aid to governmentthe profession

the public1904 to 2012

Upcoming EventsSeptember 29, 2012 DEA National Drug Take-Back Day

October 9-10, 2012 Task Force on Drug Return and Reuse Programs NABP Headquarters

October 14-16, 2012 NABP/AACP Districts 1 & 2 MeetingSkytop, PA

October 17-18, 2012 Tri-Regulator Symposium Washington, DC

October 21-24, 2012 NABP/AACP Districts 6, 7, & 8 MeetingLittle Rock, AR

October 31-November 2, 2012 NABP/AACP District 4 MeetingAnn Arbor, MI

November 13-14, 2012 NABP Interactive Executive Officer ForumNorthbrook, IL

In This Issue. . . .Legal Briefs:When is a State Agency Not a State Agency. . . But is Now a State Agency

192

Association News:NABP Assists Pharmacy Workforce Center to Develop New Ideas for Gathering Useful Workforce Trend Data

195

Association News:NABP President Appoints Members to Serve on 2012-2013 Committees and Two Single-Issue Task Forces

197

Association News:NABP Seeks Nominations for 2013 Awards to Be Presented at the 109th Annual Meeting in St Louis, MO

201

Association News:Collaboration and Stakeholder Input Contribute to Forthcoming Pharmacy Practice Site Accreditation Program

203

Oc tobe r 2012 / Vo lume 41 Numbe r 9

newsletterNational Association of Boards of Pharmacy®

(continued on page 190)

PRESCRIPTION DRUG SAFETY ®

New Law Gives FDA More Authority to Prevent and Manage Drug Shortages; NABP to Collaborate on Behalf of Member Boards

In addition to directly impacting patient care, shortages of critical, lifesav-ing prescription drugs raise the potential for unscru-pulous pricing and supply activities and for counter-feit or adulterated drugs to enter the drug supply chain. Food and Drug Adminis-tration (FDA) reported a 300% increase in shortages from 2005 to 2010, and provisions to address the rise in drug shortages are included in the FDA Safety and Innovation Act (FDASIA) of 2012, signed into law by President Obama on July 9, 2012. New authorities granted to FDA under the new law, and new reporting requirements for manu-facturers, should position the agency to prevent more drug shortages. NABP is also addressing this issue and, at the Association’s 108th Annual Meeting,

member boards adopted a resolution stressing the need for collaboration with FDA and other stakeholders to help prevent and manage drug shortages.

Prior FDA SuccessIn October 2011,

President Obama issued an executive order giving FDA the authority to require increased reporting from manufacturers, and the agency saw good prog-ress in preventing short-ages. Margaret Hamburg, MD, commissioner, FDA, explained that there was a six-fold increase in early notifications to FDA of po-tential supply disruptions in the six months following the executive order. Early notifications greatly assist FDA in preventing shortag-es, and Hamburg indicated that in the six months since the executive order was

issued, FDA was able to pre-vent 128 drug shortages and that there were fewer short-ages overall. Specifically, 42 new drugs in shortage were reported in the first six months of 2012, compared to 90 new shortages in the same time period last year. Hamburg cited examples such as supplies of cancer drugs to treat childhood leukemia and ovarian can-cer that are currently meet-ing all demands, and noted

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Drug Shortages(continued from page 189)

(continued on page 194)

Feature News

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

expressly so stated. The subscription rate is

$35 per year.

National Association of Boards of Pharmacy

1600 Feehanville Drive Mount Prospect, IL

60056 847/391-4406 www.nabp.net

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Carmen A. Catizone Executive Director/

Secretary

Larissa Doucette Communications

Manager

©2012 National Association of Boards

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

written permission of the executive director/

secretary of the National Association of

Boards of Pharmacy.

that FDA is “working hard” to help resolve shortages of additional drugs includ-ing other types of cancer treatments and anesthesia drugs. (For additional back-ground, see “FDA Takes Action to Mitigate, Prevent Drug Shortages,” April 2012 NABP Newsletter, pages 78-80.)

Increased Authority Promises Increased Effectiveness

Under the new law, FDA’s authorities relating to preventing drug shortages are further expanded and can potentially assist the agency to further increase its success rate in prevent-ing shortages.

Enhanced authorities under FDASIA include, but are not limited to, the fol-lowing:

• Early notifications to FDA of potential discontinuances will be required from all manufacturers of covered drugs. The prior law applied only to sole manufacturers.

•Manufacturers are now required to report discontinuances to FDA regardless of whether they intend to discontinue the product permanently or are facing only a temporary interruption of supply.

• FDA may require, by regulation, mandatory reporting of shortages of biological products. The prior law excluded

all biological products from the reporting requirements.

• FDA is required to issue a noncompliance letter to manufacturers who fail to comply with the drug shortage notification requirements and to make the letter and the company’s response to the letter available to the public.FDASIA also requires

that, “prior to taking any enforcement action or is-suing any warning letter that reasonably could be anticipated to lead to a disruption in supply, ap-propriate offices within FDA communicate about the action and evaluate the relative risks and benefits to patients from the shortage and enforcement action or warning letter,” as indi-cated by FDA. FDASIA also includes provisions requir-ing that FDA establish a task force to develop and implement a strategic plan for enhancing responses to drug shortages and that FDA submit an annual re-port to Congress on efforts to reduce shortages.

Members Urge Action to Prevent and Manage Shortages

In a presentation at the NABP 108th Annual Meeting, May 19-22, 2012, Cynthia Reilly, BS Pharm, director, Practice Develop-ment Division, American Society of Health-System Pharmacists (ASHP), explained that ASHP and other organizations have

been addressing drug short-ages for decades. How-ever, she indicated that the challenges of the current drug shortage situation are the extent, duration, and type of drug shortages. Further, she explained the current shortage situa-tion has presented patient safety and patient outcome challenges. The Institute for Safe Medication Practices, for example, found that pa-tients have suffered injuries from errors related to drug shortages, such as those stemming from confusion about dosages and prepara-tion of substitutes.

Recognizing that short-ages of critical medications affect patient care and safety, NABP members adopted a resolution at the 108th Annual Meeting addressing drug shortages and calling for collabora-tive work to help reduce or eliminate supply shortages. NABP intends to collabo-rate with FDA, the National Association of Pharmacy Regulatory Authorities, and other stakeholders to pursue means for reducing shortages and to develop effective mechanisms for managing such shortages when they occur.

Extended Use of Expired Drugs?

In a survey of NABP member boards of phar-macy, the consideration of one potential mechanism – allowing the use of expired medications in shortage situations and under certain conditions – elicited fairly consistent responses. All 21

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Association News

Executive CommitteeMalcolm J. Broussard ChairpersonOne-year term

Michael A. BurlesonPresidentOne-year term

Karen M. RylePresident-electOne-year term

Joseph L. AdamsTreasurerOne-year term

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

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

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

William John CoverMember, District 4Serving second year of a three-year term

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

Jeanne D. Waggener Member, District 6Serving first year of a three-year term

Mark D. JohnstonMember, District 7Serving first year of a three-year term

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

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

2012 Meeting Triathlon Is Underway; Next Stop: Washington, DC

In September, the NABP 2012 Triathlon was set in motion with the first leg, the NABP Interactive Member Forum. Held September 19-20, 2012, in Northbrook, IL, the Member Forum provided board of pharmacy members with the chance to network with their peers while discussing regulatory trends and challenges faced by their boards. Each board of phar-macy was invited to designate one member from the board to attend, and NABP covered the cost for travel, hotel ac-commodations, and meals. In addition, there was no regis-tration fee for the forum.

Topics covered during the Member Forum were determined by feedback from the members prior to arriv-ing at the forum. The agenda included topics relating to deciphering the line between secondary wholesalers and “gray market” wholesalers, the 5% distribution rule for pharmacies, pharmacy technician education, train-ing, and certification, drug

shortages, conflict of interest issues, and new and emerging pharmacy practice models.

Tri-Regulator Symposium Approaching

Leg two of the triathlon, the Tri-Regulator Sympo-sium, will take place October 17-18, 2012, in Washington, DC. The first of its kind, this symposium offers the opportunity for interprofes-sional cooperation among the boards of pharmacy, Federa-tion of State Medical Boards, and National Council of State Boards of Nursing.

The meeting agenda is set to include keynotes from Drug Enforcement Adminis-tration, Prime Policy Group, and United States Depart-ment of Health and Human Services. Sessions will include topics related to combating opioid prescription abuse; supporting state-based regu-lation of health care person-nel; assessment of profes-sional competency of doctors,

nurses, and pharmacists; and health care workforce needs in the US. Please note, space is limited for this meeting. Interested individuals should contact Dana Oberman, NABP executive meeting planner, at exec-office@nabp .net for availability.

Leg Three: Executive Officer Forum

In November, the third and final leg of the triath-lon will take place. The NABP Interactive Execu-tive Officer Forum will be held November 13-14, 2012, in Northbrook, IL, and is tailored specifically to board of pharmacy executive of-ficers. A similar format to the Member Forum, the Execu-tive Officer Forum provides the executive officers of each board with the opportunity to attend at no charge, with travel, hotel accommoda-tions, and meals covered by NABP. Invitations will be sent to the executive officers in September and an agenda will be forthcoming.

NABP 2012 TriathlonA series of fall meetings.

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Legal Briefs

When is a State Agency Not a State Agency. . . But is Now a State AgencyBy Dale J. Atkinson, JD

In a previous Newsletter article (“When is a State Agency Not a State Agency?” May

2012 NABP Newsletter), the judicial decisions of Wilkinson v. Board of Dental Examiners of Alabama, 2011 Ala. Civ. App. LEXIS 88 (Civ. App. Ct. AL 2011) and Versiglio v. Board of Dental Examiners of Alabama, 651 F.3d 1272; 2011 U.S. App. LEXIS 17802; 18 Wage & Hour Cas. 2d (BNA) 10; 23 Fla. L. Weekly Fed. C324 (U.S. App. Ct. 2011) were discussed regarding whether immunity principles applied to the Alabama Board of Dental Examiners (Board) based upon its status as a state agency. The Wilkinson case found that certain required criteria were not present, thus concluding that the Board was not a state entity and not entitled to immunity. The Versiglio case followed, whereby the federal court deferred to the state court conclusions and also held that the Board was not a state entity. Since the publication of the previous Newsletter article, the Supreme Court of Alabama has reviewed and reversed and remanded the Alabama Court of Civil Appeals. This article will outline the Alabama Supreme Court opinion.

To recap the facts as set forth in the previous Newsletter article, a former employee (Employee) of the Board was terminated after several years of service to the Board. During her tenure, the Employee was subject to yearly employment con-tracts which, in pertinent part, provided that the sole

remedy for the settlement of any and all disputes aris-ing under the terms of such agreement “shall be limited to the filing of a claim with the Board of Adjustment for the State of Alabama.”

In July 2010, the Employee filed suit against the Board seeking compensation under her employment contracts for

attendance at numerous Board meetings. Based upon her breach of contract complaint, the Employee alleged that an audit of the Board activities between October 2003 and September 2007 revealed underpayment for attendance at Board meetings and that the Board had overpaid her for other activities. The net result of the audit, according to the complaint, was that the Board owed the Employee $10,162.08. In addition to the monetary compensation, the Employee asked for a further audit of compensation and attendance at Board meetings between October 2007 and December 2009.

The Board filed a motion to dismiss the complaint argu-ing, among other defenses, that the court lacked subject matter jurisdiction over the Board as it was immune from suit under the Alabama Con-stitution. The Board argued that immunity principles barred the circuit court from hearing the Employee’s case. Section 14 of the Alabama Constitution provides that “the State of Alabama shall never be made a defendant in any court of law or equity.” Previous Alabama jurispru-dence has held that the word “State” was intended to protect from suit “only immediate and strictly governmental agencies of the State.”

The lower court dismissed the action and the court of appeals reversed finding that the Board was not an arm

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Legal Briefs

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

(continued on page 198)

of the state. The analysis of the court of appeals opinion is contained in the previous Newsletter article. The Board appealed the matter to the Alabama Supreme Court.

After addressing the standard of review, the Alabama Supreme Court turned to the merits of the case. The court examined the three characteristics used in determining whether an entity qualified as a state entity. Those characteristics are:

• The character of power delegated to the body;

• The relation of the body to the state; and

• The nature of the function performed by the Board.Regarding the character of

power delegated to the body, the court cited long standing United States Supreme Court opinions that recognize the authority of the state to regu-late a profession and require licensure as a prerequisite to practice. It then referenced the Alabama Dental Practice Act and the legislative declaration mandating licensure before practice to ensure the health, safety, and welfare of Alabama consumers. The court further noted the provisions of the practice act, which empower the Board to adopt rules, issue licenses, conduct hearings, and impose discipline on licens-ees, subpoena witnesses and documents, issue oaths to wit-nesses, and so on. In total, the court held that the Alabama Dental Practice Act promul-gated by the legislature and the

delegated powers and respon-sibilities supports a conclusion that the Board is a state entity entitled to Alabama Constitu-tional immunity.

Next the court examined the relation of the Board to the state. In significant part, the Court of Appeals found that the issues related to a lack of appropriations, self-collected fees, and Board-determined expenditures sufficiently re-moved the Board from control by the state, thereby resulting in a ruling that the Board was independent, not an arm of the state, and not entitled to immunity protections.

The Alabama Supreme Court first noted that, while significant, whether an entity receives funds from the state is not the determinative fac-tor. Further, the Alabama Supreme Court found that the Court of Appeals applied an “overly narrow definition to ‘state funds.’” Importantly, the court found that not only did the legislature empower the collection of fees by the Board and specifically referenced parameters around the fees that could be collected, the leg-islature also noted that the fees collected are “appropriated to the Board.” This reference to appropriations signified over-sight and control over what the court found to be state funds. Indeed, the court held that the “mere fact that the legislature appropriates those funds before they reach the State treasury does not alter their status as state funds.”

Also, the court found that such fees collected by the Board remained state funds in spite of the fact that they were placed in a Board bank account rather than the state treasury. Finally, the court held that the Board was not entitled to unbridled discre-tion regarding the expendi-tures of such Board-collected state funds. To further buttress its findings regarding the Board’s relationship to the state, the court noted state oversight related to hiring, retention of attorneys, and treatment of Board members who receive the same per diem and travel allowances as state employees. All such factors led to the court’s con-clusion that the relationship between the Board and the state supports a finding that the Board is a state agency entitled to immunity.

Finally, the court turned its attention to the nature and function performed by the Board. The court distin-guished a case cited by the employee and focused on an alternative case, which found that the Alabama State Board of Chiropractic Examiners was an immedi-ate and strictly governmen-tal agency of the state. Just like the Chiropractic Board, the Board was created and empowered by statute, charged with regulating the profession, authorized by law to collect and expend fees within its purpose, and

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Drug Shortages(continued from page 190)

Feature News

boards responding to the survey indicated that they have no formal position or guidance, either issued or contemplated, on the topic. Some boards indicated, however, that the topic war-ranted further discussion in their state. At the same time, some boards noted that ap-proving use of expired drugs is out of their purview, and/or that dispensing of expired drugs could constitute the dispensing of misbranded or adulterated drugs, which is prohibited by the Federal Food, Drug, and Cosmetic Act.

Some boards suggested that for expired medica-tions to be authorized for use, the expired drug would need to be tested to ensure potency and safety, and that FDA could then determine whether and for how long the expired drug could be authorized for extended use. In addition, some boards noted that in such a situation, the patient should be given the right to decide whether or not to accept the risk.

Internet Drug Outlets Exploit Shortages

In addition, the research of the Association’s Internet Drug Outlet Identification program indicates the need to address the issue of online sellers that take advantage of drug shortages, market-ing potentially substandard, adulterated, or counterfeit versions of needed drugs for sale on the Internet. The program’s April 2012 report

indicated that rogue online sellers distributing such products were among the “9,000 Web sites NABP has found to be out of compli-ance with pharmacy laws and practice established in the United States to protect the public health.”

FDA has also warned about this situation. Ilisa Bernstein, PharmD, JD, acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research told CBS News that “rogue Internet phar-macies really target products that are in short supply for counterfeiting, so patients need to be extremely vigilant and weary [sic] when they look to the Internet for medication.”

Research from pharma-ceutical security experts has also shown how online sellers exploit short-ages. Researchers Bryan A. Liang, MD, JD, PhD, and Tim K. Mackey, MAS, conducted a study that focused on 72 drugs identi-fied in shortage by FDA as of September 2011, and discovered that 68, or 94%, were offered for sale online, primarily by sites on the NABP Not Recommended list. Liang and Mackey found 291 offers for the 68 shortage drugs being mar-keted online, with 71% of the offers directly targeting consumers. These offers were made by 91 online drug sellers, with 31 selling more than one shortage drug. Of the sites offer-ing more than one drug in shortage, 68% were on the NABP Not Recommended list.

Gray Market Wholesalers Exploit Shortages

In addition, some drugs in shortage are leaked into gray market distribu-tion networks, and often by entities holding phar-macy licenses as reported by the House Committee on Oversight and Government Reform on July 25, 2012.

The committee con-ducted an investigation and examined over 300 pedi-gree documents for drugs in shortage. In two-thirds of the cases examined, they found that drugs were resold by entities holding pharmacy licenses to gray market wholesalers. In some cases, it was found that these entities were not dispensing drugs to patients, but selling their entire inventory into the gray market. In other cases, gray market wholesal-ers persuaded pharmacies to act as purchasing agents to acquire drugs in shortage for sale to the wholesaler. (continued on page 196)

Online Sellers Exploit Unavailability of Over-the-Counter Drugs

Some illegal online sellers also exploit the market when recalls, manufacturing issues, or other issues result in unavailability of over-the-counter (OTC) products. For example, Consumer Reports warned read-ers about online sellers offering Excedrin® for over $100 a bottle through Internet channels such as e-Bay. The article cautioned consumers to be wary of such online sellers, warning that they may not receive the OTC authentic drug. Further, the article points out that in the case of Excedrin, generic versions of the drug are readily available from legitimate retail sources. NABP staff was also quoted, reminding consumers to only purchase drugs from sources with which they are familiar and that have accountability to a state or federal agency in the United States.

For example, “the California Board of Pharmacy cited more than 50 pharmacies for acting as purchasing agents for gray market companies,” indicates the report.

The report stresses that once in the gray market, drugs are typically resold several times before being purchased by a hospital. These drugs are sold to hos-pitals and pharmacies at ex-orbitant prices, and further, health care providers cannot be certain of the authentic-ity or integrity of the drugs. The origin may be difficult to trace, for example, and the drugs may have been improperly stored.

Addressing such issues, NABP surveyors observing instances of questionable or illegal practices with regard to short supply drugs and distributors, work with the appropriate state and federal regulatory agencies to ad-dress such issues when they arise.

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Association News

NABP Assists Pharmacy Workforce Center to Develop New Ideas for Gathering Useful Workforce Trend Data

With the continued demand for pharmacists and the expansion of pharmacists’ responsibilities and roles in the health care world, a full understanding of pharmacist workforce trends are needed now more than ever.

NABP, along with other pharmacy and health-related organizations, met with the Pharmacy Workforce Center (PWC) on June 18-19, 2012, to discuss new ways to gather data that will provide a better understanding of the current state of the pharmacy work-force and its possible future.

PWC, formerly known as the Pharmacy Manpower Project, Inc, is a nonprofit corporation comprised of major national phar-macy professional and trade organizations, including NABP. The mission of PWC is to serve the public and the pharmacy profession by collecting data regarding the size and demographics of the pharmacy workforce. As such, PWC conducts the National Pharmacist Workforce Survey (Survey) every five years in order to capture the demo-graphic and work character-istics of the pharmacist work-force. The Survey is sent out to random licensed pharmacists in the United States and asks questions about pharmacists’ employment and licensure sta-tus; work environment; time spent on various professional activities such as dispensing, patient care, and research; and personal information, includ-ing gender, race, educational background, and age.

Although the data ob-tained through the Survey is valuable for identifying and understanding pharmacist workforce trends, PWC has found some limitations to the study. From the last Survey results published on March 1, 2010, Final Report of the 2009 National Sample Survey of the Pharmacist Workforce to Determine Contemporary De-mographic and Practice Char-acteristics, PWC found that although the study included a geographically diverse sample of pharmacists, some states were over-represented while others were under-represented. To overcome this limitation, PWC reports aggregate data rather than state- or region-specific data. Other reported limitations to the Survey include a non-response bias as it is possible that responders were more interested in the topic and/or had stronger opinions on the topics than those who chose not to respond.

After discussing these and other limitations, PWC turned the conversation to how the gathered organizations can work together to eliminate challenges that may hinder the collection of data that best represents the pharmacist workforce. Upon discussing how the state boards of phar-macy could be of assistance to PWC’s research, it was discovered that many of the questions asked on the Survey are questions that are already obtained by the state boards of pharmacy through pharmacist license renewal applications.

For example, both the Survey and renewal applications have questions pertaining to licensure status, employment background, gender, and age. Representatives from state boards of pharmacy were invited to attend the first day of the PWC meeting to discuss the feasibility of combining states’ data with Survey data. PWC believes that doing so could potentially result in data from a more diverse represen-tation of pharmacists from all over the US, thus possibly uncovering more pharmacist workforce trends specific to a state or region.

However, there are some challenges with obtaining this information as all state boards of pharmacy are not governed alike. Of primary concern to PWC is the different ways in which data is collected by each state. For example, some boards’ renewal ap-plications are in hard copy form, some are in electronic form, and some are in both forms. Aggregating data from these different hard copy and electronic files and matching questions fields for the Survey could be arduous. And finally, some states may be prohibited from sharing any such data with PWC.

Given these challenges, PWC representatives discussed the value of utilizing data ob-tained through the NABP CPE Monitortm service, which also gathers similar information to what is asked on the Survey. When an individual creates his or her NABP e-Profile and registers for CPE Monitor,

the individual must answer various questions about his or her licensure status, personal information, etc. To maintain an active CPE Monitor ac-count, pharmacists must keep all licensure information con-tained within their e-Profile up to date and accurate. In addition, NABP discussed the possibility of adding optional questions to the CPE Monitor registration process that could be used to assist in PWC’s research.

Joining PWC in this mis-sion for the first time were representatives from Health Resources and Services Administration (HRSA), a federal agency that works to improve access to health care services for people who are uninsured, isolated, or medically vulnerable. Like PWC, HRSA conducts a similar survey to discover trends in the public health workforce and to determine how to improve and maintain workforce competency and effectiveness. However, the survey HRSA conducts is a comparison of all health care professions rather than just pharmacists, and includes for example nurses, medical doc-tors, and dentists.

By working with other organizations to collect more information that it can analyze for its Survey, PWC can better under-stand the trends of the pharmacist workforce. More defined results could also be of value to NABP. For instance, with more

(continued on page 200)

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Drug Shortages(continued from page 194)

Association News

NABP Hosts Roundtable Meeting to Share Experiences and Challenges Relating to Examination Security

As new threats develop that might compromise the integrity of an examination, companies and organiza-tions must develop new strategies for preventing or handling such security threats. On July 26, 2012, NABP hosted the security roundtable meeting, which provided the opportunity for a confidential exchange of information with other organizations to discuss and share experiences affecting examination security.

Established in 2009, the security roundtable is made up of organizations from a variety of disciplines and has met regularly to

discuss security concerns of all the member organi-zations. These members come together to freely share experiences on issues threatening examination security, act as resources to one another when address-ing similar security threats, exchange information re-garding concerns that have been unearthed, and work toward establishing the best practices for the group as a whole.

Members of the security roundtable include such or-ganizations as the American Board of Internal Medicine, Certified Financial Analysis Institute, Association of

American Medical Col-leges, American Board of Internal Medicine, Certified Financial Planner Board of Standards, Graduate Man-agement Admission Coun-cil, Law School Admission Council, National Confer-ence of Bar Examiners, and National Council of Exam-iners for Engineering and Surveying.

During the meeting, members participated in brainstorming sessions and exchanged ideas on shared security topics. Members also reviewed specific cases that affected each orga-nization and shared how they handled the situation.

In addition, participants shared tips for examina-tion development, provided information about testing vendors, and discussed new developing security.

Also during the meet-ing, members were provided information for developing an effective, comprehensive exam security plan. This se-curity plan is meant to serve as an organization’s “go to” document for handling se-curity threats that may arise. As discussed at the meeting, an organization’s security plan has a constant need for updating as new security threats and challenges arise over time.

Additional NABP Actions

Since gray market sellers – both direct-to-con-sumer Internet sellers and gray market wholesalers – exploit drug shortages, FDA has advised consumers and health care providers to be cautious and to ensure they obtain medications from legitimate sources. With the instances of counterfeit can-cer medications distributed to US medical clinics in Feb-ruary 2012 and April 2012, and with reports that hospi-tals and pharmacies continue to field calls from unknown wholesalers offering drugs in shortage at exorbitant prices, FDA has reminded the health

care community “to examine their purchasing practices to ensure that they buy directly from the manufacturer or from licensed wholesale drug distributors in the United States.” In addition, FDA has noted that health care pro-viders should, when neces-sary, verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business by con-sulting the “Verify Wholesale Drug Distributor Licenses” FDA Web page.

The NABP VAWD® (Verified-Accredited Whole-sale Distributors®) program, developed in 2004, plays a pivotal role in preventing counterfeit drugs from enter-ing the US drug supply, and provides another way that health care providers can be assured of the legitimacy

of a wholesale distributor. Wholesale distributors that display the VAWD Seal as evidence of their accredita-tion are in compliance with state and federal laws and NABP’s VAWD criteria. Fur-ther, these wholesalers have undergone licensure verifica-tion, a criteria compliance review, including a rigorous review of their operating policies and procedures, sur-vey of facility and operations, background checks, and screening through the NABP Clearinghouse.

In June 2012, FDA warned consumers and health care providers about a counterfeit version of Teva Pharmaceutical Industries’ Adderall® 30 mg tablets be-ing sold on the Internet. The agency noted that “rogue websites and distribu-

tors may especially target medicines in short supply for counterfeiting” and that Adderall is currently on the drug shortage list. FDA advised consumers to be extra cautious when buying their medicines from online sources and recommended ensuring that the Internet pharmacy is VIPPS® (Veri-fied Internet Pharmacy Prac-tice SitesCM) accredited.

NABP continues to ad-dress the problem of gray market wholesalers and, in December 2012, will convene a task force on virtual wholesalers that will consider, among other is-sues, how to help ensure the security of the supply chain and protect patients from counterfeit and substandard drugs. NABP will continue to provide updates.

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Association News

NABP President Appoints Members to Serve on 2012-2013 Committees and Two Single-Issue Task Forces

NABP provides guid-ance on current topics of interest to the state boards of pharmacy through the commissioning of single-issue task forces. When an issue arises that requires special expertise or a com-mitment of time and funds, a task force is appointed to address an explicit charge and to report its findings to the Executive Committee. The task force reports are posted on the NABP Web site. This year, NABP has commissioned two single-issue task forces pertaining to the following topics: 1. Drug return and reuse

programs 2. Virtual manufacturers

and wholesalers NABP President Mi-

chael A. Burleson, RPh, has finalized his appointments for the following task forces and standing committees for the 2012-2013 year.

2012-2013 Task Forces

The Task Force on Drug Return and Reuse Programs is scheduled to meet October 9-10, 2012, at NABP Headquarters. The task force came about in response to Resolution No. 108-9-12, passed at the NABP 108th Annual Meet-ing. The resolution ac-knowledges that a number of state legislatures have enacted laws that allow for the return and reuse of previously dispensed prescriptions under certain conditions and that many of

these laws require boards of pharmacy to adopt rules to implement these return and reuse programs. Further, the resolution indicates that “many boards of pharmacy have concerns about the quality and integrity of drugs previously dispensed and returned by patients for reuse,” and that “many of these return and reuse programs have not met the intended outcomes ex-pected by the state legisla-tures.” Thus, NABP mem-ber boards agreed that the Association should study the utility, efficacy, and safety of these programs, and President Burleson has established the task force to undertake this effort.

The task force is charged with the following objectives: 1. Review available data

and studies to deter-mine if medications returned through acceptable means, as defined in the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy (Model Act), are safe for reuse;

2. Consider the develop-ment of a position statement on the issue; and/or

3. Review relevant lan-guage and recommend amendments, if neces-sary, to the Model Act to address drug return and reuse programs.Chairperson of this task

force is Ronald Klein, RPh,

executive director, Mon-tana Board of Pharmacy. Individuals appointed to serve as members include:

• Lois Anderson, PharmD, Louisiana

•Phil Burgess, MBA, RPh, Illinois

•Patricia D’Antonio, MS, MBA, CGP, RPh, District of Columbia

•Ben Fry, RPh, FIACP, FACA, Texas

•Bob Goetz, RPh, Minnesota

• Susan Kedron, JD, Texas

•Bill Mixon, RPh, North Carolina

•Nichole Penny, RPh, Michigan

• Joyce Tipton, MBA, RPh, FASHP, TexasCaren Wright-Magne,

RPh, of Florida, will serve as an alternate. The Execu-tive Committee liaison is Edward G. McGinley, MBA, RPh, member, New Jersey State Board of Pharmacy.

The Task Force on Vir-tual Manufacturers and Vir-tual Wholesale Distributors is scheduled to meet Decem-ber 11-12, 2012, at NABP Headquarters. The task force was established in response to Resolution No. 108-2-12, passed at the NABP 108th An-nual Meeting. The resolution acknowledges that “there has been a rapid increase in the number of entities that engage in the wholesale distribution of drug products without taking physical pos-session of the drug including, but not limited to, brokers, whose operations may be re-ferred to as ‘virtual manufac-

turers’ and ‘virtual wholesale distributors,’” and that this situation may “increase the risk of introducing counter-feit drugs into the United States drug supply chain.”

In addition, the resolu-tion states that as the NABP Verified-Accredited Whole-sale Distributors® (VAWD®) program has “proven its value in confirming compli-ance with state and fed-eral laws and regulations and established standards of practice of traditional manufacturers and whole-sale distributors and, thus, deterring the introduction of counterfeit drugs into the US drug supply chain,” the Association should review and revise its standards for the VAWD program to define and address virtual manufacturers and wholesale distributors and amend the Model Act if necessary. The task force is charged with the following objectives: 1. Review existing current

state laws and regula-tions addressing virtual manufacturers and vir-tual wholesale distribu-tors and relevant Model Act language.

2. Review the VAWD stan-dards.

3. Recommend amend-ments, if necessary, to the NABP Model Act and VAWD standards ad-dressing these issues. Chairperson of this

task force is Susan Del-monico, JD, RPh, Rhode Island Board of Pharmacy.

(continued on page 198)

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Association News

Individuals appointed to serve as members include:

•Buford Abeldt, Sr, RPh, Texas

•Carol Yates Day, RPh, North Carolina

• John Dorvee, Jr, PharmD, Vermont

•Mark Hardy, PharmD, North Dakota

•Robert Marshall, PharmD, RP, Nebraska

•Dennis McAllister, RPh, FASHP, Arizona

• Jeffrey Mesaros, PharmD, Florida

• Jerry Moore, JD, RPh, Alabama

• Suzanne Neuber, RPh, Ohio

•Rich Palombo, RPh, New Jersey

•Mike Podgurski, RPh, Pennsylvania

• Phil Wickizer, JD, IndianaWilliam John Cover, RPh,

member, Indiana Board of Pharmacy, is the Executive Committee liaison.

2012-2013 Standing Committees

As authorized by the NABP Constitution and

Task Force Appointments(continued from page 197)

Bylaws, the Association’s standing committees an-nually perform specific responsibilities that are essential to the success of NABP’s programs. Once a committee has explored its assigned issues, the mem-bers submit recommenda-tions or resolutions to the NABP Executive Commit-tee for consideration.

The Committee on Law Enforcement/Legislation will meet on January 22-23, 2013, at NABP Headquar-ters. The committee is charged with the following tasks: 1. Review and comment on

existing legislation and rules for the practice of pharmacy, legal distri-bution of drugs, and related areas within pharmacy, including impaired pharmacists.

2. Develop model regula-tions for pharmacy as assigned by the Execu-tive Committee, or from resolutions adopted by the members of the Association, or from reports of the other committees of the As-sociation.

3. Recommend to the Ex-ecutive Committee areas where model regulations are needed in phar-macy for improving the protection of the public health. Caroline Juran, RPh,

executive director, Virginia Board of Pharmacy, is the committee chairperson. Committee members include:

•Kevin Borcher, RP, Nebraska

• Lee Ann Bundrick, RPh, South Carolina

• Jay Campbell, JD, RPh, North Carolina

•Gayle Cotchen, PharmD, MBA, Pennsylvania

•Gay Dodson, RPh, Texas

• Lenna Israbian-Jamgochian, PharmD, Maryland

• James Koppen, RPh, Minnesota

• Susan Ksiazek, RPh, New York

•Alice Mendoza, RPh, Texas

•Tony Moye, BS, GeorgiaKevin Mitchell, RPh,

Ohio, will serve as an alternate. The Executive Committee liaison is Hal Wand, MBA, RPh, execu-

tive director, Arizona State Board of Pharmacy.

The Committee on Constitution and Bylaws will meet in April 2013. The charge of this com-mittee, as defined by the NABP Constitution and Bylaws, is to review pro-posed amendments to the Constitution and Bylaws, suggest changes where appropriate, and issue a recommendation for each proposed amendment.

Jeannine Dickerhofe, MS, RPh, president, Colorado State Board of Pharmacy, is committee chairperson. Committee members include:

•Troy Gahm, RPh, Ohio

•Gene Minton, RPh, North Carolina

•Charles Wetherbee, JD, Texas

•Dennis Wiesner, RPh, TexasPhyllis Stine, BS, of Tex-

as and Robert “Crady” Ad-ams, MBA, RPh, of Virginia will serve as alternates. Mark D. Johnston, RPh, executive director, Idaho State Board of Pharmacy is the Executive Committee liaison.

generally serve the needs of the public. Such attributes provide clear proof that the Board is an arm of the state, rather than a “franchisee licensed for some beneficial purpose.”

Accordingly, the Ala-bama Supreme Court re-versed the Court of Appeals and found the Board to be a

Legal Briefs(continued from page 193)

state agency for purposes of immunity principles under the Alabama Constitution.

While this case centers on the subject matter juris-diction of the state courts to hear an employment dispute under a contract theory (as opposed to adjudicating the employ-ment dispute through the Board of Adjustment), the overarching analysis of what constitutes a state

entity is significant in the regulatory community and could have impacted the application of immunity principles.

Based upon the Alabama Supreme Court decision rec-ognizing that the Board is an arm of the state, the 11th Circuit Court of Appeals, a federal court, also reversed its previous ruling that fol-lowed the conclusions of the state Court of Appeals and

previously found the Board was not an arm of the state. Versiglio v. Board of Dental Examiners, 2012 U.S. App. LEXIS 14437. The 11th Cir-cuit thus deferred to the Al-abama Supreme Court and also now finds the Board to be a state actor regarding the application of a Fair Labor Standards Act case and im-munity under the Eleventh Amendment of the US Con-stitution.

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Association News

Boards Report 1,329 Disciplinary Actions in Second Quarter 2012NABP continues to encour-

age the state boards of pharma-cy to report disciplinary actions to the NABP Clearinghouse. Required by the NABP Con-stitution and Bylaws, reporting these actions is an essential component to maintaining the

integrity of licensure transfer among the states.

To further assist the boards, NABP recently launched a new reporting tool that enables the boards to report disciplin-ary actions for pharmacists, pharmacy technicians, and

pharmacy interns through a secure Web application. In addition, those boards that have designated NABP as their reporting agent for the Na-tional Practitioner Data Bank and Healthcare Integrity and Protection Data Bank (HIPDB)

can utilize the reporting tool to transmit the disciplinary data directly to the federal data banks. More information on this tool is available in the June-July 2012 NABP Newsletter.

Second Quarter Reporting Results

During the second quarter 2012, the state boards of pharmacy reported a total of 1,329 disciplinary actions to the NABP Clearinghouse, an increase of 62.9% when compared to the 816 actions reported during the first quar-ter 2012. Of the 1,329 actions, 684, or 51.5%, of these were taken against pharmacists and the remaining 645, or 48.5%, were taken against pharmacy technicians.

Similar to the first quarter results, the admin-istrative or publicly avail-able fine/monetary penalty category accounted for the most actions reported with 285, or 21.4%, of the total 1,329 actions. Likewise, probation of license was the second most reported with 179, or 13.5%, of the actions reported. At 170, or 12.8%, revocation of license was the third most com-mon action reported to the Clearinghouse; however, the suspension of license and reprimand or censure cat-egories were not far behind with 12.7% (169) and 12.6% (167) of the total records, respectively. (See Figure A for a full breakdown of the actions taking during second quarter 2012.)

Data indicates that of all the actions taken during the

21.4%

13.5%

12.8%12.7%

12.6%

10.5%

7.7%

5.3%3.5%

Summary or Emergency Suspension of License (3.5)

Administrative or Publicly Available Fine/Monetary Penalty (21.4%)

Probation of License (13.5%)

Revocation of License (12.8%)

Suspension of License (12.7%)

Reprimand or Censure (12.6%)

Miscellaneous* (10.5%)

Voluntary Surrender of License (7.7%)

License Restored or Reinstated, Complete, Conditional, or Partial (5.3%)

Figure A: Disciplinary Actions Reported Second Quarter 2012

*The miscellaneous category includes denial of initial license; denial of license renewal; extension of previous licensure action; license restoration or reinstatement denied; limitation or restriction on license; modification of previous licensure action; other licensure action – not classified; reduction of previous licensure action; and summary or emergency limitation or restriction on license.

23.3%

12.2%

9.8%

8.1%6.4%

6.2%

5.4%

3.3%

6%

5.7%

3.2%3.2%

2.9% 2.3% 2%

Violation of Federal or State Statutes, Regulations, or Rules (23.3%)

Miscellaneous* (12.2%)

Diversion of Controlled Substance (9.8%)

Criminal Conviction (8.1%)

Fraud (6.4%)

Error in Prescribing, Dispensing, or Administering Medication (6.2%)

Failure to Comply with Continuing Education or Competency Requirements (6%)

Violation of or Failure to Comply With Licensing Board Order (5.7%)

Deferred Adjudication (5.4%)

License Revocation, Suspension or Other Disciplinary Action Taken by a Federal, State, or Local Licensing Authority (3.3%)

Alcohol and/or Other Substance Abuse (3.2%)

Practicing Without a License or Valid License (3.2%)

Allowing or Aiding Unlicensed Person to Practice (2.9%)

Narcotics Violations (2.3%)

Unauthorized Dispensing or Prescribing of Medication (2%)

Figure B: Basis for Disciplinary Actions Reported Second Quarter 2012

(continued on page 200)

*The miscellaneous category includes failure to cooperate with board investigation; failure to disclose; failure to pay child support/delinquent child support; immediate threat to health or safety; improper or inadequate supervision or delegation; negligence; nolo contendere plea; other – not classified; other unprofessional conduct; practicing beyond the scope of practice; substandard or inadequate care; substandard or inadequate skill level; and unable to practice safely.

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Clearinghouse(continued from page 199)

Association News

New PARE System Provides Boards with Objective Measure to Aid in Pharmacist Remediation Decisions

The Pharmacist As-sessment for Remediation Evaluationsm (PAREsm) is now available to all state boards of pharmacy, and NABP has met with members of boards of pharmacy to present informa-tion about PARE and how the boards can utilize this assess-ment tool for their specific needs.

NABP developed PARE to serve as an auxiliary tool for the boards in instances when an objective measure is needed to assist in deci-sions regarding pharmacist practice deficiencies or reentry or re-licensure after a brief departure from practice. Cre-ated to empower the boards’ decision-making in cases of

remediation, PARE provides a measure the boards can con-sider when determining con-ditional pharmacist practice licensure and can act as an aid in instances when a board is questioning a pharmacist’s adherence to pharmacy prac-tice standards.

When a board has deter-mined that an individual is required to take the PARE, the board will provide NABP with information resulting from a board order. The board will then contact the indi-vidual and notify him or her to contact NABP to register. Upon contacting NABP, examinees will be asked to verify personal informa-tion, submit payment for the

assessment, and will receive an instruction manual. After registration, the examinee will contact the board to schedule an assessment date and NABP will work with the board to set up the logistics of the admin-istration.

The 210 multiple-choice question assessment is admin-istered in an Internet-based format and is available for a two-week testing window approximately four times per year. Examinees have a maxi-mum of 4.5 hours to complete the assessment that contains three content domains: medi-cation safety and the practice of pharmacy, professional eth-ics/pharmacist judgment, and clinical pharmacy practice.

Each PARE administration costs $250.

The next available testing window is November 5-16, 2012. A listing of available testing windows for 2012 and 2013 is available on the NABP Web site at www.nabp.net/programs/assessment/pare. Boards seeking more infor-mation about PARE may con-tact the NABP Competency Assessment Department via e-mail at NABP_comp_assess@nabp.net.

information about phar-macists’ characteristics and needs, NABP may be able to better determine how the Association’s programs and services are being used by pharmacists and what

Pharmacy Workforce(continued from page 195)

changes can and should be made. Such information may also help foresee any challenges with its pro-grams and services – both new and old.

Although utilizing in-formation obtained by the state boards of pharmacy during the licensure appli-

cation process and obtain-ing information from CPE Monitor could possibly improve the results of the Survey and better uncover trends in the pharmacist workforce, no decision has yet been made regarding whether or not PWC will pursue these options.

For more informa-tion about PWC or to review the results from the 2009 Survey, visit the American Association of Colleges of Pharmacy Web site at www.aacp .org/resources/research/pharmacymanpower/pages/default .aspx.

second quarter, 23.3% (309) were taken due to violation of federal or state statutes, regulations, or rules. Con-sisting of several smaller cat-egories, the miscellaneous category held the second highest percentage overall with 12.2%. Another 9.8% (130) of the actions reported

during the second quarter were taken on the basis of diversion of controlled substances. (See Figure B for a full breakdown of the basis for action during second quarter 2012.)

Currently 32 boards of pharmacy have designated NABP as their HIPDB reporting agent; however, all boards of pharmacy are encouraged to utilize

the online tool to report pharmacy disciplin-ary actions to the NABP Clearinghouse regardless of whether NABP is their reporting agent.

Regularly updated, the NABP Clearinghouse is available to serve as a comprehensive resource for the boards of phar-macy. It houses a tremen-dous amount of disciplin-

ary data provided by the boards and tracks every-thing from the actions taken to the basis for the actions. More information on reporting to the NABP Clearinghouse, as well as designating NABP as a reporting agent for HIPDB, is available on the NABP Web site at www.nabp.net/programs/member-services/nabp-clearinghouse.

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Association News

NABP Seeks Nominations for 2013 Awards to Be Presented at the 109th Annual Meeting in St Louis, MO

Do you know an exem-plary colleague or a board of pharmacy that represents NABP’s mission of pro-tecting the public health? NABP is currently accept-ing nominations for the As-sociation’s 2013 awards that will be presented during the 109th Annual Meeting, to be held May 18-21, 2013, at the Hyatt Regency St Louis at the Arch in St Louis, MO.

Nominations are cur-rently being accepted for the following awards: 2013 Les-ter E. Hosto Distinguished Service Award (DSA), 2013 NABP Honorary President, 2013 Fred T. Mahaffey Award, and 2013 John F. Atkinson Service Award.

Lester E. Hosto DSA This award is the high-

est honor bestowed by the Association. Originally known as the Distinguished Service Award, it was renamed by NABP to serve as a memorial to the 1990-1991 NABP President Lester E. Hosto, whose motivating presence in the practice of pharmacy was recognized by practitioners of his state, pharmacy leaders across the nation, and former United States President Bill Clinton.

The Lester E. Hosto DSA recognizes those individu-als whose efforts to protect the public health greatly furthered the goals and objectives of NABP. Any individual who meets these criteria may be nominated for the DSA, regardless of

his or her member affilia-tion with NABP.

Honorary President Nominees who will be

considered for the position of honorary president must meet the following criteria:

• service on one or more NABP committee or task force;

• participation in NABP/American Association of Colleges of Pharmacy Dis-trict Meetings and NABP Annual Meetings;

• exemplary services for, or on behalf of, NABP;

• strong commitment to NABP, the mission of the Association to protect the public health, and the practice of pharmacy; and

• affiliation (either current or past) as a board mem-ber or as an administra-tive officer of an active or associate member board. Individuals submitting

nominations for the Honor-ary President must be made by an active or associate member board.

Fred T. Mahaffey Award

This award was named after the late NABP Execu-tive Director Emeritus Fred T. Mahaffey, who held the executive director posi-tion from 1962 to 1987. His leadership and contributions to NABP, state boards of pharmacy, and the protec-tion of the public health were significant and established NABP as one of the leading pharmacy organizations. The

award recognizes a board of pharmacy that has made substantial contributions to the regulation of the practice of pharmacy over the past year.

Boards considered for this award must have contrib-uted to protecting the public health and welfare through the enforcement of state and federal laws and regulations, and to the advancement of NABP goals and objectives as specified in the Association’s Constitution and Bylaws.

John F. Atkinson Service Award

Recipients of the John F. Atkinson Service Award are individuals who have provided NABP with exem-plary service in protecting the public health and have shown significant involve-ment with the Association related to pharmacy law and compliance. This award was named in honor of former NABP general counsel John F. Atkinson who served the Association for more than 40 years.

New Nomination Process

New this year, individuals wanting to submit a nomina-tion will be asked to fill out and complete a nomination form, which may be accessed by visiting the Meetings sec-tion on the NABP Web site at www.nabp.net/meetings. Directions for electronic sub-mission will be available on the online form or nomina-tion forms may be mailed to

the NABP Executive Direc-tor/Secretary Carmen A. Cat-izone at NABP Headquarters, 1600 Feehanville Dr, Mount Prospect, IL 60056.

Nominations for these awards must be received at NABP Headquarters no later than December 31, 2012. The NABP Executive Committee will review the nominations and select the honorary presi-dent and award recipients.

For more information, please contact the NABP Executive Office via e-mail at exec-office@nabp.net.

Henry Cade Memorial Award

In addition to the aforementioned awards, the Henry Cade Memorial Award will also be presented during the Annual Meeting. The NABP Executive Com-mittee selects a recipient(s) for this award who has sup-ported the goals and objec-tives of the Association and the state boards of pharmacy to protect the public health and advanced the safety and integrity of the distribution and dispensing of medica-tions. Nominations are not accepted for this award.

The Henry Cade Memo-rial Award is named in honor of the late Henry Cade, who served as NABP president from 1987 to 1988. Tireless in his efforts on behalf of NABP and the Illinois Division of Profes-sional Regulation – State Board of Pharmacy, Cade was also a long time phar-macy practitioner.

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Association News

Indiana Pilot to Increase PMP Use Sees Positive ResponseSelected prescription

monitoring program (PMP) users in Indiana are re-sponding favorably as they participate in a pilot project developed to increase the utilization of PMP data by leveraging the NABP PMP InterConnect® technology. On behalf of the Indiana Scheduled Prescription Elec-tronic Collection and Track-ing (INSPECT) program, NABP InterConnect worked with the Indiana Health Information Exchange (IHIE) to design the pilot as part of the national Enhanc-ing Access to Prescription Drug Monitoring Programs Project. Since the launch in early July 2012, authorized prescribers in the emer-gency room (ER) depart-ment at Wishard Hospital, Indianapolis, IN, have been able to access PMP reports through IHIE patient health

records without the added step of accessing INSPECT online.

As explained by lead investigator and Wishard ER doctor, John Finnell, MD, “It’s now a one-button click to see the data, as opposed to logging in to two differ-ent systems, entering the patient’s name, address, et cetera – it was easily a 10-minute process to look someone up in the [previ-ous] system.”

While the pilot is ongo-ing, INSPECT adminis-trators have already seen evidence of increased use of PMP data, as well as a positive response from PMP users in the ER. INSPECT typically generates about 5,000 patient reports per day. And with the launch of the pilot project, the average number of patient reports has increased by 500 per

day. Upon conclusion of the pilot, data tracked should provide more information on how the patient reports were used in making pre-scribing decisions.

INSPECT Director Marty Allain, Indiana Pro-fessional Licensing Agency, reports that the pilot is the first step in PMP data integration into health care systems. “The connection through the NABP Inter-Connect encourages use of PMP data by authorized prescribers by making it easier to access that data,” states Allain. “As hoped, ER doctors using the system, thus far have had a very positive response and see the technology as a time-saver that assists in providing quality patient care.”

Making the PMP data more easily accessible also benefits patient health, Al-

lain explains. PMP patient reports help prescribers to make the best treatment decisions for patients, and also help prescribers to iden-tify and provide appropriate care to patients who may be struggling with abuse or addiction. With the pilot technology, prescribers can more easily access this important data, without the additional burden of accessing the Web-based PMP to obtain a patient’s prescription history. Finnell also commented that stories from physicians “just in this short time have been quite dramatic,” and he believes if the program can be expand-ed, more doctors “can make better and more informed decisions about the care they deliver.”

Pharmacists and Technicians Encouraged to Register Now for CPE Monitor

CPE Monitor™ integration is well underway and soon all Ac-creditation Council for Pharmacy Education (ACPE)-accredited providers will require pharma-cists and pharmacy technicians to submit their NABP e-Profile ID and date of birth (MMDD) in order to obtain ACPE-accredited continuing pharmacy education (CPE) credit. In fact, many provid-ers have already integrated their systems and are requiring this information.

As of press time, more than:

• 950,000 CPE activity records are now stored in the CPE Monitor system

• 120 ACPE-accredited providers are actively transmitting CPE data electronically

• 188,000 pharmacists have created e-Profiles

• 103,500 pharmacy technicians have created e-Profiles

CPE Monitor is a national col-laborative service from NABP, ACPE, and ACPE providers that will allow

licensees to track their completed CPE credits electronically. It is anticipated that in 2013 the boards of pharmacy will be able to request reports on their licensees, eventu-ally eliminating the need for printed statements of credit for ACPE-ac-credited CPE.

To obtain an e-Profile ID, licens-ees may visit www.MyCPEmonitor .net, create an e-Profile, and register for CPE Monitor.

TM

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Association News

Collaboration and Stakeholder Input Contribute to Forthcoming Pharmacy Practice Site Accreditation Program

Standards for a pharmacy practice site accreditation will soon be finalized follow-ing the Center for Phar-macy Practice Accreditation’s (CPPA) call for input from pharmacists, health care sys-tem stakeholders, consumer groups, and patients.

As a partnership between NABP and the American Pharmacists Association (APhA), CPPA principals, policies, and standards have benefited from collaboration from initiation to implementa-tion. A community pharmacy practice accreditation concept was initiated by NABP in 2008 when the NABP Task Force to Review Accreditation Standards for Community Pharmacy convened to discuss possible standards. The task force recommended that the Association move forward with establishing a commu-nity pharmacy accreditation, and NABP began researching and planning for the initiative.

In 2010, the Association established a steering commit-tee, including APhA and many other stakeholders, to begin developing the principals and standards of the accredita-tion program. Under the guidance of that committee, NABP launched a demonstra-tion project to evaluate the draft program standards. The committee met in January and December of 2011 to approve the standards and evaluate the results of the demonstration project.

In March 2012, NABP and APhA partnered to establish CPPA in order

to develop and implement comprehensive programs of pharmacy practice site accreditation. CPPA has contracted with APhA to continue development of consensus-based standards for the accreditation.

The standards benefited from input from a wide variety of commenters, and also from the work of the program’s four support-ing committees, which are composed of a broad group of stakeholders.

The CPPA Board of Di-rectors oversees the develop-ment and implementation of the pharmacy accreditation program, and is staffed with equal representation from NABP and APhA. Members include:

• Chair: Thomas E. Me-nighan, BSPharm, MBA, ScD (Hon), FAPhA, Executive Vice President and CEO, APhA

• Lowell Anderson, DSc, FAPhA, Professor, De-partment of Pharma-ceutical Care and Health Systems, University of Minnesota

• Baeteena Black, DPh, Executive Director, Ten-nessee Pharmacists As-sociation

• Carmen A. Catizone, MS, RPh, DPh, Executive Director/Secretary, NABP

• Patricia Flemma Donato, RPh, President/Member, Capital Pharmacy Con-sultants, LLC

• Dan Luce, MBA, RPh, National Director of Phar-macy Affairs, Walgreens

The CPPA Standards De-velopment Oversight Com-mittee is chaired by APhA and responsible for the strate-gic oversight of standards de-velopment and maintenance. Members include:

• Chair: Marialice Bennett, RPh, FAPhA, Professor of Clinical Pharmacy, The Ohio State University Col-lege of Pharmacy

• Howard C. Anderson, Jr, RPh, Executive Director, North Dakota State Board of Pharmacy

• Robert Greenwood, BSPharm, President and CEO, Greenwood Drug, Inc

• Edward McGinley, MBA, RPh, Vice President of Pharmacy, Chain Drug Consortium, LLC and NABP Executive Com-mittee Member

• Elliott Sogol, PhD, RPh, FAPhA, Group Manager, Professional Services, Target Corp.

• Theresa Tolle, RPh, FAPhA, President, Bay Street Pharmacy, Inc

• Jeanne D. Waggener, RPh, Pharmacy Manager, Wal-Mart Pharmacy and NABP Executive Com-mittee MemberThe CPPA Process

Oversight Committee is led by NABP and will develop and implement an accredita-tion process based upon the consensus-based pharmacy practice accreditation stan-dards. Members include:

• Chair: Malcolm J. Brous-sard, RPh, Executive Director, Louisiana Board

of Pharmacy, and NABP Executive Committee Chairperson

•Mark Boesen, PharmD, Specialist, University of Arizona Medication Man-agement Center

•Matt Osterhaus, BSPharm, FASCP, FAPhA, Co-owner, Oster-haus Pharmacy

• Rich Palombo, RPh, Senior Director of Regu-latory Affairs, Express Scripts.

•Walt Slijepcevich, RPh, Senior Director Pharmacy Development, Pfizer, Inc

• Donna S. Wall, PharmD, BCPS, Clinical Pharma-cist, Indiana University Hospital The APhA Community

Pharmacy Practice Standards Development Working Com-mittee is composed of diverse stakeholders representing different sectors of pharmacy practice. This committee will continue development of the standards for community pharmacy practice accredita-tion, utilizing the work done by NABP and APhA, and will use a consensus-based process including a public comment period. Members include:

• Chair: Marialice Bennett, RPh, FAPhA, Professor of Clinical Pharmacy, The Ohio State University Col-lege of Pharmacy

• Jose Cervantes, PharmD, Assistant Manager, Pharmacy Professional Services, H-E-B Grocery Company, LP

(continued on page 207)

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PRESCRIPTION DRUG SAFETY®

AWARxE News

Internet Sites and Community Educators Bring AWARxE Message Across America

Reaching millions of consumers on the Internet and concentrated audi-ences of consumers at local events, AWARxE® has continued various efforts to help raise awareness about online counterfeit drug dangers and preventing prescription drug abuse.

AWARxE’s Internet Public Service Announce-ment campaign had a potential audience reach of over 48 million consumers when it concluded in mid-August 2012. The campaign included AWARxE public service announcement Web banner placements on Web sites including Lifescript .com, Goodhousekeeping .com, Reuters.com, USATO-DAY.com, and Health.com. In addition, the campaign included a social media press release with links to AWARxE videos and the AWARxE Web site, as well as several guest article posts by Internet bloggers.

Reaching out to com-munities across America, the Get Local section of the AWARxE Web site has been expanded to include pages for over 30 states. State pages include information on

• local medication disposal programs;

• AWARxE consumer education events hosted by boards of pharmacy,

pharmacy associations, and college students; as well as

• educational materials developed by local phar-macy students.

AWARxE EventsThrough commu-

nity expos and educa-tional events, AWARxE also continues to raise aware-ness about how to prevent prescription drug abuse by safely disposing of unused medications. Throughout July, August, and Septem-ber, AWARxE encouraged consumers to participate in the Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day that will take place Saturday, Sep-tember 29, 2012. Pharma-cists, board of pharmacy members, and NABP staff provided AWARxE infor-mation to attendees at the following events:

•Community Health Fairs, Central Missis-sippi, 2012 Pharmacist Kennan LeSure of Clinton, MS, provides attendees at local health fairs AWARxE information on preventing abuse through proper dis-posal, Internet drug outlet dangers, and the importance of the

pharmacist. Penny Woodbury, staff officer, Mississippi Board of Pharmacy, is familiar with LeSure’s involve-ment as a frequent pharmacist educator at community health fairs, and recommended that LeSure utilize AWARxE resources. Woodbury learned about AWARxE while attending the NABP Program Review and Training on July 25, 2012.

•School Resource Of-ficer(SRO)Training,Ohio, August 6, 2012 and October 26, 2012 As part of a new SRO training, Jesse Wim-berly, compliance agent, Ohio State Board of Pharmacy, will pres-ent information on prescription drug abuse among teens, including AWARxE facts on where teens obtain drugs and the scope of the problem.

•Senior Lifestyle Expo, Oakbrook Terrace, IL, Au-gust 21-22, 2012 NABP staff pro-vided attendees with information on Internet drug outlet dangers

and prescription drug abuse, and encouraged participation in the DEA Take-Back Day.

•Mesa Public Schools, Arizona, PTO Red Rib-bon Week, October 15-19, 2012 Pharmacist Kerry Conway has coordi-nated a red ribbon week event that will include an AWARxE anti-prescription drug abuse presentation to middle school-aged students, appropriate education for younger students, and AWARxE silicon bracelets alert-ing students and parents of AWARErx.org as a resource. Conway will also educate parents and teachers and provide them with AWARxE bookmarks.

GET INFORMED | www.AWARErx.org

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205

State Board News

Louisiana Board Adopts New Rules

The Louisiana Board of Pharmacy adopted new rules related to pharmacist-in-charge (PIC) require-ments, cognitive services, hospital and penal phar-macies, and remote order processing. Board rules now require a PIC to have accumulated at least two years of licensed practice as a pharmacist and be present and practicing in that phar-macy at least 20 hours per week during the pharmacy’s ordinary course of busi-ness, or in the alternative, at least 50% of the pharmacy’s normal business hours of operation.

Rules relating to label-ing requirements for medi-cations prepackaged in a hospital pharmacy and the labeling of sterile prepa-rations compounded in hospital pharmacies were also amended. The Board created a new rule that will allow penal pharmacies to recycle unused prescrip-tion drugs it dispenses to its own inmates, subject to prevailing professional practice standards, instead of the previous require-ment to destroy all such drugs. Finally, Board rules were amended to allow remote order processing at any time in all pharma-cies. These rule changes became effective May 20, 2012. More information about these rules is avail-able in the Library section of the Louisiana Board of Pharmacy Web site, www .pharmacy.la.gov, under Public Notices.

Tech Training Required in Minnesota

Effective January 1, 2014, the Minnesota Board of Pharmacy will not renew the registration of a pharmacy technician who was initially registered after January 1, 2013, or who was initially registered prior to that date but did not maintain con-tinuous registration, unless the individual has completed a pharmacy technician training program. Several types of training will be acceptable, one of which is an employer-based program that includes a minimum of 240 hours in a one-year period of both theoretical and practical instruction. An employer that uses an internal training program must develop and regularly update a technician training manual that must be avail-able for Board inspection.

The Minnesota Board adopted standards for employer-based training programs at its June 20, 2012 meeting. Information about the standards is avail-able in the Board’s July 2012 Newsletter at www .nabp .net/publications/assets/MN072012.pdf.

Tramadol Products Moved to C-IV in Oklahoma

Effective November 1, 2012, tramadol and all tra-madol-containing products will be classified as Sched-ule IV in the state of Okla-homa. Oklahoma-licensed pharmacies will be required to take an inventory of

their tramadol products on November 1, and keep it with their annual con-trolled dangerous substance inventory. Pharmacies are also required to start submitting all tramadol prescription information to the prescription monitoring program (PMP) as required by Oklahoma Bureau of Narcotics and Dangerous Drugs rules beginning November 1, 2012.

Virginia Legislature Reports PMP Updates

Effective July 1, 2012, Virginia’s PMP law has been modified. Under the amended law, the method of payment for a controlled substance prescription is now a required element for reporting to the PMP. In ad-dition, the new law removed the restriction on how many licensed health care professionals a prescriber could designate to serve as a delegate. The changes also expanded access to all fed-eral law enforcement with drug diversion investigatory authority and the existence of a specific open investiga-tion related to a specific per-son, prescriber, or dispenser. Further, the amended law expanded the authority of the PMP to allow the send-ing of unsolicited reports on patients who meet or exceed certain criteria to the Drug Diversion Unit of the Virginia State Police.

West Virginia Implements Changes in PMP and PSE Rules

New legislation in West Virginia has prompted

several changes to the West Virginia Controlled Substances Monitoring Program (CSMP), and to the Methamphetamine Laboratory Eradication Act.

Under the new law, the West Virginia Board of Pharmacy may require reporting of all Schedule II through IV controlled substance prescriptions to the CSMP within 24 hours of dispensing. As such, the Board prepared emer-gency rules that modified Series 8 of the rules to that effect. The new law also requires filing “zero” reports if a pharmacy does not have any dispensings within 24 hours of the prior reporting, and does not have a waiver from reporting.

Regarding the sale of methamphetamine pre-cursors – pseudoephed-rine (PSE) or ephedrine containing products – West Virginia will move to the national real-time point-of-sale database commonly referred to as National Precursor Log Exchange or MethCheck by January 1, 2013. Also, the new law limits the amount of grams a person may purchase in any 30-day period to 7.2 grams, and to no more than 48 grams in any one-year pe-riod. Also, effective June 8, 2012, on every sale of PSE or ephedrine products from behind the counter, an offer to counsel the purchaser must be given. Pharmacies will need to modify their processes accordingly.

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Professional Affairs Update

Gilead Products Distributed by MIC Potentially Suspect Due to Possible Tampering

In July 2012, Gil-ead Sciences, Inc alerted pharmacies about three instances in which patients returned bottles of Gilead products after discovering that the bottles contained a different product than the product listed on the label. In a letter to phar-macies, Gilead provides additional details about the three instances. Gilead also indicates that “Based on our investigation, in all three cases, we have con-cluded that the pharmacies purchased the products that were labeled as Gilead Viread and Atripla from Minnesota Independent Cooperative (MIC). MIC does not buy product di-rectly from Gilead, and we are unaware of the source of the product obtained by MIC.”

Gilead recommends that if you have obtained Gilead product from MIC that you verify its au-thenticity by conducting a visual inspection, and request a pedigree for each product to determine its distribution history. Fur-ther, Gilead recommends that if pharmacies have dispensed Gilead product from MIC to patients, patients should be advised to return the product to the pharmacy for visual inspection. Any potential-ly suspect bottles can be reported to Gilead Medi-cal Information by call-

ing 800/445-3235 (select option 2) or by sending an e-mail to medical information@gilead.com. Adverse events following or coincident with the use of any Gilead product may be reported to Gilead Sciences Drug Safety and Public Health by call-ing 800/445-3235 (select option 3), or to the Food and Drug Administration (FDA) MedWatch Program by calling 800/322-1088 or by completing an online report at https://www .accessdata.fda.gov/scripts/medwatch. The Gilead letter to pharmacies is available in the Newsroom on the NABP Web site at www.nabp.net/news/assets/Prod_Info_Notification_Pharmacies_WM.pdf.

FDA Database Provides Information on Pediatric Medications

An FDA database provides information on pediatric medications, making it easier for both health care providers and caregivers to locate this information. The Pediat-ric Labeling Information Database is a one-stop resource, where providers and caregivers can search for information by the product’s commercial or chemical name, or by the condition for which it was studied. The database was developed by FDA’s Office of Pediatric Therapeutics (OPT), in collaboration with the Center for Drug Evaluation and Research. The OPT also provides a Safety Reporting page with

information on products that have been tied to safety problems that spe-cifically relate to children. Additional information and a link to the database is available in the Consum-er Updates section of the FDA Web site at www .fda.gov/ForConsumers/ConsumerUpdates/ucm305040.htm.

Contraception Products Sold Online With No Prescription

Health care provid-ers should help to educate patients about the risks of prescription contraceptive products marketed online as “no prescription” and “over-the-counter” prod-ucts, pharmaceutical secu-rity researchers conclude. A study by these research-ers found that Google searches returned results for prescription contracep-tive products such as injec-tions, oral contraceptives, and patches, as well as in-trauterine devices (IUDs). All of these products were marketed as available with-out a prescription and re-searchers found that sellers provided links to YouTube videos with IUD instruc-tions. The researchers also found that these products were being promoted on social media chan-nels, including Facebook, Twitter, SlideShare, and Flickr. Researchers Bryan A. Liang, MD, JD, PhD, Tim K. Mackey, MAS, and Kimberly M. Lovett, MD, conclude that such online contraceptive sales rep-resent patient safety risks

and also suggest that policy makers should “employ legal strategies to address these systemic risks.” The study, “Suspect Online Sellers and Contraceptive Access,” is available in the May 25, 2012 issue of Contraception.

PTCB Offers Program for Pharmacy Technician Educators

The Pharmacy Techni-cian Certification Board (PTCB) announced the launch of a new program designed for pharmacy technician educational institutions and training programs that provide classroom instruction, position students for em-ployment in the evolving health care system, and prepare individuals to par-ticipate in PTCB’s national certification program. The Educator Program will offer participants free individual verification of a pharmacy technician’s cer-tification status, monthly newsletters, recogni-tion on PTCB’s Web site, discounts on the Official PTCB Practice Exam, and quarterly School Perfor-mance Reports to track class performance on the Pharmacy Technician Certification Exam. Addi-tional information and in-structions for participating in the program are avail-able in a news release on the PTCB Web site at www .ptcb.org/AM/Template .cfm?Section=Press_Releases_Post&Template=/CM/HTMLDisplay .cfm&ContentID=4854.

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october 2012

Association News

CPPA Overview and Update(continued from page 203)

• BJ Cobb, BSPharm, Pharmacy Pro-fessional Services Manager, Winn-Dixie Stores, Inc

• Tracy Furgiuele, BSPharm, Senior Vice President & Chief Pharmacist, Express Scripts

•Margherita R. Giuliano, RPh, CAE, Executive Vice President, Connecticut Pharmacists Associa-tion

• Jeff Goad, PharmD, MPH, Associ-ate Professor & Vice Chair, Univer-sity of Southern California, School of Pharmacy

• Stuart Haines, PharmD, BCPS, BCACP, BC-ADM, Professor, Vice Chair for Clinical Services, University of Maryland School of Pharmacy

•Brian C. Jensen, RPh, FACA, Consultant, Lakeshore Apotha-care Inc/Pharmacy Solutions

•Dan Kennedy, RPh, FAPhA, Outpatient Pharmacy Operations Manager, Oregon Health and Sci-ence University

•Brian K. Komoto, PharmD, Presi-dent and CEO, Komoto Healthcare

•Winnie Landis, BSPharm, CDE, FAPhA, Pharmacist, CVS/ Pharmacy

•Debbie Mack, RPh, CHC, Di-rector, Corporate Compliance, Health and Wellness Practice Compliance, Wal-Mart Stores, Inc

• Lynnae Mahaney, MBA, RPh, FASHP, VHA-CM, Assistant Chief, Pharmacy Services, William S. Mid-dleton Memorial Veterans Hospital

• Sandy Markwood, Chief Execu-tive Officer, National Association of Area Agencies on Aging

• Bill Osborn, PharmD, President, Osborn Drugs, Inc

•Mike Podgurski, RPh, Vice Presi-dent Pharmacy Operations, Rite Aid Corp.

• John Thornton, BSPharm, Direc-tor, Pharmacy Initiatives, Blue Cross Blue Shield

• Laura White, BSPharm, Pharma-cy Networks – Provider Relations, Humana, Inc CPPA will contract with NABP to

administer the accreditation process.

NABP and APhA are equal repre-sentatives and share responsibility in CPPA.

CPPA is scheduled to make the accreditation program available to ap-plicants by the end of 2012.

Individuals Sought to Safeguard Integrity and Validity of NABP Examinations as Members of ACE

NABP is currently accepting ap-plications from individuals interested in serving on the NABP Advisory Committee on Examinations (ACE). Established by NABP in 1912, this standing committee was created to safeguard the integrity and validity of NABP examinations.

ACE typically convenes three to four times per year to oversee the de-velopment and administration of all NABP examination and certification programs. In addition, ACE considers policy matters, evaluates long-range planning strategies, and recommends appropriate action to the NABP Ex-ecutive Committee.

To be considered for ACE, an individual must hold an active, unrestricted pharmacist license in any state or territory of the United States and meet at least one of the following criteria:

• be a member or administrative of-ficer of an active member board of pharmacy;

• have served within the last five years as a member or administra-tive officer of an active member board of pharmacy;

• be a practicing pharmacist; or

• serve as pharmacy school faculty. Open positions on ACE are deter-

mined by the current composition of

the committee and in accordance with NABP policy. Each ACE appointment is for a three-year term beginning June 1, 2013.

Interested individuals are asked to submit a written statement of interest and a current résumé or curriculum vitae to NABP Executive Director/Secretary Carmen A. Catizone at NABP Headquarters, 1600 Feehan-ville Drive, Mount Prospect, IL 60056 or exec-office@nabp.net no later than December 31, 2012.

Please contact the NABP Com-petency Assessment Department at NABP_comp_assess@nabp.net with any questions regarding ACE.

Newly Accredited VIPPS FacilityThe following Internet pharmacy was accredited through the NABP Verified Internet Pharmacy Practice Sitescm (VIPPS®) program:

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

AmeriPharm, Inc dba MedVantx Pharmacy Serviceswww.medvantxrx.com

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

nabp newsletter

New York Board Wins Survey of Pharmacy Law Luncheon DrawingNABP would like to congratulate the New York State

Board of Pharmacy for winning the 2013 Survey of Phar-macy Law Luncheon Drawing. The Board was awarded $125 toward a Board member and staff luncheon for returning updates to the Survey by the July 23 deadline. These important updates are requested annually by NABP to all the boards of pharmacy for inclusion into each updated Survey’s issue. NABP would like to thank

all boards for their participation, which makes the publi-cation a valuable resource for many.

Revised and published each December, the Survey of Pharmacy Law serves as a convenient reference source for individuals who require an overview of laws and regulations that govern pharmacy practice in 53 juris-dictions. For more information about the Survey, visit www.nabp .net/publications.