newsletter - nabp · 6/8/2016 · nabp newsletter 114 csa task force (continued from page 113)...

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aid to governmentthe profession

the public1904 to 2011

Upcoming EventsJuly 26-27, 2011 NABP Program Review and TrainingNABP Headquarters

August 4-6, 2011 NABP/AACP District 5 Meeting Saskatoon, Saskatchewan

August 7-9, 2011 NABP/AACP District 3 Meeting Biloxi, MS

September 21-22, 2011 NABP Interactive Executive Officer Forum NABP Headquarters

October 4-6, 2011 NABP/AACP Districts 6, 7, & 8 Meeting Seattle, WA

October 20-22, 2011 NABP/AACP Districts 1 & 2 Meeting Boston, MA

In This Issue. . . .Legal Briefs:107th Annual Meeting Report of Counsel: Catch Me If You Can

116

Association News:Annual Report of Counsel on Association Legal Affairs

121

Association News:PCOA Administration Continues to Demonstrate Students’ Progression of Knowledge

128

Association News:Pharmacist and Technician Unique Identifiers Necessary to Assist in Ensuring Accuracy of CPE Monitor e-Profiles

130

Association News:NABP PMP InterConnect Development Complete; Piloting of Data Exchange Anticipated for Late July 2011

131

June -July 2011 / Vo lume 40 Number 6

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newsletterNational Association of Boards of Pharmacy®

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Celebrating

75 Years

Task Force Recommends CSA Revisions Aimed to Support Patient Care and Safety

To address public health and patient safety issues, such as escalating rates of prescription drug abuse and medication errors, federal legislators have adopted laws amending the Controlled Substances Act (CSA), such as the Secure and Responsible Drug Disposal Act of 2010. In addition, Drug Enforcement Administration (DEA) has implemented new rules, such as the interim final rule on electronic prescriptions for controlled substances. While pharmacy regulators await the implementation of the drug disposal laws and follow guid-ance to facilitate implementa-tion of the e-prescribing rule, the need for additional CSA amendments that will support the provision of pharmacist care is recognized. With this need in mind, and with an eye toward future technolo-gies and pharmacy practice changes, the NABP Task Force to Review and Recommend

Revisions to the Controlled Substances Act has made 21 recommendations calling for amendments to the CSA itself or the related regulations. The task force also reviewed 20 ad-ditional amendments advised by its subcommittees, and ultimately recommended that these changes were unneces-sary, or, in a few cases, made alternative recommendations.

Recognizing that the prac-tice of pharmacy has changed significantly since the initial implementation of the CSA in 1970 and that current provisions of the CSA could have the unintended effect of restricting and inhibiting the provision of pharmacist care, member boards of pharmacy approved NABP Resolu tion No. 106-6-10, which called for a Task Force to Review and Recommend Revisions to the Controlled Substances Act, at the 2010 Annual Meeting.

The Task Force to Review and Recommend Revisions

to the Controlled Substances Act convened in October 2010 and accepted the following charge:1. Review selected provisions

of the CSA and accom-panying administrative regulations;

2. Identify those provisions that may require review and revision; and

3. Recommend legislative and regulatory changes to amend the CSA and accompanying adminis-trative regulations.

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CSA Task Force(continued from page 113)


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 64 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

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©2011 National Association of Boards

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secretary of the National Association of

Boards of Pharmacy.

Feature News

At this first meeting of the task force, members identified provisions that needed to be addressed and assigned each to a task force subgroup. Four subgroups were formed to focus on provisions related to the following areas: community pharmacy, hospital pharmacy, long-term care pharmacy, and a variety of CSA issues under mis-cellaneous provisions. Each of the four subgroups met via tele-conference during the month of November. The task force then reconvened in January 2011 to review the recommendations of each subgroup and make final recommendations.

Recommended Definition Revisions

With current pharmacy practice issues and potential future practice issues in mind, the task force has recommended that several definitions in the CSA and its implementing regulations be added or revised to address pharmacy practice issues. For example, it was recommended that CSA be amended to include separate definitions for “administer,” “dispense,” and “prescribe.” Members recommended that the definition for “administer” use the following language: “The term ‘administer’ means the direct application of a Drug to the body of a patient or research subject by injection, inhalation, ingestion, or by any other means.” It was also suggested that language referring to the “prescribing and administering of a controlled substance” be cut from the

definition of “dispense,” and that, instead a separate definition should be provided for “prescribe.” The following definition is recommended: “The term ‘prescribe’ means a direction or authorization, by prescription, permitting an ultimate user lawfully to obtain controlled substances from any person authorized by law to dispense such substances.” The task force aimed to develop recommended definitions that are functional in nature and broad enough to encompass future practices.

The task force also recom-mended that pharmacists should be included in the CSA definition of “practi-tioner.” Members discussed how the revision of the term would be appropriate as DEA now registers pharmacists as mid-level practitioners pursu-ant to DEA regulations. In addition, members recom-mended the definitions of “individual practitioner” and “mid-level practitioner” be amended to conform with the recommended definitions for “dispense” and “prescribe.”

LTCF Related RevisionsRevisions to several defini-

tions related to long-term care facilities (LTCFs) were also recommended. To allow for flexibility, particularly at the state level, it was indicated that the term “long-term care facility” should be defined broadly as “an institution which provides extended health care to resident patients.” Additionally, the revision of definitions for the terms “agent” and “prescrip-tion” were recommended, as these changes would help lay

groundwork for clarifying the role of agents in LTCFs. First, the task force recommended the term “agent” be defined as “a person authorized to act on behalf of a practitioner as provided by state law or written agency agreement.” Second, the task force recom-mended that medical record orders should be included in the term “prescription” to al-low for what have historically been called “chart orders.” Members also recommended that a medical record order without a quantity should be limited to a seven-day supply. Revising these definitions, along with amending ap-plicable regulations regarding the manner of issuance of prescriptions, would continue to allow designated agents to call in prescriptions to phar-macies.

The task force also recom-mended that the sections of CSA pertaining to the ad-ministering or dispensing of narcotic drugs to maintain or detoxify a patient be revised to allow for the detoxification or maintenance treatment of LTCF patients. This change is advised due to the increasing need to dispense detoxifica-tion medications in LTCFs to patients being treated for other conditions.

Prescription Elements and Allowable Changes

The task force also recom-mended several amend-ments to the CSA related to requirements for the manner of issuance of prescriptions, medical record orders, and allowable changes. Recogniz-ing that certain prescription

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Association News

Executive CommitteeWilliam T. Winsley ChairpersonOne-year term

Malcolm J. BroussardPresidentOne-year term

Michael A. BurlesonPresident-electOne-year term

Karen M. RyleTreasurerOne-year term

James T. DeVitaMember, District 1Serving second year of a three-year term

Edward G. McGinleyMember, District 2Serving second year of a three-year term

Mark T. ConradiMember, District 3Serving first year of a three-year term

William J. CoverMember, District 4Serving first year of a three-year term

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

Joseph L. “Joe” AdamsMember, District 6Serving third year of a three-year term

Cathryn J. LewMember, District 7Serving third year of a three-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.

Candidates Register for NAPLEX, MPJE with Upgraded System and More Registration Features

In an effort to be more user friendly and to allow candidates to perform more registration tasks and view their status information, NABP implemented a new online registration system for the North American Pharma-cist Licensure Examination® (NAPLEX®) and the Multi-state Pharmacy Jurisprudence Examination® (MPJE®) on March 28, 2011.

At press time, 19,623 candidates had used the new registration form, and 4,261 created new accounts to view or update registrations that were submitted before the new online form went live.

In the first couple of months of rolling out the new registration system, some candidates experienced dif-ficulties using the new online form. Some issues were related to system bugs, most of which have been rectified, while other issues were related to process changes required for the new system.

Candidates who are expe-riencing difficulties utilizing the new application will find many of the answers to their questions on the frequently asked questions pages in the NAPLEX and MPJE sections of the NABP Web site. The NABP Customer Service Department is also available to assist candidates. NABP is aware of the issues related to the new registration form and has eliminated many of the problems. The Association is continuing to work diligently to correct the remaining issues as soon as possible.

Benefits to the new regis-tration form include allowing candidates to make changes to, add to, or withdraw regis-tration, eliminating the need for candidates to call NABP for this service. Changes that can be made online include registering for the MPJE in additional jurisdictions and adding NAPLEX score trans-fer requests up to 90 days after taking the examination. The enhancements to the NAPLEX score transfer re-quest submissions eliminates the previous requirement that candidates must submit score transfer requests five busi-ness days prior to sitting for the examination. In addition, candidates who registered after March 28, may submit change of primary jurisdic-tion requests online. Due to the differences in the old and the new systems, however, those who registered before March 28, need to submit a change of jurisdiction request to NABP in writing.

The new registration form also gives candidates who miss sitting for an examina-tion or who do not cancel within two business days of their appointment the ability to submit resitting fees online rather than having to send a payment to NABP via mail. This expedites the receipt of the candidate’s new Autho-

rization to Test so that he or she may schedule another examination appointment more quickly.

An additional benefit to candidates is the ability to monitor the status of their registration. After submitting registration, candidates can log in to their profile and see if the registration has been received; if eligibility has been requested, granted, denied, or expired; if Authorization to Test has been generated; if the registration has been with-drawn or expired; and a his-tory of examinations taken. The new online registration form also allows users to up-date their profiles as needed and review past orders.

The score results for the NAPLEX and MPJE are also accessible when candidates log in to the registration, provided that the board for which the candidate tested participates in the online score interface. Currently, 24 boards utilize this service. A list of these participating boards is available in the Pro-grams section of the NABP Web site under NAPLEX and MPJE Score Results.

Candidates who registered for the NAPLEX or MPJE before March 23, 2011, must create a new user account through the new application

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On behalf of its member boards of pharmacy, NABP develops,

administers, scores, and maintains multiple examination programs for use in the licensure process. These examinations command significant attention by NABP and consume large portions of NABP staff time and financial resources. As with any high stakes licensure examination program, NABP examinations are also the subject of robust security measures to ensure that they are not compromised or subject to exposure to candidates or others looking to exploit access to secure exam materials. Pre-disclosure of exam items not only threatens the security of the program, but also threatens the legal defensibility determinations contingent upon pass-fail results.

While NABP oper-ates multiple examination programs, this report will focus on the North Ameri-can Pharmacist Licensure Examination® (NAPLEX®). The NAPLEX is a mini-mum competence assess-ment tool developed for uniform use by pharmacy boards as one indicator of licensure eligibility. The benefits of a uniform examination program are obvious pertaining to the economies of scale, legal defensibility, validity, and reliability as related to pharmacy boards, as well as

increased flexibility related to the mobility of practi-tioners. Licensure eligibil-ity criteria are established through the enactment of statutes and promulgation of regulations. Pharmacy boards are governmen-tally established regulatory entities and licensure as a pharmacist is mandatory prior to practice. Indeed, the unlicensed practice of pharmacy subjects such in-dividuals to administrative, civil, and criminal sanc-tions. Finally, and based upon this governmental oversight of the profession,

licensees are entitled to certain due process rights before an adverse action is taken by a pharmacy board. While the above-referenced recap of pharmacy boards and the licensure process may be elementary, some-times it is worth restating the obvious to place certain issues into context.

To ensure the confidenti-ality of proprietary matters and processes concerning its high stakes licensure exami-nations, NABP enters into detailed agreements with vendors, employees, and volunteers involved in the development, administra-tion, scoring, and mainte-nance of these assessment mechanisms. Further, can-didates for licensure seek-ing to sit for the NAPLEX are prohibited from using aids or obtaining assistance during the examination and cannot disclose examination content to others. In spite of these and other measures, confidential exam materials and other protected infor-mation for all the regulated professions continues to flow in the form of review courses, chat rooms, e-mail correspondence, printed text, and every other con-ceivable method of com-munication. In the techno-logically advanced world of today, protected information can be disseminated glob-ally at the push of a button. Enforcement of protected intellectual property rights

Legal Briefs

107th Annual Meeting Report of Counsel:Catch Me If You CanBy Dale J. Atkinson, JD

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is a daunting, but essential, task to ensure the defensibil-ity of the uniform licensure examination program relied upon by the NABP member boards.

The purpose of this year’s Report of Counsel is to address what appears to be a movement, whether real or perceived, of publicized activities which result in the compromise or breach of these high stakes licensure and certification examina-tions. Sometimes these alleged breaches occur at the hands of those which regula-tory boards and licensees would least likely expect. This report will not only explore some of the factual findings resulting in exam compromises, but also the legal implications to those involved in the examination process. Exam compromises affect exam owners, regu-latory boards, candidates for licensure, employers of licensees, hospitals, health care programs, academic programs, examination vendors, insurance carriers, the judiciary and, ultimately, the public served.

NABP v Board of Regents of the University System of Georgia, et al

Most NABP constitu-ents are familiar with the fact that in August 2007, the NAPLEX program was entirely shut down due to an alleged breach in exam

security. As a result, for ap-proximately five weeks, no applicant in any jurisdic-tion was able to sit for the NAPLEX and become li-censed as a pharmacist. In-vesting significant resourc-es, NABP began the process of reconstituting the exam program and ultimately brought the NAPLEX back on line for use by NABP member boards of phar-macy. The allegations were investigated resulting in the eventual commencement of litigation in federal court by NABP against those alleged to have perpetrated this compromise. Astonishingly, the defendants in this liti-gation included the Board of Regents of the University System of Georgia, as well as a professor of the phar-macy academic program who was also assistant dean for student affairs with the College of Pharmacy of the University of Georgia. The very university and profes-sor charged with educat-ing would-be pharmacists are alleged to have oper-ated a review course using examination items gathered from former students who had recently sat for the NAPLEX. These former students were alleged to have been encouraged to provide recalled items to the professor. Through this scheme, NABP contends hundreds of NAPLEX items were compromised.

Perhaps more star-tling was the fact that this

particular university and professor were the subject of previous allegations by NABP concerning similar examination compromise in the mid 1990s, which resulted in a settlement agreement wherein the school and the professor agreed to cease and desist all copying, transcrib-ing, or other use of NABP copyrighted materials and examination questions. The previous settlement agreement became a part of the litigation initiated in 2007 involving these same parties.

NABP pharmacy board members, executive direc-tors, and staff are likely familiar with the immunity principles designed to allow regulatory board public protection responsibili-ties to be undertaken free of influence and threat of litigation. Without such protective measures, vacan-cies on pharmacy boards would be rampant, as indi-viduals would be reluctant to subject personal assets to the potential revers-ible errors committed by volunteer board members in the good faith regulation of the profession. Immunity comes in different shapes and sizes dependent upon the alleged wrongdoing of the public servant and can be generally characterized as absolute immunity (or judicial immunity) and qualified immunity. Im-

Legal Briefs

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


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munity principles are also designed to limit federal court jurisdiction over state entities under the United States Constitution. The aforementioned NABP litigation is a shining ex-ample of such prohibition. Consider the following.

Based upon the facts set forth in this report, NABP instituted litigation in federal court in August 2007 against the Board of Regents for the Univer-sity System of Georgia and against two professors in their individual capacities, alleging copyright infringe-ment for appropriating NABP written materials protected by the Copyright Act. In May 2008, NABP also instituted an action in state court regarding certain other contract and tort claims.

In the federal litigation, NABP seeks damages and injunctive relief against the University System of Georgia and the professors and alleges three counts, in-cluding copyright infringe-ment. Based upon the facts alleged by NABP, an emer-gency temporary restrain-ing order was entered which prohibited the defendants from undertaking certain actions related to the ex-aminations. Also, the court ordered the US Marshall, assisted by NABP attorneys, to search and seize certain identified materials.

Soon after, the Uni-versity System of Georgia filed a motion to dismiss the case arguing the court

lacked subject matter ju-risdiction based upon the Eleventh Amendment of the US Constitution. Some characterize this Eleventh Amendment prohibition of a federal court adjudicating a case against a state as sov-ereign immunity. In short, the University System of Georgia argued that, based upon sovereign immunity, the federal court could not adjudicate this case because it involved a state entity (the University System of Georgia) being sued by a private entity (NABP) in a federal court. Complicat-ing the issues is the fact that federal courts have exclusive jurisdiction to adjudicate matters brought under the Copyright Remedy Clarifi-cation Act (CRCA). That is, NABP’s remedies under the copyright act can only be pursued in federal court set-ting the stage for this legal dichotomy.

The District Court granted the University Sys-tem of Georgia defendants’ motion to dismiss under the Eleventh Amendment and the remaining counts related to breach of the 1995 settlement agreement and misappropriation of trade secrets were also dismissed, with the court finding it lacked jurisdiction to adjudicate the remaining counts. NABP appealed the matter to the 11th Circuit Court of Appeals.

On appeal, NABP ar-gued that sovereign immu-nity does not bar its claims for damages and injunctive relief. NABP argued that Congress, through the enactment of the CRCA,

abrogated state sovereign immunity, meaning that state entities were subject to federal court jurisdiction regarding rights pursued by copyright owners.

As summarized by the Court of Appeals, “sover-eign immunity is no bar to a claim for damages when Congress validly abrogates the States’ sovereign immu-nity through legislation.” Congress may abrogate the states’ sovereign immunity when it:1. unequivocally expresses

its intent to abrogate the immunity through a clear legislative state-ment; and

2. acts pursuant to a valid exercise of constitution-al power. As stated by the court,

Congress unequivocally ex-pressed its intent to abrogate the states’ sovereign immu-nity. Having determined this congressional intent, the court turned its attention to whether the CRCA was en-acted pursuant to a consti-tutional provision granting Congress the power to ab-rogate. The court addressed this issue reviewing Article 1 of the US Constitution as well as the Fourteenth Amendment. The court also examined whether NABP was afforded due process where its “private property is allegedly expropriated by a state or legal entity of the state.” Under both theories, the court held in favor of the University System of Georgia finding that neither provision supported NABP’s arguments.

Accordingly, the court of appeals held that the

University System of Geor-gia was entitled to Eleventh Amendment immunity and that the federal courts lacked subject matter ju-risdiction to adjudicate the copyright claims for dam-ages against the University System of Georgia. The appellate court did find that the federal courts main-tained jurisdiction over the University System of Geor-gia for prospective injunc-tive relief, which NABP is seeking in order to pro-hibit future use of protected materials. NABP filed a petition for rehearing en banc requesting that the full panel of judges consider its appeal of the motion to dis-miss. The professors remain in the federal court litiga-tion related to injunctive relief and damages as they are sued in their individual capacities. The state court litigation remains pending and will adjudicate alleged contractual breaches based upon the 1995 settlement agreement.

The immunity nuances play a significant role in this very complex case. If, ultimately, it is decided that NABP or other testing organizations are without federal recourse to pursue alleged copyright infringe-ment damages against a state entity under fed-eral law, then an unequal standard is established for litigating copyright infringement matters in-volving private and public universities as defendants.

Of course, exam breach-es are not unique to phar-macy. Several other profes-sions have been the subject

Legal Briefs

Legal Briefs(continued from page 117)

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of recent exam compromise issues resulting in a variety of actions and reactions.

Federation of State Boards of Physical Therapy

The following is an excerpt from the Federation of State Boards of Physical Therapy (FSBPT) FSBPT New Brief July 2010:

FSBPT suspends NPTE examination for all graduates of certain overseas programs. In response to perva-sive, ongoing security breaches by significant numbers of graduates of physical therapy schools from certain foreign countries, the Fed-eration of State Boards of Physical Therapy (FSBPT or Federation) has temporarily sus-pended National Physi-cal Therapy Examina-tion (NPTE) testing for all graduates of schools located in those countries, pending the development of a sepa-rate, secure exam for those graduates (to be called the NPTE-YRLY). The new policy applies only to graduates of physical therapy schools in Egypt, India, Paki-stan and the Philippines, and is applied based upon the location of the applicant’s first/primary physical therapy pro-gram, not the applicant’s country of origin or citizenship.Like NABP, FSBPT is a

not-for-profit association whose membership consists

of the regulatory boards of physical therapy. FSBPT provides programs and services to its member boards, including the de-velopment, administration, scoring, and maintenance of a uniform licensure ex-amination. Based upon the security breaches, FSBPT developed an alterna-tive examination for such candidates. Such alternative exam was to be launched for use in May 2011. Thus, candidates from these identified countries were required to wait to sit for the licensure exam.

Certain impacted candi-dates filed suit in Superior Court of Fulton County Georgia seeking a declara-tory judgment finding that the exam policy was un-enforceable and injunctive relief allowing such candi-dates to sit for the NPTE, rather than the to be devel-oped NPTE-YRLY exam. The defendants in the case were both the FSBPT as well as the Georgia State Board of Physical Therapy. The Georgia State Board adopted the FSBPT decision to utilize the NPTE-YRLY.

In a very short opinion entered February 9, 2011, the superior court judge entered judgment in favor of the candidates finding that the adoption of the FSBPT decision constitut-ed the promulgation of a rule without following the procedural requirements of the Georgia Adminis-trative Procedures Act. In addition, the court held that this “testing prohibi-tion” policy exceeded the Georgia State Board’s stat-

utory authority because it resulted in the “imposi-tion of non-uniform exam requirements on otherwise qualified candidates based solely on the country in which they received their physical therapy training.” Finally, the court noted that the Georgia State Board “violated its affir-mative duty under law to individually determine the competence and qualifica-tions of each prospective physical therapy candi-date by delegating to the [FSBPT] the decision as to who is eligible to take the NPTE in Georgia.” This opinion applies only to the state of Georgia.

National Board of Examiners of Optometry

Below is an excerpt from a May 5, 2010 press release issued by the National Board of Examiners in Optometry (NBEO).

NATIONAL BOARD OF EXAMINERS IN OPTOMETRY PLACES HOLD ON PART I SCORESThe Board of Directors of the National Board of Examiners in Optom-etry (NBEO) has placed a hold on the release of Part I scores. This release was scheduled for May 5, 2010. The National Board is postponing the release of scores pend-ing an investigation into evidence of possible cheating by a signifi-cant number of exam candidates. Scores will

not be released until the investigation has been completed. This exami-nation was administered to optometry candidates at 18 different sites across the US and Canada on March 16-17, 2010. The NBEO’s investigation into that exam admin-istration is focusing on three primary concerns. The Board is investigating the possibility that some candidates may have had improper access to confidential exam items before the examination. In addition, the Board is investigating whether candidates taking the examination engaged in an organized attempt to memorize exam content in order to reproduce it for use by other students taking future administra-tions. The Board also is investigating the pos-sible involvement in such activities of at least one faculty member.Such unethical conduct, if it occurred, would constitute cheating and would be a violation of NBEO examination poli-cies and rules binding on examination candidates. Those NBEO policies and rules were established to protect the security, integrity, and credibility of the examination.

American Board of Internal Medicine

Below is an excerpt from a June 9, 2010 press release issued by the American Board of Internal Medicine (ABIM). ABIM is an entity

Legal Briefs

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which provides specialty certification to physicians.

ABIM Sanctions Physi-cians for Ethical ViolationsUnprecedented action reflects ongoing com-mitment to protect the integrity of the medi-cal board certification process Philadelphia, PA, June 9, 2010 – The American Board of In-ternal Medicine (ABIM) took formal action today to sanction 139 physi-cians for soliciting or sharing confidential examination questions used to certify doctors in internal medicine and its subspecialties. ABIM has also initiated legal ac-tion in the U.S. District Court for the Eastern District of Pennsylvania last week against five physicians who were among the most egre-gious offenders. The sanctioned physi-cians participated in Arora Board Review, an independent, New Jersey-based test-preparation course that purported to help physi-cians prepare for board certification exams. Par-ticipants in the course were encouraged to relay questions from memory to the company imme-diately after they took an ABIM examination. They were also provided with questions obtained by other physicians who had completed ABIM examinations.


Through an extensive investigation, ABIM established that the phy-sicians being sanctioned shared or solicited actual ABIM exami-nation questions – a significant breach in the professional standards ABIM requires of all of its board-certified physi-cians and any physician taking the exam for cer-tification. Hundreds of questions were compro-mised and immediately removed from the ABIM exam question pool. Each physician who signs up for an ABIM examination is directed, in writing, not to dis-cuss exam content. In addition, before each test, physicians sign a ‘pledge of honesty’ to not disclose, copy, or re-produce any portion of the material contained in the examination and are warned that ABIM will impose severe penalties on any physi-cian involved in efforts to provide examination question content to others.As a follow up, below is

an excerpt from a June 17, 2010 press release issued by ABIM.

ABIM Reaches a Settlement With Arora Board ReviewPermanent Injunc-tion is Issued Against Course and Course OperatorPhiladelphia, PA, June 17, 2010 – On June 10th, the American Board of Internal Medicine

(ABIM) reached a settlement with Arora Board Review and Rajender Arora, MD, owner and operator of Arora Board Review. Under the terms of the settlement agreement:

• Dr. Arora is not Board Certified.

• Arora Board Review and Dr. Arora are permanently enjoined from copying, distrib-uting or selling any materials that incor-porate the content of ABIM Examinations.

• Arora Board Review and Dr. Arora are permanently enjoined from collecting, solic-iting or encouraging others to collect ABIM Examination content.

• Arora Board Review may not offer a live test-prep course at any time in the future.

• Arora Board Review is paying damages to ABIM.

The permanent injunc-tion was signed by Judge Curtis Joyner of the US District Court of Penn-sylvania on Thursday, June 10 and orders that Arora Board Review is permanently enjoined from “creating, reproduc-ing copying, distributing, offering for sale, selling and/or publicly displaying any materials of any kind and in any medium that infringe ABIM’s copy-rights in its Certifying Examinations.” The in-junction also ordered that Arora is prohibited from “collecting, soliciting or encouraging third parties

to collect and/or share the content of ABIM Exami-nations.”“We are pleased that our efforts to protect the integrity of our examina-tions have been success-ful,” added Christine Cassel, President and CEO of the American Board of Internal Medi-cine. “While the damages we have received can not begin to cover the costs of replacing the questions compromised by Arora Board Review, they send an important message that we will do what it takes to protect the ex-amination process.”

But Wait, There’s More. . .

In addition to the afore-mentioned press releases and newsletter stories, the following are several titles and short synopses of ar-ticles recently in the news.

“FBI Test Scandal Explodes: Investiga-tion Finds Widespread Cheating on Domestic Spying Exam,” by Dan Froomkin, The Huff-ington Post, September 27, 2010 (Widespread cheating on an exam in-tended to test agents on domestic intelligence-gathering guidelines.)

“Security Breach Compromises ISTEP Exam,” The Indy Channel, March 7, 2011 (Security breach – test coordinator leaked question to Facebook teachers group – of the Indiana Statewide

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Association News


Annual Report of Counsel on Association Legal Affairs(Editor’s Note: This

report was released at the NABP 107th Annual Meeting, held May 21-24, 2011.)

As NABP continues to expand its services in sup-port of its member boards of pharmacy, the Legal Affairs Department increasingly interacts with board staff and third parties to further develop new and existing NABP programs that assist the boards in protecting public health.

In the first quarter of 2011, NABP and the NABP Foundation launched several major initiatives with support from the Legal Affairs Department. For instance, the NABP PMP InterConnect™ is a system that will make controlled substance dispensing infor-mation available to partici-pating states. Legal Affairs has worked closely with board of pharmacy staff in three states to success-fully negotiate agreements for their participation in NABP InterConnect, and the department continues its negotiations with other interested states. Moreover, the NABP Foundation updated and re-released the AWARErx.org Web site to provide consumers, phar-macists, and boards with information and resources regarding prescription drug misuse and medication safety in a dynamic and ac-cessible format. Department staff coordinated legal com-munications with AWARxE partners and the United States Patent and Trademark Office to further strengthen

the program and its promi-nent trademarks.

Contracts and intel-lectual property activities, from copyrights to trade-marks, remain key respon-sibilities of the Legal Affairs Department. In 2010, the department negotiated or reviewed scores of contracts executed with the boards of pharmacy for examination, inspection, and newslet-ter services; accreditation agreements; and vendor service agreements that help improve programs and services provided to NABP member boards of pharma-cy. Additionally, Legal Af-fairs successfully halted two Web sites and several users of social media that were misusing NABP trademarks.

Litigation Matters

GeorgiaIn August 2007, NABP

filed a lawsuit in federal court against the Board of Regents of the University System of Georgia and af-filiated individuals (Board), alleging copyright infringe-ment related to the North American Pharmacist Licensure Examination® (NAPLEX®) and Multistate Pharmacy Jurisprudence Examination® (MPJE®). NABP filed a second lawsuit against the Board, in state court, alleging breach of a 1995 contract. Both lawsuits are based upon allegations that the Board transcribed and used copy-righted NABP examination questions without autho-rization, which the Board

agreed to refrain from doing pursuant to the 1995 contract. NABP maintains that the integrity of the NAPLEX and MPJE were compromised and, accord-ingly, seeks damages for its injuries.

NABP appealed an April 2008 decision of the United States District Court for the Middle District of Georgia, which dismissed the copyright infringement claims against the Board of Regents of the Univer-sity System of Georgia, on the basis that the federal District Court lacked ju-risdiction over the Board, which is a state entity. In February 2011, the United States Court of Appeals for the 11th Circuit issued its opinion, which reversed the District Court deci-sion, in part, by reinstating the Board of Regents of the University System of Georgia as a defendant for purposes of the injunction that NABP seeks in the copyright infringement ac-tion. However, the Court of Appeals affirmed the deci-sion of the District Court, which dismissed the Board of Regents of the University System of Georgia as a de-fendant in the NABP claim for monetary damages resulting from the alleged copyright infringement. On March 17, 2011, NABP filed a motion for reconsideration en banc, requesting that the Appellate Court reconsider its decision and reinstate the Board of Regents as a defendant in the lawsuit related to the NABP copy-

right infringement claim for damages.

The state breach of con-tract case is in the discovery phase, but it is on hold while the parties await the Appel-late Court decision on the motion for reconsideration en banc. Flynn Warren, for-mer professor and assistant dean of the University of Georgia College of Phar-macy, remains a defendant in the state and federal lawsuits.

MichiganNABP was pleased to

learn that on April 13, 2011, the United States District Court for the East-ern District of Michigan granted NABP’s motion for summary judgment, dismissing all claims filed against the Association and Executive Director/Secretary Carmen Cati-zone by an individual who sat for the NAPLEX. The case involved a candidate for licensure in Michigan whose NAPLEX score NABP invalidated.

In its opinion, the Court stated that under Michigan law, NABP and Catizone enjoy immu-nity from civil suit for the licensure examina-tion activities performed in good faith on behalf of the Michigan Board of Pharmacy. On the immu-nity basis alone, the Court entered summary judg-ment in favor of NABP and Catizone. The Court fur-ther stated that there was no evidence that NABP or

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Testing for Educational Progress-Plus prompts the Indiana Department of Education to launch statewide investigation.)

“Alleged SAT exam breach probed,” by John Hildebrand, News Day, March 14, 2011 (National administrators investigate alleged breach of testing security in Great Neck, NY.)

“Japanese police start probe into exam breach,” The Yomiuri Shimbun, February 3, 2011 (In-vestigation into Kyoto

University entrance exam questions leaked to the In-ternet, possible criminal offense; education minis-ter asks for cell phone ban at test sites.)

“High number of erasure marks shadow soar-ing test scores in D.C. schools,” by Erica Green, The Baltimore Sun, March 28, 2011(USA Today investiga-tion finds the number of answers changed from wrong to right on standardized tests was too high; questions possible testing improprieties.)

“Magic ‘improved’ schools just happen to

have a lot of eraser marks on their tests,” by Jack Stuef, Wonkette, March 28, 2011 (USA Today inves-tigation finds consistent pattern of wrong answers erased and changed to right ones.)

“Civil Service says no police-exam breach; tip termed ‘total fabrica-tion,’” by Jeb Phillips, The Columbus Dispatch, June 30, 2010 (Civil Service Commission investigation found no evidence of a security breach on promotion exams given to police of-ficers; anonymous letter that sparked investiga-tion was a fraud.)

Some may question the moral fiber of our society as il-lustrated by a number of these and other scandals that almost appear to be an every day oc-currence. Others may applaud the discovery and publication of these events as the advent of a new day whereby cheating scandals are deemed news-worthy and merit front page coverage. Regardless, NABP and its sister organizations must continue to be diligent in their efforts to maintain the legal defensibility and security of each respective examination program. Member regulatory boards must also understand and actively participate in this process to ensure reliance is appropriate in the licensure process.

Legal Affairs(continued from page 121)

Legal Briefs

Catizone engaged in con-duct that was outrageous or extreme, so plaintiff’s claim of intentional inflic-tion of emotional distress could not be sustained. In addition, the Court stated that the NAPLEX contract between NABP and the Michigan Board of Pharmacy was primarily for the benefit of the two parties, and the plaintiff could not show that he was a party to, nor a third party beneficiary of, the contract. Finally, the Court declared that NABP and Catizone were entitled to summary judgment on the plaintiff’s defamation

claim because the state-ments of the Association and Catizone concerning the invalidation of the plaintiff’s NAPLEX score were not false when they were made, they were privileged, and the plaintiff could not show that the statements were made with actual malice.

The plaintiff has 30 days to file a notice of appeal with the United States Court of Appeals for the Sixth Circuit.

In March 2009, the plain-tiff in the case filed a lawsuit against NABP and Catizone alleging that the Association and Catizone engaged in defamatory conduct, breach of contract, negligence, and intentional infliction of emotional distress when they reported the invalidation of

the plaintiff’s June 2007 NAPLEX score to NABP member boards. Following completion of discovery, NABP and Catizone filed a motion for summary judgment in October 2010 requesting that the Court dismiss all claims against the Association and Catizone.

The examination issues in both lawsuits are of critical importance to the Associa-tion. NABP will continue to tenaciously pursue all legal channels to fulfill its unwav-ering commitment to protect the integrity and security of the NAPLEX and MPJE.

ConclusionThe Legal Affairs Depart-

ment continues to engage in a wide range of legal

activities in support of the Association mis-sion to assist member boards of pharmacy in safeguarding the public health. From wholesale drug facility inspection services to promoting excellence and integrity in its educational pro-grams, NABP strives to provide needed services that exceed expectations and alleviate the burdens of its member boards. The strong, enduring partnership between NABP and the boards of pharmacy is essential to continue advancing patient protections and regulating health in the best interest of the public.

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Association News

NABP Government Affairs Department Supports Vermont Board’s Efforts to Increase Operations Efficiency

As part of an ongoing effort to support boards of pharmacy with customized services, the NABP Govern-ment Affairs Department recently completed an assessment of operations for the Vermont Board of Pharmacy.

To assist the Vermont Board in the development and implementation of operations improvements, Government Affairs staff assessed and made recom-mendations in three areas:

• First, staff assessed the Board’s operations and procedures and made several recommenda-tions aimed to increase efficiency.

• Second, staff recom-mended existing NABP programs and services that would address cer-tain identified needs.

• Finally, recommenda-tions related to staffing were provided with the goal of facilitating ef-ficiency and decreasing the workload demands on the board of phar-macy members.

Operations Assessment

NABP Government Af-fairs staff met with senior staff in the Vermont Office of Professional Regulation (OPR) and with members of the Vermont Board of Pharmacy to understand and assess the operations procedures, including which functions are currently handled by OPR staff and

which are handled by Board members. Government Affairs staff focused on the areas of licensing, discipline/compliance, and policy in conducting the assessment.

As a result of the opera-tions assessment, Govern-ment Affairs staff made recommendations to the Vermont OPR and Board for streamlining certain functions, including advis-ing which functions could be performed by OPR staff rather than Board members, and providing suggestions for increasing the efficiency of certain permit processes.

Staff also made addition-al recommendations aimed to free Board members from certain routine operational responsibilities usually handled by Board staff, such as handling routine cor-respondence that may need pharmacy expertise. Such changes would allow Board members to spend more of their time commitment on strategic goals identified to improve the practice of pharmacy or address needed areas of regulation. Other suggestions included, post-ing a list of frequently asked questions on the Board’s Web site, and developing guidance documents re-garding the implementation of state statute and regula-tions to reduce the need for Board member responses to inquiries from licensees, registrants, and others. Another recommendation was that the Board explore the feasibility of adopting

an alternative program to traditional disciplinary action for pharmacists who are identified as possibly impaired due to drug or al-cohol abuse. Such programs can reduce the disciplinary and compliance workload for the Board. Such pro-grams also help ensure safe practice by monitoring the recovery of pharmacists allowed to return to practice and their compliance with terms and conditions estab-lished by the Board.

Government Affairs staff also recommended that the Board create the position of executive director and outlined the contributions this role makes to boards of pharmacy. After consider-ing NABP’s assessment, the Board decided to move forward with identifying a contractor to serve in the role of executive director on a part-time basis.

Support with NABP Services

Government Affairs staff also advised the Board that several existing NABP services may support the process of streamlining operations as well as provide additional regulatory sup-port.

As it developed a plan to streamline operations, the Board was encouraged to consider the following cus-tomizable NABP services:

•Customized classroom or field training to sup-port Board staff in a va-riety of capacities

• Assessments of inspection forms to provide process improvements and rec-ommended revisions

• Customized inspection services (available as a fee-based program) The Board was also

reminded to consider how legislation that recognizes or requires certain NABP accreditation programs sup-ports the regulatory functions of the Board. For example, some states either require or recognize VAWD® accredita-tion for wholesale distributors as meeting state requirements for licensure.

As result, the Vermont Board requested that NABP Government Affairs assist in an evaluation of its inspection processes and assist with the development of inspection processes for institutional pharmacies.

Government Affairs Services

As a member benefit, NABP Government Affairs offers customizable training and education, as well as op-erations and inspection pro-cesses assessments to boards of pharmacy. In addition, customized inspection ser-vices, available as a fee-based service, can support boards so that members and staff can focus on other compliance and regulatory matters.

For inquiries about the support and services offered by NABP Government Affairs, please send an e-mail to [email protected].

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Feature News

elements can be made readily available by the pharmacy, members recommended that the elements to be required on a prescription should in-clude full patient name, drug name, strength, quantity prescribed, directions for use, and practitioner name. Members recommended adding language specifying that “the address and date of birth of the patient and the address and registration number of the practitioner are not necessary on the face of the prescription if made readily available by the pharmacy and attached to the electronic record of the prescription.” Further, mem-bers recommended amend-ing the language to indicate that a pharmacist may add or change the following ele-ments: drug strength, drug quantity, directions for use, or issue date after consulting with prescriber. Since it is recommended that medical record orders be included in the definition of prescrip-tions, members advised amending the manner of issuance section to also indicate the requirements for medical record orders and to include language specify-ing that a medical record order without a discernable quantity will be limited to a seven-day supply.

Dispensing of Prescriptions

Regarding the dispensing of prescriptions, members agreed that there should be a uniform time limit for the validity of all controlled

substances prescriptions. Members recommended that the CSA be amended to allow a six-month time limit for the validity of Schedule II and Schedule V prescrip-tions to be consistent with Schedule III and Schedule IV prescriptions. In addition, it was recommended to re-move the “unable to supply” provision relating to partial-ly filling prescriptions, and to increase the time limit for the partial filling of prescrip-tions from 72 hours to 30 days. The latter changes are intended to address patient care issues such as expense, tolerability to a drug, and patient choice.

Prescription Labels and Electronic Storage

With the aim of keeping prescription label content patient-focused, two changes to provisions regarding labeling were recom-mended. First, members recommended removing the requirement that the well-known warning statement prohibiting patients from giving controlled substances to others be affixed to the prescription label or revising the warning to state “It is unlawful to share this medi-cation.” Second, members recommended removing the requirement that central fill pharmacy identification information be included on the label.

The task force also made several recommendations regarding storage of records. Many of these suggested amendments are made in light of current technology, which can securely store

records electronically. With current technology capa-bilities in mind, it was also recommended to remove the requirement that transfers of Schedule III, IV, and V pre-scriptions must be made by pharmacists if the pharma-cies share a real-time, online database.

Call for CommentaryA few recommendations

called for NABP to issue commentary to DEA as appropriate, or for encour-aging other stakeholders to submit commentary to DEA. For example, DEA is currently developing regulations to implement the Secure and Responsible Drug Disposal Act signed into law on October 12, 2010. At the recommenda-tion of the CSA Task Force, NABP will comment as appropriate on the DEA Notice of Rulemaking upon its publication. Task force members also recommend-ed that industry stake-holders be encouraged to comment upon the need for streamlining the Automa-tion of Reports and Con-solidated Orders System (ARCOS) database.

Other task force rec-ommendations addressed modernizing the language of the CSA.

Task force members included Jack “Jay” Camp-bell, RPh, JD, chairperson; Ross Brickley, RPh, MBA, CGP; Patricia “Trish” D’Antonio, RPh, MS, MBA, CGP; Kristi R. Dover, Phar-mD; Danna Droz, RPh, JD; Virginia “Giny” Herold, MS; Suzan Kedron, JD; Susan Ksiazek, RPh; Law-

rence “Larry” Mokhiber, MS, RPh; Suzanne Neuber, RPh; Jeanne Waggener, RPh; and Brenda Warren, DPH. Lloyd K. Jessen, RPh, JD, and Cathryn J. Lew, RPh served as Executive Committee li aisons.

The following guest participants were pres-ent to advise the task force on the first day of the meeting: Daniel Bellingham, Healthcare Distribution Manage-ment Association; Kevin Nicholson, RPh, JD, National Association of Chain Drug Stores; Su-san Janeczko, PharmD, National Community Pharmacists Association; Charles Thomas, RPh, FAPhA, National Associ-ation of State Controlled Substances Authorities; Rebecca Snead, RPh, Na-tional Alliance of State Pharmacy Associations; and Kelly C. Alfred, MS, Federation of State Medi-cal Boards.

In addition, the fol-lowing individuals were appointed to serve on each subgroup.

Community phar-macy subgroup members included W. Benjamin Fry, RPh, FIACP, FACA, chairperson; Donald Casar, RPh; Lenna Israbian-Jamgochian, PharmD; Heather Pasquale, RPh; William Prather, RPh; Joanne Trifone, RPh; and Den-nis Wiesner, RPh. James T. DeVita, RPh, served as Executive Committee liaison.

Members of the hos-pital pharmacy subgroup


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Association News

NABP Clearinghouse Sees More Than 100% Increase in Disciplinary Actions Reported by Boards of Pharmacy During First Quarter

Reporting trends con-tinue to ref lect consistent efforts by boards of phar-macy to report disciplin-ary actions to the NABP Clearinghouse. During first quarter 2011, a total of 1,584 actions were reported to the NABP Clearinghouse, with 990, or 62.5%, of these taken against pharmacists and the remaining 594, or 37.5%, taken against phar-macy technicians. This is an increase of 117.3% when compared to 729 ac-tions reported during the same time period in 2010.

Of the 1,584 actions, probation of license ac-counted for nearly a quar-ter of the actions recorded with 367, or 23.2%. Revocation of license was

the second most reported with 228, or 14.4%, of the actions reported. At 205, or 12.9%, suspension of license was the third most common action reported to the Clearinghouse. (See the accompanying pie chart for a full breakdown of the actions taking dur-ing first quarter 2011.)

Additionally, data indicates that of all the actions taken during this time, 18.7% were taken due to violation of federal or state statutes, regula-tions, or rules. Another 16.2% of the actions reported were taken on the basis of narcotics violations. Consisting of several smaller catego-ries, the miscellaneous category held the highest

percentage overall with 23.3%. Error in pre-scribing, dispensing, or administering medication as a basis of action experi-enced one of the larger de-creases in reporting, with 4.7% in first quarter 2011 compared to 11.1% during first quarter 2010.

Housing a tremendous amount of disciplinary data provided by the state boards of pharmacy and tracking everything from the actions taken to the basis for the actions, the NABP Clearinghouse is constantly updated to serve as a comprehensive resource for the boards. As an added benefit to the boards of pharmacy, NABP offers its services as a reporting agent for

the Healthcare Integrity and Protection Data Bank (HIPDB). Currently, 30 boards of pharmacy have designated NABP as their official reporting agent, and NABP is in discus-sion with other boards to provide this service in the near future. The Associa-tion continues to encour-age the boards to utilize this reporting service as it may assist in freeing board resources for other impor-tant issues.

More information on reporting to the NABP Clearinghouse, as well as designating NABP as a re-porting agent for HIPDB, is available on the NABP Web site at www.nabp.net/programs/member-services/nabp-clearinghouse.

Disciplinary Actions Reported First Quarter 2011

*The Miscellaneous category includes Denial of Initial License, Denial of License Renewal, Extension of Previous Actions, License Restoration or Reinstatement Denied, Limitation or Restriction on License, Other Licensure Actions - Not Classified, and Reduction of Previous Action.

23.2%

14.4%

2.1%

12.6%

9.7%

9.2%

8.3%

7.5% Probation of License (23.2%)

Revocation of License (14.4%)

Suspension of License (12.9%)

License Restored or Reinstated, Complete &Conditional (12.6%)

Miscellaneous* (9.7%)

Voluntary Surrender of License (9.2%)

Administrative Fine/Monetary Penalty (8.3%)

Reprimand or Censure (7.5%)

Summary or Emergency Suspension of License(2.1%)12.9%

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Association News

Are You AWARXE?Internet Drug Outlets Fuel Prescription Drug Misuse

GreyGrey: Black Process 70% Black: Process 100K

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81% of the nearly 8,000 Internet sites reviewed by NABP do not require a valid prescription, and such sites continue to fuel drug misuse and abuse. Over 7 million Americans use prescription drugs non-medically.FACT:

AWARXE Educates Seniors on Internet Drug Outlet Dangers and Medication Safety NABP staff helped raise AWARxEness about prescription drug safety issues among attendees to the Active Senior Expo in Orland Park, IL on May 4, 2011. Hundreds of seniors stopped by the AWARxETM booth where staff shared information about the dangers of rogue Internet drug outlets and prescription drug misuse. Staff also shared medication safety information and provided attendees with AWARxE pill boxes. Several AWARxE facts were high-lighted for attendees:

•NABP has reviewed nearly 8,000 Web sites selling prescription drugs.

•Only 4%, or 300, of these sites appear to be in compliance with state and federal laws and NABP patient safety and pharmacy practice standards.

•Of the sites reviewed, 96% are considered rogue Internet drug outlets.

Seniors attending the Active Senior Expo were encouraged to visit the AWARxE Web site for additional informa-tion and were provided with resources for safely obtaining medications through prescription drug discount pro-grams. By being aware of medication safety issues, and the importance of participating in DEA Drug Take-Back Days and other misuse and abuse prevention efforts, seniors can protect themselves and their families.

Boards of pharmacy that wish to place the AWARXE logo on their Web site, hyperlinked to www .AWARErx.org, may obtain information by sending an e-mail to [email protected]. Boards may also contact AWARxE via e-mail to share news about local AWARxE-related events.

GET INFORMED | www.AWARErx.org

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Association News

Global Threat of Counterfeit Drugs Gain Exposure; NABP Quarterly Progress Report Highlights Actions Taken

Counterfeit drugs continue to threaten the public health and safety as thousands of rogue Internet drug outlets continue to operate unhindered. These counterfeit drugs harm patients with inaccurate dose levels, contaminated, or toxic substances, and deprive patients of life-saving medications, allowing disease to spread, especially in developing countries where the incidence of counterfeit drugs is considerably higher than in the developed countries of the world. Contributing to the distribution of counterfeit drugs is the ease of access to these products over the Internet making them available to almost anyone virtually anywhere in the world.

Over the past year, awareness of rogue Internet drug outlets among the public and private sectors has considerably increased as evidenced by frequent media coverage and studies highlighting the issue. In March 2011, government officials and other security experts shared information on the growing threat of counterfeit drugs in a CBS 60 Minutes segment. During the segment, Food and Drug Administration (FDA) discussed the regulatory challenges involved in securing the increasingly globalized drug supply chain, as many pharmaceuticals in the legitimate United States drug supply chain

are manufactured overseas. Complicating the issue, many rogue Internet drug outlets obtain their drugs from unknown sources and the drugs change hands frequently along the way.

In addition, Immigration and Customs Enforcement illustrated for viewers the deceptive appearance of rogue Internet drug sites and stressed the safety issues with drugs ordered through such sites, advising consumers to purchase medications through an NABP VIPPS® (Verified Internet Pharmacy Practice SitesCM)-accredited online pharmacy.

Also taking action are US federal agencies who have expressed their commitment to curb prescription drug counterfeiting at home and abroad. The “Counterfeit Pharmaceutical Inter-agency Working Group Report” was prepared by various agencies to note that counterfeit pharmaceuticals are not just an issue in the US, but are also a global health problem. The report cites various counterfeit drug cases of concern, including a case in which anti-anxiety drugs were sold to US consumers over the Internet and were found to contain pentobarbital, a drug used for sedation before administering lethal injections to animals. The authors also describe a case in which counterfeits of a US company’s pneumonia vaccine distributed in El Salvador were found to

be missing the essential ingredient and another case in which counterfeits of two cancer drugs trademarked by a US company were illegally manufactured in China and Indonesia and were found to lack the active ingredient for the treatment of cancer.

NABP, too, has participated in efforts to fight counterfeit drugs. In April 2011, NABP hosted a meeting with the members of the Center for Safe Internet Pharmacies (CSIP), a nonprofit organization that was established to educate the public and take voluntary enforcement action against illegal Internet drug sellers. Founding members of CSIP include 11 major American Internet commerce companies that joined with the office of the Intellectual Property Enforcement Coordinator. These well-known companies include American Express, eNom, GoDaddy, Google, MasterCard, Microsoft, Network Solutions, Neustar, PayPal, Visa, and Yahoo!

Through communication and cooperation, NABP hopes to advance the efforts of regulators and other entities seeking to curtail the online trade of illicit and counterfeit drugs. In its ongoing review of Web sites selling prescription medications, NABP continues to work with the state boards of pharmacy, federal regulators, and patient advocates to educate the public on the

potential dangers of buying medications from unknown and unapproved sources over the Internet.

As of June 24, 2011, NABP has assessed 8,353 Internet drug outlets selling prescription medications and has found 8,034 (96.18%) of them to be out of compliance with state and federal pharmacy laws and practice standards. These sites are listed as Not Recommended in the “Buying Medicine Online” section, under Consumers, on the NABP Web site. Of these Not Recommended sites:

• 6,812 do not require a valid prescription

• 3,686 offer foreign or non-FDA-approved drugs

• 2,101 are located outside of the US and selling drugs illegally to patients in the US Of the total 8,353 sites

reviewed, 260 (3.11%) appear to be potentially legitimate in that they meet program criteria, based on information obtained by looking at the sites. Fifty-nine (0.71%) sites have been accredited through NABP’s VIPPS or Vet-VIPPS® programs, or approved through the NABP e-Advertiser ApprovalCM Program.

More information about the Internet Drug Outlet Identification Program is available in the quarterly progress report available on the NABP Web site at www .nabp.net/news.

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Association News

PCOA Administration Continues to Demonstrate Students’ Progression of Knowledge through Program Years

After four annual administrations, the Pharmacy Curriculum Outcomes Assessment® (PCOA®) continues to display consistent data representing the progres-sion of pharmacy students’ knowledge of pharmacy curriculum during the professional years (see fig-ure below). Measurement of students’ pharmacy knowledge as they advance through these years is evidenced in the overall data and trends gathered from the four consecutive PCOA administrations.

Each administration supported an expected outcome of improved performance as measured by comparative studies between program years.

Among repeat test takers, the changes in individual total scaled scores contin-ues to show a significant increase averaging 26 points between consecu-tive years and averaging 41 points across three administration years.

Overall, the results and trends garnered over the four years directly parallel the mission of the PCOA as an objective uniform tool for assisting schools and colleges of pharmacy with curriculum review and student performance assessment. NABP and key stakeholders original-ly developed the assess-ment in response to the need expressed by some of the United States schools and colleges of pharmacy,

the Accreditation Council for Pharmacy Education, and the US Department of Education for assistance with assessing curricu-lum and measurement of student performance and growth.

Schools and colleges of pharmacy may customize which program year(s) the PCOA is administered to, giving the schools more control of the type of data they obtain from the as-sessment. Some schools choose to have students take the PCOA all four years, while other schools find it more beneficial to administer the assess-ment to students only once during their years at the school. Still others choose the option of administer-

ing the PCOA to program year 1 and 3 students, or some other multiyear combination.

More than 10,000 students from 40 schools and colleges of pharmacy, representing nearly one-third of the schools and colleges of pharmacy in the US, have participated in the PCOA since it was first administered in April 2008. Each school is provided score reports with infor-mation on student perfor-mance. In addition, these reports allow the schools and colleges to track indi-vidual scores from year to year and document ad-vancement and progression over time in their program. Along with providing a comparison to national samples, the assessment imparts score data that may be used by the schools and colleges of pharmacy in research and correla-tional studies with existing assessment results such as Pharmacy College Admis-sion Test scores, academic proficiency, and future North American Pharma-cist Licensure Examina-tion® scores. Additional information on the PCOA is available on the NABP Web site at www.nabp.net/programs/assessment/pcoa.

Information about the 2012 PCOA administration will be sent to schools and colleges of pharmacy in August.

PCOA Mean Scores by Program Year

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100

200

300

400

500

600

700

2008 2009 2010 2011

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Association News

Foreign Pharmacy Graduate FPGEE and NAPLEX Pass Rate Trends

Pass rates for For-eign Pharmacy Graduate Equivalency Examination® (FPGEE®) candidates have fluctuated slightly, as have pass rates for North Ameri-can Pharmacist Licensure Examination® (NAPLEX®) candidates who are For-eign Pharmacy Graduate Examination Committee™ (FPGEC®) certified.

FPGEE and NAPLEXThe FPGEE is developed

to assess foreign pharmacy graduates’ knowledge of the content domains as described in Appendix B of the Accreditation Coun-cil for Pharmacy Educa-tion (ACPE) Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree. The exam tests candidates’ knowledge in four content areas: basic biomedical sciences; pharmaceutical sciences; social, behavioral, administrative pharmacy sciences; and clinical sci-ences. A pharmacist whose undergraduate pharmacy degree was conferred by a non-ACPE accredited pharmacy school, must pass the FPGEE as part of the Foreign Pharmacy Gradu-ate Examination Commit-tee™ (FPGEC®) Certifica-tion process.

Pharmacists who suc-cessfully pass the FPGEE and complete the FPGEC Certification process may apply for licensure with a

board of pharmacy in the US. Like all US educated pharmacists, graduates of foreign pharmacy schools with FPGEC Certification must pass the NAPLEX as one component of the li-censure process used by the boards of pharmacy.

The NAPLEX assesses a candidate’s compe-tence, knowledge, skills, and abilities to practice pharmacy in the US. The NAPLEX assesses whether a prospective pharmacist demonstrates sufficient knowledge to:

• Identify and assess prac-tice standards for safe and effective pharma-cotherapy and optimize therapeutic outcomes in patients

• Identify, assess, and determine safe and accu-rate methods to prepare and dispense medica-tions

• Provide and apply health care information to promote optimal health care.

FPGEE and NAPLEX Pass Rates of Graduates of Foreign Pharmacy Schools

The FPGEE pass rates for first-time test-takers have fluctuated slightly, ranging from 70.4% to 75%, over the three-year period from 2008 to 2010, with two small peaks in pass rates occurring in fall 2009 and fall 2010. In

fall 2009, the first-time pass rate was 74%, a 2.3% increase from the prior ad-ministration. The first-time pass rate then fell 3.8% to 70.2% in the spring 2010 administration. The next administration had a 4.8% increase in the pass rate for first-time test-takers, reaching 75%, the highest pass rate over the three-year period.

Overall FPGEE pass rates, which include repeat test-takers, are on average lower than the pass rates of first-time test-takers. The overall FPGEE pass rates fluctuated a bit more in the same three-year period with pass rates ranging from 49.4% to 57.3%. Two peaks in FPGEE overall pass rates, fell in fall 2009 and fall 2010, corresponding with the two peaks in first-time test-taker pass rates.

In comparison, while FPGEE pass rates show very slight dips and two small peaks over the three-year period from 2008 to 2010, the NAPLEX pass rates of graduates of foreign pharmacy schools show a steady decrease. First-time NAPLEX candidates with degrees from non-ACPE ac-credited pharmacy schools had a 72.55% pass rate in 2008, a 62.62% pass rate in 2009, and a 50.99% pass rate in 2010. This represents a 21.56% decrease in the NAPLEX pass rate, from 2008 to 2010, for candidates educated at foreign phar-

macy schools who took the exam for the first time.

In March 2010, the updated NAPLEX blueprint and revised passing stan-dard were implemented, which may have contrib-uted to the decrease in the pass rate of graduates from foreign pharmacy schools. (By comparison, the NAPLEX pass rate for graduates of ACPE-ac-credited pharmacy schools taking the exam for the first time fell 2.26% from 96.53 in 2008 to 94.27% in 2010.) At the same time, the first-time NAPLEX pass rate for graduates of for-eign pharmacy schools had already fallen almost 10% from 2008 to 2009, prior to the implementation of the new blueprint and passing standard.

Additional information about FPGEE and NAPLEX is available in the Pro-grams section of the NABP Web site at www .nabp.net/programs.

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Association News

Legal Use of SSNs by Private Entities, Including NABPAs more and more organiza-

tions require Social Security numbers (SSNs) to register for services and accounts, many con-sumers are beginning to question the legitimacy of private entities’ requests for such information.

Federal and State LawsAlthough some may believe

that non-governmental organiza-tions are prohibited from obtain-ing SSNs, in fact there is no law banning private organizations from collecting SSNs. In recent years, a federal government task force recognized the importance of SSN use by private entities and preser-vation of such use. For example, individuals and organizations such as landlords, health insurers, and

banks acquire SSNs for a variety of reasons ranging from credit checking to identity verification, to govern-ment compliance.

Many states’ laws specifically permit private entities to collect and use individual SSNs for purposes of application and enrollment processes, to confirm SSN accuracy, or for internal verification or administrative purposes. Moreover, federal law mandates the collection of SSNs, pursuant to licensure processes, under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996. Accordingly, the states have incorporated this federal requirement into their laws. Two examples are Illinois and Oregon: both codified the federal requirement into pharmacy practice laws requiring individuals to

provide SSNs for license issuance and renewal purposes.

Protections for SSNsMyriad laws require govern-

ment agencies and private entities to provide protections for SSNs. For example, most states require private entities to implement encryption technologies so that individuals can securely submit SSNs online. As a private entity that for many decades has sup-ported the boards of pharmacy in their licensure processes, NABP utilizes required technologies and protections, and adheres to state and federal laws when collecting SSNs for purposes of internal data verification and board of phar-macy licensure processes.

Pharmacist and Technician Unique Identifiers Necessary to Assist in Ensuring Accuracy of CPE Monitor e-Profiles

With CPE Monitor™ launched earlier this year, the service is well underway as pharmacists and pharmacy technicians continue to create NABP e-Profiles and obtain their permanent identifica-tion numbers for tracking their continuing pharmacy education (CPE) credit.

A common topic of concern among individu-als completing their NABP e-Profiles is the requirement for a full nine-digit Social Security number (SSN). Registrants are not able to obtain their NABP e-Profile ID until this information is provided. NABP understands the hesitation in providing this information; however,

as with many state licensure records, the SSN, along with the license number, is used to uniquely identify licensees within the system. Using the full nine-digit SSN as an identifier with other demo-graphic information such as the license number(s), allows NABP to internally verify that each profile cre-ated within CPE Monitor is unique, contains accurate information, and will match state board licensure records for CPE activities. Without these important identifiers, NABP cannot guarantee that an individual’s CPE credit will be reported to his or her respective board of pharmacy accurately.

Some pharmacists have asked about using the National Provider Identi-fier (NPI) number from the Centers for Medicare & Medicaid Services (CMS) as an alternative to provid-ing their SSN. However, applying for an NPI number requires candidates to dis-close their SSN to CMS, and may not address candidate concerns about providing their SSN to third parties. In addition, this excludes phar-macy technicians, as only pharmacists would have an NPI number.

Since nearly all boards of pharmacy already col-lect their licensees’ SSNs as identifiers in addition (continued on page 132)

to storing their license number(s), complications in matching licensees’ records when the time comes to exchange CPE data among NABP and the boards are expected to be minimal. Accurate reporting to the boards can be guaranteed only when all necessary unique identifiers, which include birth date, license number, user name, and SSN, are available.

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Association News

NABP PMP InterConnect Development Complete; Piloting of Data Exchange Anticipated for Late July 2011

The NABP PMP InterConnect™ pilot began in May 2011 with several prescription monitoring programs (PMPs) participating. The NABP InterConnect will facilitate the secure transfer of PMP data across state lines and on a national scale, enhancing the ability of PMPs to fight prescription drug abuse.

“With pill mills proliferating and recent government data showing that prescription drug abuse rates continue to climb, PMPs remain an important tool to assist states in identifying and offering help to abusers and enforcing prescribing and dispensing regula-tions,” states NABP President Malcolm J. Broussard, RPh. “The NABP PMP InterConnect increases the power of PMPs by enabling different states to securely share data using their existing PMP infrastructure. Reports requested by PMP users can be more complete,

helping prescribers and dispensers to make appropriate patient care deci-sions.”

Development of the system is complete. NABP is now focused on working with PMP software vendors to develop the appropriate interface so PMPs can communicate with the InterConnect. Initial exchanges of data with pilot programs are expected to take place in late July, and addi-tional programs will come on board throughout the remainder of 2011 as states are ready to participate. As of press time, PMPs in Connecticut, Indiana, Kansas, Mississippi, North Dakota, Ohio, South Carolina, Vir-ginia, and West Virginia have executed memorandums of understandings.

The NABP PMP InterConnect steering committee, composed of PMP administrators from several states in every region, discussed the pilot

progress via a teleconference on May 9, 2011. Members reviewed and discussed system development progress, collabo-ration with PMP vendors, and en-hanced security features of the system.

NABP will cover the annual par-ticipation fees for all participating states for at least five years, and it is the Association’s goal that states will never have to pay annual participation fees to participate in NABP InterConnect. NABP will also cover the cost for PMP software fees associated with interfacing with the NABP InterConnect. In addi-tion, NABP will cover all costs associ-ated with the development and ongoing operation of NABP InterConnect. Those interested in obtaining more informa-tion on NABP InterConnect, should contact NABP Government Affairs staff at [email protected] or visit the Government Affairs section on the NABP Web site at www.nabp.net.

Three New Members Appointed to Serve on the 2011-2012 Advisory Committee on Examinations

Three new members have been appointed to serve on the 2011-2012 Advisory Committee on Examina-tions (ACE). This standing commit-tee, established by NABP in 1912, was created to safeguard the integrity and validity of NABP examinations.

ACE oversees the development and administration of the Associa-tion’s examination and certification programs. ACE also considers policy matters, evaluates long-range planning strategies, and recommends appro-priate action to the NABP Executive Committee.

ACE typically convenes three to four times per year and consists of individuals who are affiliated mem-

bers of NABP, including current active board of pharmacy members and administrative officers, individuals who have served within the last five years as a member or administrative officer of a board of pharmacy, and non-affiliated individuals who are practicing pharmacists or serving as pharmacy school faculty.

The following members began their term on June 1, 2011. Mark T. Conradi, RPh, JD, is serving as the Executive Committee liaison.

2011-2012 ACE Members

Tom Houchens ......London, KY (Chair)

Carl W. Aron ....................Monroe, LA

David Todd Bess ....... Cane Ridge, TN

Michael Duteau ......Baldwinsville, NY

Judy Gardner .................... Atlanta, GA

Arthur Jacknowitz ...... Morgantown, WV

Sara St. Angelo ..........Indianapolis, IN

John Taylor* ................Tallahassee, FL (Ex Officio Member, one-year term)

Neal Walker* ..................Hibbing, MN (Ex Officio Member, one-year term)

Dale Wurster* ................ Iowa City, IA (Ex Officio Member, one-year term)

* Indicates new member

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Association News

CPE Social Security Number Requirements(continued from page 130)

Nine v FourThe last four digits of the

SSN are not unique to an individual, and are potentially shared with thousands of other individuals. As a result, it is possible that this data would not be sufficient to uniquely identify licensees within NABP systems, and may create prob-lems for licensees during any audit of CPE used for renewal of a license. With potential for serious adverse consequences to a licensee for failure to meet CPE requirements, NABP is determined to do everything possible to ensure that incom-plete information in its systems will not lead to such a result for the licensee and, therefore, will continue to require the full

nine-digit SSN from all CPE Monitor registrants.

Protecting the DataSecurity is a main focus

of the Association and NABP has taken extensive mea-sures to ensure protection of individuals’ personal data. Over the years the Associa-tion has invested significant resources in the security of its systems and continuously monitors data traffic to help ensure personally identifiable information is not improper-ly disclosed or unnecessarily accessed internally.

Additionally, as part of its comprehensive security program NABP deploys fire-walls, encryption technol-ogy, intrusion prevention technology, and audits. The Association continues to monitor and implement new technologies to further

strengthen the security of its systems.

CPE Monitor ProgressIn early June, the CPE

Monitor advisory group convened for its first meet-ing. Consisting of repre-sentatives from 10 different boards of pharmacy, the advisory group is responsible for determining the needs of the boards as they pertain to the CPE Monitor service. In addition, NABP held two Webinars at the end of April to provide information to the boards as well as answer questions regarding the new service.

A collaboration of NABP, the Accreditation Council for Pharmacy Education (ACPE), and ACPE pro-viders, CPE Monitor was developed to streamline and centralize the reporting of

ACPE-accredited CPE for providers, pharmacists‚ and pharmacy technicians. A centralized registry of this information will streamline the tracking of information and enhance the ability of licensees to document their CPE activities when neces-sary. It is important to note that though pharmacists and pharmacy technicians are encouraged to set up their e-Profiles now, previous ACPE-accredited CPE credit hours will not be recorded. Profiles will include only those hours submitted once the tracking portion of the CPE Monitor goes live during the fourth quarter 2011.

More information about CPE Monitor is available at www.MyCPEmonitor.net or in the Programs section of the NABP Web site at www .nabp .net/programs.


NAPLEX and MPJE(continued from page 115)

to take advantage of the application’s new features. By creating a new user registration, those candidates that registered before March 23, will be able to view historical data from the

NAPLEX and MPJE registrations, in-cluding score reports. After the candi-date registers as a new user, the system will match the newly created profile with the registrations previously sub-mitted or currently in progress so that the information will be viewable by the candidate.

For more information about the upgraded NAPLEX and MPJE ap-plication or to complete the online registration, visit the Programs sec-tion of the NABP Web site at www .nabp.net/programs or contact NABP Customer Service at custserv@nabp .net or at 847/391-4406.

included Susan Ksiazek, RPh, chairperson; Kevin Borcher, PharmD; Rebecca Deschamps, RPh; Paul Limberis, RPh; Alice Mendoza, RPh; Anne Policastri, PharmD, MBA, FKSHP; and Michael Romano, RPh. The Executive Committee liaison was Cathryn J. Lew, RPh.

The long-term care pharmacy subgroup members were Patricia D’Antonio, RPh, MS, MBA, CGP,

chairperson; William Fitzpatrick, RPh; Elizabeth Gregg, RPh; and Stanley Weisser, RPh. Gary A. Sch-nabel, RN, RPh, was the Executive Committee liaison.

Members of the subgroup for other pharmacy environments included Gay Dodson, RPh, chair-person; Robert Giacalone, RPh, JD; William Harvey, RPh; Randall Knutsen, RPh; Kendall Lynch, RPh; Rich Palombo, RPh; Michael Podgurski, RPh; Walt Slijepcevich, RPh,; and Frank Whitchurch, RPh.

The Executive Committee liaison was Michael A. Burleson, RPh.

The recommendations of the task force were re viewed and amended by the Committee on Law Enforcement/Legisla tion in March 2011 and subsequently approved by the NABP Execu-tive Committee during its May 2011 meeting. The full report of the task force is available in the Members section of the NABP Web site at www .nabp.net/ members.

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133

State Board News

PDMP Advisory Board Established in AK

The prescription drug monitoring program (PDMP) operated by the Alaska Board of Pharmacy has been focused on the creation, initial orientation, and implementation of the PDMP Advisory Board. The Advisory Board is planned to include the program coor-dinator, a pharmacist Board member, a public member, and practitioners from the veterinary, dental, nursing, and medical boards. The Ad-visory Board will have input on PDMP policies, waivers, regulations, and decisions based on the perspective of their given profession. With assistance as needed, the Advisory Board will evalu-ate the significance of data generated by the PDMP and then make recommendations to the Board of Pharmacy based on these findings. After members are identified, an orientation to the role of the Advisory Board will be scheduled. More information about the Alaska Board of Pharmacy’s PDMP is avail-able on the homepage of the Board’s Web site at www .commerce.state.ak.us/occ/ppha.htm.

WA State to Require CE for Pharmacy Technicians

Washington State will now require certified phar-macy technicians to com-plete continuing education (CE) requirements to be es-tablished by the Washington State Board of Pharmacy. The legislation (HB 1353),

signed into law by Governor Christine Gregoire on April 14, 2011, goes into effect on July 22, 2011. The full text of the law as adopted is available on the Web site of the Washington State Legislature at http://apps .leg .wa.gov/billinfo/summary .aspx?bill=1353&year=2011.

WA Bans ‘Bath Salt’ Chemicals

The Washington State Board of Pharmacy filed a second emergency rule, WSR 11-09-044, to extend the state’s ban on synthetic cannabinoid chemicals and include chemicals used in “bath salts.” The rule, adopted on April 15, 2011, effectively keeps illegal products – such as Spice and K2 – that are sold as incense and contain the chemicals JWH-018, JWH-073, JWH-200, CP-47,497, and can-nabicyclohexanol. The new rule also makes illegal bath salt products sold under names such as Ivory Wave, Vanilla Sky, and White Lightening. The chemicals in the products fluorometh-cathinone (flephedrone), methylmethcathinone (mephedrone), methy-lenedioxypyrovalerone (MDPV), methylenedioxy-methylcathinone (methy-lone), methylbenzodioxol-ylpropylamine (butylone), in addition to synthetic cannabinoids, have been classified as Schedule I con-trolled substances (CS). The Board also voted to begin the rule process for evaluat-ing the need to include these chemicals in permanent rules. As Schedule I sub-stances have a high potential

for abuse and no accepted medical use, the emergency rule makes it illegal to sell or possess these chemicals or products containing these substances. The rule also gives clear authority to law enforcement to prosecute for the sale and possession of these substances and protects the public by alert-ing them to potential health risks that could result from using them. Additional information is available on the Board of Pharmacy Web site at www.doh.wa.gov/hsqa/Professions/Pharmacy/SpiceBathSalts.htm.

OK Board to Convene Technician Rules Committee

The Oklahoma State Board of Pharmacy is plan-ning to convene a techni-cian rules committee for the purpose of reviewing current technician regula-tions and rules for both hospitals and community pharmacies.

The committee will be tasked with studying other states’ rules and regulations in comparison to Oklaho-ma. In addition, the com-mittee will make recom-mendations to the Board on such issues as minimum training, education, test-ing, permitted duties, and prohibited tasks.

The Board is currently seeking members for the committee and anticipates that the committee will begin meeting in July or August 2011. When imple-mented, the committee will continue to meet on a monthly basis for a year.

Around the AssociationAPhA Honors Past NABP Executive Committee Member

Michael A. Moné, RPh, JD, received the 2011 Linwood F. Tice Friend of APhA-ASP (American Pharmacists Association Academy of Student Pharmacists) Award for his commitment to student pharmacists at the local and national levels, including his involvement with the APhA-ASP House of Delegates, the University of Utah School of Alcoholism and Other Drug Dependencies, and Generation Rx. As an active member of NABP, Moné has served on several committees and task forces and was a member of the NABP Executive Committee from 2002 to 2005. Currently, Moné is the vice president, anti-diversion and senior regulatory counsel at Cardinal Health, Inc.

Executive Director Changes

Mark Whitten, BA, CFI, began his position as executive director of the Florida Board of Pharmacy on February 25, 2011. Prior to joining the department of health, Whitten worked at the Department of Busi-ness and Professional Reg-ulation and rose through the ranks serving in various capacities includ-ing regional supervisor,


nabp newsletter

134

Association News

Technological Challenges Delay Start of April 2011 FPGEE Administration, Pearson VUE Reports

During the April 14, 2011 Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®) administration, the Association’s test vendor Pearson VUE notified NABP of technological challenges at various testing sites throughout the United States, which resulted in a delayed testing start and af-fected 911 candidates.

At the beginning of the administration, Pearson VUE detected a disruption in its systems, causing delays ranging from less than 30 minutes to near eight hours of waiting time. At the onset of the April FPGEE admin-istration, the test vendor notified NABP that the start time for test centers in the

eastern time zone was de-layed due to a programming issue. At that time, Pearson VUE expected a delay across the country as the issue was systemic and was projected to apply to nearly all of the testing centers.

Despite the delayed start time for these candidates, NABP is happy to report that administration totals and passing rate averages were consistent with past examinations. Data indi-cate that 1,057 candidates were scheduled to take the April 14 administration and 1,031 administrations were completed. This differ-ence is attributed to 26 “no shows,” a term that ac-counts for candidates who

did not show up for the examination, candidates that were denied entrance to the examination, candi-dates that cancelled prior to the test, and candidates that chose to leave the test center and not test due to the delayed start.

At this time, Pearson VUE has set up an e-mail address, [email protected], dedicated to FPGEE candidates for any inquiries or claims on the April administration. NABP is also working closely with the test vendor to resolve any inquiries from candi-dates. All phone calls and e-mails that come to NABP regarding the incident have been documented and for-

warded to the vendor. Pear-son VUE will be evaluating all correspondence received about the April 2011 FPGEE administration and will handle each claim on a case-by-case basis.

Pearson VUE has assured NABP that all quality con-trol methods are in place for the next FPGEE administra-tion, to be held September 27, 2011. For more informa-tion about the FPGEE, visit the NABP Web site at www .nabp.net/programs.


deputy director of regula-tion, director of regula-tion, and interim deputy secretary. He earned his bachelor of arts degree from the University of South Florida.

After serving as acting executive director for the Virginia Board of Phar-macy from August 2010 to January 2011, Caroline Juran, RPh, was selected to serve as executive direc-tor of the Board. Juran has been with the Board since 2005 and previously held the position of deputy executive director. She has

been a licensed pharmacist for 15 years and worked primarily in community pharmacy and long-term care. In addition, Juran held certification as a geriatric pharmacist and served as a preceptor for the School of Pharmacy at Virginia Commonwealth University. She completed her studies at The College of William and Mary and graduated from the School of Pharmacy at Virginia Commonwealth Univer-sity.

Board Member Appointments

•James Miller, MBA, RPh, has been appointed a member of the Iowa

Around the Association(continued from page 133)

Board of Pharmacy. Miller’s appointment will expire on April 30, 2014.

•Kevin Mitchell, RPh, has been appointed a member of the Ohio State Board of Pharmacy. Mitchell’s ap-pointment will expire on June 30, 2014.

•Elizabeth Jensen, PharmD, has been ap-pointed a member of the Washington State Board of Pharmacy. Jensen’s ap-pointment will expire on January 19, 2015.

•Donna Feild, MBA, RPh, has been appointed a member of the Washing-ton State Board of Phar-macy. Feild’s appointment will expire on January 19, 2015.

Board Member Reappointments

•Dirk White, RPh, has been reappointed a mem-ber of the Alaska Board of Pharmacy. White’s reap-pointment will expire on March 1, 2015.

•Robert Davis, MD, has been reappointed a member of the Wyoming State Board of Pharmacy. Davis’s reappointment will expire on February 28, 2017.

•John McPherson, DDS, has been reappointed a member of the Wyoming State Board of Pharmacy. McPherson’s reappoint-ment will expire on Feb-ruary 28, 2017.

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135

Professional Affairs Update

Contaminated TPN Spurs ISMP Call for Action

In response to the infections of 19 Alabama patients by contaminated total parenteral nutrition (TPN), the Institute for Safe Medication Practices (ISMP) called upon Food and Drug Administra-tion (FDA) to take sev-eral actions, including collaborating with boards of pharmacy in enforcing compounding standards. An investigation lead by Alabama Department of Public Health (ADPH) and Centers for Disease Con-trol and Prevention (CDC) determined that a failure in a step of the steriliza-tion process for the com-pounded TPN most likely led to its contamination with Serratia marcescens bacteria. Of the 19 cases of infection that resulted in Birmingham, AL, area hos-pitals, nine were fatal. An investigation revealed that TPN produced by Meds IV was the common source of the infections and that a container and stirrer, and a tap water spigot at Meds IV are likely the sources of the bacteria. The product was recalled by Meds IV on March 24, 2011.

ISMP has expressed sup-port for the provision of ad-ditional resources to boards of pharmacy so that boards can survey compounding pharmacies to enforce com-pliance with United States Pharmacopeia 797 stan-dards. ISMP also calls upon FDA to work with state boards of pharmacy to sup-

port enforcement efforts. Further, ISMP calls on FDA to provide guidance documents for industry on relevant good pharmacy compounding practices. More information about ISMP’s call for action is available in an April 7, 2011 article on the ISMP Web site at www.ismp .org/Newsletters/acutecare/articles/20110407 .asp.

FDA Issues Warning Regarding Benzocaine

FDA has issued a warning to consumers and health care providers regarding the use of benzo-caine and its association with a rare, but serious condition, methemoglo-binemia. Methemoglobin-emia results in the amount of oxygen carried through the bloodstream being greatly reduced, and in the most severe cases, can result in death. Benzocaine gels and liquids are sold over-the-counter under different brand names – such as Anbesol®, Hur-ricaine®, Orajel®, Baby Orajel, Orabase®, and store brands – and are used to relieve pain from a variety of conditions including teething, canker sores, and irritation of the mouth and gums. Benzocaine is also sold in other forms such as lozenges and spray solutions. FDA notes that methemoglobinemia has been reported with all strengths of benzocaine gels and liquids, includ-ing concentrations as low as 7.5%. Further, the

cases occurred mainly in children aged two years or younger who were treated with benzocaine gel for teething. Symptoms include pale, gray or blue colored skin, lips, and nail beds; shortness of breath; fatigue; confusion; head-ache; lightheadedness; and rapid heart rate and usually appear within min-utes to hours of applying benzocaine. Symptoms may occur with the first application of benzocaine or after additional use. FDA advises that if con-sumers or their children experience any of these symptoms after taking benzocaine, they should seek medical attention im-mediately. The FDA safety warning is available at www .fda.gov/Drugs/DrugSafety/ucm250040.htm.

FDA Pradaxa Storage and Handling Reminder

FDA issued a safety alert regarding special handling instructions for Pradaxa® due to con-cerns that these require-ments are not commonly known. FDA advises that Pradaxa, an anticoagulant medication known as a direct thrombin inhibitor, should only be dispensed and stored in the original bottle or blister pack-age due to the potential for product breakdown from moisture and loss of potency. Specifically, FDA advises pharmacists that Pradaxa should only be dispensed in the original manufacturer bottle with

the original dessicant cap. Pradaxa should not be re-packaged. Patients should be advised to store the medication in the original container and avoid using pill boxes or other contain-ers for storage. Also, once a bottle is opened, the prod-uct must be used within 60 days to ensure potency. The Pradaxa label and medication guide contain more information about these storage and handling requirements. The FDA safety alert is available on the FDA Web site at www .fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm249005.htm.

Latest FDA Drug Info Rounds Released

FDA Drug Info Rounds, a series of online training videos, provides important and timely drug informa-tion to practicing clinical and community pharma-cists so they can help pa-tients make better medica-tion decisions. In the latest Drug Info Rounds video, pharmacists discuss the vital role that pharmacists play in assisting FDA with communicating drug safety messages. Drug Info Rounds is developed with contribu-tions from pharmacists in the FDA’s Center for Drug Evaluation and Research, Office of Communica-tions, and Division of Drug Information and the videos can be accessed on the FDA Web site at www.fda.gov/Drugs/ResourcesForYou/HealthProfessionals/ucm211957.htm.

National Association of Boards of Pharmacy1600 Feehanville DriveMount Prospect, IL 60056

nabp newsletter

Newly Accredited VIPPS and Vet-VIPPS Facilities The following Internet pharmacies and veterinary Internet pharmacies were accredited through the

NABP Verified Internet Pharmacy Practice SitesCM (VIPPS®) and the Veterinary-Verified Internet

Pharmacy Practice SitesCM (Vet-VIPPS®) programs, respectively:

A full listing of the accredited VIPPS pharmacy sites representing more than 12,000 pharmacies and the accredited Vet-VIPPS sites are available on the NABP Web site at www.nabp .net.

Center Pharmacy dba Center PetWashington, DCwww.centerpetpharmacy.com

(Vet-VIPPS)

Diamondback DrugsScottsdale, AZwww.diamondbackdrugs.com

(Vet-VIPPS)

Drugsdepot.com dba Brawley Pharmacy, IncBrawley, CAwww.drugsdepot.com

(VIPPS)

Kennel Vaccine Vet Supply Co, IncDavid City, NEwww.kvsupply.com

(Vet-VIPPS)

MedfusionRx, LLCBirmingham, ALwww.medfusionrx.com

(VIPPS)

newsletter - nabp · 6/8/2016 · nabp newsletter 114 csa task force (continued from page 113)...

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