January 05 Newsletter2 - nabp.pharmacy · nabp newsletter 4 (continued on page 5) Legal Briefs Takes One to Know One By Dale J. Atkinson Attorney Dale J. Atkinson is a partner in

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2005

In This Issue. . . .Association News:

January 2005 / Volume 34 Number 1

Prescription Drug Importation Update: Oregon Proposes Novel Program

(continued on page 2)

3 4 6 10

NABP Educates Pharmacy Industry on New VAWD Program, Begins Pilot Inspections

This Month on www.nabp.net:Special ItemsNominees for Open Member Positions on NABP’s 2005-2006 Executive Committee

NABP’s 101st Annual Meeting Travel Grant Application

Download the National Specifi ed List of Susceptible Products

HeadlinesNABP Educates Pharmaceutical Industry on New VAWD Program

Examinations2005 NAPLEX/MPJE Registration Bulletin

Upcoming MeetingsFriday-Sunday, January 21-23, 2005MPJE State-Specifi c Review MeetingThe James HotelScottsdale, AZ

Saturday-Tuesday, May 21-24, 2005NABP’s 101st Annual MeetingSheraton New Orleans HotelNew Orleans, LA

Sunday-Tuesday, August 7-9, 2005NABP/AACP District III MeetingMarriott HotelKnoxville, TN

Thursday-Saturday, August 11-13, 2005NABP/AACP District V MeetingMinneapolis, MN

Takes One to Know One

Legal Briefs: Feature News: 101st Annual Meeting: ‘The Big Easy’ Provides Rich Backdrop for 101st Annual Meeting Attendees

In accordance with amendments to the NABP Constitution and Bylaws adopted at the 100th Annual Meeting and Centennial Celebration in April 2004 in Chicago, IL, nominees for open Executive Committee member positions were determined at District meetings held in late summer and fall 2004. Those Districts with open member positions for the 2005-2006 Executive Committee include Districts I, III, IV, and VIII. Open Executive Committee offi cer positions include treasurer and president-elect. All open Executive Committee member and offi cer positions will be voted upon at NABP’s 101st

2005-2006 Open Executive Committee Positions Announced, New Nomination Process in Effect

Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel, New Orleans, LA.

Those individuals nominated at the District meetings for open Executive Committee member positions will be included on the fi nal ballot for the Executive Committee at the Final Business Session on Tuesday, May 24, 2005. Nominations for these open member positions will also be taken from the fl oor at the Annual Meeting in accordance with the Nominating Procedures listed later in this article. The nominees determined during the District meetings include:

District I l Susan M. DelMonico,

Rhode Island Board of Pharmacy

l John R. Dorvee, Jr, Vermont Board of Pharmacy(The term length for the District I position will be a two-year term.)

District III l Reginald B. “Reggie”

Dilliard, Tennessee Board of Pharmacy

District IV l William T. Winsley, Ohio

State Board of PharmacyDistrict VIII l Patricia F. Harris,

California State Board of Pharmacy

l Kathryn H. “Katie” Craven, Nevada State Board of Pharmacy

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

Association of Boards of Pharmacy (NABP) to educate, to inform, and to communicate the objectives and programs of the Association and its 66 member boards of pharmacy to the profession and the public. The opinions and views expressed in

this publication do not necessarily refl ect the offi cial views, opinions, or policies of NABP or any board

unless expressly so stated. The subscription rate is $35 per year.

National Association of Boards of Pharmacy

1600 Feehanville Drive Mount Prospect, IL 60056

847/391-4406www.nabp.net

[email protected] A. Catizone

Executive Director/SecretaryReneeta C. “Rene” Renganathan

Editorial Manager

© 2005 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.

Executive CommitteeDonna S. Wall Chairperson, District IV

Donna M. HornPresident, District I

Dennis K. McAllisterPresident-elect, District VIII

Lawrence H. MokhiberTreasurer, District II

Charles Curtis BarrMember, District V

Michael A. MonéMember, District III

Richard A. PalomboMember, District II

Oren M. Peacock, JrMember, District VI

Gary A. SchnabelMember, District VII

Charles R. YoungMember, District I

Association News

Executive Committee Member Nominating Procedures

The Nominating Procedures were adopted to ensure the uniformity of procedures among NABP Districts and guarantee the validity of the nomination process. The amendments to the Constitution and Bylaws call for Executive Committee member position nominations to occur at the District meeting of the respective open position. A maximum of two nominated candidates per District may be slated for election to Executive Committee member positions at the following NABP Annual Meeting. Offi cer nominations and elections will continue to be held at the Annual Meeting.

In 2004, Districts I, III, IV, and VIII used the new Nominating Procedures and designated candidates for the open Executive Committee member positions.

Following is the detailed process for open Executive Committee member positions.

Candidate Qualifi cations

In order to be considered for nomination, individuals must meet three preliminary criteria:

l The individual must be an affi liated member

Open EC Positions(continued from page 1)

(administrative offi cer or board member) of the Association serving on a board of pharmacy of an active member state at the time of nomination and election;

l The individual must not, in addition to his or her board of pharmacy activities, currently serve as an offi cer, offi cial, or board or staff member for any national or state pharmacy organization; and

l The individual must not have a confl ict of interest with the purpose, mission statement, and operation of NABP.

To be considered for nomination, individuals who meet these preliminary qualifi cations should submit a letter of intent to the NABP executive director/secretary, the District NABP chairperson, and the District secretary at least 20 days prior to the opening date of the District meeting. This includes a short (no longer than one page) narrative highlighting relevant experience and attributes that qualify the affi liated member for consideration, the expiration date for the individual’s term on the active member board, and a current resume or curriculum vitae. NABP staff will screen applicants to determine if they are qualifi ed; notice of qualifi ed candidates will be forwarded to the District NABP chairperson, District

secretary, and the individual nominees prior to the fi rst day of the District meeting. Candidate information will be available for distribution at District meetings.

District VotingOf the candidates

qualifi ed for nomination, each District may choose to nominate one or two individuals to be slated for the fi nal Executive Committee election at NABP’s Annual Meeting. To determine which members will be on the fi nal ballot, each District will conduct a written-ballot election during a Board Business Session at the District meeting. Before the District’s active member delegates vote, candidates will have the opportunity to address the boards during the Board Session for no longer than two minutes to provide additional information about themselves and their interest in serving on the Executive Committee.

Voting eligibility is similar to that used at NABP’s Annual Meeting:

l Each active member board will select one delegate.

l Active member boards may only cast one vote per board per nominee.

l The vote shall be cast by the offi cial delegate of the active member board.

l No voting by proxy shall be permitted.

l The offi cial delegate may be changed by

(continued on next page)

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Association News


completing and submitting a change of delegate form (provided by NABP) to the NABP District chairperson prior to voting.

The two candidates receiving the majority of votes of the active member boards, provided that a minimum of four boards of pharmacy are present, shall be the District nominees.

Nominations from the Floor

Nominations for each open District member position, in addition to nominations provided by the Districts, may be made from the fl oor provided individuals submit notice at least 30 days prior to the Annual Meeting to the NABP executive director/secretary in accordance with Article IV, Section 3(c)(ii) of the NABP Constitution and Bylaws. The results of the election must be submitted on the District Meeting Nomination

Reporting Form to the NABP executive director/secretary no later than 60 days prior to the NABP Annual Meeting. The election and installation of Executive Committee members will take place at the following NABP Annual Meeting.

2006-2007 Executive Committee Open Member Positions

In 2005, the nominating process will begin for the District VI and VII open member positions of the 2006-2007 Executive Committee; elections

will be held at the 102nd Annual Meeting in 2006. During the 2005 District VI and VII meetings, members will vote upon nominations for the respective open Executive Committee member positions.

For more information about the new procedures for nominating and electing Executive Committee members, visit the Association’s Web site at www.nabp.net, contact the Executive Offi ce at 847/391-4406, or e-mail [email protected].

Open EC Positions(continued from page 2)

As the launch date for NABP’s Verifi ed-Accredited Wholesale Distributors™ (VAWD™) program approaches, the Association has been familiarizing key stakeholders with the details of the new accreditation program. On November 4, 2004, NABP, in partnership with BuzzeoPDMA, introduced VAWD to pharmaceutical manufacturers during a seminar in Iselin, NJ. Also in November and December, NABP performed three pilot inspections of wholesale distributors’ facilities to refi ne its inspection processes. The program, which the Association developed to help protect

NABP Educates Pharmacy Industry on New VAWD Program, Performs Pilot Inspections

the public from the threat of counterfeit drugs infi ltrating the United States’ drug supply, accredits wholesale distributors in accordance with VAWD and state and federal laws.

Educational SeminarGeared for pharmaceutical

manufacturers, NABP’s educational seminar was well received by the attendees, which included representatives from security, compliance, quality assurance, customer service, trade relations, government affairs, and legal counsel departments of pharmaceutical manufacturers as well as state regulators,

Food and Drug Administration (FDA), and the manufacturers’ trade association, Pharmaceutical Research and Manufacturers of America. Numerous participants expressed support for the program and a strong interest in recommending that their companies require VAWD accreditation for their wholesale distributors. One attendee noted that VAWD criteria and guidelines would soon become the accepted industry standard; another noted that adhering to VAWD would “ensure [the] integrity of [the] fi nished [pharmaceutical] product.”

The representatives in attendance learned about the NABP Model Rules for the Licensure of Wholesale Distributors, which are part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy; the VAWD accreditation program including a review of the facility inspection process; state regulations pertaining to wholesale distributors; and a review of US v RxBazaar, a recent federal case involving wholesale distributors that were convicted of violations of the Prescription Drug Marketing Act. An interactive question-and-

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Legal Briefs

Takes One to Know OneBy Dale J. Atkinson

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

The State A Pharmacy Practice Act requires that certifi ed pharmacy

technicians be registered with the board of pharmacy. Among the requirements for registration are:

1. Graduation from a technician training educational program approved by the board;

2. Documentation by the pharmacist-in-charge of the pharmacy where the applicant is employed that the applicant has successfully completed a training program having assessment mechanisms approved by the board; and

3. Successful completion of an examination approved by the board.

Certifi ed pharmacy technician Jones is charged by the board of pharmacy with violations of standards of practice and engaging in unethical conduct. At the hearing the board introduces, as an expert witness, a pharmacist to establish standards of practice that a certifi ed pharmacy technician should meet in the practice. The pharmacist is not a board member but was selected because he teaches a course at the local community college on law and ethics, a part of the technician curriculum. The attorney representing Jones objected

to the witness testifying as an expert since he is not a registered certifi ed pharmacy technician. Jones was ultimately convicted and disciplined by the board. He appealed to the court based upon his objection to the expert witness.

Jones contends that only a registered certifi ed pharmacy technician can qualify as an expert in testifying as to the standards of practice for a technician, a contention that, at fi rst glance, would almost appear ludicrous. While judicial precedents set in civil actions do not commonly affect administrative hearings, an interesting civil decision has been considered by the Appellate Court of Illinois involving an issue similar to the above scenario.

In a wrongful death action brought by the estate of a patient (plaintiff) who died after surgery, malpractice was alleged against the hospital and numerous physicians based on the conduct of the hospital nursing staff. The plaintiff introduced

testimony through licensed physicians as to the standards applicable to nurses in post-operative care. The hospital appealed an adverse judgment claiming a licensed physician is not an appropriate expert in testifying as to the standards of practice of nurses.

Citing previous judicial fi ndings, the appellate court of Illinois found that to testify as an expert in the medical arena, the witness:

1. must be licensed in the same health arena as the practitioner; and

2. must be familiar with the methods, procedures, and treatments ordinarily observed by health care providers in the practitioner’s community of practice. Once these factors have

been reviewed, it lies within the sound discretion of the trial court to determine if the witness is qualifi ed to testify as an expert regarding the standard.

The court noted that nursing is a unique facet of medicine and found that a physician who is not a nurse is no more qualifi ed to testify as to the standard of care of a nurse than a nurse would be in regard to testifying as to the standard of care of a physician. It stressed the fact that nurses

january 2005

5

Association News

are graduates of accredited nursing programs, are required to pass a licensure examination, and must meet other requirements in order to become licensed.

The court was concerned that if physicians were allowed to testify as to the standards of care of nursing, the danger is that a higher standard of care may be imposed upon the nursing profession than the law would expect

or require. The court recognized the rigidity and formalistic aspects of the rule that an expert witness be required to be licensed in a specifi c profession to testify as to standards of care of that profession, but indicated it was required to follow the judicial precedent of the Supreme Court of the State of Illinois, which had established this requirement in previous decisions.

One judge on the three-judge panel that was deciding the case concurred with the decision while one dissented.

Is it likely that a court would disqualify a pharmacist as an expert concerning the standards of practice of pharmacy technicians in State A where a technician: 1. is required to be a graduate of an educational program approved by the board; 2. has passed an examination; and 3. has successfully completed a training program to be eligible for registration? Would a court view expert testimony any differently than that of a physician

testifying as to the standards of care of nurses? Should a board of pharmacy eliminate all doubt and introduce a registered technician to testify as an expert? Can the board rely on the pharmacists sitting on the board as experts in respect to the standards of practice of technicians? All of the above?

Stay tuned.

Garley v Columbia LaGrange Memorial Hospital, 813 N.E. 2d 1030, 286 Ill. Dec. 337

Legal Briefs(continued from page 4)

NABP has renewed its contract with Prometric to administer the Association’s North American Pharmacist Licensure Examination™ (NAPLEX®) and Multistate Pharmacy Jurisprudence Examination® (MPJE®) for the years 2005, 2006, and 2007. The terms of the contract dictate a small increase in examination administration and base fees for candidates in 2006; however, fees will remain at the current rate throughout 2005.

The Association renewed its contract with Prometric, formerly known as The Chauncey Group International, because of the continuum of services and responsible test security the company provides. Another benefi t

NAPLEX/MPJE Vendor Contract Renewedto retaining Prometric as the examination vendor is that the company will be transitioning the test delivery driver to present a modern display and provide a uniform and consistent look for both examinations. The updated technology will be in place before the end of 2005.

Beginning January 1, 2006, candidates sitting for the NAPLEX will pay a base fee of $325 and a vendor administration fee of $140 for a total registration fee of $465; MPJE candidates will pay a base fee of $120 and a vendor administration fee of $65 for a total registration fee of $185. The change in examination fees is due to an increase in vendor fees and steadily rising examination development fees. NAPLEX

and MPJE base fees offset and support costs for examination development and registrations, and help support non-revenue member services including meetings and publications. Vendor fees relate to the use of the test center and the on-site activities relating to the examination experience. NABP’s examination fees will not increase in 2005 and remain at the same cost that has been in effect since 2003.

“We have had a successful relationship with Prometric since the development of the computer-adaptive NAPLEX in 1996, which went live in 1997,” says NABP President Donna M. Horn. “We continue to work with Prometric to provide the states and

examination candidates with quality service in the years to come.”

Prometric, a part of The Thomson Corporation, is a global leader in technology-enabled testing and assessment services for academic, professional, government, corporate, and information technology markets. It has a network of site-based testing facilities throughout the United States and online and real-time registration services. In 2003, Prometric delivered more than eight million examinations.

For more information on the NAPLEX and MPJE, visit NABP’s Web site at www.nabp.net, or contact the Customer Service Department at 847/391-4406 or [email protected].

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Feature News

Prescription Drug Importation Update: Oregon Proposes Novel Program

Importing prescription drugs from Canada and other countries has been

a hot-button issue throughout 2004 and shows no signs of ceasing in 2005. Even though the United States Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) had, as of press time, not changed their prohibition on reimportation due to public safety concerns, an increasing number of state and local offi cials across the country are establishing avenues through which their citizens may purchase prescription medications from outside the US. This proliferation of government-sponsored plans for providing access to drugs from outside the US raises important public safety issues for state boards of pharmacy.

In the August 2004 NABP Newsletter, the Association noted that 13 states and several cities were in the planning stages of or had already established programs facilitating their citizens’ access to imported drugs. Since that time, more municipalities have entered the arena. The governors, mayors, and other politicians involved in these programs cite a sense of urgency in providing citizens with access to affordable medications, and frustration with lawmakers and regulators for not legalizing the process.

In response to these actions, regulatory offi cials continue to raise concerns over patient safety. “[HHS] Secretary [Tommy G.] Thompson has not yet been able to certify that importation would (1) pose no additional risk to the public health and safety and (2) result in a signifi cant reduction in the cost of drugs to the American consumer,” FDA noted in an August 2004 press release. HHS, meanwhile, through its Task Force on Drug Importation, is attempting to determine whether or not, and under what circumstances, drug

importation might be conducted safely. As of press time, publication of the Task Force’s fi ndings is still scheduled to be released in December 2004. (See “HHS Task Force Studies Illegal Drug Importation” in the July 2004 NABP Newsletter.)

The HHS Task Force report will also address the likely consequences that legalizing prescription drug importation would have for US consumers’ health, medical costs, and development of new medicines. The Congressional Budget Offi ce (CBO) has already issued a brief analysis of the cost-reduction issue in April 2004; it concluded that permitting nationwide drug importation from Canada would produce “a negligible reduction in drug spending,” largely because “unique aspects of the prescription drug market would limit the additional volume of prescription drugs reaching the United States.” The report noted, “[W]hile an individual can fi ll a prescription in another country and realize savings refl ecting the full difference in price, the same would not be true for the health care system overall.” The CBO assumed that drug manufacturers would take measures to restrict supplies to Canada in the case that

january 2005

7


importation to the US were legalized; it did not address the possible results if Congress outlawed such activities by manufacturers.

While those in charge of safeguarding the public health and safety examine and debate the importation issue, many individual states continue to forge ahead with their plans to help US consumers import prescription drugs. Most of these plans, like Illinois’, have been established despite federal regulations in the matter. However, a few plans continue to attempt to work within the system: Vermont fi ling a lawsuit against FDA to force the creation of importation guidelines, for example, and Oregon working closely with its board of pharmacy to develop a unique pilot program proposal.

Typical State ActivitiesSome typical state

and city actions in terms of prescription drug importation were outlined in the August 2004 NABP Newsletter article on the topic. Several of these localities including Illinois, New Hampshire, North Dakota, and Wisconsin operate offi cial Web sites that contain links to Canadian pharmacies. Others, like Springfi eld, MA, have contracted with a Canadian

company to provide a particular group (such as city employees) with prescription medications via mail order. Wisconsin now offers its citizens two options: the Web site links to the Canadian pharmacies discussed earlier, or enrollment in the Illinois-originated I-SaveRx program, discussed later.

Many states including those that have started importation programs have sought waivers from FDA that would make drug importation legal. Lawmakers and politicians in these states have expressed frustration that, thus far, FDA has not granted approval for any pilot projects or waiver requests, or developed a list of criteria that would describe “safe” importation. In May 2004, the attorneys general of 18 states and one US territory sent a letter to Secretary Thompson calling for limited, legalized importation and suggesting measures to ensure drug safety.

Oregon’s Pioneer Prescription Drug Project

One of the most striking aspects of Oregon’s Pioneer Prescription Drug Project is the initial approach taken by the state’s Governor, Ted Kulongoski: He involved

the Oregon State Board of Pharmacy.

His insistence on doing so, in fact, gained the respect and the assistance of the Board, according to Gary A. Schnabel, RPh, RN, the Board’s executive director. “[Kulongoski] asked the Board for direction, and at fi rst the Board was hesitant to work on an importation scheme,” says Schnabel. “But the governor was not discouraged.” The governor had been watching other states and their programs, says Schnabel, but did not want to follow in their footsteps. He wanted the Board’s help “to do it right.” And while the Board at fi rst was skeptical, says Schnabel, “As time went on, the governor, working with the Board, started looking at the safety factors, and the Board started to think, ‘Maybe this could work.’ . . . The Board said straight up that we can’t endorse a program that violates federal law.”

Through collaboration that involved addressing the Board’s concerns for the safety and integrity of the nation’s prescription drug supply came the proposed project’s other unique aspect: It puts the Board in a regulatory position to perform inspections and monitor the program.

Feature News

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(continued from page 7)

Feature News

Importation Update

The project would accomplish this by using Oregon pharmacies to dispense the prescription drugs received from Board-registered Canadian wholesalers. Pharmacies that register with the Board to import and sell the drugs would be able to carry medications from a formulary (also selected by the Board) of 50 to 100 drugs available in Canada at a demonstrated savings, and charge dispensing fees predetermined by the Board. These imported medications would be available only for purchase using cash, removing insurance complications.

Canadian wholesalers involved in the program, already under the auspices of Health Canada, which is the Canadian equivalent to FDA, would have to pay a registration fee and meet the same standards required of US wholesalers. (Those standards may soon become more stringent than they are at present, says Schnabel. The Board has been evaluating NABP’s new Model Rules for the Licensure of Wholesale Distributors, he says, and is likely to change its wholesaler licensing requirements in the not-too-distant future.) The Board would be in the position to perform inspections and monitor

adherence with licensing requirements using its compliance staff.

Oregon submitted its plan to then HHS Secretary Thompson for approval on August 12, 2004, and a letter from Oregon’s congressional delegation to the secretary requesting prompt approval followed on September 9. While no offi cial response has been forthcoming as yet – and secretary Thompson’s response to other states’ proposals has not been positive – telephone conversations have taken place between HHS and the governor’s staff, says Schnabel. With national elections over and the HHS Task Force report scheduled for impending release, however, a response may come soon. While Schnabel was impressed by the governor’s interest in truly addressing safety concerns, he notes that the political atmosphere is “very hot.” “We are still wondering what will happen if [HHS] says, ‘No,’ to the governor’s request,” he says. “At least everyone’s still willing to sit around the table and talk.”

I-SaveRx ProgramAt the beginning of

October 2004, Illinois and Wisconsin (later joined by Missouri) launched one of the largest initiatives to date. The “I-SaveRx” program has another distinction: It is the fi rst state-sponsored program that helps residents purchase prescription drugs not only

from Canada, but also from Ireland and the United Kingdom.

In announcing the

program’s expansion to include Missouri, Illinois Governor Rod R. Blagojevich’s 2003 proposal to launch an importation program did not receive a positive response from FDA. His response to this –in conjunction with Wisconsin Governor Jim Doyle – was to launch the I-SaveRx program. The program works through a Canadian clearinghouse, which residents of three participating states contact through a Web site or a toll-free phone number. The clearinghouse provides residents with enrollment forms as well as information on medications available through the program and prices in each of the three provider countries.

According to Blagojevich, the program includes various safeguards to ensure patient safety. These include a requirement for new enrollees to provide a health profi le form and signed prescription to the

clearinghouse; a computer scan for “appropriateness” using the same drug interaction software used in Illinois pharmacies; a restriction on available medications to refi lls of those types used long-term and that cannot spoil during shipping; and a requirement for participating pharmacies “to agree to comply with Illinois pharmaceutical standards, and to only dispense drugs that are intended as domestic product in Canada, Ireland, or the UK,” according to the governor’s offi ce.

Several organizations, however, fi nd the safeguards to I-SaveRx suspect. Tom Engels, vice president of Public Affairs for the Pharmacy Society of Wisconsin (PSW), notes that the network of 45 international wholesalers and pharmacies are not publicly identifi ed. In an August 19, 2004 Chicago Tribune article, Irish offi cials expressed surprise at their inclusion in the Illinois program and the three main fi rms that distribute drugs in Ireland also said they knew nothing of the plan. Anne Nolan, chief of the Irish Pharmaceutical Healthcare Association, told the Tribune that her organization would not be happy with the arrangement. “It would cause enormous problems for us to meet our local obligations here,” she said.


Irish offi cials expressed surprise at their inclusion in the Illinois program and the three main fi rms that distribute drugs in Ireland also said they knew nothing of the plan.

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Association News

Importation Update(continued from page 8)

After more than 10 years of calling Park Ridge, IL, its Headquarters, NABP moved to 1600 Feehanville Drive, Mount Prospect, IL 60056, over the Thanksgiving holiday weekend. After a brief offi ce closure to accommodate the move, NABP’s operations

NABP Headquarters Moves to New Locationresumed at the new Headquarters on November 30, 2004. The new phone number is 847/391-4406 and the new fax number is 847/391-4502. All printed communications can be sent to the Feehanville Drive address.

The new 57,000-square-foot building will enable

NABP to enhance its program and service offerings to the boards of pharmacy, candidates, and applicants and provide ample space for future growth.

For more information about NABP’s new Headquarters, please see “NABP Purchases New

Building for Association Headquarters” in the February 2004 NABP Newsletter.

If you have any questions concerning the Association’s new headquarters, please contact Customer Service at [email protected] or call 847/391-4406.

Wisconsin Importation Program

In addition to the I-SaveRX program, Wisconsin has its own importation site, www.drugsavings.wi.gov, which promises consumers savings of 50% or more by purchasing drugs from Canadian pharmacies. During a continuing education session at NABP’s Fall Educational Conference, held November 11-14, 2004, Engels related some disturbing violations by three of the participating Canadian pharmacies that PSW found when reviewing data reports submitted over the fi rst six months that the program was in operation.

l Prescriptions dispensed –2,299

l PSW-identifi ed violations – 526

l Wisconsin-identifi ed violations – 9 (often the

state did not specify a number in its reports)

PSW broke these violations into three main categories:

l Drugs sold but not listed on the Drugsavings.wi.gov Web site (346)

l Non-FDA approved drugs (174)

l Drugs sold that require refrigeration (6)

In response to PSW’s criticisms, the state of Wisconsin said that the organization was the only one that “has a problem,” PSW is “making up violations,” the drug listing on the Web site is simply informational, and that the Web sites have ceased dispensing non-FDA approved drugs and refrigerated items. The state of Wisconsin noted that it has sent warnings to those pharmacies in violation; however, PSW still has concerns about the public health.

PSW stated its concerns in a letter sent to Wisconsin’s

Department of Health and Family Services, “We suspect that instead of directing patrons through the front door of their pharmacies, the Canadian pharmacies are telling their patrons to use the side door: an Internet site with even less threat of regulation. . . .Just one of these many violations [those discussed earlier] would be suffi cient to close a licensed Wisconsin pharmacy, yet the state of Wisconsin did not end its relationship with the Canadian pharmacies.”

In a July 22, 2004 letter to Wisconsin Governor Jim Doyle, FDA’s Associate Commission for Policy and Planning wrote, “It is increasingly clear that the participating pharmacies continue to sell drugs to Wisconsin citizens that are in violation of the standards you have established in an attempt to assure the quality and safety of such medications and despite your Warning Letters of

April 27, 2004, to these pharmacies.”

In his concluding remarks, Engels stressed the importance of a federally regulated importation system that is carried out through licensed pharmacies.

Vermont Sues FDAAt about the same time

that Illinois’ Blagojevich announced the I-SavRx program launch and a week after FDA denied Vermont’s request for a waiver of the drug importation ban, the state of Vermont fi led suit against HHS and FDA. The goal: to force the government to establish rules and guidelines under which legal importation may take place.

The lawsuit claims that the 2003 Medicare Prescription Drug, Improvement, and Modernization Act (MMA) granted waiver authority to HHS and FDA and also required them “to publish


nabp newsletter

10

101st Annual Meeting

A Real SellNew Orleans can

trace its roots back to the Paleo Indians, but in 1699 the area changed when brothers Pierre Le Moyne and Jean-Baptist Le Moyne de Bienville became the fi rst Europeans to sail the Mississippi River upriver from the Gulf of Mexico. Led by a Native American guide, the brothers sailed north noting the narrow portage to Lake Pontchartrain; in 1718, Bienville returned to this location and founded Nouvelle Orleans. Early settlers arrived mainly from France, Canada, and Germany, while the French brought in thousands of African slaves. New Orleans proved to be an economic failure and its colonists produced an exchange economy based on smuggling and local trade.

In 1762, in exchange for help in France’s war against

‘The Big Easy’ Provides Rich Backdrop for 101st Annual Meeting Attendees

When you think of New Orleans, what comes to mind? Jazz? Mardi Gras?

The French Quarter? New Orleans offers all of these attractions plus much more including antebellum mansions, “The City of the Dead,” and streetcars. Attendees will have the opportunity to experience New Orleans, which is known for its lively and relaxed way of life, fi rsthand during NABP’s 101st Annual Meeting at the Sheraton New Orleans Hotel, May 21-24, 2005.

England, the French ceded the Louisiana territory to the Spanish. During this time of Spanish rule, the Great Fire of 1788 destroyed 856 homes including the cathedral where the St Louis Cathedral stands today. Twenty-nine years into Spanish rule, France and Spain went to war causing loyalties in New Orleans to be split and the sovereignty and ownership of the colony to come into question; Spain ultimately gained control over New Orleans.

New Orleans came under French possession again in 1800 and in 1803 United States President Thomas Jefferson purchased Louisiana in order to proceed on a path of Western expansionism. By 1840 New Orleans became the fourth city in the US to exceed 100,000 in population. And, in 1860, Louisiana became the sixth

state to secede from the Union.

It was a long road to recovery for New Orleans after the Civil War and Reconstruction, but, by the early 20th century, New Orleans came into its own with the birth of jazz, tourism, the establishment of two colleges, and, later on that century, the construction of the Louisiana Superdome in 1975.

Only in New OrleansNew Orleans has been

called “the most haunted city in the US” and in no place is this notation as evident as the city’s unusual cemeteries. These “Cities of the Dead,” as they have been nicknamed because of the rows of buildings that hold the coffi ns, are so popular with visitors that there are tours of these cemeteries. Because of New Orleans’ high sea table and the fact that most of the city is below sea level, it did not make sense to bury the dead. Instead, in the mid-1800s the locals began building richly adorned vaults that held the above-ground tombs, stacked on top of each other, which give these cemeteries their urban look.

Annual Meeting attendees will have the opportunity to observe New Orleans architecture with Spanish and French

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11



infl uences, especially in Uptown, the city’s largest historic district. Truly a “blast from the past,” 11,000 buildings comprise Uptown, 82% of which were built before 1935. Mansions, especially those from the antebellum period, abound in New Orleans – and there are many tours for those interested in exploring these historic homes. Some of the homes Annual Meeting attendees can visit are the Pitot House, a typical plantation home built in the early 1800s that today authentically recreates Creole life; the Longue Vue House and Gardens, which were home to Edith and Edgar Stern, heirs to the Sears Roebuck fortune; the Gallier House, a historic restoration of one of the city’s time-honored landmarks; and the Van Benthuysen-Elms Mansion and Gardens, a beautiful example of Italian architecture.

No trip to New Orleans would be complete without a visit to the French Quarter; the Sheraton New Orleans Hotel is a short walk from this historic neighborhood. The French Quarter and Bourbon Street are the center of excitement. The Quarter is fi lled with toe-tapping jazz, unique cuisine, narrow streets, and historic houses.

And do not forget Mardi Gras! When in New

Orleans, Annual Meeting attendees can visit Mardi Gras World, which is dedicated to the magic behind Mardi Gras – from uncovering the history of this event, to learning about the fl oats, to donning authentic, ornate carnival costumes.

Other Cultural Attractions

The “Crescent City” (see page 167 of the October 2004 NABP Newsletter to fi nd out how New Orleans got this nickname) also offers other attractions

such as the Ogden Museum of Southern Art; the Contemporary Arts Center; and the Memorial Hall Confederate Museum, which was founded in 1891 and houses many Confederate fl ags, uniforms, and weapons.

For pharmacists, a trip to New Orleans would not be complete without a

visit to the city’s Pharmacy Museum. Located in the 1823 apothecary of the country’s fi rst licensed pharmacist, the museum’s collection includes hand-carved rosewood cabinets of the 1860s stocked with hand-blown apothecary bottles fi lled with makeshift drugs, live leeches and leech jars, bloodletting devices, 19th Century trade cards, and surgical instruments that date back to the Civil War.

If the outdoors is what you desire, then you should plan on visiting Audubon Park and Zoological

Garden, which has been in existence since the 1884 World Exposition. Visitors can view a Cajun houseboat on a lagoon full of 14-foot-long alligators. Or, if history is a favorite subject, the Old Ursuline Convent may be what you seek. The oldest building in the Mississippi River Valley (completed in

New Orleans’ tradition of “secondline parades” features percussionists playing the city’s trademark jazz – and anyone can join in the fun.

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nabp newsletter

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Association News

New Orleans Attraction Contact Information

For additional information on the New Orleans sights and attractions mentioned in the article, please refer to these Web sites and phone numbers.

l The Audobon Park and Zoological Garden – 1-866/ITS-A-ZOO (487-2066), www.auduboninstitute.org

l Contemporary Arts Center – 504/528-3805, www.cacno.org

l Mardi Gras World, Inc – 1-800/362-8213 or 504/361-7821, www.mardigrasworld.com

l Memorial Hall Foundation – Confederate Civil War Museum, 504/523-4522, www.confederatemuseum.com

l New Orleans Metropolitan Convention and Visitors Bureau – 1-800/672-6124, www.neworleanscvb.com

l The New Orleans Pharmacy Museum – 504/565-8027l New Orleans Public Bus Information – 504/818-1077l New Orleans Streetcars – 504/248-3900l Old Ursuline Convent – 504/529-3040l The Van Benthuysen-Elms Mansion and Gardens –

504/895-9200, www.elmsmansion.com

1752), the Convent is the oldest surviving example of the French colonial period in New Orleans.

Getting to Your Destination

How do Annual Meeting attendees travel to all of these places? The line made famous in Tennessee Williams’ A Streetcar Named Desire line may have been eliminated, but visitors can still step back in time because New Orleans is the only city in the nation that still has an active streetcar service. The St Charles/Carrolton line costs $1.25 and the Riverfront line costs $1.50; exact fare is required. Transfers to the public bus are 25 cents and schedules can be obtained at the Regional Transit Authority Offi ce on Canal Street.

Visitor passes are available for unlimited rides on all streetcar and bus lines and are available at hotels and shopping areas. The cost for these passes is $5 for one day and $12 for three days.

Visitors can also get around New Orleans via taxi or bus. Taxis cost $2.50 plus an extra dollar for each additional passenger; $3 per person for special events or if the meter rate is greater. The Louis Armstrong New Orleans International Airport fl at rate for a taxi is $28 round trip for up to two people and $10 for each additional passenger, not to exceed fi ve people.

For those traveling from the airport, guests can purchase tickets one way for airport shuttle tickets at the airport shuttle information desks, which are staffed 24 hours a day.

Fare for New Orleans’ public buses is $1.50 one way. Buses depart from

101st Annual Meeting(continued from page 11)

the airport and go to the downtown side of Tulane Avenue between Elks Place and South Saratoga Street about every 10 minutes during the peak hours of 6 to 9 am and 3 to 6 pm; otherwise buses depart every 23 minutes.

For more information about the 101st Annual Meeting, please call the NABP Meetings Desk at 847/391-4406, e-mail [email protected], or visit NABP’s Web site at www.nabp.net.

NABP is pleased to offer voting delegates the opportunity to apply for the Association’s Annual Meeting Travel Grant for the 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA. The program will reimburse the board of pharmacy’s offi cial delegate up to $750 in travel expenses including transportation,

Apply Today for NABP’s Annual Meeting Travel Granthotel accommodations, and meals.

Those interested boards must have their offi cial delegate complete an application, which can be downloaded from NABP’s Web site at www.nabp.netor obtained through NABP’s Customer Service Department by calling 847/391-4406. Please note that grant monies cannot

be applied to Annual Meeting registration fees. All applications must be received at NABP Headquarters no later than February 4, 2005. Applicants will begin receiving notifi cation in March 2005 stating whether or not they have qualifi ed for a grant. This travel grant is available for the boards to utilize through a

grant courtesy of Pfi zer US Pharmaceuticals.

For more information, contact Customer Service at the phone number listed earlier or e-mail [email protected]. Materials should be sent to the NABP Foundation, Attn: Annual Meeting Travel Grant Program, 1600 Feehanville Drive, Mount Prospect, IL 60056.

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Saturday, May 21, 20059 AM - 6 PM

Registration Desk Open

1 - 5 PM

Educational Presentation Area Open/Poster Session

1 - 5 PM

Hospitality Suite in Presentation Area

1 - 4:45 PM

Optional Spouse/Guest Tour

1 - 2:30 PM

District Nominating Procedures Review

2:45 - 5 PM

New Member Seminar

7 - 10 PM

President’s Welcome ReceptionHonoring NABP President Donna M. HornBuffet Dinner will be served.Dress: business casual attire

Sunday, May 22, 20056:30 - 7:30 AM

Fun Run/Walk

7:30 AM - 4:30 PM


8 - 9 AM

Continental Breakfast (in Presentation Area)

8 AM - noon

Educational Presentation Area Open/Poster Session

8:30 AM - noon

Meeting of the Committee on Resolutions

1 - 1:15 PM

Welcome RemarksCarmen A. Catizone, NABP Executive Director/Secretary

1:15 - 2 PM

Keynote Address

2 - 2:15 PM

Refreshment Break

2:15 - 4:45 PM

First Business Session

May 21-24, 2005 Sheraton New Orleans Hotel New Orleans, LA

NABP and the NABP Foundation are approved by the Accreditation Council for Pharmacy Education (ACPE) as providers of continuing pharmacy education. ACPE Provider Number: 205. Participants may earn up to 5 hours of ACPE-approved continuing education credit from NABP. Participants in continuing pharmacy education programs will receive credit by completing a “Statement of Continuing Pharmacy Education Participation” and submitting it to the NABP offi ce. A validated Statement will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmacy education credit and a Statement of Participation.

Monday, May 23, 2005

7 AM - 4 PM


7 - 8 AM

NABP/USP Breakfast Sponsored by the United States Pharmacopeia, Inc

8 AM - 11 AM

Meeting of the Committee on Resolutions

8:15 - 10:15 AM

CE Programming

10:15 - 10:30 AM

Refreshment Break

10:30 - noon AM

CE Programming

12:15 - 12:30 PM

Second Business Session

12:30 - 12:45 PM

Refreshment Break

12:45 - 2:45 PM

Meet the Candidates Session

Lunch will be provided.

2:45 - 3 PM

Break

3 - 4:15 PM

Third Business Session

Tuesday, May 24, 20057:30 AM - 4 PM


8 - 9 AM

Continental Breakfast

8 - 9 AM

Past Presidents’ Breakfast (By invitation only)

9 - 10:30 AM

CE Programming

10:45 - 11:45 AM

Open Mike Session

11:45 AM - 1 PM

Lunch Break (on your own)

1 - 4 PM

Final Business Session

2:30 - 2:45 PM

Refreshment Break

7 - 10:30 PM

Annual Awards DinnerDress: semiformal attire

NABP is seeking volunteers from its active member boards of pharmacy to serve on the Association’s 2005-2006 committees and task forces. Interested executive offi cers and board members are encouraged to submit a letter of interest and

Call for Committee, Task Force Volunteersa current resume or curriculum vitae to NABP Executive Director/Secretary Carmen A. Catizone by Friday, May 6, 2005.

Letters should outline the volunteer’s applicable experiences and accomplishments, along with the reasons he or she

wishes to be considered for appointment to a committee or task force.

Please send all information to NABP Headquarters, 1600 Feehanville Drive, Mount Prospect, IL 60056. All letters and vitae will be forwarded to NABP

President-elect Dennis K. McAllister, who will make the appointments when he becomes NABP president following the Association’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel, New Orleans, LA.

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14

Association News

Around the Association


Kentucky Names New Executive Director

Michael A. Burleson, RPh, was named the executive director of the Kentucky Board of Pharmacy on October 1, 2004. Burleson, a 1974 graduate of the University of Kentucky College of Pharmacy, most recently served as a pharmacy manager with Walgreens. He was also a pharmacy owner for 19 years. Burleson fi lls the position vacated by Michael A. Moné.

New Board Offi cers The Iowa Board of

Pharmacy Examiners recently elected new offi cers:

l Michael J. Seifert, RPh – Chairperson

l Leman E. Olson, RPh – Vice Chairperson

The Mississippi State Board of Pharmacy recently elected new offi cers:

l James C. “Cliff” Kelly, III, RPh – President

l Cynthia H. Bamburg, RPh – Vice President

l Elizabeth S. LeFlore, RPh – Secretary

l Roland E. “Eddie” Mullins, Jr, RPh – Treasurer

NABP Exploring Creation of Clearinghouse for Pedigree Data

In November 2004, NABP announced that it would create a Task Force to study the possibility of creating a clearinghouse for pedigree data in order to further protect the public health and maintain the integrity of the United States drug supply. Revisions to NABP’s Model Rules for the Licensure of Wholesale Distributors, which are part of the Association’s Model State Pharmacy Act and Model Rules, were released in February 2004 and include provisions requiring the documentation, recording, and maintenance of a pedigree (Chain of Custody Record) for each package of drugs. The Model Rules anticipate that these records will be created and stored electronically. The Association notes that Florida and California have passed laws that either require or allow electronic pedigree records.

NABP supports Food and Drug Administration’s (FDA) policy that the use of radio frequency identifi cation (RFID) technology is the best means to improve the security of the nation’s drug supply. Electronic pedigrees will track and trace a drug product through the distribution system, from the time it leaves a drug manufacturer until it is

dispensed to a patient by a pharmacist. The Association also supports the need for access to relevant pedigree information in order for regulators to conduct investigations.

To facilitate the collection and maintenance of electronic pedigree information, NABP is establishing a Task Force of state regulators, manufacturers, wholesalers, retailers, government regulators, and information technology experts to explore the feasibility of creating and maintaining a clearinghouse for relevant information to establish an electronic pedigree. The Task Force will ascertain methods to facilitate the exchange of information in an effort to maintain the integrity and safety of the US drug distribution system. Additionally, the Task Force will work with EPCglobal (a provider of enabling technology for real-time, automatic identifi cation of items) to create the necessary standards for the development of e-pedigree software. The NABP Task Force may also explore ways to establish an accreditation program for e-pedigree software platforms to assure connectivity of systems throughout the US that need to communicate with each other.

During development of an e-prescribing clearinghouse, NABP will act as an honest broker to facilitate the creation of policies and business rules for the exchange of information among trading partners. The Association envisions that trading partners will make their own arrangements for the exchange of information and use the advantages of the NABP Clearinghouse to improve these exchanges.

NABP’s Model Rules were developed through a broad consensus process involving state and federal regulators, wholesale drug industry experts, national pharmacy organizations, and consumer groups. The Model Rules focus on critical areas of the licensure and regulation of wholesale distributors, identifi ed by FDA and the states, that are essential to combating counterfeit drugs. Included in the Model Rules are specifi c provisions concerning the documentation, recording, and maintenance of a pedigree for drugs distributed through the wholesale distribution system; therefore, NABP is undertaking a major initiative intended to realize these goals as e-pedigree information becomes more widely available over the next few years.

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15

Professional Affairs

In early November 2004, Food and Drug Administration (FDA) cautioned the public not to purchase or consume the products Actra-Rx and Yilishen, which have been promoted via the Internet. These products, purported as “dietary supplements” to treat erectile dysfunction and enhance sexual performance, were actually found to contain the

‘Dietary Supplements’ Contain Undeclared Prescription Drug Ingredient

active prescription drug ingredient, sildenafi l. Sildenafi l is the active drug ingredient in Viagra®, which is approved in the United States for the treatment of erectile dysfunction.

The Journal of the American Medical Association (JAMA) published a research letter that explained the results of a chemical analysis that found that Actra-Rx

(continued from page 3)

answer session provided for a welcome exchange of information between participants.

Pilot InspectionsNABP and BuzzeoPDMA

performed three pilot inspections in November and December 2004 in order to fi ne-tune the inspection processes and determine how to structure inspections. Inspectors visited one national and one regional wholesale distributor as well as a chain drug store warehouse.

“The pilot inspections allowed NABP and BuzzeoPDMA to fi nalize inspection procedures from

both format and substantive perspectives,” explains Donna M. Horn, NABP president. “In addition, NABP inspectors provided feedback to wholesalers about their operations and wholesalers shared their experiences and insights with the inspectors.”

NABP and BuzzeoPDMA inspected each facility, touring the warehouse and spending a day in the life of a prescription product. This included observing how products are received, entered into the distributor’s inventory system, and placed on shelves. Order processing and fulfi llment including picking, packing, and distribution were also examined. Another aspect of the wholesale

distributors’ business practices that was observed was how companies handled customer returns and determined whether these products could be shipped to another customer, returned to the manufacturer, or destroyed. The pilot inspections were modeled after the on-site portion of the VAWD accreditation process; however, they do not confer nor do they indicate VAWD accreditation for any participating facility.

NABP began developing VAWD after FDA requested that NABP update its Model Rules for the Licensure of Wholesale Distributors. Members of NABP’s resulting Task Force on Counterfeit Drugs and Wholesale

Distributors, which met in October 2003, revised the Model Rules and proposed the creation of an accreditation program and clearinghouse for wholesale distributors – a plan that was immediately supported by FDA – to further combat counterfeit drugs.

The target launch date for the VAWD program is the end of December 2004. After its launch, NABP plans to hold additional educational programs for other interested stakeholders.

To inquire about the VAWD program, contact NABP at 847/391-4406 or via e-mail at [email protected]. More information about BuzzeoPDMA can be obtained by visiting www.buzzeopdma.com.

New VAWD Program

contained prescription-strength quantities of sildenafi l. FDA conducted its own analysis, the results of which corroborated the analysis published in JAMA.

Sildenafi l is known to interact with a number of prescription medications. For example, sildenafi l may potentiate the hypotensive effects of medications containing nitrates, which are commonly used to treat

congestive heart failure and coronary artery disease.

FDA instructed those who are taking Actra-Rx and/or Yilishen to stop and consult their health care provider and warned that the use of these products could be dangerous to patients’ health.

For more information, please visit the following Web site: www.fda.gov/bbs/topics/ANSWERS/2004/ANS01322.html.

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16

2004 Fall Conference

Gail Bormel, president of ASPL, and NABP President Donna M. Horn, welcome participants to the Fall Conference.

Fall Educational Conference Highlights

NABP’s 2004 Fall Educational Conference, held November 11-14, 2004, at the Renaissance Vinoy in St Petersburg, FL, attracted approximately 130 attendees

with its timely continuing education (CE) sessions and knowledgeable speakers. This year, NABP and the American Society for Pharmacy Law (ASPL) co-hosted a CE session and several luncheons and refreshment breaks. Timely CE sessions covered such topics as drug importation and pending federal laws and regulations regarding importation as well as a session on drug compounding.

Joshua M. Bolin, director of the Indiana Board of Pharmacy, and his wife, Alicia, enjoy dinner at the Welcome Reception (co-hosted with ASPL) in the mezzanine of the historic Renaissance Vinoy.

Malcolm J. Brussard (left), executive director of the Louisiana Board of Pharmacy, and Louisiana Board members Joseph L. Adams (center) and Carl W. Aron (right) join other members of NABP as well as ASPL members at the Welcome Reception.

Members of NABP and ASPL gather at a co-hosted luncheon and discuss current issues affecting both associations.

Susan C. Winckler, vice president of policy and communications and staff counsel for the American Pharmacists Association, provided session participants with information and updates on current pharmacy-related bills from the 108th Congress during the session “Federal/State Regulatory and Legislative Actions in 2004.”

january 2005

17


Gary A. Schnabel (left), executive director of the Oregon State Board of Pharmacy, speaks at the CE session “The Changing Landscape of Importation: Patient Safety and Accessibility.” Also presenting at that session were Gary R. Matzke (right), a health policy fellow for Senator Judd Gregg’s (R-NH) offi ce, and Tom Engels (not pictured), vice president of Public Affairs for the Pharmacy Society of Wisconsin. Dennis K. McAllister (center), NABP president-elect, moderated the session.

Leah Foster, vice president of BuzzeoPDMA, explains the company’s role in the inspection process of NABP’s new Verifi ed-Accredited Wholesale Distributors™ program during the session “The Inspection of Accreditation of Wholesale Distributors: Regulating with Limited Resources.”

Wayne A. Michaels, diversion investigator/staff coordinator, Pharmaceutical Enforcement Section, Drug Enforcement Administration, educated participants on illegal Internet pharmacy operations and the continuing challenges in regulating Internet pharmacies during the session “Performing Internet Drug Buys.”

Attendees of the session “Recent Efforts to Address the Regulation of Pharmacy Compounding” learned about the major components of the United States Pharmacopeia’s Tests and Assays Chapter 797 and the new Pharmacy Compounding Accreditation Board (PCAB). Those on the panel included (from left to right) Jerrod Roberts, chairman, Standards Task Force, PCAB; Oren M. Peacock, member, NABP Executive Committee (moderator); Gayle A. Brazeau, associate dean for academic affairs, University at Buffalo, School of Pharmacy and Pharmaceutical Sciences; and Kevin E. Kinkade, executive director of the Missouri Board of Pharmacy.

Craig A. Miner (left), of the Division of Drug Plan Policy, Centers for Medicare & Medicaid Services (CMS), and Simon P. Cohn (right), national director for health information policy for Kaiser Permanente’s Medical Care Program, familiarized session attendees with CMS’ role in the implementation of the Medicare Prescription Drug Benefi t and the role of Medication Therapy Management and electronic prescribing during the session “Medicare Prescription Drug, Improvement, and Modernization Act of 2003: New Opportunities in Medication Therapy Management and Electronic Prescribing.” Richard A. Palombo (center), member, NABP Executive Committee, moderated the session.

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18

Federal/State Regulatory and Legislative Actions in 2004

The opening session of NABP’s Fall Educational Conference, focused on federal and state regulatory and legislative actions that occurred in 2004. During her presentation, Susan C. Winckler, RPh, Esq, vice president policy, and communications, and staff counsel for the American Pharmacists Association discussed key pharmacy-related bills from the 108th Congress, the Medicare drug benefi t, federal activity on compounding and patient safety, and

Fall Educational Conference Continuing Education Snapshots

NABP’s 2004 Fall Educational Conference, held November

11-14, 2004, at the Renaissance Vinoy in St Petersburg, FL, offered attendees continuing education (CE) sessions on topics ranging from recent legislative actions regarding illegal drug importation to NABP’s new Verifi ed-Accredited Wholesale Distributors™ (VAWD™) program. Participants of CE sessions were given the opportunity to engage in discussions with many experts from the pharmacy profession as well as policy makers from federal agencies such as the National Committee on Vital and Health Statistics (NCVHS) and the Centers for Medicare & Medicaid Services (CMS).

developments in state laws and regulations.

The participants learned about the activities tackled by federal regulators such as Drug Enforcement Administration (DEA), Food and Drug Administration (FDA), and the CMS. According to Winckler, DEA is considering re-scheduling hydrocodone combination products from Schedule III to Schedule II. In addition to DEA, Winckler explained that the United States Congress is concerned about controlled substances access issues, especially with extended-release tablets.

Winckler also covered activity at the state level

highlighting “conscience clause.” The “conscience clause” has recently received media attention for pharmacists refusing to dispense emergency contraceptives. Legislation has been introduced in six states to protect pharmacists from disciplinary action.

The Changing Landscape of Importation

During the educational session, “The Changing Landscape of Importation: Patient Safety and Accessibility,” Gary R. Matzke, PharmD, FCP, FCCP, American Association of Colleges of Pharmacy/American Association for the Advancement of Science health policy fellow with the Senate Committee on Health, Education, Labor and Pensions and the University of Pittsburgh, fi rst addressed the many safety concerns associated with drug importation and demonstrated the ease in which domestic and foreign Internet pharmacies and distributorships are created as evidenced by their own research. Dr Matzke covered the content of proposed federal legislation addressing importation from 2001 and gave a status update on federal legislation introduced


january 2005

19

during the most recent congressional sessions. The three pieces of legislation addressed by Dr Matzke included the S2307, the Grassely REMEDIES Act; S2328, the Pharmaceutical Market Access and Drug Safety Act; and S2493, the Gregg-Smith-Collins Safe Import Act. Dr Matzke further highlighted the major components of the Gregg-Smith-Collins Safe Import Act, which included provisions for personal and commercial importation.

Next, Gary A. Schnabel, RPh, RN, executive director of the Oregon State Board of Pharmacy, educated participants on Oregon’s importation proposal, the Pioneer Prescription Drug Project. Schnabel highlighted the Oregon Board’s involvement with the proposal including its concerns over patient safety, adherence to applicable state and federal law, and potential cost savings to patients. Schnabel also detailed that the proposal will only import FDA-approved drugs from a predetermined formulary, through Canadian wholesale distributors, to licensed pharmacies in Oregon. The Oregon State Board of Pharmacy would serve a critical role in implementing stringent requirements for those wholesale distributors

and pharmacies that participated in the program.

The session concluded with Tom Engels, vice president of Public Affairs for the Pharmacy Society of Wisconsin. Engels conveyed to the audience his association’s position on drug importation in that it supports efforts to enable pharmacies licensed and regulated in the US to import prescription drugs from other countries through a secure and regulated system that would provide consumers with confi dence in the integrity of their prescription drug products from the local pharmacist who they know and trust. Engels also focused on a number of fi ndings his association discovered with Wisconsin’s DrugSavings.wi.gov program. For example, according to Engels, some drugs imported were not FDA approved including products that required refrigeration; these products should not have been shipped because it may have been diffi cult to maintain the integrity of the product. It was also stated during the session that consumers were not utilizing Wisconsin’s Web site extensively because the number of prescriptions ordered online was not as high as expected.

The Inspection and Accreditation of Wholesale Distributors: Regulating with Limited Resources

On the second day of the Fall Educational Conference, participants received an update on the incidence of drug counterfeiting and diversion along with the current federal and state oversight of wholesale distributors from Charisse Johnson, PharmD, MS, NABP’s professional affairs manager. Dr Johnson challenged the audience to distinguish between fake and authentic products and reviewed a number of recent counterfeit incidences. She also addressed the current structure of the medication distribution system and illustrated how drugs may be diverted into or out of the legitimate supply chain. The majority of Dr Johnson’s presentation focused on the revised Model Rules for the Licensure of Wholesale Distributors, which are a part of the Model State Pharmacy Act and Model Rules of the National Association of Boards of Pharmacy, and NABP’s new program, the Verifi ed-Accredited Wholesale Distributors™ (VAWD™).

Dr Johnson covered the major recommendations of



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20

Recent Efforts to Address the Regulation of Pharmacy Compounding

During the session “Recent Efforts to Address the Regulation of Pharmacy Compounding,” Gayle A. Brazeau, PhD, associate dean for Academic Affairs, University at Buffalo, and a member of the United States Pharmacopeia (USP) Sterile Compounding Committee, reviewed the major components of USP Test and Assays Chapter 797, Pharmaceutical Compounding – Sterile Preparations. Dr Brazeau stressed the importance of the newly revised USP Chapter as it relates to patient safety, in preventing harm and fatality to patients that could result from compounded sterile preparations. Dr Brazeau went on to cover the foundational elements of Chapter 797 in terms of the terminology, risk levels associated with the various compounded sterile preparations, facilities/compounding environment, and personnel cleansing and garbing.

Kevin E. Kinkade, RPh, executive director of the Missouri Board of Pharmacy, talked about the Missouri Program for Randomized Testing of Compounded Products. He fi rst highlighted a few compounding incidences,

which served as major impetus for the quality assurance program, and then highlighted various compounding regulatory changes. These changes included use of a compounding

log, drug monitoring systems, drug recalls, sterile pharmaceutical risk level assignment, and fi eld procedures for random testing. Kinkade then concluded with the results of various product testing and the corresponding corrective actions such as additional/remedial training of the pharmacy and review of compounding procedures.

The session concluded with a presentation concerning the newly formed Pharmacy Compounding Accreditation Board (PCAB) by Jerrod L. Roberts, RPh, and chairman

of the PCAB Standards Task Force. Roberts conveyed the primary goal of PCAB: improving the quality of compounded preparations via voluntary accreditation of pharmacies that perform such activities. Roberts also discussed the current status of the program with respect to surveyor selection and pilot testing.

Performing Internet Drug Buys

On the last day of the Fall Educational Conference, Lloyd K. Jessen, JD, RPh, executive director/secretary, Iowa Board of Pharmacy Examiners, covered a number of Internet pharmacy investigations conducted by the Board. Jessen revealed that a number of the Internet pharmacies investigated were located both within and outside the US. Also, Jessen described the types of products the Board was able to obtain from various Web sites including controlled substances and life style medications that were sometimes priced signifi cantly above their retail value. Also, participants were reminded of the states that have specifi c regulation pertaining to Internet pharmacies along with some of the proposed federal legislation introduced that would require a bona fi de patient-physician relationship for prescriptions fi led by Internet pharmacies along the posting of pharmacists

Wayne A. Michaels, diversion investigator and staff coordinator of DEA’s Pharmaceutical Enforcement Section, gave an overview of online sales of drugs and concerns associated with consumers purchasing controlled substances from online pharmacies,

Conference Snapshots(continued from page 19)

the 2003 NABP Task Force on Counterfeit Drugs and Wholesale Distributors concerning the NABP Model Rules on the Licensure of Wholesale Distributors. Key concepts covered included the extensive application and background check; the position of designated representative; the new Criminal and Prohibited Acts section; the Pedigree requirements; the National Specifi ed List of Susceptible Products; Authentication; and Due Diligence requirements. Dr Johnson then covered the accreditation process for the VAWD program, highlighting the pathways to accreditation and an overview of the VAWD criteria. Dr Johnson concluded with state efforts to combat diversion and counterfeit drugs.

Leah Foster, vice president of BuzzeoPDMA, then relayed to the participants how her organization will assist NABP with the on-site inspections as part of the VAWD program. Foster described the process of the initial inspection, which would evaluate aspects such as a review of standard operating procedures, recordkeeping, and the overall facility of the wholesale distributor.


(continued on next page)

january 2005

21

who are affi liated with the Internet pharmacy. Jessen concluded with recommendations of what boards of pharmacy can do to address illegal Internet pharmacies.

Next, Wayne A. Michaels, diversion investigator and staff coordinator of DEA’s Pharmaceutical Enforcement Section, gave an overview of online sales of drugs and concerns associated with consumers purchasing controlled substances from online pharmacies, physicians, and other sources without the traditional protections of a physician-

patient relationship and existing federal and state laws. Michaels informed the audience about a number of online pharmacies that DEA has pursued. Michaels also highlighted the US Department of Health and Human Services Drug Abuse Warning Network’s, top 20 controlled substances that may be routinely illegally distributed drugs.

Medicare Prescription Drug, Improvement, and Modernization Act of 2003: New Opportunities in Medication Therapy Management and Electronic Prescribing

Craig A. Miner, RPh, JD, of CMS, addressed

the audience concerning Medication Therapy Management services as provided in the Medicare legislation signed into law late last year. For pharmacists and other health care providers who participate in this program, Miner emphasized the various requirements and the target benefi ciaries for this program. Specifi cally, Miner discussed the pharmacy access standards, pharmacy contracting requirements, and out-of-network access.

The session concluded with Simon P. Cohn, FACP, MD, MPH, chair of the NCVHS Subcommittee on Standards and Security and also national director for Health Information Policy

for Kaiser Permanente’s Medical Care Program. Dr Cohn mainly addressed the role of his Subcommittee as NCVHS was called upon to recommend initial standards for e-prescribing. Dr Cohn then reviewed with the audience NCVHS’ fi rst set of recommendations and observations on electronic prescribing such as the necessity of compatibility with other national/federal standards, the coordination of prescription message standards, and the inclusion of structured and codifi ed SIGs. Dr Cohn concluded by urging the state boards of pharmacy to submit comments when the proposed regulations are released.

Conference Snapshots(continued from page 20)

The Task Force to Develop Recommendations to Best Reduce Medication Errors in Community Pharmacy Practice met December 9-10, 2004 at the Hyatt Rosemont, Rosemont, IL. The members of the Task Force, from left to right, are Oren M. Peacock, Jr, Texas State Board of Pharmacy; Linda K. McCoy, Banner Good Samaritan Medical Center; David Fong, California State Board of Pharmacy; Susan DelMonico, Rhode Island Board of Pharmacy; Edward G. McGinley, New Jersey Board of Pharmacy; Karen Ryle (chair), Massachusetts Board of Registration in Pharmacy; Philip P. Burgess, Illinois Board of Pharmacy; Alan Vaida (ex-offi cio member), Institute for Safe Medication Practices; Reginald B. Dilliard, Tennessee Board of Pharmacy; and Michael Jarema (ex-offi cio member), Joint Commission on Accreditation of Healthcare Organizations.

Association News

NABP Task Force Meets

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22

New Board Members

Robb Carter was appointed as a consumer member of the Delaware State Board of Pharmacy by Governor Ruth Ann Minner. His term began July 19, 2004, and expires July 1, 2007.

Kathleen Halloran was appointed a consumer member of the Iowa Board of Pharmacy Examiners by Governor Tom Vilsack. Her term began May 1, 2004, and expires April 30, 2007.

Sara Fakhoury, RPh, was appointed a member of the Michigan Board of Pharmacy by Governor Jennifer M. Granholm. Her term began June 30, 2004, and expires June 30, 2008.

New Mexico Acting Executive Director

The New Mexico Board of Pharmacy has appointed William Harvey, RPh, as acting executive director/chief drug inspector during the process of hiring a permanent executive director to fi ll the position vacated by Joseph Montoya.

Around the Association(continued from page 14)

Boards of Pharmacy: Do your members and staff enjoy sharing information about the latest legislative issues, technology, “hot topics,” policy development, or disciplinary cases? Like hearing feedback and learning new methods and techniques from other boards of pharmacy? Then plan on participating in NABP’s Third Annual Poster Session, Saturday, May 21, from 1 to 5 pm and Sunday, May 22, from 8 am to noon, at NABP’s 101st Annual Meeting that will be held May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA.

Schools or colleges of pharmacy are also encouraged to participate in the Annual Meeting Poster Session.

Last year’s Poster Session at the 100th Annual Meeting and Centennial Celebration in Chicago, IL, featured posters with such titles as “Balancing Patient Safety and Professional Development,” “A Foundation for Patient Safety: Improving Medication Management in Schools Via a ‘Hub-and-Spoke’ Concept,” and “Ambulatory Root Cause Analysis Tool.”

Participate in the Third Annual Poster Session at NABP’s Annual Meeting

Interested in participating, but not sure where to start? Listed below are some guidelines on preparing a poster:

l Limit text and utilize graphics; double-check that all items on the poster are necessary for presentation.

l Prepare handouts to provide an overview of poster and/or additional information including contact names, should attendees have questions.

l Keep your poster title short, highlighting the topic.

l Make the font size at least 14 point and double-space paragraph lines to ensure readability from two to four feet.

l Lay out the sections of your poster in a logical order so that the poster is easy to follow. Rather than affi xing your documents to one large piece of poster board, which can cause strain on poster pins, break your materials into three or four sections. You will also be able to move

them around on the board.

l Enlist the help of students and/or interns on rotation in your

offi ce to prepare the poster.

Each participating board or school/college of pharmacy will be provided with one four-foot by six-foot bulletin board, which should be manned by a board-appointed or school representative during display times. Interested boards can notify the NABP Meetings Desk via phone at 847/391-4406 or via e-mail at [email protected] or by Monday, April 4, 2005. Please provide the poster topic. If your board is interested in displaying on only one day, please inform the NABP Meetings Desk.

Association News

january 2005

23

NABP will distribute proposed resolutions to allow boards of pharmacy to review the resolutions prior to NABP’s 101st Annual Meeting, May 21-24, 2005, at the Sheraton New Orleans Hotel in New Orleans, LA.

Proposed resolutions received at NABP Headquarters by April 8, 2005, to be presented and voted upon during the 101st Annual Meeting, will be distributed to the boards of pharmacy on April 22, 2005, for review prior to the meeting. This mailing

Deadlines Set for Advance Distribution of Proposed Resolutions

will constitute only the pre-conference distribution of proposed resolutions. All resolutions – those distributed for early review as well as those received after April 8 – will be presented to the delegates during the Annual Meeting on Monday, May 23, by the chair of the Committee on Resolutions.

To be considered during the Annual Meeting, resolutions must adhere to the requirements of Article IV, Section 6, Part (d) of the NABP Constitution, which states:

Any active member board, district, or committee of the Association may submit resolutions to the Association. . . .[A]ll resolutions submitted in writing to the Association at least twenty (20) days prior to the date of the Annual Meeting shall be presented at the Annual Meeting for consideration. Resolutions not presented within such time limitations may be presented during

the Annual Meeting, and will be considered for adoption by the Association upon the affi rmative vote of three-fourths (¾) of those Association members present and constituting a quorum.

Questions regarding resolution procedures should be directed to NABP Executive Director/Secretary Carmen A. Catizone at NABP Headquarters by calling 847/391-4406 or e-mailing [email protected].

Association News

guidance describing the circumstances under which [HHS and FDA] will consistently grant waivers to allow importation of prescription drugs for personal use. . . . Despite explicit direction from Congress in the MMA to promulgate regulations permitting importation of prescription drugs from Canada and guidance regarding waivers that would also allow importation,” the lawsuit states, “HHS and FDA denied Vermont’s petition and have taken no action to promulgate regulations or issue any guidance regarding waivers.”

FDA, while stating its appreciation that Vermont

is working within the US legal system to address its disagreement with federal authorities, reminded the public in an offi cial statement that the HHS Task Force was still in progress: “Completion of this required study is critical to making an informed decision as to whether the drug importation or not program in MMA can be implemented safely.”

The Vermont Board of Pharmacy, which was not involved in the waiver-seeking process, has not made a public statement regarding the matter. Its position on the reimportation of prescription drugs was published, however, in the Board’s June 2003 Vermont Board of Pharmacy Newsletter. “The Board

fi nds itself in a diffi cult, and potentially unpopular, position to protect the public safety,” the Newsletter states. “The practice of importing drugs from foreign jurisdictions is illegal and has been made so to support the overriding purpose of the law, namely the protection of the health, safety, and welfare of the public.”

NABP’s PositionWhile NABP sympathizes

with the economic concerns of those patients who face diffi culties affording their prescribed medications, the Association’s position is clear. “NABP does not oppose importation within the safe and secure regulatory framework of the [FDA] and state boards of pharmacy,” NABP Executive

Director/Secretary Carmen A. Catizone told the HHS Task Force when he testifi ed before it in May 2004. “NABP does oppose the illegal importation of medications which is presently occurring and compromising the integrity of our medication system and state regulation of the practice of pharmacy.”

Catizone also reiterated regulators’ concerns about patient safety. “NABP cannot accept the premise that people must die from the illegal importation of drugs before the existing laws ensuring the safety of patients are complied with and enforced,” he said. “The ‘show us the bodies’ strategy proposed by some legislators, governors, mayors, and other public offi cials is irresponsible.”

Importation Update(continued from page 9)

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24

Association Highlights

Reminder

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

nabp newsletter

The 2005 NAPLEX/MPJE Registration

Bulletin is now available online at www.nabp.net.

january 2005

The Minnesota Board of Pharmacy won the 15th annual Survey of Pharmacy Law drawing. The Board used the $125 award to defray the cost of a Board member and staff dinner. Minnesota was one of the boards of pharmacy to qualify for the drawing by returning its revised Survey data by the deadline.

Documents

January 05 Newsletter2 - nabp.pharmacy · nabp newsletter 4 (continued on page 5) Legal Briefs Takes One to Know One By Dale J. Atkinson Attorney Dale J. Atkinson is a partner in