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AN OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR PHARMACY LAW

Volume 44 Number 4July/August 2017

Overflowing with outdoor adventure, fun in the sun, and thrilling Western-style escapades, Scottsdale, Arizona is a spectacular destination for our 28th Developments in Pharmacy Law Seminar November 2-5 at the Hotel Valley Ho. ASPL’s vision statement is to be the first sought, most comprehensive, and most accessible source for information and education about United States Pharmacy Law. Consistent with this vision, our Education Committee has created an insightful and relevant course of learning for our time in Scottsdale. Now, all we need is you! Last year’s Developments in Pharmacy Law Seminar in Austin, Texas saw records in attendance, 270, as well as first time attendees, 74. I am confident that, with your help, we can surpass those numbers in Scottsdale. The strength of ASPL is attributed to our members and their engagement and the Developments in Pharmacy Law Seminar showcases the diverse collection of professionals interested and dedicated to the law as it applies to pharmacy, pharmacists, wholesalers, manufacturers, state and federal government and other interested parties. Plan to attend, encourage those unfamiliar with ASPL and the Developments in Pharmacy Law Seminar to attend and come learn and network with your peers. And, while in Scottsdale, enjoy what the area has to offer.Visit downtown Scottsdale, rich with history and filled with the spirit of both the new and Old West. Downtown is composed of

President’s Message

Michael YountASPL President

Continued on page 2

See you in Scottsdale!

Continued on page 2

Featured CaseMasters Pharmaceutical, Inc. v. Drug Enforcement Administration

864 F.3d 206 (2017)U.S. Court of Appeals for the D.C. Circuit denies

wholesale distributor’s bid to overturn the revocation of its DEA registration

By Roger N. Morris and Christopher T. Dang

On June 30, 2017, the U.S. Court of Appeals for the D.C. Circuit denied wholesale drug distributor Masters Pharmaceutical, Inc.’s (“Masters”) petition for review which sought to overturn the DEA’s revocation of Masters’ DEA registration. The roots of the litigation began in October 2008 when the DEA issued Masters an order to show cause as to why the DEA should not revoke its registration. The order alleged that Masters had “failed to maintain effective controls against diversion” of hydrocodone by failing to notify the DEA when “rogue Internet pharmacies” placed suspicious hydrocodone orders and failing to perform adequate due diligence prior to filling such orders. The DEA and Masters settled these initial charges in April of 2009. As part of the settlement, Masters agreed to pay $500,000 and bring the company into compliance with DEA regulations. This required the implementation of a compliance system to detect and report suspicious orders and to prevent diversion of controlled substances into illegal channels. The compliance system included computer monitoring to identify and hold orders that met or exceeded the definition for suspicious orders under 21 C.F.R. § 1301.74(b) (i.e., “orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency”). If an order was held, Masters’ staff would implement an investigative protocol to determine whether the order was legitimate. If the order could not be deemed non-suspicious, Masters was to treat the order as “suspicious,” report it to the DEA, and decline to fulfill it. In August of 2013, the DEA issued a second order to show cause alleging that Masters had “consistently ignored and/or failed to implement” the required policies and comply with the reporting requirements. The order also alleged that Masters had filled orders for millions of dosage units of oxycodone to eight illegitimate pharmacies in Florida and Nevada. In 2014, an Administrative Law Judge (“ALJ”) sided with Masters, finding that it had only appeared to shirk its duty to report a suspicious order in one instance and concluding that revocation was not warranted. The ALJ also found that Masters’ investigations into the orders were sufficient. The Acting Administrator of the DEA subsequently rejected the ALJ’s first recommendation, concluding that the ALJ’s interpretation of the suspicious orders reporting standard (that reports were mandated if Masters had found it “likely” that the order would be diverted) was not correct. Rather, Masters had an obligation to report if there was a suspicion, which meant “[t]he apprehension or imagination of the existence of something wrong based . . . on inconclusive or slight evidence.” According to the Acting Administrator, under this

American Society for Pharmacy Law2

President’s MessageContinued from page 1

Featured CaseContinued from page 1

ASPL is a nonprofit professional association for individuals with an interest in legal issues as they pertain to pharmacy, pharmaceuticals and related products and services. The ASPL annual seminar brings together over 250 industry professionals to share the most up-to-date, relevant and practical information. Seminar goals include:• Educate attendees on current and relevant information on wide-ranging

pharmacy law issues.• Provide pharmacy law educators with learning opportunities on the latest

teaching methodologies and course curriculums relevant to pharmacy law education.

• Assist attendees with continuing education requirements through a program comprised of speakers and topics that offer 14-16.5 hours of continuing legal and pharmacy education credits to pharmacists, attorneys, pharmacist-attorneys and pharmacy-law educators.

2017 ASPL Fall MeetingHotel Valley Ho - Scottsdale, AZ

November 2-5, 2017

a unique collection of shops, restaurants, galleries and nightclubs. In addition to being pedestrian friendly, the area is home to a free trolley service that makes getting around even easier. Constantly evolving, downtown is perfect for those who desire an authentic taste of Arizona’s history and culture or for travelers who seek a chic, urban escape with the finest in dining and entertainment. The Arts District holds more than 70 art galleries and comes to life every Thursday night from 7 to 9 p.m. with the country’s original event of its kind, Scottsdale ArtWalk, along Main Street and Marshall Way. There’s also the Scottsdale Waterfront which features ample public open space, an outdoor amphitheater, recreation paths along the canal, and eye-catching public art. Scottsdale’s Fifth Avenue District combines the ambiance of old Scottsdale with some of Arizona’s best restaurants, unique shops, salons, contemporary art and Native American galleries, upscale jewelers and nightlife. Nearly 30 eateries and more than 80 specialty shops are within a five-minute walk of Bob Parks’ Horse Fountain, one of Arizona’s most photographed spots. Stroll through Old Town and be taken back in time to the original Scottsdale, the

heart of the “West’s Most Western Town” that began more than 100 years ago. Amidst eight designated historic buildings lie treasures that range from Western wear and Southwest jewelry to home décor and dining. And, let’s not forget about our host hotel, Hotel Valley Ho! Scottsdale has been the desert playground of choice for celebrities since the 1950s when classic Hollywood stars like Zsa Zsa Gabor and Bing Crosby graced the corridors of Hotel Valley Ho with their elegant style and charm. By 1957, most of Hollywood had found its second home at the resort – and in Scottsdale – when Robert Wagner and Natalie Wood said their “I dos” at the now historic property. Hotel Valley Ho’s tennis courts also were stomping grounds for several stars, and the lobby lounge was a favorite of Jimmy Durante, who would fight fits of insomnia with spontaneous concerts on the hotel piano. More recently, the Hotel Valley Ho has welcomed actor Hugh Jackman, actress Diane Keaton, rapper and actor Ice Cube, singer and actor Jamie Foxx, the band Vampire Weekend (okay, I have no idea who this is but maybe there’s a Vampire Weekend pharmacy lawyer that’s never been to the Developments in Pharmacy Law Seminar and will now attend due to this Vampire Weekend shout out), and world-renowned cellist Yo-Yo Ma. And, in November, the Hotel Valley Ho will welcome you! See you in Scottsdale!

definition, Masters had violated the reporting requirement on hundreds of occasions by not reporting orders held by its computer system, deleting held orders or reducing their size so as not to trigger the holds, and accepting explanations from pharmacies for the held orders rather than taking steps to confirm their accuracy or plausibility. Moreover, even when Masters had information that confirmed a suspicious order, the DEA contends that it still failed to report the orders to the DEA. As a result, the Acting Administrator concluded that revocation was warranted. Masters then appealed to the U.S. Court of Appeals for the D.C. Circuit. Part of Masters’ appeal centered on the Acting Administrator’s conclusion that any held order was suspicious under 21 C.F.R. § 1301.74(b) and the Acting Administrator’s subsequent factual findings. In affirming the Acting Administrator’s decision, the Court found that there was substantial evidence to support the DEA’s finding that any order for controlled substances held by the company was suspicious within the DEA’s regulation requiring distributors to report suspicious orders to the DEA. This was because Masters’ system was designed to detect deviations in orders when they exceeded certain parameters. Accordingly, by their nature, held orders were “unusual” and not “normal.” The Court therefore found that it was reasonable for the Acting Administrator to take the position that held orders met the definition of suspicious order under 21 C.F.R. § 1301.74(b) unless Masters’ staff dispelled the suspicion. Based on this interpretation, the Court further found that there was substantial evidence supporting the DEA’s finding that the Masters had repeatedly failed to report suspicious orders. The Court ruled against Masters’ other procedural challenges and denied Masters’ petition for review.

Roger N. Morris, JD, RPh, is Partner and national chair of Quarles & Brady’s Health Law Practice Group and Christopher Dang, JD, is Associate at Quarles & Brady’s Phoenix office.

American Society for Pharmacy Law 3

Developments in Pharmacy Law Seminar XXVIII


November 2-5, 2017

Thursday, November 2, 2017

3:00 p.m. to 5:00 p.m. Registration Open

5:30 p.m. to 7:00 p.m. ASPL Opening Reception

Friday, November 3, 20177:00 a.m. to 5:00 p.m. Registration Open

7:00 a.m. to 8:00 a.m. Breakfast

8:00 a.m. to 8:30 a.m. Opening Welcome, Installation of 2018 Officers and Board of Directors

8:30 a.m. to 9:30 a.m. What’s Now in the Mix? Compounding Four Years

after NECC and the DQSA 0071-9999-17-018-L03-P (1.0 credit hours, 0.10 CEU*) This session will briefly address the state of compounding

since the passage of the DQSA. The session also will provide an overview of the current federal regulation of compounding, touching on issues involving inspections, recalls, administrative actions, and criminal and civil actions involving pharmacies and outsourcing facilities. It will also address looming issues for compounders including the new “prescription requirement,” anticipatory compounding, draft guidance addressing “essentially copies,” the state of the draft FDA/state MOU, and importantly, the effect, if any, of the Trump administration’s executive actions on FDA’s enforcement activities under 503A and 503B. Lastly, Ms. Palmer will discuss FDA’s bulk substances positive and negative lists and the quarterly meetings of the Pharmacy Compounding, Advisory Committee addressing the bullks list.

Karla Palmer, JD, Hyman Phelps & McNamara, PC

9:30 a.m. to 10:30 a.m. Goldilocks: Applying the Healthcare and IRB Law

and Ethical Policy to Big Data Companies for Ethical Use--Too Much, Too Little, or Just Right?

0071-9999-17-019-L03-P (1.0 credit hours, 0.10 CEU*) In the healthcare industry, regulations and historical

practice, (both positive and negative) have shaped the foundations of ethical collection, analysis and use of sensitive data. However, in the era of big data and companies beyond healthcare, is egregious history destined to repeat itself when it comes to use of private data and information, or can we prevent damage by providing and applying the healthcare framework to big data companies? We will explore this host of potential ethical dilemmas in this session.

Erin Albert, RPh, MBA, PharmD, JD, PAHM, Myers and Stauffer, Pharmacy Podcast; Valita Fredland, MA, JD, Indiana University

10:30 a.m. to 10:45 a.m. Break

10:45 a.m. to 11:45 a.m. PBM Contracting, Reimbursement And Auditing

Issues 0071-9999-17-020-L03-P (1.0 credit hours, 0.10 CEU*) Most states have enacted legislation that impact contracts

between pharmacies and PBMs, such as limits on audits, any willing pharmacy laws, and reimbursement standards including limits on Maximum Allowable Cost (MAC) lists. At the federal level, legal standards address pharmacy networks and reimbursement in the Medicare, Medicaid and Tricare programs. Contractual relations may undergo even greater transformation in the near future as a result of legislative and regulatory proposals related to healthcare reform. Meanwhile, PBMs recently succeeded in litigation challenging a major state PBM law, which may be a harbinger of future efforts to limit or eliminate states’ PBM standards. Pharmacies are also involved in litigation against PBMs, challenging network access limits, reimbursement policies and other PBM contracting practices. In this session two presenters will offer the pharmacy and PBM perspectives on contracting issues and the future of pharmacy-PBM relations.

Don Bell, JD, National Association of Chain Drug Stores; Barbara Levy, JD, PCMA

11:45 a.m. to 12:30 p.m. Lunch

12:30 p.m. to 12:45 p.m. Annual Meeting

1:05 p.m. to 2:05 p.m. CONCURRENT SESSIONS

The Benefits and Legal Implications of Community-based Telepharmacy

0071-9999-17-026-L03-P (1.0 credit hours, 0.10 CEU*) Telepharmacy, the delivery of pharmacist supervised

products and professional services via telecommunications, is revolutionizing the way pharmacists operate, dispense pharmaceuticals and take care of patients. Discussions on telepharmacy are growing, as is the urgency to implement remote-dispensing solutions across the United States. But what is community-based or outpatient telepharmacy? How can we use telepharmacy to benefit patients in a variety of settings? What does the regulatory environment look like? How can you go about creating or changing the telepharmacy regulations in your state? Join us for an informative discussion about the evolution of telepharmacy, the current regulatory environment and how it’s helping pharmacists improve patient outcomes in underserved areas. We’ll dive into the details of the past, present, and future of telepharmacy, including the different types, how the patient

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benefits, use cases, the regulatory environment, opportunities to improve care and what states are currently doing with rules surrounding the practice of remote dispensing.

Adam Chesler, PharmD, Cardinal Health; Michael Moné, BSPharm, JD, FAPhA, Cardinal Health

The DEA Is Here to Stay: Recent Enforcement Actions and Using Your Own Data to Protect Against Diversion

0071-9999-17-022-L03-P (1.0 credit hours, 0.10 CEU*) In 2016 and 2107, the Drug Enforcement Administration

(DEA) continued its industry-wide enforcement actions against wholesalers and large pharmacy companies that distribute and dispense controlled substances regulated under the Controlled Substances Act. Since 2013, over $300 million in fines and penalties under the Controlled Substances Act were recovered, including record-setting settlements with major retailers and distributors. In this session, we will cover recent federal enforcement trends of the Department of Justice and DEA and the challenges presented to pharmacies and wholesalers. We will discuss both typical and evolving red flag metrics targeted by DEA and how metrics may reflect patterns of ordering, prescribing, and dispensing that can be aligned with either diversion or legitimate business practices and, in some instances, both. Finally, we will discuss actions that pharmacies and wholesalers can take using their own data and compliance practices to proactively identify and address risk.

Larry Cote, JD, Quarles & Brady LLP; Crystal Pike, MBA, Analysis Group, Inc.; Barbara Rowland, JD, Post & Schell, P.C.


The Anti-Kickback Statute – Pitfalls and Safe Harbors 0071-9999-17-023-L03-P (1.0 credit hours, 0.10 CEU*) The federal Anti-Kickback Statute (AKS) poses significant legal

risks for pharmacies. The AKS broadly prohibits offering, paying, or receiving anything of value in exchange for the referral of federal health care program patients or business. Violations of the AKS can result in significant civil penalties, exclusion from participation in federal health programs, criminal fines, and imprisonment. AKS violations can also trigger liability under the False Claims Act. Because of its scope, the AKS can implicate a variety of pharmacy operations from supplier agreements to consumer marketing programs. This program will provide an overview of the current AKS regulatory scheme, including prohibited conduct and recently expanded safe harbors. The program will also review enforcement actions and discuss how pharmacies can identify potentially problematic programs.

Shannon Cox, JD; Stephen Cummings, JD; Meredith Young, JD, King and Spalding LLP

Retaliation Alleging Defamation by Pain Mill Doctors 0071-9999-17-024-L03-P (1.0 credit hours, 0.10 CEU*) In response to the more stringent constraints imposed by

the DEA and regulatory requirements of pharmacy, a wellspring of litigation alleging defamation by “pill mill” doctors against pharmacists and retail pharmacies refusing to fill their prescriptions has developed. This presentation is designed to acquaint the group with the legal ramifications arising from an allegation

of defamation/ tortious interference in a civil suit as well as a pharmacist’s standard of care when interacting with customers. A focus of this presentation will discuss the landmark holding in the LeFrock vs Walgreens case wherein the Federal District Court ruled that a qualified privilege exists between a pharmacist and their customer. This discussion will include the extent of this privilege and its ramifications related to consultation between pharmacists and their customers. Next will be discussed the topic of appropriate statements and, as importantly, inappropriate statements by pharmacists related to the non-filling of a prescription due to issues of DEA noncompliance. Examples will be provided from real case experience.

Arthur Laplante, Esq, Hinshaw and Culbertson; Martin Stern, JD, Hinshaw and Culberton; Bret Stacey, JD, Walgreen Co.

3:10 p.m. to 3:25 p.m. BREAK


Everything’s Coming Up Roses, But Watch for the Thorns!: Expanding Pharmacist Scope of Practice and Related Legal Issues

0071-9999-17-025-L03-P (1.0 credit hours, 0.10 CEU*) Pharmacists are no longer just dispensers of prescriptions

drugs. Starting with flu shots, over the past couple of decades, pharmacist services gradually have been expanding to include many other activities to better serve patients. Now, pharmacists provide not only flu shots but several other services as well. However, with these new opportunities come new or expanded legal responsibilities and risks for pharmacists and pharmacies. After starting with a brief history of the expansion of pharmacist scope of practice, the presentation will discuss the current reach of pharmacists’ expanded practice and where else it may lead, as well as potential roadblocks. It will then proceed to give a lay of the land regarding state and federal laws impacting this evolving area, moving on to identify potential future legal changes impacting the expanding practice of pharmacy. Lastly, the potential risk areas related to expanded scope of practice will be examined and illuminated by examples.

Mary Ellen Kleiman, JD, CAE, National Association of Chain Drug Stores

Prescription Drug Monitoring Programs - Solution to the Opiate Epidemic?

0071-9999-17-021-L03-P (1.0 credit hours, 0.10 CEU*) In this era of ever-burgeoning information technology,

Prescription Monitoring Programs (PMPs) continue to flourish and expand as a valuable tool to: 1) effectively regulate the dispensing of controlled substances; 2) reduce abuse of prescription opioids; 3) promote access for legitimate medical needs; and 4) provide timely information to support a prescriber’s clinical judgment while maintaining the privacy of protected health information. PMPs have rapidly grown across the country, with 49 states having implemented PMPs in some form, but many regulatory and technological differences remain, creating a barrier to effective data sharing by clinicians in different jurisdictions.

The presenters will discuss the dilemmas that PMPs present, including the various regulatory issues surrounding their creation and implementation; limiting access to authorized


users; administrating the programs on a multi-state level; privacy concerns; the current lack of clarity for the practitioner in accessing the data; additional professional time commitments by prescribers and dispensers; and the potential for under-prescribing for patients with genuine medical needs while providing appropriate access and regulating controlled substances for legitimate medical needs.

The presenters will address possible approaches to coordinating PMPs across state lines, showing how PMPs can be effective for curtailing inappropriate dispensing within the state, amongst states and potentially on a national scale.

Joseph Bova, MS RPh, Long Island University (LIU Pharmacy); Frederick Fern, RPh, Esq., Harris Beach PLLC; Marina Plotkin, RPh, Esq., Harris Beach PLLC

4:30 p.m. to 5:30 p.m. The Controversy over Prescription Drug Pricing 0071-9999-17-027-L03-P (1.0 credit hours, 0.10 CEU*) There has been a great deal of attention in the media over

the prices of prescription drugs. Drug manufacturers receive most of that attention but pharmacy benefit management companies (PBMs) and others in the chain of distribution receive their share. Pricing is a very complicated subject with unknowns at every turn. In this session, we will present the historical development of prescription drug pricing including but not limited to the cash system, along with the genesis of dispensing fees, rebates and discounts, including the birth of the PBM industry and the evolution of tiered formularies with attendant cost containment features. We will cover the changes in aggregate prescription drug prices and annual increases over time, in the United States, and will address generally pricing in other developed countries especially those in Europe. We will address the high cost therapies and methods to allow patient access to them (e.g. Prescription Assistance programs and copay foundations). We will also address the relevant regulations and policies used by the federal government and states to administer Medicaid and Medicare while controlling costs. Finally, we will address 340B programs and their development and implementation.

Francis Palumbo, PhD, JD, University of Maryland; Lee Rosebush, PharnD, MS, MBA, JD, Baker & Hostetler

6:30 p.m. to 8:30 p.m. Casual Dinner

Saturday, November 4, 2017

8:00 a.m. to 9:00 a.m. What’s Coming Down the Pipeline: State Legislative

and Regulatory Trends that impact the Practice of Pharmacy

0071-9999-17-028-L03-P (1.0 credit hours, 0.10 CEU*) This presentation will provide examples of current proposed

and recently enacted legislative and regulatory trends across the states that are being used to address specific problems in the pharmacy industry, including prescription drug abuse, medication interaction notifications and reimbursement.

Laura Carpenter, JD, RPh, LLM, Bula; Melissa Hornberg, JD, Bula

9:00 a.m. to 10:00 a.m. Marijuana Regulation and Implementation Challenges 0071-9999-17-029-L03-P (1.0 credit hours, 0.10 CEU*) The status of marijuana regulation in the US encompasses a

confusing federal policy of criminalization, and a patchwork of state legislation; twenty-eight states have passed medical marijuana laws, while eight states and the District of Columbia have approved recreational use.

Federally, marijuana falls within schedule I of the Controlled Substances Act of 1970, having been determined to have “a high potential for abuse” with “no currently accepted medical use in treatment in the United States” and “a lack of accepted safety for use of the drug or other substance under medical supervision.” (21 U.S.C. 812(b)(1)). However, the FDA states that it is willing to accept studies indicating safety and effectiveness of cannabis for medical purposes, and the Department of Justice currently does not prosecute conduct in compliance with state laws. Recent statements from a new administration reflect the potential for a new federal policy or approach may be forthcoming.

Meanwhile, as a result of state electoral victories, marijuana possession, use and regulation is treated very differently in various states. Implementation of these laws has not been simple, and issues consistently arise regarding physician professional conduct and first amendment protections for prescribing and treating patients; guidelines for production and sale of marijuana; and conflict of law resolution involving supremacy clause considerations.

Livia Cook, JD, The University of Arizona; Elizabeth Hall-Lipsy, JD, MPH, The University of Arizona

10:00 a.m. to 10:15 a.m. BREAK

10:15 a.m. to 12:15 p.m. Case Law Update 0071-9999-17-030-L03-P (2.0 credit hours, 0.20 CEU*) This annual summary provides pharmacists, compliance

personnel, and attorneys an overview of the most important court decisions, lawsuits, and settlements from October 2016 to present. Presenters will address a variety of industry-specific civil and criminal liability issues, including pharmacy employment claims, False Claims Act cases and settlements, managed care and antitrust actions, state regulatory boards’ authority to discipline licensees, and more.

Roger Morris, RPh, JD, Quarles & Brady LLP; William Stilling, RPh, MS, JD, Kimball Legal

2:00 p.m. to 3:15 p.m. Pharmacy Law Educators: Results of the Law and

Ethics Benchmarking Survey Coverage 0071-9999-17-031-L03-P (1.25 credit hours, 0.15 CEU*) We will be reviewing the results of a survey sent to all U.S.

colleges and schools of pharmacy which provides characteristics of pharmacy law and ethics courses. The results provide a glimpse into how institutions deliver pharmacy law and ethics education including: instructor characteristics, topics covered, assessment strategies, resources used, and several other areas.

Erin Albert, RPh, MBA, PharmD, JD, PAHM, Myers and Stauffer, Pharmacy Podcast; Geoffrey Mospan, PharmD, BCPS, Wingate University School of Pharmacy



3:15 p.m. to 4:30 p.m. Pharmacy Law Educators: Standards Update

and How to Prepare Students for the MPJE/CPJE, Discussion on MPJE study strategic methods and pedagogy, The Pharmacy Law Case Law Compendium - how to use it in the classroom

0071-9999-17-032-L03-P (1.25 credit hours, 0.15 CEU*) Panel members will lead an interactive discussion regarding

the structure of the MPJE and CPJE, best study methods and how to best prepare student pharmacists for examination.

Shannon Panther, PharmD, BCACP, Washington State University; Fred Brinkley, Jr., RPh, MBA, University of Texas at Austin College of Pharmacy; Robert Stein, PharmD, JD, Keck Graduate Institute School of Pharmacy

Sunday, November 5, 2017

7:00 a.m. to 12:00 p.m. Registration Open

7:00 a.m. to 8:00 a.m. Breakfast

8:00 a.m. to 9:00 a.m. The Intersection of Specialty Pharmacy and the Law 0071-9999-17-033-L03-P (1.0 credit hours, 0.10 CEU*) This session will highlight the specialty pharmacy business

model that drives unique legal issues. It will then provide a high level overview of the primary laws at issue. The speakers will apply the law to the unique specialty pharmacy business aspects highlighting the issues in specialty pharmacy that are not typical in the retail pharmacy space.

Abby Kaplan, JD General Counsel and Chief Compliance Officer, Avella Specialty Pharmacy; Shannon Wiley, JD, Bass Berry & Sims

9:00 a.m. to 10:00 a.m. Import at Your Own Risk: Why Canadian Pharmacies

Are Not the Answer 0071-9999-17-034-L03-P (1.0 credit hours, 0.10 CEU*) On any given day, thousands of websites claim to be selling

Health Canada-approved medicines to consumers online. One in four Americans buy medicines online according to the US FDA, yet 96% of the websites pushing medicine are operating illegally with many of those sites feigning legitimacy using the words “Canada” or “Canadian pharmacy.” Unfortunately, this is rarely true. These sites often sell counterfeit, unapproved and otherwise illegal medicines to patients, operate without the required pharmacy license, and sell prescription medicines without a prescription. Instead, Canadian drug sellers sell US consumers medicines from India, Turkey, and Southeastern Asia, feeding a bifurcated supply chain filled with counterfeit medications containing toxins, adulterants, or an unsafe level of drug. This patient safety issue has been thrust into the spotlight, given the introduction of federal legislation permitting online medicine sales from Canadian pharmacies. This issue raises important legal and safety concerns, especially when coupled with the growing opioid epidemic, rising cost of drugs, and changes in payment and coverage that threaten to limit patient access to medicines

through traditional pharmacies. Speakers from the Alliance for Safe Online Pharmacies (ASOP Global), an international nonprofit organization dedicated to protecting patient safety online, and the National Association of Boards of Pharmacy propose to discuss recent federal legislative and administrative efforts that would encourage US patients to buy “Canadian” medicine online. Bios below. During their presentation, Libby, John, and Marty will educate on new legal and regulatory developments, share new data on Internet pharmacy studies, and provide tips to lawyers whose pharmacy and pharmacist clients may be impacted by the trend of internet sales of medicines.

Libby Baney, JD, Alliance for Safe Online Pharmacies; Ronald Guse, National Association of Boards of Pharmacy; John Hertig, PharmD, MS, CPPS, Purdue University College of Pharmacy

10:20 a.m. to 11:20 a.m. Discipline Sanctions for Dispensing Errors:

Impediment or Aid to Patient Safety? 0071-9999-17-035-L03-P (1.0 credit hours, 0.10 CEU*) Pharmacists are held to an absolute standard of perfection

for dispensing prescriptions correctly, yet every dispensing pharmacist misdispenses drugs from time-to-time. This presentation will explore: (i) how states address single dispensing errors; (ii) factors that increase the likelihood that an error will be reported to a board of pharmacy; (iii) comparison of laws and policies governing discipline for errors between pharmacists and other health care professionals; (iv) the continuing evolution of segmented and central fill pharmacy systems; (v) allocation of fault within segmented and central fill dispensing systems; (vi) the effect of state disciplinary laws on workload balancing and other new systems designed to increase patient safety; (vii) the application of a just culture model to pharmacy errors; (viii) the use of disciplinary proceedings by plaintiffs’ counsel and effect on such proceedings on civil litigation; (ix) how to address public and political concerns and pressure about pharmacist errors; and (x) suggestions for error prevention without licensure sanctions. The presenters expect that this program will engender a lively discussion among attendees and invite attendees to contribute their insights into these issues.

William Stilling, RPh, MS, JD, Parsons Behle & Latimer; Michael Simko, RPh, JD, Walgreen Co.

*Activity Type = Knowledge


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LAST DAY TO PRE-REGISTER FOR SEMINAR - OCTOBER 20, 2017

Cancellation policy: Cancellation policy: Cancellations must be received in writing. You can email to [email protected]. 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, 2017. Refund of registration (less a $150 administrative fee) will be granted for cancellations received in writing after October 1, 2017 but on or before October 31, 2017. Refunds will not be granted for no-shows or cancellations received after October, 31, 2017 regardless of cause. In the event of a no-show or cancellation after October 31, 2017, meeting materials will be forwarded to the address provided on your registration form.

FULL CONFERENCE: Early Late/Onsite ASPL Member $625.00 $725.00 Nonmember $755.00 $855.00 Spouse/Guest $280.00 $280.00 Student $355.00 $455.00

ONE DAY REGISTRATION: ASPL Member Fri $355.00 $455.00 Sat or Sun $230.00 $330.00 Nonmember Fri $425.00 $525.00 Sat or Sun $255.00 $355.00 Student Fri $230.00 $330.00 Sat or Sun $155.00 $255.00

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

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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.


November 2-5, 2017 To Register Online Now!

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

You have a choice between receiving your conference materials electronically on a thumb drive or in a conference binder. Please select one option.

I want my materials electronically on a Thumb Drive I want my materials in print via a Conference Binder


Presorted First Class MailU.S. Postage

PAIDSpringfield, IL

Permit No. 500American Society for Pharmacy Law3085 Stevenson Drive, Suite 200Springfield, IL 62703

www.hotelvalleyho.comwww.hotelvalleyho.com

http://austintexas.gov/department/ground-transportationhttp://austintexas.gov/department/ground-transportation

Travel:Air Transportation: The Hotel Valley Ho is conveniently located 10 miles from the Phoenix Sky Harbor International Airport (PHX).

Ground Transportation: Rental car: Phoenix Sky Harbor International Airport. For a listing and contact information, visit www.skyharbor.com. Taxi: Taxis are available curbside, outside baggage claim. Approximate cost is $25 (plus gratuity) each way. Shuttle: SuperShuttle “Shared Ride” service is approximately $17 (plus gratuity) each way. Make reservations at www.SuperShuttle.com.

Accommodations: A block of rooms at a discounted rate has been reserved for the ASPL Seminar at the Hotel Valley Ho. The resort is located at 6850 E Main St, Scottsdale, AZ 85251. The discounted room rate is $189 per night plus tax as long as you make your reservation by October 10, 2017. Make your reservation by calling the hotel at (866) 882-4484 or online at www.hotelvalleyho.com and enter ASPL2017 in the Group Code to receive the discounted rate. If calling, be sure to identify that you are with the ASPL by using the group code ASPL2017 so that you get the group rate.


Editor:William E. Fassett, PhD, RPh, FAPhAProfessor Emeritus of Pharmacy Law & EthicsWashington State University – [email protected]

Contributing Editor: Roger Morris, JD, RPh 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

Michael Yount

President elect

Karen Peterson

treasurer

Anne O’Brien

immediate Past President

Steven Gray

directors

Erin Albert Martin Dix Charlie Hartig Aaron Moore Shannon Panther

executive director

Kristen Ball, CMP [email protected]

Rx Ipsa Loquitur July/August 2017

©2017, 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.orgFollow ASPL on twitter: @Pharmacy_Law and

on Linkedin


November 2-5, 2017

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