2012 Developments in Pharmacy Law Seminar XXIII

The American Society for Pharmacy Law in conjunction with the National Alliance of State
Pharmacy Associations will host the 2012 Developments in Pharmacy Law Seminar XXIII on November 15-18, 2012,  at the Ventana Canyon Resort - Tucson, Arizona.  The current CE offered includes specific information regarding human and veterinary compounding laws:

8:15 am -  9:15 am 2012 Regulatory Enforcement Update
This past year has seen new and bold actions by law enforcement and
regulators to challenge the practices of pharmacies.  The prescription
drug abuse problem continues to cast a pall on the legitimate practice
of pharmacy, and the federal government, through the DEA and FDA,
have stepped up regulatory enforcement actions at pharmacies.  It will
be the aim of this presentation to review these legal developments
and to provide guidance regarding measures that can be undertaken
by pharmacies and their counsel to protect the pharmacy and offset
the actions of the regulators. 
William E. Fassett, PhD, RPh, Washington State University College of
Pharmacy; Ronald Friedman, JD, Lane Powell (1 credit hour)
9:15am – 10:15 am Developments in Controlled Substances
Regulation and a Foggy Crystal Ball
This presentation will provide additional details about the history of
DEA regulatory interpretation and reaction to judicial decisions, the
rationale for DEA enforcement actions, and some predictions about
the future directions for DEA rule-making and enforcement. 
D. Linden Barber, JD; Larry P. Cote, JD, Quarles & Brady LLP (1 credit
hour)
10:15 am – 10.30 am Break
10:30 am – 12:00 pm Social Media Land Mines for Pharmacists
The growth of social media has challenged attorneys to apply
traditional legal principals to new technology.  This program will briefly
describe the various forms of social media and explain application
of legal principals related to defamation, privacy, trade secret,
employment, the litigation process, and attorney ethics to the still
evolving world of social media. 
Randy Dryer, JD, Parsons, Behle & Latimer (1.5 credit hours)
12:00 pm – 1:00 pm Lunch - ASPL
1:00 pm –  3:00 pm Case Law Update
Again this past twelve months, courts, including the U.S. Supreme
Court, have made far reaching decisions that will impact pharmacies,
pharmacists, and the pharmaceutical industry.  This annual
presentation will discuss the Supreme Court’s decisions to uphold
PPACA, as well as court decisions that address the scope of pharmacists’
duty to warn, the reach of the DEA authority, employee and employer
rights, privacy and patient communications, conscientious objection
sanctions, and other topics. 
Roger Morris, RPh, JD, Quarles & Brady LLP; William J. Stilling, RPh, JD,
Parsons Behle & Latimer (2 credit hours)
3:15 pm – 4:45 pm HIPAA and HITECH: More Privacy and
Security Regulations and Their Impact on Pharmacy Compliance,
Patient Counseling, and Law Firms
The passage of the Health Information Technology for Economic
and Clinical Health (HITECH) Act in 2009 heralded new privacy and
security requirements and more onerous penalties and enforcement
of HIPAA.  HHS has issued several versions of rules to implement
the security breach, business associate, and penalty provisions. 
This presentation will explain how these provisions affect how
pharmacies must comply, the impact of HIPAA and HITECH on patient
counseling, and how lawyers must comply with privacy and security
requirements as business associates. 
Kevin N. Nicholson, RPh, JD, NACDS; Susan A. Buckna, JD, Shopko
Stores Operating Company (1.5 credit hours)
6:30 pm – 9:30 pm Reception/Dinner -  ASPL/NASPA
Saturday, November 17, 2012
7:00 am – 8:00 am Breakfast - ASPL/NASPA
8:00 am– 9:30am Legislative & Regulatory Update
This annual session will provide an overview of recently enacted and
proposed laws and regulations that affect pharmacy.  
Brian Gallagher, BS Pharm, JD, American Pharmacists Association 
(1.5 credit hours)
 9:30 am – 10:30 am Ethical Decision Making for Attorneys
and Pharmacists
As professional both pharmacists and lawyers face times in their day
when ethical decisions need to be made.  In this program we will
explore selected parts of the legal Code of Professional Responsibility
and the Pharmacist Code of Ethics as principles that can be applied
to ethical decision making for both professions.  We will explore
teaching from Aristotle to General Patton and others to construct
an ethical decision making algorism. 
Kenneth R. Baker, RPh, JD, Ken Baker Consulting  (1 credit hour)
10:30 am – 10:45 am Break
10:45 am – 12:15 pm Veterinary and Human Compounding
Since the Food and Drug Administration Modernization Act (FDAMA)
of 1997 was passed, confusion has reigned over the legal parameters
for pharmacy compounding.  Contradictory court decisions, FDA’s
interpretation and enforcement of laws, and dissonance between
FDAMA and FDA guidelines, have all contributed to the confusion.
Similar factors have confounded compounders of veterinary
products. This presentation will explain the laws, regulations, and
court decisions affecting human and veterinary compounding so
attendees can better understand the law and enforcement in these
areas.  Held in cooperation with the Food and Drug Law Institute.
Mark S. Brown, JD, King and Spalding LLP (1.5 credit hours)
1:30 pm– 4:00 pm Pharmacy Law Educators
This years pharmacy law education session will include a presentation
and workshop component.  The presentation will discuss active
learning in and outside of the classroom while the workshops will
include groups developing potential exercises and assignments that
can be used for pharmacy law professors.Sunday, November 18, 2012
7:00 am – 8:00 am Breakfast ASPL
8:00 am– 9:00 am Trends in the Regulation of Automation
This session will examine the types of automation available and
application in patient care settings.  The speakers will review select
states’ regulation of automation, including an examination of the five
W’s – Who can utilize automation, What medications may be stored,
Why automation is used, Where automation is permitted, and When
automation can be used; as well as potential federal Anti-Kickback
Statute, Stark Law, and DEA issues. 
Anne M. O’Brien, JD; Edward D. Rickert, BPharm, RPh, JD, Krieg
DeVault (1 credit hour)
9:00 am – 10:00 am Drug Manufacturer Coupon Co-Pay
Programs: Legal, Policy and Business Considerations
As drug manufacturers face rigorous formulary reviews for their
products, stern generic and brand competition, and loss of
exclusivity, the advancement of coupon co-pay programs have given
them a new and forceful tool in their armamentarium to increase
market share and drive profit.  The presentation will review the legal,
policy, and business aspects of Drug Manufacturer Coupon Co-Pay
Programs and assess the value for the relevant stakeholders.
Matthew Seamon,  PharmD, JD,  Association Professor Nova
Southeastern University College of Pharmacy, Of Counsel Fuerst Ittlmen
(1 credit hour)
10:00 am – 10:15 am Break
10:15 am – 11:15 am Medication Therapy Management:
Nuts, Bolts, and Legal Considerations
Medicare Part D requires prescription drug programs to provide
Medication Therapy Management (MTM) for Medicare beneficiaries. 
This presentation will discuss the requirements for MTM, how
pharmacists carry out MTM programs, recent changes in the Part
D regulations governing MTM, the legal requirements and risks of
MTM as this type of monitoring and intervention spreads to the
private sector. 
Doug Burgoyne, PharmD, RPh, VRx Pharmacy Services (1 credit
hour)
11:15 am – 12:15 pm Challenges to Compliance in Current
Regulatory Framework
As the regulatory environment becomes more complex, pharmacies
are more frequently being investigated by administrative agencies.  
This program will discuss the ten most common compliance
issues that are being faced by pharmacies before state boards of
pharmacy, state controlled substance authorities, the Food and
Drug Administration, and the Drug Enforcement Administration.
It will also provide a framework for conducting self-audits of
pharmacy operations practices and strategies for responding to
agency investigations.    
Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; Michael
Simko, JD, Walgreens (1 credit hour)


 Register Today at www.aspl.org