Compounding Matters Quarterly Winter 2015 by IACPRxPublications

IACPRx.org | Winter 2015

7 Simple Ways You Can Get More Out of Conferences The Personalities of Personalized Care What Works For Me And More!

STANDING TOGETHER FIXING THE DRUG QUALITY AND SECURITY ACT!

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Winter | 2015 Volume 1, Issue 1 IACPRx.org IACP STAFF David G. Miller, R.Ph. Cynthia E. Blankenship, Esq.

Contents 4

A NOTE FROM THE PRESIDENT

7 SIMPLE WAYS YOU CAN GET MORE OUT OF CONFERENCES

Dagmar Anderson Scot Maitland Jennifer L. Petska, CPhT Ashlyn Grant Michelle McMahan

by Dave Kerpen

EDUCATIONAL CONFERENCE BROCHURE

WHAT TO DO IN FORT LAUDERDALE

STANDING TOGETHER FIXING THE DRUG QUALITY AND SECURITY ACT!

by Scot Maitland

Macy Pruitt Teresa Roberts COMMUNICATION COMMITTEE Richard B. Moon, Pharm.D., R.Ph., FIACP, Chair

by David Miller, R.Ph.

Lisa Ashworth, BS, Pharm.D., R.Ph. Kim Hansen, R.Ph. Robert Harshbarger, III, Pharm.D. James Matthias, CPhT Linda McElhiney, Pharm.D., R.Ph., FIACP, FASHP Lauren Onsa, BA

by Jamie Mitchell, R.Ph.

Scott Wepfer, R.Ph., FIACP PHOTOGRAPHY Amanda L. Smith Scot Maitland DESIGN Dianne Stone

I NEED HELP, AND THATâ&#x20AC;&#x2122;S OKAY (BECAUSE YOU DO, TOO)

WHAT WORKS FOR ME: ANDY RUIZ, PHARM.D. by Scot Maitland

PERSONALITY OF PERSONALIZED CARE: KATE JAMES, R.PH. FIACP by Jennifer Petska

STICK TO YOUR FITNESS RESOLUTIONS

SAVE THE DATE FOR THESE UPCOMING PROGRAMS

Compounding Matters Quarterly is published four times per year as Spring, Summer, Fall, and Winter. Compounding Matters Quarterly makes all attempts to publish accurate information; however, this publication may contain technical inaccuracies or typographical errors. The reader assumes all risk concerning the suitability and accuracy of the information within this publication. Compounding Matters Quarterly assumes no responsibility for and disclaims all liability for any such inaccuracies, errors or omissions in this publication and in other documents referred to within or affiliated with this publication.

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A NOTE FROM THE PRESIDENT The beginning of a new year is always a good time to peek back at the previous year to review lessons learned and progress made in order to help prepare a plan for the future. My predecessors, Wade Seifert and Pat Stephens, helped navigate the waters through crisis mode in 2013 and damage control in 2014. These servants need to be applauded and thanked for their diligence. While the intensity level of the storm has died down, it is time for IACP to set a solid plan for the future and replenish our war reserves for the next looming battle. The planning for 2015 actually began early in 2014 with some tweaks to our by-laws and governance policies. Then in July, a work group convened in Chicago to lay out a strategic plan for the next three years. Before the ink was dry, the plan began to be put into motion. Since government affairs is always a key component of IACP’s activities, a Legislative Committee was formed under the excellent leadership of Scott Wepfer, to monitor legislation and make recommendations to the Board for our legislative agenda. A key component to our strategic plan is to be very intentional about forming alliances to help protect and advance pharmacy compounding. That work has already begun with an unprecedented alliance of associations from the pharmacy and medical communities. This alliance has come together under the leadership of IACP to lobby Congress for technical fixes to the Drug Quality and Security Act and/or a legislative remedy, specifically for office use compounding and repackaging. In order for our strategic plan to be successful, we need your help. My three main goals for 2015 are as follows: 1. Ensure that the strategic plan is implemented 2. I ncrease our P3 (Partnership for Personalized Prescriptions) Advocacy to 200,000 members 3. Increase our fund-raising efforts to replenish our reserves We have a solid plan for the future of IACP, but it can not be accomplished without the support and buy-in from our membership. We need your help to form relationships with your elected officials... We need your help to encourage your patients and prescribers to sign on to our P3 Advocacy Program... We need your help financially. I have chosen the theme “Harnessing Change” for 2015, so I am issuing a challenge to saddle up with me for the ride. We will have to ride together to be effective in dealing with and shaping change that is sure to come.

Winter 2015 | IACPRx.org

Preserve Your Access to Customized Medicines! Join Partnership for Personalized Prescriptions (PPP), a patient advocacy society now more than 150,000 voices strong! Bringing together patients, physicians, veterinarians, nurses and pharmacists and other healthcare advocates who know how valuable compounded medicines are for modern, individualized healthcare. Together we can work to ensure continued access to personalized medications!

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7 SIMPLE WAYS YOU CAN GET MORE OUT OF CONFERENCES by Dave Kerpen

It’s that time of the year: the leaves are falling off the trees, the weather outside is getting colder, and your calendar is packed with conferences and events before the holiday season slows things down next month Many business professionals and small business owners spend time every year attending conferences. I’ve attended and spoken at over 250 conferences in the last fifteen years. And while it’s great to be inspired and to learn at conferences, the most valuable asset of a conference is the people you meet and the relationships you can form and nurture. Here are 7 simple ways you can get more out of the conferences you attend: 1. Research speakers and attendees ahead of time - and reach out. A week or two before the conference, look at the speaker list and, if available, the attendee list. Research the people you’d most like to meet and spend time with, and then reach out via email, Twitter or LinkedIn. Figure out how you can truly help them and then offer your help. By showing your friendship first, you’ll be differentiating yourself from everyone else, who just wants to get something from them. Set up a 10-15 minute meeting over coffee or a drink. That way, you won’t have to scramble and compete to get their attention once at the conference. 2. Use social media to connect with and compliment the speakers. Chances are, you want to meet and network with speakers even more than with fellow attendees. But so does everyone else. One of the best ways to grab a speaker’s attention is to engage with him or her on Twitter before the conference, and pay him/her a

Winter 2015 | IACPRx.org

genuine compliment before or during the speech. I’ll often then send a private message on Twitter to set up a meeting, so that I don’t have to fight through the crowd after his/her speech for 2 meaningless seconds of conversation. 3. Skip a panel or two and hang out in the break room. As valuable as the content of a conference can be, if you’re there to meet people, it can be more valuable to hang out outside the panels, in the break room, trade show floor, or by the coffee or snacks. There, you’ll have more time to meet people - a speaker who’s just arrived, or an attendee who stepped out to take a phone call, or a sponsor you might be able to partner with. Most conferences have built-in breaks and networking time, which can be very valuable. But consider making more of this time for yourself - you can always get the notes from that panel later. 4. Forget just giving out business cards - collect them. The traditional thinking for conferences is “Bring lots of business cards to hand out to everyone you meet.” I bring my business cards to conferences. But I’d rather be in control of who I connect with - collecting cards from the people I most want to stay in touch with. So, do ask each person you meet for his/her card- and then, do connect with them on LinkedIn either after the conference, or right then and there. Always include a personal message when connecting. 5. Ask meaningful questions of the people you meet. Everyone else is asking, “Where are you from?” and “Where do you work?” and other small talk at conferences. Larry Benet taught me to ask better questions, such as “What are you most passionate

about?” and “What charity do you care most about?” and “Who at this conference would you most like to be connected with?”That way, you get people talking about something they really care about, and you can form a more meaningful relationship faster. Of course, the most important question you can ask of someone is, “How can I help you?” When you ask these questions, listen well, and be genuinely interested. This will make a difference for you. 6. Tweet away using the conference #hashtag. It’s impossible to connect face-to-face to everyone at a conference. One way to connect with more people is to “live tweet” throughout the day using the conference hashtag. You’ll pick up followers, find new and interesting people who are also tweeting, and supplement your learning. This Thursday, I’m keynoting the New York Business Expo (along with my childhood hero Doc Gooden by the way- super excited!) and if you’re not around, you can follow along anyway on Twitter using #NYEXPO. 7. Have a signature style. I have 29 pairs of orange sneakers and shoes, and I wear one to every conference I speak at or attend. It’s noticeable, it’s memorable, and it’s a often a conversation starter. It was my orange shoes that got

the attention of a prominent investor at a conference recently, who ended up funding my new company. Of course, this doesn’t mean you should go out and buy orange sneakers - but you should think about how you can differentiate yourself. Whether it’s a certain color tie you wear, signature earrings, or a blazer having a signature look will help you stand out from the masses at conferences, meet more people, and be remembered. Above all else, when you attend a conference, have concrete goals in mind for your networking in advance, be both interesting and interested, and spend time to get to know people and help them. If you follow these simple tips, you’ll be able to meet more people and get more out of each conference you attend.

Dave Kerpen is an entrepreneur, author and former reality television personality. He is currently the CEO of Likeable Local, a social media software company for small businesses, as well as Chairman of Likeable Media, a social media marketing firm and author of the 2011 New York Times bestselling book, Likeable Social Media, as well as the 2012 book, Likeable Business, and the 2013 book, Likeable Leadership.

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IACPRx.org | Winter 2015

Save the Date!

Fort Lauderdale, Florida ~ February 25-28, 2015 Bringing the pharmacy profession together in paradise.

EducationalConference.org Scan the meeting QR code and stay in touch with the latest meeting activities, videos, speaker bios, and more. ÂŠ2014 International Academy of Compounding Pharmacists (IACP). All rights reserved.

Winter 2015 | IACPRx.org

IACPRx.org | Winter 2015

Winter 2015 | IACPRx.org

IACPRx.org | Winter 2015

Winter 2015 | IACPRx.org

IACPRx.org | Winter 2015

WHAT TO DO IN FORT LAUDERDALE by Scot Maitland

Vacation or work? With the Educational Conference, you get both! This one-of-a-kind learning event is unique in that it affords the opportunity to learn during the day. While during the afternoon, you can connect with colleagues and enjoy an array of adventures. The Harbor Beach Marriott Resort & Spa offers a luxurious day spa and dining overlooking the Atlantic Ocean. But if you’re looking to spread your wings beyond the hotel, we’ve got some ideas for you!

INTRACOASTAL WATERWAY Navigate the canals that have earned Fort Lauderdale its nickname, “Venice of America.”

What’s not to love about the beach? If shopping isn’t your thing, check out Las Olas Beach and enjoy the sand and surf!Vacation or work? With the Educational Conference, you get both! This one-of-a-kind learning event is unique in that it affords the opportunity to learn during the day. While during the afternoon, you can connect with colleagues and enjoy an array of adventures. The Harbor Beach Marriott Resort & Spa offers a luxurious day spa and dining overlooking the Atlantic Ocean. But if you’re looking to spread your wings beyond the hotel, we’ve got some ideas for you! What’s not to love about the beach? If shopping isn’t your thing, check out Las Olas Beach and enjoy the sand and surf!

FORT LAUDERDALE ANTIQUE CAR MUSEUM 1527 SW 1st Ave, Fort Lauderdale, FL 33315 (954) 779-7300 www.antiquecarmuseum.org For the car lover, this is a must! LAS OLAS BOULEVARD Eat, shop and enjoy with over 30 al fresco dining options, 10 major international art galleries, 2 world class museums and 65 shops filled with fashion, accessories, gifts, and more www.lasolasboulevard.com EVERGLADES HOLIDAY PARK 21940 Griffin Rd, Fort Lauderdale, FL 33332 (954) 434-8111 www.evergladesholidaypark.com Hope on an airboat and take in some of the wildlife! LAS OLAS BEACH What’s not to love about the beach? If shopping isn’t your thing, check out Las Olas Beach and enjoy the sand and surf!

Winter 2015 | IACPRx.org

Scot Maitland is the Director of Communications and Publications at the International Academy of Compounding Pharmacists and Editor of Pharmacy Marketing Quarterly and Compounding Matters Quarterly.

“YOU ARE MY HERO!” IACP Corporate Partners Help Protect the Future of Compounding. For the past 20 years, the International Academy of Compounding Pharmacists (IACP) has worked to protect pharmacists’ right to compound, and to advance the art and science of pharmacy compounding. Whether we’re in the halls of Congress, working with state pharmacy boards, associations and regulatory agencies. Or, helping to spread the good news to patients and practitioners about compounding and its invaluable place in the healthcare continuum, IACP is safeguarding the right to compound for patients, practitioners and communities. We are not alone in this mission. Our Corporate Partners are with us every step of the way, helping to ensure that compounding remains a viable healthcare option for all. The health of an association is often related to the company it keeps. IACP is very fortunate to have considerable corporate support – high-caliber organizations passionately committed to Protecting, Promoting & Advancing Pharmacy Compounding. To all of them, we say, “Thank you for making a difference for our profession!”

Become a Compounding Hero! For more information about IACP’s Corporate Partner program and to view a listing of our current Corporate Partners, please visit www.iacprx.org or email meridyth@iacprx.org.

STANDING TOGETHER FIXING THE DRUG QUALITY AND SECURITY ACT! by David Miller, R.Ph.

Clearly there are always unintended consequences of any legislative or regulatory act that’s taken in the heat of battle. Richard Grasso, former CEO of the NYSE When Congress enacted the Food and Drug Administration Modernization Act (FDAMA) in 1997, it created the first formal federal authority over the compounding of medications in the United States by adding section 503A to the Food, Drug and Cosmetic Act (FDCA). While that law remained on the books, court challenges to various section of the law essentially rendered 503A unenforceable in many states.

Section 503A considers all compounded preparations “new drugs.” In order for a compounder to be exempted from many of the requirements that manufacturers must comply with when introducing a new drug into the market, the compounder must adhere to the terms of section 503A. In order to qualify for the exemption, Congress used the specific wording that compounds must be for individual patient-specific prescriptions.

Then came the New England Compounding Center crisis in October 2012. For the next year, legislative debate, regulatory agency finger pointing and blame shifting, and continual cries from the media, to “do something” to prevent another such tragedy all culminated with the passage of the Drug Quality and Security Act of 2013 (DQSA). DQSA reaffirmed the original section 503A with only minor modifications, created a new section called 503B that established sterile drug outsourcing facilities, and formally codified the track-and-trace system to preserve the integrity of the United States drug supply system.

Office-use is not addressed at all by the law. It is neither permitted nor prohibited. Prior to the DQSA’s final vote, several Senators and Congressman read specific language into the Congressional record that state, in essence, that nothing in the reaffirmation of section 503A was intended to override or change existing state laws or practices related to office-use. Even so, the final wording of the law is open to interpretation.

So, here we are today with an “old-is-new-again” law that contains most of the flaws and inconsistencies it did in 1997, doesn’t contain or reflect the current state of compounding and health care practice, and leaves in its wake more uncertainties than it provides clarity. In November of 2014, IACP formally launched it’s FIX DQSA initiative, an effort to address the problems the Academy was seeing as the law was implemented by the FDA. The first and most important part of that initiative was to establish an alliance with more than 25 medical and pharmacy associations who were already seeing the unintended disruptions to patient care and access to compounds, disruptions that Congress never intended. What are some of these problems? What’s going to happen? OFFICE-USE One of the biggest and most confusing issues within the DQSA and section 503A is whether or not officeuse – the prescribing and delivery of a compounded medication to a prescriber for administration to or treatment of a patient in a practitioner’s office – was still permitted.

Wiinter 2015 | IACPRx.org

On September 15, 2014, the FDA responded to a series of Congressional letters that their interpretation of 503A is that office-use is not permitted under federal law. Those letters, sent at the request of IACP and its membership, were essential to having a clear statement by the FDA as to their position. So, on the one hand we have Congress saying in the record “we do not want office-use to go away” and on the other hand we have the FDA saying “we say it has.” To make things even more complicated – and confusing – many state Boards of Pharmacy are enacting new rules and regulations that clarify that office-use is permitted within their state. In 2014, three states passed formal legislation that codified office-use as a permissible compounding activity. It’s that “state: okay, federal: not okay” dilemma that must be resolved by fixing the language within the DQSA or obtaining clear Congressional directives to the agency. Rather than providing clarity, the DQSA has placed practitioners in the unacceptable and untenable position of following a law while still breaking another law. On December 11, 2014, IACP, and 22 other professional organizations sent a formal request for clarifying action on this issue to Senate, the House of Representatives, and the FDA. We’re waiting for a response from the new Congress and will push for, if necessary, technical

corrections to the DQSA, that specifically permit office-use where provided for within state law. BULK INGREDIENT LISTS As pharmacists, selecting the appropriate active and inactive ingredients, bases, flavorings, fillers, and binders, is all part of the compounding process. Using an Active Pharmaceutical Ingredient (API), more commonly referred to as a “bulk drug”, is part of the clinical and professional decision-making process. Within section 503A of the DQSA, compounders are limited in their use of APIs. Only those APIs that have a USP monograph or are components of previously or currently FDA approved drugs or are reviewed and approved by the FDA and published in a list may be used. APIs for homeopathic drugs and nutritional products without monographs are, for now, technically “unusable” in compounding. Twice in the past year, the FDA requested submissions of APIs to be reviewed for the list and received thousands of drugs. Unfortunately, there is no timetable established for the review of those API submissions nor has Congress or the agency provided for any exemptions or exceptions to the use of APIs under consideration during that review process. That represents another significant problem for practitioners. For example, methylcobalamin is commonly compounded for the treatment of a variety of conditions. It does not have a USP monograph. It is not a component of a formally approved FDA drug product. It, therefore, has to be reviewed by the Pharmacy Compounding Advisory Committee that was appointed at the very end of 2014. What does a compounding pharmacist do? Tell the patient and the prescriber that they can no longer continue to provide a much-needed medical treatment simply because it “isn’t on the list yet.”? The FIX DQSA stakeholders alliance is working on this issue as well. One recommendation is that clarifying language be enacted within 503A or direction be given that to the FDA that compliance with the bulk ingredient selection guidance provided for within the national standards of USP General Chapters <795> and <797> is sufficient to justify the use of an API. As part of that work, the alliance is putting together lists of these medicines and will be, when appropriate, having consumers, patients, caregivers, prescribers, and pharmacists all contact their Congressional representatives to preserve access to those and other treatments. But for now? It’s another case of potentially complying with state law that requires the provision of care and treatment to a patient using the best and most appropriate therapy available – in this case, an API for a compound – while violating a federal law enforceable by an agency that has yet to decide on whether those APIs are appropriate. THE MEMORANDUM OF UNDERSTANDING Of all the components of the reaffirmed section 503A that may substantially disrupt the accessibility to compounded preparations is the one outlined in the law’s provision for a Memorandum of Understanding (MOU) between the FDA and individual states. As written in the

DQSA, a MOU will be agreed upon by the FDA and each state that will govern the quantities of a compounded preparation that may be distributed in inter-state commerce and will also determine how and who will be responsible for the monitoring and enforcement of compliance with state and federal laws and standards affecting compounders. The MOU has the potential to nearly eliminate all interstate shipment of a compounded prescription. Although no MOU exists at present – no state has been provided a copy of the an agreement by the FDA nor has the MOU been published for public comment at the federal level – it is entirely possible that a pharmacy may have to curtail dispensing and shipment of prescriptions to a patient or practice located in other states. When comments were requested on the implementation of 503A in early 2014, IACP identified and requested a response to a discrepancy of terms within the law itself. In the section related to the MOU, the limitations on interstate shipment apply to compounded medications that are “distributed.” Patient specific prescriptions are “dispensed.” Just as practicing pharmacists know very well that paying attention to the details of a formula is critical to the protection of the patient, paying attention to the legal definitions of words is critical to IACP for protecting its members. Does the use of the word “distribute” imply that yes, Congress did intend for office-use? Is the FDA going to interpret “distribute” to include all patient-specific prescriptions mailed or delivered across a state’s border? Right now, we don’t know. Nobody knows. There is no draft MOU to review nor is there any indication when that might be published despite requests for status updates by Congressional offices. The MOU’s potential, for disrupting patient access, isn’t limited to pharmacies. Because section 503A applies to all practitioners engaged in compounding in all settings – doctors, nurses, physician assistants, dentists, hospitals, clinics, ambulatory surgery centers – the MOU will apply to them as well. Since the MOU is being created by the FDA in conjunction with the National Association of Boards of Pharmacy, IACP and many other associations are asking “how will a state Board of Pharmacy oversee compliance with that agreement when they have no authority over doctors, nurses, physician assistants, dentists, etc? Of all the components of the DQSA and section 503A in particular, the Memorandum of Understanding is the one area where there will likely be challenges in court by both practitioners and states who are seeing their authority eroded by a federal agency. WHAT’S NEXT? Over the coming year, the FIX DQSA initiative will be the top priority for IACP. In addition to our work with other associations and our own independent lobbying efforts, keeping pharmacists informed about the uncertainties we identify within section 503A, the FDA’s interpretation and enforcement actions, the conflicts with existing state laws, the promulgation and enactment of new and possibly conflicting state laws and regulations, is critical.

IACPRx.org | Winter 2015

To that end, there are five basic principles that IACP has identified as battles we will and must fight for all compounders. 1. Compounding and delivering a preparation of an “office-use” medication for administration to or treatment of a patient in a prescriber’s practice shall be subject to the exemptions provided for within 503A in those states where permitted by state law, regulation, or rule. 2. T he inspection of a traditional compounder by the FDA shall be conducted using the standards established in USP <795> and USP <797>. Only upon the determination of a state Board that the compounder is engaged in manufacturing shall the FDA conduct inspections of traditional compounders using CGMPs (Current Good Manufacturing Practices). 3. The determination to use an Active Pharmaceutical Ingredient (API) to achieve the desired therapeutic results shall be the sole responsibility of the compounder so long as the API is obtained by an FDA registered supplier and is accompanied by a valid COA. 4. T he dispensing of a compounded preparation to an individual patient located in another state shall not be impinged or restricted by any FDA Memorandum of Understanding nor shall such dispensing activities be used in the calculation of any limits as may be proposed. 5. T he compounding and distribution of preparations by 503B registered outsourcing facilities shall

not be dispensed to individual patients unless the outsourcing facility is also registered as a pharmacy and those dispensing activities subject to the oversight of a state Board of Pharmacy. As those battles are fought, there are things that you can do to help assure our collective success. Educate yourself and your colleagues by using the updates, newsletters, conferences, and webinars IACP has available at www.iacprx.org. Be ready to call, write, e-mail and FAX your Congressman and Senator to let them know how important their support is in making technical corrections and clarifications to the DQSA. Commit financially with a donation to the IACP One Fund, a financial reserve overseen by the IACP Board of Directors to hire lobbyists and advocates when needed. Tell your patients about the Partnership for Personalized Prescriptions consumer website http:// prescriptionpartnership.com/ where they can sign up and be ready to let legislators know how important it is to have access to compounded medications. Most importantly… keep the faith and don’t give up. IACP has your back.

David G. Miller, R.Ph., is the Executive Vice President and CEO of IACP. Whether working on legislation on Capitol Hill, acting as compounding pharmacy’s liaison to other pharmacy and medical organizations, or defending against voverzealous government regulation, his primary responsibility is always keeping the professional and proprietary business interests of IACP members first and foremost.

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Wiinter 2015 | IACPRx.org

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I NEED HELP, AND THAT’S OKAY (BECAUSE YOU DO, TOO). by Jamie Mitchell, R.Ph.

Let’s face it people always say, “I wake up in the morning and immediately start going over the list of things to accomplish for the day.” Truth be told how many of you wake up and immediately start thinking about how soon you can crawl back in bed and hide from everything requested of you. We eye the clock and count down... 3PM only a few more hours... 6PM.... not too much longer before I can shut my eyes... Let me say, I hear ya. I’ve been there. Heck, I’m STILL there some days. It’s scary out there. And I guess I have this ongoing fight with myself in which I am frustrated that I can’t do everything myself but also struggle because, at a subconscious level, I don’t want to do everything by myself. Let me offer a little background here. I am an only child. I am a single mom. I am an independent pharmacist. Do you see a pattern here? It has taken me quite a while, but I’m here now to testify “you can’t do it alone”. Maybe I’m a walking contradiction here, but I did come to a breaking point. As much as I have just described myself as “only,” “single,” and “independent,” I reached a point in my life where I realized that these monikers were not absolute. That was my breaking point. And I mean a real, literal breaking point. I broke my leg. Long story short: #WarriorDash2012. Adrenaline pumping, wall climbing, Pharmacist Jamie the Conqueror. Then I discovered that Redbull does NOT give you wings. My breaking point involved a compound fracture of the tibia and fibula. One rod and three pins later, I arrived at my epiphany: You can’t do it alone. No matter who you are or what you do. Personal, professional, life in general. And thinking about it now, why in the world would we want to do it alone?

Wiinter 2015 | IACPRx.org

We have built our entire civilization on the premise of cooperation. Early tribes were able to thrive because we learned to communicate best practices amongst each other. We partnered on the hunt, we partnered on the gather, and we partnered on the bounty. We as humans are unique among the creatures of this Earth as we are all blessed with the dual elements of personal drive tempered by the ability and need to engage in collaboration. So, from my painful yet constructive revelation, here are the are five things I want you to keep in mind when you feel like you may be alone on an island out there: There is strength in numbers. I know that this sounds cliche. Sometimes things are cliched for a reason... because the things are true. I have found a renewed sense of purpose by connecting with like minded people. Yes, most of this was accomplished through social media (Twitter), and I’m not ashamed to admit that. Why would I be? Social media have provided me a window to find so many pharmacists and others invested in the future of the profession. It’s refreshing. I discovered that if I start sharing my passion and ideas that my peers do want to listen. More importantly so much support has come from my buds that I am more inspired to continue blogging and reaching out. We are not meant to be alone. We were created to develop relationships with others. It’s fun. It’s ok to play. You cannot work all the time. Companionship is good for the soul. Laughing and sharing experiences with other people will continue to drive the “why” we go through this crazy life. I work hard so I can play equally as hard with my family and friends. And sometimes I play while I work. Yes, this is OK too. 3. If you try and take on everything on your own, you will be overwhelmed. Period. No denying it. You can spend

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hours in your head trying to solve problems and even prevent things from happening. I’ll speak to this from a professional and personal side. In the pharmacy, it’s easy for me to take on a project after project. During the process, it is critical to involve everyone on staff. If they see why you are so excited about the latest program, you are implementing they will be more dedicated. Dedication breeds success. If you need to justify staff involvement to a supervisor, just focus on this premise. You can’t argue with it. The other part of this is personal. Simply put, my parents are amazing. There I said it. They made me the woman I am today, and I’m never going to stop relying on them either (sorry Mom and Dad; ). I am not too proud. When my days are long and tough, I am not afraid to reach out and ask them to pick up my little guy from daycare. It’s not failure. They are grandparents. That’s why they are around. I understand that not everyone has this luxury, but I am equally baffled why some of us who do are resistant toward it. You like to know that people rely on you. It gives you a sense of purpose and sometimes when things are tough it is the singular factor that makes you push through. The same is true for parents and those who care about you. Don’t rob them of their chance to continue to matter. Unfortunately, many of us are guilty of becoming set in our ways. Trying to become so self-sufficient sometimes leads to ignorance. Again something I can attest to. I was set in my ways as a practicing pharmacist. I sat around and complained about reimbursements and not being respected. Here’s the real deal when I started talking to people, not inside the four walls of my pharmacy. I found out not everyone thinks the way I do. #shocker. But, this shouldn’t be so surprising. I was ignorant. This kind of goes back to my first point about having your voice heard. Sometimes it is more important to open your ears than your mouth. Taking all aspects in can lead you to making an even more powerful point.

B E N E F I T I N G

T H E

I A C P

F O U N D A T I O N

1 1 TH A N N U A L R X M I X E R P R E S E N T S :

SUNDAY, JUNE 7, 2015 6:30PM – MIDNIGHT RENAISSANCE WASHINGTON, D.C.

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S AV E

T H E

D AT E !

If you try and do it all on your own, you will probably find yourself in a padded room. This is not meant to be a shot to mental illness. This is a fact. You can drive yourself into a state of unrealistic views and unrealized expectations. Bottom line, depend on others and don’t be frustrated when others depend on you. Let them lift you up when you are struggling or even better when you are on the way up. Reciprocate when you can. I am so blessed to have so many people encouraging me. You can’t do it alone. No one can. I am successful in every aspect of my life, and gratitude is due to all those around me.

Jamie Mitchell is a clinical community pharmacist consultant with Creative pharmacist. She believes in connecting pharmacists to each other in hopes to collaborate and develop best practices in community pharmacy. A practicing, licensed pharmacist in both Louisiana and Mississippi. She is a true patient advocate and a proud mama. Her passion runs deep with furthering the practice beyond the pharmacy walls. Jamie is the lead organizer on the first ever Pharm2table summit focusing on rebranding the profession.

August 15, 2015 Hilton Columbus at Easton – Columbus, Ohio The Compound Conference is the only conference annually partnering with a state pharmacy association, bringing together the leaders in the pharmacy compounding profession.

106.14.158 IACP Compound Conference – .25 Page 4/c (3.625 x 4.75”) – IJPC • bertsDesign 713.825.5002

IACPRx.org | Winter 2015

WHAT WORKS FOR ME: ANDY RUIZ, PHARM.D. by Scot Maitland

TELL US ABOUT A CLINICAL SITUATION THAT CAME UP IN YOUR PHARMACY AND HOW DID YOU HANDLE THE PROBLEM? I recently received a patient informing me that they were no longer feeling the same on their BHRT. This was not usual as the patient had been compliant and not experienced any issues or complications for at least a year. Upon further questioning, I discovered she had been experiencing severe allergies and started over the counter allergy medicine. The medication was causing dry mouth, and she began to chew and spit out the remaining RDT. I discussed with her options and decided we could reformulate her dose into a sublingual liquid. I spoke with her prescriber to authorize the therapeutic interchange, and her prescriber informed me they had been noticing an increase in patients reporting similar stories. I informed them of my findings and what we could prepare for those patients experiencing the dry mouth. This interaction resulted in a larger than expected chain reaction with a number of patients converted to the liquid and reported improved outcomes once again. WHAT RESOURCES DID YOU USE? I had used the International Journal of Pharmaceutical Compounding (IJPC) as well as a number of other published pieces medical literature to aid in my formulations of the sublingual liquid. HOW DOES BEING A MEMBER OF IACP HELP YOU WITH SITUATIONS LIKE THESE? Being an IACP member helps me with these situations since I am able to rely on IACP affiliates such as IJPC. Being an IACP member has also helped me solve similar situations by being able to contact colleagues across the US for ideas and assistance. These tools have proven to be invaluable to my practice. WHAT ADVICE DO YOU HAVE FOR FELLOW COMPOUNDERS WHEN IT COMES TO UNIQUE PROBLEM-SOLVING? In this time of personalized medicine, we as compounders have a large advantage in patient care. We solve healthcare related problems with our compounding skills, which is both art and science. However, we must base our compounded preparations on the available medical literature. In order to practice evidence-based medicine we must be able to source, understand, and apply the primary literature. This is no easy task yet critical in patient care as well as for the advancement of compounding pharmacy. Our use of evidence-based medicine to contribute to personalized medicine will continue to legitimize compounding pharmacy, as well as fend off continuous attacks from outside entities. 22

Winter 2015 | IACPRx.org

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WILL YOU BE ATTENDING THE EDUCATIONAL CONFERENCE OR COMPOUNDERS ON CAPITOL HILL? I will attend both the Educational Conference and Compounders on Capitol Hill. They both provide different unique networking and learning experiences that are invaluable to my practice. I always return with a wealth of knowledge I received from both colleagues who have attended the meetings as well as from the meeting lectures.

E D U C A T I N G

A D V O C A T I N G

N E T W O R K I N G

J U N E 6 - 9 , 2 0 15 ~ WAS H I N GT O N , D C

WHY DO YOU ATTEND IACP EVENTS? I attend IACP events to learn, serve, and network. IACP has been instrumental in my professional growth through their conventions and networking with other pharmacist across the United States. Additionally, IACP has allowed me to serve on their Board of Directors, which allows me to contribute to the organization that protects and serves compounding pharmacy. There is nothing more gratifying for me than to be able to give back to my profession that has done so much for me.

Scot Maitland is the Director of Communications and Publications at the International Academy of Compounding Pharmacists and Editor of Pharmacy Marketing Quarterly and Compounding Matters Quarterly.

R E N A I SSA N C E WAS H I N GT O N , D C To register for CCH, visit

iacprx.org/cch

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2015

All new for

www.Topi-CLICK.com

We’re Just Getting Started… Topi-CLICK® revolutionized topical dosing. We are pleased to introduce the next generation in CLICKing technology! Topi-CLICK® 140

140mL + Click-Assist™ Patient Feedback Technology Pain Management / HRT / Wound Care / Scarring

4X BIGGER

Topi-CLICK® 35

35mL + Click-Assist™ Patient Feedback Technology The original only better!

Topi-CLICK® 140 (0.5mL/CLICK)

Topi-CLICK® 35

Topi-Tips™

(0.25mL/CLICK)

Nozzles Designed for Quick and Efficient Filling New larger size for filling the TC140

Topi-Tips™ Standard

Topi-Tips™ XL

Expect new products soon in the area of Women’s Health, Veterinary and Filling Solutions. Protected by U.S. Patent Nos. 7,213,994 and 7,303,349 All items 2006-2014 by Custom RX TDA, LLC.

As required for compounded prescription pharmaceuticals; verify the formulas and the weight to volume conversions before dispensing to patients. The FDA has not evaluated the Topi-CLICK® and use with prescription pharmaceuticals should always be evaluated by a licensed pharmacist.

IACPRx.org | Winter 2015

PERSONALITY OF PERSONALIZED CARE: KATE JAMES, R.PH. FIACP by Jennifer Petska photo by: Amanda L. Smith

Kate James, R.Ph. FIACP, has pharmacy in her blood. A graduate of Oregon State University, Kate and her husband William own and operate Broadway Apothecary, a compounding pharmacy, in Eugene, Oregon. Broadway Apothecary was the first PCAB-accredited pharmacy in the state of Oregon and Kate is known within the industry as a speaker, leader, award winner, fellow, friend and trusted colleague. But, perhaps, it’s Kate’s personal side that’s most interesting. I sat down with Kate to ask her what inspires her during her “off” time. The following are things that inspire her!

Winter 2015 | IACPRx.org

Kate’s Inspiration Board

1. GOATS: Like many compounders, I enjoy animals and their antics. Goats tend to be smart, mischievous and very acrobatic. What isn’t to love!? 2. WINE: I love wine because of the science behind its quality. One small change in how it’s made drastically changes its flavor. There is so much to know about wine: the growing of the fruit, the science of creating the wine, the fun of pairing with different foods. It inspires my travel, but mostly I love to share the experience with friends and family at home. 3. OREGON STATE BEAVERs There isn’t anything like the energy of a college football game! I love that feeling, especially on those occasions when we win! 4. MEXICO, INDIA AND TRAVEL IN GENERAL: Travel is an adventure in experiencing new things for our senses, learning about other cultures and being in the moment. One of our favorite things to do while traveling is see how other people solve familiar problems. For example, how a bridge is designed, how large amounts of food are prepared, how a home is heated or cooled. 5. MOTORCYCLING: A friend of ours once said that “riding a motorcycle is a great way to move through space.” Say it slowly in the voice of Matthew McConaughey. I can’t describe it any better than that. 6. SCIENCE FACTORY CHILDREN’S MUSEUM: Engage! Excite! Inspire! Now that our daughter is grown, I need other things as worthy as her to focus on when not compounding. Science and life-long learning are passions of mine, so helping at The Science Factory makes perfect sense.

Jennifer L. Petska, CPhT is the newest member of the IACP and IACP Foundation. Jennifer received a Bachelor of Science degree in Biology from University of Minnesota Duluth and is a Certified Pharmacy Technician. She was born in Columbus, MS and moved many times growing up as part of an Air Force family. She currently lives in Minneapolis, MN.

IACPRx.org | Winter 2015

STICK TO YOUR FITNESS RESOLUTIONS One week into the new year and already you’ve chowed down on a dozen brownies and missed going to the gym? Don’t be too hard on yourself, but don’t give up on the diet and exercise resolution either. Keep trying, and remember that you’re human and prone to setbacks. Don’t let a failure to stick to a plan one or two or even a few days derail you from picking up and trying again. FOLLOW THIS ADVICE: Be realistic. If you’re trying to drop 20 pounds, don’t try to lose it all in a month. Set your sights on losing no more than a pound or two a week. Set specific goals. Don’t say you’ll exercise more.

Wiinter 2015 | IACPRx.org

Instead, commit to walking 30 minutes during your lunch break three days a week. Find a partner. You’ll find sticking to your resolutions easier with a mutual support system. Get together with a buddy who’s trying to accomplish the same goals and give each other encouragement and company. Log your progress. Writing down how much weight you’ve lost, or how many times you’ve gone to the gym in the past week gives you a sense of accomplishment— and the encouragement to keep going. Also, it helps you to track any trouble spots and allows you to find solutions. WE ASKED TWO IACP MEMBERS HOW THEY STICK TO THEIR FITNESS GOALS.

Lauren Onsa, Vice President of Compounding Operations at Clinical Compound Pharmacy What’s your workout routine like? I workout 4-5 days a week alternating between CrossFit in my home garage gym and spinning at a traditional gym. My work schedule is always changing, so sometimes I workout in the mornings and sometimes after work. How do you stick to it?

Jack Korbutov, Pharm.D. Owner of The Art of Medicine How long have you been focused on your training? I have been doing CrossFit style training for about 2.5 years now. After spending a year at a local CrossFit, I found it to be the most rewarding and efficient workout available for my lifestyle. This passion carried over into starting my own CrossFit on the other side of the city. We opened in September, 2014, and it’s been great since!

I attribute a lot of my motivation to mixing up my workouts. It keeps things fresh and engaging. Friends and colleagues also play a role. Sharing my fitness journey with like minded people has created a strong support system.

How do you fit it into your schedule?

What advice would you give to someone just starting to get in shape for 2015?

How does sticking to your routine make you a better pharmacist?

First and foremost I would give them a high five! They are taking the first step in making a positive lifestyle change!

I could write a novel on this. Having a consistent exercise routine works wonders for the mind, body, and soul. Let’s face it, being a pharmacist and entrepreneur, a lot of stress accumulates. Having a place to expend physical energy helps the mental side tremendously. For me, the hour at CrossFit Rittenhouse is like meditation. It allows me to escape the stressors that add up during the day and helps me manage my stress in the most healthy way possible. I can honestly say I wouldn’t be able to serve my patients the same way without the fitness part of my life.

Find something you really enjoy doing. It will take the “work” out working out. Be patient. There is my favorite saying again “Rome wasn’t built in a day”. My experience with cross fit has proved to me my body is capable of doing things I never imagined I could do, but it took the course of a year to get there. If you put in the time you, will get the results! Celebrate your progress! That might mean a new pair of sneakers or a glass of wine!

One of the most beneficial parts of owning and managing a compounding pharmacy is the great hours. Our 9-5 workday allows plenty of time for exercise, before or after filling scripts.

Have a fitness routine that you want to share? Upload your story and pictures to our Facebook page, http:// Facebook.com/CMQuarterly.

IACPRx.org | Winter 2015

SAVE THE DATE FOR THESE UPCOMING PROGRAMS Learn More at http://www.iacprx.org/?page=11

Now, IACP is your one-stop shop for all things compounding! Compounder Calendar provides a comprehensive listing of compounding events and continuing education programs offered by IACP, state pharmacy associations, national pharmacy associations, IACP corporate partners and IACP affiliates.

FEBRUARY FEBRUARY 5 Philadelphia, PA Regional Education Meeting Location: Philadelphia, PA FEBRUARY 7 PCCA Canada Quick-Ed: Topical Compounding in a Day Location: Vancouver, BC FEBRUARY 9 - 13 PCCA Comprehensive Compounding Course (C3) Location: Houston, TX FEBRUARY 11 PCCA Webinar FEBRUARY 12 IACP AdvanCE Webinar: Ensuring Patient Safety and Quality Products–The Most Critical First Step FEBRUARY 13 PCCA Marketing-Sales-Business Location: Houston, TX FEBRUARY 13 PCCA PK Software Training Location: Houston, TX FEBRUARY 13 PCCA Advanced Compounding Techniques Location: Houston, TX FEBRUARY 13 PCCA Rx Skin Therapy Workshop Location: Houston, TX

FEBRUARY 15 Maryland Pharmacists Association Mid-Year Meeting Location: Linthicum, MD

MARCH 7 - 11 2015 AORN Surgical Conference and Expo Location: Denver, CO

FEBRUARY 19 - 21 HRT PCCA HRT Symposium 2/19/2015 » 9/21/2015 Location: Las Vegas, NV

MARCH 19 IACP AdvanCE Webinar: Marketing Research for Compounding Pharmacies

FEBRUARY 23 - 27 PCCA Australia Comprehensive Compounding Course (C3) Location: Sydney

MARCH 21 - 22 MEDISCA: 5th Annual Student Pharmacist Compounding Competition

FEBRUARY 24, 2015 PCCA Webinar

MARCH 26 San Diego, CA Regional Education Meeting Location: San Diego, CA

FEBRUARY 25 - 28 Educational Conference 2015 Location: Ft. Lauderdale, FL FEBRUARY 25 - 27 PCCA Aseptic Technique Compounding Course Location: Houston, TX FEBRUARY 25 PCCA PK Software Client Webinar

MARCH 27 APhA Annual Convention Location: San Diego

APRIL APRIL 16 Boston, MA Regional Education Meeting

MARCH MARCH 1 Pharmacy Compounding: Past, Present, and Future Webinar MARCH 2 Tampa, FL Regional Education Meeting Location: Tampa, FL

We are currently developing the 2014-2015 calendar. If you would like your compounding related events included, send an email to Macy Pruitt at macy@iacprx.org.