AN OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR PHARMACY LAW

Volume 36 Number 6

November/December 2009

At this time of year thecalendar seems to advanceat a more hectic pace.Which is one of the reasonswe provide in this issue of

Rx Ipsa a recap of the excellent programmingpresented at this year’s Developments in PharmacyLaw Seminar in Naples, Florida. We again had over100 attendees at the Seminar, where we enjoyed theeducational programs and social exchanges that haveoccurred every year at our fall meeting. This yearmarked the 20th year of the program, which wasduly celebrated along with the 35th Anniversary ofASPL itself. It also was the first year of a collaborationwith the National Alliance of State PharmacyAssociations (NASPA). We look forward to workingclosely with NASPA in the future.

If you were unable to attend, you can get aflavor of the programs from the summaries providedin this issue. Hopefully, you’ll be able to attend futureASPL meetings. In 2010, we will be, as always, atthe APhA Annual Meeting which will be inWashington, D.C. and next November we will bringthe fall meeting to Palm Springs, California. Checkthe ASPL website for more information.

This time of year also brings our year election.This year’s election will be open until January 4,2010. Interest in running for open positions wasvery high this year and I join the rest of the Board ofDirectors in thanking all of those who showed aninterest in serving. Please make sure you cast yourvote.

Membership renewal notices have also gone out.Dues for 2010 have not changed. ASPL remainsone of the best values available for those with aninterest in pharmacy law. Please check your mail andsend in your renewal early.

On behalf of the Board of Directors and staffof ASPL, best wishes during the holiday season.

President’sMessage

John CroninASPL President

American Society for Pharmacy Law2009 Developments in Pharmacy Law Seminar XX

In conjunction withNational Alliance of State Pharmacy Associations

A SuccessUpwards of 120 participants, plus members of

the National Alliance of State PharmaceuticalAssociations joined with ASPL in Naples, Florida forthe 20th annual Developments in Pharmacy LawSeminar on November 12 through 15. A joint sessionwith NASPA members was held on Friday morning,with the remaining sessions held on Friday afternoon,and Saturday and Sunday mornings. Fifteen hours oflegal and pharmacy continuing education were provided by experts from the United Statesand Australia, including a first-ever session meeting legal and pharmacy ethics requirements.The following session summaries were compiled by various members of the ASPL Board ofDirectors; persons unable to attend the seminar may purchase a copy of the handout binderfrom ASPL by contacting the ASPL office (administration@aspl.org).

Risk Evaluation and MitigationStrategy for Opioid Analgesics

Dr. Janelle Derbis, from the Office of Special Health Issues, FDA, summarized thehistory and development of the proposed risk evaluation and mitigation strategy (REMS)for long-acting opioid analgesics, arising not only from demonstrated problems with thesafe use of these drugs, but from new FDA authority under the Food and Drug AdministrationAmendments Act (FDAAA). A REMS may be applied to an individual drug or to a class ofdrugs, as a set of specific requirements for the distribution and prescribing of the coveredproduct. A REMS may consist of a required MedGuide, a communications plan, otherelements to assure safe use, and/or an implementation system necessary to insure safe productuse. REMSs are enforceable because the sponsor may not market a product in violation ofthe REMS provisions, and distribution of a covered drug in violation of REMS renders theproduct misbranded. Civil penalties may be assessed, and manufacturers may be subject tocriminal penalties as well.

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Renew Your ASPL Membership Today!Your ASPL membership will expire December 31, 2009. You shouldhave received your 2010 membership dues renewal in the mail. Youcan renew online today at www.aspl.org. Contact ASPL at 217.529.6948if you have any questions.

American Society for Pharmacy Law2

The proposed opioid REMS applies to long-acting opioidscontaining fentanyl, hydromorphone, methadone (for pain treatment),morphine, oxycodone, and oxymorphone. The proposal began with anotice to manufacturers in February 2009, meetings withmanufacturers, the public, and other stakeholders, and a public commentperiod. On October 19, the FDA extended the public comment periodfor one year. The opioid REMS does not apply to Actiq® (fentanylcitrate buccal), which has been subject to its own REMS since it wasapproved for marketing.

-- Summary by Bill Fassett

¿Habla Español? Laws and Promising Practices forProviding Language Services in Pharmacy Settings

Sarah Lichtman Spector, an attorney with the National HealthLaw Program, addressed three themes: patient safety, communication,and quality of care as they affect persons with limited English proficiency(LEP), which is defined as speaking and writing in English “less thanvery well.” According to 2008 data, there are 55 million people livingin the US who speak a language other than English, making effectiveinteraction in healthcare problematic.

Title VI of the Civil Rights Act of 1964 states that “no person…shall be, on the ground of race, color, or national origin be excludedfrom participation in, be denied benefits of, or be subjected todiscrimination under any program receiving Federal financial assistance.”Almost all healthcare providers accept Federal financial assistance and“national origin” includes LEP individuals, therefore, Federal law allowsand envisions label translation. This federal law protects all patientsreceiving services at a pharmacy whether or not their individualprescriptions are paid for with government monies.

The second federal law presented as having an impact on translationis OBRA 90 and the requirements of the offer to counsel and therequirement to record and maintain a patient medication profile whichincludes demographic data, “individual history where significant” and“comments relevant to the individual’s drug therapy.” Language isconsidered to be relevant information. Both of these elements in OBRA90 directly or indirectly support the provision of language services.

A 2007 Civil Rights complaint filed with NY Attorney Generalwas based on Title VI, state statutes and regulations including counselingrequirements for all patients and misbranding (patient must be able toread the label or it is considered misbranding), and local human rightslaw; the action led to a settlement with major New York chain pharmacies.Unique programs available to provide language services to pharmaciesserving LEP patients can be obtained from National Health Law Program(nhelp@healthlaw.org or www.healthlaw.org).

-- Summary by Donna Horn

Legislative and Regulatory UpdateAn annual Legislative and Regulatory Update was again presented

by Kristina Lunner, Vice President of Government Affairs for theAmerican Pharmacists Association (APhA). As always, her presentationwas insightful and current.

Kristina began with a discussion of recent regulatory activities fromthe FDA, CMS, and DEA. Regulatory issues discussed included:REMS; patient information; medication disposal; Medicare Part D;

health information technology; and internet pharmacy. Thereafter,Kristina turned to recent legislative activities. Issues discussed duringthis section included: anti-counterfeit and anti-trust initiatives;dextromethorphan distribution; drug disposal; fraud, waste, and abuse;HIPAA; and importation. The final part of Kristina’s presentation focusedon health care reform and APhA’s efforts. To learn more about thistopic, APhA has various tools and resources available on their website,including an extensive table entitled “Pharmacy-Related Provisions ofHealth Care Reform Proposals.”

-- Summary by Kim Burns

Pharmacy Reimbursement LitigationNick Lynn from the Duane Morris law firm provided a summary

and his insights into the various lawsuits seeking to impact pharmacyreimbursement. Nick discussed the history and current status of thelitigation that blocked the revision of Average Manufacturers Price(AMP), which is used to determine generic drug reimbursement, notingthat it is still unclear what the Obama Administration will do to resolvethe issues in that case. He next discussed the Medicaid reimbursementreduction cases from 2007 and 2008 in California and Washingtonand the success enjoyed in those cases using a Supremacy Clauseargument. The Average Wholesale Price (AWP) litigation was next,including the impact on pharmacies of the recent settlement that thatcase. Finally, he discussed briefly the current lawsuits in California,Washington, New York and Minnesota challenging the decisions bythe Medicaid programs in those states to maintain their currentreimbursement levels without adjustment for the rollback of AWP pricesfor thousands of drugs. The presentation provided useful backgroundon these lawsuits. The information will be useful as all these legalactions move forward over the next year.

-- Summary by John Cronin

International Pharmacy Law – Developments inAustralia for Handling Conduct Complaints,Impaired Pharmacists and Dispensing Errors

Christine Campbell, from the Pharmacy Board of New SouthWales, Australia, and Peter Dwyer, an Australia barrister (Maurice Byers& Chambers) discussed Australian legislative reforms addressing conductcomplaints, impaired pharmacists, and dispensing errors. The speakersused cases to show how Australia has avoided criminalizing professionalproblems.

The New South Wales (NSW) approach to dispensing errors is toNOT consider them to be professional misconduct or serious criminalbehavior. Dispensing errors that are prosecuted need to prove deliberatecourse of action or reckless behavior. A contrasting UK dispensing errorcase did result in criminal prosecution and served to illustrate the differentoutcomes in the two nations. In the UK, the aftermath of such cases hasbeen pharmacists leaving the profession, reluctance of pharmacists touse medication error logs and actions by the Royal Pharmaceutical Societyto address changes in pharmacists’ workloads, breaks and duration/length and number of consecutive shifts.

Dispensing error complaints in NSW include “poor checking, failureto counsel, expired and recycled stock supply, drugs with narrow

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Pharmacy Law Seminar Session ReviewsContinued from page 1

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investments in e-prescribing, more prescribers still need to utilize it.Furthermore, the DEA still has to finalize rules for controlled substancesand e-prescribing.

-- Summary by Kim Burns

Preemption of Drug Liability Claims Brought AgainstDrug and Device Companies

Mark Herrmann, a partner with Jones Day and one of the twoprincipal authors of the Drug and Device Law blog(druganddevicelaw.blogspot.com), returned to the Fall Conference tobring attendees up to date on the U.S. Supreme Court’s preemptionjurisprudence in drug and device product liability cases. Mr. Herrmannpreviewed upcoming cases at the 2007 Fall Conference. Since then, theSupreme Court issued opinions in Riegel v. Medtronic, Inc. and Wyeth v.Levine.

In Riegel, the Supreme Court held that product liability claimsagainst manufacturers of medical devices are largely preempted wherethe device was subject to pre-market approval. The presence of anexpress preemption clause in the Medical Device Amendments to theFood Drug and Cosmetic Act was a key factor in the decision.

In Wyeth, the Supreme Court held that a failure-to-warn productliability claim against the manufacturer of Phenergan was not preemptedby the FDA’s approval of the product’s labeling.

Mr. Herrmann explored in detail the Court’s reasoning in eachcase. He discussed both the immediate and long-term consequences toproduct liability claims in the drug and device arena specifically andpreemption doctrine generally.

-- Summary by Jay Campbell

Federal and State Drug Traceability and Pedigree EffortsDiane Darvey, PharmD, JD, of the National Association of Chain

Drug Stores, provided attendees a thorough presentation on existingand prospective federal and state pedigree laws. She discussed the federalpedigree requirements created to curb drug diversion and counterfeiting.Dr. Darvey explained how, under federal laws and regulations,wholesalers that are not authorized distributors of record (ADRs) arerequired to provide a pedigree with their sale and distribution ofprescription drugs. The “pedigree” provides information on the salesand distribution history of the prescription drug. She also describedfederal laws that require the FDA to develop standards for placingidentification numbers on individual drug packages to allow discretepackages to be traced.

Darvey also discussed litigation brought by the secondarywholesalers to stop FDA from implementing certain regulations thatwould require the pedigree to go back to the drug manufacturer. Thesecondary wholesalers feel they would be disadvantaged by thisexpansion of the pedigree requirements. Finally, she reviewed existingcongressional bills that would expand pedigree requirements. Dr. Darveyalso reviewed the variance of pedigree laws at the state level, noting thatthe states did not have uniformity in this area and highlighting Florida’sregulatory scheme in particular.

-- Summary by Mary Ellen Kleiman

therapeutic index, pediatric doses and failure to review drug history.”The goal of the Board in addressing these complaints is to investigatehow the error occurred and how to reduce to a minimum the risk ofrecurrence. This is accomplished through a peer review process.

Of note: barcode scanners are mandated for each dispensary stationin NSW since the Victorian Pharmacy Board indicated that 50% ofreported dispensing errors are selection errors. Correct use of scannersreduces the potential for selection error.

The speakers also briefly spoke about isolated “errors of judgment,”professional misconduct and addiction cases in NSW.

-- Summary by Donna Horn

New Privacy Requirements for PharmacistsKevin Nicholson, VP for Government Affairs and Policy, NACDS,

presented the attendees a comprehensive and informative review ofvery recent developments in privacy law. Attendees learned that newlegal requirements arose out of this year’s American Recovery andReinvestment Act of 2009 (ARRA) which included the HealthInformation Technology for Economic and Clinical Health Act(HITECH), intended to provide stimulus funding for the adoption ofhealth information technology (HIT) as well as boost the protection ofpatient health information (PHI). HITECH builds upon the existingHIPAA privacy requirements under which pharmacies already operate.Mr. Nicholson provided a summary of the existing HIPAA requirementsfor the benefit of all attendees. He then explained in detail how ARRA/HITECH expands those obligations to include a breach of privacynotification, expansion of the accounting of PHI disclosures requirement,new and confusing marketing requirements related to PHI, along witha number of other HIPAA privacy expansions. He provided attendees ahelpful multi-step process to determine if a breach occurred and whena notice is required. Mr. Nicholson warned about the anticipatedenforcement efforts and increased financial penalties under HITECH.

-- Summary by Mary Ellen Kleiman

E-PrescribingThe final session on Friday was presented by Laura Carpenter,

founder of the Carpenter Law Firm, and included a discussion on E-Prescribing. In addition to explaining the premise of e-prescribing,Laura also described the laws and regulations governing e-prescribing;the advantages and disadvantages of e-prescribing; and identifiedcommon risk management issues with e-prescribing.

Benefits of e-prescribing include: an increase in safety and quality;complete prescriptions; legible prescriptions; faster service for patients;and the potential for improved patient compliance. Disadvantagesinclude: training challenges; wrong drug or dosage selection by theprescriber; prescriptions being sent to the wrong pharmacy; and lack ofcodified drugs and SIGs. Laura also reviewed various e-prescribing bestpractice recommendations for pharmacies, such as: indicators that alertto a received e-prescription; trained pharmacy staff; a computer systemthat monitors the status of e-prescriptions; the ability to electronicallyrequest supplemental or clarifying information; and e-prescriptionsshould not be printed and re-entered into the computer.Laura also highlighted that although pharmacy has made significant

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Pharmacy Law Seminar Session ReviewsContinued from page 2

American Society for Pharmacy Law4

2009 Seminar NotebooksAvailable for Purchase

The 2009 Developments in Pharmacy Law Seminar notebooksare now available for purchase for $175.00. Notebooks includeall handout materials from the Seminar.

Contact the ASPL Office at 217-529-6948 oradministration@aspl.org for more information.

Pharmacy Law Seminar Session ReviewsContinued from page 1

Intersection of Legal and Professional Ethics – theAttorney’s Role in Advising Clients RegardingProfessional Commitments

Kenneth R. Baker (Renaud Cook Drury Mesaros) and William E.Fassett (Washington State University) led an interactive discussion sessionusing three cases in which the professional ethics of the attorney andthe professional ethics of the pharmacist overlap. In break-out groups,attendees discussed the application of the legal canon of ethics and thePharmacists Code of Ethics (APhA) to the facts of the cases. Of particularissue was whether the obligations of an attorney who was also apharmacist might be in conflict. Individuals who would like copies ofthe cases and instructions for their use in a discussion session may contactDr. Fassett (b.fassett@comcast.net).

-- Summary by Bill Fassett

Update on FDASusan Winckler, President and CEO of the Food and Drug Law

Institute (FDLI) provided an excellent update on activities at the FDA,including personal insight on the internal workings at the agency fromher more than two years of working at FDA. Following an overview ofthe scope of the FDA’s authority, Winkler addressed several current keyissues at FDA, including tobacco oversight, the impact of theglobalization of pharmaceutical markets and, in particular, the impactof the growth of the Chinese pharmaceutical manufacturing industry.She also discussed the new Risk Evaluation and Mitigation Strategies(REMS) program and how it intersects with other governmentprograms.

-- Summary by John Cronin

Case Law UpdateRoger Morris, Quarles & Brady LLP, and Bill Stilling, Parsons

Behle & Latimer, presented the annual Case Law Update coveringselected cases from October 2008 through October 2009. While the54-page handout contained case summaries in some 24 areas of law, theoral presentation focused on a more limited group of cases. Of particularemphasis this year, were drug pricing cases, cases with novel theories ofnegligence against pharmacists, and new decisions about pharmacistsrefusing to fill drugs based on moral or religious grounds. The presenterssummarized several cases that were too recent for the handout, which isavailable to members at the ASPL website. In Sanchez v. Wal-Mart, acase before the Nevada Supreme Court, the estate of a driver killed by apharmacy-shopping drug abuser sued several pharmacies for fillingprescriptions after being informed the driver may be abusing drugs.Another recent case that may have substantial impact on drug pricinglawsuits is AstraZennaca v. Alabama. The presenters explained thereasoning the Alabama Supreme Court used to overturn a $274 millionjury award against several drug manufacturers based on allegations ofinflating AWP prices. The presenters were especially pleased this yearby the level of audience interaction and the insights the audience,especially those close to the cases, provided.

-- Summary by Bill Stilling

Health Care Fraud Update/Medicare ReimbursementIssues.

The Fall Conference concluded with two scintillating presentationsunder the general topics of “Health Care Fraud Update/MedicareReimbursement Issues.” Following up on his excellent presentation atthe 2008 Fall Conference, Frederick “Rick” Robinson (Fulbright andJaworski, LLP) provided the attendees with a provocative session entitled“Fraud and Abuse Update for Pharmacies and Pharmacists.” Rickaddressed, generally, the federal False Claims Act, the Fraud Enforcementand Recovery Act of 2009 (“FERA”), the protections provided towhistleblowers under the American Recovery and Reinvestment Act of2009 (“ARRA”), and the enforcement provisions contained in the HealthInformation Technology for Economic and Clinical Health Act(“HITECH”), among other issues. With the change in theadministration and the government’s ongoing initiatives to reduceprescription drug costs, strict compliance remains imperative.The closing session entitled “Medicare Impossible: Can You Complyand Have a Final Claim Resolution?” was presented by attorneys RoyFranco (Director of Risk Management Strategies for Safeway Inc.) andJonathan Klein (Kelly, Hockel & Klein, P.C.). Their enlighteningpresentation was especially germane to all ASPL members involved inthe prosecution, defense or adjudication of personal injury claimsinvolving claimants with Medicare liens. The Medicare Secondary PayerAct provides Medicare with additional protections in an effort to ensurethat Medicare payments are properly and timely repaid. When dealingwith injured claimants/clients who are entitled to Medicare, there aresignificant notice and reporting requirements. Succinctly stated, a pretrialsettlement involving a claimant having a Medicare lien, now requirestimely reporting to and the active involvement of specific entitiesresponsible for the evaluation of a proposed settlement and the protectionof the Medicare’s interests, a process which may be extremely timeconsuming and which could significantly impact the viability of aproposed settlement.

-- Summary by Gary Peters

American Society for Pharmacy Law 5

American Society for Pharmacy Law2009 Developments in Pharmacy Law Seminar XX

Thank you to our Sponsors:

Gold Level SponsorsQuarles & Brady, LLP

Walgreens

Silver Level SponsorsBonner Kiernan Trebach & Crociata, LLP

National Association of Boards of PharmacyRite Aid Corporation

Bronze Level SponsorsAkerman Senterfitt

Akin Gump Strauss Hauer & Feld, LLPCarpenter Law Firm, PLLC

Clinical Pharmacology ServicesDuane Morris, LLP

Fredrickson Mazeika & Grant, LLPFulbright & Jaworski, LLPMedco Health Solutions

Metzger Grossman Furlow & BayóParsons Behle & Latimer

Pharmacists Mutual Insurance CompanyPrescriptionSolutionsSmith Rickert & Smith

Save the Date!November 18-21, 2010

Developments in Pharmacy Law Seminar XXILaQuinta Resort & Club - Palm Springs, California

Don’tForget to

ASPL will be electing a President-Elect,Treasurer and two member of the Board ofDirectors. The slate of candidates is as follows:

President-Elect: Joseph BogdanFrank Palumbo

Treasurer: Bill Fassett

James Boyd

Board of Directors: Mary Jo CardenSteve GrayMary Ellen KleimanMichael Simko

This year, ASPL is using Ballot Bin, an onlineballoting system, for its 2010-2011 electionof officers and board of directors.

You should have received an email fromballotbin.com to cast your vote. Your ballotmust be return no later than January 4, 2010 tobe valid.

Results of the election will be announcedafter the votes are tabulated. Installation ofthe newly elected officers and directors willoccur at the ASPL Annual Meeting, to be heldin conjunction with the APhA Annual Meetingin Washington, DC on March 13, 2010 at theGrand Hyatt Washington Hotel.

If you have any problems with completingthe online voting, please contact Janet Bascomat janet@assn-srvs.com or call 217-529-6948.

PLEASE VOTE. Your input on who helps toguide the organization is very important.

American Society for Pharmacy Law6

First Class MailU.S. Postage

PAIDSpringfield, IL

Permit No. 250American Society for Pharmacy Law3085 Stevenson Drive, Suite 200Springfield, IL 62703

Editor:William E. Fassett, PhD, RPhProfessor of Pharmacy Law & EthicsWashington State Universityb.fassett@comcast.net

Contributing Editors:Del Konnor, PharmMSDEA Solutions Group, LLCdelkonnor@deasolutionsgroup.com

Roger Morris, JDQuarles & Brady, LLPr.morris@quarles.com

ASPL Business Office:3085 Stevenson Drive, Suite 200Springfield, IL 62703217-529-6948 Phone217-529-9120 Fax

BOARD OF DIRECTORS

PRESIDENT

John Cronin

PRESIDENT ELECT

Kimberly Burns

TREASURER

William Fassett

IMMEDIATE PAST PRESIDENT

Jay Campbell

DIRECTORS

Donna Horn

Mary Ellen Kleiman

Gary Peters

William Stilling

EXECUTIVE DIRECTOR

Nathela Chataranathela@assn-srvs.com

Rx Ipsa LoquiturNovember/December 2009

©2009, American Society for Pharmacy Law

All rights reserved. No part of thispublication may be reproduced ortransmitted in any form or by any meanswithout the written permission of thecopyright holder.

Complete Board contactinformation can be found on the

ASPL website

www.aspl.org

March 12-15, 2010APhA 2010 Annual Meeting & ExpositionWashington, DCwww.aphameeting.org

November 18-21, 2010Developments in Pharmacy Law Seminar XXILaQuinta Resort & Club - Palm Springs, CA

Mark Your Calendar: