newsletter - NABP · 8/7/2016 · to ensure that a pharmacist maintains control of unused prescription drugs donated from an LTCF. Also, the LTCF consultant pharmacist must not disclose

newsletterNational Association of Boards of Pharmacy®

aid to governmentthe profession

the public1904 to 2006

In This Issue. . . .Professional Affairs Update: FDA Issues Proposed Rules on Medical Gas Containers and Closures

August 2006 / Volume 35 Number 7

142 144 154148

Feature News:102nd Annual Meeting CE Session Provides Disaster Planning Pointers to Boards

Legal Briefs:Thirty-Year Fixed

Fall Educational Conference: Enjoy Savannah’s Gracious Hospitality During NABP’s Fall Educational Conference

This Month on www.nabp.net:Special ItemsProceedings of NABP�s 102nd Annual Meeting

NABP Releases 2006 Model Rules for the Licensure of Wholesale Distributors

HeadlinesNABP Accredits Saddle River Marketing Concepts through VAWD Program

Upcoming MeetingsSunday-TuesdayAugust 6-8, 2006NABP/AACP District III MeetingCharleston, SC

Thursday-SaturdayAugust 10-12, 2006NABP/AACP District V MeetingInn at the Forks,Winnipeg, Manitoba, Canada

Wednesday-Saturday, October 4-7, 2006NABP/AACP District VII & VIII MeetingAnaheim, CA

Monday, September 25, 2006 & Friday, September 29, 2006NABP�s Annual Program Review and Training SessionsNABP HeadquartersMount Prospect, IL

Friday-SaturdayNovember 3-4, 2006 NABP Fall Educational Conference Hyatt Regency SavannahSavannah, GA

(continued on page 140)

NABP Launches PALS; Verizon Directories Corp, First to Utilize Program NABP recently launched its newest program – the Pharmacy Authenticated Licensure Service™ (PALS™) program, which provides credible licensure authentication services of pharmacists and online pharmacies to the boards of pharmacy and outside entities.

The rapid growth of online pharmacies that offer pharmaceutical services brought with it challenges for those entities wishing to ensure that these online pharmacies are operating with a valid license. PALS was developed to meet these challenges and to authenticate licensure for the boards of pharmacy, the public, and other

organizations. This licensure authentication will provide a directory of qualified pharmacies and pharmacists-in-charge (PIC) that can be referenced by the public, authenticating the legitimacy of online pharmacies.

PALS pharmacies will be issued a PALS hyperlink to post on their Web sites. By clicking on the link, a visitor is brought to the NABP PALS site where authenticated information about the pharmacy is maintained by NABP.

Entities that provide advertising services can easily identify PALS pharmacies and limit their clients to those pharmacies that are

authenticated to be appropriately licensed, helping to protect the public health.

The long-term goal of the program is to help each state board of pharmacy reduce the number of hours their staff spends confirming licensure and enable state boards of pharmacy to authenticate licensure in one place – through NABP’s databases.

“NABP believes that PALS will be of tremendous value to its users and the boards of pharmacy because the program will provide credible licensure authentication services and will aid in the protection of public health,” states Lawrence

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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 65 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]

Carmen A. CatizoneExecutive Director/

Secretary

Dale J. Atkinson, JDKatie Brenner

Laurel Berger O’ConnorContributing Editors

Larissa DoucetteEditorial Manager

Lisa HuxholdProofreader/Editor

©2006 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.

Association News

(continued from page 139)

NEWLY ACCREDITED VAWD FACILITY

PALS

H. Mokhiber, NABP president. “NABP is also pleased to announce Verizon Directories Corp. (Verizon) as PALS’ first participant.”

Upon completion of the authentication process, NABP will provide to Verizon, for use in its SuperPages.com service, relevant information that will state whether or not the online pharmacy and

PIC are appropriately licensed in all applicable states so that users will have that knowledge prior to doing business with the online pharmacy. SuperPages.com is

the premier Internet yellow pages and local information source.

A prelude to NABP’s Verified Internet Pharmacy Practice Sites™ (VIPPS™) program PALS authentication satisfies the first VIPPS criteria requiring online pharmacies to be licensed in all applicable jurisdictions. PALS pharmacies are encouraged to continue on with the process and seek full VIPPS accreditation.

Pictured from left to right are new Executive Committee Members Lloyd K. Jessen, RPh, JD, executive director, Iowa Board of Pharmacy Examiners; Karen M. Ryle, MS, RPh, member, Massachusetts Board of Registration in Pharmacy; and Malcolm J. Broussard, RPh, executive director, Louisiana Board of Pharmacy.

Executive Committee Members Attend New Executive Committee Member Orientation

FFF Enterprises, Inc., based in Temecula, CA has earned accreditation under NABP’s Verifi ed-Accredited Wholesale Distributors™ (VAWD™) program. FFF Enterprises is a distributor of

biopharmaceuticals, plasma products (including albumin, intravenous

immune globulin, and coagulation products), and vaccines.

More information about NABP’s VAWD program is available at NABP’s Web site at www.nabp.net.

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Feature News

Executive CommitteeDennis K. McAllisterChairperson, District VIIIOne-year term

Lawrence H. MokhiberPresident, District IIOne-year term

Oren M. Peacock, JrPresident-elect, District VIOne-year term

John R. Dorvee, Jr Treasurer, District IOne-year term

Malcolm J. BroussardMember, District VIServing fi rst year of a three-year term

Reginald B. “Reggie” DilliardMember, District IIIServing second year of a three-year term

Patricia F. HarrisMember, District VIIIServing second year of a three-year term

Lloyd K. JessenMember, District VServing a one-year term

Richard A. “Rich” PalomboMember, District IIServing third year of a three-year term

Karen M. RyleMember, District IServing a one-year term

Gary A. SchnabelMember, District VIIServing fi rst year of a three-year term

William T. “Bill” WinsleyMember, District IVServing second year of a three-year term

NABP’s Executive Committee is elected each year at the Association’s Annual Meeting. The 103rd Annual Meeting is May 19-22, 2007, at the Hilton Portland & Executive Tower, Portland, OR.


State legislatures responding to the increasing cost of prescription medications are implementing drug donation programs intended to make use of medications that would otherwise be disposed. According to a February 2006 NABP survey of state boards of pharmacy, 22 of 30 boards that responded to the survey indicated that they allow drug repositories to exist or operate and many more states have proposed such programs. In some cases, the programs utilize a central repository for unused drugs, which are then redispensed, and in other cases the pharmacy that originally dispensed the drugs track the unused supplies individually.

States have sought to utilize unused prescription drugs for the following reasons:

l Assist patients with affordability challenges. The cost of chemotherapy and adjunctive therapies can be particularly burdensome and cancer patients are the most common example of a donation program participant. Other common recipient groups include long-term care facility (LTCF) patients, the indigent, and the uninsured or underinsured;

State Boards’ Donation Programs for Unused Prescription Medications Balance Patient Needs, Safety

l Avoid disposing of unused drugs, which may endanger the public health and the environment; and

l Make use of the signifi cant fi nancial resources that have been invested in medications.

The major challenges that the state boards face in managing such programs include recordkeeping, security, and regulating participation among both patients and pharmacies.

Tracking the SupplyBryan H. Potter, executive director of the Oklahoma State Board of Pharmacy, notes that safeguards are in place for the donation program in Oklahoma, a non-central repository program. The program allows drugs from LTCFs and some assisted living centers to be donated and sent to designated pharmacies, charitable pharmacies, county pharmacies, and state mental health pharmacies, which redispense the medications to the medically indigent at no charge. The Board’s main concern about the program, says Potter, was to ensure that a pharmacist maintains control of unused prescription drugs donated from an LTCF. Also, the LTCF consultant pharmacist must not disclose patient

information through the original labeling; redacting patient information is required.

In Colorado, a statute became effective in 2005 that creates the Colorado Cancer Drug Repository Program, which allows cancer patients or family members of cancer patients in an LTCF to donate drugs or medical devices to a participating health care facility, medical clinic, or pharmacy. The drugs must be in their original, unopened, sealed, and tamper-evident unit dose packaging or unopened if in a single-unit dose package. Drugs that are not acceptable include those that are classifi ed as controlled substances; have expired; are adulterated or misbranded; require refrigeration, freezing, or other special temperature requirements beyond controlled room temperature; or can only be dispensed to a patient registered with a drug manufacturer that needs to maintain registration data. Participating health facilities, medical clinics, and pharmacies are required to maintain detailed records of medications either received or redistributed.

Nebraska also has a non-central repository donation program for cancer drugs

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Legal Briefs

Thirty-Year FixedBy Dale J. Atkinson, JD

Boards of pharmacy are empowered to protect the public through the

regulation of the licensure of pharmacists and pharmacies. As part of the legislative grant of authority, boards are authorized to investigate and discipline such licenses and licensees. The extent to which such licenses are subject to discipline is a function of the particular pharmacy practice act and the powers granted to the board.

Eventually, the Board fi led a complaint against the licensees based upon allegations of failure to keep appropriate records, maintain a complete inventory list, generate computer printouts of drugs dispensed daily, cull outdated drugs from stock, and maintain inventories and records of controlled substances (CS). In addition, the licensees were accused of dispensing CS without a valid prescription and having committed gross negligence or gross malpractice.

At a scheduled hearing on the matter, counsel for both the Board and the licensees stipulated that the evidence existed to support the charges in the complaint. Thereafter in April 2003, the Board entered an order in which the licensees were fi ned and the licenses were suspended pending the completion of a satisfactory inspection by the Board “wherein all drugs properly

labeled, out of date drugs properly disposed of and all records and documentation required by law have been provided.” Upon this satisfactory inspection, the suspended licenses would revert to probationary status.

After the April 2003 order, an investigation by the Board indicated that the licensees might have continued to dispense drugs in spite of the licensure suspension. The Board obtained an injunction by the Circuit Court and in October 2003 initiated a new administrative complaint against the licensees for engaging in the practice without a valid license. The licensees fi led a motion for a more defi nite statement of the charges and for a continuance. Both motions were denied by the Board.

At the commencement of the hearing on the October 2003 complaint, the Board’s hearing offi cer asked whether or not there were any pre-hearing matters to be addressed at which time counsel for both the Board and the licensees responded in the negative. The hearing ensued and both sides tendered witnesses and documentary evidence. At the conclusion, the Board deliberated and in November 2003 entered an order fi nding that the licensees had fi lled 838

For example, some boards are able to “permanently revoke” a license, effectively removing such individual or pharmacy from the practice of pharmacy in that jurisdiction forever. Other boards “revoke” licenses that are subject to subsequent reinstatement petitions. Again, reinstatement petitions are subject to the particular laws of the specifi c jurisdiction. Sometimes the language used in fi nal orders disciplining a licensee can determine the extent, if any, of reinstatement petitions. Clear and specifi c language addressing whether or not a license is revoked or suspended and the reinstatement rights can be very helpful to identify future licensure status. Consider the following.

A pharmacist and his pharmacy (collectively referred to as licensees) were the subject of an administrative investigation by the Alabama State Board of Pharmacy (Board).

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Legal Briefs


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

prescriptions, obtained reimbursement from third-party payors for such prescriptions, and ordered drugs from wholesalers while their licenses were under suspension pursuant to the April 2003 order. Concluding that such actions violated several statutes, the Board fi ned each licensee $10,000 and suspended each license for 30 years (subject to a right to apply for reinstatement in fi ve years). The order was signed by the secretary of the Board.

The licensees appealed the matter to the Circuit Court, which found that the licensees had adequate notice of the matters contained in the charges, that the parties had the benefi t of counsel, and that the proceedings were fair and reasonable. However, the court opined that the secretary of the Board was not empowered to sign fi nal orders and, thus, remanded the matter back to the Board to determine whether or not the November 2003 order refl ected the fi ndings of the Board. The Board responded by issuing an order in October 2004 that was signed by both the current and immediate past presidents of the Board and made no substantive changes to the November 2003 order. The Circuit Court thereafter affi rmed the Board order

and the licensees appealed to the appellate court.

On appeal, the licensees argued that the “cumulative effect” of “the lack of rules for disciplining pharmacists throughout the [administrative] process” amounted to a denial of due process in violation of constitutional principles. As interpreted and summarized by the court, the licensees argued that (1) the Board did not have suffi cient guidelines governing the institution of disciplinary actions against licensees; (2) the Board did not specify the standard of proof; (3) the Board improperly allowed its secretary to fi ll multiple roles related to investigation and adjudication of discipline; and (4) the Board improperly relied upon hearsay evidence.

Regarding the allegation that the Board did not have suffi cient guidelines governing the institution of complaints, the court held that the Administrative Procedures Act (APA) specifi cally requires “reasonable notice in writing” of the “time place and nature of the hearing,” a recitation of “the legal authority and jurisdiction under which the hearing is to be held,” reference to the “particular sections of the statutes and rules” involved, and “a short and plain statement of the matters

asserted.” The court rejected any notion that the licensees were entitled to rigorous due process requirements regarding the institution of administrative proceedings. In the current matter, the court held that the licensees received suffi cient notice as required under the APA.

The next issue argued by the licensees was that the Board failed to specify or profess adherence to a particular governing standard of proof. In rejecting this argument, the court held that the statute specifi cally references a preponderance standard and such burden must by law be applied by the Board. Thus, the court rejected the argument of the licensees that the standard was somehow vague or indefi nite.

The licensees next argued that the involvement of the Board secretary in the investigative portions of the matters (in fact the secretary testifi ed before the Board regarding the continued practice of the licensees after the initial suspension) and the adjudication of the complaint (by signing the November 2003 order) amounted to an unlawful blending of prosecution and adjudication in violation of constitutional principles related to bias and confl icts. In rejecting this argument, the court held that no

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Feature News

public safety,” he said. “This is usually done through regulations and enforcing those regulations. In this case, the Louisiana Board was asked to do something different. The governor and the Offi ce of Emergency Preparedness . . . had their hands full . . . . They asked the Louisiana Board, ‘Would you take care of the medication needs for the state of Louisiana?’”

The fi rst thing the Lousiana Board had done, of course, was to coordinate with state offi cials and the federal disaster response team to assess the situation and set up a triage area. Within a couple of days of the levee breaches, the state’s Department of Public Health’s pharmacy department (responsible for disaster response, but hampered by the inoperability of its offi ce in downtown New Orleans) opened an emergency operations center in Baton Rouge, eventually working out of the Board offi ce itself. Immediate tasks included ramping up the communications systems, coordinating volunteer pharmacist staffi ng coverage, and establishing a medication distribution system for operating shelters.

In assessing the situation in the immediate hours and days after Katrina hit,

There has been a lot of talk in recent years about government emergency

preparedness and disaster planning, talk that became all the more frequent and earnest after 9/11. And yet, when Hurricane Katrina slammed into the Gulf Coast last summer, the whole country witnessed a graphic demonstration of what we were prepared for – and what we were not.

102nd Annual Meeting CE Session Provides Disaster Planning Pointers to Boards

Katrina proved a wake-up call for the public and private sectors alike. Since then, offi cials in business and government have sought to take the lessons gained from Katrina and apply them, so that the next widespread disaster, whatever it may be and whenever it may occur, will not be met unprepared.

Lessons learned from Katrina and the steps the boards of pharmacy can and should take to prepare themselves to handle emergencies was the topic of the two-part seminar, “Structuring an Effective Disaster Plan: Lessons Learned” at NABP’s 102nd Annual Meeting in April 2006 in San Francisco, CA. During the seminar, which involved both presentations and a panel discussion, the speakers shared their own experiences in the aftermath of Katrina, noted what did and did not work during the crisis,

what they think should be improved upon for next time, what to expect from the federal government in terms of response and assistance, and steps the boards should take in the vital task of developing their own disaster plans. The fi rst half of the session was co-presented by Malcolm J. Broussard, executive director of the Louisiana Board of Pharmacy and a member of the NABP Executive Committee, and Robert J. “Bob” Dufour, a member of the Arkansas State Board of Pharmacy and pharmacy director, professional services, for Wal-Mart Stores, Inc.

What HappenedIn the aftermath of Katrina, Dufour offered his services to the Louisiana Board of Pharmacy, which was asked to take on a whole new role from its usual one. “The number-one goal at the Louisiana Board of Pharmacy is to affect the

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Feature News


with much information still sketchy, the Board realized that thousands of people – those who had been evacuated to shelters, those who had evacuated in a hurry under their own power, and even emergency response personnel – would not have their medications, nor would they be able to call their physician or their pharmacist to fi ll or refi ll prescriptions. “It was very clear,” said Dufour, “there was a need for pharmacists to dispense emergency meds without a prescription.”

And they did. In Louisiana, they were greatly aided by one section of regulations that had been on the books since 2004, said Broussard. This section “is triggered by the proclamation of a state of emergency by the governor,” said Broussard. “There are two provisions of that; the fi rst is the ability of licensed pharmacists from other states to come assist us in our state but who may not possess a Louisiana license. The rule states that during a state of emergency, if a pharmacist carries an active, current license from another jurisdiction, they may practice in our state for the duration of the declaration of the state of emergency.” The second provision, meanwhile, allows a pharmacist in

the affected area – “using sound, professional judgment” – to create and write a prescription for any medication and dispense up to a 30-day supply.

Speaker Richard A. “Rich” Palombo, an NABP Executive Committee member, recent member of the New Jersey Board of Pharmacy, and director of compliance, professional practice, for Medco Health Solutions of Franklin Lakes LLC, who joined in for the second half of the session, expressed his opinion that the latitude granted by these emergency measures contributed greatly to the caliber of patient care that pharmacists delivered under tremendously diffi cult circumstances. “We can have established rules that need to be in place all the time, but in these kinds of disasters . . . having the opportunity and the little bit of fl exibility that the Louisiana Board afforded us allowed for much better patient care,” he said. “In the magnitude of that kind of disaster, you’ve really got to rely on professional judgment and you have to rely on the distinction that pharmacists are very well trained and they will work for the benefi t of the patients.”

The importance of communication and

coordination cannot be overstated. In order to provide needed medications to Katrina’s victims, affected boards of pharmacy had to coordinate with numerous federal, state, and local agencies that were providing various aspects of relief and assistance to the medication effort, as well as agencies such as Food and Drug Administration, Drug Enforcement Administration, and United States Pharmacopeia; private sector entities – wholesalers that had the stock and knew the state’s back roads, chain and independent pharmacies that “adopted” shelters and moved in personnel and medications to make the effort work – and non-profi t aid associations such as the American Red Cross and the Salvation Army. The communication webs stretched across the country. Both Louisiana and Mississippi, along with relying heavily on the infrastructure and abilities of the private sector, also turned to the Strategic National Stockpile Program, to help supply needed medications. Its formulary, intended primarily to be of use in the case of a chemical or biological terror attack, did not fulfi ll all needs, but it certainly helped.

The logistics for those coordinating the efforts and

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Feature News

those participating in them were daunting, to say the least. Palombo related some of the factors his company faced in sending a mobile pharmacy to help a hospital near New Orleans. Medco sent two trailers, he said, one to serve as a pharmacy, the other as living quarters for the staff, as no other accommodations were available. The relief teams had to be self-suffi cient; local resources were not an option. “[The trailers] were being shipped from Ohio, because there wasn’t any local source,” said Palombo. “We had to bring fuel in on a van.”

The joint undertaking worked to a surprising degree. Thanks to ingenuity, communication, and unrelenting efforts from both the private and public sectors, and despite the fl uid shelter situation and the constant movement of displaced residents, evacuees got their medications, and hospitals and nursing homes received appropriate medications and supplies.

Important PointsIn their presentations, Dufour and Broussard highlighted a number of points important for boards to consider as they revamp or create their own disaster plans, as did the remaining speaker who joined in for the second half of the continuing

education session: Captain Christopher Jones, regional emergency coordinator for the US Department of Health and Human Services’ (HHS) Offi ce of Public Health Emergency Preparedness.

With the overriding importance of communication and coordination in the face of a catastrophe, Boards should consider their relationships with those agencies charged with the medical aspects of disaster response – now, when things are calm, said Jones. “The last thing you want to do during a disaster is come to your state health department or to your state emergency management agency and pass your business card to them and tell them who you are and where you’re from and try to begin to fi gure out at that juncture what you can do to help,” he said. “What you really need to be doing is approaching the state health departments and the state emergency management agencies, but primarily the state health departments, because they’re the ones who’ll be coordinating the health and medical response, sitting down with them and fi guring out how the state board of pharmacy can lend a hand and become integrated into the plans, adapt the plans to meet the capabilities and resources that the state boards of pharmacy bring.”

Another, related and important step for Boards

is to examine their current regulations, Broussard suggested. Louisiana’s comparatively new section providing “state of emergency” capabilities to provide emergency medications and accept the help of pharmacists not licensed in the state proved vital to the Board’s ability to help the thousands in need. While many states have 72-hour emergency prescribing provisions, few go beyond this.

State boards might want to consider other regulations as well, such as one recommended in the federal government’s report, “Katrina – LessonsLearned” (available at www.whitehouse.gov/reports/katrina-lessons-learned). In Louisiana, Broussard noted, the Board had to remind pharmacists that medications stored above 104° F for more than 24 hours could no longer be dispensed – something of a problem in the heat of a Gulf Coast summer with no electricity in sight. The Bush Administration’s report suggests that states enact legislation requiring pharmacies to have generators, at least partially addressing situations like this. (Fuel for the generators following a large-scale disaster? That is another question.)

While it is diffi cult to plan for a situation that has not occurred, boards should try to brainstorm the logistical

issues that might be faced in any disaster, and work to address them, Dufour said. As they think through various disaster scenarios, boards should keep potential logistical problems in mind. As an example, he raised several questions: How does the current infrastructure work? If that infrastructure broke down, how could the logistical challenges be met? Where could medications be stored, and how would they be unloaded, stored, and distributed?

Boards also need to plan how they will communicate with pharmacists and, potentially, the public during a disaster. “You should have newspaper ads, radio ads, information you can put on your Web site,” said Dufour. “Have that in the can now, so if something does hit, you’re prepared.”

The boards should not ignore their own needs. Broussard pointed out the importance of safeguarding board records, for example. “We need to be mindful of our duty to protect records so we have continuity of operations,” he said.

As the session’s speakers noted, and as is echoed in disaster plan advice from private, public, and non-profi t experts alike, responses to disasters do not begin at the federal level. While some criticize this policy – in the federal government’s Katrina report, the authors recommend, “In a catastrophic scenario that

Disaster(continued from page 145)

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Feature News

effective planning for other, less similar disasters.

Despite recent attention focused on the issue, particularly in relation to a fl u pandemic, tight budgets and busy offi cials pushing the matter off in favor of items that seem more urgent mean that disaster plans in general are being talked about more then actually created (or old ones seriously reviewed). As a result of Resolution 102-4-06, Emergency Preparedness, Response, and the US Distribution System, which was adopted at the Association’s 102nd Annual Meeting in April 2006, NABP will convene a task force to examine the disaster plan situation and offer more specifi c guidance to the Boards on the topic.

Hurricane Katrina pointed up many faults in local, state, and federal ability to respond effectively to an event of catastrophic proportions. But it also highlighted some positives: far-sighted, emergency-triggered regulations that facilitated assistance efforts; fl exibility, ingenuity, and sacrifi ce on the part of numerous members of the public and private sectors; and close cooperation between regulators, retailers, wholesalers, and manufacturers that allowed victims (and rescuers) to access needed medications. With comprehensive and well-thought-out plans for every jurisdiction, these positive elements can make the next big disaster less tragic.

overwhelms or incapacitates local and state incident command structures, the federal government must be prepared to assume incident command and get assistance to those in need until state and local authorities are reconstituted” – at present, said Jones, “The bottom line . . . is that during a disaster, all disasters are local disasters. The local emergency management agencies have the foremost responsibility in coordinating the response. It’s only after the disaster exceeds their capabilities and capacity to respond that they’ll ask for assistance from the state. Once the state determines that the magnitude of the event exceeds their resources to respond . . . they ask the federal government for assistance.”

Indeed, Jones said, “Every community and every state should plan for the worst. If you plan to be able to initiate a response and sustain the support for that response for a week, you’ll be in good stead. Prior to Katrina . . . I said plan to sustain a response for 72 hours . . . Katrina taught us a grave lesson, that in a catastrophic event that encompasses many communities over such a broad geographic area, there aren’t enough federal resources to go around.”

Beyond HurricanesKatrina taught everyone a lot about catastrophes and

large-scale disasters as they pertain to hurricanes, but what about other types of disasters? How transferable are Katrina’s lessons? The Department of Homeland Security’s National Response Plan identifi es 15 types of incidents that could be deemed disasters or emergencies. Any given locality may be subjected to a natural disaster, a terrorist attack, or even what Jones referred to as “technological disasters” and “immigration events.”

While some response elements remain the same, one disaster that would require a different response in many ways than a hurricane is a fl u pandemic. How would the board continue operations with signifi cant absenteeism, such as could occur at the height of a pandemic? How could pharmacies continue to operate? How would large numbers of people receive vaccinations, antiviral drugs, or other measures that might be necessary on a large scale and in a hurry?

In light of immediate concerns raised by the avian fl u pandemic and concerns that it will eventually make the leap to easy transmission by humans, HHS has provided extensive guidance on planning for a fl u pandemic. (See www.hhs.gov/pandemicfl u/plan and www.pandemicfl u.gov for the HHS plan and guidance for state and local entities, state plans, and other useful information on

the topic.) HHS has pledged to support affected states or areas by such measures as conducting outbreak investigations, working to produce and distribute vaccines, and providing guidance on such community containment strategies as quarantines or travel restrictions.

HHS also recommended that state and local governments establish a Pandemic Infl uenza Coordinating Committee representing a wide range of specialties in the public and private sectors “to oversee preparedness planning and ensure integration with other emergency planning efforts.” HHS convened a meeting of local and state offi cials from across the country in December 2005, and since then has held pandemic planning summits across the country. Plans have been drawn up and are public record in at least draft form for each state. If they have not already been involved in such planning and coordination efforts, boards of pharmacy should begin participating as soon as possible.

A side benefi t of the focus on pandemic fl u preparations is the light they can shed on other planning efforts that may or may not be moving forward, particularly other infectious disease emergencies, including bioterrorism events. They also may facilitate the communication and coordination necessary for

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Fall Educational Conference

NABP’s Fall Educational Conference, taking place November 3-4, 2006,

at the Hyatt Regency Savannah, offers attendees value-laden seminars and great opportunities for networking – not to mention the continuing education credits. But do yourself a favor if you can – build is some extra personal time to savor some of Savannah’s unique offerings.

Enjoy Savannah’s Gracious Hospitality During NABP’s Fall Educational Conference

Savannah prides itself on being visitor-friendly, and likes to show off its gracious beauty and charm as well as its eccentric character. Whether you love shopping, nightlife, golfi ng, architecture, military history, literature, outdoor pursuits, or just about anything else, Savannah has something distinctive in store.

The Hyatt Regency is located in Savannah’s Riverfront Plaza, a nine-block area designed to be explored on foot and fi lled with unique shops, art galleries, and restaurants. Moreover, it sits in the middle of the city’s Historic District, putting meeting attendees in prime position to easily explore a number of Savannah’s main attractions.

The Pull of HistorySavannah is nothing if not rich in history. Founded in 1733, Savannah was the fi rst town in the brand-new colony of Georgia,

and many of its tourist attractions help the visitor to explore the city from that time to its present.

Two fun ways to explore landmarks in Savannah are by tour. Short on time, but with a soft spot for romance? Try an hour-long tour of the Historic District in a horse-drawn carriage. A variety of tours are offered, including one that focuses on local ghost stories. Those who want to combine a guided tour with fl exibility might wish to try Old Town Trolley Tours®, which makes 16 stops and covers many of the city’s most famous attractions. Visitors may disembark for lunch or further exploration, and reboard another trolley car at their convenience.

If you prefer the do-it-yourself approach, Savannah boasts a plethora of museums, many located in historic homes. The Hamilton-Turner Inn, made famous in John Berendt’s book Midnight in the Garden of Good and Evil, is

one of these. (Indeed, if you found that book intriguing, travel guides such as Fodor’s suggest self-guided tours that walk you through the story’s environs; see, for example, www.fodors.com.) Others are the Owens-Thomas House and Museum, which features not only acclaimed examples of regency architecture but also urban slave quarters as they appeared in the early 19th century, and the Davenport House Museum, which showcases period furnishings and artifacts, also from the early 1800s.

The Savannah History Museum, located at the Savannah Visitors Center – and on the site of the Revolutionary War’s 1779 Siege of Savannah –gives visitors an overview of the city’s history since its founding. The Ships of the Sea Maritime Museum features several exhibits, and includes maritime antiques, paintings, and model ships. If you prefer to focus on recent history, the Ralph Mark Gilbert Civil Rights Museum chronicles the civil rights struggles of African Americans in the Savannah area. And if you are a military buff, Savannah will not let you down. The 24th Infantry Division/Fort Stewart Museum includes a number of exhibits, including a large collection of captured weapons and

Area Attractions

24th Infantry Division/Fort Stewart MuseumFort Stewart, Wilson Ave & Utility St, Savannah; 912/767-7885

Blythe Island Regional Park6616 Blythe Island Hwy, Brunswick; 800/343-7855;www.glynncounty.org/glynncounty.org/departments/recreation/blythe.htm

Carriage Tours of Savannah 10 Warner St, Savannah; 912/236-6756; www.savannahgeorgia.com/carriagetours

Davenport House Museum324 E State St, Savannah; 912/236-8097; www.davenporthousemuseum.org

Flannery O’Connor House207 E Charlton St on Lafayette Square, Savannah; 912/233-6014;www.llp.armstrong.edu/fl annery/foundation.html

Fort Pulaski National MonumentHighway 80 East heading toward Tybee Island; 912/786-5787; www.nps.gov/fopu

Hamilton-Turner Inn330 Abercorn St on Lafayette Square, Savannah; 888/448-8849; www.hamilton-turnerinn.com

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equipment from the Iraqi confl ict, while the Mighty Eighth Air Force Heritage Museum examines the contributions of the Eighth Air Force members from 1942 to the present. Civil War enthusiasts might enjoy a visit to the Fort Pulaski National Monument, a coastal fort that played an important role in the war. The adjoining parkland also offers nature lovers a treat, with wildlife ranging from alligators to deer and migratory birds.

Other sites give you a chance to pay homage to illustrious Savannah natives. For literature afi cionados, the Flannery O’Connor House welcomes visitors to the childhood home of acclaimed novelist and short-story writer Mary Flannery O’Connor. The mansion and birthplace

of Juliette Gordon Low, meanwhile, is run by the Girl Scouts of the USA as a memorial to the organization’s founder.

Time For ActionFor those who prefer the active life, Savannah and its environs feature a variety of options.

Golfers may take to the greens at a number of area golf courses and country clubs. Would you prefer a fl at nine-hole course suitable for all skill levels? A historic 18-hole course complete with many natural hazards? Spectacular views? Expert instruction? You can fi nd it in Savannah. Visit www.savannah.world-guides.com/savannah_golf_courses.html for descriptions of the city’s main golf courses and clubs.

Visitors can also become one with nature – St Simon’s Island, one of the nearby “Golden Isles,” offers diving, fi shing, and sailing day trips, in addition to the dry-land options of nature tours and various sports activities. Take in a show at one of the island’s theatres, or unwind at one of its restaurants.

Or head to Blythe Island Regional Park. Boat, canoe, and kayak rentals are available at a large water area; elsewhere are volleyball courts, an archery range, and hiking and biking trails. Just want to relax? You will fi nd a beach area, as well.

Another small barrier island nearby, Tybee Island, also offers beaches to frolic on, restaurants to sample, a historic lighthouse to visit, and even a marine science center that educates visitors on their watery surroundings, including aquariums with specimens of the local marine life.

NABP’s Fall Educational Conference allows attendees wonderful opportunities for networking and learning. But in between the topical discussions, attendees can also take advantage of their lovely and history-laden surroundings. Your conference experience will be all the richer for it.

Juliette Gordon Low Birthplace/Girl Scout National Center10 E Oglethorpe Ave, Savannah; 912/233-4501; www.girlscouts.org/who_we_are/birthplace

Mighty Eighth Air Force Heritage Museum175 Bourne Ave, Pooler; 912/748-8888; www.mightyeighth.org

Old Town Trolley Tours®234 Martin Luther King, Jr Blvd, Savannah; 912/233-0083; www.historictours.com/savannah

Owens-Thomas House and Museum124 Abercorn St, Savannah; 912/233-9743

Ralph Mark Gilbert Civil Rights Museum460 Martin Luther King, Jr Blvd, Savannah; 912/231-8900; www.sip.armstrong.edu/CivilRightsMuseum/Civilindex.html

Savannah History Museum303 Martin Luther King, Jr Blvd, Savannah; 912/238-1779; www.chsgeorgia.org/shm/home.htm

Ships of the Sea Maritime Museum41 Martin Luther King, Jr Blvd, Savannah; 912/232-1511; www.shipsofthesea.org

St Simon’s Islandwww.saintsimons.com

Tybee Islandwww.tybeeisland.com

A horse and carriage wait outside Savannah�s luxurious bed and breakfast mansion, the Hamilton-Turner Inn.

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Friday, November 39 AM - 5:15 PM

Registration/Information Desk Open

1 - 1:15 PM

Welcome Remarks

1:15 - 2:45 PM

Educational Session(0.15 CEUs – 1.5 contact hours)

2:45 - 3 PM

Refreshment Break

3 - 5 PM


6:30 - 8:30 PM

Welcome Reception(Buffet dinner will be served.)

Saturday, November 46:30 AM - 5 PM

Registration/Information Desk Open

7 - 8 AM

Continental Breakfast

8 - 9:30 AM Educational Session(0.15 CEUs – 1.5 contact hours)

9:30 - 9:45 AM Refreshment Break

9:45 - 11:45 AM


Noon - 1 PM

Luncheon

1:15 - 2:45 PM


2:45 - 3 PM Refreshment Break

3 - 4:30 PM Educational Session(0.15 CEUs – 1.5 contact hours)

4:15 - 4:30 PM Closing Remarks

Fall Educational Conference Program*

November 3-4, 2006 Hyatt Regency Savannah Savannah, GA*Program subject to change.

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 10 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 NABP. A validated Statement of Continuing Pharmacy Education Credit will be sent as proof of participation within approximately six weeks. Full attendance and completion of a program evaluation form for each session are required to receive continuing pharmacy education credit and a Statement of Continuing Pharmacy Education Credit.

evidence suggested that the secretary played a role in the actual adjudication of the complaint other than the ministerial act of signing the order. Thus, the secretary’s role was distinguishable from the United States Supreme Court case cited by the licensees. Accordingly, the court upheld the role of the secretary in this matter.

Finally, the court rejected the arguments of the licensees that the Board relied upon

hearsay testimony and computer printouts that also amounted to hearsay. The court cited the relaxed standards related to the rules of evidence and that certain evidence may be allowed in spite of the fact that it would be inadmissible in a judicial proceeding. In short, the court noted that the APA expressly allows admission of evidence “commonly relied upon by reasonable prudent persons in the conduct of their affairs.”

Based upon the foregoing, the appellate court upheld the lower court and

the Board of Pharmacy discipline of the licensees. The court was not asked to nor did it address the 30-year suspension of the licensees (subject to a right to apply for reinstatement in fi ve years). However, such a suspension (rather than revocation) may serve an important purpose of prohibiting reinstatement petitions for a specifi c period of time while maintaining Board jurisdiction over the sanctioned individual or pharmacy. In certain jurisdictions, revoked licensees may seek

reinstatement after a period of time specifi ed in statute (ie, one or two years). The language used in fi nal orders can, and should be, instrumental in determining the future status of licensure and should be carefully crafted. Likewise, the sanction levied may also provide an essential basis for future licensure and whether or not reinstatement petitions can be fi led and heard by the Board.

Spruell v. Alabama State Board of Pharmacy, 2006 WL 1360824 (AL Civ. App. 2006)

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The FPGEC Certifi cate allows foreign graduates to partially fulfi ll eligibility requirements for licensure in the states that recognize the certifi cation. NABP continuously alerts applicants that the FPGEC Certifi cate is not a license to practice pharmacy. Applicants who receive the FPGEC Certifi cate are qualifi ed by the state boards of pharmacy that accept the FPGEC Certifi cate to continue the licensure process and take the North American Pharmacist Licensure Examination™ and other required examinations in those jurisdictions that accept this certifi cation. To date, 50 states recognize the FPGEC Certifi cate.

Applicants with questions about the FPGEE or Pre-FPGEE®, the practice examination for the FPGEE, may visit NABP’s Web site at www.nabp.net for updated information.

Association News

June 2006 FPGEE Administration Complete; December 2006 Administration Date AnnouncedOn Saturday, June 24, 2006, 1,872 applicants sat for NABP’s administration of the Foreign Pharmacy Graduate Equivalency Examination® (FPGEE®). The FPGEE was administered in three United States locations: San Mateo (San Francisco), CA; Northlake (Chicago), IL; and New York, NY. Applicants who sat for the June 24, 2006 examination will receive their scores at the end of August 2006. The next FPGEE is scheduled for Saturday, December 2, 2006, and will be administered in the following three United States locations: San Jose, CA; Northlake (Chicago), IL; and New York, NY.

NABP provides the Foreign Pharmacy Graduate Examination Committee™ (FPGEC®) Certifi cation Program as a means of documenting the educational

equivalency of an applicant’s foreign pharmacy education, as well as his or her license and/or registration to assist state boards of pharmacy in qualifying applicants for US licensure. During the FPGEC Certifi cation process, applicants are required to submit certain documents or have the documents submitted from educational or licensure institutions that present their educational backgrounds and licensure and/or registration to practice pharmacy. Effective April 14, 2006, applicants must have their offi cial pharmacy school transcripts and degree qualifi cation verifi ed by the Educational Credential Evaluator’s, Inc. This change was made in response to a continuous increase in applications for the FPGEC Certifi cation Program. NABP continues to verify licensure

with the foreign issuing bodies.

Applicants are also required to pass the FPGEE, the Test of English as a Foreign Language™ (TOEFL®), and the Test of Spoken English™ (TSE®). Applicants who have passed the FPGEE but have not satisfi ed the language requirements for the FPGEC Certifi cate need to be aware that the TOEFL and TSE will eventually be phased out and replaced completely with the TOEFL Internet-based Testing (iBT), an online version of the TOEFL. During the phase-out period of the TOEFL and TSE and phase in of the TOEFL iBT, either minimal acceptable TOEFL iBT scores or a combination of minimal acceptable TOEFL and TSE scores will satisfy the language requirements for the FPGEC Certifi cate.

NABP is seeking item writers for its licensure and certifi cation examination programs. Pharmacists chosen to serve as item writers must hold an active, unrestricted license in any state or territory of the United States. All applicants will have their license(s) verifi ed through NABP’s National Clearinghouse of Licensure, Certifi cation, and Accreditation. Interested pharmacists should send or fax a letter of interest

NABP Seeks Item Writersindicating current practice setting, specialties, and years of experience, along with a current resume or curriculum vitae to NABP’s Executive Director/Secretary, Carmen A. Catizone, at 1600 Feehanville Dr, Mount Prospect, IL 60056; fax 847/391-4502. Applications are accepted on a continual basis and kept on fi le for a period of fi ve years.

Item writers will be selected based on the specifi c needs of the programs. Those who

are chosen will be asked to attend a three-day workshop at NABP Headquarters with travel and lodging expenses paid by NABP. These workshops occur several times per year and are typically held Friday through Sunday. Attendees will receive detailed instructions and training materials describing the item-writing process and content-related requirements for their designated examination. Item writers will then be asked to develop

new test items that will be considered for inclusion in NABP’s licensure and certifi cation examination programs.

State board of pharmacy members and community pharmacists are particularly encouraged to participate in the item-writing process. For more information about item writing, contact the Competency Assessment Department at 847/391-4406.

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among LTCFs and charitable pharmacies.

In Nebraska, the American Cancer Society (ACS) has publicized the state’s drug donation program in an effort to increase participation. The ACS launched a media campaign promoting the program and provided physician offi ces with promotional posters. At the end of 2005, the Nebraska Board conducted a survey of participants to determine how extensively the program was being used. Among the fi ndings from the 52 respondents:

l 41 indicated that they had not received or provided donated drugs;

l Nine indicated that they had received donations of cancer drugs through the program;

l Seven of these nine indicated that they had received the donated drugs from one person or entity; and

l Seven of these nine had not provided any donated cancer drugs to other patients.

With these programs in early stages of implementation, further revisions to the laws and regulations governing them undoubtedly will be made in some cases in order to further safeguard the public health. The goal of these revisions – and of new state laws and regulations mandating these programs –will be to maintain these safeguards while providing crucial assistance to those who need it.

Feature News

in which physician offi ces, pharmacies, hospitals, and health clinics can accept donated medications and redispense them to patients or distribute them to other program participants. Only medications that are in their original, unopened, sealed, and tamper-evident packaging, or if outside packaging is opened but the single-unit-dose packaging is unopened, are eligible for use in the program. The Cancer Drug Repository Program Act, originally enacted in 2003, does not limit the amount of doses that are donated. Cancer drugs that bear an expiration date prior to the date of donation, are adulterated or misbranded, or have expired while in the repository are not accepted into the program.

Nebraska’s Cancer Drug Repository Program Act received a key provision when it was revised in 2005: the creation of a participant registry. This revision required that the participant registry include the participant’s name, address, and telephone number and identify whether or not the participant is a physician’s offi ce, pharmacy, hospital, or health clinic. The participant registry is available to any person or entity wishing to donate cancer drugs to the program. The Act provides immunity from civil or criminal liability or professional disciplinary action for those who exercise

reasonable care in donating, accepting, distributing, or dispensing donated medications under the program.

Nebraska’s Cancer Drug Repository Program Act was revised again in 2006 to eliminate a requirement for unit-dose packaging and allow for donations of injectable cancer drugs that do not have temperature requirements other than controlled room temperature. Another law enacted in 2006 created the Immunosuppressant Drug Repository Program Act, which allows organ transplant centers, drug manufacturers, or patients to donate unused immunosuppressant drugs to program participants or return the immunosuppressants to the transplant center from which they were fi rst prescribed. The requirements for eligible drugs are very similar to those of the Cancer Drug Repository Program Act, except for the absence of a participant registry.

Saving MoneyBefore implementing the donation program, the Oklahoma State Board of Pharmacy conducted a pilot program in two counties in 2004 in which LTCFs donated unused, discontinued medications primarily to the Tulsa County pharmacy. A small formulary of the ten most expensive Medicaid drugs was used. There were some savings, but they

were not as much as was estimated. During 2005, the donation program started with an open formulary and the Tulsa County pharmacy saved over $200,000 the fi rst nine or ten months. Regarding the long-term savings that the program could provide, Potter says that the best opportunity exists through the mental health facilities receiving unused expensive anti-psychotic drugs. Often times these drugs are discontinued, leaving large quantities available for donation.

Becky Wisell, executive secretary of the Nebraska Board of Pharmacy, notes that a key variation among donation programs is whether or not they utilize a central repository. Utilizing a central repository for donated drugs does carry additional costs, she says.

Maximizing ParticipationThe Oklahoma program allows LTCFs and assisted-living centers, with health care professionals in control of medications, that apply to donate, and state mental health facilities, licensed charitable pharmacies, and county pharmacies to receive and dispense the medications. Potter notes that the Oklahoma Mental Health Department and the Baptist Foundation of Oklahoma have publicized the program, which is still in its infancy, in order to increase participation

Donation(continued from page 141)

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Association News

The NABP Web site redesign, an integral part of the implementation of the Association’s electronic system initiative, is nearing completion. The redesign includes an improved home page, easier navigation, the ability to modify text size directly on the Web page, and the all new members only section with secure login capabilities, just to name a few.

Through survey results and feedback gathered from member boards of pharmacy in the member satisfaction survey commissioned by NABP Chairperson Dennis K. McAllister and the NABP Executive Committee, applicants, and candidates, NABP compiled a list of insightful suggestions for improvement of the Web site. Some of the suggestions include:

l Create different text size options;

Coming Soon: NABP Web Site Redesign l Develop menus specifi c

to applicants and members;

l Less text per page;l Easier navigation;l Updated and

streamlined page layout;l More user friendly;l Increased speed of page

uploads;l Improved timeliness of

information;l Improved access to the

information;l Automated program

applications and license transfers;

l Secure member section with password access; and

l More state and member functions and services.

In response to these suggested improvements, NABP developed several features to enhance the Web site and divided these features into four key areas of focus including format, navigation, content, and members. The redesigned format of the Web site

incorporates organized features such as hyperlinks, which will allow for less text per Web page; current news headlined on the home page; and a printer-friendly option. There will also be a user option to modify the text size directly on the Web page without having to adjust computer preferences. In addition, navigational improvements include the elimination of Web page scrolling; addition of a site map; quick and easily identifi able topic links; fewer graphics, which will allow for quicker display of Web pages; and a Web site search feature.

The content of the NABP Web site will contain resource links to relevant agencies in addition to those already available. It will also be the access point for all new online application processes for the Electronic Licensure Transfer Program®,

Verifi ed-Accredited Wholesale Distributors™ program, and Pharmacy Authenticated Licensure Service™. Additionally, online meeting registration and online ordering of subscriptions and publications will be accessible from the Web site.

A brand new feature, the password protected members section, is an exciting addition not currently available to our members. Here NABP members will have the ability to submit and update board of pharmacy profi les online in addition to having access to members only information.

The improved Web site is scheduled to launch before the end of 2006. To access NABP’s current Web site visit www.nabp.net. Please look for further information on NABP’s enhanced Web site in a future issue of this Newsletter.

NABP offers the opportunity for colleges and schools of pharmacy to participate in an advanced pharmacy clerkship with an emphasis in association management during the 2006-2007 academic year. The clerkship is designed for senior professional pharmacy students and will

NABP Offers an Advanced Pharmacy Clerkship

allow students to learn how NABP assists the state boards of pharmacy in achieving their goal of protecting the public health through its various programs, services, and activities.

The student(s) will work closely with staff by identifying current issues of concern to the state boards

of pharmacy, contributing articles for inclusion in various NABP publications, and researching and compiling reference materials necessary for NABP task forces and committees to complete their assigned responsibilities.

Although students will be primarily assigned to

the Professional Affairs Department, they will still gain exposure to other departments within the Association.

For more information on NABP’s pharmacy clerkship please contact the Customer Service Department at 847/391-4406 or [email protected].

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FDA Issues Proposed Rules on Medical Gas Containers and ClosuresIn early April 2006, Food and Drug Administration (FDA) published a proposed rule in the Federal Register intended to prevent deaths and injuries from medical gas mix-ups and contamination by making the contents of medical gas containers more readily identifi able, reducing the likelihood that containers of industrial or other gases will be inappropriately connected to medical oxygen supply systems, and reducing the risk of contamination of medical gases.

Between 1996 and 2006, FDA received reports of medical gas mix-ups that resulted in at least eight patient deaths and 18 serious patient injuries. FDA believes that the number of such incidents will be reduced by implementation of the medical gas label, color, design, and dedication requirements of the proposed rule. Specifi cally, if fi nalized, it will require that:

l Gas use outlet connections on portable cryogenic medical gas containers be permanently attached or otherwise locked to the valve body so they cannot be readily removed except by the manufacturer;

l A 360° F wraparound label clearly identifying the container’s contents be affi xed near the top

of portable cryogenic medical gas containers; and

l High-pressure medical gas cylinders be painted an FDA-designated, gas-specifi c standard color.

Additionally, the proposal would prohibit the medical use of high-pressure cylinders or cryogenic containers that have previously been used to hold industrial gases.

FDA provided a 90-day public comment period and the proposed rule is expected to become fi nal in late 2006. For more information, please visit www.fda.gov/cder/dmpq/gases.htm. The April 10, 2006 Federal Register can also be downloaded from www.gpoaccess.gov/fr/index.html.

Sources: Questions and Answers on the Proposed Rule for Medical Gas Containers,www.fda.gov/cder/dmpq/MedGas_QA_20060410.htm, Federal Register, Volume 71, Number 68, Monday, April 19, 2006

JCAHO Releases Guidance to Prevent Tubing Connection ErrorsIn its April 2006 Sentinel Event Alert publication, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) reported that to date it had received nine cases involving tubing misconnection errors to its Sentinel Event Database. Of the nine incidents, eight resulted in death and one in

permanent loss of function, affecting seven adults and two infants.

The cases involved various types of tubes and catheters, including central intravenous catheters, peripheral intravenous catheters, nasogastric feeding tubes, percutaneous enteric feeding tubes, peritoneal dialysis catheters, tracheostomy cuff infl ation tubes, and automatic blood pressure cuff insuffl ation tubes.

A number of risk reduction strategies were cited included re-engineering of products and changes in work practices. JCAHO recommended a number of strategies to health care organizations to reduce tubing misconnection errors including:

l Conducting acceptance testing (for performance, safety and usability) and, as appropriate, risk assessment (eg, failure mode and effect analysis) on new tubing and catheter purchases to identify the potential for misconnections and take appropriate preventive measures.

l Rechecking connections and tracing all patient tubes and catheters to their sources upon the patient’s arrival to a new setting or service as part of the hand-off process.

l Informing non-clinical staff, patients, and their families that they must get help from clinical staff whenever there is a real or perceived need

to connect or disconnect devices or infusions.

l Emphasize the risk of tubing misconnections in orientation and training curricula.

Source: Sentinel Event Alert, Issue 36 – April 3, 2006; www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm.

Bowel Cleansers Associated with Acute Phosphate NephropathyFDA notifi ed health care professionals and consumers of reports of acute phosphate nephropathy, a type of acute renal failure, that is a rare, but serious adverse event associated with the use of oral sodium phosphates (OSP) for bowel cleansing. Documented cases of acute phosphate nephropathy included 21 patients who used an OSP solution (such as Fleet® Phospho-soda® or Fleet® ACCU-PREP®) and one patient who used OSP tablets (Visicol®).

Individuals at increased risk of acute phosphate nephropathy include: those of advanced age, those with kidney disease or decreased intravascular volume, and those using medicines that affect renal perfusion or function [diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and possibly nonsteroidal anti-infl ammatory drugs (NSAIDs)]. FDA

Professional Affairs Update


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recommended that OSP bowel cleansing be avoided in at-risk individuals for whom there is another bowel cleansing option; minimizing electrolyte abnormalities and intravascular volume depletion (dehydration) during bowel cleansing may also lower the risk of acute phosphate nephropathy. Additionally, FDA provided the following considerations for health care professionals

when choosing a bowel cleanser for patients:

l Avoid use of OSP in patients with kidney disease, impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities.

l Avoid exceeding the recommended OSP doses and avoid concomitant use of laxatives containing sodium phosphate.

l Use OSP with caution in patients taking diuretics,

ACE inhibitors, ARBs, and NSAIDs.

l Encourage patients to take the correct OSP dose and drink suffi cient quantities of fl uids during bowel cleansing. Two published articles suggest that using an electrolyte rehydration solution may decrease the electrolyte abnormalities and hypovolemia associated with OSP bowel cleansing.

l Obtain baseline and post-procedure labs (electrolytes, calcium, phosphate, BUN, and creatinine) in patients who may be at increased risk for a serious adverse event, including those with vomiting and/or signs of dehydration.

l Use hospitalization and intravenous hydration during bowel cleansing to support frail patients who may be unable to drink an appropriate volume of

Board Shuts Down Online PharmacyAccording to the April 2006 issue of South Dakota State Board of Pharmacy News, on May 27, 2005, the state of South Dakota’s Attorney General’s Offi ce, by and through the South Dakota State Board of Pharmacy, fi led a summons and complaint against defendant Canada Services, formerly known as Canada Drug of South Dakota, effectively shutting down the operation.

The South Dakota Board of Pharmacy spent two years building its case against Canada Services and over-coming several obstacles along the way. Using its adjunctive powers, the Board asked the South Dakota attorney general to look into Canada Services on the Board’s behalf. Once the case was built and brought to court, according to Dennis Jones, the Board’s executive director, it was a “slam dunk.”

The Board claimed Canada Services had infringed on South Dakota Codifi ed Law 36-11-15, 19.2, 19.3, and 19.8 by operating a retail medicine store by a person other than a registered pharmacist and allowing persons who are not registered pharmacists to dispense drugs and medicines. Judge William J. Srstka, Jr, ruled in the Board’s favor. Canada Services has since packed up, removed their sign, and allegedly relocated to Minnesota.

The South Dakota State Board of Pharmacy continues to seek out illegitimate pharmacies and pharmacists that may be violating South Dakota Law. At this time, there are no other related court cases. However, there were two similar businesses that have closed; the Board was able to simply persuade the illegitimate businesses to close without the need to build a case or ask the attorney general to step in.

The following item was published in the Washington State Board of Pharmacy News, Volume 27, No. 4 April 2006.

What is New with Patient Counseling?In October 2004, the Washington State Board of Pharmacy authorized rulemaking to consider new patient counseling regulations. The process was initiated due to a lack of compliance with the current counseling regulation coupled with the number of prescription “misfi ll” complaints.

The Board asked a stakeholder group to consider two provisions that would ensure compliance with the rule and benefi t patient care. The recommendations included documentation of patient counseling and the development of a patient counseling sign. The sign would educate patients

about a pharmacist’s duty to counsel and encourage patients to be active participants in their health care.

After receiving feedback from stakeholders, the Board elected not to pursue rulemaking for either documentation of counseling or a patient counseling sign. The Board requested that a patient sign be developed for display in the pharmacy. The sign was approved at the December 2005 Board meeting and all pharmacies are encouraged to use this sign. The Board will evaluate the effectiveness of the sign. These results will be compared to complaints received related to a lack of patient counseling.

You can fi nd a copy of the counseling sign by visiting https://wws2.wa.gov/doh/hpqa-licensing/HPS4/Pharmacy/default.htm and clicking on “What’s New.”

Update

Compliance News



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On June 24, 2006, the Accreditation Council for Pharmacy Education (ACPE) celebrated its 75th Anniversary. Established in 1932, as pharmacy’s only accrediting agency for professional education, ACPE has been a leading force in advancing pharmacy education. ACPE is an independent council with a Board of Directors appointed by NABP, the American Association of Colleges of Pharmacy, the American Pharmacists Association, and the American Council on Education. The three pharmacy organizations called for the founding of ACPE and have supported the organization with annual fi nancial grants ever since.

While pursuing its mission, which is “[t]o assure and advance quality in pharmacy education,” ACPE has formulated many developments in the pharmacy profession. In 1937, ACPE created “Standards for Accreditment of Colleges of Pharmacy,” which was the fi rst set of national standards for pharmacy education. One of ACPE’s goals is to improve on those standards every six years. Such improvements include offering an accelerated 24-month education curriculum during World War II to respond to the war emergency (1943),

ACPE Celebrates Its 75th Anniversaryincorporating practice experiences under the supervision of a preceptor into the curriculum (1974), and presenting students with the option of receiving a baccalaureate degree or with further education, allowing students to receive a doctorate in pharmacy (PharmD) (1974).

ACPE successfully kept up-to-date with the pharmacy profession while encouraging further developments, allowing them to acquire more responsibilities. For example, in 1976, ACPE expanded its responsibilities when it became the national accrediting agency for providers of continuing education (CE) programs, expanding their niche beyond pre-service education. By 1999, ACPE expanded further on CE accreditation activities by formulating standards for certifi cate programs.

Ratifi ed in 1997 the Accreditation Standards and Guidelines for the Professional Degree in Pharmacy Leading to the Doctor of Pharmacy Degree (Standards 2000) became effective in July 2000. ACPE began phasing out accreditation of the baccalaureate degree programs and only accrediting doctoral degree programs, an exceptional advancement for which many in the profession had been waiting. The last

baccalaureate student from an ACPE accredited program graduated in 2005. Following a three-year process, the standards and guidelines for the doctor of pharmacy degree were recently revised, and will become effective July 1, 2007 (Standards 2007). Suggestions submitted by NABP were addressed in the revision. For more information on Standards 2007, please visit the Web site at www.acpe-accredit.org.

ACPE made another upgrade in 2003; their name was changed from American Council on Pharmaceutical Education to the Accreditation Council for Pharmacy Education. Why change the name after so many years? Mainly to show more clearly its role as accrediting education programs, and, according to an ACPE representative, to also emphasize “pharmacy,” which is more associated with patient care than “pharmaceutical.” This change allowed for the acronym and logo, which has been recognized and respected throughout the pharmacy profession, to remain the same.

With 75 years of success behind them, we can look forward to future developments and more success from ACPE. Congratulations on 75 years!

Around the AssociationWarren Resigns from Colorado BoardSusan L. Warren, JD, MPH, has resigned from program director for the Colorado Department of Regulatory Agencies. Warren has been program director of Colorado Department of Regulatory Agencies for the Pharmacy, Veterinarian, and Optometry Boards for the past six years. She has worked for the state government for more than 26 years, taking a two-year break to obtain her masters in public health from Harvard University. Warren will escape the routine of sitting behind a desk this summer and will be volunteering at the Denver Zoo.

New Board MembersRichard C. “Dick” Holm, RPh, has been appointed as a member of the Alaska Board of Pharmacy. Holm’s term expires on March 1, 2010. He replaces Margaret D. Soden, RPh.

Susan M. Frey, RPh, has been named a member of the Iowa Board of Pharmacy Examiners. Frey’s term expires April 30, 2009. She replaces Katherine A. “Kap” Linder, RPh.

Feature News


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NABP is pleased to announce that applications for the Pharmacy Compounding Accreditation Board’s (PCAB) compounding accreditation program have been received and are currently in the processing stage. Once NABP reviews applications and verifi es the compounding pharmacies’ licenses, surveys conducted by contracted surveyors on behalf of PCAB are scheduled with the qualifying applicants. The fi rst few compounding pharmacies that submitted applications have already been surveyed and several additional surveys are scheduled to take place in the upcoming months.

PCAB was established by eight pharmacy organizations, including NABP, to recognize those compounding pharmacies that meet the highest standards of quality and to assist all compounding pharmacies to attain those standards. In 2004, NABP created the Standards for Pharmaceutical Compounding Accreditation

Surveys of Compounding Pharmacies Underway

in conjunction with the PCAB Standards Task Force Committee. These Standards are the foundation for the development of PCAB’s voluntary pharmacy compounding accreditation program and cover such pharmacy issues as:

l Regulatory Compliance;l Personnel;l Facilities and Equipment;l Chemicals, Drug

Products, and Components;

l Compounding Processes;l Beyond-Use Dating,

Stability, and Sterility;l Dispensing; l Practitioner and Patient

Education;l Quality Assurance Plan

and Continuous Quality Improvement; and

l Self-Assessment.(Please visit www.pcab.info for the complete Standards.)

In order to be accredited, compounding pharmacies must fi rst register and complete an application at www.pcab.info. Applications are then reviewed by NABP to ensure that each

pharmacy meets the intent of, and is qualifi ed for, PCAB accreditation. Once the review is complete, NABP notifi es PCAB of its fi ndings and recommends that a survey be conducted to verify the pharmacy’s compliance with the Standards listed above. After surveying is complete, the qualifying pharmacies are awarded accreditation along with the PCAB seal.

In a recent news release PCAB expressed the positive and quality-based message accreditation provides to patients, prescribers, and the public. “Accreditation will not only provide assurance to patients and prescribers that this pharmacy has been tested against very strict quality and safety standards,” notes PCAB Executive Director Ken Baker, “but it will identify it as one of the preeminent compounding pharmacies.”

For additional information on PCAB and its activities please refer to both www.pcab.info and future issues of this Newsletter.

Leigh A. Kegerreis was named a public member of the Michigan Board of Pharmacy. Kegerreis’ term expires on June 30, 2009. She replaces Maria Wolfe.

Peter John Halecky, RPh, was named a member of the New Jersey Board of Pharmacy and his term expires on May 31, 2010. Halecky replaces Ira Katz, RPh.

New Board Offi cersThe Vermont Board of Pharmacy has named two individuals to offi cer positions:

Steven M. Vincent, RPh, vice chair-person; andEarl W. Pease, PharmD, chair-person.

Board ReappointmentsJoseph J. Bova, RPh, and David Schaff, PharmD, have been reappointed as members of the New York State Board of Pharmacy. Both of their terms expire on July 31, 2010.

Edward G. McGinley, RPh, has been reappointed as a member of the New Jersey Board of Pharmacy. McGinley’s term expires on May 31, 2009.

fl uid or may be without assistance at home.

More information, including the complete MedWatch 2006 Safety summary for OSPs and acute phosphate nephropathy, as well as links

to supporting documents and product labels can be found at the following Web site:www.fda.gov/medwatch/safety/2006/safety06.htm#phosphate.

Sources:

“Food and Drug Administration Science

Background Paper: Acute Phosphate Nephropathy and Renal Failure Associated With the Use of Oral Sodium Phosphate Bowel Cleansing Products”; www.fda.gov/cder/drug/infopage/osp_solution/backgrounder.htm.

Update(continued from page 155)

Association News

Around the Asociation(continued from page 156)

nabp newsletter

158

august 2006

Reminder

National Association of Boards of Pharmacy

1600 Feehanville Drive

Mount Prospect, IL 60056

nabp newsletter

Association Highlights

NABP’s 10th annual program review and training sessions for

board of pharmacy staff will be held Monday, September 25, 2006,

and Friday, September 29, 2006 at NABP’s

Headquarters in Mount Prospect, IL.

Members of the NABP Advisory Committee on Examinations met at Association Headquarters on June 19, 2006. Pictured from left to right are Kendall M. Lynch, Nashville, TN; Jerry Moore, Indian Springs, AL; Donna S. Wall, member, Indiana Board of Pharmacy; William T. “Bill” Winsley, Executive Committee liaison; Jeff Lurey, Atlanta, GA; Tom M. Houchens, London, KY; and Stephen M. Gross, dean, Long Island University�s Arnold & Marie Schwartz College of Pharmacy and Health Sciences.

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U.S. Postage

PAID

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Schaumburg, IL 60173

Documents

newsletter - NABP · 8/7/2016 · to ensure that a pharmacist maintains control of unused prescription drugs donated from an LTCF. Also, the LTCF consultant pharmacist must not disclose