8
AN OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR PHARMACY LAW Volume 40 Number 5 September/October 2013 “Between stimulus and response, there is a space. In that space is our power to choose our response. In our response lies our growth and our freedom.” Viktor Fankl, Man’s Search for Meaning. I am thankful for my good fortune and for the opportunity to be involved with ASPL and its members. Yet, last week, I attended a CLE program sponsored by the Utah Bar’s Lawyers Helping Lawyers Section. No, this is not a confessional message à la Sylvia Plath or Bob Dylan. But, the topic was so interesting that it drew me to it where I found the two rooms overflowing with attorneys who wanted to get a handle on life while being faithful to that jealous mistress, the law. The title of the program was, Why Avoiding or Forcing Away Anxiety Can Make It Worse and What to Do Instead: A Discussion on Mindfulness and the Law. I should note up front that this message will sound like a dog whistle to those of you, maybe even a majority, who possess an innate equilibrium and who find nothing but positive energy in your professional practice and who remain nonplussed by the events that generate stress for some of us. We have all heard about the well-established benefits of meditation and mindfulness, but as attorneys and pharmacists, we often spend our days rushing ahead to the next crisis, client, confrontation, or deadline that lies in the non- existent future. The CLE program provided a kind of jui-jitsu approach to stress. With mindfulness practice, one leans into and recognizes stress and anxiety, and in a sense uses the psychological weight of the experience to alleviate it. Remember the challenge Dostoevsky posed? Try “not to think of a polar bear, and you will see that the cursed thing will come to mind every minute.” For anyone who’s President’s Message William Stilling ASPL President Continued on page 3 Continued on page 2 Payments To Pharmacist For Filling Internet Pharmacy Prescriptions Held To Be Illegal Bribes, Not Merely Illegal Gratuities United States v. Gracie – F.3d –, 2013 WL 5303479 (1st Cir. 2013) By Katea Ravega and Roger Morris On September 23, 2013, the First Circuit held that the District court properly sentenced a pharmacist for acts of bribery after that pharmacist pled guilty to soliciting and accepting monetary kickbacks from Internet pharmacies in exchange for filling prescriptions. The U.S. District Court for the District of Maine had accepted the phar- macist’s plea and applied a sentence according to the Sentencing Guidelines for bribery. The pharmacist appealed, arguing that the district court should have sentenced him for accepting an illegal gratuity rather than bribery. Reginald Gracie, Jr. was the pharmacist-in-charge (“PIC’) and Director of Operations for PIN Rx, LLC, a mail order pharmacy wholly owned and operated by the Penobscot Indian Nation. PIN Rx’s business included filling prescriptions for online pharmacies. The PIC before Gracie resigned because of concerns about the Internet-based prescrip- tions. Gracie admitted in his plea that he became PIC and thereafter, began accepting payment from Internet pharmacy sites for whose patients PIN Rx filled prescriptions. The payments were deposited into his personal bank account. The federal government indicted Gracie on charges related to these payments, and among other charges, Gracie pled guilty to “soliciting and accepting kickbacks” in viola- tion of 18 U.S.C. § 666(a)(1)(B). Based on this plea, the trial court sentenced Gracie to 46 months imprisonment. Gracie appealed his sentence, arguing that the court’s sentence reflected an incorrect application of the federal Sentencing Guidelines. When Gracie was sentenced, courts could craft a sentence for violations of 18 U.S.C. § 666(a)(1)(B) by choosing between the sentence for a receipt of an illegal bribe or the sentence for receipt of an illegal gratuity. If the court decided to apply the illegal gratuity sentencing guidelines, Gracie’s sentence would have been shorter. The First Circuit began its analysis by comparing a bribe with a gratuity, and de- termined that the District Court properly concluded that Gracie had accepted bribes. Bribes are distinct from gratuities because a bribe “requires a quid pro quo, the exchange of something of value for influence over some official conduct of the recipient.” Gra- cie had pled guilty to soliciting and receiving payments intended to influence him in connection with filling prescriptions. Gracie argued that the payments were gratuities because the payments awarded him for staying in his position and continuing to risk his license in questionable business. The court rejected that argument, however, noting that the charge to which he pled guilty stated that Gracie demanded and accepted the payments, which is not consistent with a gratuity or the facts. In addition, Gracie also argued that as a pharmacist, he was not a “public official” and could not be sentenced under the bribery Sentencing Guideline. This argument pointed to the background notes in the U.S. Sentencing Guidelines manual, found at U.S.S.G. sections 2C1.1 and 2C1.2, discussing bribe and gratuity recipients as public officials, and an unrelated section of the Sentencing Guidelines, U.S.S.G. § 2E5.1 (applying to labor

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Page 1: An OfficiAl PublicAtiOn Of the AmericAn SOciety fOr PhArmAcy lAw … · 2013-10-23 · An OfficiAl PublicAtiOn Of the AmericAn SOciety fOr PhArmAcy lAw Volume 40 Number 5 September/October

An OfficiAl PublicAtiOn Of the AmericAn SOciety fOr PhArmAcy lAw

Volume 40 Number 5 September/October 2013

“Between stimulus and response, there is a space. In that space is our power to choose our response. In our response lies our growth and our freedom.” Viktor Fankl, Man’s Search for Meaning. I am thankful for my good fortune and for the opportunity to be involved with ASPL and its members. Yet, last week, I attended a CLE program sponsored by the Utah Bar’s Lawyers Helping Lawyers Section. No, this is not a confessional message à la Sylvia Plath or Bob Dylan. But, the topic was so interesting that it drew me to it where I found the two rooms overflowing with attorneys who wanted to get a handle on life while being faithful to that jealous mistress, the law. The title of the program was, Why Avoiding or Forcing Away Anxiety Can Make It Worse and What to Do Instead: A Discussion on Mindfulness and the Law. I should note up front that this message will sound like a dog whistle to those of you, maybe even a majority, who possess an innate equilibrium and who find nothing but positive energy in your professional practice and who remain nonplussed by the events that generate stress for some of us. We have all heard about the well-established benefits of meditation and mindfulness, but as attorneys and pharmacists, we often spend our days rushing ahead to the next crisis, client, confrontation, or deadline that lies in the non-existent future. The CLE program provided a kind of jui-jitsu approach to stress. With mindfulness practice, one leans into and recognizes stress and anxiety, and in a sense uses the psychological weight of the experience to alleviate it. Remember the challenge Dostoevsky posed? Try “not to think of a polar bear, and you will see that the cursed thing will come to mind every minute.” For anyone who’s

President’s Message

William StillingASPL President

Continued on page 3 Continued on page 2

Payments To Pharmacist For Filling Internet Pharmacy Prescriptions Held To Be Illegal Bribes, Not Merely Illegal

GratuitiesUnited States v. Gracie – F.3d –, 2013 WL 5303479 (1st Cir. 2013)

By Katea Ravega and Roger Morris

On September 23, 2013, the First Circuit held that the District court properly sentenced a pharmacist for acts of bribery after that pharmacist pled guilty to soliciting and accepting monetary kickbacks from Internet pharmacies in exchange for filling prescriptions. The U.S. District Court for the District of Maine had accepted the phar-macist’s plea and applied a sentence according to the Sentencing Guidelines for bribery. The pharmacist appealed, arguing that the district court should have sentenced him for accepting an illegal gratuity rather than bribery. Reginald Gracie, Jr. was the pharmacist-in-charge (“PIC’) and Director of Operations for PIN Rx, LLC, a mail order pharmacy wholly owned and operated by the Penobscot Indian Nation. PIN Rx’s business included filling prescriptions for online pharmacies. The PIC before Gracie resigned because of concerns about the Internet-based prescrip-tions. Gracie admitted in his plea that he became PIC and thereafter, began accepting payment from Internet pharmacy sites for whose patients PIN Rx filled prescriptions. The payments were deposited into his personal bank account. The federal government indicted Gracie on charges related to these payments, and among other charges, Gracie pled guilty to “soliciting and accepting kickbacks” in viola-tion of 18 U.S.C. § 666(a)(1)(B). Based on this plea, the trial court sentenced Gracie to 46 months imprisonment. Gracie appealed his sentence, arguing that the court’s sentence reflected an incorrect application of the federal Sentencing Guidelines. When Gracie was sentenced, courts could craft a sentence for violations of 18 U.S.C. § 666(a)(1)(B) by choosing between the sentence for a receipt of an illegal bribe or the sentence for receipt of an illegal gratuity. If the court decided to apply the illegal gratuity sentencing guidelines, Gracie’s sentence would have been shorter. The First Circuit began its analysis by comparing a bribe with a gratuity, and de-termined that the District Court properly concluded that Gracie had accepted bribes. Bribes are distinct from gratuities because a bribe “requires a quid pro quo, the exchange of something of value for influence over some official conduct of the recipient.” Gra-cie had pled guilty to soliciting and receiving payments intended to influence him in connection with filling prescriptions. Gracie argued that the payments were gratuities because the payments awarded him for staying in his position and continuing to risk his license in questionable business. The court rejected that argument, however, noting that the charge to which he pled guilty stated that Gracie demanded and accepted the payments, which is not consistent with a gratuity or the facts. In addition, Gracie also argued that as a pharmacist, he was not a “public official” and could not be sentenced under the bribery Sentencing Guideline. This argument pointed to the background notes in the U.S. Sentencing Guidelines manual, found at U.S.S.G. sections 2C1.1 and 2C1.2, discussing bribe and gratuity recipients as public officials, and an unrelated section of the Sentencing Guidelines, U.S.S.G. § 2E5.1 (applying to labor

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American Society for Pharmacy law2

For more than a year a coalition that includes the California Society of Health-System Pharmacists and the California Pharmacists Association have been working on a Bill (SB 493) regarding “Provider Status” and “Prescriptive Authority.” The primary goals were to facilitate fee-for-service billing for clinical services, e.g., MTM and CDTM, and expand the practice scope for all California pharmacists. SB 493 will become law on January 1, 2014, but some provisions will take months to be legally able to implement via Pharmacy Board regulations or effective communication and documentation. First all lab companies have to be notified that all California pharmacists will be able to order medication therapy related lab tests, if they have documented competence and are allowed to do so by their employer. Next all California pharmacists will be able to “provide” immunizations for patients over 3 years of age, and “furnish” prescription travel medication, hormonal contraceptives, and nicotine replacement smoking cessation therapy once statewide protocols are adopted by the Pharmacy and Medical Boards. Pharmacists will have to document their

California Expands Pharmacist’s Scope, Makes Provisions for Provider Status

Contributed by Steven Gray

From the States

competence and employer authorization to perform these functions as well. Finally, the Bill creates the State Board official category of “Advanced Practice Pharmacist” (APP). It retained the State’s current CDTM provisions but provides another path to gain even more authority and official State recognition of individual pharmacists as having APP status. Recognition will be in accordance with regulations to be developed by the Pharmacy Board that will most likely take the form of criteria for recognition of certification agencies. It is expected that recognition of APPs will help implement the Provider Status goals and facilitate the role of pharmacists as part of team healthcare in Medical Homes, ACOs and other Health Systems. SB 493 is a fine example of teamwork and very difficult undertaking that could not have been successful without all pharmacists support and the help of our colleagues in medicine, nursing, optometry and government! Steven W. Gray, PharmD, JD, is Pharmacy Professional Affairs Leader in the National Pharmacy Programs and Services Office of Kaiser Permanente, in Downey, CA

Featured CaseContinued from page 1

unions and welfare benefits), which describes bribery in relation to public officials, and gratuities as everything else. Gracie argued that his decision to continue working was not an official action, and therefore he could not be bribed to do it. The court rejected this argument for several reasons. First, as PIC and Director of Operations, Gracie was legally and professionally responsible for all activities related to the practice of pharmacy within the retail drug outlet, making his ac-tions official acts. Second, the statute that he violated, 18 U.S.C. § 666(a)(1)(B), was not limited to public officials. Third, the Sentencing Guideline sections that applied,

U.S.S.G. §§ 2C1.1 and 2C1.2, state that they apply to defendants who are “public officials” and “otherwise.” Fourth, the court found U.S.S.G. § 2E5.1 irrelevant, and further noted that case law distinguishes bribes from illegal gratuities. As a result, after briefly pointing to case law that occurred while the appeal was pending but did not affect the outcome of its decision, the First Circuit denied Gracie’s appeal and the 46 month sentence based on bribery was affirmed. Katea Ravega, JD, is an Associate in Quarles & Brady’s Health Law Group, at the Phoenix office. Roger Morris, BS Pharm, JD, is a Partner and Chairman of Quarles & Brady’s Health & Life Sciences Industry Group, in the firm’s Phoenix office.

ASPL is pleased to announce that Donna Horn RPh, DPh (hon), Director of Patient Safety for Community Pharmacy at The Institute for Safe Medication Practices, has been named the 2013 recipient of the Larry M. Simonsmeier Fellowship. Established in 2011, this Fellowship awards tuition-free enrollment in the Online Master of Science in Pharmacy program at the University of Florida College of Pharmacy to a member who demonstrates leadership in pharmacy law and a commitment to the mission of ASPL. The Institute for Safe Medication Practices (ISMP) is a non-profit health-care organization that specializes in understanding the causes of medication errors and providing error-reduction strategies to the healthcare community, policy makers, and the public. Donna directs ISMP’s patient safety activities in community/ambulatory practice. She serves as an author and editor of ISMP’s four newsletters for acute care providers, nurses, ambulatory/community care providers, and consumers, publications that reach over 2 million health professionals and consumers in the US, as well as regulatory authorities and others in over 30 foreign countries. Donna is also part of the consulting service at ISMP assisting in reviewing the medication use processes in pharmacies around the country. She has more than 25 years of experience in the retail/chain community pharmacy practice setting and 10 years of experience with state and national board of pharmacy activities. The Fellowship honors the late Larry M. Simonsmeier, former ASPL executive director and president, Rx Ispa Loquitur editor, educator and all-around supporter of ASPL’s educational mission since 1974. Larry touched the lives of so many ASPL members through his friendship, selfless work and dedication.

Larry M. Simonsmeier Fellowship

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American Society for Pharmacy law 3

The ASPL Simonsmeier Award recognizes outstanding scholarship related to pharmacy law published during the previous two years and is named in honor of the late Larry Simonsmeier, former editor of Rx Ipsa Loquitur, ASPL’s newsletter. The 2013 Simonsmeier Award recipient is Jason Cetel for his article Disease Branding and Drug-Mongering: Could Pharmaceutical Industry Promotion Practice Result in Tort Liability?1

Jason’s practice at GrayRobinson’s Alcohol Beverage and Food Law primarily focuses on the rules, regulations, and business practices that govern the licensure, production,

Simonsmeier Award

marketing, sale, and consumption of distilled spirits, wine and beer. He also has experience advising clients on regulatory compliance issues for other Food and Drug Administration (FDA) regulated industries. GrayRobinson’s Alcohol Beverage and Food Law practice groups have extensive experience advising clients on regulatory compliance issues for FDA-regulated industries, including alcohol, food, dairy, and tobacco. Additionally, GrayRobinson’s Intellectual Property and Technology practice group has experience in drafting and successfully prosecuting pharmaceutical, medical device, and biotechnological patent applications, as well as managing life sciences intellectual property portfolios. In 2009, Jason received his bachelor’s degree from Vassar College with departmental honors in political science, and was awarded the Ida Frank Guttman Prize for the best thesis in political science. Jason’s award-winning

thesis analyzed the historical institutional development of the FDA’s regulatory authority over the pharmaceutical industry. In 2012, Jason received his juris doctorate magna cum laude from Seton Hall University School of Law and was inducted into the Order of the Coif. During law school, he was a member of the Seton Hall Law Review where he held positions as Associate Editor and Senior Articles Editor, and wrote his law review comment, which is the recipient of this year’s 2013 Larry M. Simonsmeier Writing Award. Jason also served as a judicial intern to the Honorable Dolores K. Sloviter, the former Chief Judge of the U.S. Court of Appeals for the Third Circuit, and has publications in the Maryland Law Review, Seton Hall Law Review, and National Association of License Compliance Professionals Newsletter.

142 Seton Hall L. Rev. 643 (2012)

Jason Cetel

camped in Glacier National Park or other remote western areas, you may relate better to thoughts of grizzly bears while trying to sleep. Several of the examples the presenters used involved just taking some time to become focused on what’s going on (e.g., by breathing deeply and paying attention) and to make choices based on whatever one discovers in that space between stimulus and response. According to the presenters, professionals who feel a great responsibility for their clients or patients, tend to ruminate on problems thereby creating a vortex of anxiety that obstructs reasoned action and accomplishment. With the Developments in Pharmacy Law XXIV at Amelia Island quickly approaching, I’m reminded about how getting away to my favorite annual meeting can evoke a certain level of angst in the days just before leaving. No matter when the meeting is, clients, judges, opposing counsel, or partners unwittingly (or for the paranoid, purposefully) conspire to make travel seemingly impossible in light of the “crisis” or emergency they create. Ah! This is when a mindful practice comes in handy. Examining such catastrophic thinking

in a focused manner reveals the worry for what it is—a polar bear. And the polar bear has no clothes. It’s simply that limbic brain screaming for attention. After all, if I stay home to address a crisis, I would miss educational programs that will benefit me, and my clients, in the long run. Perhaps more importantly, I would miss the camaraderie of friends and colleagues who I sometimes only see once a year at this ASPL meeting. Indeed, the energy I derive from memories of seeing friends and having “nights on the town” keeps me coming back year after year. Once again, science provides another benefit for attending. Ample research demonstrates that human connection is a reliable predictor of good health, happiness, and longevity. By way of one well known example, for more than 70 years researchers conducting the Harvard Grant Study followed 268 men who began college in the 1930s. The current director of the study, George Valliant, was asked what he learned from following those men for so many years. His response: “The only thing that really matters in life are your relationships to other people.” Despite the one-sided gender sample, not unusual in the 1930s, it seems reasonable to expect the same would have been said of women. The ASPL meeting in Amelia Island provides an excellent opportunity to foster relationships you’ve established and to build

new ones. For those of you who don’t know us, please introduce yourself to the ASPL Board members. No matter how long we’ve been attending the ASPL annual meeting, each of us makes new friends at every meeting and we hope you can be among them. If you bring a spouse, family, or friend, so much the better, as the trip will further cement those important ties. The ASPL Board and staff are thrilled by the response for this year’s program. We have a record number of registrants, a series of relevant educational programs with experienced speakers, and a most welcoming, warm location as the days shorten and grow colder. If you haven’t registered yet, do so quickly. With Thanksgiving approaching on the heels of the ASPL Developments in Pharmacy Law XXIV, our time there can provide us all an opportunity to take some deep breaths of ocean air and to contemplate our good fortune to be among friends; to have professions that provide financial, intellectual, and psychic rewards; and to be able to make good choices in the spaces between the stimulus and response. I look forward to seeing you all at Amelia Island and also want to be the first to wish you a happy, fulfilling, and mindful Thanksgiving.

President’s MessageContinued from page 1

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American Society for Pharmacy law4

We invite you to join us to attend 11 informative educational sessions and earn 15 hours of legal and pharmacy continuing education credits while networking with your colleagues and friends.

Register Today at www.aspl.org

November 14-17, 2013Omni Amelia Island PlantationAmelia Island, Florida

2013 Developments in Pharmacy Law Seminar XXIVAmerican Society for Pharmacy Law

Thank you to our SponsorsPlatinum Level

Walgreens

Gold LevelBulaLaw, LLCKrieg DeVault

Quarles & Brady, LLP

Silver LevelMedAvail Technologies, Inc

National Association of Boards of PharmacyRite Aid Corporation

Bronze LevelAffiliated Monitors, Inc.

Akerman Senterfitt

Akin Gump Strauss Hauer and Feld

AlixaRX

Cardinal Health

Catamaran Corporation

Cooper & Scully, PC

DaVita RX

Duane Morris, LLP

Express Scripts

Hall, Render, Killian, Heath & Lyman

Lane Powell PC

Parsons Behle & Latimer

Pharmacists Mutual Companies

Roetzel & Andress

Shook, Hardy & Bacon

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American Society for Pharmacy law 5

Thursday, November 14, 2013

9:00 am – 5:00 pm ASPL Board Meeting

3:00 pm – 5:00 pm Registration Open

5:30 pm – 7:00 pm Opening Reception

Friday, November 15, 2013

7:00 am – 5:00 pm Registration Open

7:00 am – 8:00 am Breakfast

8:00 am – 8:15 am Welcome

8:15 am – 9:45 am Legislative and Regulatory Update and Special Report on Health Care Reform

This annual session will provide an overview of recently enacted and proposed legislation and regulations that affect pharmacy.

Mary Jo Carden, RPh, JD, Academy of Managed Care Pharmacy; Stacie Maass, RPh, JD, American Pharmacists Association (1.5 credit hours)

9:45 am – 10:00 am Break

10:00 am – 11:00 am Impact and Implementation of the New HITECH Privacy Rules

In January, the Department of HHS published the final rule implementing The HITECH Act of 2009. This presentation will provide a practical overview for implementing the final rule, which becomes effective in September 2013. Information on new privacy rules under consideration, HHS privacy and security updates, and activities at the Office of the National Coordinator for Health Information Technology also will be discussed.

Susan Buckna, JD, ShopKo Stores; Kevin Nicholson, RPh, JD, National Association of Chain Drug Stores (1 credit hour)

11:00 am – 12:00 noon Pharmacy Antitrust Issues: Playing Offense and Defense in Multi-Billion Dollar Disputes

Competition in the pharmaceutical industry is the focus of ongoing antitrust litigation by pharmacies and enforcement actions by government agencies. Antitrust litigation by pharmacies and the FTC is expected to grow as a result of a recent Supreme Court decision in FTC v. Actavis regarding drug manufacturer “pay for delay” agreements. This session will provide an update on the principal antitrust lawsuits and enforcement actions that exert a major impact on pharmacies.

Don Bell, II, JD, National Association of Chain Drug Stores (1 credit hour)

12:00 noon – 1:00 pm Lunch

1:00 pm – 3:00 pm Case Law Update Once again, the U.S. Supreme Court issued several opinions

impacting pharmacy and the pharmaceutical industry. This presentation will summarize these cases and others, including rulings on cases involving pharmacy board decisions, effect of anti-kickback laws on pharmacy gift cards and coupons, HIPAA and conflicting state laws, pharmacists’ liability, ERISA and PBM duties, pharmacists’ employment discrimination claims, any willing provider laws, and more.

Roger Morris, RPh, JD, Quarles & Brady; William Stilling, RPh, MS, JD, Parsons Behle & Latimer (2 credit hours)

3:00 pm – 3:15 pm Break

3:15 pm – 5:15 pm Current Trends in the Law of Compounding Pharmacy

Due to high-profile events involving contaminated compounded products in recent months, compounding pharmacies have been the focus of increased Congressional scrutiny and FDA investigations. This session will review existing precedents regarding sterile compounding, discuss the FDA’s call for increased federal oversight of compounding pharmacies, and discuss legal implications for the practice and regulation of compounding pharmacy.

Joe Cabaleiro, RPh, Pharmacy Compounding Accreditation Board; Rachael Pontikes, JD, Duane Morris, LLP; Karen Ryle, RPh, Massachusetts Board of Pharmacy (2 credit hours)

6:30 pm – 8:30 pm Reception

Saturday, November 16, 2013

7:00 am – 8:00 am Breakfast

8:00 am– 10:00 am A Case-Based Approach to Pharmacy Ethics: Different and the Same

Study Legal and Pharmacy ethics as they deal with better rather than worse decision-making both for the client and the safe and effective use of drug products. This program attempts to explore legal and pharmacy ethics by examining decisions and incidents of the past in both professions.

Ken Baker, BS Pharm JD, Renaud Cook Drury Mesaros, PA; Bruce D. White, DO, JD, Alden March Bioethics Institute (2 credit hours)

10:00 am – 10:15 am Break

10:15 am – 11:15 am 340B Drug Discount Program: Updates and Changes Affecting Contracting Pharmacies

This session will explore the 340B Discount Drug Program, including recent issues affecting the program, and its impact on contract pharmacies.

Edward Rickert, RPh, JD, Krieg DeVault, LLP; Jaya White, JD, Krieg DeVault, LLP (1 credit hour)20

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November 14-17, 2013 - Omni Amelia Island Plantation - Amelia Island, Florida

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American Society for Pharmacy law6

Travel:Air Transportation: The Omni Amelia Island Plantation is conveniently located 29 miles from Jacksonville International Airport (JAX).

Ground Transportation: Rental Car: Eight (8) National chains service the Jacksonville International Airport: Advantage, Alamo/National, Avis, Budget, Dollar, Enterprise, Hertz, and Thrifty. Self-parking is complimentary for those who have a room in the ASPL room block. Taxi: The official taxi company servicing the Jacksonville International Airport: Gator City Taxi, (904) 741-0008. Taxi service is approximately $70 (plus gratuity) each way. Shuttle Service: The Omni Amelia Island Plantation Transportation Department (904-261-6161) provides direct service to and from Jacksonville International Airport with no additional hotel stops. Discounted rate for ASPL Seminar attendees is $30 per person (includes gratuity and tax) each way. Advance reservations is required for the discounted rate.

Continuing Legal Education CreditsIf you intend to apply for continuing legal education credits, please be sure to indicate the state (or states) in which you are licensed and the corresponding license number(s) on the conference registration form. Quarles & Brady, LLP will process the CLE credits for the Developments in Pharmacy Law Seminar. Continuing Legal Education credit will be applied for based on attendee return of the “Continuing Legal Education Credit Certificate of Attendance Form” at the conclusion of the seminar.

Participants may earn up to 15 contact hours (1.5 continuing education units) of Accreditation Council for Pharmacy Education (ACPE)-accredited continuing pharmacy education (CPE) credit. Sessions approved for CPE credit are listed with an ACPE universal activity number and number of continuing education units. To receive credit for successful completion for any activity, the participant must complete an attendance form and an activity evaluation form at the conclusion of the program. Verification of participation will be reported to the CPE tracking service, CPE Monitor, within 4 weeks after the program, and will then be accessible to participants at MyCPEMonitor.net. You will need your NABP e-profile ID to note on your CE form so that it may be reported to CPE Monitor. If you have not yet obtained your NABP e-Profile ID, you may do so by visiting MyCPEMonitor.net, creating an e-Profile, and registering for CPE Monitor. Be sure to register for CPE Monitor to ensure that your e-Profile ID is fully activated. The Washington State University College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

ACPE Continuing Education Credits

Saturday, November 16, 2013 - continued

11:15 am – 12:15 pm Globalization of the Pharmacy Profession Within the past year, major U.S. retail pharmacy chains have

expanded their international presence and purchased stakes in European and South American pharmacy chains. Each international jurisdiction has its own version of FDA, DEA, and local regulators. Each new jurisdiction presents new regulatory challenges.

Eli G. Phillips, Jr., PharmD, JD, University of the Incarnate Word, Feik School of Pharmacy; Joselia Manfio, Prati-Donaduzzi Pharmaceuticals (1 credit hour)

2:00 pm – 4:30 pm Pharmacy Law Educators This year’s pharmacy law education session will present two

specific topics. The Nuts, Bolts, and Wrenches for Developing a Pharmacy •Law Course Syllabus and How Much Is Enough or Too Much: Introducing the Legal •System to Pharmacy Law Students

(2 credit hours)

Sunday, November 17, 20137:00 am – 8:00 am Breakfast

8:00 am – 9:00 am Painful Prescription: Legal Issues and Risks for Prescribing and Dispensing Pain Medications

Given the national focus on the deaths caused by abuse of prescription controlled substances, this program will examine the various actions taken by federal and state agencies in the last year to address prescription pain medication abuse and diversion.

Shannon Cox, JD, King & Spalding; Catherine O’Neil, JD, King & Spalding (1 credit hour)

9:00 am – 10:00 am The Evolving Concept of a Pharmacist’s Corresponding Responsibility for Controlled Substances Prescriptions

This presentation will review the history of federal statutory and regulatory provisions that impose obligations on a pharmacist when dispensing controlled substances and will trace the evolution of pharmacists’ “corresponding responsibility” through federal criminal cases and DEA administrative actions. The session will provide practical guidance for pharmacists and practice pointers for attorneys representing pharmacists and pharmacies.

Linden Barber, JD, Quarles & Brady; Larry Cote, JD, Quarles & Brady (1 credit hour)

10:00 am – 10:15 am Break

10:15 am – 11:45 am Pharmacy Malpractice Panel This session will discuss the logistics of defending pharmacies

and pharmacists in malpractice cases, including suit prevention, early case evaluation and settlement possibilities, dealing with problematic facts and witnesses, and conflicts between insurers and insureds. The presentation will conclude by studying a successful malpractice defense of a pharmacy and pharmacist.

Joseph McHale, JD, Stradley Ronon Stevens & Young, LLP; Carol Romano, JD, Renaud Cook Drury Mesaros, PA (1.5 credit hours)

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American Society for Pharmacy law 7

Name: ________________________________________________________________________

Credentials: (i.e. RPh, JD, PharmD, etc.) __________________________________________

For CLE Credit, please provide:

Licensure State(s): ______________________ License #(s) ____________________________

Company: ___________________________________________________________________

Address: _____________________________________________________________________

City: ________________________________ State: ____________ Zip: __________________

Phone: _______________ Fax: ______________ E-mail: ______________________________

I want my materials electronically on a Thumb Drive

I want my materials in print via a Conference Binder

Medically necessary dietary needs: ______________________________________________

In case of emergency contact: __________________________________________________

Phone: _______________________________________________________________________

Registered guest(s): _____________________________________________________________

Payment Method: Check enclosed for full payment.

Please charge my: MasterCard Visa

Card Number: ______________________________________

Exp. Date: _______________________ CVV#___________

Name on Card: ____________________________________

Signature: __________________________________________

Please print or type participant information exactly as you would like it to appear on your badge. Please use a separate form for each registrant.

Last Day to PRE-REgistER foR sEMinaR - oCtoBER 31, 2013

Cancellation policy: Cancellations must be received in writing. You can email to [email protected] or fax to 217-529-9120. Your cancellation is null and void unless you receive confirmation of cancellation from the ASPL office. Refund of registration (less a $50 administrative fee) will be granted for cancellations received in writing on or before October 1, 2013. Refund of registration (less a $150 administrative fee) will be granted for cancellations received in writing after October 1, 2013 but on or before October 31, 2013. Refunds will not be granted for no-shows or cancellations received after October, 31, 2013 regardless of cause. In the event of a no-show or cancellation after October 31, 2013, meeting materials will be forwarded to the address provided on your registration form.

FULL CONFERENCE: By 10/31 After 10/31 ASPL Member $570.00 $645.00 Nonmember $700.00 $800.00 Spouse/Guest $225.00 $225.00 Student Tech. Paralegal $300.00 $375.00

ONE DAy REgistRAtiON: ASPL Member Fri $300.00 $350.00 Sat Sun $175.00 $225.00 Nonmember Fri $370.00 $420.00 Sat Sun $200.00 $250.00 Student Tech. Paralegal Fri $175.00 $205.00 Sat Sun $100.00 $130.00

Please indicate: Pharmacist Attorney Pharmacist/Attorney Student Technician Paralegal Other _____________

Registration fee for Seminar includes attendance at all seminar sessions, breakfast, refreshment breaks, Thursday and Friday receptions, Friday lunch and all seminar materials.

REgistER By oCtoBER 31 foR EaRLy BiRD DisCount

Total Fees: _________________ Register on-line at www.aspl.orgASPL is accepting on-line registrations at www.aspl.org

or, you can mail registration form to:

American Society for Pharmacy Law3085 Stevenson Drive - Suite 200 - Springfield, IL 62703

or fax to: 217-529-9120. Payment must accompany registration.

Direct registration questions to Janet Bascom at [email protected] or 217-529-6948

ASPL is a 501(c)(3) non-profit, voluntary professional association and all contributions are fully tax deductible. The ASPL Federal Tax ID Number is: 52-1250852.

2013 Developments in Pharmacy Law Seminar XXIIIOmni Amelia Island Plantation - Amelia Island, Florida

Sponsored by: American Society for Pharmacy Law

To Register Online Now!

Please indicate which meals you/guests plan to attend:Thursday Reception Friday Breakfast Lunch Reception Saturday Breakfast Sunday Breakfast

Page 8: An OfficiAl PublicAtiOn Of the AmericAn SOciety fOr PhArmAcy lAw … · 2013-10-23 · An OfficiAl PublicAtiOn Of the AmericAn SOciety fOr PhArmAcy lAw Volume 40 Number 5 September/October

American Society for Pharmacy law8

Presorted First Class MailU.S. Postage

PAIDSpringfield, IL

Permit No. 500American Society for Pharmacy law3085 Stevenson Drive, Suite 200Springfield, IL 62703

Editor: William E. Fassett, PhD, RPh Professor of Pharmacy Law & Ethics Washington State University [email protected]

Contributing Editor: Roger Morris, JD Quarles & Brady, LLP [email protected]

ASPL Business Office: 3085 Stevenson Drive, Suite 200 Springfield, IL 62703 217-529-6948 Phone 217-529-9120 Fax

Board of directors

President

William Stilling

President elect

Laura Carpenter

treasurer

James Boyd

immediate Past President

Donna Horn

directors

Aaron Moore

Steve Gray

Brian Guthrie

Michael Yount

executive director

Nathela Chatara [email protected]

Rx Ipsa Loquitur September/October 2013

©2013, American Society for Pharmacy Law

All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the written permission of the copyright holder.

Complete Board contact information can be found on the ASPL website

www.aspl.org

Register Todaywww.aspl.orgEarly Bird Registration Ends October 31.

Developments in Pharmacy Law Seminar XXIV

November 14-17, 2013

Omni Amelia Island Plantation ResortAmelia Island, Florida