local community pharmacy for students to acknowledge barriers of the current struclocated in San Isidro, San Pablo or San Rafael. If the phar- ture and gain a comprehensive perspective of the macy was located in San Pablo or San Rafael students healthcare system in Costa Rica.

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SUCOP Students in Costa Rica

May 2013 This experience has constantly tested our critical thinking skills and has expanded our perspective of the Latino culture. Despite the challenges we faced, the experiences gained from this international rotation are invaluable.

Conclusion As third year students at Sullivan University College of Pharmacy, we understand that APPE rotations are designed to impart knowledge and solidify the curriculum learned in our first two years of classes. These rotations are a critical part of our education and aid in preparing us for our careers as practicing pharmacists. The Costa Rica APPE rotation met all of these criteria and exceeded our expectations as an educational experience. This rotation differed greatly from the traditional APPE in the United States; however, we felt that we gained valuable knowledge from living in Costa Rica that would have been impossible for us to obtain in Kentucky. It was structurally organized well and reemphasized our areas of interest.

References 1. Costa Rica Country Specific Information (5/29/12).

Travel.State.Gov. Web site. Available at: http:// travel.state.gov/travel/cis_pa_tw/cis/cis_1093.html. Accessed March 15, 2013.

2. Costa Rican Humanitarian Foundation (n.d.). The Costa Rican Humanitarian Foundation Web site. Available at: http://www.crhf.org/about-us/. Accessed March 15, 2013.

KPPAC Contribution Form Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPPAC)

Mail to: Kentucky Pharmacists Political Advocacy Council, 1228 US Highway 127 South, Frankfort, KY 40601

CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election.

Individuals may contribute no more than $1,500 per year to all PACs in the aggregate.

In-kind contributions are subject to the same limits as monetary contributions.

Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election.

(This information is in accordance with KRS 121. 150)

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2013 Legislative Wrapup

May 2013

SUMMARY OF PHARMACY ISSUES 2013 Kentucky General Assembly A Member Update from YOUR KPhA Overview: KPhA gratefully acknowledges the engagement of pharmacist members throughout the Commonwealth who made legislative advocacy a personal priority during the 2013 legislative session. Pharmacists were united in your resolve to make a difference by conducting regular telephone calls and engaging in one-on-one conversations with your state senators and representatives. From the Government Affairs Committee, Chair Richard Slone and the entire Board of Directors: Give yourself and your colleagues a well-deserved “pat on the back” for your due diligence and commitment. Your advocacy continues to make a difference! For the second year in a row, the top priority for YOUR KPhA advanced through the legislative process, this year without a dissenting vote! Be sure to cess the complete sumthank your legislators and let them know what their support maries prepared by legmeans to pharmacy in Kentucky. islative staff and all action on the measures, KPhA acknowledges and thanks our advocacy partners for as well as review the this session: American Pharmacy Cooperative, Inc., Amerfull text of individual bills ican Pharmacy Services Cooperative, EPIC Pharmacies, and resolutions. Bills Inc., Kentucky Independent Pharmacy Alliance, Kentucky enacted during the Retail Federation, National Association of Chain Drug 2013 Session will take effect on June 25 unless a specific Stores and the National Community Pharmacists Associaeffective date was included in the legislation or the legislation. tion contained an emergency clause which made it effecLawmakers adjourned the 2013 General Assembly at mid- tive as soon as it was signed by the Governor. night March 26, 2013. This year’s session was a busy and Pharmacy Benefit Managers (PBM): Governor Steve productive one for YOUR KPhA. The KPhA grassroots Beshear signed SB 107 on March 22. The bill represents a efforts led to passage of the association’s three key legismajor victory for Kentucky’s pharmacies as it establishes a lative priorities including PBM transparency legislation (SB set of basic disclosures that PBMs must make in their 107), revisions to Kentucky’s controlled substance statutes dealings with contracted pharmacies. It requires that a (HB 217) and a clarification of the state’s pseudoephedrine PBM disclose in its contract with the pharmacy the pricing law (HB 8). KPhA also was successful in stopping legislaindices used to calculate the reimbursement paid to the tion restricting the substitution of opioids (HB 74), another pharmacy for drug products. It also specifies that if the legislative priority. The KPhA legislative team followed PBM uses maximum allowable cost (MAC) to determine more than 30 pharmacy-related bills this session and the reimbursement, it must disclose to the pharmacy what Association had significant input on many of these products are subject to MAC and what the MAC is for each measures. of those drugs. SB 107 requires PBMs to update MAC lists The following summary provides a narrative regarding the at least every 14 days and establishes parameters for activity on some of the major issues affecting the pharma- price appeals by pharmacies. The bill was amended in the cy community that were considered during this year’s leg- Senate to delay the requirement that PBMs provide retroislative session. The electronic version of the 2013 Sumactive reimbursement for successful MAC appeals. That mary of Pharmacy Issues on the KPhA Website language requires the PBM to include in their contracts (www.kphanet.org) under the Advocacy tab, includes links with pharmacies a process for retroactive reimbursement to the legislature’s official website so you can easily acfor successful appeals no later than one year following the 11

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2013 Legislative Wrapup

May 2013

effective date of the act. The bill was sponsored by Senate Health and Welfare Committee Chairman Julie Denton (RLouisville) and had broad bipartisan support in both chambers, passing without a single no vote in either chamber.

Controlled Substances: A bill revising the comprehensive anti-prescription drug abuse law enacted in 2012 quickly won legislative approval and was signed into law by the Governor on March 4. HB 217, sponsored by House Speaker Greg Stumbo (D-Prestonburg), incorporated many suggestions put forth by physicians, KPhA member Barry Eadens and other pharmacists, Executive Director Robert McFalls and law enforcement officials brought up in hearings on the issue during the interim. It was designed to mitigate some of the unintended consequences caused by the passage of HB 1 during a 2012 special session. Two major changes of interest to pharmacies are included in the proposal. HB 217 eliminates the requirement that hospitals and long term care facilities report drugs administered directly to patients to the state’s electronic controlled substances database (KASPER). Another provision eliminates the need for pharmacists to report the loss or theft of controlled substances to the state police. This requirement created unnecessary duplicate reporting requirements since pharmacists must already file reports with the DEA, Board of Pharmacy and local law enforcement officials. Both of these changes were requested by KPhA members and partners during the interim hearings. HB 217 contained an emergency clause making it effective upon the Governor’s signature (March 4).

Stumbo (D-Prestonsburg) sponsored the legislation granting the Department of Insurance more authority over payments to providers by Medicaid Managed Care Organizations (MCOs). HB 5 was a response to ongoing problems health care providers are experiencing with getting paid for services provided to Medicaid recipients enrolled in managed care. Currently, providers have to deal with both the state Medicaid agency and the Department of Insurance to resolve payment delay issues. Oftentimes providers are frustrated with their inability to get final resolution. HB 5 seemed to stall in the Senate but ultimately received approval in the last days of the 2013 Kentucky General Assembly. Governor Beshear, however, vetoed the bill on April 5 and since the legislature adjourned in March, there was no opportunity to override the veto. Beshear issued a press release following the veto pledging to aggressively pursue a plan to ensure prompt payment to health care providers participating in Kentucky’s managed care Medicaid system.

Although Governor Beshear vetoed the bill, he announced a multi-pronged action plan to address the legislature's concerns, including: 

Prompt pay disputes to be reviewed by Ky. Dept. of Insurance: Keeping with the intent of HB5, the first action directed by the Governor was to move all responsibility for governmental review of provider complaints relating to prompt payment of medical claims from DMS to DOI. DOI has a well-established prompt payment dispute resolution process in place for use in the private health insurance market. This mechanism will allow for efficient review and resolution of claims. If improper payment practices are discovered, DOI can impose sanctions.

Pseudoephedrine Sales: Unlike recent legislative ses sions, the issue of pseudoephedrine (PSE) sales was not at the forefront. One measure relating to PSE sales, however, was acted upon by the legislature and is now law. HB 8, a bill dealing with synthetic drugs, contained a provision clarifying that pharmacies may continue to use a written signature to comply with the state’s PSE purchasing restrictions. The language was supported by KPhA and the pharmacy community as well as the Kentucky Office of Drug Control Policy. A stand alone bill, HB 146, also addressed the issue but that measure stalled in the House.

Since HB 8 contained an “emergency clause”, it became  effective on March 19.

Targeted audit of each statewide MCO by Ky. Dept. of Insurance: The Governor directed DOI to conduct targeted audits of the three statewide MCOs. These reviews, called "Targeted Market Conduct Examinations," will seek out whether systemic changes are needed to address areas such as claim or complaint handling, prior authorization practices or emergency medical service payments. MCOs will pay for the examinations, and reports are expected to be complete no later than August 15. Failure to comply with policies will result in sanctions.

REMINDER FROM 2012 Session: As a result of HB 1 from 2012, pharmacies will be required to report to KASPER by the end of the next business day beginning on July 1, 2013.

Medicaid Managed Care: A number of proposals dealing with Medicaid managed care were filed this session but only one was approved by the legislature and that measure was vetoed by Governor Beshear. House Speaker Greg 12

Education forums on best practices: The Governor directed enhanced educational efforts to improve the managed care system. The Cabinet for Health and Family Services (CHFS) will sponsor educational forums in each of the eight Medicaid regions to allow medical providers, MCO representatives and DOI rep-

THE KENTUCKY PHARMACIST

2013 Legislative Wrapup

May 2013

resentatives to meet face-to-face to discuss concerns about proper billing, appeals processes and any specific regional issues related to managed care. In addition, these forums are designed to foster conversations about how to improve the overall system of health care delivery. The schedule can be found on the KPhA website under Resources, Medicaid Information, Managed Care Organizations.

Representative Bob Damron (D-Nicholasville) and Senator Bob Leeper (I-Paducah) introduced similar proposals (HB 299 and SB 178) requiring Medicaid managed care organizations to abide by certain provisions of the insurance code regarding patient protection. Since the expansion of managed care in the state’s Medicaid program in 2011, patients as well as providers have voiced complaints about the provision of services, coverage and payment. Although the managed care organizations are licensed by the Department of Insurance, they are not subject to many of the rules that apply to other insurance companies. Last session, patient and provider groups joined forces to urge the legislature to compel MCOs to follow the same rules as commercial insurers. That effort fell short, and no legislation was enacted. Damron’s bill, HB 299, died in the House while Leeper’s bill, SB 178, never received a hearing in the Senate committee to which it was assigned. Other proposals impacting Medicaid managed care also were filed but failed to pass, including one to require MCOs to establish uniform copayments for drugs. HB 449 easily cleared the House but died on the Senate floor after the state Medicaid officials voiced concerns over the measure.

sentative Watkins filed a floor amendment to make changes requested by KPhA and the pharmacy community. The amendment clarified that the bill would not restrict returns of outdated or unsalable products or impact transfers between pharmacies. Two other proposals broadening the rules for inter-pharmacy transfers of drugs also failed to pass. HB 322 and HB 449 proposed to exempt interpharmacy transfers between unrelated pharmacies from the definition of “drug wholesaling.” Current law limits the amount of drugs that can be transferred between unrelated pharmacies before the activity is considered wholesaling.

“Conscience Clause” Legislation: After a lull of several years, the issue of a “conscience clause” again surfaced this session. Representative Joe Fischer (R-Ft. Thomas) filed HB 143 allowing a health care provider, health care institution or payor to refuse to provide or pay for a medical service that violates his or her conscience. The issue was a hot topic shortly after the FDA approved the “morning after” pill several years ago but has since died down. HB 143 was likely prompted by new federal rules on health insurance coverage for contraceptives contained in the Affordable Care Act. The bill died in the House Health and Welfare Committee without receiving a hearing.

Naloxone: The free conference committee on HB 366, a bill dealing with infant health, added language to the bill addressing the prescribing and dispensing of naloxone.

The conferees included the provisions of HB 79 that limit the liability of persons prescribing or dispensing naloxone for opioid overdoses in their free conference committee report and the report was passed by both chambers. Earlier in the session, HB 79 stalled in the House after a numRestrictions on Generic Substitution: Representative Addia Wuchner (R-Burlington) once again introduced legis- ber of unfriendly amendments were filed to the bill. HB 366 lation restricting the substitution of tamper-resistant opioid contains an “emergency clause” making it effective upon drugs. HB 74 prohibited a pharmacist from substituting an the Governor’s signature on April 4. opioid that does not have tamper-resistant qualities for one Advanced Practice Nurse Practitioners (APRNs): Comthat does unless the pharmacist obtained written permispeting proposals affecting collaborative practice agreesion from the prescriber. The measure received a hearing ments between APRNs and physicians were filed this sesin House Judiciary Committee but no vote was taken. The sion but did not pass. SB 51 proposed to eliminate the cursponsor withdrew HB 74 and made several attempts to rent requirement that APRNs must have a collaborative revive the proposal as an amendment to other healthpractice agreement with a physician in order to prescribe related bills. Those attempts were unsuccessful. nonscheduled drugs. SB 94, on the other hand, would Drug Wholesaling: A measure to prohibit sales to whole- have set stricter standards for these agreements. Neither salers by retail pharmacies bogged down on the House bill addressed the existing requirements for the prescribing floor after clearing the House Health and Welfare Commit- of scheduled drugs. HB 8, a bill that has been signed into tee. HB 371 was sponsored by Representative David Wat- law, will potentially have an impact on APRN prescribing of kins (D-Henderson) as a response to problems with “gray controlled substances. That measure contains a provision market” drugs entering the market through transactions that preserves the prescribing privileges of provider involving the sale of drugs by pharmacies to wholesale dis- groups, including APRNs and optometrists, if hydrocodonetributors. It was pushed by the Kentucky Office of the Attor- containing drugs are rescheduled. Currently, the federal ney General and the Kentucky Board of Pharmacy. Repre- Drug Enforcement Administration is considering moving 13

THE KENTUCKY PHARMACIST

2013 Legislative Wrapup

May 2013

these drugs from Schedule III to Schedule II, a move opposed by the NCPA, among others.

these diseases for a patient’s partner who does not have a patient-provider relationship.

Physician Assistants (PAs): Unlike past legislative sessions, PAs did not seek the authority to dispense prescription drugs. Physician assistants scored a victory, however, with the passage of HB 104. The bill eventually eliminates the requirements that a newly-licensed PA practice at the same location as the authorizing physician for a period of 18 months after licensure. The requirement is reduced to three months until May 31, 2014 and then is completely eliminated. The provision was added to the bill in the Senate after SB 43, a stand-alone bill making the change, stalled in the House.

Dextromethorphan Sales: A bill to prohibit the sale of products containing dextromethorphan as the sole active ingredient to anyone under the age of 18 died in the Senate after obtaining approval in the House. HB 19 also would have made it illegal for those less than 18 years of age to falsify their age in order to purchase the product. Before passing the measure, the House adopted a floor amendment removing a provision banning a person from giving a product containing dextromethorphan to a person under 18 after concerns were raised that would make it illegal for a parent to give dextromethorphan to a child for a valid medical reason.

Other Pharmacy Issues: 

HB 358, a bill requiring that female children between the ages of nine and 16 and male children between the ages of 10 and 16 years be immunized against human papipillomavirus (HPV) died in the Senate after narrowly passing the House. The bill contains an “opt out” provision for parents that did not want their child to receive the vaccine.



Legislation to allow expedited partner therapy for the treatment of certain sexually transmitted diseases died in its original committee. HB 429 would have allowed the prescribing and dispensing of drugs used to treat



HB 181, a bill placing new limits on the amount of pharmacy school scholarships available under a program to encourage students from coal-producing counties to attend pharmacy school, was signed by the Governor on March 22.



A bill to block the expansion of Medicaid eligibility (SB 39) died in the House. The bill would have prevented the state from implementing the Medicaid expansion provision of the federal health care reform act without express legislative approval.

Therapeutic Shoe Fitting by pharmacy technicians and interns

YOUR KPhA worked with the Kentucky Board of Pharmacy to clarify the issue of Therapeutic Shoe Fitting by Pharmacy Technicians in relationship to the KY Prosthetics, Orthotics and Pedorthics Practice Act of 2010. This issue was advanced as a legislative priority by the KPhA House of Delegates at the 2012 KPhA Mid-Year Conference. Pharmacists worried that legislation passed in 2010 would prevent pharmacy technicians and pharmacy interns from assisting in the fitting of therapeutic shoes for diabetic patients. The Board of Pharmacy, in a letter dated March 11, 2013, clarified that it had consulted with the Board of Prosthetics, Orthotics and Pedorthics and the two Boards were in agreement on this issue. Pharmacists are exempt from licensure under KRS Chapter 319B and may continue to provide therapeutic shoes to their patients pursuant to their pharmacist's license, and that pharmacist technicians who meet the educational requirements of KRS 319B(8)(a),(b),or (c) along with pharmacy interns working under the supervision in a pharmacy can continue to assist pharmacists in the fitting of therapeutic shoes. KPhA worked with APSC and the KRF on this issue.

KPhA gratefully acknowledges our engagement with the Kentucky Retail Federation and the great work of our lobbyists, Jan Gould and Gay Dwyer.

You can now 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.

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THE KENTUCKY PHARMACIST

Bowl of Hygeia

May 2013

Help support the Bowl of Hygeia Award!

This year another 50+ Bowl of Hygeia recipients will be added to our ranks. All are dedicated pharmacists who take community service seriously and endeavor to make a difference in a way that is meaningful. Their stories are inspiring, and their attitudes are humble. All will make you proud.

The Bowl of Hygeia has a rich history within pharmacy and it represents well members of our profession. That’s why I’m excited to be helping to carry forth the Bowl of Hygeia tradition through collaboration with the Kentucky Pharmacists Association as our Association works with the “stewards” of the Bowl of Hygeia, the National Alliance of State Pharmacy Associations, the APhA Foundation and the American Pharmacists Association. Before these national Pharmacy groups assumed responsibility for the Bowl, this prestigious award was in jeopardy of being extinguished. If it were not for their agreement to carry forward the honor through a professional collaboration, 2010 would have been the last year the Bowl of Hygeia was awarded.

sonally giving to this fund, and it’s why I think you’ll be interested to join me in making an investment in the future of the award. After all, it is the future recipients of the award that guarantee the legacy of our own awards.

Our goal is to raise $5,000 as a collective gift from members of the Kentucky Pharmacists Association.

As of March 2013, we had collected $900. We’re eager to show our state pride by either meeting or exceeding this goal. Won’t you please help by making a contribution? We need 41 $100 gifts to meet this goal!

There are two ways to give: Online at: http://www.aphafoundation.org and choose the Bowl of Hygeia endowment button.

Kentucky will get credit by your address.

Or, you can send your check to: APhA Foundation – Bowl of Hygeia 2215 Constitution Ave., NW Washington, DC 20037-2985 Thank you in advance for joining me in this effort.

Sincerely in Service I am, George Hammons, RPh Owner/President Knox Professional Pharmacy Given that this is an award presented at the state lev- Bowl of Hygeia Award Recipient, 2012 el, the State Pharmacy Associations — including your Kentucky Pharmacists Association — along with NASPA, are working together to help make sure this award we hold so dearly is never at risk again. In order to sustain the award, each state association is working together to build an endowment sufficient to generate dividends that will fund the program in perpetuity.

The APhA Foundation, a national nonprofit 501 (c) (3), has agreed to be the home of the endowment account, and to date we are almost half way to our goal of $600,000.

As a recipient of the award, I am excited to be a leader in helping the Kentucky Pharmacists Association kick off its campaign. I want to be sure the Bowl of Hygeia continues to represent the hallmark of community service in our profession. That’s why I am per-

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THE KENTUCKY PHARMACIST

May 2013 CE—Nicotine Replacement in Pregnant Women

May 2013

Should Pharmacists Discourage the Use of Nicotine Replacement Therapy In Pregnant Women?

There are no financial relationships that could be perceived as real or apparent conflicts of interest.

By: Jarrod Williams, Brittany Bowen, Wade Barton, William Reesor, and James R. Pauly, Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky

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

Universal Activity # 0143-0000-13-005-H01-P&T 2 Contact Hours (0.2 CEU) Goal The goal of this article is to discuss the problems associated with tobacco smoking during pregnancy in Kentucky and the unsatisfactory pharmacotherapeutic approaches that are currently employed to treat these patients.

Objectives At the conclusion of this article, the reader should be able to: 1. Recognize the association between tobacco smoke and negative reproductive outcomes.

2. Explain the alterations in developmental trajectories from birth to adolescence that occur following in utero tobacco smoke exposure.

3. Describe the key components of tobacco smoke that are thought to lead to unfavorable reproductive outcomes.

4. Recognize the FDA-assigned pregnancy safety categories for medications used in smoking cessation paradigms.

5. Discuss the risks and benefits of using nicotine replacement therapy for treatment of smoking cessation during pregnancy. and 47.5 percent, respectively. In all Kentucky counties combined, it is estimated that 12,196 infants were born to Dr. Lee Todd, the 11th president of the University of Kentobacco smoking mothers in 2011 alone [3]. Thus a structucky, coined the phrase “The Kentucky Uglies” to refer to tured smoking cessation program focused on these patients serious socioeconomic and health care crises that affect the could have a very positive impact on community health. citizens of the Commonwealth, including high rates of diabetes, obesity, lung cancer, illiteracy and poverty [1]. Tobacco Unlike other commonly abused substances (e.g. alcohol, smoking was part of this indictment due to the universally cocaine, oxycodone), the burning of tobacco produces a recognized correlation between tobacco use and lung can- large conglomeration of toxic chemicals, many of which cer. One detrimental aspect of tobacco smoking that did not have the potential to have some type of negative impact on reach Dr. Todd’s attention was the effect of tobacco smoke the maternal-fetal unit, and/or the fetus itself. Thus it is good exposure on fetal and infant brain development. At a recent practice when health care practitioners recommend that lecture, Dr. Ruth Ann Shepherd, M.D., the Director of the women quit smoking in the early stages of pregnancy planDivision of Maternal and Child Health for the Kentucky Dening. Of course achieving this goal is quite difficult, and partment for Public Health stated that the “number one way” many women who do quit or reduce tobacco smoking during to improve the lives of infants and children in Kentucky was pregnancy do so with the aide of nicotine replacement therto decrease maternal tobacco smoking [2]. In the Appalachi- apy (NRT). Thus it comes as no surprise that some rean regions of Kentucky, the high rate of tobacco smoking searchers in the name of harm reduction, advise the use of during pregnancy is a particular problem. According to NRT as a smoking cessation tool, and it is hard to argue Joyce Robl, Division of Maternal and Child Health, Kentucky against the stance that NRT is safer than continued smokDepartment for Public Health, in 2011 the incidence of toing [4,5]. However, “safer” does not mean safe. In the rebacco smoking during pregnancy was over 40 percent in mainder of this article, we will build the argument that the many eastern Kentucky counties, with Robertson County use of NRT is in fact dangerous to the fetus, and also lacks and Elliot County having the highest rates at 53.1 percent efficacy in these patients. This problem is definitely a Introduction

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May 2013 CE—Nicotine Replacement in Pregnant Women

May 2013

“Kentucky ugly,” and we believe that pharmacists are in a unique position of accessibility and knowledge to facilitate distribution of this most pertinent information to pregnant patients.

membranes are also compromised. There is histological evidence that a placenta exposed to chronic tobacco smoke will develop vascular remodeling evidenced by reduced capillary volume, total surface area and length.

Thickening of the villous membrane contributes to in utero Effects of Tobacco Smoking on Pregnancy Dynamics malnourishment, as gas and nutrient exchange are reReproductive health is negatively impacted by tobacco duced [19]. In addition to vasoconstriction caused directly smoking at all stages, beginning with preconception. The by nicotine, other tobacco smoke constituents like carbon infertility rate among smokers is significantly higher commonoxide and cyanide compound the hypoxia by further pared to non-smokers, although the specific mechanisms displacing oxygen carried by hemoglobin [19]. Many studhave not been clearly unraveled. Interestingly, second ies have shown that developmental tobacco smoke expohand smoke exposure also is associated with a higher rate sure causes low fetal birth weight; animal studies suggest of infertility, even in non-smokers [6]. Animal models sugthat fetal tobacco smoke exposure also is associated with gest that tobacco-smoke related oxidative stress may be a significant reduction in brain weight, corresponding to a involved with the reduced fertility [7], and tobacco smoking diminished number of cells in the cerebral cortex [20]. has been shown to significantly reduce follicular levels of endogenous anti-oxidants such as beta-carotene and vita- As awareness of tobacco smoke exposure and its effects on pregnancy expands, evidence of post-natal complicamin A [8]. Endocrine problems associated with tobacco use tions is likely to become progressively less disputable. Precould also contribute to a reduction in fertility as smokers vious research has established a significant link between have higher rates of idiopathic ovarian failure [8], and lower maternal smoking and the incidence of sudden infant death rates of embryo implantation as compared to non-smoking syndrome (SIDS). SIDS is considered a diagnosis when an counterparts [9]. If conception and implantation occur, the infant dies before one year of age, and there is no known road to full term gestation for the developing fetus can be attributable cause. In special populations known to have a difficult in a tobacco using woman. Published studies have high rate of tobacco use, an increase in SIDS has been shown strong correlations between the rate of tobacco documented. For example, it is estimated that 55-70 persmoking by mothers and increased spontaneous abortions. cent of Native American Indian women use tobacco during Mechanistically, spontaneous preterm birth related to topregnancy, and the incidence of SIDS in this population is bacco smoking is usually attributed to either induction of nearly seven times greater than the national average [21]. premature labor or premature rupture of placental memAnother study in Sweden determined after the “Back to branes. Tobacco use also is associated with many different Sleep Campaign” (a major movement to spread awareness fetal problems including abruptio placentae, improper imof SIDS) that the two most effective ways to reduce SIDS plantation, preeclampsia, ectopic pregnancy, miscarriage were to put babies in the supine sleeping position and to and fetal growth restriction[10-16]. Reduced fetal growth in stop tobacco smoking during pregnancy. In fact, tobacco utero, coupled with premature labor and delivery, represmoking is the only positive risk factor for SIDS that persents a dual threat to infant development from the time of sists after correcting for sleep position [22]. The causative birth onward. factor that links tobacco use in pregnancy to SIDS is unEffects of Tobacco Smoke on Neonatal Physiology known, but it may involve changes in nicotinic receptor function critical to a cardiorespiratory defense mechanism In addition to increasing the incidence of preterm births, [23]. Clinically this defect could lead to reduced respondevelopmental tobacco smoke exposure has also been shown to be one of the most common causes of low gesta- siveness to arousal along with changes in respiratory and tional weight infants. One study cites that of 5,890 women cardiovascular responses experienced during hypoxia.

Thus developmental tobacco smoke exposure significantly followed, smokers’ babies averaged 153 grams less at contributes to the “perfect storm” of adverse events that gestation than non-smokers and 120 grams less than leads to SIDS. There also is some evidence in support of a those who quit smoking after learning of their pregnancy [17]. Others have shown that while a baby born to a smok- fetal nicotine withdrawal syndrome in newly born children.

Barros et al [24] demonstrated that tobacco-exposed ining mother may not necessarily have a low birth weight (defined as < 3,000 grams), he or she may still have a ges- fants showed increased arousal, excitability and stress, as early as two hours postnatally and the severity of these tational weight categorized as small (10th percentile) [18].

Not only does the fetus suffer direct insults in these cases, symptoms was positively correlated with the number of daily cigarettes consumed during pregnancy. but the integrity and function of the protective placental

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THE KENTUCKY PHARMACIST

May 2013 CE—Nicotine Replacement in Pregnant Women

May 2013

are collectively known as nicotinic cholinergic receptors (nAChRs). NAChRs are widely distributed in the peripheral and central nervous systems. Nicotine has complex actions on cholinergic receptors, initially acting as an agonist, but over the long term also may cause desensitization of these receptors. At various stages of nervous system development, acetylcholine has important roles in cellular communication through interactions with nAChRs. However, nicotine acting on these receptors at inappropriate times may “hijack” the normal function of these receptors causing a neuronal signaling deficit that irrevocably alters the normal behavioral trajectory [see references 28-31 for an extensive review of this literature].

Neurobehavioral Consequences of In Utero Tobacco Smoke Extend Into Adolescence, and Beyond The adverse effects of developmental tobacco smoke exposure on infant brain and behavioral development continue for many years. From late gestation through early adolescence, a child’s brain undergoes extensive architectural modifications and refinements including neuronal proliferation, cellular differentiation, synapse formation and myelination. These and other important ontogenic processes sculpt the developing brain and gestational exposure to tobacco smoke causes significant and persistent changes in this developmental trajectory. Previous studies have shown that behavioral control is significantly diminished in children exposed to developmental tobacco smoke. Increased incidence of ADHD, negative toddler behavior, conduct disorder, learning disabilities, delinquency and an increased risk of future tobacco use are just a few of the behavioral issues that are commonly seen in this population. Previous studies have shown that childhood inattentiveness is one of the key predictors for adolescent and adult tobacco use [20,25,26]. Interestingly, the detrimental effects of tobacco smoke exposure on developmental changes in behavioral conduct seem to affect male offspring to a greater degree than females. Since ADHD occurs at a higher rate in males than females, the gender differences in response to developmental nicotine are very interesting. Whereas some substances such as alcohol and opiates produce a more recognized neonatal abstinence syndrome, the neurobehavioral consequences attributed to in utero tobacco smoke exposure may not be fully recognized until the exposed child reaches six to 10 years of age [20,27].

Indeed, many studies using a variety of animal models have demonstrated that nicotine, in the absence of the other harmful ingredients in tobacco products, is capable of producing neurobehavioral abnormalities that resemble those seen in human infants. Mice exposed to developmental nicotine have significant locomotor hyperactivity that persists throughout life [32, 33], and a significantly reduced regional brain volume [33]. Cognitive problems, anxiety and other neurobehavioral changes have also been reported. These studies highlight the fact that nicotine itself causes direct disruptions in fetal development and that nicotine is not a benign, “natural” chemical, as believed by many. Also, NRT as a tool for smoking cessation is less efficacious in women as compared to males [34]. These findings raise serious questions regarding the wisdom and safety of NRT for use in pregnant women. A clinical study evaluating the safety of NRT in pregnancy was recently halted because women in the NRT arm of the study had premature labor, similar to what has been observed in tobacco smokers.

Is Nicotine a Culprit in Tobacco Smoke Related Developmental Impairments?

Since there are many potential nervous system toxicants in tobacco smoke, it is not known which substance (or set of substances) leads to the pervasive negative consequences that have been reported in children. Pre-clinical studies using animal models however have clearly established that nicotine could be one important component of tobacco smoke that results in abnormal development. Although there is some controversy, nicotine is typically considered to be the primary psychopharmacological agent present in tobacco smoke that leads to tobacco addiction. The ecological role of nicotine as a tobacco alkaloid is related to its’ insecticidal activity. However, nicotine has a chemical configuration that closely resembles that of the endogenous neurotransmitter acetylcholine. Once in the body, nicotine interacts with a family of acetylcholine binding proteins that

Alternatives to Nicotine Replacement for Pregnant Smokers Given the pervasive and detrimental consequences of tobacco smoking on reproductive health, it is clear that there is an immediate and urgent need for effective smoking cessation interventions for pregnant women. Nicotine replacement therapy (NRT) is the only pharmacotherapy for smoking cessation that has been rigorously tested in randomized controlled trials conducted in pregnancy. NRT is commonly used to attack this problem despite the fact that previous trials showed 1) insufficient evidence of efficacy and 2) safety concerns regarding the use of NRT during pregnancy [35]. Currently, the US Food and Drug Administration (FDA) has classified NRT as a Pregnancy Category C or D, depending on the route of delivery. Transdermal forms of NRT are most commonly used, and are assigned

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THE KENTUCKY PHARMACIST

May 2013 CE—Nicotine Replacement in Pregnant Women to the “D” category by the FDA. Drugs in this FDA category are known to potentially cause harm to both the mother and the fetus. It is disconcerting that NRT is so commonly used in pregnant patients, and that health care practitioners do little to attract attention to this important issue. Many studies justify using NRT during pregnancy by claiming that the human and animal data conducted to date has suggested that the risk of cigarette smoking during pregnancy is far greater than the risk of exposure to pure nicotine. While it is fair to assume that the use of NRT might be less dangerous than smoking during pregnancy, it has not been conclusively shown to be effective, and it certainly involves significant risks to the mother and fetus. A meta-analysis of three reported clinical trials of NRT use in pregnancy indicates that there is no clear evidence for efficacy of NRT for smoking cessation in this population [5]. One possible explanation behind the lack of efficacy of NRT for cessation in pregnancy involves the pharmacokinetics of nicotine. Estrogen accelerates the catabolism of nicotine and could reduce plasma nicotine to an ineffective level. So standard doses of NRT may not be adequate to substitute for the levels of nicotine that women would have otherwise received from smoking, potentially leading to more withdrawal symptoms and, subsequently, a higher relapse rate to smoking than nonpregnant women. This phenomenon results in “double-dosing,” thereby increasing fetal exposure to nicotine, possibly making NRT actually more dangerous than smoking during pregnancy. Due to the constant delivery of nicotine via a skin patch, transdermal nicotine in particular, is likely not a very good option for pregnancy. Intermittent-use formulations, such as nicotine gum, nasal sprays and inhalers, may be preferred over continuous delivery devices, such as the transdermal patch, because they will deliver a lower total daily dose of nicotine: however, more research needs to be performed in this area [36].

Concerns and questions regarding optimal nicotine dose, preparation and route/duration of therapy remain, which mandates the need for additional long-term, prospective studies demonstrating safety and efficacy of NRT in pregnancy. The American Congress of Obstetricians and Gynecologists (ACOG) has stated in its Committee Opinion #471 that “the use of nicotine replacement therapy should be undertaken with close supervision and after careful consideration and discussion with the patient of the known risks of continued smoking and the possible risks of nicotine replacement therapy. If nicotine replacement is used, it should be with the clear resolve of the patient to quit smoking [37].” Alternative agents for smoking cessation include the nicotinic receptor partial agonist, Varenicline (Chantix®) and the antidepressant Buproprion (Zyban®), which acts by

May 2013

blocking the presynaptic reuptake transporter for the neurotransmitters dopamine and norepinephrine. According to the FDA safety in pregnancy ratings, these drugs are considered safer alternatives to transdermal nicotine, and they are both assigned the category C (animal studies raise some concerns, but there are no good human data). A recent study using rats showed that similar to nicotine, pregnant animals treated with Bupropion have reduced birth weight. [38] Consequently much like NRT, there are no studies that show sufficient safety or evidence of efficacy for the use of these alternative cessation tools in pregnancy.

Can Pharmacists Play A Role in Smoking Cessation Programs for Pregnant Women?

Based on the discussion above, it is clear that there is a tremendous need for further clinical trials to identify new safe and efficacious pharmacological interventions for smoking cessation in pregnancy. There is an equally important demand for healthcare providers to play an increasingly active role in tobacco prevention strategies in these patients. Given the lack of efficacy and safety data for NRT, it is clear that initial interventions for smoking cessation by pregnant patients should involve education and behavior modification/cognitive therapies. A health care scare related to tobacco smoking is often a powerful impetus to ramp up smoking cessation efforts. So just simply educating pregnant patients about the fetal dangers of tobacco use and NRT might convince some women to quit “cold turkey”.

In addition to the monetary savings, abstinence is clearly the best choice for the health of the mother and fetus. The inclusion of behavior modification/cognitive therapies is essential when quitting attempts are made with no pharmacological support. Since the vast majority of pregnant women are prescribed prenatal vitamins, an interaction with a Pharmacist is often the first point of contact between the pregnant patient and a health care professional. We propose that a program could be developed that involves Pharmacists, Pharmacy technicians and student pharmacists as the first line of information and support about tobacco/NRT use in pregnancy. Any women dispensed prenatal vitamins could be provided with information about the dangers of tobacco use and NRT in pregnancy. Pregnant smokers should clearly be advised to avoid over-thecounter NRT products due to the lack of efficacy and concerns over safety. Also, it is important that they be provided resources for help and support with smoking cessation. A warning sticker placed on every bottle of prescription vitamins might provide a daily reminder about the dangers of tobacco and nicotine in pregnancy. If behavior modification/ cognitive therapy is not sufficient, the inclusion of a smok-

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May 2013 CEâ&#x20AC;&#x201D;Nicotine Replacement in Pregnant Women

May 2013

ing cessation agent like Zyban or Chantix therapy could be recommended by their physician, since these drugs are safer, at least according to the current FDA ranking system.

If these drugs fail, NRT is another potential option, but transdermal approaches should only be considered as the last resort. Of course any woman that uses NRT as a smoking cessation agent also should combine the pharmacological support with behavioral counseling.

Pharmacists exist in a unique place in the world of healthcare due to their accessibility and knowledge base. It should be unacceptable for any woman to think that tobacco smoking during pregnancy is innocuous, or for a woman to use nicotine replacement therapy simply because no one provided her with the information she needed to make a better choice. Instead of accepting the current model, which lacks direction and is full of confusion, pharmacists are in the perfect place to provide the correct information Summary and Conclusions and intervene early in an attempt to prevent future probThe effects of tobacco smoking during pregnancy can have lems. Every healthcare provider should be charged with the profound and persistent detrimental effects on the trajecto- task of explaining to every tobacco user considering pregry of brain and behavioral development. Many health care nancy, with clarity and detail, the risks nicotine presents to professionals assert that the single most modifiable risk the lifestyle the child can expect to have. factor for having a healthy child is abstaining from the use References of tobacco products. Nicotine replacement therapy, although possibly safer than continued smoking, is a less 1. Finder A. Getting a University to Aim Higher. 2007 New than perfect solution. NRT is perhaps the only FDA catego- York Times, August 1 edition. ry D medication commonly prescribed to pregnant women, 2. Shepherd, R.A. Child Health in Kentucky: Past, Present and is also available OTC. Given the exceptionally high and Future. Thomas H. Pauly Excellence in Neonatology rates of tobacco use in pregnancy by Kentucky residents, it Lectureship, UK Department of Pediatrics, October 4th, is not hard to imagine that this problem is a bigger issue in 2012. the Commonwealth, than any other US state. Clinical trials 3. Office of Vital Statistics, State of Kentucky. Excel file in this patient population are obviously fraught with methprovided to Dr. Pauly on Feb 5, 2013. odological and ethical issues. So what to do? Given the scope and magnitude of this issue, it is surprising that this problem has not been more aggressively pursued by health care agencies across our state. Pharmacists are in a unique position of accessibility and influence since, in many cases, pregnant women are prescribed prenatal vitamins prior to visiting their primary care or Ob/GYN physician. We strongly believe that Pharmacists can play an important role in the education and treatment of pregnant tobacco users. For the mother and fetus, the safest option is clearly abstinence. Convincing the mother to quit without NRT will benefit her health and improve the chances that her child is free from developmental problems related to respiratory, cardiovascular and neurobehavioral problems related to nicotine exposure. The withdraw symptoms that may manifest are very real and should not be taken lightly; cravings, negative effect (social withdrawal, decreased motivation), physical symptoms and hunger are issues that will likely need attention [39]. Is it fair to ask a woman undergoing so many physiological changes associated with pregnancy to take on this additional burden? Some medical professionals argue that the â&#x20AC;&#x153;stressâ&#x20AC;? of smoking cessation is perhaps more detrimental to the health of the mother and fetus than continued smoking. However, there is no evidence to support this defeatist opinion that only considers short-term outcomes, and disregards the long term behavioral trajectory of the child.

4. Benowitz N, Dempsey D. Pharmacotherapy for smoking cessation during pregnancy. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S189-202 5. Coleman, T., Recommendations for the use of pharmacological smoking cessation strategies in pregnant women.

CNS Drugs, 2007. 21(12): p. 983-93.

6. Neal, M.S., et al., Sidestream smoking is equally as damaging as mainstream smoking on IVF outcomes. Hum Reprod, 2005. 20(9): p. 2531-5.

7. Agarwal, A., et al., The effects of oxidative stress on female reproduction: a review. Reprod Biol Endocrinol, 2012.

10: p. 49.

8. Schuh-Huerta, S.M., et al, Genetic variants and environmental forces associated with hormonal markers of ovarion reserve in Caucasian and African American women. Human Reproduction. Vol. 27. 2012. 594-608.

9. Tiboni, G.M., et al., Influence of cigarette smoking on vitamin E, vitamin A, beta-carotene and lycopene concentrations in human pre-ovulatory follicular fluid. Int J Immunopathol Pharmacol, 2004. 17(3): p. 389-93.

10. Chang, S.H., et al., Premenopausal factors influencing premature ovarian failure and early menopause. Maturitas, 2007. 58(1): p. 19-30.

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11. Kyrklund-Blomberg, N.B., F. Granath, and S. Cnattingi- (12 Pt 1): p. 1544-9. us, Maternal smoking and causes of very preterm birth.

24. Barros, M.C., et al., Prenatal tobacco exposure is relatActa Obstet Gynecol Scand, 2005. 84(6): p. 572-7. ed to neurobehavioral modifications in infants of adoles12. Saraiya, M., et al., Cigarette smoking as a risk factor cent mothers. Clinics (Sao Paulo), 2011. 66(9): p. 1597for ectopic pregnancy. Am J Obstet Gynecol, 1998. 178(3): 603. p. 493-8.

25. Bruin, J.E., H.C. Gerstein, and A.C. Holloway, Long13. Shao, R., et al., Revealing the hidden mechanisms of term consequences of fetal and neonatal nicotine exposmoke-induced fallopian tubal implantation. Biol Reprod, sure: a critical review. Toxicol Sci, 2010. 116(2): p. 364-74.

2012. 86(4): p. 131.

26. Burke, J.D., et al., Inattention as a key predictor of to14. Ness, R.B., et al., Cocaine and tobacco use and the bacco use in adolescence. J Abnorm Psychol, 2007. 116 risk of spontaneous abortion. N Engl J Med, 1999. 340(5): (2): p. 249-59. p. 333-9.

27. Wakschlag, L.S., et al., Is prenatal smoking associated 15. Armstrong, B.G., A.D. McDonald, and M. Sloan, Ciga- with a developmental pattern of conduct problems in young rette, alcohol, and coffee consumption and spontaneous boys? J Am Acad Child Adolesc Psychiatry, 2006. 45(4): p. abortion. Am J Public Health, 1992. 82(1): p. 85-7.

461-7.

16. George, L., et al., Environmental tobacco smoke and 28. Pauly JR, Slotkin TA. Maternal tobacco smoking, nicrisk of spontaneous abortion. Epidemiology, 2006. 17(5): p. otine replacement and neurobehavioural development.

500-505.

Acta Paediatr. 2008. 97(10): 1331-7.

17. Frank, P., et al., Effect of changes in maternal smoking 29. Smith A.M., Dwoskin L.P. and Pauly J.R. Early expohabits in early pregnancy on infant birthweight. Br J Gen sure to nicotine during critical periods of brain developPract, 1994. 44(379): p. 57-9. ment: Mechanisms and consequences. Journal of Pediatric Biochemistry. 2010. 1: 1–17.

18. Jaakkola, J.J., N. Jaakkola, and K. Zahlsen, Fetal growth and length of gestation in relation to prenatal expo- 30. Slotkin, T.A., If nicotine is a developmental neurotoxisure to environmental tobacco smoke assessed by hair cant in animal studies, dare we recommend nicotine renicotine concentration. Environ Health Perspect, 2001. 109 placement therapy in pregnant women and adolescents?

(6): p. 557-61.

Neurotoxicol Teratol, 2008. 30(1): p. 1-19.

19. Jauniaux, E. and G.J. Burton, Morphological and biological effects of maternal exposure to tobacco smoke on the feto-placental unit. Early Hum Dev, 2007. 83(11): p.

699-706.

20. Thompson, B.L., P. Levitt, and G.D. Stanwood, Prenatal exposure to drugs: effects on brain development and implications for policy and education. Nat Rev Neurosci, 2009. 10(4): p. 303-12.

31. Cornelius, M. and N.M. De Genna, Prenatal cigarette smoking exposure: Effects on offspring, in Encyclopedia on Early Childhood Development, L.S. Wakschlag, Editor.

2011, Centre of Excellence for Early Childhood Development and Strategic Knowledge Cluster on Early Child Development: Montreal, Quebec. p. 1-8.

32. Pauly, J.R., et al., In utero nicotine exposure causes persistent, gender-dependant changes in locomotor activity and sensitivity to nicotine in C57Bl/6 mice. Int J Dev Neurosci, 2004. 22(5-6): p. 329-37.

21. Duncan, J.R., et al., The effect of maternal smoking and drinking during pregnancy upon (3)H-nicotine receptor brainstem binding in infants dying of the sudden infant 33. Zhu J., Zhang X., Xu Y., Spencer T.J., Biederman J., death syndrome: initial observations in a high risk popula- Bhide, P.G. Prenatal Nicotine Exposure Mouse Model tion. Brain Pathol, 2008. 18(1): p. 21-31.

Showing Hyperactivity, Reduced Cingulate Cortex Volume, Reduced Dopamine Turnover, and Responsiveness to 22. Chong, D.S., P.S. Yip, and J. Karlberg, Maternal smokOral Methylphenidate Treatment. 2012. J. Neurosci 32 ing: an increasing unique risk factor for sudden infant (27): 9410 –9418. death syndrome in Sweden. Acta Paediatr, 2004. 93(4): p.

471-8.

34. Pauly JR. Gender differences in tobacco smoking dynamics and the neuropharmacological actions of nico23. Hafstrom, O., J. Milerad, and H.W. Sundell, Prenatal tine. Front Biosci. 13: 505-16, 2008. nicotine exposure blunts the cardiorespiratory response to hypoxia in lambs. Am J Respir Crit Care Med, 2002. 166 35. Coleman, T., et al., Pharmacological interventions for 21

THE KENTUCKY PHARMACIST

May 2013 CE窶年icotine Replacement in Pregnant Women promoting smoking cessation during pregnancy. Cochrane Database Syst Rev, 2012. 9: p. CD010078.

36. Dempsey, D.A. and N.L. Benowitz, Risks and benefits of nicotine to aid smoking cessation in pregnancy. Drug Saf, 2001. 24(4): p. 277-322.

37. Committee opinion #471 smoking cessation during pregnancy. The American College of Obstetricians and Gynecologists 2010 [cited 2012 December 25]; Available from: www.acog.org.

May 2013

38. De Long N, Hyslop JR, Nicholson CJ, Morrison KM, Gerstein HC, Holloway AC. Postnatal Metabolic and Reproductive Consequences of Fetal and Neonatal Exposure to the Smoking Cessation Drug Bupropion. Reprod Sci. 2013 Feb 28. [Epub ahead of print] 39. Javitz, H.S., C. Lerman, and G.E. Swan, Comparative dynamics of four smoking withdrawal symptom scales. Addiction, 2012. 107(8): p. 1501-11.

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22

THE KENTUCKY PHARMACIST

May 2013 CE—Nicotine Replacement in Pregnant Women

May 2013

May 2013 — Should Pharmacists Discourage the Use of Nicotine Replacement Therapy In Pregnant Women?

1. Which neurotransmitter is the endogenous ligand that activates neuronal nicotinic receptors?

A. Dopamine B. Acetylcholine C. Norepinephrine D. Serotonin E. None of the above

and well-controlled studies in pregnant women).

C. Category C (Animal reproduction studies have shown an adverse effect on the fetus but there are no adequate and well-controlled studies in humans).

D. Category D (There is positive evidence of human fetal risk in humans, but potential benefits may warrant use of the drug in some pregnant women despite the risks).

E. Category X (There is positive evidence of human fetal 2. According to the Director of the Division of Maternal risk in humans, and the potential risks to the fetus outweigh and Child Health for the Kentucky Department for Public any benefit to the mother).

Health, what is the best way to improve the health and well being of children in Kentucky?

6. The FDA-assigned pregnancy safety category for buA. Reduce obesity propion (Zyban®) is: B. Control gestation diabetes A. Category A (Adequate and well-controlled studies have C. Reduce maternal tobacco smoking failed to demonstrate a risk).

D. Ban the use of nicotine replacement therapy in pregnant B. Category B (Animal reproduction studies have failed to women demonstrate a risk to the fetus but there are no adequate and well-controlled studies in pregnant women).

3. The FDA-assigned pregnancy safety category for C. Category C (Animal reproduction studies have shown an transdermal nicotine is: adverse effect on the fetus but there are no adequate and A. Category A (Adequate and well-controlled studies have well-controlled studies in humans). failed to demonstrate a risk).

D. Category D (There is positive evidence of human fetal B. Category B (Animal reproduction studies have failed to risk in humans, but potential benefits may warrant use of the demonstrate a risk to the fetus but there are no adequate drug in some pregnant women despite the risks). and well-controlled studies in pregnant women).

E. Category X (There is positive evidence of human fetal C. Category C (Animal reproduction studies have shown an risk in humans, and the potential risks to the fetus outweigh adverse effect on the fetus but there are no adequate and any benefit to the mother). well-controlled studies in humans).

D. Category D (There is positive evidence of human fetal 7. What factors contribute to low birth weight in neorisk in humans, but potential benefits may warrant use of the nates exposed to maternal tobacco smoke? drug in some pregnant women despite the risks).

A. Reduced intrauterine growth E. Category X (There is positive evidence of human fetal B. Premature labor and delivery risk in humans, and the potential risks to the fetus outweigh C. Both A and B any benefit to the mother).

D. None of the above 4. The FDA-assigned pregnancy safety category for Nicorette® gum or lozenge is: A. Category A (Adequate and well-controlled studies have failed to demonstrate a risk).

B. Category B (Animal reproduction studies have failed to demonstrate a risk to the fetus but there are no adequate and well-controlled studies in pregnant women).

C. Category C (Animal reproduction studies have shown an adverse effect on the fetus but there are no adequate and well-controlled studies in humans).

D. Category D (There is positive evidence of human fetal risk in humans, but potential benefits may warrant use of the drug in some pregnant women despite the risks).

E. Category X (There is positive evidence of human fetal risk in humans, and the potential risks to the fetus outweigh any benefit to the mother).

8. Outside of sleep position, what environmental factor is most closely associated with an increase in the incidence of sudden infant death syndrome (SIDS)?

A. Maternal alcohol use B. Gestational diabetes C. Maternal tobacco smoking D. Poor nutritional status of the mother E. Maternal use of anti-convulsants

5. The FDA-assigned pregnancy safety category for Varenicline (Chantix®) is: A. Category A (Adequate and well-controlled studies have failed to demonstrate a risk).

B. Category B (Animal reproduction studies have failed to demonstrate a risk to the fetus but there are no adequate

10. Nicotine replacement therapy (NRT) as a tool for smoking cessation is most efficacious in: A. Men B. Women C. NRT is equally efficacious in men and women

9. In adolescence what outcome is most commonly observed in children that were exposed to developmental tobacco smoke?

A. Decreased motor coordination B. Diminished cognitive capacity C. Increased alcohol use D. Decreased behavioral control

23

THE KENTUCKY PHARMACIST

May 2013 CE—Nicotine Replacement in Pregnant Women

May 2013

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, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: May 15, 2016 Successful Completion: Score of 80% will result in 2.0 contact hours or 0.2 CEUs. Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. May 2013 — Should Pharmacists Discourage the Use of Nicotine Replacement Therapy In Pregnant Women?

Universal Activity # 0143-0000-13-005-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 2. A B C D

3. A B C D E 4. A B C D E

5. A B C D E 6. A B C D E

7. A B C D 8. A B C D E

9. A B C D 10. A B C

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve 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 I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature _________________________________________________ Date _________________________________

NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) PHARMACISTS ANSWER SHEET May 2013 — Should Pharmacists Discourage the Use of Nicotine Replacement Therapy In Pregnant Women?

Universal Activity # 0143-0000-13-005-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D E 2. A B C D

3. A B C D E 4. A B C D E

5. A B C D E 6. A B C D E

7. A B C D 8. A B C D E

9. A B C D 10. A B C

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve 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 Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature _________________________________________________ Date _________________________________

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

24

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THE KENTUCKY PHARMACIST

Drug Information Center at SUCOP

May 2013

DRUG INFORMATION CENTER UPDATE

New director has vision for center at SUCOP The Sullivan University College of Pharmacy has made some big changes. The Drug Information Center (DIC) at SUCOP is an academic-based drug information center. It is proudly the only one in Kentucky.

druginfo.sullivan.edu

In January, Dr. Amber Cann was named as director of the DIC, and as assistant professor in the College of Pharmacy. The arrival of a new director represents a new direction for the Center. Since her arrival, Dr. Cann has implemented a comprehensive review of the College's print and online resources. She is working to catalog and update the library, bringing on several new digital databases and journals.

Students and preceptors have access to the DIC to supplement their research and patient care. All pharmacists and health care providers can call the DIC when those patient care situations arise that require literature searches and research.

Dr. Cann comes to Sullivan from a career in healthcare informatics. She holds a doctor of pharmacy degree from the University of Kentucky and a master’s degree in business administration from the University of Louisville. Her

502-413-8638 or toll-free 866-272-2215 Twitter @DrugInfo_KY areas of interest include addiction pharmacy and information technology.

One of the newest developments since January is the connectivity of the DIC. There are numerous ways to contact Dr. Cann in the DIC. The new website address is druginfo.sullivan.edu. You can call the DIC at 502-413-8638 or toll-free 866-272-2215. The DIC is also on Twitter @DrugInfo_KY and on LinkedIn. The email is druginfo@sullivan.edu.

“My vision for the DIC is for it to expand to a health sciences resource center,” Dr. Cann said. “I want to modernize and digitize our collection. It’s all about providing excellent service to our students, faculty and the pharmacists of the Commonwealth.”

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.  

 



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.

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

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 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 Articles should address topics designed to narrow at the beginning of the article. gaps between actual practice and ideal practice in Article should begin with the goal or goals of the pharmacy. Please see the KPhA website overall program – usually a few sentences. (www.kphanet.org) under the Education link to see Include 3 to 5 objectives using SMART and meas- previously published articles. urable verbs.



Articles must be submitted electronically to the KPhA director of communications and continuing education Feel free to include graphs or charts, but please submit them separately, not embedded in the text (ssisco@kphanet.org) by the 15th of the month preceding publication. of the article.

25

THE KENTUCKY PHARMACIST

June 2013 CE — Testosterone Replacement

May 2013

Testosterone Replacement: An Overview and Clinical Applications By: Tyler Alex James, PharmD Candidate, Christopher P. Harlow, PharmD There are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-0000-13-006-H01-P&T 1.0 Contact Hour (0.1 CEUs)

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

Objectives: At the conclusion of this lesson, the reader should be able to: 1. Identify the characteristics of metabolic syndrome.

2. Interpret the testosterone treatment recommendations as set forth by the guidelines.

3. Recognize the signs and symptoms of hypogonadism in the aging male.

4. Evaluate the advantages and disadvantages of the available formulations of testosterone replacement and apply them in practice.

5. Discuss the role testosterone replacement plays in the treatment of metabolic syndrome. displaying a variety of chronic disease states and life style choices. This makes defining a relationship between dis“Andropause” and “low T” are terms that have become commonplace among patients and health care profession- tinct symptoms or conditions and low testosterone levels als alike. Drug manufacturers, through advertising and pro- quite difficult. Therefore, providers must practice diligence during diagnoses and treat only those patients that are motion of new formulations of testosterone, have created clearly indicated. awareness for a syndrome that was once thought of as a normal aspect of aging. The objective of this review is to The most prevalent circulating androgen in men is testosaddress the safety, efficacy, and indications for testosterone. During a usual male lifespan, testosterone typically terone replacement in adult males with low levels of endog- peaks during the third decade and displays a gradual deenous testosterone. Additionally, this review will examine crease estimated at 0.4-1 percent per year afterwards.1 the proposed benefits testosterone replacement have on Provided that these estimates are accurate, 20 percent of lipid profiles and glucose control in aging males for the pre- men over 60 and 30-50 percent of men over 80 would be vention of metabolic syndrome. considered below the normal testosterone threshold1. UnIntroduction

Background “Andropause” is a term often used to define middle-aged men and older with both clinical symptoms of androgen decline and hypogonadism, or low levels of testosterone.

Symptoms such as decreased libido, diminished ability to achieve erection, increased fat mass (particularly in the abdominal region), decreased lean body mass, vasomotor symptoms and difficulty achieving orgasms as well as conditions like metabolic syndrome, type II diabetes mellitus, heart disease, osteoporosis and mood disorders, have all been attributed to less than normal levels of testosterone in men.1 The decline in sex related hormones are often far more gradual in males when compared to females. Thus, symptoms in males are often less abrupt and more difficult to assess making “andropause” less detectable than menopause.

Middle-aged men represent a diverse demographic often

fortunately, it is difficult to accurately interpret the significance of testosterone levels. In patients middle-aged and older, testosterone levels are greatly influenced by patient specific factors such as body mass index (BMI), alcohol consumption, smoking, physical activity and chronic disease states.1 Hypogonadism in men is a clinical syndrome in which the testes fail to produce physiological levels of testosterone. 2 Guidelines recommend making a diagnosis of androgen deficiency by measuring serum testosterone levels only in men who present with clinical manifestations of low testosterone (Table 1).2 Guidelines also suggest physicians to consider screening in patients presenting with less specific signs and symptoms (Table 1).2 It is important to note that guidelines do not recommend screening for androgen deficiency in the general population and clinical markers associated with metabolic syndrome are not included as a mani-

26

THE KENTUCKY PHARMACIST

May 2013

June 2013 CE — Testosterone Replacement Table 1. Indications for Diagnosis of Androgen Deficiency More Specific Signs and Symptoms

Less Specific Signs and Symptoms

Incomplete or delayed sexual development Reduced sexual desire (libido) and activity

Decreased energy, motivation, initiative and selfconfidence Feeling sad or depressed

Decreased spontaneous erections

Poor concentration and memory

Breast discomfort, gynecomastia

Sleep disturbance, increased sleepiness

Loss of body (axillary or pubic) hair, reduced shaving

Mild anemia (normochromic, normocytic)

Very small or shrinking testis

Reduced muscle bulk and strength

Inability to father children, low or zero sperm count

Increased body fat, body mass index

Height loss, low trauma fracture, low bone mineral density

Diminished physical or work performance

Hot flashes, sweats festation of low testosterone independently. However, screening is recommended in patients with chronic diseases such as diabetes mellitus, end stage renal disease (ESRD) and chronic obstructive pulmonary disease (COPD), in patients who are also experiencing symptoms such as sexual dysfunction, unexplained weight loss, weakness or limited mobility.2 Guidelines identify 300 ng/ dL as the threshold for normal total testosterone and any measurement below this is considered a deficiency.2 Metabolic syndrome is a composition of different conditions. In general, metabolic syndrome’s components include abdominal obesity, insulin resistance, dyslipidemia and elevated blood pressure.3 Metabolic syndrome also has been associated with a pro-inflammatory and prothrombotic state, fatty liver and reproductive disorders. 3 Patients suffering from metabolic syndrome are at a considerably increased risk for cardiovascular disease and diabetes mellitus.3 The cause of metabolic syndrome is unknown, but abdominal fat and a state of insulin resistance seem to be central to its development.3

els. Patients with low testosterone levels are at increased risk of insulin resistance and type II diabetes mellitus.1,5 Pathophysiological mechanisms such as testosterone related deficiencies in genes related to glycogen metabolism and nutrient sensing in skeletal muscle have been thought to cause this relationship, but definitive evidence has not been proven.1 Low testosterone levels also increase a patient’s risk for obesity.1 It has been proposed that an androgen deficiency in men is associated with an atherogenic lipid profile consisting of low levels of high-density lipoproteins (HDL) and higher levels of low-density lipoproteins (LDL) and triglycerides.6 Less than normal testosterone levels have been shown to increase a patient’s risk for atherosclerosis, abdominal aortic aneurysm, coronary artery disease, stroke and transient ischemic attacks.1

Testosterone’s role in cardiovascular disease is not well defined and many pathophysiological mechanisms have been thought to explain its role. Research has demonstrated that testosterone may have anti-anginal properties and may produce coronary artery dilation, which, in turn, may Testosterone and Metabolic Syndrome: increase coronary artery blood flow.1 Therefore, a deficienMen are at an increased risk for cardiovascular disease cy may have deleterious effects on coronary artery blood and, until recently, the assumption has been that testosflow and cause an increased risk of coronary heart disease terone has a negative effect on the cardiovascular sysin men with low testosterone. Some propose that fatty tem.4 Research now suggests that a testosterone deficienacid synthase, an androgen-regulated gene that is key to cy, not gender alone, may be related to this increased synthesis, transport and metabolism of long chain saturatrisk.4 ed fatty acids and cholesterol is affected by a deficiency in testosterone.6 It also has been proposed that insulin reInsulin concentrations and fasting blood glucose levels demonstrate an inverse relationship with testosterone lev- sistance affects lipid profiles in androgen deficient men.

27

THE KENTUCKY PHARMACIST

June 2013 CE â&#x20AC;&#x201D; Testosterone Replacement

May 2013

Table 2. Available Manufactured Products: Brand Preparation Strength Dose Name

Maximum Dose

Indication

Adverse Reactions

50 mg applied once daily in the morning to the shoulder and upper arms or abdomen 40.6 mg applied once daily in the morning to the shoulder and upper arms or abdomen 40 mg once daily in the morning applied to the thigh 5 grams applied once daily (preferably in the morning) to the shoulder and upper arms 150-450 mg every 3-6 months

100 mg daily

Hypogonadism

Skin irritation, secondary exposure risk*

81 mg daily

Hypogonadism

Skin irritation, secondary exposure risk*

70 mg daily

Hypogonadism

Skin irritation, secondary exposure risk*

10 g daily

Hypogonadism

Skin irritation, secondary exposure risk

450 mg every 3 months

Hypogonadism

Infection, expulsion of pellet Fluctuation in mood or libido, pain at injection site, excessive erythrocytosis (especially in older patients), coughing episodes immediately following injection Fluctuation in mood or libido, pain at injection site, excessive erythrocytosis (especially in older patients), coughing episodes immediately following injection Alterations in taste, irritation of the gum

Androgel

Gel

1%

Androgel

Gel

1.62%

Fortesta

Gel

10mg/ actuation

Testim

Gel

1%

Testopel

Implant

75 mg

DepoTestosterone (oil as cypionate)

Intramuscular injection

100mg/mL

50-400 mg every 2-4 weeks

400 mg every 2 weeks

Hypogonadism

Delatestryl (oil as enanthate)

Intramuscular injection

200mg/mL

50-400 mg every 2-4 weeks

400 mg every 2 weeks

Hypogonadism, inoperable metastatic breast cancer in women

Striant

Mucoadhesive buccal system

30 mg

30 mg applied twice daily

Hypogonadism

Androderm

Transdermal system

2 mg/24 hours, 4 mg/24 hours

6 mg applied daily

Hypogonadism

Skin reactions at application site

Axiron

Solution

30mg/ actuation

Apply 30 mg to gums above the incisor tooth twice daily Apply 4 mg patch daily to back, upper arms, thigh, or abdomen 60 mg applied every morning to the axilla (arm pit)

120 mg daily

Hypogonadism

Skin irritation

Insulin sensitivity decreases free fatty acid release from adipose tissue, inhibits very low-density lipoprotein production and increases the lipolysis of very low-density lipoproteins.6 Therefore, a deficiency in testosterone may cause a reduction in insulin sensitivity and cause this mechanism to work in reverse. Additionally, research has shown that women with complete androgen insensitivity syndrome have commonly presented with increased body fat, abnormal values of cholesterol and insulin resistance suggesting that a disruption in androgen signaling can be a risk factor for metabolic disorders.7

as well as an increased body mass index (BMI).4 These findings emphasize the fact that testosterone may play a distinct role in metabolic homeostasis and that a reduction in androgen hormones below the normal threshold may be detrimental.4 Treatment

Prescribing rates of testosterone replacement in the United States remains low. Studies estimate that only 5 percent of men with a clinical diagnosis of hypogonadism receive appropriate testosterone replacement.1 Guidelines recommend testosterone replacement in men with androgen defiAndrogen deprivation therapy, in men with prostate cancer, ciency in order to maintain secondary sexual characterishas been studied in order to more clearly define testostics and bone mineral density and to improve sexual functeroneâ&#x20AC;&#x2122;s role in cardiovascular disease.4 Patients undergo- tion and a sense of well being.2 Testosterone replacement ing androgen deprivation therapy were at an increased risk is not recommended in men with prostate or breast cancer, for metabolic syndrome, type II diabetes, and insulin sensi- patients with increased prostate specific antigen (PSA) tivity.4 Furthermore, androgen deprivation therapy patients (PSA>4ng/mL or PSA>3ng/mL in African Americans or had increased levels of LDL, total cholesterol, triglycerides men with first degree relatives with prostate cancer), pa28

THE KENTUCKY PHARMACIST

June 2013 CE â&#x20AC;&#x201D; Testosterone Replacement tients with a hematocrit above 50 percent, untreated severe obstructive sleep apnea, severe lower urinary tract symptoms (American Urological Association (AUA)/International Prostate Symptom Score (IPSS) 19), patients with uncontrolled or poorly controlled heart failure or patients desiring fertility.2 Clinical and biological markers should be evaluated every three to six months after initiation of testosterone replacement and should be evaluated at least yearly thereafter.1 Studies using testosterone replacement as a means of treating elevated lipids and poor glycemic control in men with androgen deficiency have been proven unsuccessful.

Meta-analyses have shown small and clinically negligible effects of testosterone replacement on lipid levels, blood pressure and glycemic control in men with varying levels of testosterone deficiencies.8

May 2013 Transdermal systems avoid fluctuations in peaks and troughs and offer a relatively stable concentration of testosterone.9 Additionally, transdermal systems have been shown to mimic the circadian rhythm of testosterone release more closely than other preparations.9 Transdermal testosterone can be an alternative to patients experiencing unwanted variations in mood or libido when treated with intramuscular injections. Irritation at the application site is common, but the manufacturer recommends application of over-the-counter hydrocortisone cream to the application site after system removal to avoid irritation.10 Serious skin reactions require patients to discontinue therapy. 9 The optimal sites of administration are back, thigh, upper arm and abdomen in descending order.9

Topical gels can also cause irritation to the skin, but are often less severe than transdermal patches and rarely re9 There are many different preparations of testosterone avail- sult in discontinuation. Thus, a gel may be utilized as an able for replacement in hypogonadal men. They are differ- alternative for patients experiencing irritation with a transentiated by route, ease of administration, cost and pharma- dermal patch. The primary concern for patients using topicokinetic profile. A table displaying all manufactured formu- cal gels is secondary exposure to another person. These preparations carry a black box warning for secondary expolations of testosterone replacement available in the United sure and extreme caution must be used in households with States can be seen in Table 2. children. Children exposed to testosterone gels may develOral preparations of testosterone should not be used due to op enlarged genitalia, premature development of pubic hair, their high risk for hepatotoxicity and their potential for inadvanced bone age, increased libido, aggressive behavior creasing low density lipoproteins (LDL).1 Currently, oral for- and precocious puberty.9 mulations of testosterone are not marketed in the U.S. A topical solution applied to the underarm is the newest *Black Box Warning innovation in the testosterone replacement market. It is disTestosterone administered by the buccal route has the ad- pensed in a meter-dosed pump that provides fragrance free vantage of bypassing first pass metabolism. It enters the testosterone.9 Steady state testosterone levels can be body by way of the mouth via venous drainage into the su- reached by day 15 of treatment.9 Deodorant and antiperspiperior vena cava.9 Physiological levels of testosterone are rants can be used concomitantly with the solution, but it is reached within four hours and patients reach steady within recommended that they be used prior to the solution to 24 hours of the first dose. Buccal administration has been avoid cross contamination of the actuator.9 known to cause gum irritation, which should resolve over Topical testosterone preparations may be compounded to time, and taste alterations.9 an individual dose as instructed by a provider. Guidance on Intramuscular testosterone cypionate and enanthate reach proper dosing and administration is limited, but small trials peak concentrations shortly after administration and decline have shown that doses of testosterone between 30 and 120 gradually over the next two weeks.9 Testosterone injections mg administered daily have been shown to provide positive can provide patients with an alternative to daily dosing, results.11 which may lead to increased compliance, but there are drawbacks. The injection demonstrates a wide peak to Compounding testosterone can be extremely beneficial and trough pharmacokinetic profile, which can lead to some un- has advantages over commercially prepared products. wanted side effects such as fluctuations in mood or libido.

Compounding provides prescribers with the ability to tailor Pain at the injection site also has been reported. Additional- doses specifically to a patientâ&#x20AC;&#x2122;s needs. This flexibility would ly, these injections have been associated with coughing allow prescribers to titrate doses more precisely in order to episodes immediately following administrations although achieve optimal patient outcomes. By compounding testosthey are rare. The mechanism by which this occurs is not terone, physicians can provide patients with unique concenfully understood, but it has been attributed to the oil formu- trations in a variety of formulations and dosage forms that lation of these injections.2 are not commercially available.

29

THE KENTUCKY PHARMACIST

June 2013 CE — Testosterone Replacement

May 2013

Pharmacies and pharmacists who specialize in the comhttp://dx.doi.org/10.1016/j.maturitas.2012.11.009 pounding of bio-identical hormones also can be a valuable 2. The Endocrine Society. Testosterone Therapy in Adult resource for prescribers treating hypogonadal men. These Men with Androgen Deficiency Syndromes: An Endoinstitutions can offer guidance in the preparation, stability, crine Society Clinical Practice Guideline. The Journal pharmacokinetics and administration of compounded tesof Clinical Endocrinology and Metabolism. 2010; 95(6): tosterone. It is the responsibility of both prescribers and 2536-2559. pharmacists to diligently monitor the proper use and preparation of compounded testosterone. Improper use or prep- 3. Cornier MA, Dabelea D, Hernandez TL, et al. The Metabolic Syndrome. Endocr Rev. 2008: 29; 777-822. aration can have detrimental effects.

Conclusion The decline in testosterone is often gradual in men and, therefore, the signs and symptoms are often subtle and difficult to assess. Testosterone deficiency increases a patient’s risk for many symptoms and conditions including metabolic syndrome. Hypogonadism in the aging male population continues to be a problem and there are many different options for treatment. Formulations should be assessed based on pharmacokinetic profile, cost, ease of administration and patient preference.

4. Traish AM, Kypreos KE. Testosterone and cardiovascular disease: An old idea with modern implications.

Atherosclerosis. 2011: 214(2); 244-248.

5. Corrales JJ, Burgo RM, Garcia-Berrocal B, et al. Partial Androgen Deficiency in Aging Type 2 Diabetic Men and Its Relationship to Glycemic Control. Metabolism.

2004: 53(5); 666-672.

6. Mäkinen JI, Perheentupa A, Irjala K, et al. Endogenous testosterone and serum lipids in middle-aged men.

Atherosclerosis. 2008; 197: 688-693.

While testosterone replacement has been proven success- 7. Traish AM, Miner MM, Moregntaler A, et al. Testosful in treating sexual dysfunction, studies have shown that terone Deficiency. The American Journal of Medicine. the treatment of dyslipidemia and insulin resistance offer 2011: 124 (7); 578-587. limited results. The utility of testosterone replacement for 8. Haddad RM, Kennedy CC, Caples SM, et al. Testosthe prevention of metabolic syndrome in men with androterone and Cardiovascular Risk in Men: A Systemic gen deficiencies is questionable and warrants further longReview and Meta-analysis of Randomized Placeboterm research.

Controlled Trials. Mayo Clin Proc. 2007: 82(1); 29-39.

Some have hypothesized that there is a direct relationship between the normal processes of male aging, testosterone 9. Abadilla KA, Dobs AS. Topical Testosterone Supplementation for the Treatment of Male Hypogonadism. levels and the development of metabolic syndrome. In othDrugs. 2012: 72(12); 1591-1603. er words, testosterone levels will decrease in the latter part of every male’s life and this predisposes all males to an 10. Androderm [package insert]. Parsippany, NJ. Watson increased risk for the development of metabolic syndrome.

Laboratories; 2012.

If this is true, a reasonable assumption is that testosterone 11. Cutter CB. Compounded Percutaneous Testosterone level monitoring in all aging males and prevention of hyGel: Use and Effects in Hypogonadal Men. JABFP. pogonadism with testosterone replacement would provide 2001: 14(1); 22-32. positive outcomes. There have not been any large, longterm studies to affirm this assumption.

12. Isidori AM, Giannetta E, Greco EA, et al. Effects of testosterone on body composition, bone metabolism Testosterone replacement is still considered, by some, to and serum lipid profile in middle-aged men: a metabe unwarranted and dangerous. While others believe it to anaylsis. Clinical Endocrinology. 2005: 63; 280-293. be the answer to many metabolic conditions affecting aging males. One can only be certain that the controversy 13. Lexicomp Web Site. https://online.lexi.com/lco/action/ surrounding testosterone replacement in the aging male doc/retrieve/docid/patch_f/7742. Accessed December has not been settled and that further long-term evaluation 31, 2012. is critical to its success.

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

References: 1. Samras N, et al. A view of geriatrics through hormones. What is the relation between andropause and well-known geriatric syndromes? Maturitas. 2012.

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THE KENTUCKY PHARMACIST

June 2013 CE — Testosterone Replacement

May 2013

June 2013 — Testosterone Replacement: An Overview and Clinical Applications 1. Oral formulations of testosterone replacement are not recommended because they have been associated with: A. Nephrotoxicity B. Hepatotoxicity C. Hypersensitivity reactions D. Gynecomastia 2. An uncommon, but possible, side effect of testosterone administered via intramuscular injection is: A. Stevens-Johnson Syndrome B. Thrombocytopenia C. Coughing episodes D. Urinary frequency 3. Guidelines recommend testosterone replacement in men with androgen deficiency in order to achieve all of the following purposes except: A. Maintain secondary sexual characteristics B. Maintain bone mineral density C. Improve sexual function D. Lower blood pressure 4. Fluctuations in mood and libido due to a wide peak and trough ratio can be experienced in men treated with this formulation of testosterone: A. Intramuscular injection B. Transdermal system C. Topical gel D. Mucoadhesive buccal system

8. Topical testosterone carries a black box warning for: A. Secondary exposure risk B. Worsening of heart failure C. Skin irritation D. Taste alterations 9. Manufacturers of transdermal testosterone recommend ______________ for the treatment of application site reactions?

A. Diphenhydramine B. Topically applied hydrocortisone C. There is no treatment; patients must discontinue therapy D. Second generation antihistamines 10. What is the normal individual threshold for testosterone?

A. 200 ng/mL B. 300 ng/mL C. 400 ng/mL D. 1,000 ng/mL 11. All of the following are more specific signs and symptoms of hypogonadism except: A. Reduced libido B. Loss of body hair C. Incomplete or delayed sexual development D. Insulin resistance

5. All of the following are aspects of metabolic syndrome except: A. Elevated blood pressure B. Abdominal obesity C. Insulin resistance D. Less than normal testosterone levels

Nominate your peers for a new feature in

6. Testosterone replacement is not recommended in men with: A. Uncontrolled or poorly controlled heart failure B. Hepatic impairment C. Renal impairment D. Suicidal thinking/behavior

We are looking for members to profile in coming editions of The Kentucky Pharmacist who are making the world a better place. Do you know someone who goes above and beyond the “above and beyond the call of duty”? Let us know!

The Kentucky Pharmacist

7. Which formulation of testosterone is thought to most closely mimic the natural circadian rhythm of testosterone release in the male body?

A. Topical gel B. Intramuscular injection C. Transdermal systems D. Topical solutions applied to the underarm

Email Scott Sisco at ssisco@kphanet.org with a brief description of the story or to schedule a time to discuss.

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THE KENTUCKY PHARMACIST

June 2013 CE — Testosterone Replacement

May 2013

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, 1228 US 127 South, Frankfort, KY 40601. Credit will be applied to your CPE Monitor Profile.

Expiration Date: May 15, 2016 Successful Completion: Score of 80% will result in 1.0 contact hour or 0.1 CEUs. Participants who score less than 80% will be notified and permitted one re-examination.

TECHNICIANS ANSWER SHEET. June 2013 — Testosterone Replacement: An Overview and Clinical Applications Universal Activity # 0143-0000-13-006-H01-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

11. A B C D

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve 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 I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature _________________________________________________ Date _________________________________

NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) PHARMACISTS ANSWER SHEET June 2013 — Testosterone Replacement: An Overview and Clinical Applications Universal Activity # 0143-0000-13-006-H01-P Name ________________________________________________ KY Lic. # __________________________________ 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

11. A B C D

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve 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 Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party.

Signature _________________________________________________ Date _________________________________

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.

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

THE KENTUCKY PHARMACIST

KPhA Emergency Preparedness Initiative

May 2013

Many Kentuckians across the Commonwealth have experienced natural disasters within recent years. As healthcare professionals, pharmacists can volunteer their services by registering through KHELPS and being assigned to the local Medical Reserve Corps (MRC) unit in their area.

The Kentucky Pharmacists Association has partnered with the Kentucky Department for Public Health (KDPH) to develop a state wide plan for pharmacy emergency preparedness. This plan includes the activation of a mobile pharmacy. The mobile pharmacy will be stocked with necessary medications and supplies to be delivered to the areas in need, when deployed by the KDPH. KPhA is recruiting a pharmacist in each area of the state to serve as a pharmacy district coordinator. In addition to serving as a volunteer with the MRC, the pharmacy district coordinator would assist the KPhA Director of Pharmacy Emergency Preparedness in contacting pharmacists and pharmacy technicians in that district to assist with the dis-

pensing activities on the mobile pharmacy.

Please contact Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness (ltolliver@kphanet.org, 502-2272303) for more information. You may also go to the KPhA web site (www.kphanet.org) to sign up with the KHELPS registry and find other Emergency Preparedness information under the Resources link.

KPhA Emergency Preparedness Initiative Interest Form Name: _____________________________________

QS/1 Experience: Yes____ No _____

Status (Pharmacists, Technician, Other): ___________________________ Interest in serving as a volunteer: Yes____ No _____ If yes, please go to KHELPS link on KPhA Website to register (www.kphanet.org under Resources) ____ I would like to serve as pharmacy district coordinator (PDC). A PDC will be included in the KPhA emergency preparedness communication tree and will assist in dispensing activities on the mobile pharmacy.

Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email at ltolliver@kphanet.org, or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601.

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THE KENTUCKY PHARMACIST

KPhA New and Returning Members

May 2013

KPhA Welcomes New and Renewing Members March-April 2013 Frankie Abner Barbourville

Douglas Bradley Carr Hopkinsville

Jackie Evans Gray

Stephen Hill Liberty

Elaine Adams Crestwood

James Fred Carrico Louisville

John B Evans Henderson

Janet Hodge Louisville

Sandra Foster Anderson Monticello

Matt Carrico Louisville

William J Farrell Ft. Mitchell

Karen Hubbs Gray

Patrick J Ary Columbus, OH

Patricia Chadwell Lexington

Joseph L Fink Lexington

Ronald Huening Cincinnati, OH

Harold C Beck Benton

BC Childress Shelbyville

Maureen Fink Lexington

Jennifer Ihrig Hebron

Cassandra Beyerle Louisville

Jessika Chinn Beaver Dam

Reed Ginn Cerulean

Karen Jackson Paducah

Cynthia Ann Biecker Edgewood

Joseph Chowning Berea

Patricia Ann Gooch Pikeville

Tim Jenkins Louisville

Stefani Brinn Billington Murray

Charles Chris Clifton Villa Hills

Shirley A Good Hopkinsville

Scott King Hazard

Sherry Bilyeu Russellville

Katy Clifton Villa Hills

Ben W Gower Henderson

Steven King Bloomfield

Raymond J Bishop Louisville

Sharon Clouse Glasgow

Scott A Greenwell Louisville

Shannon Kinney Artemu

David E Bowman Columbia

John H Curry Louisville

Karen Groce Byrdstown, TN

Betty Klaas Woodbury

Michael Branstetter Glasgow

Johnnie E Dando Liberty

William Reed Hall Whitesburg

Darren Lacefield Bowling Green

Kathryn M Breeze Lexington

Judith Davenport Louisville

George Hammons Barbourville

Jane Lacefield Bowling Green

Larry K Bright Campbellsville

Holly Divine Versailles

Kathy Hardy Smiths Grove

Bruce Lafferre Louisville

Jennifer L Brock Barbourville

James M Dixon Barbourville

Chris Harlow Louisville

Sarah M. Lawrence Louisville

Julie N. Burris Louisville

Gerald Durr Crescent Springs

Julie Hawkins Pewee Valley

Thomas Lawrence Carlisle

Bill P Burton Owensboro

David Eckmann Lexington

Joseph Stephen Hays Smiths Grove

Michelle Loos Covington

Quint C Butler Munfordville

Lynne Eckmann Lexington

Paula Hieneman Ashland

Julie Losch Bowling Green

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THE KENTUCKY PHARMACIST

KPhA New and Returning Members

May 2013

Philip Losch Bowling Green

Jeffrey Osman Lexington

Michael Schweighardt Lexington

Terry Sutton Henderson

James William Marshall Leitchfield

Angela Parrett Simpsonville

Kimberly Scott Frankfort

Neil Taylor Hardinsburg

Thomas Charles Mason Fairfield, OH

Julie Perry Paducah

Anna L Sharp Campbellsville

Marla Tolley Ashland

Joey Mattingly Prospect

Chad Phelps Greensburg

Kenton Shearer Albany

Angela Tracy Shelbyville

Sunni Mauk Paducah

Stephen Pollock Prospect

Catherine l Shely Morehead

Hieu Tran Louisville

John B McClanahan Ashland

Walter Powell Louisville

Tina Simpson Heidrick

Steven Gregory Treadway Elizabethtown

Jill McIntosh Louisville

Amanda Powers Boaz

Patti Sizemore-Mink London

Clifford Tsuboi Lexington

Anne Megibben Finchville

Ronald Renfrow Bowling Green

Patricia Slone Hindman

Joseph Vennari Lexington

Daniel Meier Edgewood

Felix G. Reynolds Lancaster

Richard Slone Hindman

William Wagers Berea

Janet Mills Louisville

Gary Rice Corbin

Zena Slone Hindman

Amanda Jo Ward Louisa

Jeff Mills Louisville

Adam Robinson Brandenburg

Edwin Snider Louisville

Tonya Westmoreland Lowmansville

Mickey Monroe Frankfort

Frank Romanelli Lexington

Rodney Chandler Stacey Cumberland

Jack Wikas Cold Spring

James Wesley Murphy Whitley City

Doug Russell Louisville

Jamie L Stake Greenup

Samuel Willett Mayfield

Chanin Nelson Middlesboro

Jessica Salmons Hindman

Veronica Stith Vine Grove

Carol Wills Lexington

Brad Newcomb Paducah

Dustin Salyer Bowling Green

Christopher Scott Stovall London

Clyde Wilson Danville

Mark Nybo Crescent Springs

Anthony Samaan Lexington

Brooke C Strong Barbourville

Ernest L. Wilson Paris

Will Osborn Trenton

Lisa Sawvell La Grange

J. Eddie Sutton London

Are you connected to KPhA? Join us online!

@KyPharmAssoc @KPhAGrassroots

KPhA Company Page

Facebook.com/KyPharmAssoc

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Pharmacy Law Brief

May 2013

Pharmacy Law Brief: Corresponding Responsibility and Liability of the Pharmacist Author: Peter P. Cohron, B.S.Pharm., J.D., Practicing pharmacist and attorney, Henderson, KY. Question: I have a doctor who consistently tells me it is OK Submit Questions: jfink@uky.edu to do early refills, so much so that patients are getting 30 day supplies of medications every 15-22 days. Do I have market at that time. Hayes made no effort to speak to the any liability here? I spoke with someone at the Board and single prescriber or refuse to honor any of the prescriphe used the phrase “corresponding liability.” tions. The court ruled that Hayes’ failure to assess the high Response: Corresponding liability is the duty placed upon likelihood of misuse, abuse and probable intent to sell the pharmacists to ensure a patient’s safety and health by as- drugs more than met the criteria for assuming correspondsuring that the patient’s prescriptions are written for a legiti- ing responsibility for the misuse, etc. mate medical purpose in the prescriber’s usual course of professional practice. Thus, a pharmacist has a duty to make a reasonable assessment of each prescription as being for a legitimate medical purpose. If the assessment is that the prescription is not for a legitimate medical purpose, the prescription should be refused or delayed, e.g., if the refill is too early. Failure to make this reasonable effort or to make an insufficient effort can lead to pharmacist liability.

This duty arises out of federal law -- 21 C.F.R. §1306.04: “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose … in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment … is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.”

Case decisions show that courts, despite this issue not being cut and dried, have had little problem in holding pharmacists liable. The case most often cited in articles regarding corresponding liability is United States v. Hayes, 595 F.2d 258 (CA 5th Cir. 1979). Pharmacist Hayes in one month for one patient dispensed 34 prescriptions for Dilaudid and 75 for Preludin®, an anorexiant drug on the

In a more recent case in Ohio, a pharmacist was stripped of his license based on corresponding responsibility. The pharmacist dispensed sometimes up to 500 controlled substance prescriptions a day from a single prescriber at a pain treatment clinic. The Board stated in its decision that any reasonable pharmacist would have known that a single prescriber could not see (i.e., take a history, perform an examination, etc.) enough patients in a single day to warrant anywhere near that number of prescriptions for a legitimate medical purpose.

More in line with the question above, there is the case of McLaughlin v. Hooks-SupeRx Inc., 642 N.E. 2d 514 (Ind. 1994). The pharmacist dispensed a large number of propoxyphene prescriptions for McLaughlin, prescriptions that were always early. McLaughlin, after seeking treatment for addiction to the drug on three separate occasions but continuing to take the drug after each rehab, ended up taking so much of the drug that he attempted suicide. Without using the phrase “corresponding responsibility,” the court held Hooks liable under the same principal: that the pharmacist had a separate duty to the patient to assure safe prescription therapy. The court held that Hooks should have stopped honoring the propoxyphene prescriptions when the calculated daily dose became dangerous to McLaughlin.

So what factors should a pharmacist look for to reasonably ensure the legitimacy of a prescription? The commentators on this issue agree on these: the practitioner’s prescribing practices, how far away the patient lives, how far away the prescriber is located, paying cash for large quantities of CS, younger patients, scripts presented to pharmacy late

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

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THE KENTUCKY PHARMACIST

Pharmacy Law Brief

May 2013

at night or weekends, patient appears to be nervous or in a hurry, early refills without a change in directions or other good reason, patient has scripts for multiple medications but only wants the controlled substances, etc. When one or more of these is present, the pharmacist must make an assessment as to whether to honor the request for dispensing. A major factor in that assessment should be, if possible, to speak to the prescriber.

lawyer’s considered legal opinion that the pharmacist is making reasonable efforts to ensure patient safety and the legitimacy of prescriptions. While not a “cure-all,” that commentator believes that this will provide some protection to the pharmacist seeking to honor legitimate controlled substance prescriptions for treatment of pain.

Finally, it is my legal opinion that corresponding responsibility could be extended to prescriptions for non-controlled How does a reasonable pharmacist avoid this liability? substances under the right circumstances. Pharmacists Along with the above, one commentator suggests speaking should not limit their assessment to requests to dispense to a lawyer and getting a written statement that it is the controlled substances.

REGISTER ONLINE AT WWW.KPHANET.ORG! For more information, contact Scott Sisco at ssisco@kphanet.org.

Mycpemonitor.com All of your CE Credit for 2013 and beyond will be uploaded to CPE Monitor 37

THE KENTUCKY PHARMACIST

Pharmacy Policy Issues

May 2013

PHARMACY POLICY ISSUES: The Impact of Marijuana Legalization to the Pharmacy Profession Author:

Katherine E. Bentley is a second professional year Pharm.D. student at the University of Kentucky College of Pharmacy and is concurrently pursuing a Master of Public Health. A native of Louisa, KY, she earned her Bachelor of Science in Human Nutrition from the University of Kentucky.

Issue:

In states where medicinal marijuana has been legalized, should pharmacists support patients’ decisions regarding marijuana use?

Discussion: Currently, 18 states have enacted laws permitting use of marijuana for medicinal purposes. Contingencies on procurement, maximum quantity allowed and other nuances vary on a state-by-state basis, and pharmacists in these states should be well versed on these laws.

If a patient presents to a pharmacy with questions regarding marijuana, the pharmacist should know how to respond appropriately. Always remember that marijuana is federally classified as Schedule I and still considered illegal in the eyes of the DEA. However, our professional right to counsel patients on the use of medicinal marijuana does not make us liable for prosecution by the DEA. Pharmacists must be careful not to cross the line into abetting, for example, helping the patient to procure marijuana. Providing patients access to drug therapy is a major aspect of the pharmacy profession, so the legal aspect of marijuana distribution should be discussed with patients since many may come to the pharmacy expecting information on where to find marijuana.

with the indication of treating nausea and vomiting associated with chemotherapy. As a healthcare provider, patient safety should be our primary concern. Marinol and Nabilone have been tested by the scientific community and proven safe and effective. They also come in a form that provides accurate, consistent dosing. Cannabis sativa, on the other hand, is a plant containing over 400 compounds, and the effects of all of these compounds on the human body are not well documented. If THC appears therapeutically necessary, these synthetic options should be suggested in lieu of medicinal marijuana.

If a patient does decide to use natural marijuana instead of synthetic THC medications, there are important counseling points that should be discussed. First, it is the position of the DEA, along with several other health agencies that smoked marijuana has no medical value1. Medicinal marijuana should be ingested to be effective. In addition, dispensaries are not regulated to the extent of a pharmacy. It cannot be guaranteed that what is dispensed has undergone any quality control whatsoever. Also, in a state where meAs healthcare providers, it is vital that we stay tuned in to dicinal use of marijuana has been legalized, patients’ emwhat our patients are using to treat their health-related isployers still have the right to discipline them for failed drug sues, as these “alternative” treatments may cause dangertest, as long as company policy addresses this. Employees ous adverse effects and drug interactions. Because natural need to discuss ramifications of marijuana use with their marijuana, or cannabis sativa, is not an FDA approved employers and take this into consideration. Contrary to medication, information regarding pharmacodynamic/ popular belief, marijuana can be addictive and signs of adpharmacokinetic properties must be obtained through peerdiction should be discussed so that patients and their famireviewed, published research that has been appropriately lies can be cognizant of any psychological changes and sanctioned. Marijuana legalization is the outcome of find help, if necessary. patient-rights advocates, not necessarily healthcare research. Just because it is legal, does not mean it is safe, Reference: nor effective; therefore, our professional judgment is paraU.S. Department of Justice, Drug Enforcement Adminmount to patient health. istration. (2011). The DEA position on marijuana.

Marinol and Nabilone are synthetic THC medications that Retrieved from website: http://www.justice.gov/dea/ have undergone FDA clinical trials and are on the market docs/marijuana_position_2011.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.

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THE KENTUCKY PHARMACIST

May 2013

Kentucky Renaissance Pharmacy Museum

The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy.

While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration. Friend of the Museum $100  Proctor Society $250 Damien Society $500 Galen Society $1,000

Name______________________________________ Specify gift amount________________________ Address ____________________________________ City____________________Zip______________ Phone H____________________W________________ Email___________________________________ Employer name_____________________________________________________for possible matching gift.

Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually.

Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com

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THE KENTUCKY PHARMACIST

May 2013

Pharmacists Mutual

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THE KENTUCKY PHARMACIST

Senior Care Corner

May 2013

Senior Care Corner from the KPhA Academy of Consultant Pharmacists The KPhA Academy of Consultant Pharmacists and the Kentucky Chapter of ASCP held an excellent continuing education program April 20, 2013 at Sullivan University College of Pharmacy in Louisville.

Baker presents Leah Tolliver, PharmD, with the ASCP-Kentucky Chapter President’s Award.

Top Left: Sean Jeffery, Clinical Professor, University of Connecticut, School of Pharmacy; Noll Campbell, PharmD, BCPP, Research Assistant Professor, Purdue University, IU Center for Aging Research, Regenstrief Institute; Jason Baker, Jason K Baker, PharmD, President and CEO, Clinical Pharmacy Consulting and Staffing; and Demetra Antimisiaris, PharmD, CGP, FASCP, Associate Professor, Department of Family Medicine and Geriatrics, U of L Dept. of Neurology were instrumental in planning and presenting at the event. Above: Participants listen intently to the presenters.

SECOND ADVANCING PHARMACY PRACTICE IN KENTUCKY SUMMIT The second Advancing Pharmacy Practice in Kentucky Summit was recently held, and once again, a passionate and engaged group of individuals came together to work towards advancing the profession and 27 new Coalition members were added. KPhA was represented by President Kim Croley and Executive Director Robert McFalls along with a number of other KPhA members.

As a result of 2012’s Summit, the Advancing Pharmacy Practice in Kentucky Coalition was formed, and four broad focus areas were identified with work groups organized to support them. As the results and accomplishments of the first year’s activities were evaluated, it became apparent the goals may have been too broad and numerous for meaningful progress.

as short-term goals, with the other three as long-term goals. During the closing session, the participants narrowed the four short-term goals down to two for the primary focus of the coalition’s activity this year – Expansion of CCAs and working to achieve provider status for the healthcare activities pharmacists currently conduct. The need for communications to support the efforts was reaffirmed, and Education & Credentialing was identified as a longer-term goal, along with several other long-term priorities.

The Coalition would like to hear from those who were unable to attend the summit about this proposed reorganization of priority goals and work groups to support them, and have created a survey to get your input. You are encouraged to participate in the coalition's process to finalize goals for the As a result, the key goal for this year’s summit was to agree next year by completing the survey at on more focused priority actions to advance the profeshttps://redcap.uky.edu/redcap/surveys/?s=qFXkWv . Watch sion. Seven ideas were presented for consideration as goals eNews and visit YOUR KPhA web site for updates on the and using an audience response system, four were selected activities of the Coalition..

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THE KENTUCKY PHARMACIST

KPhA Board of Directors/Staff

May 2013

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Lewis Wilkerson, Frankfort rphs2@aol.com

Chairman 502.695.6920

Matt Martin, Louisville matt67martin@gmail.com

Kimberly Croley, Corbin kscroley@yahoo.com

President 606.304.1029

Cassandra Beyerle, Louisville Vice Speaker of the House cbeyerle01@gmail.com

Duane Parsons, Richmond dandlparsons@roadrunner.com

President-Elect 502.553.0312

KPERF ADVISORY COUNCIL

Frankie Hammons Abner, Barbourville frankiehammons@gmail.com

Secretary 606.627.7575

Glenn Stark, Frankfort glennwstark@aol.com

Treasurer

Donnie Riley, Russelville Past President donnierileyatclinicpharmacy@msn.com Directors Molly Trent, Georgetown mjtren2@uky.edu

Student Representative

Lance Murphy, Louisville lmurph8942@my.sullivan.edu

Student Representative

Matt Carrico, Louisville matt@boonevilledrugs.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington* trish.freeman@uky.edu Chris Killmeir, Louisville cdkillmeier@hotmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Bob Oakley, Louisville Boakley@BHSI.com

Speaker of the House

Kim Croley, Corbin kscroley@yahoo.com Ann Amerson, Lexington amerson@insightbb.com

KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Nancy Baldwin Receptionist/Office Assistant nbaldwin@kphanet.org

Richard Slone, Hindman richardkslone@msn.com Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee

KPhA sends email announcements weekly. If you arenâ&#x20AC;&#x2122;t receiving: eNews, Legislative Updates, Grassroots Alerts and other important announcements, send your email address to ssisco@kphanet.org to get on the list.

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THE KENTUCKY PHARMACIST

50 Years Ago/Frequently Called and Contacted

May 2013

50 Years Ago at KPhA SPECIAL COMMITTEE ON AFFILIATION KENTUCKY PHARMACEUTICAL ASSOCIATION A Progress Report As instructed by a resolution passed by the Paducah Convention, a special committee has studied the desirability and means of affiliating our Association with the American Pharmaceutical Association, and is now in the process of preparing its final report for the Convention in Lexington.

The Committee believes it desirable to affiliate and has selected a plan that seems to offer us the best means of accomplishing this act.

A united front is essential in effecting a solution to our many problems, most of which are nation-wide in nature.

- From The Kentucky Pharmacist, Vol. XXVI, No. 5, May 1963

COMMITTEE MEMBERS Robert L. Barnett, Louisville William E. Danhauer, Owensboro Crawford Meyer, Louisville Joe McMurtry, Nicholasville J.J. Thompson, South Fort Mitchell Jesse G. Wallis, Murray Jesse DeJarnette, Lexington (ex officio) E.M. Josey, Frankfort (ex officio) Norman H. Franke, Chairman, College of Pharmacy, Univ. of Ky., Lexington

Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South 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 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 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 Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu Kentucky Regional Poison Center (800) 222-1222

KPhA Remembers KPhA desires to honor members who are no longer with us.

Please keep KPhA informed by sending this information to ksheets@kphanet.org.

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

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THE KENTUCKY PHARMACIST

May 2013

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

The 2013 KPhA Board of Directors Election will be held online at www.kphanet.org. You will need to log in to the site to cast your vote.

Paper ballots will be available, but ONLY upon request.

Call the KPhA Office at 502-227-2303 for more information.

DEADLINE MAY 21, 2013 AT 8 P.M. EDT

Register now!

135th KPhA Annual Meeting June 6-9, 2013 Louisville Marriott Downtown

Visit www.kphanet.org to register.

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THE KENTUCKY PHARMACIST