The Kentucky Pharmacist Vol. 10, No. 3 by Kentucky Pharmacists Association

Y K C U T N E K THE T S I C A M R A PH Vol. 10, No. 3 May/June 2015

Gov. Beshear signs HB 377, the Collaborative Care Bill See inside: 2015 Legislative Wrap-Up

Membership Matters in YOUR KPhA News & Information for Members of the Kentucky Pharmacists Association

Table of Contents

May/June 2015 May 2015 CE — Top 10 Dietary Supplements May Pharmacist/Pharmacy Tech Quiz Kentucky Renaissance Pharmacy Museum KPhA New and Returning Members Pharmacy Time Capsules Pharmacy Law Brief Pharmacy Policy Issues KPhA Emergency Preparedness Pharmacists Mutual Cardinal Health KPhA Board of Directors 50 Years Ago/Frequently Called and Contacted

Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective 137th KPhA Annual Meeting & Convention KPhA Immunization Training From your Executive Director APSC 2015 Kentucky General Assembly Wrap-Up 2014 KPPAC and Government Affairs Contributors Technician Review April 2015 CE — OTC Oral Rehydration Salt Solutions April Pharmacist/Pharmacy Tech Quiz

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21 30 31 32 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 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.

Editorial Office: © Copyright 2015 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bi-monthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editor-in-Chief: Robert McFalls Managing Editor: Scott Sisco 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.

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. 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. 2

THE KENTUCKY PHARMACIST

President’s Perspective

May/June 2015

The Year in Review PRESIDENT’S PERSPECTIVE

build our membership and to strengthen our relationships with current members. KPhA is partnering with KSHP in a survey this summer of recent graduates from UKCOP and SUCOP. The goal is to identify the factors that influence the decisions of new and recent graduates to become or not Robert Oakley become members of their state professional associations. KPhA President My hope is that we can learn from this research project and extend the research to other levels of practice. I know that 2014-2015 the KPhA Membership Engagement Committee will be reIt is hard to believe that it viewing a number of additional ideas to help build our memhas been a year since I bership base. Another membership initiative of KPhA was urged pharmacists and stuto initiate discussions with the local pharmacy associations dents to “Get Involved and to see if we could boost membership and services to the Stay Involved” in YOUR local chapters through the services of KPhA. As a longtime KPhA. The time has gone by member of JCAP, I have seen membership numbers dwinquickly. I have enjoyed the opportunities I have had to meet dle over time. Chris Harlow, JCAP President, has done a KPhA members and potential KPhA members throughout great job trying to revitalize the local association; however, the state. I have been impressed by the hard work and efit is still a challenge. I know similar efforts are underway in fort that so many of our members have shown to support other areas of the state. The thought became how can and promote our profession and association. I think KPhA KPhA help the local associations grow? The conversation has accomplished much this past year, but I recognize we started at the Mid-Year Conference with the Presidents of have even greater opportunities ahead of us. As part of my three of the larger local associations (JCAP, Bluegrass and preparation for this article, I had the opportunity to review Northern Kentucky). The idea is to formalize the relationitems that I had written for JCAP and KPhA in the 90s. I ship between each of the local associations with KPhA so hope the articles that I wrote this past year for The Kenthat KPhA can provide the local association with any level tucky Pharmacist are a little more coherent than my earlier of administrative support that they need. By helping the ones were! This past year KPhA has been very active in local associations grow, it is hoped that the new members many areas, but I will focus on four primary areas – contin- in the local associations also would be interested in joining uing education, membership and membership relations, KPhA. This becomes a win-win situation for both organizalegislative initiatives and our Rebuilding for the Future tions, and it makes the pharmacy profession stronger Campaign. across the state. JCAP has signed the affiliation agreement. This agreement will be offered to the other local asThe first area of review will be education or as most of you sociations (if it hasn’t already) in the near future. Get Inknow it, CE. KPhA always has been known for the high volved and Stay Involved works at the local level too! Anquality of the CE provided. The annual and mid-year meetother membership initiative undertaken by Ethan Klein, ings put together by the KPhA staff were excellent proSpeaker of the House, and Chris Harlow, Vice Speaker of grams. I know the programs in 2015 will be even better. the House, was to modernize the by-laws of KPhA to modiRecently, I attended a Board of Pharmacy meeting. One of fy the levels of membership and to expand voting in the the more unpleasant tasks (in my opinion) for the Board is House of Delegates to all pharmacist members of KPhA. I the need to take disciplinary action against a large number also had the opportunity to lead the Kentucky delegation to of pharmacists who chose not to complete their CE requirethe APhA House of Delegates at the APhA annual meeting. ments for licensure. I do not understand why professionals It was an honor and a privilege to represent the state. The do not meet this requirement when KPhA offers a wide varimost amazing thing that I saw there was the high level of ety of excellent CE material and programs that meet all of energy and enthusiasm shown by the students at the meetyour CE requirements. This will continue to be a strong ing. If they maintain this same level of energy following point for our organization as we move forward. As an organization, we are only as strong as our membership. We undertook a number of initiatives this past year to

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THE KENTUCKY PHARMACIST

137th KPhA Annual Meeting & Convention

May/June 2015

Watch for the July/August edition for more pictures!

THE KENTUCKY PHARMACIST

KPhA Immunization Training

May/June 2015

Visit www.kphanet.org to register today!

Immunization Training from YOUR KPhA August 1, 2015 2 p.m. to 7 p.m. EDT Natural Bridge State Resort Park 5 Contact Hours

0143-0000-13-015-L04-P&T

Cathy Hanna, PharmD, Director of Research and Education, APSC will lead the training. Application-based. $150.00 per participant Register TODAY on the KPhA Website at www.kphanet.org. For more information, contact Scott Sisco at ssisco@kphanet.org or 502-227-2303.

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

Objectives: 1. Understand basic scientific principles of immunization and immunity. 2. Describe the microbial and immunologic characteristics of pneumococcal, influenza, hepatitis B, meningococcal and varicella disease. 3. List key questions to identify indications and contraindications to immunization. 4. Identify the correct dosage and route for pneumococcal, influenza, hepatitis B, meningococcal and zoster vaccines. 5. Describe proper procedures for reporting adverse events after immunization. 6. Describe general principles for emergency response to anaphylaxis. 7. Describe marketing material for advertisements of adult immunization programs. 8. Describe storage and handling requirements for vaccines. 9. Understand the legal, regulatory, and liability issues involved with and adult immunization program. 10. Understand record-keeping requirements and develop a documentation system. 11. Describe general principals of immunization technique and administer an IM and SQ injection.

THE KENTUCKY PHARMACIST

From Your Executive Director

May/June 2015

MESSAGE FROM YOUR

EXECUTIVE DIRECTOR Robert “Bob” McFalls YOUR KPhA may have an office in Frankfort, but its reach is statewide, national—yes, even global!

“Good Morning from the Kentucky Pharmacists Association” began our journey which is now more than 2,600 tweets long and can be seen by more than 1,700 followers! In 2011, YOUR KPhA launched a social media campaign to If you’re not along for the ride, get engaged and follow us at reach a new audience for our communications. We started www.twitter.com/KyPharmAssoc. with a Facebook page that had been run by new practitioner volunteers and had Following our strategic about 100 fans. We planning retreat with our redesigned it and Board of Directors in have since built that August 2012, YOUR 1500 base to more than KPhA added a second 1,000 fans, earlier Twitter handle dedicated 1004 1020 887 916 970 1000 this year thanks to to Legislative Grass638 608 many of our memroots efforts Fans 347 433 500 bers—you—for shar(www.twitter.com/ 211 ing our page with KPhAGrassroots). Staff your colleagues. utilizes this account to 0 Jan. Oct. Feb. Nov. Jan. Nov. Jan. March May June These fans come quickly update YOU on 2012 2012 2013 2013 2014 2014 2015 2015 2015 2015 from all over Kenlegislative issues by tucky, the United Live Tweeting legislative States and a few in committee meetings other countries as and sharing grassroots well! We try to keep alerts. this page updated While we don’t have 2000 1631 1 687 with the latest infor1385 1501 very many videos yet, 1294 1500 mation, interesting check out YOUR KPhA 691 765 articles and some fun 1000 36 9 YouTube channel as 272 500 posts along the way. well 0 Now. Let’s get to the (www.youtube.com/ Oct. Feb. Nov. Jan. Nov. Jan. March May June heart of the matter: if KyPharmAssoc). We 20 12 2013 2013 2014 2014 2015 2015 2 015 2015 you’re on Facebook have videos from our and haven’t liked us Open House programs, Followers yet, check out what a few legislative you’re missing at presentations and an www.facebook.com/KyPharmAssoc. We also added a Fa- interview with Bob Lichtenfeld who served as KPhA Execucebook page for the younger set of the profession, which tive Director during the construction of the current KPhA has seen steady growth as well. It is at www.facebook.com/ Headquarters building. KPhANewPractitioners, and is geared toward student pharWe will continue to grow our social media presence, but we macists and those who have been out of school for 10 can’t do it without you! Like us, Follow us, Share us. Help years or less. us put the social in our social media! It’s one more exciting KPhA also ventured into the realm of 140 character upway to engage with YOUR Kentucky Pharmacists Associadates when we shared our first tweet on Nov. 11, 2011. tion!

KPhA Facebook Fans

Twitter Followers: @KyPharmAssoc

THE KENTUCKY PHARMACIST

From Your Executive Director

May/June 2015

Finally on the legislative front, there is still much work to be done in 2016. Among the many key areas of focus will be graduation, the profession will have a great future with increased PBM transparency, MAC issues and medical mathese students remaining as KPhA members following grad- rijuana among many potential issues. KPhA and its memuation and work to help protect their future in pharmacy. bers will play a key role in working with our state legislature on these issues. Please continue to generously support the I thought the legislative year in 2014 was a great success Government Affairs Committee and KPPAC so we can confor our patients with the passage of a number of legislative tinue our legislative initiatives for 2016 and beyond. initiatives such as the parity for oral chemotherapy bill. This initiative was a great accomplishment for KPhA and its The final area of review is the campaign I started calling: members. Another of the 2014 legislative successes was KPhA: Rebuilding for the Future Campaign. Our current the effort of KPhA to get the Pharmacy Technical Advisory office is nearly 50 years old and in constant need of repairs. Committee reestablished within the state Medicaid departWith the help of Bob McFalls, the Board has evaluated a ment. The PTAC had its first meetings this year. KPhA is number of options. The primary options are to 1) do nothing blessed to have an excellent group chosen for the commit- and let the building continue to deteriorate, 2) repair and tee. They are excited about their role and the opportunity renovate the current building, 3) seek a current building in they will have to have a positive impact on patient care. An- Frankfort that better meets our current needs and allows for other patient care opportunity our members are participating future expansion and growth, or 4) build a new building as in is the state project for the State Innovation Model Design our predecessors did 50 years ago. The options were taken for Health Care Transformation. The work already has beto the House of Delegates in June. Based on their vote, we gun with pharmacist participation at most levels. It will be will establish a building fund campaign to pay for the proexciting to see what initiatives occur based on the work of ject. My goal is to renovate/buy/build a new KPhA office that this group. As good as 2014 was on the legislative front, I everyone can be proud of. believe 2015 was even better. This year saw the passage of I want to thank Bob McFalls for keeping me on track this bills to revise the section of the pharmacy practice act for past year, Scott Sisco for his help on getting these articles Collaborative Care Agreements. This will allow pharmacists in a readable format, and Leah Tolliver for all she does for to work more closely with physicians and patients to better emergency preparedness. I also want to thank Angela and manage their drug therapies. Another bill for medication Liz for keeping Bob, Leah, and Scott on track. As I reflect synchronization will require insurance companies to pay on the year, one conversation that I had heard was when a pharmacies in order to get patient refills to a common date. non-KPhA member asked one of our Board members “What This will be more convenient to our patients and hopefully is KPhA’s position on this?” when discussing one of the relead to better patient compliance with their medications. cent legislative issues. If this pharmacist was interested in The 2015 bill that has so far received the most press is the what KPhA thinks, then the best thing he/she can do is join “Naloxone Bill.” One of the provisions of the bill is to grant and get involved! Pharmacists should not stand on the sidepharmacists who have completed special training the ability lines and expect to reap the benefit of the work of KPhA to dispense naloxone subject to a physician approved proand its members. They should Get Involved and Stay Intocol. These legislative successes would not have hapvolved! For those who may complain that they do not join pened without the hard work of Jan Gould and the Kentucky KPhA because the cost of dues is too high, I would ask Retail Federation, our own Bob McFalls, Richard Slone and them how much they spent on dinner the last time they ate the members of the Government Affairs Committee, and at a nice steak house. My guess is (based on recent experiyou the members of KPhA who took the time out of your ence taking my family to dinner), KPhA dues is a great barbusy day to personally contact members of the Kentucky gain. legislature. This was evident when HB 377 (Collaborative Care) passed both the House and the Senate without a sin- Thank you for the opportunity to serve as president of YOUR KPhA. gle dissenting vote.

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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.

THE KENTUCKY PHARMACIST

APSC

May/June 2015

THE KENTUCKY PHARMACIST

2015 Kentucky General Assembly

May/June 2015

SUMMARY OF PHARMACY ISSUES: 2015 Kentucky General Assembly

A Member Update from YOUR Kentucky Pharmacists Association The Guardian of the Profession Overview: KPhA gratefully acknowledges the engagement of pharmacist members throughout the Commonwealth who made legislative advocacy a personal priority during the 2015 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 President Bob Oakley, the Government Affairs Committee, Chair Richard Slone, YOUR KPhA Board of Directors, Executive Director Bob McFalls & Staff: Thank you for your due diligence and commitment. Your advocacy continues to make a difference!

Legislative Successes

KPhA acknowledges and thanks our advocacy partners for this session: American Pharmacy Cooperative, Inc., American Pharmacy Services Cooperative, EPIC Pharmacies, Inc., Kentucky Independent Pharmacy Alliance, Kentucky Retail Federation, National Association of Chain Drug Stores and the National Community Pharmacists Association.

Medication Synchronization: Also set to become law is a bill to require insurance companies to pay for pharmacy claims to "synchronize" refills to a common date. Senate Bill 44, sponsored by Senator Julie Raque Adams (R-Louisville) easily passed the Senate but temporarily stalled in the House after an unrelated floor amendment was filed to the bill by Representative Johnny Bell (D-Glasgow). Bell later withdrew the amendment paving the way for the final passage of the bill. An identical bill, HB 140, was filed in the House but died in committee. Senate Bill 44 has an effective date of Jan. 1, 2016.

The 2015 session was a busy one for pharmacy legislation. KPhA tracked nearly 50 bills directly or indirectly dealing with pharmacy and was actively involved in more than a dozen bills. The legislature unanimously passed KPhA's top legislative priority-legislation to make it easier for pharmacists to enter into Collaborative Care Agreements with prescribers. KPhA also was successful in gaining the passage of legislation to require insurers to pay for medication synchronization and legislation to repeal the HIV/AIDS continuing education requirement.

Collaborative Care Agreements: House Bill 377, the bill to make it easier for pharmacists and physicians to enter into Collaborative Agreements to cooperatively manage patients' care, is set to become law. It streamlines the process for establishing Collaborative Care Agreements by allowing multiple pharmacists to enter into an agreement with multiple practitioners. The measure was sponsored by freshman Representative Dean Schamore (D-Hardinsburg) and was the top legislative priority of KPhA. House Bill 377 passed both chambers without a dissenting vote.

KPhA led the coalition that sought the passage of the bill and testified in favor of the proposal in committee.

HIV/AIDS Education: The legislature passed legislation to eliminate mandatory HIV/AIDS continuing education (CE) for health care providers. House Bill 248 repealed the current law that requires all licensed health care providers to The following narrative summary provides information about obtain HIV/AIDs CE once every 10 years. The bill was key legislation affecting the KPhA members that lawmakers amended in the Senate to include the provisions of HB considered this session. The electronic version of the sum- 139 which permits authorized entities such as restaurants and other places open to the public to stockpile epi-pens for mary includes links to the legislature's website so you can use in the case of emergencies. The House agreed to the easily access additional information about specific bills. These links provide the complete summary prepared by leg- changes and the bill cleared its final legislative hurdle on the islative staff and a chronological list of actions on the legis- last night of the session. lation. You also can access the complete text of each bill or Heroin/Naloxone (Pharmacist Dispensing)/ resolution by way of the link. Zohydro: Prior to the legislative session, most political pundits would have bet that if the legislature did nothing else, Unless otherwise noted, legislation that passed the 2015 they would pass comprehensive measures to address the Kentucky General Assembly becomes effective 90 days heroin epidemic in Kentucky. More than a dozen bills dealfollowing the sine die adjournment of the legislature. The Attorney General officially calculated the date and issued a ing with the issue were introduced. But as the session drew to a close, it looked like the chances of passing a heroin bill notice that the effective date is June 24, 2015. 9

THE KENTUCKY PHARMACIST

2015 Kentucky General Assembly

May/June 2015

were slim as the House and the of this relatively new high-powered Senate were deadlocked on the pain drug. details. Each chamber had Dextromethorphan: Unlike in past passed its own version of the bill sessions, a measure to prohibit the but could not agree on key provisale of products containing dextrosions such as penalties for trafmethorphan to anyone under age ficking, a needle exchange pro18 won legislative approval this gram and others. Late in the sesyear. As introduced, HB 24 only sion, the House put forth a covered products that contained "compromise" proposal as an dextromethorphan as the sole acamendment to SB 192. It cleared tive ingredient but it was amended the House but the Senate refused in the House to cover all products to agree with the changes made containing dextromethorphan. KPhA Member Alyson Roby testifies with to the bill. It wound up in a free KPhA's legislative team worked House Speaker Greg Stumbo on the need for conference committee that apwith the bill's sponsor, Representapharmacists to be involved in the discussion of peared to be deadlocked. But tive Fitz Steele (D-Hazard), to shortly before the session ended, marijuana use should it be approved for medimake other changes to the procal purposes in the future. legislative leaders announced posal that were incorporated in the that the committee had reached final version of the bill. Penalties were reduced for persons consensus. The Free Conference Committee Report was that "knowingly" sell to a minor and fines added for a minor quickly passed by both chambers and was signed by Goverwho attempts to purchase the product. The defense for a nor Beshear on March 25. retailer who makes the sale based on a fraudulent ID that One of the provisions in SB 192 grants specially-certified was contained in the original bill was maintained. The repharmacists the authority to initiate the dispensing of nalox- quirement for a photo ID still applies if the seller has reason one, an opioid antagonist, subject to a physician-approved to believe that the prospective buyer is under age 18. protocol. The Board of Pharmacy was directed to establish Legislation Advocated and/or Monitored the certification process and set the guidelines for the protocol by regulation. The provision was the product of negotiaPBM Transparency: Senator Julie Raque Adams (Rtions between the pharmacy and medical communities and Louisville) filed SB 126 to tighten up the existing law that will help make this potentially life-saving drug more readily deals with the use of "maximum allowable cost" (MAC) as a accessible. The concept was originally proposed by House reimbursement mechanism for pharmacies. The legislature Judiciary Chair John Tilley (D-Hopkinsville) who introduced passed a bill regulating the use of MACs in 2013, but pharlegislation to enhance the role of pharmacists in addressing macists continue to report problems with PBMs not updating heroin overdoses (HB 105). Tilley played a major role in pricing and failing to respond to appeals on a timely baworking out the compromise on the comprehensive heroin sis. Senate Bill 126 was designed to make enforcement of bill and made sure that the additional authority for pharmathe existing law easier and to clarify the responsibilities of cists was included in the final product. PBMs. It included a provision calling for a new licensing scheme for pharmacy benefit managers. Senate Bill 192 contained an emergency clause making it Senator Raque Adams, who chairs the Senate Health and immediately effective upon the governor's signature. The Welfare Committee, originally intended to have an informaBoard of Pharmacy, however, must promulgate the necessary regulations to implement the provision allowing pharma- tional hearing on the bill in early March, but decided to defer the issue to the interim because of time restraints and the cists to initiate the dispensing of naloxone via a protocol. KPhA is working with the Board to quickly develop the appro- complexity of the issue. priate regulatory scheme. One provision that was not included in the final version of the heroin bill would have made the painkiller Zohydro a Schedule I drug. If passed, the provision would have banned the sale of the product in Kentucky. Several versions of heroin legislation introduced this session contained the ban. Many lawmakers expressed concerns about the potential for abuse 10

KPhA will continue to pursue this issue on multiple fronts during the interim and during the 2016 Kentucky Legislative Session. Medical Marijuana: Legalizing medical marijuana was again a topic of discussion this year but with a couple of new twists. House Speaker Greg Stumbo filed a medical marijuana bill (HB 3) on the session's opening day adding a great

THE KENTUCKY PHARMACIST

2015 Kentucky General Assembly

May/June 2015

deal more political clout to the effort comdrugs was introduced but failed to pass. KPhA gratefully acknowledges pared to previous sessions. Another interRepresentative Jeff Greer (D-Brandenburg) our engagement with the esting twist happened when Speaker filed HB 538 mandating that insurers cover Kentucky Retail Federation and Stumbo endorsed the idea of putting phartamper-resistant painkillers as preferred the great work of our macists in the medical marijuana dispensdrugs in their formularies. The measure saw lobbyists, Jan Gould, Gay ing loop. At the request of KPhA, language no action in the House. Dwyer, and Shannon Stiglitz. was drafted as an amendment to HB 3 that Medical Malpractice Reform: A large coawould have required all medical marijuana dispensaries to lition of health care providers and business groups including have pharmacists on staff to review orders and counsel paKPhA again sought the passage of legislation to address tients. medical malpractice. Senate Bill 6 would have established The House Health and Welfare Committee held an informa- "medical review panels" to prescreen medical malpractice tional hearing on the bill early in the session. Along with claims. The panel's decision would be non-binding but would Speaker Stumbo, KPhA member Alyson Claywell Roby pre- be admissible in court. As in past sessions, the bill cleared sented testimony supporting the requirement that pharmathe Senate but stalled in the House. A similar measure (HB cists play a role in the dispensing of medical marijuana 398) was introduced in the House but was not heard. should the legislature deem it to be legal. The committee Repeal of Board of Pharmacy Term Limits: Legislation took no action on the measure but Committee Chair Tom that would have allowed members of the state Board of PharBurch (D-Louisville) pledged to continue the discussions over macy to serve an unlimited number of terms died in the the interim. House Health and Welfare Committee. The bill was schedSenator Perry Clark (D-Louisville) also introduced medical uled for a hearing by the House panel but the sponsor, Repmarijuana legislation as he has done for the past several resentative Leslie Combs (D-Pikeville), asked that HB years. Senate Bill 40 did not include pharmacists in the chain 456 not be called for a committee vote after learning that of distribution. The bill did not receive a hearing in the Senate KPhA, KSHP and other pharmacy groups opposed the committee to which it was assigned. measure. Bio-similar Substitution: Although expected, legislation Durable Medical Equipment Licensing: A last-minute was not introduced this session to place restrictions on the amendment to a bill dealing with colorectal cancer screening substitution of bio-similar products once the FDA determines clarifies Kentucky's licensing law affecting out-of-state durainterchangeability. Bills are being pushed in other states by ble medical equipment (DME) dealers. The amendment major manufacturers of biologics, but the issue did not surto HB 69 specifies that the requirements for licensure reciface in Kentucky. The KPhA legislative team met with key procity with contiguous states, including but not limited to the legislative leaders prior to the session after learning that the requirement for a physical location, be substantially similar to biotech industry was targeting Kentucky for legislative action Kentucky's requirements. It also requires that the Board of this year. KPhA was prepared to oppose this legislation as it Pharmacy Advisory Council have two representatives from is currently being proposed. the DME industry among its membership. DME dealers are Limitations on Drug Co-payments: Three bills limiting the licensed by the Kentucky Board of Pharmacy. The amended amount of co-payment an insurer could impose for prescrip- bill was approved by the legislature and was signed by Govtion drugs were filed. Senate Bill 31, introduced by Senator ernor Beshear. Tom Buford (R-Nicholasville) drew the most attention. His Representative Jody Richards (D-Bowling Green) filed a sepproposal would have prohibited health plans from establisharate bill early in the session that contained the language ing a co-payment for a prescription drug in excess of $100. that was added to HB 69. Richards' bill, HB 246, bogged The bill also proposed to limit the amount of co-payments on down in the House Health and Welfare Committee. drugs to $200 per month per patient in the aggregate. Senate Provider Contracts: A number of bills were filed this year Bill 31 received a hearing in the Senate Health and Welfare Committee, but the panel did not vote on the measure. Rep- that would have impacted the relationship between health resentative James Kay (D-Versailles) filed an identical bill in care providers and insurers. Senate Bill 87 proposed to set requirements regulating changes to provider agreements the House. House Bill 146 failed to receive consideration in the House Banking and Insurance Committee. Kay also intro- with insurers. The measure passed the Senate but died in duced a slightly different version of the bill (HB 99) which he the House Health and Welfare Committee. later withdrew. Another bill (SB 120) would have required the Cabinet for Another proposal dealing with health insurance coverage for Health and Family Services to set up a process for providers 11

THE KENTUCKY PHARMACIST

2015 Kentucky General Assembly

May/June 2015

to appeal reimbursement by Medicaid managed care organizations. Its provisions were later added to HB 71 but ultimately none of these measures cleared the General Assembly.

these boards have proportional representation from various health professions and reduces the number of consumer members required. The changes were pushed by Northern Kentucky legislators who argued that current law resulted in their district board becoming unwieldy due to the large Health Departments: Language changing the membership number of members required by statute. The amendment of independent district boards of health was added as an also makes it clear that these boards cannot implement amendment to SB 107 in the waning days of the session. policies that conflict with state laws or regulations. The origThe provisions of HB 215 were added to the bill by the inal bill, SB 107, deletes certain reporting requirements for House and the change was concurred in by the Senate. Medicaid providers. The change removes the current statutory requirement that

2014 Kentucky Pharmacists Political Advisory Council Contributors The Kentucky Pharmacists Political Advisory Council collected $13,615 in 2014, funds which were used to support candidates in Kentucky who are friendly to pharmacy issues. The members of the KPPAC board thank the contributors and encourage YOU to add your name for 2015. Only individuals can donate up to $1,500 a year to ALL PACs.

Support the Candidates who support Pharmacy in Frankfort!

Gold Supporters ($999-$500)

Members (No Minimum Pledge)

Board Supporters ($1,500)

George Hammons Duane Parsons Ron Poole Joel Thornbury

James Blackmer Alexander Brewer Heather Bryan Jonathan Burdick Danielle Corbett Cody Greenlaw Alexandra Hughes Mary Thacker Leah Tolliver Irina Yaroshenko

candidates have already begun approaching KPPAC for support. Help KPPAC

Earnest Watts

Matt Carrico James Carrico Leon Claywell Larry Hadley Richard Slone Zena Slone

Diamond Supporters This is an election year, and ($1,000-$1,499)

Silver Supporters ($499-$365) Kim Croley

Bronze Supporters ($364-$200) Michelle Easton Jacob Hutti Ethan Klein Bob Oakley

2014 KPhA Government Affairs Contributors KPhA Members contributed $3,350 to the Government Affairs Fund in 2014 to support the Associationâ&#x20AC;&#x2122;s lobbying efforts on YOUR behalf in Frankfort and Washington, DC. YOUR KPhA acknowledges the support from those listed below, and encourages YOU to add your name to the list for 2015! Individuals and businesses may contribute.

Board Supporters ($1,500)

Silver Supporters ($499-$365)

None

Diamond Supporters ($1,000-$1,499)

Bronze Supporters ($364-$200)

Matt Carrico Richard Slone

None

Gold Supporters ($999-$500) Duane Parsons

John Lutz George McDonald Julie Owen George Patterson Charles Peterson Eugene Riley Joel Thornbury Leah Tolliver

Members (No Minimum Pledge) Timothy Armstrong & Patty Taluske in honor of Randy Gaither 12

THE KENTUCKY PHARMACIST

Technician Review

May/June 2015

Technician Review From the KPhA Academy of Technicians The KPhA Pharmacy Technician Academy would like to share what we have been working on. The Academy is focused on recruiting new members to increase our strength of voice.

profession into the future, and we still believe that each and every proposed goal remains a valuable step in evolving our profession; however, we are going to submit a revised set of proposals. The Academy delegates will start working on the second edition of our proposals after the KPhA Annual Meeting and Convention June 25-28. If you would like to be a part of the discussions, please join our monthly phone conferences.

The Academy has routinely sent representatives to the Board of Pharmacyâ&#x20AC;&#x2122;s Advisory Council meetings to help further our profession. The Advisory Council has been discussing topics that will help to increase the medication safety in Kentucky. The Academy helps to provide insight from the technicianâ&#x20AC;&#x2122;s perspective.

If you are not a member of the Academy it is very easy to join. If you are already a member of KPhA, all you need to do is contact Don Carpenter at dacarpenter@st-claire.org, or Scott Sisco at ssisco@kphanet.org. You also can log into the KPhA website and join the Pharmacy Technician Academy.

Our original set of proposals was drafted with the best intentions for guiding the technician

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April 2015 CE â&#x20AC;&#x201D; OTC Oral Rehydration Salt Solutions

May/June 2015

The Use of Over-the-Counter Oral Rehydration Salt (ORS) Solutions By: T. Joseph Mattingly II, PharmD, MBA, Assistant Professor, Department of Pharmacy Practice & Science, University of Maryland School of Pharmacy; and Christopher Miller, PharmD, MS, MBA, BCNSP, Clinical Training Coordinator & Clinical Assistant Professor, Department of Pharmacy Practice & Science, University of Kentucky College of Pharmacy, UK/Norton Healthcare Academic Partnership

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

There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-0000-15-005-H01-P&T 2.0 Contact Hours (2.0 CEU) Objectives: At the conclusion of this Knowledge-based article, the reader should be able to:

1. Describe the components and concentrations of an effective oral rehydration salt (ORS) solution. 2. Describe the differences between the WHO/UNICEF ORS formula and other rehydrating beverages. 3. Define appropriate indications and limitations for use of ORS therapy. 4. Describe appropriate ORS dosing strategies used to treat volume depletion during the repletion and maintenance phases. Acknowledgements: The authors would like to thank Six Sigma Laboratories for providing additional information regarding the formulation of NormaLyte. are expected to have the background knowledge to either recommend appropriate use for over-the-counter ORS or Oral rehydration salts (ORS) has been credited as the therrefer the patient to a more immediate treatment facility. A apy responsible for decreasing deaths due to diarrhea from greater understanding of potential uses for this therapy, 5 million per year in 1980 to 2.2 million in 1999, making it desirable diagnosis specific ingredient concentrations of one of the most important clinical developments in the past these solutions, patient symptoms of dehydration, along few decades.1 Although acute gastroenteritis is common in with knowledge of risks and benefits of ORS will allow pharthe United States and is estimated to cost $1 billion annualmacists to effectively advise patients on these therapies. ly in the pediatric outpatient population alone, appropriate Dehydration ORS treatment is still underused.2,3 Introduction

In order to reduce mortality in infants and young children suffering from acute diarrheal diseases, the World Health Organization (WHO) and the United Nations Childrenâ&#x20AC;&#x2122;s Fund (UNICEF) joined to support and promote ORS for the treatment of dehydration.4 In addition to treating the dehydration side effects of acute diarrhea, ORS may play a role in other indications. For example, the International Olympic Committee (IOC) recommended the use of rehydration strategies that include replenishing carbohydrates and sodium in its 2010 Consensus Statement on Sports Nutrition.5 ORS also have been suggested to combat hypovolemic shock following a major burn injury as an alternative to IV rehydration.6 Community based pharmacists are in a position to play a key role in assessing patient needs for ORS therapy. They

The balance of total body water (TBW) and electrolytes is tightly controlled by homeostatic mechanisms within the body under normal conditions. Acute or chronic stressors such as diarrhea, physical activity or environmental conditions could cause an imbalance of this system.7,8 The typical distribution of water between intracellular and extracellular space is approximately two-thirds intracellular to onethird extracellular respectively.9 Dehydration occurs when the output of water exceeds the input without a proportional reduction in electrolytes (primarily sodium and potassium). 10 Water Absorption The fact that sodium and glucose transport is coupled in the small intestine where glucose facilitates absorption of solute and water is an important physiological concept. The human body passively absorbs water rather efficiently 14

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April 2015 CE — OTC Oral Rehydration Salt Solutions

May/June 2015

(approximately 99 percent) through three mechanisms 1,11:

incidence of biochemical hyponatremia was found in the new formula group but the hyponatremia was asymptomat1. Neutral sodium absorption in the small intestine ic in all but one case of a hyponatremic child who experithrough a cation and anion exchanger maintaining inenced a generalized seizure.14 When using ORS in patients tracellular pH. with short bowel syndrome (SBS) it is recommended that 2. Sodium absorption coupled with glucose and amino the ORS sodium concentration should be in the range of 90 acids. –120 mm/L.15 SBS is a condition associated with major abnormalities of fluid and electrolyte balance. The degree of 3. Electrogenic sodium absorption where sodium enters dehydration is based on the remaining bowel anatomy after the cell across an electrochemical gradient. resection, and if the colon is still intact which is instrumental The process by which the intestines absorb water explain in fluid and electrolyte reabsorption. The use of water or the importance of electrolytes and provide the theoretical hypotonic solutions should be avoided in this patient popuframework by which rehydration formulas have been devel- lation because they result in increased loss of sodium, esoped.1 pecially those with proximal jejunostomies who are net fluid and sodium secretors.15 WHO/UNICEF Recommendations for ORS For the past 50 years, the WHO and UNICEF have approved, recommended and distributed ORS for the treatment of clinical dehydration.4 In 2001, further technical review and recommendations led to the reduction of sodium concentration, glucose concentration and total osmolality to the current standard for ORS which is recommended for most conditions causing dehydration (See Table 1). Providing an ORS with equivalent molar concentrations of sodium and glucose along with maintenance needs of potassium in a resultant hypotonic solution has been demonstrated to be effective in most instances. Subsequent clinical research has supported the WHO/UNICEF revised hypotonic formula, especially for the treatment of diarrhea. The findings in these studies have found that children treated with the reduced osmolarity formula experienced less vomiting, less stool output, reduced need for intravenous infusion and shorter duration of illness when compared to the older WHO formulation.12 The older “standard” formula was slightly hypertonic and contained sodium chloride at 90 mm/L and carbohydrates at 20 gm/L. Table 1: ORS “Reduced-Osmolarity formula” endorsed by WHO/UNICEF Concentration Component Sodium 75 mmol/L Potassium 20 mmol/L Chloride 65 mmol/L Glucose, anhydrous 75 mmol/L Citrate 10 mmol/L 245mOsm/L Total Osmolarity Controversy around the reduced osmolarity formula still exists for conditions where greater sodium concentrations may be beneficial or required (e.g., cholera, short bowel syndrome).13 In the CHOICE study group evaluating new and old WHO formulas in cholera patients, an increased

In addition to the concentrations recommended, the new WHO/UNICEF guidance provides the recommended four ingredients and amounts (sodium chloride 2.6g, anhydrous glucose 13.5g, potassium chloride 1.5g and dihydrate trisodium citrate 2.9g) to produce 1 liter of ORS solution.4 The WHO/UNICEF guidance has the aim of making this essential formula available at an affordable price to improve public health. Stability of the solution is a factor to consider with ORS solutions. The citrate component of ORS is recommended due to its stability in tropical countries allowing for an extended shelf-life.4 WHO/UNICEF also recommends multiply laminations with aluminum foil, polyethylene and polyester to allow heat-sealing of the packaging and reduces the container’s permeability to gas and moisture.4 Comparing Rehydration Beverages Two of the most commonly advocated products in the United States for use in dehydration are Pedialyte and Gatorade.16 Products such as Enfalyte, NormaLyte and Gatorade G2 also are marketed for rehydration and some clinicians have suggested adding ½ teaspoon of table salt to one quart of Gatorade G2 to get closer to the WHO/ UNICEF concentrations for ORS.17-19 In addition to adherence to the WHO/UNICEF recommendations, other factors that may influence the decision between ORS options may include cost, availability, composition, use of artificial sweeteners, taste and convenience.4,2021 When managing dehydration in a pediatric population, a caregiver may weigh taste preferences even more depending on the child. ORS Role in Dehydration ORS therapy is the preferred first-line treatment for mild to moderate dehydration due to diarrhea caused by gastroen15

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April 2015 CE — OTC Oral Rehydration Salt Solutions

May/June 2015

Table 2: Comparison of solutions for rehydration along with common beverages. 20 Sodium Potassium Chloride Base* Carbohydrate** (mmol/L) (mmol/L) (mmol/L) (mmol/L) (gm/L) Old-WHO 90 20 80 30 20 New-WHO 75 20 65 30 13.5 Pedialyte 45 20 35 30 25 Enfalyte 50 25 45 34 30 NormaLyte+ 74 20 65 30 13.5 Gatorade++ 20 3.2 N/A 13.9 59 Gatorade G2 20 3.2 N/A 13.9 20 Soda 1.6 N/A N/A 13.4 112 Apple juice 0.4 44 45 N/A 120 *May be citrate, lactate, acetate, etc. **May be glucose, fructose, sucrose, etc. + NormaLyte is a powder with the instructions to dissolve with one liter of drinking water. ++ Using Gatorade Thirst Quencher (Gatorade, Chicago, IL) Beverage

Osmolarity (mOsm/L) 311 245 250 200 246 290 N/A 650 730

Table 3. Dehydration symptoms according to the Centers for Disease Control and Prevention (CDC).20 Symptom

Minimal or no dehydration (<3 percent of body weight)

Mild to moderate dehydration (3-9 percent loss of body weight)

Severe dehydration (>9 percent loss of body weight)

Mental status Thirst Heart Rate Quality of Pulses Breathing Eyes Tears Mouth & Tongue Skin Fold Capillary Refill Extremities

Alert

Normal, fatigued or restless, irritable

Apathetic, lethargic, unconscious

Normal

Thirsty; eager to drink

Drinks poorly; unable to drink

Normal

Normal to increased

Tachycardia, with bradycardia in severe cases

Normal

Normal to decreased

Weak or impalpable

Normal

Normal; fast

Deep

Normal

Slightly sunken

Deeply sunken

Present

Decreased

Absent

Moist

Dry

Parched

Instant recoil

Recoil in < 2 seconds

Recoil in > 2 seconds

Normal

Prolonged

Prolonged; minimal

Warm

Cool

Cold; cyanotic

Normal to decreased Decreased Minimal Urine output *Adopted King CK, Glass R, Bresee JS, Duggan C. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR 2003;52:RR-16.

teritis in children. In addition to dehydration, ORS may be used to treat volume depletion due to gastroenteritis regardless of age. Using the oral route for rehydration is most appropriate for mild to moderate dehydration and preferred over intravenous hydration due to cost, ease of administration and fewer complications such as phlebitis.22 When patient assessment necessitates treatment of more severe dehydration, the patient should be referred to a more immediate care facility to receive intravenous rehydration treatment.

dration is divided into two phases, repletion and maintenance (Table 4). A testimonial use of ORS, which the pharmacist can guide and counsel on is dehydration associated with a “hangover” caused by alcohol consumption. Although clinical trial data is sparse in this area, dehydration from alcohol consumption is often underreported and patients self-treat. Adequate hydration is recommended for the occasional hangover but there is no evidence to suggest it would have any effect on the other neurological or hormonal issues with intoxication and subsequent hangover.24

Since determination of status of hydration is critical for patient assessment and recommendations, it is essential that the healthcare professional be familiar with symptoms and In addition to the above potential uses in the treatment of classification of dehydration (Table 3). Once the determina- mild to moderate dehydration and volume depletion, ORS tion of mild or moderate dehydration has been made, rehy- has become important in athletics and sports nutrition. Ex16

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April 2015 CE — OTC Oral Rehydration Salt Solutions

May/June 2015

Table 4: Summary of rehydration strategies for mild to moderate dehydration. 20,22-23 Treatment Repletion Phase

Description ORS administered in frequent, small amounts to avoid accumulation in the stomach and potential vomiting.

Recommendations 50-100mL/kg of body weight over three-four hours

Maintenance Phase

Replaces ongoing losses of water and electrolytes and vary depending on clinical status.

24 Hour Maintenance Fluid: <10kg body weight: 100mL/kg 10kg-20kg: 1000mL for 1st 10kg of body weight plus 50mL/kg for additional weight over 10kg >20kg: 1500mL for 1st 20kg plus 20mL/kg for additional weight over 20kg (Max of 2.4L of fluid daily)*

*Above 65kg, this method begins to overestimate maintenance fluid needs. 22 ercise-associated hyponatremia has been studied in athletes competing in events that require sustained physical activity (marathons, triathlons, etc.) and the use of ORS has been shown to improve performance.25 The evidence supporting ORS hydration strategies during athletic events even led to the endorsement of the IOC in 2010.5

ORS may allow pharmacists to guide patients on making an ORS solution at home with basic ingredients found in a grocery store.

The Pharmacist’s Role

the pharmacist must be adequately trained and up to date on current treatment recommendations.

Pharmacy technicians also may benefit from additional knowledge around ORS. Often as the “first line” of contact for patients in community settings, technicians play a valuaORS Limitations & Barriers ble role in triaging patients to the pharmacist. Advanced Despite several recommendations for use of ORS, several training for pharmacy technicians in the area of hydration barriers still exist including lack of parental knowledge, lack could help improve awareness around the issues raised in this article concerning over-the-counter treatment in dehyof training of health professionals, cost and preference for 20 IV hydration by some clinicians. The “salty” taste is also a dration. potential problem for ORS formulas and manufacturers typ- Finally, the pharmacist must be able to recognize and apically add sweeteners and flavoring to their formula. The propriately classify the hydration status of the patient via WHO/UNICEF recommendations discuss the theoretical interview and observation to ensure the most appropriate advantages with some additives but do not support the use treatment option for the patient. In 1991, investigators in of additional ingredients beyond the primary four compoGreat Britain found that although pharmacists are widely nents discussed. WHO/UNICEF simply takes the stance used by parents for over-the-counter recommendations for that “responsibility for demonstrating clinical value, safety treating acute diarrhea, their advice is not always appropriand chemical stability rests with the manufacturer” in reate.26 The pharmacist can be an excellent resource for in4 gards to additives. formation and guidance regarding rehydration; however, In community pharmacy settings, several commercially available products provide the patient or caregiver several options for rehydration strategies. In order for the pharmacist to make a contribution to patient care in this arena, it is essential that the pharmacist be educated on the WHO/ UNICEF recommended formula concentrations and why these are deemed most effective.

References 1. Guarino A, Albano F, Guandalini S. Oral rehydration: toward a real solution. J Pediatr Gastroenterol Nutr. 2001;33:S2. 2. Ladinsky M, Duggan A, Santosham M, Wilson M. The World Health Organization oral rehydration solution in US pediatric practice: a randomized trial to evaluate parent satisfaction. Arch Pediatr Adolesc Med. 2000;154:70005.

Additionally, the pharmacist will need to evaluate commercially available products using the WHO/UNICEF formula as a standard of comparison to ensure recommendations are made for treatment with a proven effective formula. The pharmacist can play a key role in counseling these patients 3. Kelly DG, Nadeau J. Oral rehydration solution: a “lowon the proper rehydration fluid to use. When a commercial tech” oft neglected therapy. Practical Gastroenterology. product is not available, understanding the composition of 2004;21:51-62. 17

THE KENTUCKY PHARMACIST

April 2015 CE â&#x20AC;&#x201D; OTC Oral Rehydration Salt Solutions 4. Oral Rehydration Salts: Production of the New ORS. WHO. 2006.

May/June 2015 accessed on April 10, 2015.

18. Dehydration. NormaLyte Pharmaceutical-Grade Hydration. Available at: http://www.normalyte.com/, accessed on April 10, 2015.

5. IOC Consensus Statement on Sports Nutrition. IOC. 2010. Available at: http://www.olympic.org/Documents/ Reports/EN/Consensus-final-v8-en.dpf, accessed January 9, 2015.

19.Diet and Hydration. The Oley Foundation. Available at: http://www.oley.org/, accessed on April 10, 2015.

6. Vyas KS, Wong LK. Oral rehydration solutions for burn management in the field and underdeveloped regions: a review. Int J Burn Trauma. 2013;3:130-136.

20. King CK, Glass R, Bresee JS, Duggan C. Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR. 2003;52:RR-16.

7. Cotter JD, Thornton SN, Lee JKW, Laursen PB. Are we being drowned in hydration advice? Thirsty for more? Extrem Physiol Med. 2014;3:18.

21. Molina S, Carolina V, Peerson JM, Solomons NW, Brown KH. Clinical trial of glucose-oral rehydration solution 8. Riebl SK, Davy BM. The hydration equation: update on (ORS), rice-dextrin-ORS, and rice flour-ORS for the manwater balance and cognitive performance. ACSMs Health agement of children with acute diarrhea and mild or modFit J. 2013;17(6):21-28. erate dehydration. Pediatrics. 1995;95:191-197. 9. Jequier E, Constant F. Water as an essential nutrient: the 22. Freedman S. Oral rehydration therapy. In: UpToDate, physiological basis of hydration. Eur J Clin Nutr. 2010;64 Mattoo TK, Stack AM (Ed), UpToDate, Waltham, MA. (2)115-23. Accessed on April 10, 2015. 10. Sterns RH. General principles of disorders of water bal23. Somers MJ. Maintenance fluid therapy in children. In Upance (hyponatremia and hypernatremia) and sodium balToDate, Mattoo TK (Ed), UpToDate, Waltham, MA. Acance (hypovolemia and edema). In: UpToDate, Emmett cessed on April 10, 2015. M (Ed), UpToDate, Waltham, MA. Accessed on April 10, 24. Wiese JG, Shlipak MG, Browner WS. The alcohol hango2015. ver. Annals of Internal Medicine. 2000;132(11):897-902. 11. Diamond JM. Solute-linked water transport in epithelia. 25. Davis DP, Videen JS, Marino A, et al. ExerciseIn: Membrane transport processes, Hoffman F (Ed), Raassociated hyponatremia in marathon runners: a twoven Press, New York; 1978:257. year experience. J Emerg Med. 2001;21(1):47-57. 12. Duggan C, Fontaine O, Pierce NF, et al. Scientific ra26. Goodburn E, Mattosinho S, Mongi P, Waterston T. Mantionale for a change in the composition of oral rehydration agement of childhood diarrhea by pharmacists and parsolution. JAMA. 2004;291(21):2628-31. ents. Is Britain lagging behind the Third World? BMJ. 13. Nalin DR, Hirschhorn N, Greenough W, Fuchs GJ, Cash 1991;302:440-3. RA. Clinical concerns about reduced-osmolarity oral rehydration solution. JAMA. 2004;291(21):2632-5. 14. CHOICE Study Group. Multicenter, randomized, doubleblind clinical trial to evaluate the efficacy and safety of a reduced osmolarity oral rehydration salts solution in childred with acute watery diarrhea. Pediatrics. 2001;107:613-618. 15. Buchman AL. The medical and surgical management of short bowel syndrome. MedGenMed. 2004;6(2):12. 16. Rao SSC, Summers RW, Rao GRS, Ramana S, Devi U, Zimmerman B, Pratap BCV. Oral rehydration for viral gastroenteritis in adults: a randomized controlled trial of 3 solutions. J Parent Enteral Nutr. 2006;30(5):433-39.

Send Potential CE topics to Scott Sisco at ssisco@kphanet.org

17. Enfamil Enfalyte Product Information. Mead Johnson & Company. Available at: https://www.meadjohnson.com/,

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April 2015 CE — OTC Oral Rehydration Salt Solutions

May/June 2015

April 2015 — The Use of Over-The-Counter Oral Rehydration Salt (ORS) Solutions 1. Which of the following best represents the intestinal absorption of water: A. Minimal water is absorbed in the small intestine with most being actively absorbed in the colon. B. A passive process that requires the movement of solutes. C. An independent active process. D. A combination of active and passive processes.

7. In patients with small bowel syndrome (SBS) without a colon, the sodium concentration of an effective ORS should be in the following range: A. 40 – 60 mEq/L. B. 60-75 mEq/L. C. 90- 120 mEq/L. D. > 130 mEq/L.

2. The intestinal transport of sodium can best be defined by the following: A. Sodium absorption is a complex process and absorption occurs by specific mechanisms in different parts of the intestine. B. Sodium is primarily absorbed by an active transport throughout the intestinal. C. Sodium absorption is primarily influenced by the presence of sugar throughout the intestine. D. Sodium absorption is a passive mechanism that involves movement with the concentration gradient.

8. Which of the following does not fit the properties of an effective ORS as defined by WHO? A. Equimolar concentrations of glucose and sodium B. Total osmolarity between 200 – 310 mOsm/L C. Glucose concentration > 20 gms/L D. Potassium concentration between 15-25 mEq/L

9. A mother comes in your store with her child who has been having bouts of severe diarrhea and now has the following symptoms: deeply sunken eyes, very low urine output, cold and cyanotic, deep breathing and drinks poorly. The most appropriate recommendation would be: 3. Why is it recommended to administer ORS in freA. Give her instructions on using an effective commercially quent, small amounts as compared to large bolus doses available WHO based ORS such as Normalyte to treat during the repletion phase? moderate dehydration. A. Avoid potential accumulation in the stomach B. Instruct her on making a home based ORS using 1 quart B. Reduce vomiting of water, ¾ teaspoons of table salt, 6 teaspoons of table C. Improved taste sugar and mix with crystal light for flavoring as this D. Both a & b would be a cheap and effective treatment. C. Recommend the patient be taken to an immediate care 4. The current reduced osmolarity WHO formula center for intravenous treatment of severe dehydration. contains the following concentrations of glucose and D. Instruct her to force the child to drink plenty of water sodium: which will effectively treat the dehydration. A. 90mM/L Sodium and 75mM/L anhydrous glucose. B. 90mM/L Sodium and 20 gms/L of anhydrous glucose. 10. G2 Gatorade contains less sugar than the standard C. 75 mM/L Sodium and 2 percent anhydrous glucose Gatorade, which enhances the potential for this product concentration. to be used as an effective ORS. The ingredient D. 75 mM/L Sodium and 13.5 gms/L of anhydrous glucose. concentrations of G2 Gatorade are as follows per 591 ml: Sodium 270 mg, potassium 75 mg, and 5. Which of the following is true of commercially carbohydrates 12 grams. How would the pharmacist available sports drinks as an ORS treatment option for need to counsel a patient making this more effective dehydration? with regard to molar concentration of sodium and A. They contain a high concentration of carbohydrates carbohydrate: compared to the electrolytes provided making them less A. Instruct the patient to add ½ - ¾ teaspoons of table salt than ideal. to 4 cups of G2 Gatorade to improve the molar ratio. B. They contain high amounts of sodium with low B. Instruct the patient to add 2 teaspoons table sugar and carbohydrate concentrations making them less than ¾ - 1 teaspoons of table salt to 4 cups of G2 Gatorade ideal. to improve the molar ratio. C. Both the sodium and carbohydrate concentrations are C. Instruct the patient to add 1.5 teaspoons of table salt to too low to be effective for treatment. 4 cups of G2 Gatorade to improve the molar ratio. D. Commercially available sports drinks represent a superi- D. Instruct the patient to add 1 tablespoons of table sugar or ORS solution compared to the outdated WHO formuto 4 cups of Gatorade to improve the molar ratio plan. las.

2015 KPhA Legislative Conference

6. True/False: A base, such as citrate, is added to ORS formulas for stability and to enhance shelf life. A. True B. False

November 13-14, 2015 Hyatt Regency Downtown Lexington, KY 19

THE KENTUCKY PHARMACIST

April 2015 CE — OTC Oral Rehydration Salt Solutions

May/June 2015

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: June 24, 2018 Successful Completion: Score of 80% will result in 2.0 contact hour or .2 CEU. Participants who score less than 80% will be notified and permitted one re-examination. TECHNICIANS ANSWER SHEET. April 2015 — The Use of Over-The-Counter Oral Rehydration Salt (ORS) Solutions (2.0 contact hours) Universal Activity # 0143-0000-15-005-H01-T Name _______________________________________________KY Cert. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B

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

9. A B C D 10. 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 If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ____________(MM/DD) PHARMACISTS ANSWER SHEET April 2015 — The Use of Over-The-Counter Oral Rehydration Salt (ORS) Solutions (2.0 contact hours) Universal Activity # 0143-0000-15-005-H01-P Name ________________________________________________ KY Lic. # __________________________________ Address ______________________________________________Email_____________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 3. A B C D 5. A B C D 2. A B C D 4. A B C D 6. A B

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

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

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No 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 If yes, please explain on a separate sheet. Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature ____________________________________________Completion Date___________________________

Personal NABP eProfile ID #_____________________________ Birthdate ___________________(MM/DD) The Kentucky Pharmacy Education & Research Foundation is accredited by The Accreditation Council for Pharmacy Education as a provider of continuing Pharmacy education.

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

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May 2015 CE—Top 10 Dietary Supplements

May/June 2015

Top 10 dietary supplements: What Should You Know? By: Ahmed Shammisaldeen, PharmD candidate; Peggy Piascik, PhD University of Kentucky College of Pharmacy There are no financial relationships that could be perceived as real or apparent conflicts of interest.

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

Universal Activity # 0143-0000-15-006-H01-P&T 2.0 Contact Hours (2.0 CEU) Goal: The goal of this activity is to enhance pharmacists’ knowledge about the current evidence and the safety precautions associated with the most commonly used dietary supplements. Objectives At the conclusion of this Knowledge-based article, the reader should be able to: 1. 2. 3. 4.

Describe general trends in the dietary supplements industry. Discuss the most common uses of the top 10 dietary supplements and the evidence to support these indications. Discuss the safety precautions associated with the top 10 dietary supplements. Apply practical aspects associated with the use of the top 10 dietary supplements.

Introduction The use of dietary supplements has increased over the last decade in the United States. Most of the data about current use of dietary supplements comes from the National Health Interview Survey (NHIS) which is conducted every five years.1 The National Center for Complementary and Integrative Health (NCCIH) is responsible for constructing the section regarding use of complementary and alternative medicine. According to the NCCIH, approximately one third of adults in the United States used complementary medicine approaches in 2012.1 During the period between 2007 and 2012, the use of fish oil, probiotics and melatonin has increased with fish oil as the number one supplement used by adults.1 The popularity of glucosamine/chondroitin, echinacea and garlic has decreased over the same time period, but they still rank in the top 10 most commonly used supplements (Figure 1).1 In 2014, the Council for Responsible Nutrition (CRN) conducted a survey to evaluate the use of dietary supplements among American adults.2 CRN represents the largest coalition of dietary supplement manufacturers in the United States. According to the CRN survey, females are more likely to take dietary supplements than males.2 In addition, there was a correlation between age and the use of dietary supplements with elderly Americans comprising the majority of consumers.2 The vast majority of U.S. adults take dietary supplements for general well-being and to supplement their diets.2 According to the CRN survey, most consumers view doctors as a good source of information regarding 21

dietary supplements with pharmacists as the second choice.2 Pharmacists should always consider the efficacy and safety of herbs and dietary supplements in addition to their patients’ prescription medications. As the most accessible healthcare providers, pharmacists have a responsibility to explain that “natural” does not mean safe and “more” does not equal better. Unfortunately, the pharmacy ranks as the No. 7 location where patients purchase dietary supplements following the internet, health food stores, warehouse clubs, mail order catalogs, supermarkets and vitamin stores.3 A review of the most commonly used dietary supplements and the evidence to support their use follows. These monographs were developed with information pro-

Figure 1. Top 10 Dietary Supplements Percent of U.S. adults Dietary supplement using that supplement Fish Oil Glucosamine/Chondroitin Probiotics /Prebiotics Melatonin Coenzyme Q10 Echinacea Cranberry

7.8 percent 2.6 percent 1.6 percent 1.3 percent 1.3 percent 0.9 percent 0.8 percent

Garlic Ginseng

0.8 percent 0.7 percent

Ginkgo

0.7 percent

Source: National Center for Complementary and Integrative Health (NCCIH): The National Health Interview Survey1

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May 2015 CEâ&#x20AC;&#x201D;Top 10 Dietary Supplements

May/June 2015 Proposed Mechanism of Action: Omega3 fatty acids have anti-inflammatory and antithrombotic activity competing with arachidonic acid in the cyclooxygenase and lipoxygenase pathways. They also affect lipids in several ways including decreasing secretion of very low density lipoproteins (VLDLs).

Figure 3: Classifications of Levels of Evidence Level Definition A High-quality randomized controlled trial (RCT) or High-quality meta-analysis (quantitative systematic review) B Nonrandomized clinical trial; Nonquantitative systematic review; Lower quality RCT; Clinical cohort study; Case-control study; Historical control; or Epidemiologic study C Consensus or expert opinion D Anecdotal evidence; In vitro or animal research Source: Adapted from Natural Medicines Comprehensive Database4

Efficacy: NMCD ranks fish oil as effective for treating hypertriglyceridemia, likely effective for heart disease and possibly effective for many conditions including agerelated macular degeneration, asthma, atherosclerosis, ADHD, bipolar disease, cachexia, psychosis, dysmenorrhea, endometrial cancer, heart failure, heart transplant, hypertension, psoriasis, osteoporosis, Raynaudâ&#x20AC;&#x2122;s syndrome, rheumatoid arthritis and stroke. Safety: NMCD ranks fish oil as likely safe for most patients when taken in doses <3 g/day. Larger doses may have an anticoagulant/antiplatelet effect. Belching, halitosis, diarrhea, nausea, heartburn, rash and nosebleeds are common side effects of this supplement. Consumption of large quantities of fatty fish, such as albacore tuna, is possibly unsafe due to high levels of mercury.

Drug Interactions: Fish oil may have additive effects with antihypertensive medications and the triglyceride lowering effects of fish oil might be diminished by oral contraceptives. NMCD gives these interactions a moderate rating and B for level of evidence. By reducing fat absorption, Orlistat may decrease absorption of omega-3 fatty acids. vided by the Natural Medicines Comprehensive Database NMCD gives these interactions a moderate rating and D for (NMCD)4 and ConsumerLab.5The NMCD is a multidiscipli- level of evidence. In addition, fish oil supplements may innary, peer-reviewed continuously updated database. Con- teract with other herbs and supplements that have anticosumerLab is an independent testing company that provides agulant/antiplatelet or hypotensive effects to potentiate product reviews as well as an encyclopedia of natural and their effects. alternative treatments. A decision making tool for recomPractical considerations: mending dietary supplements based on the evidence for safety and effectiveness from the NMCD is provided in Fig- 1. The dose for treating hypertriglyceridemia ranges from ure 2. The basis for the quality of evidence ratings provided 1-4g daily. Doses above 3g have antiplatelet effects. It in the monographs below is presented in Figure 3. may be difficult for patients to achieve sufficient DHA/ EPA from dietary supplement sources and may need to Fish Oil use an FDA-approved prescription product such as Fish oil is a rich source of omega-3 fatty acids, in particular Omacor that contains 840 mg of DHA and EPA per eicosapentaenoic acid (EPA) and docosahexaenoic acid capsule. Epanova contains a similar amount of DHA/ (DHA). Another name for these products is polyunsaturated EPA. fatty acids or PUFAs. Other products containing omega-3 2. When shopping for fish oil supplements, patients fatty acids include algal oil, krill oil, calamari oil and the should determine the actual amount of EPA and DHA plant source of omega-3 fatty acids, alpha linolenic acid per dose rather than the amount of fish oil that may (ALA). Some good sources of ALA include flaxseed, chia consist of other fats including cholesterol and saturated seeds, black currant seeds and walnuts. 22

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or trans fats. 3.

allergy because some products are made from shells of shrimp, crab and lobster. However, the allergic response is The FDA recommends that consumers do not exceed a commonly caused by the meat rather than the shell, and total of 3g/day of EPA and DHA with no more than 2g there have not been reports of allergic reactions. Chonfrom a dietary supplement unless there is a medically droitin sulfate may cause mild gastrointestinal discomfort. A diagnosed need for higher doses. theoretical concern with manufacture of chondroitin sulfate Fish oil supplements can spoil. Keep product out of comes from the potential for contamination due to diseased heat and light and seal tightly. Refrigerate if possible animal tissue that could transmit bovine spongiform en(may become slightly cloudy which is normal). Spoilage cephalopathy. No reports of this issue have appeared in leads to â&#x20AC;&#x153;fishierâ&#x20AC;? taste and greater gastrointestinal dis- the literature and the risk appears very low. turbance. Drug Interactions: A major drug interaction is possible Taking fish oil with meals and dividing doses increases between glucosamine (with or without chondroitin) and warabsorption and decreases adverse gastrointestinal farin resulting in serious bruising or bleeding. Level of evievents. dence is rated as D. Chondroitin alone also has a moderate interaction that can cause an increased effect of warfarin. Obtaining omega-3 fatty acids from food is preferable Level of evidence is rated as D. when possible. The American Heart Association recommends two 3 oz. servings of fish per week. For patients with heart disease or cardiac risk factors, that recommendation rises to four 3 oz. servings weekly.

Practical Considerations:

1. Glucosamine sulfate is thought by some researchers to be preferred over glucosamine hydrochloride or NGlucosamine/chondroitin acetyl glucosamine because the sulfate moiety is required for cartilage production making the sulfate salt These supplements can be used independently but most more effective. often are used in a combination product. Multiple salt forms of glucosamine are available. Since most of the research 2. Glucosamine/chondroitin combinations of 1500/1200 has been done with glucosamine sulfate, only the sulfate mg per day or 500/400 mg three times daily are recomsalt is discussed in this monograph. Chondroitin sulfate is mended for osteoarthritis treatment. Glucosamine may manufactured from animal sources such as bovine or pornot work as well for patients with severe osteoarthritis cine cartilage. or those patients who are elderly or seriously overweight. It may take several weeks up to three months to see benefit from supplementation. If no benefit is seen within three months, supplementation is not likely to be effective for that patient.

Proposed MOA: Both glucosamine and chondroitin are endogenous substances involved in production of synovial fluid, tendons, ligaments and cartilage. Glucosamine supplements may promote cartilage production or repair. Chondroitin sulfate is a component of cartilage. Supplements may promote water retention and elasticity in cartilage as well as inhibiting destructive enzymes that break down cartilage. Efficacy: The NMCD lists glucosamine sulfate as likely effective for osteoarthritis. Most research has been conducted on arthritis of the knee. However, other sites including hip and spine may also benefit from glucosamine therapy. Pain relief as well as a slowing of joint damage in osteoarthritis patients is possible. Chondroitin sulfate is possibly effective for osteoarthritis with most of the positive studies done on arthritis of the knee or hand. Pain relief from chondroitin alone appears to be less effective than glucosamine alone. Safety: NMCD rates glucosamine sulfate and chondroitin sulfate as likely safe when used orally. Glucosamine can cause some mild side effects including nausea, heartburn, diarrhea and constipation. There is concern about shellfish

3. Some glucosamine plus chondroitin combination products also contain manganese. Be aware of daily manganese consumption to avoid exceeding the safe daily limit of 11 mg. Excessive manganese intake for more than a few weeks may cause neurological toxicity. Probiotics These helpful organisms are available in a variety of forms including yogurt and other cultured milk products, beverages such as smoothies and juices, powders, tablets and capsules. The most commonly used organisms are strains of lactobacillus and bifidobacteria. Proposed Mechanism of Action: Probiotics refer to live microorganisms that contribute positively to general health. Prebiotics, on the other hand, are considered the energy source (food) for these bacteria to grow and thrive. Probiotics can play a vital role in human health through a variety of mechanisms. The main benefits of probiotics are their abil-

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ity to compete with harmful bacteria and create a healthy 3. Most probiotic products are dosed by colony forming microflora in the digestive tract. In addition, byproducts of units (CFUs) and are likely to contain 108-1012 organprobiotics metabolic pathways are thought to be antimicroisms/dose. Patients will require assistance in choosing bial. Probiotics also can activate the immune system appropriate products since these doses will be unfamilthrough stimulation of macrophages and increasing produciar to them. tion of IgA antibodies. 4. Patients with milk allergies should use probiotics with caution due to potential presence of milk proteins. Efficacy: One of the main uses of probiotics is to prevent antibiotic-associated diarrhea. Antimicrobials do not distin5. Patients should separate their antibiotic and probiotic guish between good and bad bacteria. The disruption in doses by a minimum of two hours. normal microflora gives the opportunity for harmful bacteria to flourish. Overall, clinical studies support the use of probi- 6. Counsel patients on immunosuppressant medications or with immune-compromised conditions to avoid using otics as a way to prevent overgrowth of harmful microorprobiotics. ganism. Melatonin

Lactobacillus rhamnosus is considered likely effective for rotaviral diarrhea. A variety of lactobacillus strains are considered possibly effective for antibiotic-associated diarrhea, eczema, atopic disease, bacterial vaginosis, chemotherapy -induced diarrhea, clostridium difficile diarrhea, H pylori, infantile colic, irritable bowel syndrome, pouchitis, respiratory tract infections, traveler’s diarrhea and ulcerative colitis. Bifidobacteria strains are considered possibly effective for constipation, H pylori, irritable bowel syndrome, necrotizing enterocolitis, pouchitis, respiratory tract infections, rotaviral infections, traveler’s diarrhea and ulcerative colitis.

Melatonin is a hormone produced in the brain from the amino acid tryptophan. However, supplements are likely to be synthetic. Melatonin is sometimes combined with other sleep inducing herbs such as valerian. Proposed Mechanism of Action: In order to regulate circadian rhythms, the body secretes multiple hormones and neurotransmitters. When the brain doesn’t receive light signals from the optic nerve, the pineal gland begins to secrete melatonin. Melatonin plays a major role in regulating and synchronizing sleep habits by binding to melatonin receptors (MT1 and MT2).

It is important to note that beneficial effects of probiotic organisms are strain specific. The specific strain that has been shown to be effective in well-designed studies should be used for a particular indication. Safety: In general, probiotics are considered likely safe to consume with some notable exceptions. Patients with drugor disease-related immunosuppression status should avoid using probiotics due to the risk of developing blood-stream infections. In addition, it is advised that patients do not take their antibiotics and probiotics at the same time to avoid killing the live microorganisms by the antimicrobial agent. In general, probiotics are well-tolerated by patients, but can lead to bloating due to an increase in gas production.

Efficacy: The NMCD ranks melatonin as likely effective for circadian rhythm sleep disorders and sleep-wake cycle disturbances and possibly effective for insomnia, jet lag, and pre-operative anxiety and sedation. Safety: NMCD ranks melatonin as likely safe when used short term. Nausea, vivid dreams and drowsiness are common side effects of this supplement.

Drug Interactions: Some research points to melatonin in terms of its ability to lower blood pressure. Interestingly, melatonin can raise the systolic and the diastolic blood pressure in patients who are taking antihypertensive medications. Until more research is done, patients should be Practical considerations: counseled to monitor blood pressure closely while on mela1. In general, it is recommended to store the supplements tonin. NMCD gives this interaction a moderate rating and A away from moisture, heat and light. Some supplements for level of evidence. require refrigeration, but this can vary by manufacturer Special Populations: Melatonin should not be recomand species. mended to be used in young children and pregnant females 2. Products should have a “best buy” date on the label as it ranks as possibly unsafe in both populations. The indicating the date by which the product still contains main concern arises from the proposed ability of melatonin sufficient viable organisms to achieve the desired ther- to affect testosterone and estrogen levels. This can affect apeutic effect. This is different from the number of orreproductive development and ovulation cycle in the pregganisms per dose at the time of manufacture. nant female and the fetus.

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2. Take CoQ-10 with meals since most forms are better absorbed with fat. Absorption varies greatly depending 1. The dose for insomnia ranges from 0.3-5 mg at bedon the product formulation. Solubility enhancers like time. It is recommended to start low and go slow to polysorbate 80 or water-soluble beadlets generally inavoid excessive sleepiness. crease absorption. Using the active form, ubiquinol, 2. Blood pressure should be monitored closely in patients also produces better absorption. with hypertension. 3. CoQ-10 has been promoted to reduce statin-induced 3. Counsel patient to take melatonin at least 30 minutes myopathy. HMG CoA reductase inhibitors have been before bed time and for a total of four days to aid in shown to reduce serum CoQ-10. While some researchinsomnia related to jet lag. ers suggest that this drop in CoQ-10 levels might result in statin-related adverse effects such as myopathy, and CoenzymeQ-10 some clinical research has supported that theory using This supplement, also known as CoQ-10 and ubiquinol, is doses of 100 mg daily, many studies have shown no widely used throughout the world. In Japan, it is approved benefit of supplementing with CoQ-10. At this time, the for treating congestive heart failure. While it is produced in scientific evidence does not support use of CoQ-10 to adequate amounts in vivo in humans particularly in heart, prevent statin-induced myopathy. liver, kidney and pancreas, the supplement is prepared by Echinacea fermenting beets and sugar cane with yeast. Small amounts of CoQ-10 are provided in meats and seafood. Echinacea is native to North America and was traditionally Endogenous levels decline with age. used by Great Plains Indian tribes. It also is known as purPractical considerations:

ple coneflower, American coneflower and Black Susan.

Proposed MOA: CoQ-10 is fat soluble and has a vitaminlike action. It has antioxidant and membrane stabilizing properties as well as functioning as a cofactor in metabolic pathways for production of ATP in oxidative respiration. Efficacy: The NMCD lists CoQ-10 as likely effective for deficiency symptoms (these are rare) and genetic or acquired mitochondrial encephalomyopathies. A specific product, UbiQGel, is FDA-approved as an orphan drug for this group of diseases. CoQ-10 is listed as possibly effective for a group of diseases including age-related macular degeneration, congestive heart failure, myocardial infarction, hypertension, diabetic neuropathy, HIV/AIDS, Huntington’s disease, migraine and Parkinson’s disease. Safety: NMCD rates CoQ-10 as likely safe. It is welltolerated causing gastrointestinal symptoms including nausea, vomiting, diarrhea, appetite suppression, heartburn and epigastric discomfort in <1 percent of patients. Dividing doses >100 mg daily can decrease incidence of adverse effects.

Proposed Mechanism of Action: Echinacea is thought to modulate its activity through activation of the immune system. Echinacea can stimulate the release of tumor necrosis factor (TNF), interleukin-1 (IL-1) and interferon beta-2 through activation of macrophages. Echinacea also has some antiviral properties. Efficacy: NMCD ranks echinacea as possibly effective for the common cold and prevention of vaginal candidiasis. Safety: NMCD ranks echinacea as likely safe when used in the short term, up to four months. Side effects include fever, gastrointestinal symptoms, unpleasant taste, sore throat, dry mouth, headache, numbness of tongue, dizziness, insomnia, disorientation, joint and muscle aches. Drug Interactions: Echinacea can increase levels of acetaminophen, clopidogrel and diazepam due to inhibition of CYP1A2. Also, echinacea can increase caffeine levels significantly due to inhibition of CYP1A2. These interactions are rated as moderate with an evidence level of B.

Drug Interactions: CoQ-10 has a moderate rating for inPractical considerations: teraction with antihypertensive agents to increase the blood 1. Counsel patients with ragweed allergy to avoid using pressure lowering effect. The level of evidence is rated as echinacea due to cross-reactivity. B. CoQ-10 also may decrease the anticoagulant effects of warfarin with a moderate potential and a level of evidence 2. If a patient wants to try a liquid form of echinacea, recof D. ommend keeping the liquid in the mouth for at least 10 seconds to achieve a regional effect. Practical Considerations: 1. Doses vary depending on the indication but most regimens are between 50-200 mg daily.

Cranberry Cranberry is a small green shrub common in North Ameri25

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ca. It has traditionally been used by Native Americans for treating urinary conditions.

allinase converts alliin to allicin, the compound primarily responsible for the typical garlic odor. Allicin breaks down quickly and many commercial garlic preparations have no Proposed Mechanism of Action: The beneficial effects of alliin or allicin remaining in a purchased product, particularcranberry have traditionally been attributed to its ability to ly odorless products. Fresh garlic contains approximately 1 decrease urine pH. Current thought is that proanthocyapercent alliin. One milligram of alliin is converted to 0.458 nidins, one of the major constituent of cranberry, decrease mg allicin. There is some debate whether allicin is the acattachment of bacteria to the epithelial walls of the urinary tive principle of garlic or whether it is merely the precursor tract as the major mechanism of action. Because it is a to active metabolites including ajoene and S-allyl-Lsignificant source of salicylic acid, cranberry can have anticysteine (SAC). inflammatory properties. Garlic may act as a HMG-CoA reductase inhibitor to lower Efficacy: NMCD ranks cranberry as possibly effective for cholesterol levels. For age-related vascular changes and prevention of urinary tract infections and possibly ineffecatherosclerosis, garlic is thought to protect vascular endotive for diabetes. There is no reliable evidence that supthelial cells from injury by reducing oxidative stress, inhibitports the use of cranberry as a treatment for benign prosing low-density lipoprotein (LDL) oxidation, and through tatic hyperplasia (BPH), urinary odor and kidney stones. antithrombotic activity. Garlic has antiplatelet properties, Safety: NMCD ranks cranberry as likely safe for adults and antithrombotic properties, fibrinolytic activity, increases children. Drinking large amounts of cranberry juice may prothrombin time, and prevents conversion of arachidonic cause mild stomach upset and diarrhea. Drinking >1 liter of acid into prostaglandins and other products. Raw garlic juice daily for an extended period of time may increase has more potent antiplatelet properties than cooked garlic. likelihood of developing kidney stones. Crushing garlic before cooking might prevent loss of some antiplatelet activity. Garlic may reduce blood pressure by Drug Interactions: Due to its anticoagulant ability, cransmooth muscle relaxation and vasodilation by activating berry may interact with warfarin. Also, flavonoids may inproduction of endothelium-derived relaxation factor (EDRF, crease warfarin levels due to competitive inhibition of nitric oxide). CYP2C9. However, some clinical research shows that drinking cranberry has no effect on INR in patients on warfarin therapy. NMCD gives this interaction a moderate rating and B in terms of level of evidence. Another theoretical interaction is due to the acidic properties of cranberry. Urinary acidification can lead to ion-trapping of basic drugs and hence an increase in their clearance. Practical considerations: 1. Counsel patients to seek medical attention for urinary tract symptoms and not rely on cranberry as a sole treatment method. 2. The usual dose ranges from 300-400 mg twice daily. 3. If a patient would like a natural source of cranberry, 816 oz. of pure juice is recommended.

Efficacy: The NMCD lists garlic as possibly effective in treatment of atherosclerosis, hypertension, colorectal and gastric cancers, tinea infections (topical gel) and tick bites. Safety: Garlic is considered likely safe when used orally and appropriately. It is possibly safe when used topically due to the possibility of severe skin irritation. Dose-related adverse effects include breath and body odor, gastrointestinal disturbances and skin reactions including dermatitis, eczema and blisters. Adverse effects can be intensified with consumption of raw garlic or in patients unaccustomed to eating garlic. Garlic can possibly increase the risk of bleeding due to the antiplatelet effect.

4. If a patient is on warfarin therapy, counsel patients to inform their health care providers that they are consuming cranberry extract.

Drug Interactions: Garlic preparations containing allicin may increase metabolism of protease inhibitors and nonnucleoside reverse transcriptase inhibitors by CYP3A4 causing treatment failure and drug resistance. This is considered a major interaction with an evidence level of B.

Garlic:

Practical Considerations:

This edible bulb of the lily family has a long history of use as a spice as well as a medicinal agent.

1. A typical dose of garlic is 900 mg/day of garlic powder extract standardized to 1.3 percent alliin. This will provide about 12,000 mcg of alliin daily, or 4-5 mg of allicin.

Proposed MOA: Garlicâ&#x20AC;&#x2122;s medicinal properties are thought to be due to conversion of the relatively odorless substance, alliin. When garlic is crushed or cut, the enzyme

2. Garlic preparations may be enteric coated to protect

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the active constituents from degeneration by stomach acid.

Practical considerations: 1. Patients should stop using ginseng if they are on warfarin therapy.

3. Garlic is aged to reduce sulfur compounds and the common garlic odor. The process to produce odorless 2. Counsel patients about the signs and symptoms of hyaged garlic extract reduces the alliin content to only 3 poglycemia, especially if they are taking antidiabetic percent of fresh garlic. Alliin-free aged garlic is normally medications. dosed at 1-7.2 g daily. 3. Advise patients with a history of hormone-dependent 4. Patients should use garlic with caution when preparing malignancies to avoid using ginseng. to have surgery or dental work or if the patient has a Ginkgo bleeding disorder.

The long-lived ginkgo tree is cultivated for ceremonial as well as medicinal purposes. The tree has been known to live more than one thousand years. It is the most commonly prescribed herbal product in Germany and is primarily used for dementia.

Ginseng: American ginseng grows wild in North America. It is in high demand as a stimulant, stress reducer and immunostimulant. American ginseng has been declared an endangered or threatened species in some states. Two other forms of ginseng, panax or Siberian ginseng and Asian ginseng, differ in their properties from the American plant described below.

Proposed MOA: Ginkgo leaf is most commonly used as an extract. The extracts are standardized to contain active constituents, flavonoid glycosides (~25 percent) and terpenoids (6 percent). These constituents are thought to work Proposed Mechanism of Action: American Ginseng also synergistically through one of several mechanisms: antioxiknown as panaxquinquefolius belongs to the family Aralia- dant and free radical scavenging, inhibition of platelet activating factor, improving circulation, inhibition of betaceous. The dried root is considered the active component of this plant. One of the main constituents of the root is gin- amyloid peptide effects and GABA-ergic effects. senosides that might affect insulin sensitization and reEfficacy: The NMCD lists ginkgo as possibly effective in lease. It also is postulated that ginsenosides have estrogen treatment of dementia, cognitive function, anxiety, peripher-like actions. al vascular disease, vertigo, diabetic retinopathy, glaucoEfficacy: NMCD ranks American Ginseng as possibly effective for respiratory tract infections and diabetes and possibly ineffective for increasing athlete performance. There is no reliable evidence to support the use of American Ginseng as a treatment for cancer-related fatigue, insulin resistance and attention deficient-hyperactivity disorder (ADHD). Safety: NMCD ranks American Ginseng as likely safe when used for a maximum period of 3 months. Common side effects include diarrhea, itching, insomnia, headache and nervousness. Drug Interactions: American ginseng can cause hypoglycemia especially when used in combination with antidiabetic medications. NMCD gives this interaction a moderate rating and B for level of evidence. Another major interaction involves warfarin therapy due to ginsengâ&#x20AC;&#x2122;s ability to decrease the INR. NMCD gives this interaction a major rating and B for level of evidence. Special Populations: American Ginseng should not be recommended for pregnant women and breast-feeding females due to the teratogenic potential of its constituents.

ma, PMS, schizophrenia and tardive dyskinesia. Safety: Ginkgo is rated by NMCD as likely safe when used orally and appropriately. In typical doses, it can cause mild gastrointestinal upset, headache, dizziness, palpitations, constipation and allergic skin reactions. Ginkgo seeds contain the neurotoxin ginkgotoxin, a possible cause of seizures, paralysis and death. Another potential concern with ginkgo use is episodes of bleeding, potentially severe, that may occur particularly when other risk factors for bleeding are present. Topical ginkgo fruit and pulp can cause severe allergic skin reactions and irritation of mucous membranes. Drug Interactions: Many interactions are proposed for ginkgo. The most significant is with efavirenz resulting in a decreased drug concentration and increased viral load. This is considered a major drug interaction with an evidence level of D. Research suggests that ginkgo affects a number of cytochrome P450 enzymes including induction of CYP2C19 and inhibition of CYP1A2, CYP2C9 and CYP2D6. There is conflicting evidence regarding its effect on CYP3A4. These interactions are rated as moderate with an evidence level of B. It is proposed that the antiplatelet effect of ginkgo takes 2-3 weeks to become significant.

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Caution when using higher doses of ginkgo in combination purchase product only from reputable companies. Purwith antiplatelet and anticoagulant drugs is recommended. chasing a USP-verified or ConsumerLab tested product High doses of ginkgo seeds can cause seizures and there will ensure the content of the ginkgo product. have been anecdotal reports of seizures after taking ginkgo References leaf products. Patients should avoid using ginkgo in combination with other supplements that lower seizure threshold 1. National Center for Complementary and Integrative Health. Use of Complementary Health Approaches in including melatonin, folic acid, huperzine A and gamma the U.S. hydroxybutyrate. https://nccih.nih.gov/research/statistics/NHIS/2012/ Practical Considerations: about. Accessed June 9, 2015. 1. Dosing of ginkgo varies considerably depending on the 2. Counsel for Responsible Nutrition (CRN). The CRN proposed use. For forms of dementia and peripheral Consumer Survey on Dietary Supplements: 2014. vascular disease, the recommended dose is 40-80 mg http://www.crnusa.org/CRNconsumersurvey/2014. Acthree times a day of standardized extracts of ginkgo cessed June 10, 2015. leaf. It is recommended that patients discontinue gink3. ConsumerLab.com. Survey of Vitamin and Supplement go supplements two weeks before planned surgeries to Users. February 2013. Accessed June 10, 2015. prevent bleeding complications. 4. Natural Medicines Comprehensive Database. http:// 2. Ginkgo is thought to be one of the most adulterated naturaldatabase.therapeuticresearch.com/home.aspx? herbs. Some manufacturers will use small amounts of cs=&s=ND. Accessed June 11, 2015. ginkgo and spike the product with less expensive flavohttps://www.consumerlab.com. Acnol glycosides like rutin that can appear to be real gink- 5. Consumerlab. cessed June 10, 2015. go in many tests of product quality. It is important to

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May 2015 â&#x20AC;&#x201D; Top 10 Dietary Supplements: What Should You Know? 1. Which of the following is a major adverse effect associated with the use of American Ginseng? A. Hypotension B. Fatigue C. Nasal congestion D. Hypoglycemia

7. A dietary supplement that is commonly adulterated with inexpensive flavonol glycosides to pass a quality test is: A. Chondroitin. B. Garlic. C. Ginseng. D. Ginkgo. E. Glucosamine.

2. Based on the current evidence, for which of the following patients should you recommend cranberry? A. 45 year old male with kidney stones B. 60 year old female with diabetes C. 40 year old female with recurrent urinary tract infections D. 65 year male with benign prostatic hyperplasia (BPH)

8. The component of garlic that provides the characteristic odor and is thought to provide the pharmacologic properties is: A. Ajoene. B. Alliin. 3. Which of the following is a true statement? C. Allicin. A. Probiotics are the energy source for live bacteria whereas D. S-allyl-L-cysteine. prebiotics are live bacterial colonies. B. Patients should separate their antibiotics and probiotics 9. Appropriate information to provide to patients taking by a minimum of two hours. glucosamine/chondroitin supplements for osteoarthritis C. The most common adverse effects of probiotics are is: diarrhea and abdominal pain. A. Combinations of glucosamine/chondroitin/manganese are D. It is safe to recommend probiotics for patients with likely to be more effective than glucosamine and immune-compromised status. chondroitin alone and are unlikely to cause any additional adverse effects. 4. Which of the following is true regarding melatonin? B. If a combination product containing 1500mg glucosamine A. Melatonin is an effective treatment option for patients with and 1200mg chondroitin is not effective after two months, ADHD. increase the dose by one-half. B. Diarrhea and fatigue are the most common adverse C. Patients with a shellfish allergy cannot take glucosamine. effects experienced by patients taking melatonin. D. Patients taking warfarin concurrently must be monitored C. Melatonin is a safe option to recommend for pregnant for INR and possible decrease in warfarin dose. females with insomnia. D. Blood pressure should be monitored carefully in patients 10. A patient determines that he would improve his using melatonin in combination with antihypertensive overall health by taking a fish oil supplement. He is in medications. good health and takes only a medication for migraine and peptic ulcer disease. Which of the following is 5. A 37 y/o female with a history of vaginal yeast infection appropriate patient information for this man? and no allergies to medications mentions that she is A. EPA/DHA are likely to interact with his ulcer medication allergic to ragweed. She would like to take echinacea in due to changes in stomach pH. addition to her antifungal cream to prevent recurrence of B. He will need a prescription omega-3 fatty acid product to vaginal candidiasis. Should you recommend echinacea achieve the necessary amount of DHA and EPA daily. to this patient? C. He should limit fish oil consumption to <1 g of dietary A. No because echinacea is ineffective for this indication. supplement daily. B. No because the patient is allergic to ragweed, and there D. It is preferred that he obtain his omega-3 fatty acids from is chance of cross-reactivity. a dietary source. C. No because there is insufficient evidence regarding use of echinacea for vaginal candidiasis. D. Yes because it is indicated and safe for use in this particular patient. 6. Important patient counseling information to provide when purchasing coenzyme Q-10 is: A. Concurrent use with a statin will prevent statin-induced myalgia. B. CoQ-10 might increase tendency to bleed in a patient taking warfarin. C. Divide the daily dose of 150mg into two or three doses to decrease GI upset. D. Take the supplement on an empty stomach.

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

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

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

THE KENTUCKY PHARMACIST

Kentucky Renaissance Pharmacy Museum

May/June 2015

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

For more information on the Kentucky Renaissance Pharmacy Museum, see www.pharmacymuseumky.org or contact Gloria Doughty at g.doughty@twc.com or Lynn Harrelson at lharrelsonky@aol.com. Pharmacists Mutual Insurance offers Medicare Surety Bond In 2009 the Centers for Medicare and Medicaid Services (CMS) implemented Surety Bond Requirements for suppliers of Durable Medical Equipment, Prosthetics and Supplies (CMS-6006-F). This ruling requires that each existing supplier must have a $50,000 surety bond to CMS.

To see if you qualify for a $250 Medicare Surety Bond, or would like information regarding our other products, please contact us:   

Pharmacists Mutual Insurance Company, through its subsidiary PMC Advantage Insurance Services, Inc. d/b/  a Pharmacists Insurance Agency (in California), led the way to meet this requirement by negotiating the price of the bond from $1,500 down to $250 for qualifying risks.

Call 800.247.5930 Extension 4260 E-mail medbond@phmic.com Contact a Pharmacists Mutual Field Representative or Sales Associate http://www.phmic.com/phmc/ services/ibs/Pages/Home.aspx In Kentucky, contact Bruce Lafferre at 800.247.5930 ext. 7132 or 502.551.4815 or Tracy Curtis at 800.247.5930 ext. 7103 or 270.799.8756.

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

May/June 2015

KPhA Welcomes New and Renewing Members March-April 2015 Frankie Abner Barbourville

Michael Branstetter Glasgow

Katy Clifton Villa Hills

Elaine Adams Crestwood

Angela Rene Brunemann Union

Sharon Clouse Glasgow

Sandra Foster Anderson Monticello

David S. Burgess Lexington

Mildred Cook Tyner

Michael J Arnold Wilder

Julie N. Burris Louisville

Carrie Coons Bowling Green

Maryann Awosika Cold Spring

Billy P Burton Newburgh, Ind.

Charles Travis Crawford Barbourville

Jason K Baker Louisville

Quint C Butler Munfordville

Chuck Cummins Hopkinsville

Jennifer Baker Louisville

Amber Dale Cann Louisville

Heather L Daniels Hazard

Barbara C Batsel White Plains

Douglas Bradley Carr Hopkinsville

Alan Daniels Georgetown

Maureen Fink Lexington

Harold C Beck Benton

James Fred Carrico Louisville

Judith E Davenport Louisville

Joseph L Fink III Lexington

B. Michael Beller Poca, W.Virg.

Matt Carrico Louisville

Thomas Detraz Hopkinsville

Matthew J Foltz Villa Hills

Mike Berry Maysville

Mike Cayce Hopkinsville

Holly Divine Versailles

Daniel France Independence

Cassandra Beyerle Louisville

John C Cerrito Louisville

Gerald Durr Crescent Springs

Suzanne Marie Francis Florence

Cindy Biecker Edgewood

Ashley Thompson Cheuvront Somerset

John R Eastridge Campbellsville

Dana Fuller Lexington

Nikita M Evans South Shore

Paula R Gibson Manchester

Jackie Evans Gray

Shirley A Good Hopkinsville

William J Farrell Ft. Mitchell

Ben W Gower Henderson

Stefani Brinn Billington Mayfield Raymond J Bishop Louisville Marissa M. Boelhauf Lexington

BC Childress Owensboro Andraya Clark Vine Grove Chris Clifton Villa Hills

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

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

May/June 2015

Elizabeth Ann Haegele Erlanger

Mamie Ivey McKee

Laurie Meeks Lexington

Michael Pipkin Gilbertsville

Tina Hall Greenup

Daniel W. Johnson Hagerhill

Daniel Meier Edgewood

Steve Pollock Prospect

George Hammons Barbourville

Melinda Joyce Bowling Green

Erica Nicole Melton Mayfield

Myra S Ray Smiths Grove

Kathy Hardy Smiths Grove

Sarah Kaufman Evansville, Ind.

Lisa Miles Bardstown

Anna Remley Fort Thomas

Deborah Hargis Louisville

Megan Kramer Urbandale, Iowa

Benjamin Mudd Lebanon

Felix G. Reynolds Lancaster

Chris Harlow Louisville

Jane Lacefield Bowling Green

Theresa L Mullins Hindman

Herbert Wayne Rice Grand Rivers

Matthew Harman Dublin, Ohio

Darren Lacefield Bowling Green

Mary Beth Murley Bowling Green

Betty Ritchie Jeff

Jimmi Hatton Kolpek Lexington

Thomas Lawrence Carlisle

Shelley Elane Nall Lexington

Barry Rose Clay City

Julie Hawkins Pewee Valley

Andrew Losch Louisville

Chanin Nelson Middlesboro

Doug Russell Louisville

Joseph Stephen Hays Smiths Grove

Claire W. Love Lexington

Mark Nybo Crescent Springs

Lisa Sawvell La Grange

James E. Hicks Whitesburg

James William Marshall Leitchfield

Julie Oestreich Lexington

Frances Sherrill Paducah

Stephen Hill Stanford

Joseph Mashni Florence

Tara Olash Louisville

Patti Sizemore-Mink London

Janet Hodge Louisville

Sunni Mauk Paducah

Jeffrey Osman Lexington

Zena Slone Hazard

Karen Hubbs Gray

John B McClanahan Ashland

Julie A Owen Louisville

Richard Slone Hazard

Brooke Hudspeth Lexington

Sara McCubbins Bardstown

Angela Parrett Simpsonville

Kelly M Smith Lexington

Ronald Huening Cincinnati, Ohio

Brittany Kidwell McIntyre Bardstown

Mike Patrick Booneville

Marla Rae Smoot Crittenden

Jennifer Ihrig Hebron

Charles Edward McQuillan Florence

Chad Phelps Greensburg

Sally J Stiltner Berea

THE KENTUCKY PHARMACIST

KPhA New and Returning Members

May/June 2015

Veronica G Stith Vine Grove

Elizabeth Traxel Maysville

Karen White Lewisburg

Laura W Stone Louisville

Steven Gregory Treadway Elizabethtown

Jack Wikas Cold Spring

Misty M Stutz Crestwood

Clifford Tsuboi Lexington

Samuel Willett Mayfield

Neil Taylor McDaniels

Donald Eugene Webb Middlesboro

Clyde J. Wilson Danville

Stephanie Taylor Corbin

Amie Lynn Weber Florence

Pamela K Wright Mayfield

Judy B Thompson Argillite

Tonya Westmoreland Lowmansville

Michael B Wyant Finchville

Scott Yates Auburn

Know someone who should be on this list? Ask them to join YOU in supporting YOUR KPhA!

KPhA Honorary Life Members Ralph Bouvette

Leon Claywell

Kenneth Roberts

Gloria Doughty

Ann Amerson Stewart

Pharmacy Time Capsules 2015 (Second Quarter) 1990  Human genome project launched.  74 colleges of pharmacy in US. 1965  While working on an ulcer drug, James Schlatter, a G.D. Searle chemist, accidentally discovers aspartame. 1940  RH Factor discovered and named after the rhesus monkey from where it was discovered. 1915  NCPA Partners in Pharmacy, formerly WONARD, began offering student scholarships. By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America's history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out: www.aihp.org

THE KENTUCKY PHARMACIST

2015 KPhA Legislative Conference

May/June 2015

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

SAVE THE DATE

THE KENTUCKY PHARMACIST

Pharmacy Law Brief

May/June 2015

Pharmacy Law Brief:

Legalization of Marijuana Use - Federal Perspectives Author: Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy and Kentucky Pharmacists Association Professor of Leadership, Department of Pharmacy Practice and Science, UK College of Pharmacy Question: I keep seeing on television and reading in the newspaper about states taking steps to legalize the use of marijuana, usually for “medicinal purposes.” At least one report stated that over 20 states have enacted laws along these lines with many more considering such action. How can this be? I thought marijuana was a Schedule I drug under the Controlled Substances Act. Are the feds asleep at the switch on this issue? I cannot imagine that they are given the resources at their disposal.

Submit Questions: jfink@uky.edu 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.

Response: You are indeed correct – Congress has classified marijuana as falling within Schedule I of the Controlled Substances Act since that statute was enacted durgether, and whether to engage in plea bargaining. Most ing 1970. To refresh our recollection, to be placed in noteworthy for this discussion is that the U.S. Attorney is Schedule I, a substance must present a high potential for the administrative leader of his or her office and, as such, abuse along with the absence of an accepted medical use. has decision making authority over allocation of the reEnactment of the legislative ban on distribution and use of sources available to operate the office. marijuana was consistent with the 1961 ratification of the With all that as background, the 2009 memorandum from treaty known as the Single Convention on Narcotic Drugs. the Deputy Attorney General (think chief operating officer of This is an international agreement among the U.S. and 183 the Department of Justice) entitled “Investigations and other countries to classify marijuana as a banned subProsecutions in States Authorizing the Use of Medical Maristance. It is noteworthy that a treaty is a higher form of law juana” stated this as federal priority: “The prosecution of than a statute and, thus, prevails over an inconsistent provisignificant traffickers of illegal drugs, including marijuana.” sion in a national statute. So efforts to change the federal But it went on to state that persons acting in “clear and unlaw would need to take into account the nation’s assent to ambiguous compliance” with state statutes addressing use the terms of the Single Convention. Further, in deciding the of marijuana for medicinal purposes were not an enforce2005 case of Gonzales v. Raich (545 U.S. 1) the U.S. Sument priority. preme Court ruled that the federal government may classify as criminal activity the production and use of home-grown Two years later increased action by the states led the Depcannabis even though some states may have approved its uty Attorney General to again issue a memo in a further use for medicinal purposes. attempt to clarify the federal policy on enforcement activity in this area. Here he stated that jurisdictions authorizing The U.S. Department of Justice takes the lead on enforcing “multiple large-scale, privately operated industrial marijuana federal laws and from time to time the agency or its leader, cultivation centers” are not to be shielded from federal enthe U.S. Attorney General, releases policy interpretations or forcement activities and prosecution. guidance on a variety of topics. Several such memoranda are relevant to this issue. The first was a memo released on Then in 2013 the Deputy Attorney General issued yet a Oct. 19, 2009, addressing the exercise of prosecutorial dis- third memorandum on the topic with this one responding to cretion by U.S. Attorneys around the nation. These federal the actions of states taking actions to legalize possession of prosecutors have authority within a specified geographic small amounts of marijuana and to regulate production, area, e.g., Eastern Kentucky versus Western Kentucky. processing and sale of the plant and its constituents. MakThat authority confers on them discretion or decision- ing reference to “cooperative federalism,” he noted that making authority on such matters as whom to charge with a states with strong and effective regulatory and enforcement federal crime, what federal crimes should be alleged, if and systems to control the cultivation, distribution, sale and poswhen such charges should be modified or dropped alto- session of marijuana are less likely to pose a threat to fed36

THE KENTUCKY PHARMACIST

Pharmacy Law Brief

May/June 2015

eral enforcement priorities. His conclusion was that in such instances, “enforcement of state law by state and local law enforcement and regulatory bodies should remain the primary means of addressing marijuana -related activity.” Hence, the bottom line of all this activity and positioning appears to be that federal law enforcement officials will tend to defer to state and local officials when the state legislature has enacted state statutes in this area. But having said that, what about reported actions such as those in California where U.S. attorneys aimed enforcement-related letters to the landlords of commercial establishments selling marijuana? Activities like that will be addressed in two future columns dealing with civil law, not criminal law, issues related to conducting business operations for production, distribution and sale of marijuana – and there are many such issues.

Dr. George Digenis receives Mosaic Award Dr. George Digenis, retired Chair/ Director of Medicinal Chemistry and Pharmaceutics at UK, was one of the recipients of the 2015 Mosaic Awards. Dr. Digenis, a native of Greece, was honored for his exceptional professional contributions and for his work with the Louisville Greek Orthodox community. He received his award during a ceremony May 21, 2015 at the Louisville Marriott Downtown. The Mosaic Awards honor new or firstgeneration international Americans who are making a significant contribution in their profession and community.

Are you connected to YOUR KPhA? Join us online!

Facebook.com/KyPharmAssoc

@KyPharmAssoc @KPhAGrassroots

KPhA Company Page

THE KENTUCKY PHARMACIST

Pharmacy Policy Issues

May/June 2015

PHARMACY POLICY ISSUES: Growth of Internet Pharmacies and Their Relation to Patient Education Author: Brian P. Garcia is a third year Doctor of Pharmacy degree candidate at the UK College of Pharmacy. A native of Fisherville, Ky., he completed his pre-professional education at UK. Issue: Over the flow of my career, I’ve seen the development and growth of pharmacies offering to serve patients in my community through the Internet. This is true with other aspects of our society, witness the growth of Amazon.com. While there may be advantages for some few patients through that approach, I’ve got to think that the disadvantages outweigh the advantages. There may well even be dangers to some patients. Thoughts? Discussion: The growing availability of Internet pharmacies brings with it a new hurdle to pharmacists providing safe, efficacious medications and related services to the American public. These types of pharmacies are mostly based outside of the United States, where there exists a lack of protections for the public from potentially harmful prescription medications. Because of the duty of pharmacy professionals to protect and advise their patients, these same professionals must now strive to keep their patients from resorting to the cheaper alternative medications, and the attendant risks, that Internet pharmacies promise.

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.

serves as a regulatory body for only a limited number of aspects related to websites, making it difficult for them to enforce laws specific to individual countries, like the United A simple search on the Internet for many prescription mediStates. As it stands, there is little that the agency’s limited cations brings up results from a number of sites that allow staff and minute authority in international law can do to patients to purchase their medications with no prescriptions stop the dangers that these pharmacies pose. and no guarantee that what they’ve been promised is actually what they will be receiving. Many people are at risk for Though the systematic changes that need to be made to receiving drugs that are “adulterated, counterfeit or tainted stop Internet pharmacies are not easily achieved, pharmawith unsafe excipient.”1 Furthermore, by engaging in this cy professionals can act on the individual level. They have illicit activity, patients also lose the interaction with their an obligation to work with their patients and counsel them pharmacists and thus lose the opportunity for counseling on the risks associated with using online pharmacies. All and education. patients must be aware of the potential dangers of these sites, and it is the job of those in the pharmacy field to eduGiven this information, one might wonder how these Intercate them. Many in the general public believe that these net pharmacies are still in business. Though it may seem drugs are simply cheaper because they are not coming like an easy fix to simply shut them down, the process is from regulated American companies, but what they do not not that simple. Because the Internet was created as an know is that by using these unregulated medications, they international free market, the only true regulatory agency may be sacrificing their health, or worse, their lives. Pharcurrently overseeing it is the Internet Corporation for Asmacists and their colleagues must ensure that at-risk pasigned Names and Numbers (ICANN). ICANN, considered tients, generally those with lower incomes, are not taking the Internet’s central administrator, received reports of at medicines from illegitimate sources. If costs would prohibit least 4,700 suspicious Internet pharmacies, registered to these low-income patients from safely obtaining their nine different companies, between February 2014 and Ocdrugs, the pharmacy personnel should work with the pretober 2014. Only 700 of these sites have actually been shut scribers to find affordable alternatives to the costly medica2 down. What’s more, in July 2014, the FDA partnered with tions. Interpol to lobby for a particular Chinese company to shut down over 1,300 of these kinds of websites, but the com- Internet pharmacies, though easily accessible for many pany refused, and the websites remained open. ICANN patients, provide potentially dangerous alternative medica38

THE KENTUCKY PHARMACIST

May/June 2015

KPhA Emergency Preparedness

tions that could possess dangerous and even fatal qualiOnline Medication Safety in Long-Term Follow-Up of ties. Professionals in the field of pharmacy must keep pa136 Internet Pharmacies: Illegal Rogue Online Pharmatients healthy by giving pertinent education on these dancies Flourish and Are Long-Lived. Journal of Medical gers and prepare patients for the empty promises that interInternet Reseach (2013) 15 (9). net pharmacies provide. This way, the public can make informed, knowledgeable decisions about the medications 2. Elder, J. Icann, Regulators Clash Over Illegal Online Drug Sales; FDA, Interpol Want Internet Gatekeeper to that they put on and in their bodies. Take Action Against Suspicious Websites, but Ican References Says Its Powers Are Limited. Wall Street Journal. (October 27, 2014). 1. Fittler, A., Bosze, G., & Botz, L. Evaluating Aspects of

How to Make a "Smart" Phone "Undumb" in a Disaster Technology is continually expanding and ever changing. The first cellphones were large, difficult to carry and in some cases had to be transported in a suitcase. As technology advanced, cellphones became small enough to fit into pants or shirt pockets. The trend is now reversing back to large phones designed to store substantial amounts of information and to display the data on oversized screens. Many, if not most, people with cellphones have enormous amounts of information about their lives stored on this single device. People rely on their cellphones to wake them, deliver the morning news and keep them on track throughout the day. When cell towers cease to function after a disaster, those who rely so heavily on these devices still could utilize their cellphones beyond the traditional method. There are now applications (apps) on the market that do not require a cellular connection and can provide the owner with useful information and even connectivity to emergency and community services. To read more about these apps and find where to download them, navigate your smart phone to the Domestic Preparedness Journal website at http://www.domesticpreparedness.com/pub/docs/DPJFebruary15.pdf.

KPhA Pharmacy Emergency Preparedness Initiative Interest Form Name: ______________________

Status (Pharmacist, Technician, Other): ___________________

Email: ______________________________ Phone: ___________________________ Interest in serving as a volunteer: Yes____ No ____ Interest in serving as a Volunteer District Coordinator: Yes____ No _____ You also may join the Medical Reserve Corps by following the KHELPS link on KPhA Website to register (www.kphanet.org under Resources) Please send this information to Leah Tolliver, KPhA Director of Pharmacy Emergency Preparedness via email at ltolliver@kphanet.org, fax to 502-227-2258 or mail at KPhA, 1228 US 127 South, Frankfort, KY 40601. 39

THE KENTUCKY PHARMACIST

May/June 2015

Pharmacists Mutual

THE KENTUCKY PHARMACIST

Cardinal Health

May/June 2015

THE KENTUCKY PHARMACIST

KPhA Board of Directors/Staff

May/June 2015

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Duane Parsons, Richmond dandlparsons@roadrunner.com

Chair 502.553.0312

Ethan Klein, Louisville kleinethan@gmail.com

Speaker of the House

Bob Oakley, Louisville Boakley@BHSI.com

President

Chris Harlow, Louisville cpharlow@gmail.com

Vice Speaker of the House

Chris Clifton, Villa Hills chrisclifton@hotmail.com

President-Elect

KPERF ADVISORY COUNCIL

Brooke Hudspeth, Lexington brooke.hudspeth@kroger.com

Secretary

Matt Carrico, Louisville matt@boonevilledrugs.com

Glenn Stark, Frankfort glennwstark@aol.com

Treasurer

Kim Croley, Corbin kscroley@yahoo.com

Raymond J. Bishop raybishop13@gmail.com

Past President Representative

Christen Schenkenfelder cschenkenfelder@sullivan.edu

Directors Matt Carrico, Louisville* matt@boonevilledrugs.com

Mary Thacker, Louisville mary.thacker@att.net

Tony Esterly, Louisville tonye50@hotmail.com

KPhA/KPERF HEADQUARTERS

Matt Foltz, Villa Hills mfoltz@gomedcare.com Chris Killmeier, Louisville cdkillmeier@hotmail.com Mallory Megee, Nicholasville mallory.megee@uky.edu

University of Kentucky Student Representative

Jeff Mills, Louisville jeff.mills@nortonhealthcare.org

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 www.twitter.com/KPhAGrassroots www.youtube.com/KyPharmAssoc Robert McFalls, M.Div. Executive Director rmcfalls@kphanet.org

Chris Palutis, Lexington chris@candcrx.com Christian Polen cpolen7392@my.sullivan.edu

Kimberly Daugherty, Louisville kdaugherty@sullivan.edu

Sullivan University Student Representative

Richard Slone, Hindman richardkslone@msn.com Mary Thacker, Louisville mary.thacker@att.net Sam Willett, Mayfield duncancenter@bellsouth.net * At-Large Member to Executive Committee

Scott Sisco, MA Director of Communications & Continuing Education ssisco@kphanet.org Angela Gibson Director of Membership & Administrative Services agibson@kphanet.org Leah Tolliver, PharmD Director of Pharmacy Emergency Preparedness ltolliver@kphanet.org Elizabeth Ramey Receptionist/Office Assistant eramey@kphanet.org

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. 42

THE KENTUCKY PHARMACIST

50 Years Ago/Frequently Called and Contacted

May/June 2015

50 Years Ago at KPhA FROM SCOOPS ‘N’ SCRAPS By E. Murphy Josey MEDICARE—Recently some drug stores in Kentucky have been advertising they fill Medicare Prescriptions free. This is a misleading statement. It gives the patient the idea that he can get drugs at the drug stores without the drugs being paid for. Actually you are reimbursed for Medical Care Prescriptions. The Kentucky Pharmaceutical Association and the Medical Care Program in the State of Kentucky frown on such advertising. It may be necessary to cut some drug stores off of the Medical Care list if they do not cease advertising in such a way. - From The Kentucky Pharmacist, May 1965, Volume XXVIII, Number 5.

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 (PTCB) 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Kentucky Society of Health-System Pharmacists P.O. Box 4961 Louisville, KY 40204 (502) 456-1851 x2 (502) 456-1821 (fax) www.kshp.org info@kshp.org 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

The Kentucky Pharmacist is online! Go to www.kphanet.org, click on Communications and then on The Kentucky Pharmacist link.

Would you rather receive the journal electronically? Email ssisco@kphanet.org to be placed on the Green list for electronic delivery. Once the journal is published, you will receive an email with a link to the online version.

THE KENTUCKY PHARMACIST

May/June 2015

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

Show your Pharmacist Pride with a KPhA Roamey Window Cling ($5) or your own personalized Roamey ($25)! All proceeds benefit the KPhA Building Fund Available at the KPhA Online Store www.kphanet.org, click on About Tab, Online Store

For more upcoming events, visit www.kphanet.org. 44

THE KENTUCKY PHARMACIST