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newsletter National Association of Boards of Pharmacy ® aid to government the profession the public 1904 to 2009 February 2009 / Volume 38 Number 2 Upcoming Events March 9-20, 2009 PCOA Administrations April 7, 2009 Committee on Constitution and Bylaws Conference Call April 14, 2009 Computerized FPGEE Administration May 16-19, 2009 NABP 105 th Annual Meeting Hyatt Regency Miami Hotel Miami, FL July 22-23, 2009 NABP Program Review and Training NABP Headquarters In This Issue. . . . Symposium 2008: Symposium Provides Platform for Stimulating Debate on Counterfeit Drugs, BTC Class 23 Legal Briefs: Consentequences 24 Association News: NABP Testifies in Trials Leading to Convictions, Shutdown of Internet Drug Outlets 27 105 th Annual Meeting: Tucker Carlson to Provide a Behind- the-Scenes Look at Changes in Washington during Keynote Address 31 State Board News: DEA Responds to Alabama’s ‘Take- Back’ Prescription Disposal Programs 38 (continued on page 22) Federal, State Governments Pass Legislation to Address Rogue Internet Drug Outlets Easy access to prescrip- tion medications via rogue Internet drug outlets remains a serious problem, as millions of doses of con- trolled substances (as well as other prescription drugs) continue to find their way to consumers without a legitimate prescription or meaningful medical over- sight. Regulators and lawmak- ers have not been idle, how- ever. On both the state and federal levels, they continue to investigate and prosecute rogue Internet drug outlets and those responsible for them, and lawmakers in state legislatures as well as in the United States Con- gress continue to debate and pass legislation that could help to combat those sites that, as Ohio State Board of Pharmacy Execu- tive Director William T. “Bill” Winsley, MS, RPh, told the House Subcom- mittee on Crime, Terrorism and Homeland Security in a June 24, 2008 hearing, more closely resemble street- corner drug dealing than legitimate medical care. Federal Law Passed The Internet phar- macy legislation of 2008 garnering the most attention – and deliver- ing the most impact – was the US Congress’s passage of the Ryan Haight On- line Pharmacy Consumer Protection Act, which President George Bush signed into law in October. The new law, named for a teenager who died in 2001 of an overdose of Internet- obtained prescription drugs, addresses controlled substances, containing such provisions as spelling out what makes a prescription legitimate (including an in-person medical evalu- ation by the prescribing doctor, with some excep- tions), requiring Internet sites to obtain a Drug Enforcement Administra- tion (DEA) registration, and increasing penalties for unlawfully dispens- ing Schedule III through V medications. “This is really making explicit what has been implicit,” Senator Dianne Feinstein (D-CA), the bill’s lead sponsor in the Senate, told The Wall Street Journal last October.

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  • newsletterNational Association of Boards of Pharmacy®

    aid to governmentthe profession

    the public1904 to 2009

    February 2009 / Vo lume 38 Number 2

    Upcoming EventsMarch 9-20, 2009PCOA Administrations

    April 7, 2009Committee on Constitution and Bylaws Conference Call

    April 14, 2009Computerized FPGEE Administration

    May 16-19, 2009NABP 105th Annual MeetingHyatt Regency Miami HotelMiami, FL

    July 22-23, 2009NABP Program Review and TrainingNABP Headquarters

    In This Issue. . . .Symposium 2008:Symposium Provides Platform for Stimulating Debate on Counterfeit Drugs, BTC Class

    23

    Legal Briefs:Consentequences

    24

    Association News:NABP Testifies in Trials Leading to Convictions, Shutdown of Internet Drug Outlets

    27

    105th Annual Meeting:Tucker Carlson to Provide a Behind-the-Scenes Look at Changes in Washington during Keynote Address

    31

    State Board News:DEA Responds to Alabama’s ‘Take-Back’ Prescription Disposal Programs

    38

    (continued on page 22)

    Federal, State Governments Pass Legislation to Address Rogue Internet Drug Outlets

    Easy access to prescrip-tion medications via rogue Internet drug outlets remains a serious problem, as millions of doses of con-trolled substances (as well as other prescription drugs) continue to find their way to consumers without a legitimate prescription or meaningful medical over-sight.

    Regulators and lawmak-ers have not been idle, how-ever. On both the state and federal levels, they continue to investigate and prosecute rogue Internet drug outlets and those responsible for them, and lawmakers in state legislatures as well as in the United States Con-gress continue to debate and pass legislation that could help to combat those sites that, as Ohio State Board of Pharmacy Execu-tive Director William T. “Bill” Winsley, MS, RPh, told the House Subcom-

    mittee on Crime, Terrorism and Homeland Security in a June 24, 2008 hearing, more closely resemble street-corner drug dealing than legitimate medical care.

    Federal Law PassedThe Internet phar-

    macy legislation of 2008 garnering the most attention – and deliver-ing the most impact – was the US Congress’s passage of the Ryan Haight On-line Pharmacy Consumer Protection Act, which President George Bush signed into law in October. The new law, named for a teenager who died in 2001 of an overdose of Internet-obtained prescription drugs, addresses controlled substances, containing such provisions as spelling out what makes a prescription legitimate (including an in-person medical evalu-ation by the prescribing

    doctor, with some excep-tions), requiring Internet sites to obtain a Drug Enforcement Administra-tion (DEA) registration, and increasing penalties for unlawfully dispens-ing Schedule III through V medications. “This is really making explicit what has been implicit,” Senator Dianne Feinstein (D-CA), the bill’s lead sponsor in the Senate, told The Wall Street Journal last October.

  • nabp newsletter

    22

    The NABP Newsletter (ISSN 8756-4483) is published 10 times a year by the National

    Association of Boards of Pharmacy (NABP)

    to educate, to inform, and to communicate the objectives and programs of the Association and its 66 member boards

    of pharmacy to the profession and the

    public. The opinions and views expressed in this publication do not necessarily reflect the

    official views, opinions, or policies of NABP or any board unless

    expressly so stated. The subscription rate is

    $35 per year.

    National Association of Boards of Pharmacy

    1600 Feehanville Drive Mount Prospect, IL

    60056 847/391-4406 www.nabp.net

    [email protected]

    Carmen A. Catizone Executive Director/

    Secretary

    Larissa Doucette Communications

    Manager

    ©2009 National Association of Boards

    of Pharmacy. All rights reserved. No part of this publication may be reproduced in any manner without the

    written permission of the executive director/

    secretary of the National Association of

    Boards of Pharmacy.

    Feature News

    Rogue Internet Drug Outlets(continued from page 21)

    Indeed, other than fulfilling some information-posting requirements and obtaining the DEA endorsement, the Ryan Haight Act will affect legitimate online pharma-cies scarcely at all.

    The new law also strengthens the hands of the states in pursuing rogue sites (at least those dealing in controlled substances) across state borders. Now, each state’s Attorney General may, among other things, bring a civil action on behalf of a state’s resi-dents in a federal district court to enjoin the actions of an online pharmacy or person acting in violation of the new statute, provided the state has served prior written notice to the US At-torney General, giving him or her the opportunity to intervene in the litigation. This provision expands each state’s ability to act against online pharma-cies beyond the geographic boundaries of that state.

    State ActivitiesThe states remained ac-

    tive in 2008 in pursuing the investigation and prosecu-tion of rogue Internet drug outlets and their brick-and-mortar partners, both by employing existing regula-tions and, in some cases, enacting new laws spe-cifically addressing Internet pharmacies.

    According to the NABP 2009 Survey of Pharmacy Law, 46 out of 50 US state

    boards of pharmacy require nonresident pharmacies providing prescription drugs to residents of the relevant state to be licensed or registered. Only three boards reported a sepa-rate licensing category for Internet or online pharma-cies; 15 boards reported that their states officially recognize NABP’s Verified Internet Pharmacy Practice Sites™ (VIPPS®) accredita-tion for online pharmacies. Four of these 15 states go a step further and specifically require VIPPS accreditation as a condition of licensure. As the NABP Newsletter has reported on several occa-sions in the past, however, a number of states are ad-dressing rogue Internet drug outlets by enacting legisla-tion defining the patient-practitioner relationship necessary for the legal issuance of a prescription; most of these definitions require such elements as an in-person examination and a diagnosis, particularly when prescribing controlled substances. These defini-tions render inadequate the online questionnaires gener-ally used by rogue Internet pharmacies before issuing a prescription, facilitating state prosecution of the operations involved.

    Boards of pharmacy have been active in remind-ing pharmacists licensed in their states about the inad-visability of filling Internet-generated prescriptions that do not appear to be based on a valid patient-practitioner relationship. In the October 2007 Ohio State Board of Pharmacy

    News, the Board reviews the physical examination requirement for prescribing dangerous drugs, and the exceptions to the rule. “All pharmacists should be able to see that a scheme where the physician, ‘patient,’ and pharmacy are all separated by large distances will have difficulty meeting this stan-dard,” the Board notes. By using good judgment, the Board states, pharmacists “should be able to avoid dealing with the criminal and administrative reper-cussions that could result.”

    Similarly, the Colorado State Board of Pharmacy advised pharmacists in its August 2008 Newsletter that some Web sites, rather than using affiliated pharmacies to fill prescriptions, generate a physical prescription based on a questionnaire that the “patient” can then present at his or her local pharmacy, or that can be faxed to a phar-macy of the patient’s choice. “…[E]very effort should be made to verify the authentic-ity of the order, particularly those written by unfamiliar practitioners to unfamiliar patients,” states the Board. “Regulation 3.00.21 states, among other things, that a pharmacist shall not dis-pense a prescription drug if the pharmacist knows or should have known that the order for such drug was issued on the basis of an In-ternet-based questionnaire, Internet-based consultation, or a telephonic consultation, all without a valid preex-isting patient-practitioner relationship.”

    New Hampshire joined the ranks of those states

    (continued on page 26)

  • february 2009

    23

    Executive CommitteeOren M. Peacock, JrChairpersonOne-year term

    Rich PalomboPresidentOne-year term

    Gary A. Schnabel President-electOne-year term

    William T. “Bill” WinsleyTreasurerOne-year term

    Karen M. RyleMember, District 1Serving second year of a three-year term

    Elizabeth Scott “Scotti” RussellMember, District 2Serving second year of a three-year term

    Michael A. BurlesonMember, District 3Serving first year of a three-year term

    Gregory Braylock, SrMember, District 4Serving first year of a three-year term

    Lloyd K. JessenMember, District 5Serving second year of a three-year term

    Malcolm J. BroussardMember, District 6Serving third year of a three-year term

    Cathryn J. LewMember, District 7Serving second year of a two-year term

    Hal WandMember, District 8Serving first year of a three-year term

    NABP Executive Committee elections are held each year at the Association’s Annual Meeting.

    Symposium 2008

    Symposium Provides Platform for Stimulating Debate on Counterfeit Drugs, BTC Class

    The NABP 2008 Sym-posium held December 4-5, 2008, featured informative, fast-paced sessions covering prescription drug coun-terfeiting and a behind-the-counter (BTC)class of drugs. More than 20 speak-ers presented fresh, innova-tive information about the topics while attendees had a chance to apply their per-sonal knowledge along with what they learned from the speakers during roundtable discussions.

    The Counterfeit Problem

    The presentations on counterfeiting began with Francis B. Palumbo, MS, PhD, JD, RPh, professor and executive director at the University of Maryland School of Pharmacy Center on Drugs and Public Policy, pointing out the link be-tween counterfeit drugs and illegal importation of medi-cations. He also noted that the World Health Organiza-tion (WHO) estimates 60% of counterfeit drug cases are

    in developing countries and 40% of the cases are in the West.

    Frederick L. Fricke, MS, director of the Food and Drug Administration’s (FDA) Forensic Chemistry Center, further discussed the statistics of counterfeit drugs in the US distribution system, stating that in 2008 the FDA’s Office of Criminal Investigations opened 56 counterfeit drug cases; how-ever, he said, this number is somewhat misleading as to the scope of the problem of counterfeit drugs in the US, since one case can involve 20 different types of counterfeit drugs.

    Attendees of the Sym-posium also learned about disturbing numbers related to the prevalence of coun-terfeiters distributing their products on the Internet. Frederick Felman, BS, chief marketing officer at Mark-Monitor, explained that counterfeit drugs are not just being pedaled through spam e-mails anymore; counterfeits are so lucra-

    tive that those selling them are now paying to advertise through search ads and oth-er online marketing tools. He said that MarkMonitor studied 11,836 search engine advertisements for drugs, which equals an estimated $26 billion in spending on advertising. MarkMoni-tor also found that these more than 11,000 ads were purchased by just 131 Web site domains, with more than 66% of these domains committing trademark infringement. Along with advertising, these counter-feiters have created profes-sional looking Web sites that are consumer friendly and look legitimate.

    Cybercrime tactics, such as unleashing malware to infect citizens’ computers, turning innocent people into hosts for fraudulent Web sites without them ever being aware, allows counter-feiters to send out millions of spam e-mails. Cybercrime networks are highly complex and organized, and are often

    (continued on page 32)

  • nabp newsletter

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    Legal Briefs

    ConsentequencesBy Dale J. Atkinson, JD

    Boards of pharmacy are charged with vital public protection powers related to the regulation of the practice of the profession, including enforcement actions against individuals and entities that do not comply with legal mandates. Numerous investigations are resolved short of formal administrative hearings through informal resolution, sometimes referred to as consent orders. These consent orders provide certainty to the board and accused licensee(s) in the resolution of alleged wrongdoings and should be carefully drafted to reflect the allegations, agreement of the parties, resulting sanctions, and disposition of the license. It is essential that all parties agree and understand the terms and conditions of a consent order to avoid future disputes, to provide the licensee with conditions of compliance, to set a record for future board members and staff, and to establish a precedence record. Consider the following:

    Following an investiga-tion, the New Jersey Board of Nursing filed an admin-istrative complaint against a licensed nurse. The com-plaint alleged wrongdoing on the part of the nurse in restraining and medicat-ing an epileptic patient in a hospital emergency room. The complaint also alleged failure to prepare required incident reports and advise supervisory personnel, as well as the infliction of vari-ous injuries to the patient.

    Shortly before a sched-uled administrative hearing on the matter, the parties settled the dispute and executed a consent order whereby the licensee admit-ted to various allegations re-lated to improper restraint, failure to report, and failure to notify superiors of the incident. The attorney for the licensee also signed the consent order which provid-ed a three-month suspen-sion of his license, with the entire period of suspension

    stayed, pending licensee’s successful completion of a nine-month period of probation. Under the terms of probation and as set forth in the consent order, the licensee was required to perform nine months of actual employment as a nurse in a “non-clinical or structured clinical setting” and not in an environment where nursing supervision was unavailable.

    During the period of probation, the licensee was required to submit to the board quarterly self-assess-ments, along with progress reports from his employer, and complete a specified program of continuing education. In the event of a violation of the conditions of probation, “the stay shall be lifted and Respondent’s license may be actively suspended in accordance with [citation to New Jersey law].”

    Shortly after entry of the consent order, counsel for the licensee through letter requested a hearing indicat-ing that the licensee did not understand the ramifica-tions when executing the consent order. The request of the licensee was treated as a motion to vacate the consent order which was countered by the Attorney General in a cross motion to enforce the agreement. On behalf of the licensee, it was argued that he was a Nigerian who spoke English as a second language and “lacked an adequate un-

  • february 2009

    25

    (continued on page 36)

    Legal Briefs

    Attorney Dale J. Atkinson is a partner in the law firm of Atkinson & Atkinson, outside counsel for NABP.

    derstanding of the settle-ment documents to have voluntarily and intelligently consented to their terms.”

    After consideration and based upon findings by the Board that the licensee had adequate understanding of the consent agreement as exhibited by representa-tion by counsel, extensive input into the language of the final agreement, ample opportunity to discuss the matter with counsel, and licensee’s practice as a regis-tered nurse, the facts “belie the belated unsupported claim that [licensee] lacks a sufficient understanding of the English language to ap-preciate the meaning of the Order he signed.” Thus, the Board held that the consent order should be enforced and that the probationary period would commence upon service of the order to the licensee.

    After receipt of the determination of the Board regarding the enforcement of the consent order, the licensee, through a letter from his attorney, stated that the licensee was tender-ing his license to the Board for purposes of agreeing to the 90-day suspension, rather than adherence to the nine-month probationary period with the attendant practice restrictions. The Deputy Attorney General responded that because the suspension was stayed, the licensee must comply with the terms of probation, including the supervised

    practice setting and educa-tional requirements.

    Several months later, the attorney for the licensee moved for relief from the consent order stating that the licensee, although he had complied with the educational requirements, had not been able to secure employment as a nurse within the stated restric-tions of the order. The letter argued that the licensee was “unemployable” under the conditions of the consent order having been turned down by at least seven po-tential employers. Coun-sel for the licensee filed a motion requesting that the consent order be modified to restore the practitioner’s license without restriction. The Attorney General op-posed the motion.

    After the motion was filed, the licensee received a job offer providing unsupervised, individual-ized, in-home care. Upon inquiry, the Board found that such a position did not comply with the terms of the consent order. Addition-ally, the Board denied the motion to allow unrestrict-ed practice through the restoration of the license. The Board held that failure to secure employment based upon a consent order for egregious acts did not merit setting aside supervisory requirements. The licensee appealed the matter to the Superior Court.

    On appeal, the licensee argued that the Board’s

    refusal to restore his license was arbitrary and capricious in light of his “consistent, diligent efforts to secure suitable employment and his inability to obtain it.” Alternatively, he argued that the Board should have allowed for the three-month suspension, in lieu of the probationary period and requirements. He argued:

    [Licensee] did not know-ingly, voluntarily and intelligently consent to the entry of the Order as the [licensee] did not fully understand the terms of the Order. More importantly, the [licens-ee] did not validly waive his right to a hearing as the [licensee] could not foresee that it would be impossible to satisfy the supervised employ-ment provision of the Order, thereby effectively permanently ending his nursing career.The court noted that

    substantial deference will be afforded to the actions of the Board because of its expertise and superior knowledge related to the practice of nursing and that the court will only interpose its views where the agency has mistakenly exercised its discretion or misperceived its own statutory authority. The court found that the licensee did not substantiate any overreaching activities on the part of the Board which imposed discipline in compliance with the

  • nabp newsletter

    26

    Feature News

    Rogue Internet Drug Outlets(continued from page 22)

    spelling out elements of a le-gal patient-practitioner rela-tionship in June 2008, when the state’s governor signed into law a bill that specified the need for such a relation-ship in the issuance of a pre-scription, and included such provisions as a prohibition on prescriptions based on submission of an electronic or online medical history form that fails to establish a valid patient-practitioner relationship. Minnesota’s legislature, too, passed a law in 2008 requiring that prescriptions for controlled substances and certain other drugs be based on a documented patient evalua-tion, including an in-person examination; the Board highlighted this law – and disciplinary actions taken against pharmacies and pharmacists that had filled Internet-generated, non-valid prescriptions – in its October 2008 Newsletter.

    Other states that consid-ered similar legislation in 2008 included Illinois (a bill that emphasized the need for a physical examination as part of the patient evalu-ation) and Massachusetts (a bill seeking to establish procedures for Internet pre-scription consumer protec-tion).

    Oregon, like many other states, has been relying on existing laws to regulate Internet pharmacies do-ing business in the state, including the requirement that prescriptions be issued as part of a doctor-patient relationship, the definition

    of which is spelled out in both the state’s pharmacy and medical board regula-tions, says Gary A. Schnabel, RN, RPh, executive director of the Oregon State Board of Pharmacy. Up to this point, the Board has licensed phar-macies using the Internet no differently than other pharmacies doing business in Oregon.

    Now, however, Oregon is – again, like a number of other states – consider-ing adding laws specific to Internet pharmacies. Legisla-tion that, at press time, was scheduled to be introduced early in the Oregon Legis-lature’s 2009 session would, among other measures, make it criminal to operate an illegal online pharmacy and to illegally distribute drugs over the Internet, as well as require online phar-macies to have a valid pre-scription before dispensing a prescription drug (controlled substance or otherwise). Ex-emptions would be provided in some cases, sometimes at the discretion of the Board of Pharmacy. Passage of the bill would require the Board to develop regulations and a registration or licensing pro-cess, according to Schnabel.

    If the proposed legisla-tion becomes law, says Schnabel, it would “provide the Board of Pharmacy with additional tools and authority to identify illegal online pharmacies and take appropriate compliance and enforcement action.” At present, he says, the Board can investigate, for example, a brick-and-mor-tar pharmacy that fulfills orders for a Web site, but has fewer tools to address

    the Web site itself. While a new law would not neces-sarily simplify the always difficult process of identi-fying noncompliant sites, Schnabel notes, it would require the Web site using any registered Internet domain name to facilitate the dispensing of prescrip-tion drugs, regardless of its location, to register with the Board.

    Judging EffectivenessWill this spate of legisla-

    tion and regulation prove effective against the ever-shifting tactics of rogue Internet drug outlets? Not everyone is sure.

    “The Ryan Haight bill is a good first step, but it will have very little immedi-ate impact,” Mathea Falco, president of the nonprofit research organization Drug Strategies, told the Colum-bus Dispatch last October. “It depends completely on prosecution and conviction, and that’s a cumbersome process.” As additional measures, she has suggested barring financial institu-tions from allowing their payment systems to be used for Internet drug sales, and discouraging owners of search engines from selling advertisements for illegal pharmacy Web sites.

    Benjamin Gluck, JD, a criminal defense attorney who has worked on several Internet pharmacy cases across the country and pre-sented the program “Case Strategy: How to Investigate an Internet Pharmacy” at the NABP 104th Annual Meeting in May 2008 in Baltimore, MD, has voiced some skepticism that

    enforcement will move as smoothly as legislative pro-ponents hope. One concern is that rogue Internet drug outlets will cease to become even marginally legitimate – filling prescriptions with FDA-approved medications from US pharmacies – and move predominately off-shore, where US law enforce-ment cannot easily reach. Gluck predicted on his pharmacy-law blog (http:// internetpharmacylaw .wordpress.com) that one effect of the Ryan Haight Act “will eliminate the sellers of controlled sub-stances that purported to follow the law. This means that the questionnaire sites for controlleds [controlled substances] will give way to the ‘brown bag’ sites that don’t even pay lip service to the law.” Typical character-istics of “brown bag sites,” Gluck told NABP Annual Meeting attendees, include no doctors, no prescriptions, an offshore location, foreign drugs, and mailing the drugs into the US.

    There are some hints, however, that regulatory and law enforcement actions are having a positive effect on the availability of drugs over the Internet. A recent study published in the Journal of Studies on Alcohol and Drugs observed that the avail-ability of opioid analgesics from online pharmacies had decreased between 2005 and 2007. “This self-reported change in drug availability may be related to increased regulation of and law enforcement operations directed against Internet pharmacies,” the researchers concluded.

  • february 2009

    27

    NABP Testifies in Trials Leading to Convictions, Shutdown of Internet Drug Outlets

    The operator of a so-called pharmacy established to fill prescriptions ordered over the Internet testified that he ran the operation like a production assembly line. Neither he nor a phar-macist ever reviewed the thousands of prescriptions filled per week for medica-tions including controlled substances.

    An NABP representa-tive testified on October 27, 2008, as an expert witness on this issue in the trial of the United States of America vs Antonio and Herman Quinones. The defendants were later convicted for il-legally dispensing controlled substances. The defendants operated several pharma-cies, including Waterview Pharmacy and Park & Clay Pharmacy in Maryland.

    Primarily at issue was the validity of the prescrip-tions being filled. For a prescription to be valid, it must be issued pursuant to a legitimate patient-prescriber relationship, which requires the following to have been established: (a) the patient has a legitimate medical complaint; (b) a face-to-face physical examination ad-equate to establish the legiti-macy of the medical com-plaint has been performed by the prescribing practitio-ner, or through a telemedi-cine practice approved by the appropriate practitioner board; and (c) a logical connection exists between the medical complaint, the medical history, and the

    physical examination and the drug prescribed.

    In this case, however, thousands of prescription drug orders were written by one prescriber in Puerto Rico for patients throughout the United States who filled out an online questionnaire on any one of twenty-some Web sites. As cited in the trial, one such question-naire that was supplied with an order for the diet drug phentermine provided no height or weight informa-tion. Another described a female patient as “eight feet tall two inches” weighing 143 pounds. Nonetheless, virtually all prescription orders were filled, mostly in the absence of a licensed pharmacist, whose primary purpose in the operation was to hang his license on the wall. The operator of the drug outlet, Lazaro Vega, was paid for each prescrip-tion filled.

    “I was running the Park and Clay Pharmacy pretty much like a line assembly, totally with disregard of the drug for legitimate use of the customer, and also be-ing aware that the customer have never seen the doctor before,” Vega testified.

    The previous week, Vega had pled guilty to conspir-acy to distribute a Schedule IV substance. By testifying in this case, he hoped to have his sentence reduced.

    NABP Executive Director/Secretary Car-men Catizone, MS, RPh, DPh, was called upon to

    render an expert opinion regarding whether the pharmacy was engaged in legitimate or illegal activi-ties. “My opinion is that the operations were illegal and characterized as a rogue Internet pharmacy and did not qualify as a legitimate or legal Inter-net pharmacy operation,” Catizone testified.

    As the basis for his opinion, he cited the requirements of state and federal laws, including the Controlled Substances Act and the Federal Food, Drug, and Cosmetic Act. In this case, he said, the defendants “failed to fol-low any of these laws, they dispensed medications without a valid prescrip-tion, and their activities were dangerous to the . . . public health and warrant them being considered ille-gal and rogue pharmacies.”

    In regard to the require-ment for a valid prescrip-tion and what constitutes a valid prescription, Catizone explained, “[t]he laws governing the practice of pharmacy, involving the se-curity of a pharmacy, what is a legitimate and valid prescription, and what is a legitimate patient-prescrib-er relationship are uniform across the states.”

    He further remarked that, in 46 of the 50 states, a pharmacy cannot dispense medications outside of its state unless it is licensed in every state where it dispens-es medication.

    Catizone also pointed out that, in a traditional brick-and-mortar pharmacy, or a legal Internet pharmacy, the majority of prescriptions filled would be for drugs prescribed for a variety of diseases and indications such as diabetes and high blood pressure. Prescriptions for controlled substances, on the other hand, typically ac-count for a small percentage of a pharmacy’s prescription drug orders. One of the Web sites in question, however, showed the percentage of prescriptions for controlled substances to be approxi-mately 80%, one factor that often is a strong indication its activity is illicit.

    Although the defen-dants themselves were not dispensing the prescrip-tions, it was their operation that dispensed the pre-scriptions, and thus, they were held accountable. “Just because the person is not a pharmacist or doctor, they still own the business, are engaged in those activi-ties; they’re legally respon-sible for those activities,” Catizone said.

    Catizone has testi-fied as an expert witness in three similar cases in 2008. Defendants in all three cases either pled or were found guilty of ille-gally dispensing controlled substance medications, resulting in these opera-tions being shut down. He is scheduled to testify in several additional cases in 2009.

    Association News

  • nabp newsletter

    28

    Association News

    December FPGEE Scores Released; First Administration of New Computerized Examination Approaches

    A total of 1,359 appli-cants sat for the December 6, 2008 NABP Foreign Pharmacy Graduate Equivalency Examina-tion® (FPGEE®). As a new benefit, in January 2009 examination scores were made available to applicants through electronic down-load from a secure Web site, rather than being mailed.

    The examination was held in three United States locations: New York City, NY; Northlake (Chicago), IL; and San Jose, CA; and was the final administra-tion of the paper-and-pen-cil FPGEE. Beginning with the April 14, 2009 adminis-tration, the FPGEE will be provided in a computerized format. Like the paper-and-pencil examination,

    the computerized FPGEE will be administered once in the spring and once in the fall; however, applicants will be able to choose from more than 200 Pearson VUE testing sites located within the continental US instead of only three. See “NABP Restores Computer-ized FPGEE with Increased Security, More Test Sites for Applicants,” in the November-December 2008 NABP Newsletter for more information on the com-puterized FPGEE.

    Applicants are required to take the FPGEE as a component of the NABP Foreign Pharmacy Gradu-ate Examination Commit-tee™ (FPGEC®) certifica-tion process. The FPGEC Certificate serves as a

    means of documenting the educational equivalency of applicants’ foreign phar-macy education and their foreign licensure and/or registration status. In addi-tion to passing the FPGEE, applicants are required to demonstrate English language proficiency by attaining the combination of the minimum passing Test of English as a Foreign Language™ (TOEFL®) and Test of Spoken English ™ (TSE®) scores or the mini-mum passing TOEFL Internet-based Test (iBT) score.

    NABP encourages ap-plicants preparing to sit for the FPGEE to take the Pre-FPGEE®, the official FPGEE practice examination written and developed by NABP and

    designed to help familiarize applicants with the FPGEE. This Web-based practice examination exhibits the types of questions provided on the actual FPGEE and supplies applicants with a score estimate upon comple-tion of the examination. The cost of the Pre-FPGEE is $50. Additional information re-garding the FPGEE, FPGEC, and Pre-FPGEE is available in the FPGEC Application Bulletin and in the Examina-tion Programs section of the NABP Web site at www.nabp .net.

    NEWLy ACCREDITED VAWD FACILITIES

    The following facilities were accredited through the NABP Verified-Accredited Wholesale Distributors® (VAWD®) program:

    A full listing of accredited VAWD facilities is available on the NABP Web site at www.nabp.net.

    Baush & Lomb, IncGreenville, SCAccredited November 5, 2008

    Fresenius USA Manufacturing, Inc dba Fresenius Medical Care North AmericaKenosha, WIAccredited November 17, 2008

    McKesson Medical-Surgical Minnesota Supply, IncGlendale Heights, IL Accredited November 16, 2008

    McKesson Medical-Surgical Minnesota Supply, IncMaple Grove, MNAccredited November 16, 2008

    McKesson Medical-Surgical, IncAuburn, WAAccredited November 16, 2008

    Patterson Logistics Services, IncKent, WAAccredited November 5, 2008

    Patterson Logistics Services, IncBlythewood, SC Accredited November 16, 2008

    Smith’s Food & Drug Centers, Inc dba Peyton’s PhoenixPhoenix, AZAccredited November 5, 2008

  • february 2009

    29

    105th Annual Meeting

    Register Now for 105th Annual Meeting in Miami

    NABP Accepting 105th Annual Meeting Travel Grant Applications

    NABP Extends Deadline for Educational Poster Session

    Register now to attend the 105th Annual Meeting, “NABP MIAMI: Quality Care – It’s Hot! Hot! Hot!” to be held May 16-19, 2009, at the Hyatt Regency Miami Hotel in Florida.

    Prospective attendees can register directly online using the new and

    improved online registration form by visiting the Meetings section of the NABP Web site at www.nabp.net. A printable registration form can also be downloaded by anyone wishing to mail or fax the form to NABP. Both types of registration offer attendees

    three payment options: (1) mailing in the payment, (2) using a credit card, or (3) paying in Miami.

    Registration and additional information about the 105th Annual Meeting is available in the Meetings section of the NABP Web site.

    NABP is again offer-ing a travel grant for the 105th Annual Meeting in Miami, FL. Designated state board of pharmacy voting delegates will have the opportunity to receive up to $1,200 in

    The deadline to participate in the Educational Poster Session has been extended. To present a poster during the 105th Annual Meeting event, interested state boards of pharmacy and staff are asked to contact NABP Professional Af-fairs Manager Eileen Lewalski via e-mail at [email protected] by Monday, March 16, 2009.

    Themed “CQI on Fire,” the ses-sion will be held Sunday, May 17, from 8 to 11:30 am during the 105th Annual Meeting, May 16-19, 2009, in Miami, FL. State board of phar-macy members and staff as well as students and faculty of schools and colleges of pharmacy are encour-aged to partake in this event, which will offer those displaying posters the opportunity to share

    information about their organiza-tions’ latest legislative issues, tech-nology, policy development, and disciplinary cases as they relate to continuous quality improvement.

    Participants and present-ers will also be able to earn one contact hour (0.1 CEU) of Ac-creditation Council for Pharmacy Education(ACPE)-approved con-tinuing pharmacy education (CPE) credit for their attendance and participation. In order to comply with the new ACPE criteria, both participants and presenters must spend at least 60 minutes inter-acting with other Poster Session presenters to earn CPE.

    Presenters will be provided with one 4-foot by 6-foot bul-letin board, which should be

    manned by a qualified represen-tative during display times. All posters must coincide with the Poster Session theme, “CQI on Fire,” and presenters are asked to submit two learning objectives and two self-assessment questions along with their poster topics. Assembly time will be available on Sunday, May 17, from 6:30 to 7:45 am. Please note, all student presenters must be accompa-nied by a licensed pharmacist to participate. Pharmacy school students who participate in the poster session will receive a free voucher valued at $50 to take the Pre-NAPLEX®, a practice exami-nation for students preparing for the North American Pharmacist Licensure Examination®.

    grant monies to assist in funding travel expenses, including airfare, ho-tel rooms, meals, taxis, parking, and tips. The grant does not include Annual Meeting registra-tion fees.

    Grant applications may be obtained from NABP upon the direct requests of executive officers of the state boards of pharmacy. NABP requests that ap-plications be submitted by executive officers to

    NABP Headquarters prior to the Annual Meeting. Questions may be direct-ed to exec-office@nabp .net. All applicants will be informed of whether or not they have qualified for the grant.

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    105th Annual Meeting

    Saturday, May 16, 20099 am - 7 pm Registration/Information Desk Open1:30 - 4:30 pmPre-Meeting CPEMaxims, Monarchy, and Sir Thomas MoreACPE #205-000-09-001-L03-P (0.275 CEUs – 2.75 contact hours)

    5 - 6 pmAnnual Meeting Orientation7 - 10 pmPresident’s Welcome ReceptionHonoring NABP President Rich Palombo and his wife SandraDinner will be served.Dress: business casual

    Sunday, May 17, 20096:30 am - 5:15 pmRegistration/Information Desk Open7:30 - 8:30 amFun Run/Walk8 - 11:30 amJoint CPEEducational Poster Session – CQI on FireACPE #205-000-09-002-L05-P (0.1 CEU – 1 contact hour)

    8 - 11:30 amHospitality Brunch and Educational Table Top Display

    Noon - 4 pmFirst Business Session12:30 - 1:30 pmKeynote AddressTucker Carlson, Senior Campaign Correspondent, MSNBC4 - 5 pmJoint CPEDEA Update ACPE #205-000-09-003-L03-P (0.1 CEU – 1 contact hour)

    Monday, May 18, 20097 am - 2 pmRegistration/Information Desk Open7 - 8:15 amNABP/USP Breakfast8:15 - 10:15 amJoint CPEPatient Counseling – Catch the WaveACPE #205-000-09-004-L03-P (0.2 CEUs – 2 contact hours)

    10:30 am - noon Second Business SessionNoon - 12:30 pmInformal Member/Candidate Discussion1:30 - 5 pmMagic City Tour(Afternoon free)

    Tuesday, May 19, 20097:30 am - 4:15 pmRegistration/Information Desk Open

    8 - 9 amContinental Breakfast 9 - 10:30 amExecutive Officer and Board Member CPECompounding Inferno – “For Office Use”ACPE #205-000-09-005-L03-P (0.15 CEUs – 1.5 contact hours)

    9 - 10:30 amCompliance Officer CPEe-Tools “Out of Hand!”ACPE #205-000-09-006-L03-P (0.15 CEUs – 1.5 contact hours)

    10:45 am - 12:15 pmJoint CPEStandardization of Technician Education – Want it? Need it?ACPE #205-000-09-007-L04-P (0.15 CEUs – 1.5 contact hours)

    12:15 - 1:30 pmLunch Break (On your own)1:30 - 4 pmFinal Business Session5:45 - 6:45 pmReception7 - 11 pmAnnual Awards DinnerDress: semiformalNote: The 105th Annual Meeting schedule is subject to change.

    NABP and the NABP Foundation is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. ACPE Provider Number: 205. Participants may earn up to 9.75 contact hours (0.975 continuing education units) of ACPE-approved continuing pharmacy education credit from NABP. Participants in continuing pharmacy education programs will receive credit by completing a “Statement of Continuing Pharmacy Education Participation” and submitting it to NABP. A validated Statement of Continuing Pharmacy Education Credit will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmacy education credit and a Statement of Continuing Pharmacy Education Credit.

    Meeting ProgramNABP 105th Annual Meeting • May 16–19, 2009 • Hyatt Regency Miami Hotel • Miami FL

    Continuing Legal Education (CLE) Policy: NABP staff will be available to assist attendees on an individual basis to apply for CLE credit for attending CPE sessions. To apply for CLE credit, attendees must initiate the program approval process in their own states by completing and submitting the appropriate application materials and forms. NABP will provide documentation as necessary.

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    List of Not Recommended Internet Drug Outlets Grows

    The list of Internet drug outlets on the NABP Web site that do not appear to meet state and federal laws and NABP patient safety and pharmacy practice standards grew to 1,659 as of February 20, 2009.

    Of these:

    •1,584 sites do not require a valid prescription

    •946 sites offer foreign or non-FDA-approved drugs

    •697 sites are located out-side the United States

    and selling drugs illegal-ly to patients in the USSixteen sites are

    listed as Recommended. These sites are accredited through the NABP Veri-fied Internet Pharmacy Practice Sites™ program.

    A full listing of Rec-ommended and Not Rec-ommended sites, along with program criteria and related patient informa-tion, is available in the Internet Pharmacies section of the NABP Web site at www .nabp.net.

    PCOA Administration Scheduled to Take Place in March

    The second annual Pharmacy Curriculum Outcomes Assessment® (PCOA®) administration is scheduled to be held March 9-20, 2009. Par-ticipating schools and col-leges of pharmacy chose one date within this two week time period to ad-minister the assessment to their students. As of press time, 15 schools have signed up to participate in the administration.

    The PCOA is a com-prehensive assessment

    tool developed by NABP and key stakeholders in response to the need expressed by the United States schools and col-leges of pharmacy for assistance with cur-riculum development and measurement of student performance and growth.

    Additional informa-tion regarding the PCOA is available in the Assess-ment Programs section of the NABP Web site at www.nabp .net.

    105th Annual Meeting

    Tucker Carlson to Provide a Behind-the-Scenes Look at Changes in Washington during Annual Meeting Keynote Address

    Tucker Carlson, senior campaign correspondent for MSNBC, will provide his witty and insight-ful views on political headlines and current events during the key-note address at the NABP 105th Annual Meeting to be held May 16-19, 2009, at the Hyatt Regency Miami Hotel in Florida. Speaking on the political landscape, Carlson will discuss the significant changes President Barack Obama is expected to bring to American life, business, and politics. Carlson is intimately fa-miliar with the key play-ers who will be reshaping Washington, and will offer attendees a candid,

    up-to-the-moment look at events as they unfold.

    Carlson has held his position as a senior campaign correspondent for MSNBC since March 2008. He joined MSNBC in February 2005 from CNN, where he was the youngest anchor in the history of that network. Prior to be-coming a senior campaign correspondent, Carlson hosted MSNBC’s Tucker, a fast paced, no-holds-barred conversation about the day’s developments in news, politics, world issues, and pop culture. At CNN, he hosted a num-ber of shows and specials, including the network’s political debate program, Crossfire. During the same

    period, Carlson also hosted a weekly public affairs program on PBS, Tucker Carlson: Unfiltered.

    A longtime magazine and newspaper journal-ist, Carlson has reported from around the world, most recently from Iraq and Lebanon. He has been a columnist for New York magazine and Reader’s Di-gest and currently writes for Esquire, The Weekly Standard, and New York Times Magazine. Carlson began his journalism career at the Arkansas Democrat-Gazette news-paper in Little Rock. His first book, Politicians, Par-tisans and Parasites: My Adventures in Cable News, was published in fall 2003.

    Information and online registration for the 105th Annual Meeting are avail-able in the Meetings Sec-tion of the NABP Web site at www.nabp.net.

    MSNBC Senior Campaign Correspondent Tucker Carlson will present the 105th Annual Meeting Keynote Address.

  • nabp newsletter

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    2008 Symposium

    Presenters Take A Closer Look at Drug CounterfeitingMeeting attendees heard from experts on the scope of drug counterfeiting issues as well as some solutions for prevention. Pictured left to right: Brian Donnelly, PhD, RPh, director, Americas Region, Global Security, Pfizer Inc (Prevalence of Counterfeit Drugs from Manufacturer to Patient); Virginia Herold, MS, executive officer, California State Board of Pharmacy (California Pedigree Law Update); Catherine M. Polley, RPh, vice president, pharmacy services, Food Marketing Institute (Pedigrees: From Tomatoes to Jalapeños to Pharmaceuticals); Matthew E. Ziemniak, MS, program director of cyber operations, National Cyber-Forensics and Training Alliance (Malware Ties to Online Drug distributors and Organized Crime: What are the Implications?); and session moderator Malcolm J. Broussard, RPh, member, NABP Executive Committee.

    2008 Symposium(continued from page 23)

    modeled on the mafia, reap-ing hundreds of millions of dollars in profit, stated Matt Ziemniak, MS, program director of cyber operations at the National Cyber-Foren-sics and Training Alliance. Through the use of viruses and other types of malware, these criminals have wide-spread networks for selling counterfeits.

    CountertacticsAfter attendees were

    versed on the scope of the problem of counterfeit drugs in the US distribu-tion system, they learned about the progress of steps being taken to combat counterfeits. Catherine M. Polley, RPh, vice president of pharmacy services at the Food Marketing Institute, discussed the challenges of implementing track-and-trace technologies for food items in a grocery setting, giving participants an understanding of what the pharmacy profession is fac-ing as it executes a pedigree system for prescription drugs.

    Virginia Herold, MS, executive officer of the California State Board of Pharmacy, explained the current status of the Cali-fornia pedigree legislation, noting while some compa-nies have met the January 1, 2009 deadline for pedigrees, many have not due to the complexity of developing pedigree programs. There-fore implementation has been changed to a stepped plan that begins in 2015

    with all implementation complete by 2017.

    A pedigree system will go a long way to identifying counterfeit drugs that enter the distribution system, but keeping counterfeit drugs out of the system to begin with is ideal. Robert H. Caldwell, BA, cofounder and managing partner of G2 Web Services, LLC, dis-cussed how cutting coun-terfeiters off at their money source can be a very effective way to combat counterfeit-ers. He explained that credit card companies can quickly and easily shut down a mer-chant account if the vendor is violating the rules of the credit card association. He noted that, while law enforcement is sometimes inhibited by jurisdictional issues, credit card networks specifically require a trans-action to be legal in all juris-dictions of the transaction. Therefore if a credit card company is given evidence that one of their merchants is acting illegally in a state that it is doing business, the card company will cut off the merchant no matter where in the world the busi-ness is based.

    Roundtable Discussions Spark New Ideas

    During the Roundtable Discussion “The ‘Haves’ and the ‘Have Nots’ of Pedigrees,” participants dis-cussed a case study regarding the investigation of a whole-sale distributor that did not utilize pedigrees or other forms of proper record keep-

    (continued on page 33)

    Experts Offer Insight on Issues with Counterfeit DrugsSpeakers during the session “Counterfeit Drugs: Serious Threat or Ploy?” provided attendees with a look at the problem of drug counterfeiting and what can be expected in the future. Pictured left to right: session moderator Oren M. Peacock, Jr, RPh, chairperson, NABP Executive Committee; Ronald J. Ziance, PhD, professor of pharmaceutical sciences, University of Southern Nevada College of Pharmacy (The Hard Evidence of Counterfeit Drugs); Francis B. Palumbo, MS, PhD, JD, RPh, professor and executive director, University of Maryland School of Pharmacy Center on Drugs and Public Policy (Issue Introduction and Overview); Frederick Felman, BS, chief marketing officer, MarkMonitor (A Global Look at Counterfeiting); and Frederick L. Fricke, MS, director, Forensic Chemistry Center, Food and Drug Administration (The Hard Evidence of Counterfeit Drugs).

  • february 2009

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    2008 Symposium

    ing. The varied professions of the participants – inves-tigators, board of phar-macy members, lawyers, and law enforcement officials – provided a well rounded look at the possible pitfalls and the solutions for bringing a dishonest distributor to justice.

    The participants then moved on to the topic “Educating about Internet Drug Safety – Strategies for Informing and Educat-ing Patients,” where they brought forth many ideas on how to inform the pub-lic about safely purchasing prescription medications from Internet pharmacies.

    2008 Symposium(continued from page 32)

    (continued on page 34)

    Point-Counterpoint Provides Positive and Negative Views on ImportationProponents and opponents of prescription drug importation outlined their positions during the presentation Illegal Importation: Point-Counterpoint, on December 4, 2008. Pictured left to right: session moderator Oren M. Peacock, Jr, RPh, chairperson, NABP Executive Committee; Andy Troszak, RPh, past president/board member, Canadian International Pharmacy Association; Connie T. Jung, RPh, PhD, senior policy advisor for pharmacy affairs, Food and Drug Administration (FDA); Gabriel Levitt, MA, vice president, PharmacyChecker.com; Frederick L. Fricke, MS, director, Forensic Chemistry Center, FDA; and Joseph W. Cranston, PhD, director division of science, research, and technology, American Medical Association.

    All the groups agreed that the most far reaching plan would be a national advertis-ing campaign that included print, television, and radio ads. Recognizing that the cost for such a plan was well beyond the resources of NABP, the participants recommended partnering with other organizations to gain assistance in funding. Potential partners included other pharmacy associations, pharmacy benefit managers, and pharmaceutical com-panies. Social network sites were also cited as an excel-lent venue for educating the public about safety issues associated with purchasing prescription drugs online.

    Lower cost options were also put forward and included boards working

    with local health reporters and newspapers to get the information in the news. Some groups also suggested developing public service announcements that would be distributed to the boards’ local networks for placement on the air. To offset pro-duction costs, it was again suggested that NABP work with other organizations and special interest groups to fund such projects.

    Other suggestions from the groups included brochures and other take away materials placed in hospitals and pharmacies, partnering with DARE, and working with the federal government to create a warning that must be included on all Web sites that advertise the sale

    of prescription drugs online.

    The final roundtable discussion, “The Dream Team: A Strategy for Com-bating Counterfeit Drugs,” gave participants the opportunity to determine who is needed to create the ideal team for com-bating counterfeit drugs. In their discussions, the breakout groups identi-fied counterfeit drugs as a domestic and an interna-tional problem requiring tougher state and federal laws as well as education and outreach to patients and practitioners. In light of this recognition, the groups suggested that the dream team include WHO and other international

    Presenters Stress Need for Collaboration to Halt Drug CounterfeitingPresenters expressed the need for the industry and regulators to share information obtained in their efforts to protect products and cooperate for effective outcomes as well as provided information on current and potential future efforts by NABP to curb counterfeiting, avert illegally operating rogue Internet drug outlets, and protect the public health. Pictured left to right: NABP staff Eleni Z. Anagnostiadis, RPh, associate executive director and Melissa A. Madigan, PharmD, JD, policy and communications senior manager presented Collaborative Efforts for Tomorrow, and Robert H. Caldwell, BA, cofounder and managing partner, G2 Web Services, LLC (not pictured) presented The Global Threat of Counterfeit Drugs: Necessary Partnerships among the Industry and Regulators. Lloyd K. Jessen, RPh, JD, member, NABP Executive Committee, moderated the session.

  • nabp newsletter

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    2008 Symposium

    Participants Hold Invigorating Discussions during RoundtablesAttendees had the opportunity to participate in three Roundtable Discussions, The “Haves” and the “Have Nots” of Pedigrees, Educating about Internet Drug Safety – Strategies for Informing and Educating Patients, and The Dream Team: A Strategy for Combating Counterfeit Drugs. These discussions challenged participants to create solutions for counterfeit cases, develop various programs to inform the public of the dangers of purchasing medications on the Internet, and determine the requirements for a team that is successful in combating counterfeit drug outfits.

    2008 Symposium(continued from page 33)

    organizations along with domestic law enforcement, legislators, manufactur-ers, wholesale distribu-tors, boards of pharmacy, NABP, and other phar-macy organizations.

    The groups identified some key legislative activ-ities that could help curb counterfeiting includ-ing amending the Ryan Haight Act to include all prescription drugs, increasing the penalties of the Federal Food, Drug, and Cosmetic Act, rede-fining mail fraud to apply to common carriers such as UPS and FedEx, and all 50 states creating uniform laws regarding Inter-net pharmacies. NABP recorded the group’s ideas and is researching and ex-ploring the suggestions to see if they fall within the scope of the Association’s

    mission and if resources are available to accomplish them.

    BTC Class of Medications

    A lively debate on the merits of a BTC class of medications took center stage on the final day of the Symposium. The oppo-nents stated that the current system works fine as it is and that the potential impact of a BTC class is unknown. David C. Spangler, AB, JD, senior vice president of Policy and International Affairs at the Consumer Healthcare Products As-sociation, argued that a BTC class would remove the physician from the diagnosis entirely, which would be det-rimental to the patient. He stated that some symptoms are very difficult to detect and that only a physician can deal with people who have multiple diseases and many drug regimens.

    Proponents of a BTC class countered this argu-ment stating that the pharmacist’s role in such a situation is not to diag-nose patients, but to build relationships and become involved with patients. Sandra Carey, BSc Pharm, a pharmacist in Canada and president of the National Association of Pharmacy Regulatory Authorities (NAPRA), pointed out that in Canada where they have had such a drug class for several years, physicians will diagnose a patient’s condition and then send the patient back to the pharmacist so the two can discuss the best medica-tion or product to use for treatment.

    Spangler stated that a BTC class is unnecessary because the current system is already flexible enough, giving the example of age monitoring for smok-ing cessation drugs and

    emergency contracep-tives. Harry P. Hagel, MS, RPh, senior vice president of govern-ment and professional affairs at the American Pharmacists Association, pointed out that a BTC class would increase access for patients, as pharmacists are avail-able on weekends and often times, in rural settings, the pharmacist is the only health care professional in the area at any time.

    Both sides are await-ing the release of a new report on the BTC class from the Government Accountability Office. This is a follow up to the 2005 report that found no need for such a class of drugs; how-ever, the original report underlined the lack of adequate information on the effects, good or bad, of a BTC class.

  • february 2009

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    2008 Symposium

    FDA Explores the Effects of a BTC Class of DrugsFood and Drug Administration Senior Policy Advisor for Pharmacy Affairs Connie T. Jung, RPh, PhD, provided the “ins” and “outs” of establishing a behind-the-counter class of drugs, explaining the effects on board of pharmacy regulation during the presentation BTC Issue Overview. Gary A. Schnabel, RPh, RN, president-elect, NABP, moderated the session.

    NAPRA Discusses BTC Drug Class ExperienceRepresentatives from the National Association of Pharmacy Regulatory Authorities (NAPRA) shared their experiences with a behind-the-counter class of drugs during the presentation BTC Class in Canada. Pictured left to right: Barbara Wells, RPh, DPh, founder and consultant, B.A. Wells Healthcare Consulting Inc; Carole Bouchard, BPharm, MAP, executive director, NAPRA; and session moderator Cathryn J. Lew, RPh, member, NABP Executive Committee.

    Law Issues Investigated Regarding Allowance of a BTC Class of DrugsDuring the presentation Federal and State Law Issues, Frederick H. Branding, RPh, JD, partner, Reed Smith, discussed how the Federal Food, Drug, and Cosmetic Act would have to be amended to allow for a behind-the-counter (BTC) class of drugs in addition to how state pharmacy practice laws and regulations may affect the dispensing of BTC medications. Karen M. Ryle, MS, RPh, member, NABP Executive Committee, moderated the session.

    Presenters Debate their Views on BTC Drug ClassThe benefits and risks of creating a third, behind-the-counter, class of drugs were debated by proponents and opponents during BTC Point-Counterpoint. Pictured left to right: Sidney M. Wolfe, MD, director, Health Research Group, Public Citizen; Barbara Wells, RPh, DPh, founder and consultant, B.A. Wells Healthcare Consulting Inc; David C. Spangler, AB, JD, senior vice president, policy and international affairs, Consumer Healthcare Products Association; Holly W. Henry, RPh, president, National Community Pharmacists Association; Harry P. Hagel, MS, RPh, senior vice president of government and professional affairs, American Pharmacists Association; Joseph W. Cranston, PhD, director, division of science, research, and technology, American Medical Association; Sandra Carey, BSc Pharm, president, National Association of Pharmacy Regulatory Authorities; and session moderator, William T. “Bill” Winsley, MS, RPh, treasurer, NABP .

    Presentation hand outs can be found on the NABP Web site at www.nabp.net in the Meetings/2008 Sym posium section.

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    Professional Affairs Update

    Deadline for Computer-Generated Faxed Prescriptions Extended

    Centers for Medicare and Medicaid Services (CMS) has extended its deadline for the exemp-tion of computer-generated faxed prescriptions used by physicians who participate in Medicare by three years. The new deadline is Janu-ary 1, 2012. The deadline change is included in the 2009 Medicare Physician Fee Schedule final rule an-nounced by CMS on Octo-ber 30, 2008. The final rule with comment appeared in the November 19, 2008 Fed-

    eral Register. Comments on designated provisions were accepted through December 29, and a final rule respond-ing to the comments will be published at a later date. The text of the fee schedule final rule is available via the CMS Web site.

    Internet Drug Outlets Raided by Authorities in Nine Countries

    Authorities in nine countries have raided busi-nesses suspected of dispens-ing prescription medica-tions illegally over the Internet, Reuters reported on November 13, 2008. Coordinated by Interpol, the operation reportedly

    involved dozens of loca-tions in Britain, Germany, Ireland, Israel, New Zea-land, Singapore, Switzer-land, Canada, and the United States. The complete article is posted under “In the News” in the Internet Pharmacies section of the NABP Web site.

    FDA Warns Consumers of Extortion by Impersonators

    Food and Drug Admin-istration (FDA) is warn-ing consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as “FDA special

    agents” or other FDA of-ficials. Several instances have been reported to FDA of calls enticing consum-ers to purchase discounted prescription drugs by wir-ing funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subse-quent call is received from a fraudulent “FDA special agent” informing the con-sumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action. More information is available in the FDA news release dated November 12, 2008.

    Legal Briefs(continued from page 25)

    uniform administrative procedures applicable to licensure matters. The court also agreed with the Board that the evidence of good faith efforts by the licensee to secure employment was sparse and did not support his claim that the consent order rendered him unem-ployable.

    Further, the court noted that the terms of the consent order did not permit the licensee to unilaterally deter-mine to accept the three-month suspension in lieu of the completion of the nine-month probation period of supervised employment. The court stated:

    We are satisfied that the terms of the consent order do not permit [licensee] to unilaterally determine to accept a three-month suspen-

    sion of his license in lieu of completion of the required nine-month probationary period of supervised employment. In this respect, the State has a strong interest in assuring the health and welfare of its residents through regulation and supervision of licensed nurses. . . . In this case, the Board acted to safeguard the public by ordering that the discipline imposed upon [licensee] as the result of his professional misconduct include mechanisms designed to correct his professional failings and to avoid their repetition. That salutary goal would be under-mined if [licensee] were permitted, without good cause, to avoid the condi-tions placed by the Board on his nursing practice by demanding, instead, a

    limited loss of licensure. While the Board may request the institution of proceedings to convert the stayed suspension to an active suspension through the mechanism of a provisional order of discipline, we have been cited to no author-ity, and we are aware of none, that would permit [licensee] to initiate that step. . . .Because we agree with the Board that [licensee] voluntarily and intel-ligently waived his rights to a hearing when he entered into the settle-ment of the disciplinary proceedings against him and executed the Novem-ber consent order, and we agree that he failed to demonstrate good cause for modification of that order, we find neither a violation of [licensee’s] substantive or procedural

    due process rights in con-nection with this matter.Boards of pharmacy

    are encouraged to care-fully draft consent orders to specifically set forth the requirements of all parties. Drafters of consent orders may wish to specifically include language prohibit-ing a post consent order election by a disciplined licensee to forgo probation-ary conditions in favor of a suspension. Alternatively, suspension periods could be lengthened to deter such an election. Of course and while not present in this case, severe restrictions on practice settings of licensees may provide an arguable claim of an inability to gain employment and boards are cautioned to consider the impact on the enforceabil-ity of such an order.

    In re Odefemi, 2008 WL 2677872 (Superior Ct NJ 2008)

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    Association News

    Committee Convenes to Discuss Law Enforcement, LegislationThe Committee on Law Enforcement/Legislation met January 20-21, 2009. Pictured above from left to right: Chairperson David W. Dryden, RPh, JD, executive secretary, Delaware State Board of Pharmacy; Dennis K. McAllister, RPh, member, Arizona State Board of Pharmacy; Jerome J. Wiesenhahn, RPh, member, Ohio State Board of Pharmacy; Jennifer Edwards, PharmD, member, Virginia Board of Pharmacy; and David Potters, JD, executive director and general counsel, West Virginia Board of Pharmacy.

    Members Review New NAPLEX ItemsThe North American Pharmacist Licensure Examination® (NAPLEX®) Review Committee convened at NABP Headquarters to review and code new items for the examination. The NAPLEX consists of 185 multiple-choice test items, which include 150 scored and 35 pretest items. Pictured above: Darla Gallo, RPh, of Pennsylvania, and Eric F. Schneider, PharmD, BCPS, associate professor, University of Arkansas for Medical Sciences, College of Pharmacy.

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    State Board News

    DEA Responds to Alabama’s ‘Take-Back’ Prescription Disposal Programs

    In its November 2008 Newsletter, the Alabama State Board of Pharmacy published Drug Enforce-ment Administration’s (DEA) response to prescrip-tion disposal programs. According to Mark W. Caverly, chief, Liaison and Policy Section, Office of Diversion:

    The Controlled Sub-stance Act and its implementing regula-tions establish a closed system of distribution for controlled sub-stances, which requires those individuals or firms desiring to handle controlled substances to be registered with DEA. This closed system facilitates an accu-rate accounting of all controlled substances from their manufacture through and includ-ing their disposition. In addition, this closed system reduces the potential for diversion of controlled substances from these registrants because of the audit trail and the ability of this system to detect excessive, suspicious, and unusual orders or shipments. The ulti-mate user is a nonreg-istrant, and there is no provision in the Con-trolled Substance Act to allow a DEA registered pharmacy to acquire controlled substances from a nonregistrant.

    Pharmacy Interns Must be Registered with Virginia Board

    The Virginia Board of Pharmacy now requires individuals to register as pharmacy interns in order to gain practical experi-ence hours needed for licensure as a pharmacist in a pharmacy located in Virginia. An intern regis-tration may be issued to a student who is enrolled in an approved Virginia school of pharmacy, or it may be issued to a student who is enrolled in an ap-proved school of pharmacy located in another state but who wishes to obtain hours of practical experi-ence in a pharmacy located in Virginia. A pharmacy intern registration may also be issued to a qualified graduate of a foreign col-lege of pharmacy needing to obtain hours of practical experience or a pharmacist licensed in another state who has not practiced the required number of hours.

    The Virginia Board notes that registration as a pharmacy intern in another state does not qualify the individual to obtain hours of practical experience in Virginia. The Board has seen situations where students enrolled in out-of-state pharmacy schools have worked for an entire summer in a Virgin-ia pharmacy but never ob-tained a pharmacy intern registration from the Vir-ginia Board. Without being registered, these hours will not qualify for meeting the required number of hours

    of practical experience. The Board recommends that pharmacists can help prevent this situation by ensuring that all pharmacy interns gaining hours of practical experience are appropriately registered with the Virginia Board.

    Oregon Board Transitions to Certified Technician Requirement

    The transition from pharmacy technician to certified Oregon pharmacy technician came to a close on October 1, 2008. By that date all qualified applicants for renewal as certified Oregon pharmacy techni-cians received their annual licenses.

    As of October 1, 2007, ap-plicants who had not passed one of the national certifica-tion examinations received a one-year nonrenewable “pharmacy technician” license. This license allowed them to work as pharmacy technicians in Oregon for up to one year. The Board states that if a technician did not pass one of the national certification examinations within this year, the techni-cian license was not renewed and the individual is unable to work as a technician until he or she can provide evi-dence of certification to the Board. The Board further reiterates that no person may perform the duties of a pharmacy technician in Or-egon unless licensed by the Board of Pharmacy as either a pharmacy technician or a certified Oregon pharmacy technician.

    Around the Association

    Board Member Appointments

    •Frances Carlson, has been appointed a public member of the Montana Board of Pharmacy. Carlson’s appointment will expire on July 1, 2013.

    •Rebekah Matovich, CPhT, has been appointed a member of the Montana Board of Pharmacy. Matovich’s appointment will expire on July 1, 2013.

    •Denise DuBois has been appointed a public member of the New York State Board of Pharmacy. DuBois’ appointment will expire on September 30, 2013.

    Board Officer Changes

    The Montana Board of Pharmacy has elected the following officers to the Board:

    •William Burton, RPh, President

    • Mark Meredith, RPh, Vice President

    • Susan Hagan, M Ed, LCPC, Secretary

    The Ohio Board of Pharmacy has elected the following officers to the Board:

    • Nathan Lipsyc, RPh, President

    • Elizabeth Gregg, RPh, Vice President

  • february 2009

    39

    Association News

    NABP President Rich Palombo to Receive 2009 Joseph B. Sprowls Lecturer Award from Temple University

    Rich Palombo, RPh, president of NABP, has been named the 2009 Jo-seph B. Sprowls Lecturer by Temple University School of Pharmacy in Philadelphia, PA. As part of this honor, Palombo will address Temple’s student body and faculty on March 23, 2009, after which he will be pre-sented with a recognition plaque during a luncheon honoring him.

    Developed in memory of Joseph B. Sprowls, PhD, dean of the School of Phar-macy from 1950-1967, the award provides for an an-nual lecture by an outstand-ing alumnus who has made a significant contribution to the practice of pharmacy over the past year.

    “Rich plays an active and influential role in pharmacy and is very deserving of this honor,” said NABP Execu-tive Committee Chairper-son Oren M. Peacock, Jr, RPh. “As the 2008-2009 NABP president he has contributed significantly to

    the regulation of pharmacy practice and the Associa-tion, forming the initiative for a community pharmacy accreditation program to promote continuous quality improvement and consider-able improvements in pa-tient safety and protection of the public health.”

    Palombo assumed the office of NABP president after completing a one-year term as president-elect. Prior to his election as president-elect, he served a three-year member term on the NABP Executive Com-mittee representing District 2. He is currently a member of the New Jersey Board of Pharmacy, which he was reappointed to in 2007; he also served on the Board from 1996 to 2005. Pal-ombo served as president of the Board from 1998 to 2001 and, in addition, was the liaison to both the New Jersey State Legislature and the Enforcement and Inspections Bureau and was the committee chair for

    continuous quality im-provement.

    In addition, Palombo has served on many NABP committees and task forces including the Commit-tee on Law Enforcement/Legislation, and he was the Executive Committee liaison for the Task Force on Continuous Quality Improvement, Peer Review, and Inspecting for Patient Safety and the Task Force on Emergency Prepared-ness, Response, and the US Drug Distribution System.

    Currently, Palombo is the director of professional practice – pharmacy com-pliance for Medco Health Solutions, Inc, where he is responsible for assessing and monitoring the effi-cacy and proficiency of the compliance program. He also served as an emergency response team member in the aftermath of Hur-ricane Katrina, opening and directing operations of an emergency mobile pharmacy to supply patients

    with prescription medica-tions from September 1-28, 2005. Palombo is a mem-ber of many professional organizations including the American Pharmacists Association and the New Jersey Pharmacists Associa-tion.

    In addition to his phar-macy services, Palombo serves as mayor of Up-per Township, NJ. Before becoming mayor in 1999, he served as councilman of Upper Township from 1997-1999. He holds a bachelor of science degree in pharmacy from Temple University School of Pharmacy.

    of the NABP Web site at www.nabp .net.

    NEWLy ACCREDITED DMEPOS FACILITIESThe following facilities were accredited through the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) program:

    A full listing of accredited DMEPOS facilities is available on the NABP Web site at www.nabp.net.

    Barbour Drugs, Inc, dba Edgewood PharmacyBurlington, NCAccredited December 8, 2008

    M&A Pharmacy Corp dba Medex PharmacyWoodhaven, NYAccredited December 29, 2008

    Stewart’s Drugs, IncSevierville, TN Accredited November 24, 2008

    Tech Pharmaceuticals, IncHialeah, FL Accredited December 29, 2008

  • february 2009nabp newsletter

    National Association of Boards of Pharmacy

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    Association Highlights

    Register now for the NABP 105th Annual Meeting.See page 29 for details.