cmq q2 2015 by IACPRxPublications

IACPRx.org/Publications | Spring 2015

Six Things I Have Learned From Compounding Pharmacy Crises The Personality of Personalized Care IACP Foundation History

THE

MOU POLITICAL • LEGAL • PATIENT

The science of skin rejuvenation starts here. Two ideal solutions that promote healing of scars, burns, wounds and more. Letco Medical’s new Enhanced Scar Care Base and Wound Care Creams will greatly enhance your patients’ skin healing process. Enhanced Scar Care Base – a topical anhydrous silicone gel that has been clinically shown to improve the appearance of most scars, including keloid and hypertrophic scars. This improved formula contains ingredients shown to treat the color and texture of scars by reducing inflammation and renewing the skin. The result is softer, smoother skin, and less noticeable scars. Wound Care Cream – a polyethylene glycol (PEG) gel clinically shown to promote the optimal healing environment for immediate and ongoing wound management. Our advanced base quiets the wound area and cultivates clean, moist conditions to encourage faster and more noticeable healing.

The ideal combinations of ingredients for superior skin healing. - Gel base is non-greasy, quick drying, colorless, odorless, and water-soluble - Invisible when dry - Safe for sensitive skin - Excellent anti-inflammatory and healing properties

Please call today for more information.

facebook.com/letcomedical linkedin.com/company/letco-medical

800.239.5288 • www.letcomedical.com

IACP STAFF David G. Miller, R.Ph. Cynthia E. Blankenship, Esq. Dagmar Anderson Scot Maitland Jennifer L. Petska, CPhT

Contents 4

A NOTE FROM THE PRESIDENT

SIX THINGS I HAVE LEARNED FROM COMPOUNDING PHARMACY CRISES by David A. Ball

Ashlyn Grant Michelle McMahan Macy Pruitt

Teresa Roberts

by David G. Miller, R.Ph., Executive Vice President & CEO

COMMUNICATION COMMITTEE Richard B. Moon, Pharm.D., R.Ph., FIACP, Chair Lisa Ashworth, BS, Pharm.D., R.Ph.

THE MOU – A PHARMACIST’S PERSPECTIVE

PERSONALITY OF PERSONALIZED CARE: LOREN MADDEN KIRK

Kim Hansen, R.Ph. Robert Harshbarger, III, Pharm.D. James Matthias, CPhT Linda McElhiney, Pharm.D., R.Ph., FIACP, FASHP Lauren Onsa, BA Andy Ruiz, Pharm.D., MSc, FACA Scott Wepfer, R.Ph., FIACP

THE MEMORANDUM OF UNDERSTANDING What It is, What It Says, And What Happens Next

by Scott Karolchyk, MS, RPh, FIACP

by Scot Maitland

IACP FOUNDATION HISTORY PART 1 2015

SAVE THE DATE FOR THESE UPCOMING PROGRAMS

by Lisa D. Ashworth, BS Pharm, RPh

PHOTOGRAPHY Melea Kirk Scot Maitland DESIGN Dianne Stone

IACPRx.org/Publications 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.

FLIP MAGAZINE OVER TO READ

KEEP IT

SHARE IT

RECYCLE IT

A NOTE FROM THE PRESIDENT Compounders on Capitol Hill is just around the corner. If you have not yet made plans to attend, I would like to offer my top ten reasons you should sign up NOW: 10. Discounted Travel – get discounted travel by visiting IACPRx.org/CCH and click on meeting discounts. 9. We’re Back in DC – IACP has moved Compounders on Capitol Hill back to Washington D.C.! 8. Get Away from the store to get re-energized and spend some time in our nation’s Capitol, and possibly consider bringing the family for some sight-seeing. 7. The Rx Mixer – a fun-filled night of casino games, music, dancing and live auctions to raise funds for the IACP Foundation. One highlight each year is the excitement created by Bob Brensel at the craps table. 6. Networking – an opportunity to network with some of the brightest minds in the compounding industry. Don’t forget those business cards! 5. Exhibit Hall – Did you know that IACP as more than 70 Corporate Partners? These are vendors offering every service imaginable for compounding pharmacy. This is your opportunity to stay abreast of the new services and innovations in compounding. 4. Continuing Education Credits – The opportunity to catch up on live C.E. 3. Legislative and Regulatory Updates – Learn the latest in Federal and State proposed and adopted legislation that affects our ability to provide compounding services to our patients. 2. Litigation Updates – No getting around the fact that there is always ongoing or pending litigation in our industry. 1. Visit With Your Elected Officials – This is always the number one reason IACP conducts this annual event. I can’t overestimate the importance of developing relationships with your elected representatives and their staff persons. I have found that developing a relationship with a key staff member is just as important as the relationship with the Representative or Senator. The health policy advisor for one of my Senators was in constant contact with me when legislation was being drafted, and later became the Drug Quality and Security Act. This person was so interested in knowing more about the compounding industry that he scheduled a visit at my pharmacy. Did we eventually get what we wanted? NO. But we were part of the process, and we developed relationships that will help in any future legislation. Please, if you do plan on attending CCH this year, stay for Hill Day on Tuesday, because, in the final analysis, that is THE reason we go to Washington each year.

Spring 2015 | IACPRx.org/Publications

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!

Join PPP at www.PrescriptionPartnership.com, today!

SIX THINGS I HAVE LEARNED FROM COMPOUNDING PHARMACY CRISES by David A. Ball

Our firm has worked with compounding pharmacies across the country in dealing with a multitude of crises, including patient deaths, product contamination, recalls, FDA warning letters, state board of pharmacy ceaseand-desist orders, indictments, and civil actions. We believe strongly in the mission of compounding pharmacies because their work is vital, and they sustain and save lives. Since the New England Compounding Center tragedy in 2012, this profession has been under attack in a way experienced by few others. Compounding pharmacies today operate in one of the most highly regulated environments, and they are subject to review, inspection, and scrutiny like few other organizations. At the first hint of an issue with the quality of a product, a cascade of events begins that could result in a pharmacy’s temporary or permanent closure. Sometimes the outcome is worse, and a pharmacist can be charged with a crime or personally sued. All businesses have inherent risks, such as larceny, fire, and flood, and pharmacies must manage against those risks. The risks that are specific to compounding pharmacies add an entirely separate and new layer of complexity. In thinking back to all of the pharmacies that we have been honored to help deal with a crisis, there are six clear lessons.

Spring 2015 | IACPRx.org/Publications

1. Putting Potential Crises Out of Mind is Not A Strategy—Nobody ever wants to think the unthinkable will happen to them. The odds are, however, that a compounding pharmacy will be confronted with a crisis because there are simply so many things that can go wrong. It is imperative for compounding pharmacy owners to think through the scenarios and how they would deal with them, and to have a crisis plan that is regularly updated on which staff are briefed and frequently drilled. 2. Budget for a Crisis—The one thing you will need above all else in a crisis is money. The experts to guide you, including clinical consultants, lawyers, recall specialists, and public relations practitioners, will be costly. If you need to lease satellite space, put a modular lab in place, or make emergency repairs, the costs will be even greater. Lastly, in most cases, once a crisis begins, the revenue stops. Either because a regulatory agency has shut the pharmacy down or because of a loss of customer confidence. Either way, you will need funds to get by and to take care of loyal staff. Every pharmacy should have a significant financial reserve and have access to a credit line. Don’t wait for a crisis to apply for a credit line, because you likely won’t get one. Have a credit facility in place. 3. IT is the Backbone of Your Business—Data is king, and having access to it in a crisis is essential. IT investment should be a priority for your compounding

pharmacy because it will enable your business to grow. Its value in a crisis multiplies. The right database can have a huge impact if you need to contact all customers or implement a recall. Making sure that data is backed up in a safe, accessible, off-site location is key. 4. Evaluate Your Insurance—How much is enough insurance for a compounding pharmacy? Whatever your answer is, it likely needs to be doubled or tripled. An independent insurance expert should review your business and its needs and make recommendations about the right level of coverage. Before filing an insurance claim, a public insurance adjuster can provide the expertise you need to ensure fairness in the claims process. 5. Have Your Experts on Hand—Now is the time to build professional relationships that can be a lifeline in a crisis. If you are a compounding pharmacy and your only attorney is the real estate lawyer who reviews your lease or the labor attorney who writes your offer letters, establish a relationship with an attorney that has the regulatory experience needed to successfully interact with the federal and state agencies that would be involved in a crisis. Identify a public relations practitioner who has crisis management capabilities – if you engage them to develop a crisis plan there will be no ramp-up time in a crisis.

6. Keep the Lines of Communication Open with Patients and Providers—Many organizations in crisis forget how important it is to keep customers informed during a crisis. Your website and social media sites are excellent vehicles for keeping the public apprised of your challenges and how you are dealing with them. In our experience, loyalty will be retained as long as the pharmacy keeps in contact with its key constituents. This is a new age for compounding pharmacies. The public demands the highest level of quality and compounders are providing it. Still, things can go wrong. Often, they will be things over which you have no control. So give yourself some control. It is essential to be prepared for whatever may come your way. If you are ready, you will likely weather the storm.

David A. Ball is President of Ball Consulting Group, LLC, a public relations and crisis management firm that serves the compounding pharmacy profession.

How PR Can Have an Impact In much the same way that a slow drip from the hot water heater can quickly evolve into a ruptured tank and a basement with six feet of water, the New England Compounding Center (NECC) crisis began in Fall of 2012 with one or two isolated calls to IACP from reporters wanting to learn more about compounding pharmacies. It seemed that there was a meningitis outbreak relating to a large compounding facility west of Boston and that there were now patient deaths being reported. Those early media calls led to a tidal wave of international media interest, as hundreds of patients took ill, and deaths began to be reported by the CDC seemingly every day. As details emerged about unsafe practices at NECC and a lack of government oversight, journalists were demanding answers, soon to be followed by members of Congress. IACP’s objective was clear: to educate the public about the compounding pharmacy profession and to demonstrate that the practices of NECC were in no way representative of the profession. A backlash that could have prevented patients from getting their medications and potentially put compounding pharmacists across the country out of business had to be stopped. The volume of media calls for an association with a lean staff was overwhelming. CNN, Reuters, CBS, NBC, ABC, Associated Press, The New York Times, The Washington Post, The Wall Street Journal and hundreds of other

outlets all wanted access and answers. They were waiting for the profession to say something. The risk of being unresponsive in a crisis like that is a loss of credibility among media and the members. Journalists remember not getting their calls returned and to do so would limit IACP’s future access to the media. Moreover, if the message could not be perfected and provided, the entire profession would be under an assault that would have deep and farlasting consequences. A black mark would forever be associated with the practice of compounding pharmacy. “For those who lead associations, you often have an intuitive feel about when an event is so extraordinary that outside help is urgently needed,” said IACP EVP & CEO David G. Miller, RPh. “We needed help, our members needed help, and we activated a plan to bring in the resources that we needed to gain control over the situation.” IACP engaged Ball Consulting Group, LLC, a public relations and crisis communications firm in the Boston area that had experience in, and familiarity with, compounding pharmacy issues. The firm came up with a strategy for dealing with the crisis. It developed messages, issued statements, prepared IACP leaders for media interviews, and ensured that every media call would get a response. Continued on page 9

IACPRx.org/Publications | Spring 2015

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

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

Continued from Page 7

“NECC came as a complete shock to us,” said David Ball, President of the firm. “In our many years of working with the pharmacy profession, we saw the healing, helpful work of compounding pharmacists. Now here was a situation that didn’t just contain one element of a crisis, it had virtually all of them: alleged violations of federal and state law; cover-ups and obstructed investigations; patient injuries and deaths; and investigators, prosecutors, and former employees ready to talk about the wanton disregard for professional standards and horrific safety violations that occurred there.” “We could not let the actions of NECC define this profession,” Ball said. “We put in place a strategy that maintained open lines of communications, provided journalists with essential information, and we made clear with our messaging that NECC in no way represented what this industry is about; that NECC, according to the government, was an illegal manufacturer disguised as a compounding pharmacy to evade public oversight.” “We also needed to remember at every turn,” Ball said, “that this was a national tragedy that took the lives of 64 good people – mothers, fathers, sisters, brothers – and that sickened almost 700. While the profession at large and its association were not to blame, we had to be very sensitive in everything that we said and did. The level of

human suffering, not only by the victims but among the families that depended on them, was immense.” The strategy enabled IACP to get a handle on the situation and ultimately prevented that feared backlash. While Congress did ultimately enact the Drug Quality and Security Act, the law identified a continued vital role for compounding pharmacy – a vast improvement over earlier dialogue around eliminating the practice of sterile compounding pharmacy altogether. With the crisis under control, a second phase of the strategy involved a media tour that enabled IACP to educate the media and the public about the continued need for compounding and that emphasized the high quality work and rigorous standards currently in place. One-on-one meetings were conducted with journalists from Boston, New York, Washington, D.C., and Los Angeles, and everywhere in between. IACP and its members have emerged from the cloud created by one rogue enterprise. The organization has taken a position at the forefront of Congressional dialogue over the implementation of the Drug Quality and Security Act, and the profession continues to enjoy significant growth.

NEW for 2015

Topi-CLICK® 140 Pain Management / Scar Care / HRT / Wound Care

The Best Just Got

Larger CLICK-Assist™ - The Next Generation in Topical Dosing Technology Topi-CLICK® 140

Topi-CLICK® 140

A proprietary Super-CLICKer™ mechanism is at the heart of this 2nd generation dosing system. This new technology provides stronger audible CLICKs, heavier tactile sensations and improved visual indicators. 140 mL Capacity

0.50 mL/CLICK

Topi-CLICK® 35

4X Larger than TC35 0.25 mL/CLICK

REFILL

TOPICAL DOSING APPLICATOR

Protected by U.S. Patent Nos. 7,213,994 and 7,303,349 All items 2006-2015 by Custom RX TDA, LLC.

0.50 mL/CLICK

www.DoseLogix.com 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/Publications | Spring 2015

THE MEMORANDUM OF UNDERSTANDING

What It is, What It Says, And What Happens Next

by David G. Miller, R.Ph., Executive Vice President & CEO

In 1997, the Food and Drug Administration Modernization Act (FDAMA) was enacted by Congress. In addition to addressing ways to streamline the drug approval process for branded medications, it also included the first language providing for federal oversight over compounding pharmacy practice. We short-hand reference that language as 503A to designate its section appearance within the Food, Drug, and Cosmetics Act (FDCA). In order to be exempted from specific requirements for the marketing of “new drugs” – which compounds are considered to be by the FDA – pharmacists and physicians must comply with several sections. This includes the use of bulk ingredients, the preparation of “copies” of commercially available medications, and the monitoring of interstate distribution through a memorandum of understanding (MOU). The MOU language of FDAMA’s 503A provided for three things. First, a template would be developed by the FDA and the National Associations of Boards of Pharmacy (NABP) for the states to use. Second, that the MOU would address “inordinate amounts” of compounded drug products. Third, that a state agency would be responsible for investigating complaints about compounds sent in interstate commerce. Fourth, that in the absence of an executed MOU, a traditional compounder – defined as both a physician

Spring 2015 | IACPRx.org/Publications

and a pharmacist – would be automatically limited to distributing no more than five (5) percent of their compounds out-of-state. Shortly after FDAMA was enacted and before many of the provisions of 503A could be put into place, it was challenged in court, because of language that prevented advertising, marketing or even discussions about compounded medications between physicians and pharmacists.” In a landmark Supreme Court ruling that section of 503A was deemed an unconstitutional restriction of free speech in 2002 (Thompson, et.al. v. Western States Medical Center et. al.). The Court decided the case based upon an appeal by the Department of Health and Human Services that originated within the Ninth Circuit where 503A was essentially nullified in its entirety throughout the states of California, Washington, Oregon, Alaska, Hawaii, Arizona, Idaho, Montana, and Nevada. Even though, a draft MOU had been circulated to States in the late 1990’s, the existence of the Western States challenge essentially put all further work on hold. The case was decided, and so many states were no longer required to engage in a discussion of an MOU with the FDA. As a result, all work on developing, negotiating, and instituting the FDAMA MOU stopped. That remained the case until the enactment of the Drug Quality and Security Act of 2013. In passing DQSA,

Congress removed the unconstitutional clause that had resulted in the original court challenge and reaffirmed the remaining language of 503A. For the first time since 2002, section 503A was the law throughout the country and work started again to develop the template for the MOU. Released formally for initial public comment on February 18, 2015, the MOU is still “a work in progress.” WHAT DOES THE LAW SAY Before examining the draft language of the proposed “new” MOU, it’s important to look closely at what the language of 503A says. • There’s no prohibition on interstate distribution. The first part of the 503A language requires that an MOU be put in place that addresses the interstate distribution of compounded preparations. It does not say prohibits or prevents or any other language that would disallow such an act by a traditional compounder. Just that this issue must be “addressed” in the MOU. Nothing in the language mandates that the FDA be involved, or reported to by a state agency, or anything other than the MOU has to in some manner deal with interstate shipments. • It specifically cites the term “inordinate amounts”. The MOU is intended to address (not prevent or prohibit) an undefined and nebulous quantity of compounded medication deemed “inordinate.”

THE MOU PROVISIONS IN §503A OF THE FOOD, DRUG, AND COSMETICS ACT (B) such drug product is compounded in a State– (i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or (ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician. The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).

IACPRx.org/Publications | Spring 2015

and possibly through this language acknowledged that office-use sales or distribution is what is actually to be addressed. These three points of law will no doubt form the basis of any legal challenge to the MOU and where the line is between federal authority over mail-order prescription services. THE 2015 DRAFT MEMORANDUM OF UNDERSTANDING The FDA distributed a draft MOU on February 13, 2015 and then subsequently filed that document with the Federal Register on February 18, 2015. The public – including all health care stakeholders, regulatory agencies, consumers – are invited to review and submit comments on the draft no later than June 18, 2015 through the regulations.gov website. As proposed, the MOU goes far further than the language enacted by Congress, imposing substantial actions by state regulatory agencies that agree to sign the MOU. It’s important to understand that until those comments are reviewed and considered by the FDA, the MOU still does not officially exist. A revised draft may be offered for additional comment. A revised draft may go directly to the states for signing. The original draft, without any changes to content regardless of the comments submitted, may be presented to the states for signing. What’s contained in the draft?

There is no scientific basis for the determination of what that means, especially given the varied nature of pharmacy practice and the geographies of states which are contiguous to multiple states where it’s not uncommon for patients to use an out-of-state pharmacy to meet their medical needs (e.g., New England, the Mid-Atlantic regions). Without specific definition by Congress, this is up to substantial interpretation or guesswork by a regulatory agency, , the FDA, or by the state agency that is entering into the MOU. It is entirely possible that “inordinate” may have two distinctly different meanings to each of those entities. • The law uses the terms “dispense” and “distribute.” These terms are not synonymous and are specifically used in different ways by Congress, further indicating that they are not interchangeable. Dispensing is a formal act by a pharmacist or other practitioner authorized to fulfill a valid prescription for a patient or, in some states, an office-use medication as defined both at the state level and within other sections of the FDCA. Distribution, meaning a sales transaction, is also similarly defined within the FDCA. As written in 503A, the MOU is intended to address the latter. No mention is made of the former proper and legal dispensing of medications. It does not appear that Congress intended to in any manner limit legal and appropriate interstate dispensing of valid patientspecific compounded preparations, at a minimum,

Spring 2015 | IACPRx.org/Publications

REQUIRING STATE OVERSIGHT In the draft of the MOU, if a State enters into an MOU with FDA, the State where the pharmacist, pharmacy, or physician is located must investigate complaints received regarding compounded medications distributed outside the State. Complaints that the State must investigate include adverse drug experiences or product quality issues that could lead to public health risks: •A n adverse drug experience can include an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action. •A product quality issue can include any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; any bacteriological contaminations; any significant chemical, physical, or other change or deterioration in the distributed drug product; or any failure of one of more distributed batches of the drug product to meet the applicable specifications. Contamination including mold, fungal, bacterial or particulate contamination is a product quality issue. The State investigation must include a determination of whether there is a potential public health risk or safety concern associated with the compounded medication and confirmation that any risk or safety concern is adequately contained. If a complaint is found to be valid, the State must take action to require the pharmacy

to determine the root of the problem and correct the issue, must notify FDA within 72 hours of receiving any complaint, and keep records of their actions for at least three years. Is that what the law, as written by Congress, says? While it places the responsibility for investigation of complaints squarely within the jurisdiction of the state agency, most likely the state Board of Pharmacy, it does not mandate or provide for a required reporting to the FDA within a specific time frame, nor does it define what constitutes a complaint, nor does it mandate recordkeeping. Is that what Congress truly intended? That question may have to be answered in the courts. Of particular concern to many Boards of Pharmacy is this: there will be a substantial financial burden to hire new investigators, new staff, and new technical infrastructure to comply with these requirements. This new “unfunded mandate” may have the untoward effect of preventing a state from even considering the MOU solely upon the basis of an economic impact on budgets that are already struggling with increased expenses. DEFINING INORDINATE QUANTITIES AND THE STATES’ RESPONSIBILITY In addition to the reporting requirements for adverse drug reactions or quality issues, the draft MOU requires that a State review compounding records during inspections. They need to determine whether the pharmacy, pharmacist or physician is distributing

inordinate amounts of the compounded medications interstate. This is where the definition of “inordinate amounts” appears for the first time: • “ Inordinate Amount”–If the number of units of compounded human drug products distributed interstate in a calendar month is equal to or greater than 30% of the number of units of compounded and non-compounded drug products distributed or dispensed both interstate and interstate.

–T he only exception to this rule – prescriptions that have been dispensed to an out-of-state patient at the facility in which the drug was compounded, and the patient or the patient’s agent carries that across state lines, are not counted in the calculation.

If the State determines that the pharmacy, pharmacist, or physician has in fact distributed inordinate amounts of compounded drugs interstate, the State must notify FDA within seven days. The State must also take action against the pharmacy, pharmacist, or physician that may include a warning letter, enforcement action, suspension or revocation of a license, or other action consistent with State law. The FDA may also take action against the pharmacy, pharmacist, or physician. There’s another important issue here that may require judicial interpretation. The language of 503A specifies that the issue or distributing “inordinate amounts” be “addressed”; as proposed in the draft MOU, it requires

We check your compliance before they do. Gates Healthcare Associates is a full-service pharmaceutical consulting firm with expertise in: • • • • • • • •

Strategic Planning and Business Development Quality Assurance Licensure and Accreditation Regulatory Affairs DEA/Controlled Substance Compliance Monitoring USP Compliance Pharmacy Practice and Training Compounding Lab Design

Visit our website to learn more about our capabilities. www.gateshealthcareassociates.com

IACPRx.org/Publications | Spring 2015

specific action against the compounder. That isn’t what the law says. Nothing in the law says that a state agency has to take any action—including reporting their findings to the FDA within a seven-day period. Most importantly, in this draft FDA has defined “distribution” to include individual patient-specific prescriptions. That’s dispensing and something that the law clearly cites as being different. WHAT’S MISSING? Section 503A applies to all traditional compounders and specifically defines those as pharmacists and physicians. Nothing in the proposed MOU addresses physician compounding activities nor does it address the jurisdictional conflict between a state Board of Pharmacy and a state Board of Medicine. Who will be responsible for monitoring physicians? Who will be responsible for collecting adverse event reports? Will this be shared between multiple state agencies? If so, what additional cost burden will a state incur in trying to implement the proposed MOU? The definition of a traditional compounder is also important to keep in mind because the MOU provides for actions against a pharmacist, a physician, and a pharmacy. Nothing within 503A includes the physical practice location as subject to the oversight of the FDA. Of particular concern is the noted absence of possible actions against a medical practice, an ambulatory surgery center, a hospital or any other practice location for physicians. Only pharmacies.

WHAT HAPPENS NEXT The timeline for the MOU and its eventual implementation is still unclear. What we do know at this point is that all comments on the draft must be submitted to the FDA no later than June 18, 2015. After that, the FDA will publish the final MOU and begin circulation to the states for review and adoption. The unknown: when will that happen and how long will that take? Once the states have received the MOU, each state will need to follow its internal process for review, negotiation of terms, and whether or not to agree to the MOU. That process varies significantly from state to state and will no doubt involve Boards of Pharmacy and Medicine, Attorneys General offices, and potentially legislatures. That may involve state-level hearings that are subject to public notification and publication requirements. Those hearings may need to occur at multiple occasions and could result in requests for changes to the MOU as the impact on both in-state businesses and consumers are addressed. The unknown: when will that happen and how long will that take?

Given that the ability to execute the MOU is dependent upon a state’s agreement to take on the additional reporting burdens, and the costs associated with those, state budget changes may be required. That involves submission by the Governors’ offices to the legislature, hearing and review and eventual voting by the CompoundConf_.25pgAD_3.625x4.75_ad_r3x_Layout 1 11/18/14 5:52 PM legislators, Page and then the allocation of those resources. The budget process in most states lasts for a good year.

S AV E

T H E

D AT E !

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

Spring 2015 | IACPRx.org/Publications

The unknown: when will that happen and how long will that take? There are already sufficient discrepancies between the intent of Congress, the law as written within 503A, and how the draft MOU has been presented for public comment. Although the MOU does not yet formally exist, there is no real cause for petitioning a court for redress. However, once it is final and, states begin to take it up for consideration the clock begins to count down for when a pharmacist or physician may be harmed professionally or economically by the language and can take the judicial remedy. FDAMA was enacted in 1997. It took five years for court challenges to be resolved. Might the new MOU trigger another five-year court challenge by pharmacists, physicians, and even states themselves? That’s also an unknown–and one that will be uppermost on the minds of all those impacted by these four lines of law in the DQSA. David G. Miller, R.Ph., IACP’s Executive Vice President and CEO, works with our volunteer Board and leadership to set and execute the IACP agenda. Whether working on legislation on Capitol Hill, acting as compounding pharmacy’s liaison to other pharmacy and medical organizations, or defending against overzealous government regulation, his primary responsibility is always keeping the professional and proprietary business interests of IACP members first and foremost.

THE MOU: A PHARMACIST’S PERSPECTIVE by Scott Karolchyk, MS, RPh, FIACP

On Friday, February 13, 2015, the Food and Drug Administration released four guidance documents that further explain the regulatory framework the agency intends to use in enforcing the Drug Quality and Security Act (DQSA). One of them is the Memorandum of Understanding (MOU). After reviewing FDA’s most recent MOU regarding a 30% interstate shipping cap restriction for pharmacies, it begs the question: what are we trying to accomplish with this new rule? DQSA is supposed to increase patient safety and quality of sterile compounding, yet the MOU does nothing to address these issues. It reduces patient access, restricts interstate commerce and punishes successful law abiding pharmacies. Compounding pharmacies were already regulated heavily before DQSA by our state boards of pharmacy, the FDA, out of state boards of pharmacy, NABP, and our accreditation associations. The intent of the original MOU was to limit compounders from becoming manufacturers, by limiting office use. The newly issued MOU includes patient specific, dispensed scripts. The rules have changed with no scientific or evidence basis. There should be no limit to shipping scripts across state lines as long as the pharmacy follows the laws of both their state and that of the state where the patient resides. The cap is a more restrictive 5% if a state fails to sign an agreement – a memorandum of understanding – with the FDA. This MOU has emboldened certain compounders’ arguments that other compounders should only work within their state. I disagree for reasons outlined in this article and because of principle and what’s a right of pharmacy. That attitude has been prevalent in all areas of the business when one person is more successful than another, and it’s shortsighted, ignorant and wrong. If you are good at what you do, follow the regulations and laws of your state and the state you are shipping into, there is no difference where your patient lives.

Patient access to medically necessary treatments will be compromised and limited. Compounding pharmacies are not interchangeable. Many medication formulas are proprietary and require highly trained formulators, pharmacists and technicians to prepare these doses in a safe and effective manner. Expensive capital equipment and adhering to accreditation standards are additional factors that set apart these pharmacies. The advent of modern technology and logistics has created the opportunity to service any patient’s custom medication needs from a centralized pharmacy location. With next day FedEx (and in emergencies same day delivery) and E-prescribing, the patient experience has been elevated to having the convenience of home health care services within 24-72 hours. The triad relationship is the same whether the patient lives in your state or across the country. The implementation of this MOU is an unfunded mandate, implemented by an agency of the Federal Government with no authority to tax or set fees. The State Boards of Pharmacy would incur additional costs to monitor and enforce these provisions, depending on whether a pharmacy is using the 5% or 30% standard and whether the home state signs the MOU. Limited resources are already near bandwidth and in some states already maxed so one can only imagine the extra taxpayer dollars this added requirement would cost. The main argument is that the proposed MOU does not increase patient safety or quality. In fact, these new proposals seem to benefit Big Pharma, especially where Avastin compounding is concerned and how Big Pharma is influencing the proposed changes. When recently asked by a New York Times reporter if I had proof of this statement, I answered that there was no proof I was wrong. The implementation of any MOU would force pharmacies to turn away the patients they serve. How do they explain this to their loyal and trusted prescribers that

IACPRx.org/Publications | Spring 2015

reside outside their state? Where will patients find pharmacies willing and able to serve them, case by case? Will they be accredited? Will they have the expertise and capability to prepare the treatments? But more importantly, uniformed ‘experts’ and lobbyists for Big Pharma have recently weighed in on this issue: ‘The landscape is shifting,” says Gabrielle Cosel, the manager of drug safety at Pew Trusts. “Access is very important, but you don’t want to preserve access at the expense of quality and safety.” This is a telling statement in America, proactively limit and restrict compounding in case something happens in the future. Exactly how does an MOU increase quality and safety? The FDA prides itself on being evidence based, but there is no scientific evidence on where these restrictive percentages originated. One final thought about drug safety and quality: while the FDA has set its’ eyes on compounding pharmacies, Hospira has had 52 recalls since January 2014, including IV bags of saline. It seems their primary mandate from Congress needs to be addressed. Your voices are needed by the patients you serve, by the physicians you assist, by the health professionals you work with and by your colleagues and IACP. IACP is collaborating with other pharmacy groups and the medical associations,

which recognize there are numerous problems and unanswered questions which will jeopardize and affect patients and their access to needed medications. Speak up, write and send comments to IACP and your representatives and attend Compounders on Capital Hill this June. If not now, when? David Miller, EVP of IACP, recently wrote in article that appeared in the winter 2015 Compounding Matters Quarterly that the MOU’s potential for disrupting patient access isn’t limited to pharmacies. Section 503A applies to all practitioners engaged in compounding in all settings – doctors, nurses, physician assistants, dentists, hospitals, surgery centers – the MOU will apply to then as well. Since the MOU is being created by the FDA in conjunction with the National Association of Boards of Pharmacy, IACP is asking “how will each state board of pharmacy will oversee compliance with that agreement when they have no authority over doctors, nurses, dentists, etc?” Scott Karolchyk, MS, RPh, FIACP is VP of Formulations at QmedRx Compounding Pharmacy in Maitland, Florida. He is a past President of IACP and has worked in and taught compounding for the past 30 years.

EXAKT ointment mills are used in more than 30,000 pharmacies worldwide. No matter which preparation or formula, the EXAKT ointment mill delivers elegant and effective topical applications for you and your customers. EXAKT ointment mills are engineered for easy cleaning, maintenance and operation. And our customer service makes it easy for busy pharmacies.

The compounders’ choice for more than 60 years Each ointment mill is backed with a two-year warranty, factory-trained technicians, and professional technical support. When you have questions, we’re a call or click away.

RX.com

800.866.7172

Spring 2015 | IACPRx.org/Publications

PERSONALITY OF PERSONALIZED CARE: LOREN MADDEN KIRK by Scot Maitland

Photo by Melea Kirk Welcome back to another edition of The Personality of Personalized Care. This issue we reached out to one of our student members of IACP, Loren Madden Kirk. Loren is a pharmacy student at East Tennessee State University, and I met him several years ago at IACP’s Compounders on Capitol Hill when he was interning for PCAB. I caught up with Loren right before the APhA trade show in San Diego. Scot Maitland: Loren, I have the benefit of not just being a colleague of yours, but your friend too. So I know that you’re more than just a pharmacy student. You posted a photo on Facebook, which started this conversation, can you tell our readers about the photograph?

Spring 2015 | IACPRx.org/Publications

Loren Madden Kirk: So, I’ve ridden horses competitively in multiple different disciplines since I was seven. When I would try and escape pharmacy school or try and get pharmacy school off my mind, I would go out to the barn, and I wouldn’t be able to necessary escape that. I wouldn’t be able to forget about my to-do list. Or all of the things that I needed to study before an exam. Even on horseback, when I used to be able to be able to experience was the escape. Where I didn’t have to think about anything except me and the horse and what was going on underneath me. And what was going on with the horse, how fast they were going, how slow they were going, what they were looking at. But like I said, it has now become autopilot. I’m no longer focused on the horse. I was focused on what I was supposed to be

doing instead of what I was doing right then and there on the back of a horse.

actives as well as empowering them to get involved within the profession.

So my solution to that was to try something new. So I had a break here, for spring break, and I the coach of the North Carolina Polo Team. And asked him if I could have a few lessons. And he offered a spot, and I went out and I took my first two polo lessons. Polo is, in my mind, attractive for two reasons. It’s something new; I hadn’t tried it before. And two it adds the element, a completely different element, that you’re hitting a ball from atop a horse, which is unique to any other horse discipline. There’re not many other ways of riding that involves hitting a ball into a goal from the top of a horse.

SM: So, one final question for you, what would you say to fellow student pharmacists out there who might be struggling with their course load and trying to be active and having a personal life?

SM: I think it’s brilliant that you took something that you love, but was becoming stale for you and mixed it up. You found a new way revitalize it. I know our readers can take a lot from that because pharmacy can get that way. It can become monotonous, compounding in the lab or behind the counter. Even doing patient consults can become tedious, and you can lose your passion for it. I think one of the great things about pharmacy today is the variety it offers. As I mentioned at the beginning of the interview, I met you when you were interning for PCAB and Compounders on Capitol Hill. What other things have you been up to as part of your student career? LMK: Since my time at the Pharmacy Compounding Accreditation Board, I’ve begun to focus on the broader aspects of pharmacy. I’ve worked primarily with the American Pharmacist Association’s Academy of Student Pharmacists. At this point, I am three weeks away from finishing my year-long term as the APhA-ASP Speaker of the House*. In that role, I am one of the five student pharmacists that represent over 34,000 student pharmacists across the country. It’s an honor and a privilege and quite a heavy responsibility to be able to represent those individuals and be a facilitator of all the policy and advocacy actives that APhA offers to student pharmacists. I kind of got started within the policy and advocacy realm when my chapter at East Tennessee University in Johnson City Tennessee began to approach collaborative practice within Tennessee. And how the state’s pharmacy practice act did not include provisions for pharmacists to be able to collaborate with other health care providers. So my school began to take that on as a larger issue. And I got involved with that, and it rolled on from there to where I became very interested and enjoyed the policy and advocacy side of pharmacy. And from then on I pursued a regional position with APhA-ASP and then finally was elected last year to the APhA-ASP Speaker of the House position. SM: So what’s the next step? LMK: Well that is a very good question Scot. At this point, my next step is to graduate. It has always been the constant pursuit, but I have a lot of unique experiences, that I’m very excited about planned for my fourth and final year as a student pharmacist, in that rotation year, so I’m quite, excited to hone in on those experiences and make sure I get the most out of those over the next year. But that doesn’t mean I won’t be involved extracurricular with both riding as well as APhA-ASP. I’ll likely seek a few more positions and see where I can be helpful to student pharmacists in facilitating their policy and advocacy

LMK: I would have to say that the one piece of advice is to learn to prioritize. There are times when an example is the priority. There are times when finishing a compounding lecture or finishing reviewing a lecture for a quiz, and that’s the priority. There are times when working with a group member, in order to complete an assignment for class, is the priority. There are also times when you are the priority. When you’ve been studying all night, and ultimately you are the priority at the end of the night whenever you need to get rest and go into the exam fresh. So learning those priorities is going to be able to allow you to strike a balance within life and by no means have I found the balance. And by no means have I not struggled with finding that balance. But the designation of priorities is what has allowed me to find some degree of success as I’ve worked through finding that balance within life. * Publisher’s note: at the time of the interview, Loren was still serving as the Speaker of the House for APhA-ASP.

Scot Maitland is the publisher of IACP’s two publications Compounding Matters Quarterly and Pharmacy Marketing Quarterly and host of our new IACPodcast. He coordinates with other IACP Communications staff to promote the visibility of IACP and the IACP Foundation.

SIMPLE. ACCURATE. RELIABLE. • The most USP/ PCAB compliant pump • UVA and UVB protection above USP standards • 5 bottle sizes and 4 interchangeable dosing options • The most accurate and consistent dosing • Mention you attended CCH15 to receive free shipping on first order www.topipump.com / 877-323-3376

IACPRx.org/Publications | Spring 2015

IACP FOUNDATION HISTORY by Lisa D. Ashworth, BS Pharm, RPh

Will Rogers said, “If you want to be successful, it’s just this simple. Know what you are doing. Love what you are doing. And believe in what you are doing. “ This is why, in 1991, a group of passionate compounding pharmacists formed Professionals and Patients for Customized Care (P2C2). Originally consisting of less than 300 members, its mission was to protect the birthright of pharmacy, the practice of compounding. In 1996, P2C2 changed its name to the International Academy of Compounding Pharmacists (IACP), expanded its mission and scope, and had grown to almost 4,000 pharmacist, technician and student pharmacist members. In hitting the stride of those teenage years, IACP was seeing constant change in the highly complex and everevolving world of the art and science of compounding medications for humans and animals, not unlike today, this shifting landscape presented challenges. In the Spring of 2003, the IACP Board established the non-profit IACP Foundation to acquire its own physical space for IACP and the IACP Foundation offices (that was housed at Professional Compounding Centers of America (PCCA) since its inception) and pursue growth along with endeavors to provide scientific data supporting compounding. The “Bricks, Mortar and Pestle: Building a Foundation for the Future” Capital Campaign was launched to raise $1.5 million for the new facility as well as establish an endowment to support research and education for the profession of pharmacy, specifically compounding. One million dollars would go to secure or acquire a building for IACP to establish a permanent home and prepare for growth as well as honor achievement within our profession and $500,000 to establish an endowment. Protection and 20

Spring 2015 | IACPRx.org/Publications

advancement of the compounding profession were of the utmost importance. As the first-ever permanent endowment in the field of compounding pharmacy, the Foundation pledged to fund research studies and develop programs to: • R aise awareness with consumers and healthcare professionals of the critical role compounding pharmacists play in promoting patient health • Develop and validate best practices for pharmacy compounding • Promote studies to ensure employee safety and quality of medications (e.g. effectiveness, stability) • Advocate for basic scholastic education and training necessary for compounding in pharmacy school / college curriculums • Promote programs that facilitate interested students to pursue a career in this profession (e.g. scholarships) • Enhance the credibility and reputation of pharmacy compounding The support from the compounding community was phenomenal, the goal of $1.5 million was met…and exceeded. In a suite at the Washington Court Hotel, Washington, DC in the summer of 2003, a group of around 40 pharmacists who were passionate advocates for compounded medications convened to establish the Research arm for the Foundation. Our goals were to develop a grant application process, determine what kinds of studies we wanted to fund and when we were going to start distributing funding.

Over the last 12 years, the endowment has been used in ways to educate the public and healthcare professionals in an effort to maintain the profession’s viability. Did you know that just about every pharmacy compounds? Most retail pharmacists compound something at some point, hospitals and homecare pharmacists may do both sterile and nonsterile, even prisons and jails may have a pharmacy owned by the government that employs pharmacists that compound necessary medications. Hospital ships, military installation hospitals or floating hospitals, the veterans affairs, even the mail order PBMs, nuclear and Positron Emission Tomography (PET) pharmacies, research facilities (including BIG Pharma research facilities), the National Institutes of Health, AND let’s not forget our animal companions who need sterile and nonsterile medications compounded that are supplied by veterinary schools, veterinarian, veterinarian offices, and retail pharmacies all compound. Education about how to compound, quality of all compounds, testing, stability, etc. is of the utmost importance to the IACP Foundation. In June 2004 the Foundation started an annual fundraiser aptly titled the “RxMixer” and dubbed, “A Party with A Purpose.” Since that time more than $1.6 million dollars have been raised to sustain the endowment and fund research and educational grants. Through lawsuits such as the Western States vs Tommy Thompson with the Supreme Court Ruling, Midland States vs FDA, split on estriol and the current demands from payers to provide evidence for use of compounded preparations the Foundation continues to educate patients, patient caregivers, prescribers, and pharmacists to the benefit of compounded medications. Personalized medications are becoming more personalized in both the human and animal world, and most have to be compounded. Compounding is not going away.

Keeping track of this ever evolving landscape is a challenge. The IACP Foundation and its committees are focused on providing education and research support to patients, prescribers, pharmacists, and students who are studying to become prescribers and pharmacists through scholarships to attend meetings and grants for research. “Rewind: Back to the 80’s” and join us at this year’s RxMixer – “A Party With A Purpose” to raise funds for a good cause and have fun at the same time on Sunday, June 7, 2015 in Washington D.C. during Compounders on Capitol Hill (CCH). In the next issues read more about the IACP Foundation: Part II – History of the RxMixer and the celebration of 15 years in 2019 Part III – History of Research and Education funded

Lisa D. Ashworth, BS Pharm, RPh is the Compounding Specialist and Clinical Pharmacist at Children’s Health System of Texas. She is President of the IACP Foundation and has worked in the pharmacy industry for over 35 years. References: IACP Foundation. Bricks Mortar & Pestle: Building A Foundation For The Future Campaign Brochure. 2003. 2003 Annual Meeting & Compounders on Capitol Hill, An Official Publication of the International Academy of Compounding Pharmacists. 2003 2015_RxMixer_.25pgAD_3.5x4.625_ad_rx_Layout 1 9/30/14 12:55 PM Page 1

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 :

Many people have played many roles in the formation and growth of the IACP Foundation. The original committee in 2003 consisted of: John Preckshot and Kathy Jackson as Co-Chairs ohn was the Lead for Campaign Development with J two committees: • Facilities Committee—Lead by Eric Vidrine with members of Dean King, Chuck Leiter, and Phil Pylant. • Public Relations, Marketing & Advertising Committee— Lead by Peter Ford with members of Patricia Paget, Shelley Capps, and Patti Storey Kathy was the Lead for Solicitation with three committees: • Membership—Lead by Matt Kopacki with members of Mike Stein, Jim Paoletti, Ray Moreno and Eldon Armstrong • Stakeholders—Lead by Mike Leake with members of Mike Jones, Ron Petrin and Tom Marks

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

106.14.151 IACPF Rx Mixer – 1/4 Page 4/c Ad (3.5 x 4.625”) • bertsDesign 713.825.5002

IACPRx.org/Publications | Spring 2015

SAVE THE DATE FOR THESE UPCOMING PROGRAMS Learn More at http://tiny.cc/IACPRxCalendarSpring

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.

MAY

JUNE

JULY

MAY 1–3 Contemporary Compounding– Intensive CE - A Certificate Course

JUNE 1 Pharmacy Compounding: Past, Present, and Future Webinar

JULY 17–18 Letco Medical: Veterinary Compounding Essentials

Location: Ponoma, California

MAY 8–9 Freedom Pharmaceuticals Inc. CPCSI Training Course Location: New Orleans, Louisiana

MAY 13–15 Letco Medical: Fundamental Compounding & Calculations Location: Bartlett, Tennessee

MAY 13 Webinar: 2015 OSHA Training– Bloodborne Pathogens

JUNE 6–9 Compounders on Capitol Hill– Register today at IACPRx.org/CCH Location: Washington D.C.

JUNE 20 Sterile Compounding–New Laws and Regulations 2015 Update Location: Pomona, California

JUNE 22–24 Letco Medical: Comprehensive Sterile Compounding Location: Bartlett, Tennessee

JUNE 23 Webinar: 2015 OSHA Training– Bloodborne Pathogens JUNE 26–27 Letco Medical: Compounding for Natural Hormone Replacement Location: Bartlett, Tennessee

JUNE 29–30 Letco Medical: Compounding Options for Pain, Wound, & Scar Location: Bartlett, Tennessee

Location: Bartlett, Tennessee

JULY 17–18 Freedom Pharmaceuticals Inc.: CPCSI Training Course Location: Tulsa, Oklahoma

JULY 23 Chicago, IL Regional Education Meeting Location: Chicago, Illinois

JULY 25 MEDISCA NETWORK: Preparing for a State Board of Pharmacy Compounding Practice Inspection Pro Location: Los Angeles, California

We are currently developing the 2015-2016 calendar. If you would like your compounding related events included, send an email to Macy Pruitt at macy@iacprx.org.