napb 4857 mac gn - national association of boards of pharmacy … · 2016. 4. 7. · newsletter...

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2008

A p r i l 2 0 0 8 / Vo l u m e 3 7 N u m b e r 4

Upcoming Events

May 17-20, 2008NABP 104th Annual MeetingBaltimore Marriott WaterfrontBaltimore, MD

June 5-6, 2008MPJE Item-writing WorkshopNABP HeadquartersMount Prospect, IL

June 28, 2008FPGEE AdministrationNew York City, NYNorthlake, ILSan Mateo, CA

July 30-31, 2008NABP Program Reviewand Training SessionNABP HeadquartersMount Prospect, IL

In This Issue. . . .Association News:NABP Launches PCOA to Assist Schools, Colleges of Pharmacy in Curriculum Assessment

59

Association News:FPGEC Certifi cation Process Streamlined; US Educational Standards Maintained

63

104th Annual Meeting:Opportunity to Earn Nine Hours of Continuing Education Credit

65

104th Annual Meeting:2008 NABP Award Recipients to be Honored at the 104th Annual Meeting

66

Professional Affairs Update:Medicare Pilot Project Nears End

70

(continued on page 58)

State, Federal Regulatory Authorities Combat Rogue Internet Drug Distributors

The public health risk posed by Internet drug distributors that operate in unapproved, unsafe, and illegal manners has continued to grow over the last couple of years. (See “Internet Drug Distributors Posing New Concerns” in the March 2008 issue of the NABP Newsletter.) Combat-ing this epidemic has been a challenge for the state boards of pharmacy and law enforcement agencies as well as federal regulatory agencies. The fl uidity and anonymity offered by the Internet and the prevalence of foreign-operated sites that lie outside the United States regulatory juris-diction provide a barrier behind which these rogue operations hide.

Nonetheless, those in charge of safeguarding the public health and enforc-ing compliance with state

and federal laws continue the fi ght. The most effec-tive approaches generally have been multi-pronged and have involved commu-nication and collaboration between various entities.

State ActionsWhile some states have

taken legislative action specifi cally targeting illicit drug distributors operating on the Internet, others ap-ply existing laws to address the issue. States generally have taken one of three approaches to regulating Internet drug distribu-tors: out-of-state pharmacy licensing requirements, valid patient-practitioner relationships, and state con-trolled substance laws.

Not every state spe-cifi cally addresses Internet drug distributors in its regulations. But the vast majority require out-of-

state drug distributors that dispense medications to state residents to be reg-istered or licensed in that state – a requirement that encompasses Internet phar-macies.

The Wisconsin Phar-macy Examining Board’s description of its require-ments for out-of-state drug distributors is fairly stan-dard: “No pharmacy that is in another state may ship, mail, or otherwise deliver a prescribed drug or device to

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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 refl ect the

offi cial 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

60056847/391-4406www.nabp.net

[email protected]

Carmen A. CatizoneExecutive Director/

Secretary

Larissa DoucetteCommunications

Manager

©2008 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

persons in Wisconsin unless the pharmacy is licensed in Wisconsin.” While the re-quirements for this license are not identical to those for in-state drug distributors (“An out-of-state phar-macy . . . is not required to comply with Wisconsin law relating to the professional service area of a pharmacy or the minimum equipment requirements . . . ”), the requirement allows the state to weed out rogue drug distributors and provides a mechanism to sanction drug distributors that dis-pense without a license.

Other states fi nd it use-ful to cite Internet drug distributors in their regula-tions. Kentucky and North Carolina, for example, specifi cally require Internet drug distributors dispens-ing in those states to hold the NABP Verifi ed Internet Pharmacy Practice Sites™ (VIPPS®) accreditation.

Meanwhile, out-of-state pharmacy regulations are supplemented with state requirements concerning the patient-practitioner rela-tionship for a prescription to be considered legitimate by the pharmacist. (See “States Begin to Defi ne What Con-stitutes Legitimate Patient-Prescriber Relationships” in the September 2007 issue of the NABP Newsletter.) In general, that relationship in-cludes at least the following elements: a medical history; a physical examination; and some logical connection between the patient’s medi-

cal complaint, the medi-cal history, the physical examination, and the drug prescribed. State boards of pharmacy in Arkansas, North Carolina, West Vir-ginia, and Colorado, for ex-ample, emphasize the need for a legitimate patient-practitioner relationship in determining the validity of a prescription that may be dispensed. California, in another example, specifi es the need for such a relation-ship particularly in relation to controlled substances available via the Internet (“No person or entity shall dispense or furnish, or cause to be dispensed or furnished, dangerous drugs or dangerous devices . . . on the Internet for deliv-ery to any person in this state without a prescription issued pursuant to a good faith prior examination of a human or animal for whom the prescription is meant if the person or entity either knew or reasonably should have known that the prescription was not issued pursuant to a good faith prior examination.”) The many rogue Internet drug distributors that sell pre-scription medications based solely on an online ques-tionnaire do not meet these legitimacy requirements.

Last, many rogue Internet drug distribution sites offer would-be patients easy access to controlled substances and, in doing so, run afoul of numerous state and federal laws and regulations. In his May 2007 testimony during a US Senate Judiciary Committee hearing, Joseph T. Rannaz-

zisi, JD, deputy assistant administrator at the Drug Enforcement Administra-tion’s Offi ce of Diversion Control, stated that, in par-ticular, Schedule III and IV drugs, such as anti-anxiety medications, hydrocodone combination products, and anabolic steroids, “are increasingly accessible and often illegally purchased through the Internet.” The process violates both fed-eral and state laws address-ing controlled substances.

Doubtless, states will continue to draft legislation that ever more specifi cally addresses the problem of rogue Internet drug dis-tributors. The diffi culty in combating the rogue operations, however, often seems to be one more of enforcement than of having the appropriate regula-tions on the books. Often, determining if a site has violated the law is glaringly obvious, while information for shutting down or pros-ecuting the operation is not. The Internet often yields few clues as to the identity of the site’s operators, or even the country in which they live. Fortunately, drugs are tangible products that have to be purchased from manufacturers and shipped to customers. It is attacking these physical steps where law enforcement has had its greatest impact.

Laws and regulations calling for a legitimate patient-practitioner rela-tionship and limiting access to controlled substances often give state regula-tors another potent tool in combating rogue Internet

Rogue Internet Drug Distributors(continued from page 57)

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Executive CommitteeLawrence H. “Larry” MokhiberChairpersonOne-year term

Oren M. Peacock, JrPresidentOne-year term

Richard A. “Rich” PalomboPresident-electOne-year term

Gary A. Schnabel TreasurerOne-year term

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

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

Reginald B. “Reggie” DilliardMember, District 3Serving third year of a three-year term

William T. “Bill” WinsleyMember, District 4Serving third year of a three-year term

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

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

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

Patricia F. HarrisMember, District 8Serving third year of a three-year term

The NABP Executive Committee is elected each year at the Association’s Annual Meeting.

Association News

NABP Launches PCOA to Assist Schools, Colleges of Pharmacy in Curriculum Assessment

NABP is pleased to an-nounce that 24 schools and colleges of pharmacy par-ticipated in the fi rst admin-istration of the Pharmacy Curriculum Outcomes Assessment™ (PCOA)®, which took place in April 2008. 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 colleges of pharmacy requesting assistance with curriculum develop-ment and measurement of student performance and growth.

Earlier this year NABP provided all schools and colleges of pharmacy with PCOA information kits, encouraging each school and college to select an assessment date within the two-week period of April 7-18, to administer the PCOA to their students. As an added benefi t, those schools and colleges that chose to participate in the April 2008 assessment did so at no charge. After this fi rst administration, the PCOA will be administered annually by participat-ing schools and colleges of pharmacy during a desig-nated window of time at a cost of $75 per student.

“Assessment is necessary in all areas, not just phar-macy,” states Stephen M. Gross, MA, EdD, professor of pharmacy administra-tion and dean, Long Island University, Arnold and

Marie Schwartz College of Pharmacy and Health Sciences. “It is important to have measures that will evaluate the effectiveness of curricula.” The college of pharmacy set up an as-sessment day this spring for students to take the PCOA as well as a series of objective structured clinical examinations. Along with participating in the admin-istration of the PCOA, the college also took part in the beta testing of the PCOA.

Developing a Reliable and Valid Tool

In the spring of 2007, with the assistance of eight schools and colleges of pharmacy from various regions of the United States, NABP administered a beta test of the PCOA. The beta test was conducted as a follow up to the initial pilot studies in 2005 and 2006.

As an active participant in both the pilot stud-ies and beta tests, “The University of Utah Col-lege of Pharmacy remains committed to development of a nationwide, standard-ized, validated examination for curricula assessment to the benefi t of our students, the academy, and the profession,” states Mark A. Munger, PharmD, FCCP, professor and associate dean for academic affairs at the university. The uni-versity was one of the key stakeholders in initiating development of the PCOA.

With the cooperation from the University of Utah College of Pharmacy, the Long Island University, Arnold and Marie Schwartz College of Pharmacy and Health Sciences, and six other schools and colleges of pharmacy, the beta test was successfully administered as a 200-item multiple choice paper-and-pencil assessment to a total of 1,307 P1 through P4 students and upon completion, an independent psychometric consultant performed a thorough analy-sis of the PCOA data. The results of this analysis not only supported the PCOA’s reliability and validity, but were used by NABP to fur-ther fi ne-tune the assessment tool. The assessment will continue to undergo annual revisions by subject-matter experts, regular item analy-ses, reliability and validity studies, and annual statisti-cal equating in accordance with an ongoing assessment validation process set in place by NABP.

The construct of the PCOA was infl uenced by ACPE’s Accreditation Stan-dards and Guidelines for the Professional Program Leading to the Doctor of Pharmacy De-gree, and consists of four ma-jor pharmacy content areas, including: basic biomedical sciences, pharmaceutical sciences, social/behavioral/administrative pharmacy sci-ences, and clinical sciences. Each of these four areas is further broken down into additional competencies.


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60

Legal Briefs

TAP Dance RevisitedBy Dale J. Atkinson, JD

Boards of pharmacy may, under certain circumstances, be impacted

by decisions of other entities that may also share jurisdiction or authority over licensees, whether pharmacists or pharmacies. Judicial decisions also impact future board actions in the administrative arena should they reverse a particular matter or interpret a statute or regulation in a manner inconsistent with previous board interpretations. As discussed in “Legal Briefs” in the February 2007 issue of the , the impact of a settlement agreement in a criminal investigation related to the Prescription Drug Marketing Act (PDMA) was addressed by the Missouri Appellate Court, which recognized the authority of the Missouri Board of Pharmacy to place a facilities permit holder (licensee) on probation based upon the settlement agreement, rejecting arguments of the licensee that the settlement precluded any further action by the state (including the board of pharmacy).

A recap of the relevant facts identifi es settlement of criminal and civil investiga-tions instigated in 1996 and 1997 by the United States Attorney’s Offi ce in Boston and the US Department of Justice in Washington, DC. The investigations involved infl ated prices and improper sales and marketing practices designed to induce physi-cians to prescribe a particu-

lar product. In addition, the licensee was accused of fi ling false claims with the Medi-care and Medicaid programs. The licensee settled with the federal government, all 50 states, and the District of Columbia regarding the Medicare and Medicaid al-legations. The settlement in-volved the licensee pleading guilty to felony conspiracy to violate the PDMA and

conspiracy to violate sections 331(t) and 333(b) of title 21 of the US Code by causing billing for free drug samples.

As part of the resolution with Missouri, the licensee and the state entered into a settlement agreement whereby the state, received monetary consideration and, in exchange, agreed to release any civil claims against the licensee relating to its con-duct in the underlying guilty plea. The US District Court for the Western District of Massachusetts accepted the guilty plea in Decem-ber 2001. The settlement agreement with the state of Missouri was also executed in December 2001.

Thereafter, in January 2003, the attorney represent-ing the Missouri Board of Pharmacy fi led an admin-istrative complaint with the Board related to the felony conviction. After a hearing, the Board placed the licensee on probation for a three-year period with an effective date of February 25, 2005. The circuit court reversed the Board order, and the court of appeals reversed the circuit court, thus upholding the Board of Pharmacy sanc-tion. The licensee appealed the matter to the Missouri Supreme Court.

On appeal, the licensee argued that the Board’s ac-tions did not comport with due process based upon insuffi cient notice and that the Board was not a fair and impartial tribunal under applicable constitutional

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Legal Briefs

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

principles. Also, the licensee argued that the settlement agreement with the state of Missouri precluded the Board from instituting the administrative proceedings. Because the court could ren-der its opinion based upon the interpretation of the settlement agreement, it did not address the due process arguments.

Regarding the settlement agreement, the particular paragraphs in question read as follows:

Paragraph 2: In consider-ation of this Agreement and payment set forth herein and subject to the exceptions from release set forth in Paragraph 3 below, the state of Missouri on behalf of itself, its offi cers, agents, agencies and depart-ments shall release and forever discharge [licensee], its predeces-sors, subsidiaries, joint venture owners, and their corporate parents and affi liates, succes-sors and assigns, and their current and former directors, offi cers, and employees from any civil or administrative claims for damages or penalties that the state of Missouri has or may have relating to the Covered Conduct as defi ned in Preamble Paragraph F. The pay-ment of the Settlement Amount fully discharges [licensee] from any obligation to pay Med-icaid-related restitution,

damages, and/or any fi ne or penalty to the State for the Covered Conduct [emphasis added].Paragraph 4: In consid-eration of the obliga-tions of [licensee] set forth in this Agreement, conditioned upon TAP’s payment in full of the Settlement Amount and except as reserved in paragraph 3 above, the state of Missouri agrees to release and refrain from instituting, direct-ing or maintaining any administrative claim or any action seeking exclu-sions from the state of Missouri’s Medicaid pro-gram against [licensee], its predecessors, sub-sidiaries, joint venture owners, their corporate parents and affi liates, successors and assigns, for the Covered Conduct or for [licensee’s] convic-tion in the Criminal Action. Nothing in this Agreement precludes the state of Missouri from taking action against [licensee] in the event that [licensee] is excluded by the federal govern-ment, or for conduct and practices other than the Covered Conduct or the conviction in the Crimi-nal Action. The Medicaid Fraud Control Unit for the state of Missouri further agrees to refrain from recommending, causing or attempting to cause any administra-tive action or sanction,

including debarment, by any other government agency of the state of Missouri for the Cov-ered Conduct or for the conviction in the Crimi-nal Action. [Licensee] acknowledges that the state of Missouri does not have the authority to release [licensee] from any claims or actions which may be asserted by private payors or insurers, including those that are paid on a capitated basis for providing health care to the States’ Medicaid programs [emphasis added].Paragraph 5: This Agree-ment is expressly condi-tioned upon resolution of the Criminal Action. In consideration of the Criminal Action, the state of Missouri agrees that it shall not investi-gate, prosecute, or refer for prosecution or inves-tigation to any agency, [licensee], its predeces-sors, subsidiaries, joint venture owners, and their corporate parents and affi liates, successors and assigns for the Cov-ered Conduct [emphasis added].The Board also noted that

these provisions were modi-fi ed by paragraph 3 of the agreement, which states “. . . Missouri specifi cally does not herein release [licensee] from . . . any and all of the following . . . (f) except as explicitly stated in this Agree-ment, any administrative

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Legal Briefs

liability, including mandatory exclusion from Federal health care programs.”

Thus, the court was presented with the issue of the impact such settlement agreement language had on the ability of the Board of Pharmacy to sanction the li-censee as a permit holder. The court noted that a settlement agreement is treated as a con-tract between the parties and that the intent of such parties will be interpreted from the language of such agreement. It noted that the agreement does not contain the words discipline, license, or phar-macy permit, as related to the

Legal Briefs(continued from page 61)

licensee. The court focused on the language of paragraph 2 whereby the state released the licensee from “adminis-trative claims for damages or penalties.”

In fi nding that the Board had the authority to adminis-tratively sanction the licensee, the lower court held that the regulatory Board actions were not “penal” in nature, as they were intended to be remedial and protect the public. The Board argued that because its administrative actions are remedial, they cannot be construed a “penalty” under the agreement. The Mis-souri Supreme Court found that such a line of reasoning “misses the mark.” It held that the word penalty is often

used in a broader context to include both penal and re-medial acts. While pharmacy licensure discipline is primar-ily remedial in nature, “such does not preclude the Board’s actions from being described as a penalty.”

The court also recog-nized the prohibitions from administrative prosecution as set forth in paragraph 4 of the agreement noting the disjunctive “or” as referring to alternative possibilities releasing the licensee from any administrative claims.

Using the rules of contract construction of language con-tained therein, the Missouri Supreme Court held that the settlement agreement barred any administrative actions

against the licensee based solely upon the covered con-duct. It held that the language of paragraph 3, upon which the Board relied, allowed for administrative claims based upon activities outside of the covered acts defi ned in the agreement. The specifi c language contained in the settlement agreements can be essential in determining the impact of such an agreement on ancillary matters. Boards of pharmacy are cautioned to understand this principle and eliminate, to the extent possible, unintended conse-quences.

TAP Pharmaceutical Products, Inc v State Board of Pharmacy, 2007 WL 4111477 (MO 2007)

NABP Seeks Experts for Exam Review CommitteesNABP welcomes those

interested in volunteering to serve on the Association’s examination review com-mittees. Volunteers must have the knowledge and expertise of pharmacists, educators, and regulators to write, edit, and assess potential questions for the Association’s competency assessment programs as well as assist in establishing passing standards.

At this time, volunteers are needed for the North American Pharmacist Licensure Examination™ (NAPLEX®), the Multistate Pharmacy Jurisprudence Examination® (MPJE®), and the Foreign Pharmacy Graduate Equivalency Ex-amination® (FPGEE®).

Ideal candidates for the NAPLEX Review Commit-

tee are practioners from community and hospital settings, educators, and regulators who have previ-ous experience as NAPLEX item writers.

The MPJE Review Com-mittee has openings for vol-unteers familiar with state and federal jurisprudence requirements. Participa-tion is limited to individu-als from those states that participate in the MPJE program. Previous experi-ence in writing examina-tion questions would be helpful.

The FPGEE Review Committee requires indi-viduals with experience in preclinical, pharma-ceutical, and biomedi-cal sciences; social and behavioral sciences; and pharmaceutical services

management or pharmacy administration. As stated before, previous experi-ence in writing examina-tion questions would be helpful.

Review committee meetings are typically held from Thursday to Saturday, and all travel and meal expenses are covered by NABP.

Any individual in-terested in serving as a member of an examina-tion review committee may submit a letter of interest and a current resume or curriculum vitae to NABP Executive Director/Secretary Car-men A. Catizone, 1600 Feehanville Dr, Mount Prospect, IL 60056; fax 847/391-4502 no later than July 15, 2008.

Clarifi cationIn the March 2008

NABP Newsletter article “Standardized Medication Container Labels Touted as Prescription for Patient Safety,” it was incorrectly reported that “Texas House Bill 948 establishes require-ments for prescription drug retail labels, including cautionary statements, to be printed in visible type at least 8-point size, to avoid potential patient error.” Al-though the bill was initially introduced with this lan-guage, it was amended dur-ing the session and passed with new language requir-ing that the labels and drug information “be in plain language and printed in an easily readable font size for the consumer.” NABP regrets any confusion this may have caused.

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1India to Introduce Five-Year Doctor of Pharmacy Program [letter]. Am J Pharm Educ. 2007; 71(2): 38.

Association News

FPGEC Certifi cation Process Streamlined; US Educational Standards Maintained

With continued efforts to protect public health, NABP took a closer look at its Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) Certifi cation Program. Through several changes, the Association has im-proved the fl uidity of the certifi cation process while maintaining the standards of United States pharmacy school curriculum.

The FPGEC Certifi cation Program is the product of a recommendation made in the early 1980’s by the Com-mittee on Law Enforcement/Legislation suggesting that NABP prepare an examina-tion by which foreign phar-macy school graduates could demonstrate the equivalency of their education to that of graduates from Accredita-tion Council for Pharmacy Education (ACPE)-accredit-ed undergraduate programs in the US. Hence, with the assistance of ACT, Inc, the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) was created as a requirement of FPGEC certifi cation and the fi rst administration took place in April 1984. Currently all states require FPGEC certi-fi cation for foreign pharma-cists wishing to practice in the US.

Upholding Educational Standards

In 2003, coinciding with the update to curriculum

requirements for US schools and colleges of pharmacy and ACPE’s expected revi-sion to the Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy De-gree, which was fi nalized in 2007, the FPGEC ad-opted a new policy requir-ing that foreign-educated pharmacists obtain their professional degrees from a fi ve-year curriculum program in order to apply for certifi cation. Although initially met with resistance by some foreign schools and colleges of pharmacy, NABP is by no means alone in its goal to uphold edu-cational standards. Many foreign schools and col-leges of pharmacy have had fi ve-year pharmacy curri-cula in effect for years, and others are in the process of changing their programs to meet these requirements. In some cases, the schools and colleges are developing bridge programs to assist current pharmacy stu-dents enrolled in four-year programs with meeting the fi ve-year curriculum requirement.

It is important for schools that are develop-ing bridge programs to create a “fi fth” year as a continuation of the four-year program rather than adding an advanced degree option; the FPGEC does not accept advanced degrees in

pharmacy as a replacement of a fi ve-year, curriculum-based bachelor of pharmacy degree (eg, a foreign-educat-ed student with a bachelor of pharmacy degree from a four-year curriculum program and a master of sci-ence degree in clinical phar-macy does not meet FPGEC requirements). The fi ve-year curriculum must lead to one entry-level degree.

Recently, the Pharmacy Council of India proposed a plan to start a fi ve-year “PharmD” program in India. A letter to the American Journal of Pharmaceutical Education states, “The idea is to educate and train phar-macy students in India to meet the shortage of phar-macists in Indian hospitals and also to match the entry level PharmD curriculum in the United States. The new NABP requirement . . . is the key reason for this change in pharmacy education.”1 Al-though this degree is labeled as an advanced “PharmD” degree, it may still meet the FPGEC requirements if it is treated as an entry-level fi ve-year curriculum program.

“Safeguarding and pro-moting the academic stan-dards for pharmacy remains a top priority for NABP,” states NABP President Oren M. Peacock, Jr, RPh. “By adhering to these standards and updating pharmacy programs to meet them, the foreign schools and colleges

Who Qualifi es as a Foreign Pharmacy Graduate?

The FPGEC defi nes a “foreign pharmacy gradu-ate” as a pharmacist whose undergraduate pharmacy degree was conferred by a recognized school of pharmacy outside the 50 United States, the District of Columbia, and Puerto Rico. US citizens who have completed their pharmacy education outside the US are considered to be for-eign pharmacy graduates, while foreign nationals who have graduated from schools in the US are not.

What is the FPGEC Certifi cation Process?

In order for foreign pharmacy graduates to apply for FPGEC certifi ca-tion, they must provide documents that verify their educational back-grounds and licensure and/or registration. In April 2006, NABP began using the services of the Educational Credential Evaluators, Inc, a not-for-profi t public service organization specializing in the evaluation of foreign educational credentials to review applicants’ offi cial pharmacy school tran-scripts and degrees. In ad-dition to providing the ap-propriate documentation, applicants are required to pass the FPGEE as well as the TOEFL and TSE, or the TOEFL iBT. The FPGEC Certifi cate allows foreign pharmacy graduates to partially fulfi ll eligibility requirements for licensure in the states that consider the certifi cation.

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Association News

FPGEC Certifi cation(continued from page 63)

of pharmacy are helping to sustain quality in the practice of pharmacy and acknowledging the im-portance of protecting the public health.”

Applicant TrendsIn 2007, the FPGEC

received a total of 3,541 applications, with 3,107 ap-plicants qualifying to sit for the FPGEE. This decrease of approximately 9% from the 2006 total, when 3,885 applications were received and 3,182 applicants quali-fi ed to sit for the FPGEE, matches the trend over the past six years of the gradu-ally decreasing number of applicants. The decrease can likely be attributed to the high number of ap-plications received in 2000 and 2001. During this time, companies were heavily recruiting foreign pharma-cists to alleviate the defi cit of pharmacists in the US. In addition, the number of applications increased signifi cantly in 2002 when NABP announced that the FPGEC would require a fi ve-year, curriculum-based degree. Even though the fi ve-year curriculum requirement only applied to those foreign-educated pharmacy students gradu-ating after January 1, 2003, many pharmacists were concerned that they would not qualify regardless of their current educational status and applied prior to the 2003 deadline. It is expected that in the future, FPGEC applications will

not fl uctuate as greatly as they have in the past 10 years as changes to curri-cula and pharmacy prac-tice in the US and foreign countries are standardized.

Streamlining the Certifi cation Process

In addition to creating an infl ux in applications, the adoption of the fi ve-year curriculum requirement provided NABP the op-portunity to take a closer look at ways to streamline the FPGEC certifi cation process. In mid-2006, focus-ing on maintaining the fl uidity of the certifi cation process while ensuring that the requirements remained in line with the standards of education, NABP revised the requirements regarding licensure status. The policy originally required that of-fi cial proof of a license and/or registration to practice pharmacy in the country or jurisdiction where the applicant earned a phar-macy degree be presented when applying for certifi ca-tion; however, issues arose for students who obtained their degrees outside of the country in which they are a citizen. Without citizenship, many students were unable to obtain licensure where their degree was earned, and in some cases, where pharmacy schools were not available in the country or jurisdiction of citizen-ship, the students returned home to practice. In order to resolve this issue, NABP amended the FPGEC re-quirements to state:

If licensure and/or registration is required

to practice pharmacy in the country or jurisdic-tion where the applicant earned a pharmacy ...de-gree [but,] at the time of graduation [neither] licensure nor registra-tion were obtained due to non-citizenship, the applicant must submit the following: (1) offi cial proof of the license and/or registration in which-ever country or jurisdic-tion it was obtained; and (2) an offi cial statement, issued by the appropriate government offi cial of the country or jurisdiction where the applicant earned the pharmacy degree, con-fi rming the eligibility of the applicant to practice pharmacy in that coun-try although neither licensure nor registra-tion were obtained.The original require-

ments made FPGEC certifi -cation virtually unattainable for pharmacists who ob-tained their degrees outside of the country in which they are a citizen; however, with this recent modifi cation, the door has opened for many more foreign-educated pharmacists.

Additionally, the FPGEC no longer requires the two-year time limit for applicants to take and pass the Test of English as a Foreign Language™ (TOEFL®) and Test of Spoken English™ (TSE®) or the TOEFL Internet-based Test (iBT) from the time they pass the FPGEE. Once NABP receives the offi cial score report, that score will remain valid until the

applicant passes the other examination affi liated with certifi cation or the fi le is closed. TOEFL, TSE, and TOEFL iBT scores will con-tinue to be reported by the Educational Testing Service for up to two years only. Elimination of this time limit further streamlines the certifi cation process, relieving some applicants of the necessity to reapply for the FPGEC Certifi cation Program in order to retest.

Extensions for Exten-uating Circumstances

As more foreign-educated pharmacists seek licensure to practice in the US, obtaining a visa continues to remain a huge concern. At times, an individual is required to wait an entire year before he or she is eligible to reapply for a visa if turned down initially, oftentimes delaying an applicant’s ability to take the FPGEE. The FPGEC

June FPGEE Administra-tion Approaching

The next FPGEE will be administered on June 28, 2008, in three US locations: New York City, NY; North-lake (Chicago), IL; and San Mateo, CA. The New York site has reached its capacity and is now closed. FPGEC applicants who have been accepted to take the FPGEE must register for the ex-amination by May 16, 2008, or before all test sites have reached capacity, whichever occurs fi rst. It is important to note that seating for the examination is limited.


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104th Annual Meeting

As of January 1, 2008, the Accreditation Council for Pharmacy Education (ACPE) revised its defi ni-tion of continuing phar-macy education (CPE) for the profession of phar-macy to better refl ect the movement toward genuine lifelong learning.

Last updated in 2003, the new defi nition is meant to clarify the quality of CPE that ACPE requires and to guide CPE


104th Annual Meeting Offers Opportunity to Earn Nine Hours of Continuing Pharmacy Education Credit

Attendees of the NABP 104th Annual Meeting, to be held May 17-20, 2008, at the Baltimore Marriott Waterfront in Baltimore, MD, have the opportu-nity to earn up to nine (9) contact hours (0.9 continu-ing education units [CEU]) of Accreditation Council for Pharmacy Education (ACPE)-approved continu-ing pharmacy education (CPE) credit from NABP. CPE is designed to address current issues affecting the regulation of pharmacy practice. All Annual Meet-ing participants will have the opportunity to attend four joint programming sessions. In addition, there will be a special pre-meet-ing session as well as two sessions held concurrently: one geared for state board of pharmacy executive of-fi cers and members and the other for compliance staff.

Saturday, May 17Teen Addiction – Prescrip-tion Medications: The New Heroin?

According to statistics, teen addiction to prescrip-tion pain medications is reaching catastrophic proportions. Sponsored by Walgreen Co, this special training session will discuss the issues with this rising problem, including sources of prescription drugs, the role the Internet plays, and strategies in abuse pre-vention. Speakers for this presentation include three representatives from the Partnership for a Drug-Free America: Thomas A. Hedrick, Jr, BA, senior communications offi cer and founding member, Barbara Delaney, MBA, director of research, and Phil Bauer, member, par-ent advisory board. Par-ticipants in this session

can earn up to two contact hours (0.2 CEUs) of CPE credit.

Sunday, May 18Educational Poster Session

Boards of pharmacy and colleges of pharmacy will present public health protec-tion activities via a poster session. One contact hour (0.1 CEU) of CPE is earned though interactive partici-pation with presenters.

Legislative and Regulatory Update

Sponsored by Medco Health Solutions, Inc, this session will offer par-ticipants the opportunity to review recent federal and state legislative and regula-tory initiatives of interest to boards of pharmacy. NABP’s Joshua M. Bolin, BA, state relations manager, and Ei-leen Lewalski, PharmD, JD, professional affairs manager,

will speak at this session. One contact hour (0.1 CEU) of CPE credit will be given to all that attend.

Monday, May 19Pedigree Update: RFID and Diversion from Com-mon Carriers

During this session, sponsored by CVS Ca-remark Corporation, participants will examine how industry and enforce-ment officials have incor-porated electronic tools in order to control counter-feit drugs and devices that pose significant threats to the public health, as well as to optimize the effi-ciency and effectiveness of the drug distribution pro-cess. Attendees will hear from speakers Ilisa Bern-stein, PharmD, JD, director of pharmacy affairs at the Food and Drug Administra-

providers in planning pro-grams to contribute to the professional development of pharmacists and pharmacy technicians, setting differ-ent standards for each. All defi nitions refl ect the input from several pharmacy and health care stakeholders.

According to the revised defi nition, CPE should “sup-port the continuing devel-opment of pharmacists and/or pharmacy technicians to maintain and enhance their

competence.” CPE should also “promote problem-solving and critical think-ing and be applicable to the practice of pharmacy.”

The Universal Program Number (UPN) and state-ment of credit for any CPE activity should refl ect the content and the intended audience by assigning P designation to each activity targeted for pharmacists, or T targeted for technicians. If the CPE program is intended

for both pharmacists and technicians, the CPE prov-ider must use two UPNs – one with the P designation and the other with a T designation.

Also revised in the new defi nition is the addition of the topic designator, Patient Safety, which includes the prevention of health care errors and the elimination or mitigation of patient injury caused by health care errors.

ACPE Revises Defi nition of Continuing Education

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2008 NABP Award Recipients to be Honored at 104th Annual MeetingNABP will honor leaders

at the forefront of public health protection during the NABP 104th Annual Meeting to be held May 17-20, 2008, at the Balti-more Marriott Waterfront in Baltimore, MD. The awards to be presented for 2008 include the Lester E. Hosto Distinguished Ser-vice Award (DSA), Lester E. Hosto Inspector DSA, the Henry Cade Memorial Award, and the NABP Hon-orary President Award.

Lester E. Hosto DSAsReceiving the 2008

Lester E. Hosto DSA, Bryan H. Potter, DPh, will be recognized for his exemplary service in protecting the public health and signifi cant involvement with NABP. This award is the highest honor bestowed by NABP. Serving more than 30 years with the Oklahoma State Board of Pharmacy, fi rst as a member in 1971 and currently as the executive director, a position he began in 1989, Potter accomplished much during his tenure with the Board. With his leadership, the Board successfully changed its designation of pharmacists from registered pharmacist to doctor of pharmacy as well as began electronic tracking of Schedule II prescription drugs. Prior to, and during, his position with the Board, Potter owned and operated a pharmacy in Elk City, OK. In addition, Potter has served on the

board of directors for the Southwestern Pharmacy Alumni Foundation, and as an active member of the Oklahoma Pharmacists Association. He served three years as acting director of Pharmacy Providers of Oklahoma and was also on the NABP Executive Committee, serving fi rst as a member and then as president-elect, president, and fi nally chairperson. He has received numerous awards including the Knoll Pharmaceutical Company Dedication to Pharmacy Award in 1999 and the Bowl of Hygeia Award in 2005. He was also inducted into the Oklahoma Pharmacy Hall of Fame in 1996. Potter obtained his bachelor of science degree in pharmacy from the Southwestern Oklahoma State University School of Pharmacy.

George T. Grubbs will receive the 2008 Lester E. Hosto Inspector DSA be-cause of his commendable service in protecting the public health as an inspec-tor for the Alabama State Board of Pharmacy and noteworthy contributions to NABP. Grubbs has been an inspector for the Ala-bama Board since 1984, and during this time discovered and proved the diver-sion of over 435,000 doses of controlled substances from a single community pharmacy. Prior to this, he was a police offi cer for the city of Birmingham, AL, and also served as a United

States Navy air control-man. In 2007, Grubbs was nominated for the Alabama Retail Association Law Enforcement Offi cer of the Year Award. He attended the police training school in the city of Birmingham and the School of Alcoholic Studies at both the Univer-sity of Georgia and Rutgers University. Additionally, Grubbs obtained his as-sociate degree in applied science from Jefferson State Junior College; studied law enforcement at several institutes including the National Crime Prevention Institute, the University of Alabama Law Enforcement Institute, and the Texas Crime Prevention Institute; and studied homicide in-vestigation at the Alabama Advanced Criminal Justice Academy.

Henry Cade MemorialIn recognition of their

support of the goals and objectives of NABP and the state boards of phar-macy and for advancing and maintaining the safety and integrity of the distribution and dispensing of medica-tions, Tom M. Houchens, RPh, FASCP, Arthur I. Jacknowitz, MS, PharmD, RPh, W. Steven Pray, MPH, PhD, RPh, and David B. Roll, PhD, will each receive the 2008 Henry Cade Me-morial Award.

Tom M. Houchens is currently the director of pharmacy services at Laurel Housing Inc, in London, KY. Prior to this position, he was the manager of Begley

Drug Company. Houchens was also a member of the Kentucky Board of Phar-macy from 1985 to 1995, serving on the advisory council from 1985 to 1990 and as president of the Board in 1993 and 1995. He is an active member of several NABP committees including the NABP District 3 Nominations Committee and ACE, serving as chair-person in 2008, and is also an active participant in the North American Pharma-cist Licensure Examina-tion™ (NAPLEX®) Review Committee. In addition, Houchens is a member of the National Community Pharmacists Association, the American Pharma-cists Association (APhA), the American Society of Consultant Pharmacists (ASCP), and the Kentucky Pharmacists Association. In 1996, he received the Kentucky Pharmacist of the Year Award and in 2000, the Bowl of Hygeia. Houchens obtained his bachelor of science degree in pharmacy from Samford University.

A registered pharmacist in Maine, Pennsylvania, and West Virginia, Arthur I. Jacknowitz has been a professor and distinguished chair in clinical pharmacy at West Virginia University (WVU) School of Pharmacy since 2001. Prior to this, he was professor and chairman for the Department of Clinical Pharmacy at WVU. Jacknowitz has numerous published articles to his

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Register Now for the NABP 104th Annual Meeting

Register now for the 104th Annual Meeting to be held May 17-20, at the Baltimore Mar-riott Waterfront in Baltimore, MD. Regis-tration is available in the Meetings section of the NABP Web site

at www .nabp.net ; pro-spective attendees can register directly online or download and print the registration form to mail in or fax. Pay-ments may be made by cash, check, or credit card.

name including several within the American Journal of Pharmaceutical Education. His extensive involvement in professional organizations includes, but is not limited to, chair for the American Association of Colleges of Pharmacy (AACP) Awards Committee (1990-1993), member of the NAPLEX Review Committee and the APhA Drug Information Advisory Board, and mentor for the American Society of Health-System Pharmacists (ASHP). Jacknowitz obtained his bachelor of science degree in pharmacy from the Brooklyn College of Pharmacy of Long Island University and his master of science degree in biochemical pharmacology from State University of New York at Buffalo. He earned his doctor of pharmacy degree from the Philadelphia College of Pharmacy and Sciences.

W. Steven Pray has held his position as professor for nonprescription products and devices at Southwest-ern Oklahoma State Uni-versity since 1992. Prior to that he was an associate professor at the university. Pray also works as a part-time staff pharmacist for Wal-Mart Stores, Inc, and as an independent contrac-tor. Currently, he is an active member of the NAPLEX Review Committee and AACP. Pray also served as a member for the American Public Health Association, the Parenteral Drug As-sociation, and ASCP. He has received several awards including AACP Teacher of

the Year in 1995, 1998, and 1999, and has had a copious number of articles published in professional journals. Pray earned a bachelor of science degree in pharmacy from Southwestern State College and a bachelor of arts degree from South-western Oklahoma State University and his master of public health degree from Oklahoma University Health Sciences Center. He also holds a doctor of phi-losophy degree from Purdue University.

David B. Roll most recently held the position of director, dietary supple-ments at the United States Pharmacopeia (USP). Prior to his position with USP, Roll was employed at the University of Utah as a pro-fessor of medicinal chem-istry; an adjunct professor for the Division of Foods and Nutrition, College of Health; and associate dean for academic affairs at the College of Pharmacy. He was also a congressional fellow for the Offi ce of Senator Byron L. Dorgan. Roll has been an active member of the NAPLEX Review Committee since 1979. In addition, he served as chair of AACP and has served on the advisory board of the American Council on Science and Health. He has received numerous honors including the Lester E. Hosto DSA in 1989 and the Presidential Teaching Scholar Award in 1994, 1995, and 1996. Roll obtained his bachelor of science degree in pharmacy from the University of Montana, and his doctor of

philosophy degree from the University of Washington.

Honorary PresidentReceiving the 2008

NABP Honorary President Award, Charles Curtis “Curt” Barr, PharmD, RP, has shown a strong commitment to the NABP mission and the profession of pharmacy and has provided exemplary service for, and on behalf of, NABP. Currently, Barr is an associate professor of pharmacy practice and assistant dean for alumni relations at Creighton University School of Pharmacy and Health Professions. He began teaching at the university in 1974 as an adjunct professor and in 1998 he became an associate professor. In addition, he is the owner/operator of Barr Pharmacy and Blair Medical Supply, Blair, NE. Barr also served on the Nebraska Board of Pharmacy from 1997 to 2006 in various positions. In addition, he was a member of the NABP Executive Committee from 2004 to 2006 and has participated in several NABP committees and task forces including the

Committee on Constitution and Bylaws, Advisory Committee on Examinations (ACE), Committee on Resolutions, and the Task Force on Licensing of Pharmacy Benefi t Managers, just to name a few. He is an active member of numerous professional organizations and has received honors including the Nebraska Pharmacists Association Committee Award, Innovative Pharmacy Practitioner Award, and Bowl of Hygeia, as well as the National Association of Retail Druggists National Preceptor of the Year (1994). Barr earned a doctor of pharmacy degree from the University of Nebraska College of Pharmacy in 1981 and a bachelor of science in pharmacy from Creighton University School of Pharmacy in 1974.

By exemplifying the Association’s mission, these leaders have shown their dedication to protect-ing public health and will be honored at the NABP Annual Awards Dinner on Tuesday, May 20, 2008, from 7 - 10:30 PM.

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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 nine hours 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.

Continuing Legal Education (CLE) Policy: NABP staff will be available to assist attendees on an individual basis to apply for CLE credit for attend-ing conference 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.

May 17-20, 2008 Baltimore Marriott Waterfront Baltimore, MDSaturday, May 17, 2008

10 AM - 7 PM

Registration/Information Desk Open

2 - 4 PM

Pre-Meeting CPE Programming

Teen Addiction – Prescription Medications: The New Heroin?Sponsored by Walgreen CoACPE #205-000-08-001-L04-P(0.2 CEU – 2 contact hours)

5 - 6 PM

Annual Meeting Orientation

7 - 10 PM

President’s Welcome ReceptionSponsored by Wal-Mart Stores, IncDinner will be served.Dress: business casual

Sunday, May 18, 2008

6:30 AM - 5:15 PM


6:30 - 7:30 AM

Fun Run/WalkSponsored by Pfi zer Inc

8 - 11:30 AM

Hospitality Brunch Sponsored by Pearson VUE(Same area as Poster Session.)

Educational Table Top • Displays

8 - 11:30 AM

Joint CPE Programming

Educational Poster SessionACPE #205-000-08-002-L04-P(0.1 CEU – 1 contact hour)

12 - 4 PM

First Business Session Welcome Remarks•

- Call to Order - Presentation of Colors- National Anthem- Greetings from the

Host StateKeynote Address: • Tom Daschle, Former Senate Majority LeaderSponsored by Abbott LaboratoriesReport of the Executive • CommitteePresident’s Address• Report of the Treasurer• Report of the Committee on • Constitution and Bylaws

- Reading of Proposed Amendments to the

Constitution - Reading of Proposed

Amendments to the Bylaws

Announcement of • Candidates for Open Executive Committee Offi cer and Member Positions

4 - 5 PM

Joint CPE ProgrammingLegislative and Regulatory UpdateSponsored by Medco Health Solutions, IncACPE #205-000-08-003-L03-P(0.1 CEU – 1 contact hour)

Monday, May 19, 2008

7 AM - 2 PM


7 - 8 AM

NABP/USP BreakfastSponsored by United States Pharmacopeia

8:15 - 10:15 AM


Pedigree Update: RFID and Diversion from Common CarriersSponsored by CVS Caremark CorporationACPE #205-000-08-004-L03-P(0.2 CEU – 2 contact hours)

10:30 AM - noonSecond Business Session

Report of Executive • Director/SecretaryReport of the Committee on • Resolutions

- First Reading of Resolutions

Discuss and Vote on • Proposed Amendments to the BylawsCandidate Speeches for • Open Executive Committee Offi cer and Member Positions

Noon - 12:30 PM

Informal Member/Candidate Discussion

1:30 - 5 PM

Optional Tour

Baltimore Charm City(Afternoon free.)

Tuesday, May 20, 2008

7:30 AM - 4:15 PM


8 - 9 AM

Continental Breakfast

9 - 10:30 AM

Executive Offi cer and Board Member CPE Programming

Medicaid Fraud: Tamper-Resistant Prescription Pads and BeyondSponsored by Merck & Co, Inc

ACPE #205-000-08-005-L03-P(0.15 CEU – 1.5 contact hours)

9 - 10:30 AM

Compliance Offi cer CPE Programming

Case Strategy: How to Investi-gate an Internet PharmacyACPE #205-000-08-006-L03-P(0.15 CEU – 1.5 contact hours)

10:45 AM - 12:15 PM


Compounding Update: Where is USP 797?ACPE #205-000-08-007-L03-P(0.15 CEU – 1.5 contact hours)

12:15 - 1:30 PM

Lunch Break On your own.

1:30 - 4 PM

Final Business Session Election of 2008-2009 • Executive Committee Offi cers and MembersRemarks of the Incoming • PresidentInstallation of Executive • Committee Offi cers and MembersFinal Report of the • Committee on Resolutions

- Discuss and Vote on Resolutions

Invitation to the 2009 • Annual Meeting

5:45 - 6:45 PM

NABP/NACDS ReceptionSponsored by the National Association of Chain Drug Stores

7 - 10:30 PM

Annual Awards Dinner Dress: semiformal

Program subject to change.

april 2008

69

Association News

Members of the 2008-2009 NAPLEX Review Committee AnnouncedNABP is pleased to introduce the North Ameri-

can Pharmacist Licensure Examination™ (NAPLEX®) Review Committee members for 2008-2009. Composed of faculty and pharmacists who are representative of the diversity of pharmacy practice, the NAPLEX Review Committee is responsible for reviewing the examination questions, attending and participating in meetings, and writing new test questions. These dedicated volunteers, acting under the policy and planning guidance of the Advisory Committee on Examinations and the Executive Committee, share the task of safeguarding the integrity and validity of the Association’s examination. NABP appreciates the assistance of these committee members as they evaluate examination content and ensure that it meets the specifi ed competency assessment statements, which, in essence, determine the question pool. The NAPLEX Review Committee members begin their term each year on February 1.

NAPLEX Review Committee MembersMember ......................................................... Marie A. Abate West Virginia University

Member ....................................................... Loyd V. Allen, Jr Edmond, OK

Member ........................................................... Jennifer Beall Birmingham, AL

Member .......................................................... Christi Capers Hermitage, TN

Member ............................................ Michael B. Cockerham Shreveport, LA

Member ........................................................Andrea Collaro, Deerfi eld, IL

Member ................................................................Betty Dong University of California, San Francisco

Member ......................................................Thomas S. Foster University of Kentucky

Member .............................................................. Darla Gallo Elkins Park, PA

Member ............................................... W. Franklin Gilmore Butte, MT

Member ................................................Robert P. Henderson Samford University

Member ...........................................William A. Hopkins, Jr Big Canoe, GA

Member ....................................................Tom M. Houchens London, KY

Member ................................................ Arthur I. Jacknowitz West Virginia University

Member ......................................................... William Kehoe University of the Pacifi c

Member ............................................................Susan C. Lutz Altoona, IA

Member .....................................................David W. Newton Shenandoah University

Member ............................................... Stephen M. Ouellette Oakland, ME

Member ............................................................Roy C. Parish University of Louisiana at Monroe

Member ............................................................ David B. Roll Granbury, TX

Member .........................................................Theresa Salazar Indianapolis, IN

Member .......................................................Eric F. Schneider Charlotte, NC

Member ....................................................James A. Seaboldt Thornton, CO

Member .............................................................. Cindy Sieck Vancouver, WA

Member ...........................................................John L. Szarek Edison, NJ

Member .......................................................... Neal F. Walker Hibbing, MN

Member ...........................................................Siu-Fun Wong Western University of Health Sciences

Surveyors Overcome Brutal Chicago Winter to Attend Training

On February 5, 2007, NABP held accreditation surveyor consultant training. Despite the treacherous weather, devoted NABP surveyors joined accreditation staff at NABP Headquarters in Mount Prospect, IL, for the day-long event. The training provided surveyors with critical information on the Verifi ed-Accredited Wholesale Distributors® (VAWD®) and Verifi ed Inter-net Pharmacy Practice Sites™ (VIPPS®) programs as well as an in-depth look at the components and tools of the durable medical equipment, prosthetics, orthotics, and supplies accreditation survey process.

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Professional Affairs Update

Medicare Pilot Project Nears End

Phase I of the Medicare Health Support (MHS) program will end in July 2008, after three years of operations by fi ve Medicare health support organiza-tions, according to Centers for Medicare and Medicaid Services (CMS).

The MHS program was established by the Medi-care Prescription Drug, Improvement, and Mod-ernization Act of 2003 as a two-phased initiative. Phase I is a pilot program designed to test a variety of care management inter-ventions for some 68,000 fee-for-service Medicare benefi ciaries with heart failure or diabetes. CMS will determine whether to expand the MHS program for Phase II based on the results of an independent evaluation, which will as-sess whether the program has improved clinical quality and benefi ciary satisfaction, and achieved savings targets. Preliminary evaluations indicate that Phase I of the program is not meeting these criteria.

More information is available on the CMS Web site at www.cms.hhs.gov/CCIP/downloads/EOP_Fact_ Sheet_FINAL_ 012808.pdf.

DME Sellers Convicted for Medicare Fraud

The owners of nine Miami, FL-based health care corporations were con-victed of Medicare fraud and sentenced to prison terms in mid-January 2008, the United States Depart-

ment of Justice (DOJ) an-nounced.

The nine defendants were charged with fi ling a collective total of $56.6 million worth of fraudulent Medicare claims for un-necessary durable medical equipment (DME) and infusion therapy. According to data from CMS, Miami-Dade County alone ac-counted for more paid DME claims than 44 other states.

The full press release is posted on the DOJ Web site at www.usdoj.gov/usao/fl s/PressReleases/080123-01.html.

FDA Plans to Set up Shop Abroad

Food and Drug Admin-istration (FDA) Commis-sioner Andrew von Eschen-bach recently announced that FDA is moving forward with plans to establish per-manent offi ces outside the US. By stationing person-nel in US embassies, FDA hopes to be in a better posi-tion to improve the safety of food and medicines com-ing into the US.

Von Eschenbach named fi ve regions where FDA inspectors and technical advisers potentially could be staffed: China, India, Europe, Central and South America, and the Middle East. Funding for the pro-gram, dubbed “FDA beyond Our Borders,” reportedly will be incorporated into FDA’s budget request for fi scal year 2009.

Clarifi cation Sets Apart Two OTC Product Rules

Citing stakeholder confusion over two recent

statutory amendments affecting over-the-counter (OTC) drug products, FDA has issued the following clarifi cation:

Action 1: On December 22, 2007, FDA’s Center for Drug Evaluation and Research published a notice in the Federal Register announcing the availability of a draft guidance for industry entitled Questions and Answers Regarding the Labeling of Nonprescrip-tion Human Drug Prod-ucts Marketed Without an Approved Applica-tion as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. This document is intended to assist stakeholders in comply-ing with the labeling requirements of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.Section (d) of this law

added section 502(x) to the Federal Food, Drug, and Cosmetic (FD&C) Act, which requires the label of an OTC drug marketed in the United States without an approved application to include a US address or phone number by which the responsible person (ie, the manufacturer, packer, dis-tributor, or retailer identi-fi ed on the drug label) may receive a report of a serious adverse event associated with the use of the drug product.

This new statutory provi-sion (and draft guidance) ap-plies to OTC drug products

Around the AssociationBoard Member Appointments

Donnie Calhoun, RPh, • has been appointed a member of the Alabama State Board of Pharmacy. Calhoun’s appointment will expire on December 31, 2012.

James Burgard, BSME, • has been appointed a public member of the California State Board of Pharmacy. Burgard’s appointment will expire on June 1, 2009.

Anika Calloway, JD, • has been appointed a public member of the Indiana Board of Pharmacy. Calloway’s appointment will expire on July 1, 2010.

Board Offi cer ChangesThe Alaska Board of Pharmacy has elected the following offi cers to the Board:

Mary Mundell, RPh, • Chairperson

Richard Holm, RPh, • Vice Chairperson

Dirk White, RPh, • Secretary

The Indiana Board of Pharmacy has elected the following offi cers to the Board:

William Cover, RPh, • President

Del Fanning, RPh, • Vice President

april 2008

71

Professional Affairs Update

that are marketed without applications [new drug appli-cations (NDAs) or abbrevi-ated new drug applications (ANDAs)] approved under section 505 of the FD&C Act, including those marketed under the OTC Monograph Drug Review. Section 502(x) of the FD&C Act does not apply to OTC drug products marketed under approved NDAs or ANDAs.

Action 2: In an unrelat-ed action, on January 3, 2008, FDA published an interim fi nal rule (the toll-free number interim fi nal rule) to comply with section 502(f) of the FDA Amendments Act of 2007. Although the toll-free number interim fi nal rule largely applies to pharmacy dis-tribution of prescription drugs, it also includes some provisions appli-cable to the labeling of OTC drug products that are approved under an NDA or ANDA.

Under the toll-free number interim fi nal rule (21 CFR 201.66(c)(5)(vii)), OTC drug products that (1) are marketed pursuant to an application approved under section 505 of the FD&C Act and (2) do not include on their packaging a toll-free number through which consumers can report complaints to the manufacturer or distribu-tor must include a specifi ed label statement in the OTC drug facts format contain-ing the toll-free number for reporting adverse events to FDA (FDA’s MedWatch telephone number). The label statement reads, in pertinent part: “You may report side effects to FDA at 1-800-FDA-1088.”

FDA Takes Action against Compounded BHRT Drugs

FDA sent letters warning seven pharmacy operations that the claims

they make about the safety and effectiveness of their so-called bio-iden-tical hormone replace-ment therapy, or BHRT products are unsupported by medical evidence, and are considered false and misleading by the agen-cy. FDA has expressed concern that unfounded claims like these mislead women and health care professionals. The phar-macy operations receiving warning letters use the terms bio-identical hor-mone replacement therapy and BHRT to imply that their drugs are natural or identical to the hormones made by the body. FDA regards this use of bio-identical as a marketing term implying a benefi t for the drug, for which there is no medical or scientifi c basis. The FDA news release is available at www.fda.gov/bbs/topics/NEWS/2008/NEW01772 .html.

FPGEC Certifi cation(continued from page 64)

understands that this situation is beyond the applicant’s control and has refl ected this in an additional amendment to the certifi cation policy regarding the applicant’s opportunity to test. Now, on a case-by-case basis, the FPGEC will deter-mine whether to allow an applicant’s record to remain open until the ap-plicant is able to obtain a visa and take the FPGEE.

Provided that the ap-plicant is able to present supporting documenta-tion that attributes the delay to a visa, health, or job-related problem, the FPGEC will take the situation into full con-sideration. In some cases, an application to test may remain open for up to three years. Prior to this change, applicants only had two consecu-tive opportunities to take the FPGEE after which, the applicant needed to resubmit his or her ap-

plication form along with the fee.

With these adjust-ments to the FPGEC, NABP is able to ensure that foreign-educated pharmacists encounter a streamlined certifi ca-tion process without compromising the US standards of pharmacy education.

Additional information on the FPGEC and FPGEE is available in the Examina-tion Programs section of the NABP Web site, www .nabp.net.

NEWLY ACCREDITED VAWD FACILITIESThe following facilities were recently accredited through the NABP Verifi ed-Accredit-ed Wholesale Distributors® (VAWD®) program:

Fresenius USA Manufacturing, Inc dba Fresenius Medical Care North AmericaPerrysburg, OHAccredited January 18, 2008

JOM Pharmaceutical Services, IncShepherdsville, KYAccredited January 17, 2008

McKesson Corporation dba McKesson Drug CompanyWilsonville, ORAccredited January 18, 2008

McKesson Corporation dba McKesson Drug CompanyAurora, COAccredited January 18, 2008

McKesson Corporation dba McKesson Drug CompanyCanada, MNAccredited January 18, 2008

Perrigo Pharmaceuticals CompanyGreenville, SCAccredited January 18, 2008

Perrigo Pharmaceuticals CompanyAllegan, MIAccredited January 18, 2008

Wal-Mart Stores, LP dba Wal-Mart Pharmacy Warehouse #46Williamsport, MDAccredited January 18, 2008

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

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72

State Board News

Alaska Considers CS Prescription Monitoring Program

Alaska may soon join many other states that already have in place pre-scription drug monitoring programs to monitor the use of controlled sub-stances in the state. This central data bank could be consulted, for example, by a pharmacist who sus-pects that a patient who is presenting a prescrip-tion is “doctor shopping,” or by physicians prior to writing prescriptions for controlled substances.

The Alaska Division of Corporations, Business, and Professional Licens-ing is working under a grant to bring such a program to Alaska and will pursue legislation to support its use. Legisla-tion will be necessary for implementation and will help ensure patient record confidentiality and define who could access the information. Currently 48 states either have such programs in place or are working towards imple-mentation.

Arizona Adopts New CS Prescription Monitoring Program

Arizona’s 48th leg-

islature passed House Bill 2136, establishing a controlled substance prescription monitor-ing program in the state. Funded and administered entirely by the Arizona State Board of Pharmacy, the program will collect,

securely store, and review data provided by pharma-cies and medical practitio-ners who dispense Sched-ule II, III, or IV controlled substances.

The Board may, using a protocol established by a governing task force, re-lease data collected by the program to assist medical practitioners and pharma-cies in providing phar-macist care to individual patients. The program is not intended to interfere with the legitimate treat-ment of patients, but will provide approved infor-mation to treating medical practitioners and dispens-ing pharmacies if their pa-tients receive prescriptions from other providers.

This information will facilitate and encourage the identification, inter-vention, and treatment of individuals who are misusing or diverting con-trolled substances. When the system is operational, pharmacists and provid ers will receive instructions on how to access the da-tabase. The new statutes, known as Title 36, Chap-ter 28, are available in the Rules & Statutes section of the Board’s Web site, www.azpharmacy.gov.

Iowa Board Proposes Mandatory Certifi cation for Pharmacy Technicians

The Iowa Board of Pharmacy is proposing to revise its regulations on pharmacy technician cer-tifi cation and registration

(sections of 657 Chapter 3 of the Iowa Administrative Code). The proposed rules would require national certifi cation for pharmacy technicians beginning July 1, 2010.

National certifi cation would not supplant the need for licensed pharmacist con-trol over the performance of delegated functions, nor exempt pharmacy techni-cians from registration with the Board. The proposed rules recognize successful completion of the Pharmacy Technician Certifi cation Board (PTCB) certifi cation program as fulfi lling the requirement for national certifi cation.

The Board further proposes that, beginning July 1, 2009, a person who is in the process of acquir-ing national certifi cation as a pharmacy technician must register with the Board as a pharmacy technician trainee. The registration would expire after one year and would be nonrenew-able. Beginning July 1, 2010, all applicants for new or renewed pharmacy techni-cian registration would be required to provide proof of current national pharmacy technician certifi cation and to complete the application for certifi ed pharmacy tech-nician registration.

Louisiana Board Requires CPE to Include Live Presen-tations

In 2007, the Louisi-ana Board of Pharmacy approved a change to its

continuing pharmacy education (CPE) regula-tions, which take effect in 2008. With respect to the renewal of pharmacist licensure, at least three of the minimum 15 hours of Accreditation Council for Pharmacy Education (ACPE)-accredited CPE earned during 2008 must be obtained via live pre-sentations. Live presenta-tions will contain the L designation in the Uni-versal Program Number.

Pharmacists unable or unwilling to earn at least three hours of live ACPE-accredited CPE during 2008 will be required to earn an additional five hours of ACPE-accredited CPE via their method of choice, for a total of at least 20 hours of ACPE-accredited CPE, in order to renew a license for 2009. The requirement for live CPE is for phar-macists only – not techni-cians – at this time.

New Jersey Adopts Must-Fill Law

New Jersey adopted legislation (Senate Bill 1195) on November 2, 2007, establishing a pharmacy’s duty to fill a prescription for in-stock medications or devices without delay, notwith-standing a pharmacist’s personal convictions.

According to the act [P.L.2003, c.280 (C.45:14-40 et seq], “[a] pharmacy practice site has a duty to properly fill lawful prescriptions for prescription drugs or


april 2008

73


devices that it carries for custom-ers, without undue delay, despite any conf licts of employees to fill-ing a prescription and dispensing a particular prescription drug or device due to sincerely held moral, philosophical or religious beliefs.” The act is effective immediately.

If a pharmacy does not have in stock the item for which a patient presents a prescription, the phar-macy must offer to obtain the item under its standard expedited ordering procedures, or locate a nearby pharmacy (of the patient’s choice) that has the item in stock, and transfer the prescription there.

North Carolina Board Implements New CPE Requirements

As of January 1, 2008, new CPE requirements are in effect in North Carolina. To renew a pharmacist license for 2009, the licensee must acquire 15 hours of CPE, and eight of those hours must be contact hours.

Up to fi ve surplus CPE hours

CPE(continued from page 65)

tion, and Federal Bureau of Investigation representative Ryan Tool, supervisory spe-cial agent. Two contact hours (0.2 CEUs) of CPE credit be given to all that attend.

Tuesday, May 20Medicaid Fraud: Tamper-Resistant Prescription Pads and Beyond

In this session, spon-sored by Merck & Co, Inc, Jason Weinstock, JD, from the Centers for Medicare and Medicaid Services (CMS), Medicaid Integrity

Group, and Michael A. Burleson, RPh, executive director of the Kentucky Board of Pharmacy, will discuss Congress’s fi ndings pertaining to fraudulent activities in pharmacy and its efforts to combat such activities, as well as how boards of pharmacy may work with CMS in these efforts. One and a half contact hours (0.15 CEUs) of CPE credit can be earned by attendees.

Case Strategy: How to Investi-gate an Internet Pharmacy

There have been an increasing number of

Internet “pharmacy” sites that are placing the public health at risk. During this session, meeting participants will discuss strategies to build a case against an Internet pharmacy using all available resources in order to put these sites out of business. The speaker for this session is Benjamin N. Gluck, MA, JD, partner and shareholder from Bird, Marella, Boxer, Wolpert, Nessim, Drooks, and Licenberg, A Professional Corporation. Attendees at this session can earn

up to one and a half con-tact hours (0.15 CEUs) of CPE credit.

Compounding Update: Where is USP 797?

Representatives from United States Pharmaco-peia, Claudia C. Okeke, PhD, RPh, scientifi c fellow, and Ruth K. Miller, JD, senior counsel, will exam-ine the recent updates to the United States Pharma-copeia Chapter 797 sterile compounding standards. Meeting participants in this session can earn up to one and half contact hours (0.15 CEUs) of CPE credit.

State Board News(Continued from page 72)

may be carried over for up to one year. In other words, a pharmacist who acquires 20 hours of CPE in 2008 may carry over the excess fi ve hours into 2009. Surplus hours acquired in 2007, however, may not be carried over to 2008. CPE will continue to be reported annually with each renewal application.

South Dakota Board Developing Telepharmacy RulesThe South Dakota State Board of Pharmacy is in the process of developing rules pertaining to telepharmacy. South Dakota adopted legislation (House Bill 1031) in March 2007 to provide for the regulation of telepharmacy.

The legislation defi nes telepharma-cy as “the practice whereby a licensed pharmacist uses telecommunications technology to provide personalized, electronically documented, real-time pharmaceutical care to patients at a remote pharmacy, including prescrip-tion dispensing and counseling, and to oversee and supervise remote phar-macy operations.”

The Board is requesting com-ments and suggestions from pharma-cists regarding the development of these rules.

Washington Implements New Naturopathy RulesIn November 2007, the Washington State Department of Health finalized new rules for the practice of naturopathy. The rules allow naturopathic physicians to prescribe any legend drug except botulinum toxin, and any codeine or testosterone product in Schedules III through V.

The new rules follow a law passed in 2005 that redefined naturopathy practice, stating that naturopathy drug use is based on current practice rather than medicines of mineral, animal, and botanical origin. To prescribe controlled substances, natur-opathic physicians must complete four hours of training and obtain Drug Enforcement Administra-tion registration.

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Feature News

Rogue Internet Drug Distributors(continued from page 58)

drug distributors – by making it easier to tackle those in-state, brick-and-mortar drug distributors with which those amor-phous, ever-changing, often untraceable Web sites may contract to dispense the actual drugs.

A number of state boards of pharmacy, in-cluding in North Carolina, Oklahoma, and Texas, have reminded their licensees of the illegality of agreeing to dispense medications for such Web sites, and to alert them to the issue. “The Board is aware that some Internet-based opera-tions are actively soliciting pharmacists – particularly independent pharmacists – to act as a dispensing clear-inghouse for Internet-based prescriptions,” warns the North Carolina Board of Pharmacy on its Web site. “Internet-based prescrip-tions generated without a physical examination or a prior prescriber-patient relationship . . . are not valid, and fi lling them vio-lates state law. Filling such prescriptions for controlled substances also violates federal law.”

Boards are asking phar-macists to advise them and/or Food and Drug Admin-istration (FDA) about such solicitations. While some solicitations appear to come from foreign sites (“[Texas State Board of Pharmacy] has obtained information that these domains appear to be linked to Internet

Protocol (IP) address[es] located outside the United States,” reports the Texas Board on its Web site), oth-ers appear to be generated domestically. The North Carolina Board has issued cease-and-desist letters to a number of Internet drug distribution sites.

Cooperation outside the pharmacy regulation arena also helps. In Kentucky, then-Attorney General Greg Stumbo highlighted the role of shipping facilities in a 2006 seizure of illegal pre-scription drug shipments. “Shipping hubs across the state are to be commended for their vigilance in recog-nizing when packages ar-riving at their hubs are not from a registered Internet pharmacy,” Stumbo stated in a press release. “We urge commercial carriers to be alert to what is passing through their hubs and call upon them to alert the KBI [Kentucky Bureau of Investigation] of suspicious packages from unlicensed pharmacies,” he said.

He also emphasized collaboration among dif-ferent law enforcement entities and across states. “KBI agents are working in cooperation with Ken-tucky State Police, Drug Enforcement Administra-tion, Kentucky National Guard, Florida Offi ce of the Attorney General and the Florida Department of Law Enforcement in its efforts to crack down on rogue In-ternet Pharmacies shipping drugs into Kentucky,” the release stated.

Reminders and warnings are not limited to board

of pharmacy licensees. Many boards of pharmacy (and state governments in general) have endeavored to reach out to consumers as well, to inform them of the hazards of ordering drugs from unlicensed Internet pharmacies.

Federal EffortsBecause of the Internet’s

role in consumers’ illegal acquisition of controlled substances, DEA has necessarily been active in the effort to combat rogue online pharmacies. As on the state level, the nature of the Internet has made enforcement efforts dif-fi cult. “[T]he Internet has provided drug traffi cking organizations with the perfect medium,” stated DEA’s Rannazzisi in his congressional testimony. “It connects individuals from anywhere in the globe at any time; it provides anonymity, and it can be deployed from almost anywhere with very little formal training. All of these features allow for a more rapid means of diverting larger and larger quantities of controlled substances.”

Again similar to the states, the DEA’s successes have involved those tan-gible, real-world aspects of drug distribution. “DEA is using the Automation of Reports and Consolidated Orders System (ARCOS) to identify high or excessive volume purchases and de-termine which retail phar-macies and practitioners are likely to be involved in the illicit distribution of controlled substances via

the Internet,” said Ran-nazzisi. While the ARCOS information is limited to narcotics, he noted, it is useful in developing leads and assisting investigations in general.

Collaboration fi gures in here, too. “DEA has also developed a productive relationship with other businesses that are affected or inadvertently used to fa-cilitate these Internet phar-macies,” Rannazzisi stated. “DEA’s Internet Industry Initiative was established to exploit the weaknesses inherent to the schemes used by Internet traffi ck-ers who rely extensively on the commercial services of three principal legitimate business sectors: Internet service providers; express package delivery compa-nies; and fi nancial services companies, including major credit card companies and third-party payment service providers.”

Both DEA and FDA have embarked on public education efforts, advising consumers about the legali-ties and dangers associated with purchasing drugs from unlicensed Internet drug distributors. To assist patients with identifying li-censed facilities, FDA directs them to the NABP VIPPS program.

Despite occasional efforts by Congress to transfer regulation of In-ternet drug distributors to the federal government – a recent attempt was Sena-tor Judd Gregg’s 2007 bill, which specifi ed regulatory requirements for Inter-net drug distributors and

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Feature News

would have allowed the Secretary of Health and Human Services to suspend or terminate the license of an Internet pharmacy – these powers have remained with the states.

A slightly different ap-proach was taken by Sena-tor Dianne Feinstein and Representative Jeff Sessions, who jointly submitted legislation titled “The Ryan Haight Online Pharmacy Consumer Protection Act of 2007” in an effort to combat those Web sites that sell controlled substances without a valid prescrip-tion. Their bill, which was approved by the Senate Judiciary Committee and subsequently incorporated into an omnibus crime bill (the “Crime Control and Prevention Act of 2007,” in-troduced by Senator Joseph Biden in late 2007), would, among other provisions:

prohibit online drug • distributors from selling controlled substances without a valid prescription, including a practitioner’s in-person examination;require online drug • distributors to comply with the requirements of each state in which they operate;require an online drug • distributor to post

ownership and licensing information on its home page;increase criminal • penalties for certain controlled substance offenses, and clarify that Internet distributors, like other drug dealers, could be prosecuted in federal courts; andallow a state attorney • general, after giving the US Department of Justice notice and opportunity to intervene, to shut down a rogue Internet drug distribution site across the country, not just in his or her state.

NABP ContributionsNABP was early to

recognize the potential public health implications of unregulated Internet drug distributors and, in 1999, launched the VIPPS program, which remains the cornerstone of the As-sociation’s efforts and is an excellent countermeasure for fraudulent sites. The VIPPS accreditation seal tells patients (and state boards of pharmacy) that a particular Web site has complied with licensing and inspection requirements in each state in which it dis-penses prescription medica-tions, and, further, that it has demonstrated compli-

ance with such criteria as patient rights to privacy, au-thentication and security of prescription orders (includ-ing the presence of a valid patient-practitioner rela-tionship), and the availabil-ity of meaningful consulta-tion between patients and pharmacists. In consumer education efforts by both state and federal authorities, VIPPS accreditation is held up as the easiest – and often the most effective – way to ascertain that a Web site is legitimate.

NABP has continued in efforts to assist the state boards of pharmacy in protecting the public from rogue Internet drug distrib-utors in other ways, from public education efforts to congressional testimony. At the Associaton’s 103rd An-nual Meeting in May 2007, members passed Resolution 103-3-07, “Internet Pharma-cy Public Safety Awareness,” which resolved “that NABP continue to collaborate with federal agencies and other interested stakeholders to educate the public and health care professionals of the dangers of acquiring drugs illegally through the Internet and from foreign sources.”

As a result of this resolu-tion, and with a grant from Pfi zer Inc, NABP is launch-

ing a new initiative to assist patients in purchasing medications safely online. (See “NABP Developing Program to Monitor Online Drug Distributors” in the March 2008 issue of the NABP Newsletter.) The goal of this initiative, dubbed the Internet Drug Distribu-tor Identifi cation (IDDI) program, is to establish a comprehensive database of Internet sites involved in the distribution and dispensing of prescription medications. The project will identify illegitimate drug distributors that are not properly licensed in the states where they are doing business. Information on noncompliant Internet drug distributors will be provided to the state boards of pharmacy and law en-forcement authorities.

Unfortunately, the only thing that seems to evolve as fast as the Internet is Internet-enabled fraud and crime. Meanwhile, regula-tory and law enforcement authorities continue to make inroads in their ef-forts to protect the public from rogue Internet drug distributors: by working together to adapt existing tools, focusing on consum-er education, and cooperat-ing across jurisdictional boundaries.

Curriculum Assessment(continued from page 59)

Inferences can be drawn from the PCOA data analysis provided regarding phar-macy curricula. The assess-

ment will offer more detailed information than the North American Pharmacist Licensure Examination™ (NAPLEX®) results. While the NAPLEX specifi cally measures the student’s ability

to apply his or her knowledge and skills necessary for entry-level pharmacy practice, the PCOA is appropriate for stu-dents in all four professional years and provides valuable data on individual student’s

strengths, weaknesses, and progress from year to year.

Additional information on the PCOA is available in the Assessment Programs section of the NABP Web site at www.nabp.net.

april 2008nabp newsletter

National Association of Boards of Pharmacy

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nabp newsletter

Association Highlights

NABP 104th ANNUAL MEETINGOnline registration is available in the Meetings section of the NABP Web site at www.nabp.net.

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