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Y K C U T N E K E H T T S I C A PHARM Vol. 7, No. 2 March 2012

KPhA At APhA KPhA was well represented in the APhA House of Delegates March 9-12 in New Orleans. KPhA’s contingent included (seated) President-Elect Kimberly S. Croley, Melinda Joyce, President Lewis Wilkerson, Executive Director Robert McFalls and Joe Carr . For more pictures from APHA, see page 31.

Registration form and other information inside!

New Practitioners visited the Penguin Experience at the Newport Aquarium in January. See more photos on page 4.

News & Information for Members of the Kentucky Pharmacists Association


Table of Contents

March 2012 KPhA Membership Invitation April CE-Theory and Practice of Compounding Otic Preparations April Pharmacist/Pharmacy Tech Quiz APhA Award Winners Pharmacy Technician Certification Board Advancing Pharmacy Practice In Kentucky Pharmacy Policy Issues KPhA Government Affairs/APSC Pharmacists Mutual Companies KPhA Board of Directors Frequently Called and Contacted/Classifieds

Table of Contents Table of Contents— Oath— Mission Statement President’s Perspective KPhA New Practitioners Winter Event 2011 Bowl of Hygeia Award Winners KPhA Annual Meeting 2012 March CE—Medications and Breastfeeding March Pharmacist/Pharmacy Tech Quiz CPE Monitor Information Pharmacy Law Brief KPPAC Contribution Form

2 3 4 5 6 12 18 19 20 21

22 23 30 31 32 33 34 36 37 38 39

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.

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.

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.

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

Editorial Office: © Copyright 2012 to the Kentucky Pharmacists Association. The Kentucky Pharmacist is the official journal of the Kentucky Pharmacists Association published bimonthly. The Kentucky Pharmacist is distributed to KPhA members, paid through allocations of membership dues. All views expressed in articles are those of the writer, and not necessarily the official position of the Kentucky Pharmacists Association. Editorial, advertising and executive offices at 1228 US 127 South, Frankfort, KY 40601. Phone 502.227.2303 Fax 502.227.2258. Email ssisco@kphanet.org. Website http://www.kphanet.org.

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President’s Perspective

March 2012

President’s Perspective

Lewis Wilkerson PharmD, CGP KPhA President 2011-2012

hosted by the new Center for the Advancement of Pharmacy Practice (CAPP) at the University of Kentucky College Of Pharmacy. It will be held on April 13th and 14th. This pharmacy summit will help chart the course for the future of pharmacy, and is being titled, “Advancing Pharmacy Practice in Kentucky”. If you are asking yourself, “Should I attend?”, here are a few questions that might help you decide. Do you love pharmacy, but are concerned with where the profession stands currently? Are you ever frustrated at work or dread going into the pharmacy? Do you have concerns that pharmacy is the right profession for your kids to go into? Are you willing to come with unbiased opinions and ideas on how to advance the profession and not a specific agenda? Do you have ideas on where the profession should be headed and they’ve gone unheard? If yes to any of these, then I encourage you to say, “Yes, I will” and attend! See page 33 for the agenda. My hope is that the meeting is overflowing with people and overflowing with a willingness to put aside practice biases so that we can set the course for the advancement of our profession.

In addition to the summit meeting, I hope you have marked your calendar for the 2012 KPhA Annual Meeting. It will be In my last article, I referenced the anticipation and resolution needed for our profession in 2012. My wish is that your held at the Marriott Griffin Gate in Lexington, Ky., on June 13 – 16th. Registration is live at year has begun with great hope and enthusiasm, and a desire to be involved and make a difference in 2012. In this www.kphanet.org/2012annualmeeting and on Page 6. If position, I continue to be inspired by the work of our Board you have never attended or if you haven’t attended in more of Directors, our committees, our academies and our staff! than five years or maybe since you were a student, please consider attending. Our association moves forward only through your engagement! Our new Executive Director, Bob McFalls, is working tirelessly to represent our association. His work ethic is tremendous, and his experience in association management There are a lot of positives going on within our association. is evident and exemplary. If you have not had a chance to However, as I have outlined consistently, the health of our association is dependent on the engagement and membermeet Bob yet, I know he would love to hear from you. So pick up the phone, shoot him an email or stop by the office ship of our pharmacists and technicians. For this journal’s article, I considered simply typing “Join or Renew Now, and if you are in Frankfort. If you stop by the office, you will Bring a Colleague” in size 72 font. I really do want to hear have the pleasure of meeting our office manager, Kelli from you. If you have concerns or questions about how to Sheets. She has been a real asset to our association and be involved, please email me at rphs2@aol.com. is, as well, extremely dedicated to seeing our association grow and thrive. Mainly because I have teenage kids, but I am beginning to become more “plugged in” technology wise. In addition to the old fashioned email account, I now have a Facebook and Twitter. Hopefully you have noticed that your association is now “plugged in” as well. Scott Sisco is our new Director of Communications and Continuing Education. Regular communications are now going out via eNews, tweets and post. If you are not following the association, please connect with us via one of those media. Word has it that we are just slightly behind Coach Cal on Twitter followers. Scott is also looking for support in the area of continuing education, and would welcome any aspiring authors to develop a C.E. article for the journal. Contact him at the office for more information on the process.

KPhA Social Media Links www.facebook.com/ KyPharmAssoc www.twitter.com/KyPharmAssoc

Hopefully by now you have seen information and made plans to attend the most important meeting in Kentucky Pharmacy this century. KPhA is helping sponsor this event

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KPhA New Practitioners Winter Event

March 2012

KPhA New Practitioners Winter Event

The New Practitioners Committee organized a trip to the Newport Aquarium in January. The attendees enjoyed a behind-thescenes up close penguin experience before touring the main aquarium. The pharmacists learned about how the penguins are cared for, including their pharmacological needs.

Sharing with student pharmacists KPhA member Kelly Whitaker poses with UK College of Pharmacy Professor and KPhA Board member Trish Freeman (far left), and UK COP students Zack Thompson and Brent Simpkins after Whitaker shared her experiences with a group of about 100 students. Whitaker, who is running for Kentucky House District 2, shared the importance of advocacy at a convocation event in February.

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2011 Bowl of Hygeia Award Winners

March 2012

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134th KPhA Annual Meeting

March 2012

134th Kentucky Pharmacists Association Annual Meeting Registration Form June 13-16, 2012 Marriott Griffin Gate, Lexington, KY

Please Type or Print the following: __________________________________ ________ __________________________ First Name

MI

Last Name

____________________________________________________ PharmD RPh CPhT Other Business Affiliation

_____________________________________________ _________________________ ______ ­ _____ Street Address

City

State

Zip

__________________________ _______________________________________________________________ Daytime Phone

Student- Free Full Registration: By June 1 After June 1 Single Day Registration: By June 1 After June 1

Email Address

Registration Fees: Please circle applicable Fee Member Non-Member Technician/Resident $200 $250

$375 $425

$105 $195 $130 $220 Circle Day: Thursday

Friday

$85 $110

$25 $35

$55 $80

$20 $30 Saturday

Meal Events: Please indicate the total number that will be attending each meal event. Welcome Luncheon: Thursday ____yes ____ no _____ additional guest $30 Kroger Luncheon: Friday ____yes ____ no _____ additional guest $30 Ray Wirth Awards Banquet: Friday ____yes ____ no _____ additional guest $45 Luncheon: Saturday ____yes ____ no _____ additional guest $30 Guest Name(s): ______________________________________________________________________________ Please include your guests’ name(s) if you have purchased additional event tickets Registration $ _______ Additional Meal Tickets $ _______ Credit Card Information: AMEX Discover MasterCard

Total Enclosed $_________ Visa

Number: ___________________________________________ Expiration Date:______________ NOTE: If billing address is different than above, please include on back of sheet, or separate sheet. Please make checks payable to KPhA Annual Meeting. Mail to: KPhA Annual Meeting 1228 US 127 South Frankfort, KY 40601. For overnight accommodations: Contact Marriott Griffin Gate via the KPhA custom web reservation site at https:// resweb.passkey.com/go/KYPharmacistAssoc, or call1-800-266-9432 and reference Group Code KY Pharmacists Associa­ tion for the special rate of $129/night. Cut-off for this rate is May 22, 2012. Lodging rate includes parking on site and wireless internet access. Special Assistance. If you require special assistance or diet to attend, please indicate need on back of this sheet, call 502.227.2303 or email ssisco@kphanet.org. 6

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134th KPhA Annual Meeting

March 2012

KPhA 2012 Professional Awards The Kentucky Pharmacists Association annually recognizes individuals from across the Commonwealth that exhibit exceptional service to patients and their community, continuously promote the profession of pharmacy, and demonstrate innovative pharmacy practice. The KPhA Organizational Affairs Committee is accepting nominations for the professional awards below: Bowl of Hygeia sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingelheim Distinguished Service Award

Professional Promotion Award

Pharmacist of the Year

Young Pharmacist of the Year

Excellence in Innovation Award sponsored by Upsher-Smith Laboratories, Inc. Technician of the Year

Cardinal Health Generation Rx Champions Award Sponsored by Cardinal Health Foundation

To nominate an individual, please submit a letter of nomination including the award information and the nominee’s accomplishments with regard to the award criteria. Multiple letters of support are accepted and highly encouraged. Individuals and recognized pharmacy organizations in Kentucky are encouraged to submit nominations. Individual nominators need not be a member of the Association; however, pharmacist and technician nominees must be a member of KPhA. Nominations: Nominations may be submitted electronically to the Organizational Affairs Committee Chair, Joey Mattingly at joeymattingly@gmail.com or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March

31, 2012.

The KPhA President, President-Elect, and the Chairman of the Board, participating in any voting for awards shall not be eligible for nomination or selection for any award. Conferral of any of the awards of the Association shall be at the discretion of the Organizational Affairs Committee and is not mandatory on an annual basis.

KPhA Board of Directors Nominations for 2012-13 The Kentucky Pharmacists Board of Directors is ac- Consulting Pharmacists and Academy of Compounding Pharmacists). cepting nominations for the following positions to serve on the KPhA Board for the 2012-13 year: The academies are required to have the following officers:  President-Elect  Secretary  Chair  Director (3 open spots)  Vice Chair  Director (3 positions) Nominations also are being accepted for leadership in the recognized academies of KPhA (Academy of Nominations: Nominations may be submitted electronically to the Organizational Affairs Committee Chair, Joey Mattingly at joeymattingly@gmail.com or mailed to KPhA, Attn: Scott Sisco 1228 US 127 South, Frankfort, KY 40601 no later than March

31, 2012. 7

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134th KPhA Annual Meeting

March 2012

KPhA 2012 Professional Award Criteria and Past Recipients Martin W. Nie Ralph Schwartz Dwaine K. Green W. Vance Smith Richard L. Roeding William J. Farrell, Sr. Joseph L. Scanlon Joseph T. Elmes, Jr. H. Joe Russell Alvin R. Bertram Norman C. Horn H. Joseph Schutte D.H. "Sonny" Ralston Arthur G. Jacob James M. Brockman Richard E. Murray Randolph N. Smith Oliver E. Mayer Donald C. Morwessel James Phillip Arnold William D. Morgan Ernest M. Davis W.F. Bettinger Arvid E. Tucker Vernon B. Hager Sidney Passamaneck John H. Voige E. Crawford Meyer James J. Hamilton

Bowl of Hygeia Award sponsored by the American Pharmacists Association Foundation and the National Alliance of State Pharmacy Associations with support from Boehringer Ingelheim

Criteria – To recognize an individual who has demonstrated outstanding community service in pharmacy. Eligibility – The recipient must be an Active or Honorary Life member of the Association. The recipient must be a pharmacist with a current valid license to practice in Kentucky. The recipient must be living; awards are not presented posthumously. The recipient has not previously received the award and is not currently serving nor has he/she served within the past two years on the selection committee or as an officer of the Association in other than ex-officio capacity. The recipient has compiled an outstanding record of community service that apart from his/her specific identifications as a pharmacist reflects well on the profession. Bowl of Hygeia Recipients William I. McMakin, III Kim Croley Patricia Thornbury Dave Peterson Charles Fletcher Gloria Doughty Larry Hadley Harold Cooley Brian Fingerson Simon Wolf Richard Ross Tom Houchens Phil Losch Lucy Easley Nick Schwartz Michael Cayce Bill Borders Gerald Deom Kenneth Calvert Joseph G. Bessler Michel A. Burleson Lynn Harrelson William A. Conyers, Jr. Daniel R. Kovar, Jr.

2011 2010 2009 2008 2007 2006 2005 2004 2003 2002 2001 2000 1999 1998 1997 1996 1995 1994 1993 1992 1991 1990 1989 1988

1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959

Distinguished Service Award Criteria- To recognize individual members who have made significant contributions to the Association or the profession at large over an extended period of time. Eligibility – Only Active or Honorary Life members of the Association shall be eligible for the award. No individual shall be a recipient of the award more than once. Distinguished Service Award Recipients Kenneth Roberts Ann Amerson & Lynn Harrelson Larry Hadley Dwaine Green 8

2011 2010 2009 2008

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134th KPhA Annual Meeting John Brislin Donnie Riley Gloria Doughty Coleman Friedman Joe Fink III Melinda Joyce David Jaquith R. Paul Easley & Jeff Osman Ralph Bouvette Pat Chadwell Jordan Cohen and Marty Nie Mike Montgomery Richard Ross Thomas Weisert R. David Cobb Joseph G. Bessler & Arthur G. Jacob Paul E. Davis Norman Horn & Robert E. Lee Sandlin Joseph V. Swintosky J.H. (Jack) Voige Charles T. Lesshafft, Jr. Jerry Budde William H. Nie R.N. (Randy) Smith

March 2012 2007 2005 2004 2003 2002 2002 1999 1998 1997 1996 1995 1994 1993 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981

Brian Fingerson Martin W. Nie Judy Minogue Paul Ruwe Joseph L. Fink III Steven R. Adams William J. Farrell Harold G. Becker Dwaine K. Green R. David Cobb Richard E. Murray Richard Rolfsen Gloria H. Doughty Joseph G. Bessler Emil Baker Robert L. Barnett Joseph L. Scanlon John B. Anneken Alvin R. Bertram Patricia A. Donahue H. Joseph Schutte Willard Alls Joe D. Taylor Richard L. Ross Ralph J. Schwartz George W. Grider Robert J. Lichtefeld E.M. Josey Julius T. Toll Charles E. Otto Charles F. Rosenberg R.N. Smith E. Crawford Meyer Charles A. Walton Ernest C. Williams George W. Grider Ray Wirth Nathan Kaplin Marion Hardesty

Pharmacist of the Year Award Criteria – To recognize a pharmacist for outstanding professional activities undertaken during the current or previous calendar year, which resulted in demonstrable benefit to the profession of pharmacy. Eligibility – Only Active or Honorary Life members of the Association shall be eligible for nominations and receipt of this award. Pharmacist of the Year Recipients William Grise Holly Byrnes Dave Sallengs Kelly Smith Joseph Bickett Paul Easley John Anneken Kim Croley Ralph Bouvette David Jaquith Melinda Joyce Michael Wyant Phil Losch Tom Houchens & Bob Kuhn Don Ruwe Mark Edwards C. Dave Peterson

2011 2010 2009 2008 2007 2006 2005 2004 2003 2001 1999 1998 1997 1996 1995 1994 1993

1992 1991 1990 1989 1988 1987 1986 1985 1984 1983 1982 1981 1980 1979 1978 1977 1976 1975 1974 1973 1972 1971 1970 1969 1968 1967 1966 1965 1964 1963 1962 1961 1960 1959 1958 1957 1956 1955 1954

Professional Promotion Award Criteria – To recognize individuals or organizations who have exhibited outstanding efforts to demonstrate the importance of pharmacy as a health care profession, and which promote proper application of pharmacists’ professional services. Eligibility – Open to persons or organizations. Professional Promotion Recipients Lynne Eckmann Gloria Doughty & Lynn Harrelson Jordan Covvey Jeff Mills Trish Freeman 9

2011 2010 2009 2008 2007

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134th KPhA Annual Meeting

March 2012

Sherry DeCuir 2006 Pete Orzali 2005 John Armistead, Don Kupper & Willie Newby2004 Kroger Pharmacy Mid South Division, Holly Divine, Randy Gaither, Bill Grise & Laura Jones 2003 Jefferson County Academy of Pharmacy, Dean Ken Roberts, Ph.D 2002 Paul Easley, Bob Oakley and Michael Wyant 2001 Judy Minogue 2000 Ralph Bouvette 1999 Rodger Smith, Barbara Woerner, Mary Ann Wyant, and Rick Vissing 1998 Larry Spears 1997 John B. Anneken 1996 Phil Losch 1995 Jordan Cohen 1994 Judy Minogue 1994 Kentucky Academy of Student of Pharmacy 1993 Celeste Flick & Clarence Sullivan III 1988 William H. Nie 1987 Student Kentucky APhA 1986 Northern KY Pharmacists Association 1986

Pan Haeberlin Kim Croley Phillip Sandlin Jeffrey W. Danhauer Mark S. Edwards Susan Murray Kathman Melinda Cummins Joyce

1994 1993 1992 1991 1990 1989 1987

Distinguished Young Pharmacist Award Recipients Aimee Ruder Karen Hubbs Matt Martin Tiffany Self Angela Parrett Janet Mills Alyson Schwartz Nancy Horn Jennifer O’Hearn Karen Altsman Kim Wilson Kim Harned Michael Box Dan Yeager Dan Minogue

Rx Champions Award sponsored by Cardinal Health Foundation

Excellence in Innovation Award Sponsored by Upsher-Smith Laboratories Criteria – To recognize a pharmacist who has demonstrated innovative pharmacy practice resulting in improved patient care in the previous year or over an extended period of time. Eligibility – A recipient must be a pharmacist who is an Active or Honorary Life member of the Association. A recipient may receive the award more than once. Innovative Pharmacy Practice Award Recipients

James Nash & BC Childress 2011 Lynne Eckmann & Cathy Hanna 2010 Ann Albrecht 2008 Lisa Short 2005 Young Pharmacists of the Year Award sponsored Holly Divine, Amy Nicholas 2004 by Pharmacists Mutual Insurance Company Judy Minogue 2003 Trish Freeman 2002 Criteria – To recognize a young pharmacist’s outMary Ann Wyant 2001 standing contribution to the profession and/or commuJoyce Korfhage Rhea 2000 nity. Cathy Edwards 1999 Eligibility – The recipient must be an Active member Celeste Flick 1998 of the Association. The recipient must be licensed to Jeanne Zeis 1997 practice for nine years or less. The recipient must Dave Wren 1996 have a valid, active license to practice in Kentucky. Preston Art 1995 The recipient must have demonstrated participation in W. Michael Leake 1994 a national pharmacy association, professional program(s) and/or community service. New Award for 2012: Cardinal Health Generation 2011 2010 2009 2008 2007 2006 2005 2004 2003 2001 1999 1998 1997 1996 1995

Criteria – This award program recognizes excellence in community-based prescription drug abuse prevention at state pharmacy associations. This award honors a pharmacist who has demonstrated outstanding commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community. The award is also intended to encourage educational prevention efforts aimed at patients, youth and other members of the community. In addition to the award, to honor the pharmacist’s work to fight prescription drug abuse, APMS, state pharmacy associations and the Cardinal Health Foundation will donate $500 to a charity of the award recipient’s choice.

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134th KPhA Annual Meeting

March 2012

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March 2012 CE-Medications and Breastfeeding

March 2012

Medications and Breastfeeding: Evaluating Safety and Selection in Common Conditions

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

By: Emily Sutton, PharmD The Albany College of Pharmacy and Health Sciences, Colchester, VT and Deborah Minor, PharmD The University of Mississippi Medical Center, Jackson, MS Reprinted with permission of the authors and the Mississippi Pharmacists Association where this article originally appeared. There are no financial relationships that could be perceived as real or apparent conflicts of interest.

Universal Activity # 0143-9999-12-003-H05-P 1.0 Credit Hours (0.1 CEUs) The goal of this article is to familiarize pharmacists with the safety of various medications that are used to treat common conditions in women who are breastfeeding and to identify resources that may be used to determine the medication’s safety. Objectives:

1. Describe mechanisms and factors affecting mother to infant medication delivery during lactation. 2. Identify resources for evaluating medication therapy in lactation. 3. Review preferred medication therapies for common disease states in lactating mothers. 4.

Highlight medications that should be avoided during lactation.

Breastfeeding may be beneficial for both mother and child. The American Academy of Pediatricians (AAP) policy statement acknowledges that breastfeeding is the preferred feeding method for most infants, with only certain conditions excluded (see table page 14). The AAP recommendation is for an exclusive diet of breast milk until 6 months of age and continued breast feeding until at least 12 months of age.1 Healthy People 2020 also has included goals to increase breastfeeding rates in the United States from baseline values collected in 1998. New goals include increasing breastfeeding during the early postpartum period from 64 percent to 75 percent, 6-month-old feeding from 29 percent to 50 percent, and 1-year-old feeding from 16 percent to 25 percent.2 According to the 2011 CDC Breastfeeding Report Card we have made great progress nationally with 74.6 percent of infants have ever been breastfed, 44.3 percent of infants at 6 months continue to be breastfed and at 12 months 23.8 percent are still breastfed. These numbers are strikingly lower in Kentucky, at rates of 57.8 percent, 32.9 percent and 18.6 percent, respectively.3 Pharmacists and other healthcare providers can help promote the prac-

tice of breastfeeding in many ways. Encouraging discussions and information exchanges with other healthcare providers and/or lactating mothers about the use of prescription and non-prescription medications, including herbs and supplements, during lactation may benefit the mother and infant. For the purpose of this article, the term lactating or breastfeeding mothers will include any woman who is producing milk for the purpose of feeding an infant. This article will review and address medications used for common conditions in breastfeeding mothers, resources that may be helpful in determining safety of medications in lactation and factors that affect drug delivery and exposure to the infant. Factors Affecting Mother to Infant Medication Delivery Breast milk is composed of fat and protein suspended in a carbohydrate and mineral solution. Because breast milk is made entirely by the mother, other substances from the mother may also enter her milk. These substances, including medications, may cross into breast milk through active or passive diffusion as

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March 2012 CE-Medications and Breastfeeding

March 2012

well as transcellular diffusion. From a medication therapy standpoint, small molecular weight drugs pass more easily into breast milk than larger drug molecules. Medications with higher binding profiles for milk protein, as opposed to plasma protein, become more concentrated in breast milk than other body fluids. Lipophilic drugs more quickly diffuse into breast milk than water soluble drugs. And, because the pH of breast milk is between 6.35 and 7.65, the more basic a drug is, the greater its ability to concentrate in breast milk. The amount of drug transferred into the milk compared to the amount of drug found in the maternal plasma is called the milk to plasma ratio (M/P ratio). This ratio is used to make clinical judgments regarding the amount of medication that the infant may be exposed to. It is assumed that a medication will not exert an effect on the infant if the fraction of the maternal dose consumed by the infant is 5 percent or less.4 Alteration in maternal factors such as drug clearance or dosage may increase infant drug exposure. Infants may have varied physiologic responses to medications based on the exposure level. Because infants have a larger volume of distribution and a lower fat content, hydrophilic medications may achieve higher blood concentrations in infants than older children or adults. Physiologic changes also affect infant drug exposure as renal excretion patterns and protein binding abilities change from the neonate phase throughout infancy. The Exposure Index (EI) is a measure of infant drug exposure that factors in the M/P ratio and the infant’s drug clearing abilities (EI=(10mL/min/kg x M/P)/Cl). If the infant’s clearance is unknown, the adult’s clearance can be used in the equation. A larger EI equates to an exposure level closer to therapeutic levels. Practical considerations include the medication’s half life and peak plasma levels as well as timing of maternal medication administration relative to infant feeding time.4

level.6 Ratings are assigned as L1-L5 with the designation L1 being the safest and L5 being contraindicated. Dr. Hale also has established the InfantRisk Center which operates a website and helpline (806-3522519, http://infantrisk.org) for medication safety in pregnancy and during breastfeeding. The website also has a forum for questions specifically from health professionals. In addition to print resources, the National Library of Medicine offers a free online database, LactMed (http://toxnet.nlm.nih.gov/cgi-bin/sis/ htmlgen?LACT), with more than 400 peer-reviewed drug records, including alternative medications to consider if selected drugs are contraindicated. Recommendations for drug utilization during lactation are also available free of charge from AAP through their policy statement, “The Transfer of Drugs and Other Chemicals into Human Milk” which is also available at their website (http://aappolicy.aappublications.org/cgi/ content/full/pediatrics;108/3/776).7 Medications for Common Disease States Hypertension

When anti-hypertensive therapy is needed during lactation, options are available in most drug classes. If a diuretic is needed, a low-dose, short-acting thiazide diuretic is preferred. Higher doses, longer durations of action, and other classes of diuretics may suppress lactation or have higher drug levels in the infant. Spironolactone is considered safe for breastfeeding but has very little evidence of safety. Excretion of betablockers into breast milk varies by agent but is generally high. Labetalol and propranolol have the lowest levels of excretion into breast milk and are considered safer for the infant.8,9 Of the calcium channel blockers, nifedipine and verapamil have very little excretion into breast milk and more evidence for use than others in their drug class while bepridil and nicardipine should be avoided.10 Generally angiotensin-converting enzyme inhibitors (ACEIs) with minimal excretion into Resources for Medication Therapy in Lactation breast milk are recommended for neonates. Captopril The gold standard for information about drugs in lactalisted as compatible tion is “Drugs in Pregnancy and Lactation” by Gerald and enalapril are the only ACEIs 7-9 with breastfeeding by the AAP. The American SociBriggs. More than 1,100 drugs are included with entries listing manufacturer safety designations followed ety of Hypertension states that ACEIs can be resumed quickly postpartum in women with proteinuria and diaby a discussion regarding designation accuracy and 5 betes, but does not specify a preferred drug.11 Curan entry summary. Another source, Thomas Hale’s “Medication and Mother’s Milk,” lists pharmacokinetic rently, there is no evidence for the use of angiotensin 8,9 information and assigns drug ratings based on safety II receptor blockers (ARBs) or renin blockers. 13

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March 2012 CE-Medications and Breastfeeding

March 2012 Of the antipsychotics, haloperidol has the most evidence for safety. It has not been associated with infant ADRs when administered as antipsychotic monotherapy. Risperidone and quetiapine also have no reports of infant ADRs when used by nursing mothers, though there is minimal information available regarding quetiapine. Olanzepine has been associated with infant ADRs; however, most of the infants in the study demonstrating this association also had in utero exposure to the drug. Clozapine has been associated with potentially severe infant ADRs including seizures, agranulocytosis and lethargy.15-18

Clonidine should be used with great caution because it achieves high levels in breast milk and suppresses maternal prolactin levels.8,9 Alpha-adrenergic antagonists should be avoided in lactating mothers due to both the lack of evidence and safety recommendations.9 Methyldopa has low breast milk excretion and is considered compatible with breastfeeding.9 Hydralazine enters breast milk in small amounts and is considered compatible with breastfeeding.9 Diabetes Mellitus There is little evidence regarding the safety of oral hyperglycemic use in lactating women. Available information shows low or no excretion of second generation sulfonylureas (glyburide, glipizide) or metformin in breast milk.12,13 Little to no information is available regarding thiazolidinediones or incretin mimetics, although pioglitazone, rosiglitazone, and exenatide are listed as usually compatible with breastfeeding by the AAP. Insulin may be used by breastfeeding mothers, but it is important to note that insulin requirements may be lower and nursing mothers may be more prone to hypoglycemic episodes.14

Benzodiazepines are generally considered safe if used for a short time, intermittently, or in low doses. Shorter half life agents are recommended due to the possibility of accumulation. One review found that alprazolam, clonazepam and lorazepam were not associated with infant ADRs and had low infant exposure levels. Diazepam was associated with lethargy and sedation and had higher levels of exposure.15

Breastfed infants of mothers taking mood stabilizers must be monitored closely. Many mood stabilizing agents either accumulate in high levels in breast milk and the infant and/or cause infant ADRs. Carbamazepine is found in high concentrations in breast milk and infant plasma, but it is rapidly metabolized by the newborn and very few ADRs are reported. There are no reports of infant ADRs with oxcarbazepine. Valproic acid has been associated with infant blood dyscrasias but is only found in low concentrations in the nursing infant. Lithium has high concentrations in breast milk Psychiatric Disorders with infant plasma levels associated with infant cyanoMental health issues affecting breastfeeding women sis, thyroid dysfunction and lethargy. The use of can cover a wide range. Of the available data on se- lamotrigine is controversial. There are no reports of lective serotonin inhibitors (SSRIs), sertraline and par- ADRs in infants but infant drug concentrations can oxetine have the most evidence of safety, the least reach therapeutic levels through breast milk expoincidence of infant adverse drug reactions (ADRs), sure.18 and the lowest infant drug concentrations. Fluoxetine, Anti-infectives which has the greatest accumulation in infants, and citalopram both have been associated with infant ad- As a class, penicillins and cephalosporins are considverse effects such as excessive sleepiness and fussi- ered safe for breastfeeding mothers because they have little excretion into breast milk and few if any reness. Escitalopram and fluvoxamine have not been ported infant ADRs.19,20 Tetracycline antibiotics are associated with adverse effects in infants, but have not recommended, however, if necessary, doxycycline less evidence for safety.15-17 of a short treatment duration is considered the best 14

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March 2012 CE-Medications and Breastfeeding

March 2012

option.19,21 Of the fluoroquinolones, ciprofloxacin is least preferred. Levofloxacin, ofloxacin and norfloxacin have the lowest concentrations.21 Metronidazole in topical form is acceptable; however, prolonged oral use is not recommended.21 In general, the macrolide class of antibiotics is considered safe with little absorption for the infant; however, due to the possible accumulation of clarithromycin and azithromycin in the infant, erythromycin is preferred. Rifampin, vancomycin, gentamycin and clindamycin are all compatible with breastfeeding.19

may be used as a method of contraception as long as the mother is not supplementing more than 5-10 percent of feedings, has not resumed menses, and the child is less than 6 months old. Other non-hormonal methods of contraception include copper intrauterine devices and barrier methods, such as condoms and diaphragms.26,27

If hormonal contraception is desired, progestin-only oral contraceptives and implants have no ADRs on the infant or on milk production and can be used as early as 6 weeks postpartum. Combined estrogenThe preferred azole antifungal is itraconazole. Ketoprogestin contraceptives may decrease milk supply conazole is also acceptable, but use may be limited due to drug interactions. Fluconazole may be used and should be started in lactating women no earlier but there are concerns for liver damage and also drug than 6 weeks postpartum and only after lactation is interactions. Terbenafine and griseofulvin are not rec- well established. Maternal use of combined oral conommended.22 traceptives while breastfeeding may also be associatAcyclovir is the most studied antiviral in lactation and ed with lower infant weight gain.26,27 does pass into breast milk, but has no reports of inGastrointestinal Disturbances fant ADRs. Valacyclovir is rapidly converted to acyclovir and is found in similar concentrations in breast Famotidine is the H2 receptor antagonist with the 23 milk as acyclovir. Zanamavir has smaller drug con- least amount of drug found in the nursing infant and centrations in breast milk compared to oseltamivir. the fewest ADRs. Cimetidine and ranitidine reach Amantadine and rimantadine do pass into breast milk, higher drug levels in the infant, and nizatidine causes but there is little information on the use of these drugs the most ADRs.29,30 Proton-pump inhibitors have very in lactation.22 few studies of safety in lactating mothers or breastfed Analgesia infants. Omeprazole and pantoprazole have very low levels passing to the infant and pantoprazole has not Acetaminophen, morphine, and fentanyl are consid30 ered safe for breastfeeding. Ibuprofen and diclofenac been associated with any ADRs in infant follow-up. have undetectable levels in breast milk, and therefore Use of bismuth subsalicylate should be avoided due should also be safe.20,24 Piroxicam has extremely low to the salicylate component and potential for Reye’s levels in breast milk, but should be used intermittently syndrome and blood dyscrasias.28 Antacids containdue to its long half life and potential for accumulaing aluminum and magnesium have not been assocition.24 In case reports, naproxen was associated with ated with infant ADRs.29 a case of an infant gastrointestinal bleed, anemia, nausea and vomiting and indomethacin was shown to Bulk-forming laxatives are the preferred laxative due to poor oral absorption. Senna and docusate have have a weak association with infant seizures.20,24,25 low drug levels detected in the infant and senna has Codeine is safe for nursing mothers in doses of less not been associated with infant ADRs.23 than 240 mg daily. Meperidine should be used cautiously due to drug accumulation and reports of neuDrugs to Avoid rologic depression.20 Aspirin should be avoided in nursing mothers as it does pass through breast milk, Because lactating women traditionally have been exis absorbed by the infant and may cause bleeding cluded from drug trials, many drugs are of unknown 25 problems and Reye’s syndrome. safety. The AAP recommends that drugs of abuse, cyclophosphamide, cyclosporine, methotrexate, and Contraception doxorubicin be contraindicated in breastfeeding; addiThe use of non-hormonal methods of contraception tionally, nursing mothers should temporarily discontinare preferred while breastfeeding. Breastfeeding itself ue breastfeeding while receiving radioactive drugs.7 15

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March 2012 CE-Medications and Breastfeeding

March 2012

5. Briggs GG. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk . 8 t h ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2009. 6. Hale, TW. Medication and Mother’s Milk: A Manual of Lactational Pharmacology. 14th ed. Amarillo, TX: Hale Publishing; 2010. 7. American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics 2001 Sep;108(3):776-89. 8. Ellsworth A. Pharmacotherapy of hypertension while breastfeeding. J Hum Lact 1994;10(2):121-4. 9. Ghanem FA, Movahed A. Use of antihypertensive drugs during pregnancy and lactation. Cardiovasc Ther 2008;26(1):38-49. 10. Shannon ME, Malecha SE, Cha AJ. Calcium channel Conclusion antagonists and lactation: an update. J Hum Lact There are many drugs available to treat common con2000;16(1):60-4. 11. Lindheimer MD, Taler SJ, Cunningham FG. ASH Posiditions found in women of childbearing age that are tion Paper: Hypertension in Pregnancy. J Clin Hypersafe for the nursing mother and infant. Even with the tens 2008;11: 214–225. lack of sufficient clinical data to determine a drug’s 12. Feig DS, Briggs GG, Koren G. Oral antidiabetic agents in pregnancy and lactation: a paradigm shift? Ann safety, there are ways to make an appropriate and Pharmacother 2007;41(7):1174-80. well-informed recommendation. When evaluating a 13. Benz J. Antidiabetic agents and lactation. J Hum Lact drug’s safety for the infant, consider pharmacokinetic 1992;8(1):27-8. factors and drug properties as well as physiologic fac- 14. Riviello C, Mello G, Jovanovic LG. Breastfeeding and the basal insulin requirement in type 1 diabetic women. tors including the infant’s age and feeding patterns. Endocr Pract 2009;15(3):187-93. Avoid the recommendation of known drugs that 15. Malone K, Papagni K, Ramini S, Keltner N. Antideprescause ADRs in the infant and those likely to cause sants, antipsychotics, benzodiazepines, and the breastfeeding dyad. Perspectives in Psychiatric Care ADRs, such as radioactive, cytotoxic, and some im2004;40(2):73-85. munomodulating drugs as well as drugs of abuse. 16. Kendall-Tackett K, Hale TW. Review: The use of antiAppraisal of new information and literature regarding depressants in pregnant and breastfeeding women: a review of recent studies. J Human Lact 2010;26:187lactation and infant ADRs can help direct informed 195. drug therapy recommendations for nursing mothers. 17. Gentile S, Rossi A, Bellantuono C. SSRIs during Pharmacists, as drug experts, are in a unique posibreastfeeding: spotlight on milk-to-plasma ratio. Arch Womens Ment Health 2007;10: 39-51. tion to guide and influence appropriate selection and 18. Gentile S. Prophylactic treatment of bipolar disorder in the use of medications in the nursing mother. pregnancy and breastfeeding: focus on emerging mood stabilizers. Bipolar Disord 2006;8:207-220. References: 19. Nahum GG, Uhl K, Kennedy DL. Antiobiotic use in 1. American Academy of Pediatrics: Section on Breastpregnancy and lactation. What is and is not known feeding. Breastfeeding and the Use of Human Milk. about teratogenic and toxic risks. Obstet Gynecol Pediatrics 2005; 115(2): 496 – 506. 2006;107:1120-38) 2. US Department of Health and Human Services. 20. Bar-Oz B, Bulkowstein M, Benyamini L, et al. Use of Healthy People 2020. Washington, DC: US Departantibiotic and analgesic drugs during lactation. Drug ment of Health and Human Services, Public Health Safety 2003; 26(13): 925-35. Service, Office of the Assistant Secretary for Health; 21. Chin KG, McPherson CE 3rd, Hoffman M, et al. Use of 2010. anti-infective agents during lactation: Part 2-3. Breastfeeding report card – United States, Aminoglycosides, macrolides, quinolones, sulfona2011. Department of Health and Human Sermides, trimethoprim, tetracyclines, chloramphenicol, vices, Centers for Disease Control and Prevenclindamycin, and metronidazole. J Hum Lact 2001;17 tion. (1):54-65. http://www.cdc.gov/breastfeeding/ 22. Mactal-Haaf C, Hoffman M, Kuchta A. Use of antipdf/2011BreastfeedingReportCard.pdf . infective agents during lactation, Part 3: Antivirals, antiAccessed 2/6/2012. fungals, and urinary antiseptics. J Hum Lact 2001;17 4. Bailey B, Ito S. Breast -Feeding and Maternal (1):160 Drug Use. 1997;44(1):41 -54. 23. Sheffield JS, Fish DN, Hollier LM, et al. Acyclovir con-

Due to concerns of long-term suppression of the immune system and infant drug accumulation, most immunomodulating drugs should be used with caution in nursing mothers even if there are no immediate concerns for infant ADRs.25,31 Amiodarone should be used with caution and close infant monitoring, due to the variable excretion in breast milk (up to 50 percent of maternal dose) and possibility of thyroid dysfunction development. Ergotamines should be used with extreme caution as this class has been associated with infant diarrhea, vomiting and convulsions.32

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March 2012 CE-Medications and Breastfeeding

24. 25.

26. 27. 28.

centrations in human breast milk after valacyclovir administration. Am J Obstet Gynecol 2002;186(1):100102. Spigset O, Hagg S. Analgesics and breast-feeding, safety considerations. Paediatr Drugs 2000;2(3):223238 Janssen NM, Genta MS. The effects of immunosuppressive and anti-inflammatory medications on fertility, pregnancy, and lactation. Arch Intern Med 2000;160:610-19. King J. Contraception and lactation. J Midwifery Womens Health 2007:52(6); 614-620. Guthmann RA, Bang J, Nashelsky J. Combined oral contraceptives for mothers who are breastfeeding. Am Fam Physician 2005 Oct 1;72(7):1303-4. Hagemann TN. Gastrointestinal medications and

March 2012 breastfeeding. J Hum Lact 1998:14(3);259-262. 29. Broussard CN, Richter JE. Treating gastrooesophageal reflux disease during pregnancy and lactation. What are the safest therapy options? Drug Safety 1998 :19(4);325-337. 30. Nava-Ocampo AA, Velazquez-Armenta EY, Han JY, Koren G. Use of proton pump inhibitors during pregnancy and breastfeeding. Can Fam Physician 2006:52;853-854. 31. Gisbert JP. Safety of Immunomodulators and biologics for the treatment of inflammatory bowel disease during pregnancy and breast-feeding. Inflamm Bowel Dis 2010;16(5): 881-95. 32. Moretti ME, Lee A, Ito S. Which drugs are contraindicated during breastfeeding? Practice Guidelines. Can Fam Physician 2000:46;1753-57.

March 2012 — Medications and Breastfeeding: Evaluating Safety and Selection in Common Conditions 1. What condition is contraindicated for breastfeeding accord- C. She should stop breastfeeding while using clonazepam. ing to the AAP? D. None of the above A. B. C. D.

Oral Herpes Simplex Lesions Treated latent tuberculosis Well controlled, treated HIV All of the above

2. What factors affect the amount of drug that an infant is exposed to?

A. Infant age B. C. D. E.

Drug molecule size Milk to plasma ratio Drug half-life All of the above

3. In a nursing mother with diabetes, what would be a safe regimen for her treatment (assuming the following regimens have no contraindications for her and would bring her condition under control)? A. B. C. D.

Metformin Insulin Glyburide All of the above

4. Which mood stabilizers has the least incidence of adverse effects on the infant? A. Lithium B. Valproic Acid C. Oxcarbazepine 5. A mother presents with a prescription for sertraline daily and clonazepam as needed. She is concerned about nursing her child while on these medications. You counsel her that:

6. Another healthcare provider asks you if penicillin is safe to give a nursing mother diagnosed with strep throat. You answer: A. Yes B. No 7. What medication(s) should be avoided in nursing mothers? A. B. C. D.

Aspirin Ibuprofen Morphine All of the above

8. Which method of birth control is preferred in lactating women seeking contraception? A. Combined oral contraceptives B. Progesterone only contraceptives C. Non-hormonal methods 9. A nursing mother would like an over the counter medicine for occasional heartburn. Which of the following would you advise her to avoid? A. B. C. D.

Famotidine (Pepcid) Omeprazole (Prilosec) Bismuth Subsalicylate (Pepto-Bismol) Cimetidine (Tagamet)

10. A nursing mother tells you she occasionally uses cocaine and was told she should stop breastfeeding because of this. This is:

A. True B. False A. They are totally safe. Her baby will be fine. B. She should use the clonazepam only when needed to avoid drug accumulation in the infant, and the sertraline is not known to have negative effects on the baby. 17

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March 2012 CE-Medications and Breastfeeding

March 2012

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601. Expiration Date: March 1, 2015 Successful Completion: Score of 80 percent will result in 1.0 contact hours or 0.10 CEUs. Participants who score less than 80 percent will be notified and permitted one re-examination. March 2012 — Medications and Breastfeeding: Evaluating Safety and Selection in Common Conditions TECHNICIANS ANSWER SHEET. Not ACPE approved for Technicians. Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D E

3. A B C D 4. A B C

5. A B C D 6. A B

7. A B C D 8. A B C

9. A B C D 10.A B

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP #_________________________________ Birthdate ____________________(MM/DD)__ March 2012 — Medications and Breastfeeding: Evaluating Safety and Selection in Common Conditions Universal Activity # 0143-9999-12-003-H05-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D E

3. A B C D 4. A B C

5. A B C D 6. A B

7. A B C D 8. A B C

9. A B C D 10.A B

Information presented in the activity: Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No Unmet Objectives:______________________________________________________________________________ I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP #_________________________________ Birthdate _____________________(MM/DD)__

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

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CPE Monitor

March 2012

Attention all Pharmacists and Pharmacy Technicians!!!! KPERF will be transitioning to CPE Monitor in 2012 for all ACPE accredited CE programs. You MUST sign up for a NABP e-Profile ID to receive CE credit from KPhA or any other ACPE Provider. Visit www.kphanet.org/CPEMonitor for more. Watch for Member Updates from your Kentucky Pharmacists Association!

CPE Monitor: Information for Pharmacists and Pharmacy Technicians What is CPE Monitor? CPE MonitorTM is a national, collaborative effort by the Accreditation Council for Pharmacy Education (ACPE) and the National Association of Boards of Pharmacy (NABP) to provide an electronic system for pharmacists and pharmacy technicians to track their completed continuing pharmacy education (CPE) credits. It will also offer boards of pharmacy the opportunity to electronically authenticate the CPE units completed by their licensees, rather than requiring pharmacists and pharmacy technicians to submit their proof of completion statements (i.e. statements of credit) upon request or for random audits. How CPE Monitor Works Pharmacists and pharmacy technicians will receive a unique identification number (ID), known as the NABP e-Profile ID, after setting up their e-Profile with NABP (see How to Register for CPE Monitor). Many ACPE-accredited CPE providers are now requiring pharmacist and pharmacy technician participants to provide their NABP e-Profile ID and date of birth (DOB in MMDD format) to the ACPE-accredited provider when they register for a CPE activity or submit a request for credit. It will be the responsibility of the pharmacist or pharmacy technician to provide the correct information [i.e. ID and DOB (in MMDD format)] in order to receive credit for participating in a CPE activity. The CPE Monitor system will direct electronic data from ACPE-accredited providers to ACPE and then to NABP, ensuring that CPE credit is officially verified by the providers. Once information is received by NABP, pharmacists and pharmacy technicians will be able to log in to access information about their completed CPE activities. How to Register for CPE Monitor Pharmacists and pharmacy technicians are asked to obtain their NABP e-Profile ID now at www.MyCPEmonitor.net to ensure their e-Profile is properly setup prior to implementation of CPE Monitor. As ACPE-accredited providers begin transitioning their systems to CPE Monitor throughout 2012, the eProfile ID and DOB in MMDD format will be required by those providers to receive credit for any ACPEaccredited CPE activities. By the end of 2012, all ACPE-accredited CPE providers will require the e-Profile ID and the DOB in MMDD format to receive CPE credit. NABP Customer Service custserv@nabp.net Tel: 847-391-4406 Fax: 847-391-4502 Hours: Monday - Friday, 9 AM to 5 PM central time

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Pharmacy Law Brief

March 2012

Pharmacy Law Brief: Class Action Lawsuits Author:

Joseph L. Fink III, B.S.Pharm., J.D., Professor of Pharmacy Law and Policy Department of Pharmacy Practice and Science, UK College of Pharmacy

Question: From time to time, I’ve heard references in the media to “class-action lawsuits.” Sometimes they even involve a group of pharmacies or pharmacists joining together to maintain a lawsuit to correct some perceived wrong. Then recently I got a mailing about such a lawsuit giving me the option of participating in a settlement or opting out of that. Can you shed some light on that? Response: A class action lawsuit is filed by a single individual, often referred to as the “named plaintiff”, who claims to represent not only his own interests in the suit, but also the interests of all others who are similarly situated with regard to the alleged cause of the legal damages. The named plaintiff is advancing the lawsuit on behalf of the entire class of potential plaintiffs, hence the designation “class action.” The named plaintiff launches the lawsuit by alleging in the initial filings with the court that a class of plaintiffs exists. The burden of establishing that a class action approach to adjudicating the claim is appropriate falls on the named plaintiff. If the judge is convinced that this is indeed the best way to handle this, the judge will “certify” the matter to proceed as a class action. In determining whether a class action approach is appropriate, the judge looks at whether all members of the class have enough in common with regard to the alleged wrongdoing that proceeding as a class action makes sense for all involved – the parties on both sides of the case as well as the court. Will proceeding this way be fundamentally fair for both parties? Is proceeding in this fashion an efficient use of court resources? Will the named plaintiff be an effective representative of the members of the class? Is there really a common or shared core of facts among the class members and are the legal issues the same for all class members? Class action lawsuits can be found in both federal and state courts. This procedural or administrative mechanism allows the consolidation of claims having a common core set of facts based on an undergirding allegation that the defendant committed an action for which a legal remedy exists, such as breaching an agreement. One element of interest is that the members of the class must be notified of any proposed settlement of the lawsuit and be given an opportunity to opt out of the agreement. That would preserve the option for that individual to maintain his or her own lawsuit regarding the matter. A Kentucky example of a class action lawsuit was decided during 2010. In this class action lawsuit decided in U.S. District Court it was established that Pikeville Medical Center unlawfully billed for copies of medical records that should have been provided for free [Carter, et al v. Pikeville Medical Center, Inc., et al., 2010 U.S. Dist. LEXIS 116177 (E.D. Ky. Nov. 1, 2010)]. The amount of damages for which recovery is sought in a class action suit can be quite substantial because the damages are being aggregated from a number of alleged wrongs that were similar in nature. The class action mechanism for pursuing perceived wrongs works best where a large number of people have had a similar or even identical experience in a given type of transaction. Disclaimer: The information in this column is intended for educational use and to stimulate professional discussion among colleagues. It should not be construed as legal advice. There is no way such a brief discussion of an issue or topic for educational or discussion purposes can adequately and fully address the multifaceted and often complex issues that arise in the course of professional practice. It is always the best advice for a pharmacist to seek counsel from an attorney who can become thoroughly familiar with the intricacies of a specific situation, and render advice in accordance with the full information.

Submit Questions: jfink@uky.edu

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KPPAC Contribution Form

March 2012

KPPAC Contribution

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

CONTRIBUTION LIMITS The primary, runoff primary and general elections are separate elections. The maximum contribution from a PAC to a candidate or slate of candidates is $1,000 per election. Contributions from a PAC to a school board candidate are limited to $200 per election. Individuals may contribute no more than $1,500 per year to all PACs in the aggregate. In-kind contributions are subject to the same limits as monetary contributions. Cash Contributions: $50 per contributor, per election. Contributions by cashier’s check or money order are limited to $50 per election unless the instrument identifies the payor and payee. KRS 121.150(4) Anonymous Contributions: $50 per contributor, per election, maximum total of $1,000 per election. (This information is in accordance with KRS 121. 150)

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

The Kentucky Renaissance Pharmacy Museum offers several ways way to show support of the Museum, our state's leading preservation organization for pharmacy. While contributions of any size are greatly appreciated, the following levels of annual giving have been established for your consideration. Friend of the Museum $100  Proctor Society $250 Damien Society $500 Galen Society $1,000 Name_________________________________ Specify gift amount________________________ Address ______________________________ City____________________Zip______________ Phone H_______________W____________ Email___________________________________ Employer name_____________________________________________for possible matching gift Tributes in honor or memory of_____________________________________________________ Mail to: Kentucky Renaissance Pharmacy Museum, P.O.Box 910502, Lexington, KY 40591-0502 The Kentucky Renaissance Pharmacy Museum is a non-profit 501(c)(3) business entity and as such donations are tax deductible. A notice of your tax deductible contributions will be mailed to you annually. Questions: Contact Lynn Harrelson @ 502-425-8642 or Lharrelsonky@aol.com

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KPhA Membership

March 2012

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April 2012 CE—Theory and Practice of Compounding Otic Preparations KPERF offers all CE articles to members online at www.kphanet.org

March 2012

Theory and Practice of Compounding Otic Preparations

By: Y. Pramar, Ph.D., Professor of Pharmaceutics Xavier University of Louisiana, College of Pharmacy, New Orleans, Louisiana Reprinted with permission of the author and the Louisiana Pharmacists Association where this article originally appeared. This activity may appear in other state pharmacy association journals. There are no financial relationships that could be perceived as real or apparent conflicts of interest. Universal Activity # 0143-9999-12-004-H04-P 1.5 Credit Hours (0.15 CEUs) Goals: The goals of this article are to provide basic information on the anatomy, physiology and common disorders of the ear and discuss examples of compounded drugs and dosage forms used in their treatment.

ing a variety of topical dermatological preparations. Anatomy and Physiology of the Ear

The external ear is made up of the pinna (auricle) and the external auditory canal. Terminating the end of the external auditory canal is the tympanic membrane, which forms the beginning of the middle ear. The auriObjectives: After reading and studying the article, the cle consists of a thin layer of highly vascular skin firmly attached to cartilage. There is generally no fatty tisreader will be able to: sue or subcutaneous tissue in the auricle, except for 1. Describe the anatomy and physiology of the ear. the ear lobe, which is composed primarily of fatty tissue with fewer blood vessels than the rest of the auri2. Exhibit an understanding of common otic disorcle. ders. Starting from the exterior and moving along into the external auditory canal, the first one-third to one-half in treating otic disorders. is the outer cartilaginous portion, followed by the inner 4. Exhibit an understanding of the physicochemical body or osseous portion. The end of the ear canal considerations in developing otic preparations. ends in a cul-de-sac. The external auditory canal of 5. Counsel a patient on the proper use of otic prepa- adults tends to be “S” shaped and that of children tends to be shorter and straighter. rations.

3. List common drugs and their dosage forms used

Introduction Otic disorders are usually treated with medications applied locally. Administration of medications to the ear involves placing a liquid in the ear and inserting a cotton plug to keep the medication from draining out. Ear irrigants are another common class of otic preparations that are used to clean debris from the ear. Otic (aural) preparations may consist of solutions, suspensions, ointments, gels, and powders. Liquid ear preparations are usually placed in the ear canal drop-wise for the removal of excessive cerumen (ear wax) or for the treatment of ear infections, inflammation, or pain. Since the outer ear is a skin-covered structure, skin conditions which arise are treated us-

The auricle is susceptible to bleeding when scratched because it is more rigid and lacks the flexibility normally provided by a subcutaneous layer of fat. The auricle area contains many nerves which can cause enhanced pain sensations when inflamed. Moving further into the external auditory canal, the skin becomes thicker and contains both apocrine and exocrine glands along with hair follicles. The skin lining the external auditory canal is continuous with that forming the tympanic membrane outer layer. Cerumen is produced as a part of the body’s normal defense mechanisms. Cerumen is formed when the oily secretions from the exocrine gland mixes with the milky, fatty fluid from the apocrine glands. The cerumen serves to lubricate the canal and entrap dust and foreign materials; it also provides a waxy, water-proof

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April 2012 CE—Theory and Practice of Compounding Otic Preparations barrier to the entry of pathogens. Under normal conditions, bacterial growth is inhibited because the cerumen contains lysozymes and has an acidic pH. Normal skin growth results in a continuous shedding of the external layer, including the skin in the ear canal. The shed skin cells are continuously mixed with the cerumen. This mixture normally moves outward to the external opening of the ear when the jaw moves, such as while talking or chewing. The ear canal is usually self-cleaning. The cerumen may progress from an oily and paste-like appearance to that of being dry and flaky. The color ranges from light gray to orange or brown and may darken upon exposure to air. Common Otic Disorders Under certain circumstances, such as when moisture accumulates, the external auditory canal can form a dark, moist, warm environment that is ideal for bacterial growth. The protective layer of the skin can be challenged and traumatized by fingernails, cottontipped swabs, hair pins or any other object inserted into the ear in attempts to clean it. Once the integrity of the skin is penetrated, pathogenic organisms can enter and initiate an infection. Other injuries can result from burns, sporting accidents, ear piercing and improperly fitted ear molds or hearing aids. Ear complaints affect patients of all ages and range from simple, including excessive ear wax, to more complex disorders, including very painful ear infections. Impacted Cerumen Ear wax impaction may be experienced by up to about 6 percent of the general population; this is one of the most common ear problems presented to physicians. Some individuals are more prone to impacted cerumen, especially those with narrow or mis-shaped ear canals and those with excessive hair growth in the canal. Others with a greater than average tendency for impacted cerumen are those with overactive glands, those wearing hearing aids, as well as those using ear plugs to prevent water from entering the ear and to muffle loud noises. If cerumen is prevented from its natural migration outward to the opening of the ear canal, it may build up and dry out, forming a plug. As cerumen becomes dry, it is more difficult to remove from the ear. Impacted cerumen buildup is experienced by the patient as a sense of fullness or pressure within the ear, sometimes associated with a dull pain. It is obvious from this discussion that any object placed in the ear may tend to compress the cerumen and alter its normal outward flow within the ear. In fact, cotton-tipped swabs can result in pushing the

March 2012

cerumen back deeper into the ear. There are a number of methods of breaking up the cerumen and aiding its removal from the ear, including preparations containing hydrogen peroxide, glycerin, carbamide peroxide and olive oil. The carbamide peroxide and hydrogen peroxide create a mechanical “bubbling” action that can serve to soften and break up dried cerumen and move the pieces of ear wax toward the outer portion of the ear canal; they also have anti-infective properties. Glycerin is hygroscopic and can absorb moisture from the environment and soften the cerumen. The olive oil partially dissolves the cerumen and acts as a softening agent, allowing its easy removal. These liquids are viscous and will tend to stay within the ear canal if a small piece of cotton is placed at the entrance to the ear. Water-Clogged Ears If cerumen builds up in an ear and the ear is exposed to water, as when one takes a shower or swims, water may get behind the cerumen in contact with the tympanic membrane. The presence of this moisture may result in maceration of the skin lining the ear and the tympanic membrane, contributing to inflammation and infection of the external auditory canal, a condition known as swimmer’s ear. This situation can also result from excessive sweating in humid environments, as well as from the improper use of aqueous products to clean the ear. Symptoms of water-clogged ears include a feeling of fullness and wetness of the ear; this may be accompanied by some gradual loss of hearing. As the condition progresses, it can result in tissue maceration, leading to itching, pain, inflammation and/or infection. Preparations used to treat water-clogged ears include iso-propyl alcohol, glycerin, boric acid, hydrocortisone, ethyl alcohol and acetic acid. Infections can also be treated with otic drops containing a mixture of aminoglycoside antibiotics and anti-inflammatory corticosteroids in an acidic vehicle (neomycin sulfate, polymyxin B sulfate and hydrocortisone). The alcohols aid in reducing surface tension and mix with the water, thus facilitating its removal through the ear canal. The glycerin also aids in absorbing the water. Acetic acid reduces the pH in the ear canal which minimizes bacterial growth. Hydrocortisone assists in reducing inflammation, and the antibiotics help reduce infection. Disorders of the Skin in the Ear Disorders of the skin in the ear can include contact dermatitis, seborrhea, psoriasis and boils. Contact

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April 2012 CE—Theory and Practice of Compounding Otic Preparations dermatitis may result from either an allergy or an irritant and may present as maculopapular rash and vesicles. The rash may be associated with pruritis, erythema and edema. Mild irritants such as soaps and detergents can cause an inflammatory response similar to allergic contact dermatitis. Contact dermatitis can be treated with a 2.5 percent aluminum acetate solution that has antipruritic, anti-inflammatory and some antibacterial properties. This astringent precipitates proteins and dries the affected area. It can also reduce the pH of the area, which can inhibit bacterial and fungal growth. Seborrhea affecting the ear presents with visible drying and flaking of the skin, with or without fissuring of the skin. The associated itching can be treated with topical hydrocortisone-containing preparations.

March 2012

water out of the inflamed sites and into the vehicle. This in turn helps to relieve pain associated with the swelling. These vehicles similarly deprive microorganisms of moisture, thus decreasing microbial growth. These preparations are commonly employed to relieve the symptoms of acute otitis media. Drugs used in treating otic disorders Categories of medications commonly used in the ear include local anesthetics, cleansing agents (peroxides), anti-infectives, and antifungals. Also included are liquids for cleaning and/or drying out the external ear and for removing any fluids that may be entrapped by a local waxy buildup.

Anti-infective agents include drugs such as chloramphenicol, ciprofloxacin, colistin sulfate, gentamicin sulfate, neomycin and polymyxin B sulfate. For fungal Psoriatic lesions present as thickened, erythematous, infections, nystatin, ketoconazole, amphotericin and silvery scales that occur most frequently on the clotrimazole are used. These agents are formulated knees, elbows, torso and scalp, including the ear. into ear drops (solutions or suspensions) in a vehicle These can be treated with routine medications used of anhydrous glycerin or propylene glycol. These visto treat psoriasis, as well as hydrocortisonecous vehicles permit maximum contact time between containing preparations for the discomfort. the medication and the tissues of the ear. In addition, Localized infections of hair follicles can result in boils their hygroscopicity causes them to draw moisture or furuncles. The causative organism often is a from the tissues thereby reducing inflammation and Staphylococcus species. The boil generally begins as diminishing the moisture available for the life process a red papule and develops into a superficial pustule of the microorganisms present. To assist in relieving with a core of pus and a reddened area around the the pain which frequently accompanies ear infections, base. The lesion slowly enlarges and becomes firm a number of anti-infective otic preparations also conbefore softening and opening in a couple of weeks, tain analgesic agents such as antipyrine and local andischarging its contents. Pain can be caused by the esthetics such as lidocaine, dibucaine, and benzoswelling and the tight skin. Generally, boils are selfcaine. limiting. Treatment can include warm compresses and Dosage forms used in treating otic disorders topical antibiotics. Otic preparations can be in liquid, ointment, gel or In the event of excessively dry skin in the ear canal, powder dosage forms. The liquid dosage forms, i.e. mineral oil or olive oil may help counteract dryness otic solutions and suspension, are intended to be inand repel moisture. stilled into the ear. Solutions are also used for irrigating the ear. Otic irrigating solutions may consist of Ear Pain surfactants, weak sodium bicarbonate, boric acid (0.5 Pain in the ear frequently accompanies ear infection - 1 percent), or aluminum acetate solutions. These or inflamed or swollen ear tissue. The pain is often solutions may be warmed to 370C before instillation out of proportion to the actual condition. Because the into the ear. These irrigating solutions may be used to ear canal is so narrow, even a slight inflammation can remove ear wax, purulent discharges of infection, and cause intense pain and discomfort for the patient. foreign bodies from the ear canal. Topical analgesic agents are generally employed together with internally administered analgesics, such Otic suspensions can be used when sustained drug as aspirin, and other agents, such as anti-infectives to action is desired, or when the drug is not soluble in combat the cause of the problem. the vehicles commonly used in otic preparations. Pharmacists should be aware that there may be subTopical analgesics for the ear are usually solutions stantial differences in the formulation of some otic and frequently contain the analgesic antipyrine and suspensions that could be potentially bothersome to the local anesthetic benzocaine in a vehicle of propylthe patient. This is particularly true with regard to the ene glycol or anhydrous glycerin. The hygroscopic inactive or inert ingredient differences between formuvehicles reduce the swelling of tissues by drawing

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March 2012

FORMULATIONS FOR TREATING OTIC DISORDERS Removal of cerumen Urea and Hydrogen Peroxide Otic Solution Rx Carbamide Urea 6.5 g Glycerin, qs 100 mL Dissolve the carbamide urea in sufficient glycerin to volume, package and label. A beyond-use date of up to six months can be used for this preparation. Treatment of water-clogged ears Boric Acid 2 percent in Isopropyl Alcohol Rx Boric Acid 2g Isopropyl alcohol 70 percent, qs 100 mL Dissolve the boric acid in sufficient isopropyl alcohol 70 percent to volume, package and label. A beyond-use date of up to six months can be used for this preparation. Skin disorders of the ear 1. Aluminum Acetate Otic Solution Rx Aluminum subacetate topical solution 54.4 mL Glacial acetic acid 1.5 mL Purified water, qs 100 mL Slowly, and with stirring, add the glacial acetic acid to the aluminum subacetate topical solution. Add sufficient purified water to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. 2. Hydrocortisone and Acetic Acid Otic Solution Rx Hydrocortisone 1g Glacial acetic acid 2 mL Propylene glycol, qs 100 mL Add the hydrocortisone and glacial acetic acid to sufficient propylene glycol to volume and mix well. The hydrocortisone will slowly dissolve. Gentle heat can be used if required. Package and label. A beyond-use date of up to six months can be used for this preparation. 3. Acetic Acid and Glycerin Otic Solution Rx Glacial acetic acid 0.5 mL Glycerin 20 mL Purified water, qs 100 mL Mix the glacial acetic acid and glycerin. Add sufficient purified water to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. 4. Ciprofloxacin 1 percent Otic Drops Rx Ciprofloxacin 1g Propylene glycol 50 mL Glycerin, qs 100 mL Pulverize sufficient ciprofloxacin tablets to a very fine powder (or use ciprofloxacin hydrochloride USP mono-

lations from various manufacturers which are considered equivalent on the basis of the active ingredient (s) and strength. For example, several suspension combinations of polymyxin B sulfate, neomycin sulfate and hydrocortisone have been shown to be more

hydrate powder). Add the propylene glycol slowly and mix well. Add sufficient glycerin to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. 5. Gentamicin Sulfate 0.1 percent Otic Solution Rx Gentamicin sulfate 100 mg (equivalent activity) Glycerin, qs 100 mL Add the gentamicin sulfate to sufficient glycerin to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. 6. Nystatin 100,000 units/mL Otic Suspension Rx Nystatin 10,000,000 units Propylene glycol 25 mL Glycerin, qs 100 mL Add the nystatin to the propylene glycol and mix well. Add sufficient glycerin to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. 7. Neomycin Sulfate, Polymyxin B Sulfate, Triamcinolone and Nystatin Otic Suspension Rx Neomycin Sulfate 350 mg Polymyxin B Sulfate 1,000,000 units Triamcinolone 100 mg Nystatin 10,000,000 units Propylene glycol, qs 100 mL Blend the powders with sufficient propylene glycol to volume and mix well. Package and label. A beyond-use date of up to 30 days can be used for this preparation. 8. Clotrimazole and Gentamicin Sulfate Otic Liquid Rx Clotrimazole 1g Gentamicin sulfate 300 mg Propylene glycol 300, qs 100 mL Add the clotrimazole and gentamicin sulfate to sufficient polyethylene glycol 300 to volume and mix well. Low heat can be used if needed to effect solution. Package and label. A beyond-use date of up to six months can be used for this preparation. 9. Triamcinolone 0.1 percent Otic Solution Rx Triamcinolone 100 mg Propylene glycol 50 mL Glycerin, qs 100 mL Add the triamcinolone to the propylene glycol. Add sufficient glycerin to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation. Treatment of Ear Pain

acidic, i.e., pH 3.0 to 3.5, compared to some commercial products which posses a higher pH in the range of 4.8 to 5.1. Consequently, there is a risk that a burning, stinging sensation can occur when the drops are introduced into the ear of young children, especially 26

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March 2012

1. Lidocaine Hydrochloride 0.5 percent Otic Solution Rx Lidocaine Hydrochloride 500 mg Glycerin 50 mL Propylene glycol, qs 100 mL Add the lidocaine hydrochloride to the glycerin and sufficient propylene glycol to volume and mix well. Package and label. A beyond-use date of up to six months can be used for this preparation.

3. Antipyrine and Benzocaine Otic Solution Rx Antipyrine 810 mg Benzocaine 210 mg Glycerin, qs 15 mL Add the antipyrine and benzocaine to sufficient glycerin to volume, mix well and allow to sit until all dissolved. Package and label. A beyond-use date of up to six months can be used for this preparation.

2. Tetracaine 30 percent Otic Solution Rx Tetracaine 30 g Propylene glycol, qs 100 mL Add the tetracaine to sufficient propylene glycol to volume and mix well. Package and label. A beyond-use date of up to 30 days can be used for this preparation.

Note: As an option, 0.25 percent phenylephrine hydrochloride can be added to this preparation. A beyond-use date of only 14 days can be used for this modified formulation, when stored in the refrigerator.

those with tympanostomies.

ic, some fluid may be withdrawn from the ear, thereby releasing some of the pressure. If the product is hypotonic, however, some fluid may flow into the area.

Otic ointments and gels are semisolid preparations that are applied to the exterior of the ear. Any ointment base can be used in their preparation. They Because many ear conditions are related to the diffimay include antibacterial, antifungal, or corticosteroid culty in cleaning the ear, the presence of a surfactant in the preparation helps the medication diffuse ingredients. throughout the ear, and aids in emulsifying and Insufflations are preparations made of finely divided breaking up ear wax. This action makes it easier to powders that are administered to the ear canal. Insufremove any foreign material. flating a powder into the ear canal is not too common because the ear lacks fluids and a powder-wax Many otic preparations are self-preserving because of buildup may occur. Fine powders used as insufflathe high concentration of solvents such as glycerin tions may contain an antibacterial and/or an antifunand propylene glycol. If these agents are not present, gal that will create a repository for the drug. A small it may be wise to add a preservative to minimize the rubber or plastic bulb insufflator (powder blower, puff- chance of introducing bacteria that might grow in an er) can be used to blow, or insufflate, the powder into unpreserved product. As determined on an individual the ear. product basis, some liquid otic preparations require preservation against microbial growth. When preserPhysicochemical Considerations vation is required, agents such as chlorobutanol (0.5 Physicochemical considerations in developing otic percent), thimerosal (0.01 percent), and combinations preparations include solubility, viscosity, tonicity, sur- of the parabens are commonly used. Antioxidants, factant properties and inclusion of preservatives. Alt- such as sodium bisulfite, and other stabilizers are alhough sterility is not generally a consideration, the so included in otic formulations, as required. Ear products need to be “clean.” preparations are usually packaged in small (5 to 15 mL) glass or plastic containers with a dropper. Many drugs are soluble in the vehicles commonly used in these preparations. If a drug is insoluble in these vehicles, the preparation can be formulated as a suspension. Since most of these vehicles are relatively viscous agents, the addition of suspending agents may not be necessary. The viscosity of the preparation is important in keeping the medication in the ear canal. If the preparation is too thin, the medication will drain out of the ear. On the other hand, if the medication is too thick, it may not reach the inner recesses of the ear. Tonicity and hygroscopicity are important in the product’s ability to aid in withdrawing fluids from the immediate area of the ear. If the product is hyperton-

Vehicles Vehicles used most often in otic preparations are glycerin, propylene glycol and the lower molecular weight polyethylene glycols (PEGs), especially PEG 300. These vehicles are viscous and will adhere to the ear canal. Water and alcohol (ethanol and isopropyl) can be used as vehicles and solvents for some medications; however, they are used primarily for irrigation, since one of the therapeutic aims of these preparations is to keep the ear canal dry to minimize bacterial/fungal growth. Alcohol can be used full strength. Vegetable oils, especially olive oil, are also good vehicles. Mineral oil has been used as a vehicle 27

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April 2012 CE—Theory and Practice of Compounding Otic Preparations

March 2012

for some antibiotics and anti-inflammatory medications. Otic ointments primarily contain petrolatum as a vehicle, whereas otic powders may contain talc or lactose as a vehicle.

The pharmacist should make sure the patient or the parent understands that administration is intended for the ear and its frequency of application. To facilitate patient acceptance, the pharmacist should point out that the bottle or container of medication should first Quality Control be warmed in the hands, and if the product is a susThe compounding pharmacist should follow standard pension, shaken well prior to withdrawal into the quality control procedures. These include checking dropper. The pharmacist should also explain the the volume/weight, pH, viscosity, appearance, and need to store the medication in a safe place out of odor of these products. the reach of children and away from extremes of temperature. Packaging, Storage and Labeling When instilled into the ear, the ear lob should be held Otic preparations should be packaged in dropper up and back in order to allow the drops to run in containers, puffers, syringes (without needles) or deeper. For a child, the ear lobe should be held down tubes as deemed appropriate for the product and method of administration. Generally, otic preparations and back. For convenience it is probably easier to have someone other than the patient administer the should be stored at either room or refrigerated temperatures. They should not be frozen. These prepara- drops. tions should be labeled “For the Ear”, “Discard after [appropriate date]”, and “Use only as directed” and “Keep Out of Reach of Children.”

Some ear drops by virtue of their formulation, i.e., low pH, may cause stinging upon administration. Parents and children should be forewarned, especially if a child has tympanostomy tubes in the ear for example. Stability and Beyond-Use Dates for The patient should also be made to understand the Otic Preparations length of time in days that the medication is intended The following beyond-use recommendations can be to be used. For antibiotic ear drops, it is not necesexceeded if there is valid scientific information to sup- sary to finish the entire bottle because therapy could port the stability of the product. last 20 to 30 days, depending upon the dosage regimen. Therefore, patients should be instructed to conBeyond-use dates for water-containing formulations tinue using the drops for 3 days beyond the time ear are no later than 14 days, when stored at cold temsymptoms disappear. Products for swimmer’s ear or peratures, for products prepared from ingredients in solid form. If nonaqueous liquids are prepared using otitis externa may take up to 7 to 10 days to demona manufactured product, the beyond-use recommen- strate efficacy. dation is no later than 25 percent of the time remain- If a child is prone to developing ear infections as a ing on the product’s expiration date or 6 months, result of swimming or showering, it might be advisawhichever is earlier, and 6 months if prepared from ble to recommend that the parents consult a physiingredients with a USP-NF monograph. For all other cian for prophylactic medication to use during swimproducts, the beyond-use recommendation is the in- ming season, and consider using form-fitting ear tended duration of therapy or 30 days, whichever is plugs that fit snugly in the ear when swimming and earlier. showering. Further, after the child emerges from the water or shower, the parents can be advised to use a Proper administration and use of otic drops hair dryer on a low setting to dry out the ear. The dryPatients should be instructed on how to apply drops er should not be positioned too close to the child’s to the ear from dropper bottles. They should also be ear. told to place a cotton or gauze pad in the ear to keep Suggested Readings the liquid from escaping. 1. ‘A practical guide to contemporary pharmacy When ear drops are prescribed, it is important for the practice’ by Judith E. Thompson, Third Edition. pharmacist to first determine how the drops are to be Lippincott, Williams & Wilkins. 2009 used. For example, ear wax removal drops should be instilled and then removed by the patient with an ear 2. ‘Pharmaceutical Dosage Forms and Drug Delivery Systems’ by Howard C. Ansel, Nicholas G. syringe. Alternatively, drops intended to treat external Popovich, and Loyd V. Allen, Jr. Ninth Edition. otitis infection are intended to be instilled and left in Lippincott, Williams & Wilkins. 2011. the ear.

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April 2012 CE—Theory and Practice of Compounding Otic Preparations

March 2012

April 2012 — Theory and Practice of Compounding Otic Preparations 1. Common Otic Disorders include: A. B. C. D.

Impacted cerumen Water-clogged ears Disorders of the skin in the ear All of the above

2. Physicochemical considerations in developing otic preparations include all of the following, EXCEPT: A. B. C. D.

Solubility Sterility Viscosity Surfactant properties

3. Vehicles used most often in otic preparations include all the following, EXCEPT: A. B. C. D.

Glycerin Propylene glycol Simple Syrup Polyethylene glycol 300

6. Which of the following statements concerning the benefits of using glycerin in otic preparations is FALSE? A. Glycerin draws moisture out of inflamed sites. B. Glycerin deprives microorganisms of moisture. C. Glycerin imparts a sweet taste. D. Glycerin itself has antimicrobial properties making the otic preparation self-preserving. 7. Drugs used to relieve pain in the ear include all of the following, EXCEPT: A. B. C. D.

Antipyrine Benzocaine Lidocaine Hydrochloride Ethyl alcohol

8. Identify the FALSE statement about otic preparations from the following:

A. Olive oil should not be used in otic preparations. B. Acetic acid reduces the pH in the ear canal which minimizes bacterial growth. 4. Which of the following is NOT an antimicrobial preserva- C. Hydrocortisone can be used to reduce inflammation. tive used in otic products? D. Aminoglycoside antibiotics such as neomycin sulfate can be used to combat infections in the ear. A. Chlorobutanol B. Methyl and propyl paraben 9. Otic preparations should be labeled with the following, C. Thimerosal EXCEPT: D. Polysorbate 80 A. “Apply medication using a cotton-tipped swab inserted 5. Water-clogged ears can be treated with preparations into the ear” containing the following, EXCEPT: B. “For the Ear” C. “Use only as directed” A. Glycerin D. “Keep Out of Reach of Children” B. Iso-propyl alcohol C. Acetic acid 10. Typical anti-fungals used to treat otic infections include D. Water all of the following, EXCEPT: A. B. C. D.

Nystatin Sodium bisulfite Ketoconazole Amphotericin

Attention all Pharmacists and Pharmacy Technicians!!!! KPERF will be transitioning to CPE Monitor in 2012 for all ACPE accredited CE programs. You MUST sign up for a NABP e-Profile ID to receive CE credit from KPhA or any other ACPE Provider. Visit www.kphanet.org/CPEMonitor for more. Watch for Member Updates from your Kentucky Pharmacists Association!

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April 2012 CE—Theory and Practice of Compounding Otic Preparations

March 2012

This activity is a FREE service to members of the Kentucky Pharmacists Association. The fee for non-members is $30. The fee for duplicate certificates is $5. Please send a self addressed, stamped envelope to KPERF, 1228 US 127 South, Frankfort, KY 40601. Expiration Date: March 1, 2015 Successful Completion: Score of 80 percent will result in 1.5 contact hours or 0.15 CEUs. Participants who score less than 80 percent will be notified and permitted one re-examination. April 2012 — Theory and Practice of Compounding Otic Preparations TECHNICIANS ANSWER SHEET. Not ACPE approved for Technicians. Name _______________________________________________KY Cert. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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

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

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

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

Met my educational needs ___Yes ___No Figures and tables were useful ___Yes ___No Achieve the stated objectives ___Yes ___No Posttest was appropriate ___Yes ___No Was well written ___Yes ___No Commercial bias was present ___Yes ___No Is relevant to my practice ___Yes ___No I hereby certify that I completed this self-study program independently and without assistance from any other party. Signature _________________________________________________ Date _________________________________

NABP #_________________________________ Birthdate _____________________(MM/DD)__ April 2012 — Theory and Practice of Compounding Otic Preparations Universal Activity # 0143-9999-12-004-H04-P PHARMACISTS ANSWER SHEET Name ________________________________________________ KY Lic. # __________________________________ Address ________________________________________________________________________________________ PLEASE CIRCLE THE APPROPRIATE ANSWERS: 1. A B C D 2. A B C D

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

Information presented in the activity: Met my educational needs ___Yes Achieve the stated objectives ___Yes Was well written ___Yes Is relevant to my practice ___Yes

5. A B C D 6. A B C D ___No ___No ___No ___No

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

Figures and tables were useful Posttest was appropriate Commercial bias was present

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

___No ___No ___No

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

NABP #_________________________________ Birthdate ______________________(MM/DD)__

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

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THE KENTUCKY PHARMACIST


March 2012

KPhA Members at APhA

KPhA Members shine at APhA

KPhA Board Director Dr. Trish Freeman received the 2012 APhA Good Government Pharmacist-ofthe-Year Award.

UK College of Pharmacy Dean Tim Tracy; Kelley Ratermann, third-year student pharmacist and current APhA-ASP Chapter President at UKCOP; UKCOP Faculty Joseph L. Fink, III; and KPhA Board Director Joey Mattingly pose at the APhA Annual Meeting. Ratermann received the APhA Student Leadership Award. Fink received the 2012 Linwood F. Tice Friend of APhAASP Award. Photos courtesy of UK College of Pharmacy

Upcoming event KPhA’s Academy of Consultant Pharmacists and KY-ASCP CE Event KPhA’s Academy of Consultant Pharmacists is working with KY-ASCP to conduct a Joint Long-Term Care CE Event from 12:30 until 5:00 p.m. on Sunday, April 29, 2012 at the Kentucky Renaissance Pharmacy Museum. For more information, visit https://flexiblerx.wufoo.com/forms/w7x2z1/ .

Check the KPhA website for registration forms and more information updates on the KPhA 134th Annual Meeting www.kphanet.org/2012annualmeeting

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THE KENTUCKY PHARMACIST


Pharmacy Technician Certification Board

March 2012

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March 2012

Advancing Pharmacy Practice in Kentucky

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THE KENTUCKY PHARMACIST


Pharmacy Policy Issues

March 2012

PHARMACY POLICY ISSUES:

Pharmacy Education Supply – The Harmful vs. Helpful Complexity By: Kelley Louise Ratermann Author: Kelley L. Ratermann is a third-year student pharmacist and current APhA-ASP Chapter President at the University of Kentucky College of Pharmacy. Kelley completed her pre-professional education at the University of Kentucky and is a native of Tipp City, Ohio Issue: Since the mid-1990’s, there has been a noticeable increase in schools and colleges of pharmacy throughout the nation – due in large part to a shortage of qualified pharmacists available to meet demand during that time period. The expansion of pharmacy education is evident through larger class sizes, the formation of entirely new colleges of pharmacy and even multiple satellite campuses for existing schools. This exponential increase of pharmacy graduates has prompted many within the profession to question the quality of education current students receive, as well as to gauge the impact of this occurrence on the job market. Discussion: Many pharmacy associations and stakeholder groups within the profession have chosen to address the topic of pharmacy education expansion through social media, printed publications and even white papers. This growing concern has been on the minds of students and practitioners alike, as perceptions such as “job market saturation” and the “poor economy” have seemingly translated into decreased availability of jobs in both community and health systems-oriented positions, increasing unemployment rates for recent graduates, salary plateaus, and the decrease or elimination of ‘once abundant’ signing bonuses. According to the white paper, Concerns about the Accelerating Expansion of Pharmacy Education: Time for Reconsideration, published jointly by APhA and ASHP in December 2010, the number of pharmacy schools in 1987 was 72 and had remained relatively constant up until that time. 1 The most recent data (as of July 2011) posted by the American Association of Colleges of Pharmacy (AACP) lists the current number of U.S.accredited schools and colleges of pharmacy at 119, noting that an additional five schools have already achieved pre-candidate status.2 Considering the domino effect of this acute increase in student pharmacist enrollment, the challenge of retaining and recruiting outstanding pharmacy faculty and educators has also been noted. Based on survey responses from 101 schools during the 2008-2009 academic year, there were 396 total vacant/lost faculty positions, down from 425 for the 2007-2008 academic year.1 There is definitely a need to find ways to decrease this number so that the quality of education for student pharmacists is not diminished in any way. Despite this information, the Accreditation Council for Pharmacy Education (ACPE) has strictly listed its duties as follows: The essential purpose of the accreditation process is to provide a professional judgment of the quality of a college or school of pharmacy's professional program and to encourage continued improvement thereof. Accreditation concerns itself with both quality assurance and quality enhancement.3

This organization provides a service that is essential to ensure proper nurturing, continual development and advancement of the profession of pharmacy. Therefore, if a specified educational entity has proven its competence by accomplishing stated goals and maintaining a high level of quality education, then ACPE will appropriately grant accreditation status, as is their charge. In conclusion, there appears to be some uncertainty shrouding the future of the pharmacy job market due to several interesting factors, which will only be revealed with the unraveling of time. The ultimate goal—whether the trend of pharmacy education expansion continues or not—is for pharmacy education to prepare graduates who are equipped intellectually, emotionally and professionally to contribute to the transformation of practice and to cope with the transition process.1 As current practitioners, faculty and student leaders explore 34

THE KENTUCKY PHARMACIST


March 2012

Pharmacy Policy Issues

ways to sustain and improve the profession of pharmacy, preserving a patient-oriented focus of pharmacy education must remain as the central core value. To garner a more complete understanding of the issues surrounding the pharmacy education expansion, readers are highly encouraged to examine the aforementioned white paper, as it was written by experts from APhA and ASHP who are on the forefront of these emerging changes (see reference #1 below). References: 1. http://www.pharmacist.com/Content/ContentFolders3/NewsReleases/2010/OctDec/ WP_Concerns_about_the_Accelerating_Expansion_of_Pharmacy_Education_FINAL.pdf. 2. http://www.aacp.org/about/Pages/Vitalstats.aspx 3. https://www.acpe-accredit.org/students/standards.asp. 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.

Do you have a story to tell?

WANTED: Blood Glucose Test Strips

Coming in future editions of The Kentucky Pharmacist

I buy unopened, unexpired diabetic test strips.

My Story: A Profile of a KPhA Member

The following brands are what I look for

The Kentucky Pharmacists Association is looking for members with a story to tell. Have a patient success story to share? Find a new way to provide a service to the community? What makes you stand out in a crowd? Why did you become a pharmacist?

Accu Chek Aviva Accu Chek Compact Accu Chek Active plus Bayer Contour Bayer Breeze2 Freestyle lite One Touch Ultra Blue

If you would like to be featured in The Kentucky Pharmacist, email Scott Sisco at ssisco@kphanet.org with a brief description of your story.

Please contact Tim at Green Horseshoe Healthcare at 502 287 2763.

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THE KENTUCKY PHARMACIST


KPhA Government Affairs Contribution Form

March 2012

KPhA Government Affairs Contribution Name: _________________________________ Pharmacy: __________________________________________ Address: _________________________ City: ___________________ State: _________ Zip: ____________ Phone: ________________ Fax: __--_______________ E-Mail: ______________________________________ Contribution Amount: $_________ Check ____ (make checks payable to KPhA Government Affairs) Credit Card (AMEX; Discover; MasterCard; VISA) Account #: ____________________ Expiration date: _______ Address to which credit card statement is mailed (if different from above) ____________________________________________________________________________________________ Mail to: Kentucky Pharmacists Association 1228 US Highway 127 South Frankfort, KY 40601

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THE KENTUCKY PHARMACIST


Pharmacists Mutual Companies

March 2012

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THE KENTUCKY PHARMACIST


KPhA Board of Directors

March 2012

KPhA BOARD OF DIRECTORS

HOUSE OF DELEGATES

Clay Rhodes, Louisville crhodes1@humana.com

Chairman 502.476.1796

Tyler Whisman, Florence tyler.whisman@gmail.com

Lewis Wilkerson, Frankfort rphs2@aol.com

President 502.695.6920

Matt Martin, Louisville Vice Speaker of the House matt67martin@gmail.com

Frankie Hammons, Barbourville frankiehammons@gmail.com

Secretary 606.627.7575

KPERF ADVISORY COUNCIL

Duane Parsons, Richmond dandlparson@roadrunner.com

Treasurer 502.553.0312

Kimberly Croley, Corbin kscroley@yahoo.com

President-Elect 606.304.1029

Leon Claywell claywell24@gmail.com

Past President

Kelley Ratermann klrater200@uky.edu

Student Representative

Amanda Jett ajett1706@my.sullivan.edu

Student Representative

Amanda Burton, Lexington amandastarkburton@gmail.com Chris Clifton, Erlanger chrisclifton@hotmail.com Trish Freeman, Lexington trish.freeman@uky.edu Joey Mattingly, Prospect joeymattingly@gmail.com Matt Martin, Louisville matt67martin@gmail.com Jeff Mills, Louisville jeff.mills@nortonhealthcare.org Glenn Stark, Frankfort glennwstark@aol.com Sam Willett, Mayfield duncancenter@bellsouth.net

Speaker of the House

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

KPhA/KPERF HEADQUARTERS 1228 US 127 South, Frankfort, KY 40601 502.227.2303 (Phone) 502.227.2258 (Fax) www.kphanet.org www.facebook.com/KyPharmAssoc www.twitter.com/KyPharmAssoc Robert McFalls Executive Director rmcfalls@kphanet.org Matt Worthy, PharmD Director of Professional & Clinical Services mworthy@kphanet.org Scott Sisco Director of Communications and Continuing Education ssisco@kphanet.org Kelli Sheets Office Manager ksheets@kphanet.org Christine Richardson Clinical Pharmacist crichardson@kphanet.org Darcie Nixon Administrative Coordinator & Billing Specialist dnixon@kphanet.org

Leah Tolliver, Lexington leahtolliver@tollivergroup.net Richard Slone, Hindman richardkslone@msn.com

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Frequently Called and Contacted

March 2012

Frequently Called and Contacted Kentucky Pharmacists Association 1228 US 127 South Frankfort, KY 40601 (502) 227-2303 www.kphanet.org

Kentucky Regional Poison Center (800) 222-1222 American Pharmacists Association (APhA) 2215 Constitution Avenue NW Washington, DC 20037-2985 (800) 237-2742 www.aphanet.org

Kentucky Board of Pharmacy State Office Building Annex, Ste. 300 125 Holmes Street Frankfort, KY 40601 (502) 564-7910 www.pharmacy.ky.gov

National Community Pharmacists Association (NCPA) 100 Daingerfield Road Alexandria, VA 22314 (703) 683-8200 info@ncpanet.org

Pharmacy Technician Certification Board 2215 Constitution Avenue Washington, DC 20037-2985 (800) 363-8012 www.ptcb.org

Drug Information Center Sullivan University College of Pharmacy 2100 Gardiner Lane Louisville, KY 40205 (502) 413-8638 www.sullivan.edu

Kentucky Society of Health Systems Pharmacists 1501 Twilight Trail Frankfort, KY 40601 (502) 223-5322 www.kshp.org

skills. This is a long-term position that will be structured for a 40-30 hour work week depending on the ideal schedule Western Kentucky Pharmacist available for relief/part-time of the candidate selected. We offer a competitive salary work. Experienced in retail, long-term care, home IVs, hos- depending on experience. pital and consulting. Willing to drive. Respond to The Kentucky Pharmacist (ssisco@kphanet.org) or cell (270-625Interested candidates should email ssisco@kphanet.org. 2434.)

KPhA Classifieds

Growing closed-door multi-state pharmacy is looking for one PIC manager and one relief manager to oversee dispensing and shipping operations. If you are tired of dealing with insurance and retail issues, have a super positive attitude and like to wear multiple hats, this is an excellent opportunity. Must carry out all duties in compliance with multistate pharmacy laws and will be required to secure nonresident pharmacist licenses in required states which currently include: Arizona, Arkansas, Louisiana, Nebraska, Tennessee, and Oregon. All direct expenses will be paid. Must currently be registered and in good standing in the state of Kentucky. This is a Louisville based mail-order closed door pharmacy and you will be responsible for overseeing and managing a small group of technicians, picking and dispensing medications and boxing and packaging for shipment. Must be capable of working independently with multiple computer systems and have excellent oral and written communication

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

THE KENTUCKY PHARMACIST


March 2012

THE

Kentucky PHARMACIST 1228 US 127 South Frankfort, KY 40601

SAVE THE DATE June 13-16, 2012 134th KPhA Annual Meeting Griffin Gate Marriott Resort and Spa Lexington, KY Visit www.kphanet.org for updates.

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THE KENTUCKY PHARMACIST


The Kentucky Pharmacist Vol. 7 #2