newsletter National Association of Boards of Pharmacy®

February 2006 / Volume 35 Number 2 aid to government Groups Advocate Various Plan B the profession the public Classifications as FDA Delays 1904 to 2006 Decision on OTC Application

At the end of 2005, Food 1999. If taken as directed been realized. If women This Month on and Drug Administration within 72 hours after know about and have access www.nabp.net: (FDA) found itself unprotected intercourse to EC, proponents say, the embroiled in a controversy or contraception failure, number of unintended Special Items in the highly charged area these EC drugs have been pregnancies could be cut Register Online for the NABP of reproductive medicine shown to reduce the risk dramatically – as could nd 102 Annual Meeting or, more specifically, of pregnancy by 89%, and the subsequent emotional, 2005 Fall Educational emergency contraception they are more effective the financial, and physical Conference CE Summaries (EC). As of press time, earlier they are taken. Since costs to women; the costs Headlines FDA had yet to issue a final they largely impede pre- to society of overburdened Author Provides Insight into Development of Dangerous decision on whether or not fertilization events such as families, teen mothers, Doses at Fall Educational to categorize an emergency release of an egg from the or neglected children; Conference contraceptive marketed ovary or fertilization of the and the health care and as Plan B® as an over-the- egg by the sperm and do not social services costs to Upcoming counter (OTC) drug. interfere with an established governments. Moreover, Meetings Two dedicated EC pregnancy (after the it has been estimated that medications have been fertilized egg has implanted nearly half of unintended Thursday-Friday in the uterus), ECs are pregnancies are terminated February 23-24, 2006 available by prescription for Committee on Constitution the last several years – not medically or legally by induced abortion, so and Bylaws Preven®, containing considered abortifacients. widespread use of EC could NABP Headquarters substantially reduce the Mount Prospect, IL estrogen and progestin, Proponents of EC feel that which was approved by it holds great promise for abortion rate. Indeed, the Saturday-Tuesday Alan Guttmacher Institute April 8-11, 2006 FDA in 1998, and Plan B, improving public health NABP 102nd Annual Meeting containing only progestin, and affecting social policy, estimated in a 2002 report Westin St Francis, which was approved in some of which has already (continued on page 26) San Francisco, CA Sunday-Tuesday August 6-8, 2006 In This Issue. . . . NABP/AACP District III Meeting Legal Briefs: Feature News: 102nd Annual State Board Charleston, SC Gimme a Break!!! NABP Testifies Meeting: News: Thursday-Saturday at Counterfeiting More Florida’s Strict August 10-12, 2006 Hearing Before Opportunities Law to Curb NABP/AACP District V Meeting Congressional to Share Counterfeit Winnipeg, Manitoba, Canada Subcommittee Information and Medications Saturday-Tuesday to Network Goes Into Effect May 19-22, 2007 in July NABP 103rd Annual Meeting Hilton Portland & Executive Tower Portland, OR 28 30 34 41 Feature News nabp newsletter Plan B behaviors, such as failing on the pharmacy owner, to take precautions that not the pharmacist. “This The NABP Newsletter (continued from page 25) (ISSN 8756-4483) is would prevent sexually rule creates a precedent for published ten times a that 51,000 abortions were transmitted diseases as well [the] government to use year by the National averted by women’s use as pregnancy. license capacity to coerce Association of Boards of EC in 2000, and that of Pharmacy (NABP) The issue has created a private business owners, 43% of the decrease in to educate, to inform, moral dilemma for some and the citizens they are, to total abortions between and to communicate the pharmacists as well. In abandon deeply held moral objectives and programs 1994 and 2000 could be the continuing education principals,” he says. of the Association and attributed to EC. its 66 member boards session “Refusal to A Third Class of pharmacy to the Efforts to broaden the Dispense” at NABP’s 2005 profession and the availability of EC are Fall Educational Conference of Drugs public. The opinions NABP has long advocated and views expressed in moving slowly on a state- in Sunny Isles Beach, FL, this publication do not by-state basis, giving many in December 2005, Edward an alternative classification necessarily reflect the public and women’s health R. Martin, Jr, JD, attorney for medications that do not official views, opinions, or advocates greater hope in and director of the Center seem entirely appropriate policies of NABP or any for OTC status, yet have board unless expressly so FDA’s consideration of an for Rights of Conscience at stated. The subscription application to allow the Americans United for Life, characteristics that present rate is $35 per year. marketing of Plan B as an and Luke Vander Bleek, compelling reasons to OTC drug. This proposal RPh, owner of Fitzgerald remove the drug from National Association of has, however, also raised and Eggleston Pharmacies, the prescription-only Boards of Pharmacy category: Create a third, 1600 Feehanville Drive great concerns among other discussed their stance on Mount Prospect, IL 60056 groups, and the prospect of current state legislation that transitional or “counseling” 847/391-4406 making Plan B available on affects pharmacists’ rights of class of drugs that could www.nabp.net an OTC basis has met with be dispensed without a [email protected] conscience. Martin, lawyer less than universal support. for Vander Bleek in his prescription, but only by licensed health care Carmen A. Catizone Based on responses lawsuit against the state of professionals authorized to Executive Director/ provided to FDA during Illinois, which has ruled that prescribe and/or dispense Secretary a recent comment period pharmacies must dispense prescription drugs. Dale J. Atkinson, JD regarding the Plan B emergency contraceptives Laurel Berger O’Connor despite their moral beliefs, NABP has been urging the Contributing Editors application, some of this resistance stems from a pointed out that 45 states adoption of this counseling Larissa Doucette have conscience laws that class of drugs since 1995, Editorial Manager basic confusion of Plan B with abortion-inducing only protect certain health when the Association passed Don Talend care professionals and st Technical Editor drugs such as mifepristone. a resolution at its 91 Annual Others object to EC on are focused on abortion, Meeting calling for its Lara R. Jackson Editor the grounds that it might and three states have no creation. In his comments protections. Shortcomings to FDA this fall, NABP Lisa Huxhold prevent implantation, and Proofreader the belief that life begins of current conscience laws Executive Director/Secretary with fertilization of the are that they often only Carmen A. Catizone wrote, ©2006 National egg, not implantation cover abortion and not “NABP believes that a Association of Boards of Pharmacy. All rights of the fertilized egg in emergency contraception, counseling class of drugs reserved. No part of the uterus. Still others cloning, or research. could significantly contribute this publication may are concerned that some Vander Bleek discussed to the overall safety of be reproduced in any women, particularly young how Illinois’ rule, which the public health as more manner without the written permission of teens, would rely on Plan states that pharmacies must drugs are transitioned from the executive director/ B as their primary means provide all contraceptives, ‘prescription drug’ status. secretary of the National of birth control and would including Plan B, or none A counseling class of drugs Association of at all. He noted that the Boards of Pharmacy. increase their sexual activity or risk-taking onus of the rule is being put (continued on page 36)

26 Association News february 2006 2006-2007 Open Executive Committee Executive Officer, Member Positions Announced Committee In accordance with NABP’s The Executive Committee meet all qualifications for Donna M. Horn Constitution and Bylaws, member representative for office shall be eligible to be Chairperson, District I the following individuals District I, John R. Dorvee, nominated from the floor. One-year term are seeking a position has declared his intent to The letter of intent should Dennis K. McAllister President, District VIII on NABP’s Executive seek the office of Treasurer include a short (no longer One-year term Committee. The election on NABP’s Executive than one page) narrative Lawrence H. Mokhiber will be held during NABP’s Committee. This creates highlighting relevant President-elect, District II 102nd Annual Meeting, April an open member position experience and attributes One-year term 8-11, 2006, at the Westin for District I for a one- that qualify the affiliated Charles R. Young St Francis Hotel in San year term. member for consideration Treasurer, District I One-year term Francisco, CA. District V to be nominated to the Charles Curtis “Curt” Barr (one-year term) Executive Committee, the Officer Positions Member, District V Open term expiration date on President-elect Serving second year of a The Executive Committee the active member board (one-year term) three-year term member representative for on which the affiliated Charles Curtis “Curt” Reginald B. “Reggie” Dilliard District V, Charles Curtis member presently serves, Member, District III Barr, Nebraska Board of “Curt” Barr, has declared his and a current résumé or Serving first year of a three- Pharmacy intent to seek the office of curriculum vitae. year term Oren M. Peacock, Jr, President-Elect on NABP’s John R. Dorvee, Jr Texas State Board of Schedule Executive Committee. This Member, District I Pharmacy During the First Business Serving first year of a two- creates an open member Treasurer (one-year term) Session on Sunday, April 9, year term position for District V for a John R. Dorvee, Jr, NABP President Dennis K. Patricia F. Harris one-year term. Vermont Board of McAllister will announce Member, District VIII Pharmacy the final ballot. Serving first year of a three- Requirements for year term Member Positions Floor Nomination At the Second Business Richard A. Palombo District VI According to NABP’s Session on Monday, April Member, District II (three-year term) Constitution and Bylaws, 10, 2006, there will be time Serving second year of a three-year term Malcolm J. Broussard, Article IV, Section 3, (b)(ii) designated for candidate Oren M. Peacock, Jr Louisiana Board of and (c)(ii), nominations speeches and/or speeches given on the candidate’s Member, District VI Pharmacy for both officer and Serving third year of a three- Robert Joseph “Bob” member positions may behalf. A maximum of two year term Dufour, Arkansas State be made from the floor speeches may be given for Gary A. Schnabel Board of Pharmacy during the designated each candidate, including Member, District VII District VII business session of the a candidate’s own speech. Serving third year of a three- (three-year term) 102nd Annual Meeting. Those individuals making year term Gary A. Schnabel, Only those individuals such speeches must limit William T. Winsley Oregon State Board of from active member their remarks to two Member, District IV minutes. Those individuals Serving first year of a three- Pharmacy boards who have notified year term District I the Executive Director/ giving candidate speeches must be affiliated members NABP’s Executive Com- (one-year term) Secretary in writing 30 days mittee is elected each year Karen M. Ryle, (March 10, 2006) prior of NABP. Following the at the Association’s Annual Massachusetts Board to the Annual Meeting Second Business Session, Meeting. The 102nd Annual of Registration in of his or her intention to the “Meet the Candidates Meeting is April 8-11, 2006, Pharmacy seek office and have been Session” will take place at the Westin St Francis in San Francisco, CA. determined by NABP to (continued on page 35)

27 Legal Briefs nabp newsletter Gimme a Break!!! By Dale J. Atkinson, JD A permit holder shall not require oards of pharmacy are statutorily a pharmacist to created and empowered to protect work longer than 12 B continuous hours per the public through enactment by the work day. A pharmacist legislature of enabling legislation, working longer than usually referred to as a practice act. six continuous hours per work day shall be While authorized to use their expertise to allowed during that promulgate rules/regulations intended time to take a 30- to add detail to the regulatory scheme minute break and one set forth in the practice act, the adoption additional 15-minute break. of such rules/regulations by the boards The RRC objected to is also limited by the statutory authority the proposed rule based of the enabling legislation. The scope upon a finding that the of authority provided to the boards Board lacked the statutory must be examined to determine if a authority to enact the rule. The Board did not proposed rule/regulation is within these change the rule, leading statutory mandates. On occasion, judicial to a stalemate between the interpretation of board authority defies RRC and the Board. In logic. Consider the following. March 1999, the Board filed a Petition for Declaratory The North Carolina whether or not a proposed Ruling with the RRC Board of Pharmacy is the rule is within the authority seeking a declaration as to occupational licensing of the Board, is clear and the validity of the proposed board for pharmacists and unambiguous, is reasonably rule. The RRC did not is the executive branch necessary, and was adopted issue a ruling or response agency responsible for the in accordance with the which, under applicable enforcement of the North procedural requirements procedures, results in a Carolina Pharmacy Practice of the Administrative denial of the petition. Act. The Board is responsible Procedures Act. Thereafter, the Board filed a for enforcing the Act and In 1998, the Board of complaint against the RRC the laws pertaining to the Pharmacy published and its members in their distribution and use of drugs. required notices official capacities seeking a The Board is empowered regarding the adoption judgment recognizing the to adopt rules related to its of administrative rules statutory authority to enact duties and responsibilities addressing pharmacist the proposed rule, as well as under applicable working hours. Following a declaratory judgment that administrative procedures. the applicable procedures, the actions of the RRC were North Carolina has a Rules the Board held hearings and unconstitutional. The lower Review Commission (RRC) eventually adopted final court held in favor of the responsible for reviewing language of the rule. The RRC, and the Board appealed. submissions from regulatory proposed rule submitted to On appeal, the Board boards to determine the RRC for approval stated: argued that the lower court

28 Legal Briefs february 2006

erred by (1) concluding held that the practice act regulation is solely through that the Board lacked the did not specifically grant the Wage and Hour Act. statutory authority to adopt the authority to regulate the Thus, the appellate court the proposed rule and (2) working hours at a pharmacy. upheld the lower court refusing to rule on the The Board cited the determination that the constitutional challenge to statutory authority to Board of Pharmacy was the authority of the RRC to annually register each not acting within the “veto” the proposed rule. pharmacy and require authority delegated to it by Initially, the appellate court the identification of all the General Assembly when addressed the standard personnel employed in the adopting the proposed rule. of review identifying that pharmacy as a basis for agency and lower court Next, the court turned its exercising authority over the attention to the second issue determinations will only number of hours worked. be disturbed under certain of whether or not the rule- This argument was also making process and the veto circumstances. Questions rejected by the court, which of law are reviewed under a authority of the RRC were stated that even a liberal within the constitutional de novo standard whereby construction of the plain the court assesses the matter bounds of authority. meaning of the statute did The court cited the well- anew and is free to substitute not extend Board authority its own judgment for that of established rule that rulings to the working hours of on constitutional questions the agency. Questions of fact pharmacists. are reviewed under a whole are only undertaken when record test whereby the Finally, the Board argued such a determination is court recognizes deference that the section of the unavoidable and necessary to the agency determinations practice act that authorizes to resolve the matter. In and cannot freely substitute the Board to “adopt rules the current matter, the judgment except under governing the filling, appellate court upheld the limited circumstances. refilling, and transfer of lower court determination prescription orders” in an refusing to address the In addressing the statutory effort to “assure the safe constitutional claim. The authority basis for the and secure distribution of appellate court noted that appeal, the court reviewed drugs” provided a basis for the Board did not challenge the statutes cited by the the authority to adopt the the constitutionality of the Board as supportive of the proposed rule. Again, the process until it received encompassing authority court rejected the argument an unfavorable outcome of the Board to regulate stating that “setting limits from the RRC. Citing a the practice of pharmacy on the number of hours a North Carolina Supreme in the interest of the pharmacist can work and Court decision, the court legislative mandate of public requiring breaks for meals stated that “ . . . one who Attorney Dale J. Atkinson is protection. The Board and otherwise, clearly does voluntarily proceeds under a partner in the law firm of argued that it has not only not concern the filling, a statute and claims benefits Atkinson & Atkinson, counsel the authority but the duty to refilling, and transfer of thereby conferred will not for NABP. regulate pharmacies, under prescriptions.” The court be heard to question its applicable administrative continued stating that the constitutionality in order to procedures. In rejecting North Carolina Department avoid its burdens.” the argument that such of Labor is the only entity authority empowered the Thus, the appellate court with the authority to upheld the lower court Board to promulgate the regulate working hours proposed rule, the court of pharmacists and such (continued on page 39)

29 Feature News nabp newsletter NABP Testifies at Counterfeiting Hearing Before Congressional Subcommittee

sense of urgency characterized by touching on the progress a November 1, 2005 House and status of legislative and A regulatory safeguarding Subcommittee on Criminal Justice, efforts as well as one case Drug Policy, and Human Resources that serves as a typical hearing that featured testimony by example of how easily drugs NABP Executive Director/Secretary can be counterfeited on the wholesale market. Carmen A. Catizone, among other Amid some testimony experts, on solutions to the growing that gave specifics as to the public health threat of counterfeit drug urgency of the counterfeiting infiltration of the United States drug threat, the subcommittee supply. The experts noted that the members cited the efforts of NABP and several state urgency is driven by circumstances that boards of pharmacy, such are creating tremendous incentives for as the Indiana Board of unscrupulous individuals who stand to Pharmacy, to safeguard the US drug supply at the wholesale profit enormously from prescription drug level of the supply chain. counterfeiting: the avian flu threat, the proliferation of global organized crime, State Efforts Credited In his opening remarks, and the existence of a significant “gray Elijah Cummings (D-MD), market” in which prescription drugs are senior member of the sometimes purchased from unregulated subcommittee, credited the wholesalers and resold at a significant work of NABP and the state boards, several of which have price markup, to name a few. incorporated NABP’s Model Rules for the Licensure of Representative Mark exists because no uniform Wholesale Distributors, a Edward Souder (D-IN), the enforcement standards component of the Model subcommittee chairman, have yet been implemented State Pharmacy Act and opened the hearing by among states. Peter Pitts of Model Rules of the National listing several reasons why the Center for Medicines Association of Boards of the need for implementing in the Public Interest Pharmacy, into legislation counterfeiting safeguards and a former associate addressing wholesale drug is so urgent. A significant commissioner of Food and distribution. In his testimony, amount of counterfeit Drug Administration (FDA) Catizone stated that, should avian flu treatment could later testified that counterfeit Congress draft federal compound the health drugs will comprise an legislation to safeguard the threat from a flu epidemic; estimated 16% of the global US wholesale drug supply, it organized crime is drug market by 2010 – a should follow the example proliferating on a global scale, 72% increase over a five-year of states such as Indiana. In and many of these groups see period. Subsequent expert May 2005, Indiana passed a tremendous profit potential testimony illustrated for the law giving the Indiana Board in the illegal prescription subcommittee the gravity of of Pharmacy authority to drug trade; the gray market the counterfeiting problem

30 Feature News february 2006

recognize NABP’s Verified- the quality of drugs that Lutter also noted that Accredited Wholesale consumers purchase from FDA’s Office of Criminal Distributors™ (VAWD™) US pharmacies remains Investigations initiated 58 accreditation and require high; however, he added that counterfeit drug cases in pedigrees. FDA cannot offer the same 2004 compared with 30 Several times during their quality assurances for drugs cases initiated in 2003. He testimony, experts indicated purchased outside of FDA’s also cited several highly the need for “track and trace” regulatory jurisdiction. He publicized FDA investigations requirements for prescription noted that while domestic that prevented the sale of drugs at every stage of counterfeiting is not counterfeit variations of distribution, as in a bill widespread, counterfeiting drugs such as Lipitor® and introduced by Representative activity is increasing. Lutter Viagra®. He added that less Steve Israel (D-NY) that credited stepped-up FDA than 1% of the legitimate primarily calls for paper enforcement efforts in US prescription drug supply pedigrees to accompany drug this area, including the is counterfeit although, shipments at all points in establishment of the FDA upon further questioning the supply chain. During his Counterfeit Task Force in by subcommittee members, testimony, however, Catizone 2003 and the February 2004 he acknowledged that no asked the subcommittee report titled “Combating reliable statistical data exists not to assume that federal Counterfeit Drugs: A Report to support his claim. legislation would completely of the Food and Drug None of the remaining eliminate the counterfeiting Administration,” which expert testimony provided threat. He pointed out that recommended a multi-tiered a similarly positive some wholesalers still have approach to safeguarding the view that the US drug not agreed to uniform US drug supply, including supply is protected from pedigree standards that were securing drug products, counterfeiting. These proposed by FDA more packaging, and movement included testimonies from than 17 years ago, following through the supply chain; Investigative Reporter passage of the Prescription enhanced regulatory Katherine Eban and family Drug Marketing Act (PDMA) enforcement; stricter members of two individuals by Congress. penalties for counterfeiters; who were killed by taking and increased international counterfeit drugs that entered Other testimony at the collaboration. hearing revolved around two the legitimate US drug supply. major themes: how safe the Lutter also credited NABP Eban, author of Dangerous US prescription drug supply and the state boards for Doses: How Counterfeiters chain is from counterfeiting aiding this multi-tiered are Contaminating America’s and the urgent need for the safeguarding approach. He Drug Supply, described the implementation of pedigree cited efforts such as NABP’s complicated path through requirements. Model Rules for Licensure the gray prescription drug of Wholesale Distributors market that counterfeit Drug Supply Security as well as several states’ Epogen® took from the Scrutinized adoption of them, the VAWD manufacturer to Timothy Randall Lutter, acting program, and Indiana’s Fagan who, in 2002, was 16 associate commissioner legislation requiring VAWD and recovering from a liver for policy and planning accreditation. with FDA, testified that (continued on page 38)

31 Association News nabp newsletter Updated Model Act Incorporates Amendments Addressing Key Professional Issues

In January 2006, NABP recommendations for Improvement (CQI) CQI programs re-released its amended changes to the Model Act Programs privilege from enhance patient Model State Pharmacy Act that were approved by the discovery in litigation. safety and operate and Model Rules of the Executive Committee. Section 105(q) of the most effectively National Association of The first recommendation Definitions reads: when privilege Boards of Pharmacy (Model called for language [“CQI”] means a of discovery laws Act), which incorporates specifying the roles and system of standards and/or regulations recommended changes responsibilities of the and procedures to protecting CQI data that were approved PIC in drug shortages/ identify and evaluate and information are by NABP’s Executive discontinuances. Section quality-related events, enacted and included Committee from 2A(2)(a) Comment of the and to constantly as a component of the 2003-2005. The Model Act was added and enhance the efficiency CQI process. recommendations were reads: and effectiveness In May 2005, the Executive made by the NABP of the structures Committee approved Committee on Law The [PIC], as part of the responsibilities to and processes of a further recommended Enforcement/Legislation pharmacy system changes to the Model Act (LE/L) (2003-2004 and manage as effectively as possible a patient’s that determine put forth by the LE/L. 2004-2005); the Task Force the outcomes of Updates to the Model Act on Limited Distribution therapy to avoid a harmful interruption medication use. included those sections and Shortage of addressing telepharmacy Medication (2003-2004); of therapy because The recommendation of a shortage or called for the addition of and sterile pharmaceuticals and a revised version of as well as the integration changes to the Model limited distribution the following sentence to of medications, can the end of Section 105(q): of provisions and language Rules on the Licensure of from the Model Rules for Wholesale Distributors proactively improve All information, pharmacy operations the Licensure of Wholesale resulting from input communications, Distributors. from the Task Force on by developing a or data maintained Counterfeit Drugs and systematic approach as a component of Several recommendations Wholesale Distributors to address such such a system shall were made and approved (2003-2004), the wholesale circumstances. be privileged and concerning telepharmacy, distributor industry, References such as confidential and not as the LE/L recognized that and regulatory and state the ASHP Guidelines subject to discovery the practice has evolved, legislative activity (2005). in Managing Drug in civil litigation. no longer limited to just Product Shortages interstate practice, but The updated Model Act could be used A new comment was also also intrastate practice. is available online in as resources for recommended for Section This evolution, and the Microsoft® Word format developing policies 105(q): current status of drug on NABP’s Web site at and procedures if States should importation, prompted the www.nabp.net. appropriate. continue efforts LE/L to recommend that to develop and it be specifically stated in Committee on The other implement recommendation called the definition of “Practice Law Enforcement/ requirements for of Telepharmacy” that Legislation for amended Model [CQI] programs Act language providing such practice is limited to In December 2003, in pharmacies, Continuous Quality pharmacies and patients the LE/L made two recognizing that

32 Association News february 2006 located within United Annual Meeting and Philadelphia, PA, in May Distributors following States jurisdictions. Centennial Celebration 2003. feedback and comments Ultimately, the LE/L in Chicago, IL, in April One recommendation put received from the state recommended that the 2004, the LE/L’s final forth by the Task Force boards of pharmacy, the Executive Committee recommendation was to amended the Model Act to pharmacy profession, commission a task force amend Model Act language incorporate the following the wholesale distributor to examine the evolving in the Model Rules for amendment: industry, and regulatory practices of telepharmacy Sterile Pharmaceuticals. Change the comment and state legislative in the context of the The Resolution directed section of the Model activity after NABP’s regulatory issues that the NABP to communicate Act, Model Rules for initial release of the Model state boards of pharmacy to its member Pharmaceutical Care, Rules for the Licensure of are being asked to boards information Section 2, Part A, Wholesale Distributors in define and address. The concerning United States Subsection 2 [(Duties February 2004, pursuant LE/L determined that Pharmacopeia (USP) and Responsibilities to the recommendations the existing Model Act Tests and Assays Chapter of the Pharmacist- of the Task Force on should be amended to 797: Pharmaceutical in-Charge (PIC)] to Counterfeit Drugs and incorporate contemporary Compounding – Sterile read: Wholesale Distributors. telepharmacy concepts; Preparations, and its The Model Rules were integration into the Model The PIC must initially provided to however, the LE/L develop, implement, recommended that it was Act. Although the Model aid the state boards of Act cites the current USP – and maintain policies pharmacy in maintaining prudent for NABP to and procedures convene a task force to National Formulary the integrity of the US chapters on compounding that address medication distribution amend the model language drug shortages in consideration of: and sterile product system through the preparation in its Good or drug product regulation of wholesale 1. Regulatory and patient Compounding Practices discontinuance. distributors and is the safety standards; Applicable to State References such result of an intensive effort 2. Scope of practice; Licensed Pharmacies, the as the American between NABP and other 3. Personnel; and LE/L agreed that the NABP Society of Health- representatives from the 4. Quality assurance. Model Rules for Sterile System Pharmacists’ pharmacy profession, Food Additionally, in Pharmaceuticals warranted ASHP Guidelines and Drug Administration conjunction with the 2004 amending to generally on Managing Drug (FDA), Drug Enforcement revisions to the Model refl ect the USP Chapter 797 Product Shortages Administration, state Rules for the Licensure of content and provisions. could be used regulatory authorities, and Wholesale Distributors, in developing the wholesale distributor the LEL recommended Task Force on the policies industry to protect the amendments to the Limited Distribution and managing public from the ill effects of language of the Model medication shortage counterfeit drugs and devices. Act in Article II (Board and Shortage of or discontinuance of Pharmacy), Article III Medication situations. Having received wide- (Licensing), and Article V This Task Force met ranging feedback on (Licensing of Facilities). in November 2003 in Licensure of the Model Rules for the response to Resolution Licensure of Wholesale Lastly, as a result of Wholesale 99-3-03, which had Distributors, the EC Resolution 100-11-04, Distributors called for formation of approved several signifi cant Sterile Products, which In March 2005, NABP the Task Force at NABP’s changes. (For a summary of was passed by the NABP amended and re-released 99th Annual Meeting in changes, see the May 2005 the Model Rules for the delegation during the NABP Newsletter, page 94.) Association’s 100th Licensure of Wholesale

33 102nd Annual Meeting nabp newsletter More Opportunities to Share Information and to Network

Once again, NABP’s Tour must register by 102nd Annual Meeting March 24, 2006, as space is programming and limited. optional events will offer participants the chance New Member to share information Seminar and network with other Recently appointed board attendees. The Association’s of pharmacy members or 102nd Annual Meeting, to those members attending be held April 8-11, 2006, at their fi rst NABP Annual the Westin St Francis in San Meeting are encouraged to Francisco, CA, will include attend the New Member the popular Optional Seminar, to be held on Spouse/Guest Tour, the Photo Bureau Visitors & Convention San Francisco Saturday, April 8 from 5:45 Alcatraz Island was home to some of America’s most notorious New Member Seminar, and criminals, none of whom were thought to have successfully escaped. to 6:45 PM, where they will the Fun Run/Walk. hear about the Association’s many programs and Alcatraz than any other Nixon allowed the Federal Alcatraz Excursion service offerings as well inmate. Throughout its Bureau of Investigation to Attendees will have the as procedures followed operation no offi cially use a removal plan and the opportunity to take a tour during the Annual Meeting successful escapes from government forced them off of Alcatraz Island, which Business Sessions. starts at Fisherman’s Wharf, the penitentiary were the land. and experience “The Rock” ever recorded – in all of After visiting Alcatraz, Annual Fun Run/Walk fi rsthand from 1 to 5 PM the attempts the escapees attendees have the option to NABP will offer its Fun on Saturday, April 8, 2006. were either shot dead or stay at Fisherman’s Wharf Run/Walk for the eighth Participants will be led by believed to have drowned to explore on their own. consecutive year – a tour guide on the island, in the frigid San Francisco Fisherman’s Wharf has a providing attendees a followed by an audio tour Bay. Thirty-six prisoners wide array of shops where chance to kick off their of the prison. attempted to escape; seven attendees can shop for fi ne day with some fitness were shot and killed, Tour participants will art and jewelry, clothing, and fresh air. The three two drowned, fi ve are explore the Golden Gate and souvenirs. mile walk/run begins at unaccounted for, and the Union Square across from National Recreation Area’s Guests who are interested rest were recaptured. Two the Westin St Francis most popular destination, in staying longer than prisoners made it off the from 6:30 to 7:30 AM on Alcatraz Island, which was the allotted time at island but were returned in Sunday, April 9, and guides used as a military fortress Fisherman’s Wharf 1945 and 1962. participants past such from 1850-1933 and then as must find their own attractions as Chinatown, a maximum security prison Also, from 1969-1971, transportation back to the North Beach, the from 1934-1963. Presently, Native American Indians hotel. The tour company Embarcadero, the Ferry, Alcatraz is a historic site affi liated with the American recommends Desoto Cabs and then back to Union managed by the National Indian Movement (415/970-1300), but there Square. Participants must Park Service. attempted to reclaim the are many cabs available at land, stating that an 1868 register (for no charge) by During its 29 years of the Wharf. The Wharf is federal treaty allowed March 24, 2006. use, the prison held such open from 9 AM to 5 PM. Native Americans to use For more information infamous criminals as Al The cost of the tour, which all federal territory that nd Capone; Robert Franklin about the 102 Annual the government was not is $50 per person, includes Stroud, the Birdman of Meeting or to register, visit actively using. After nearly motor-coach and ferry Alcatraz; and Alvin Karpis, NABP’s Web site at two years of occupation transportation. Those who served more time at www.nabp.net. President Richard M. interested in the Alcatraz

34 102nd Annual Meeting february 2006 April 8-11, 2006 Westin St Francis San Francisco, CA (Program subject to change.)

Saturday, April 8, 2006 1:15 - 2 PM 12:15 - 1:15 PM Program #: 205-000-06-005-L04 (0.15 CEUs – 1.5 contact hours) 9 AM - 7 PM Keynote Address Second Business Session Registration Desk Open Jeff Salz, Cultural 1:15 - 2:45 PM 10:30 - 10:45 AM Anthropologist, Explorer, and 1 - 5 PM Meet the Candidates Session Refreshment Break Journalist Educational Presentation (Lunch will be provided.) 10:45 AM - 12:30 PM 2 - 2:15 PM Area Open/Poster Session 2:45 - 3 PM Joint CE Programming Refreshment Break 1 - 5 PM Break Structuring an Effective Disaster 2:15 - 4:45 PM Hospitality Suite in 3 - 4:15 PM Plan: Lessons Learned First Business Session Presentation Area Third Business Session Part I: Rising to the Occasion: 4:45 - 5:45 PM The State Boards of Pharmacy 1 - 5 PM Open Microphone Session Tuesday, April 11, 2006 Vital to Hurricane Relief and Spouse/Guest Tour: Alcatraz Recovery Efforts 7:30 AM - 4:15 PM Island Tour Part II: Where Do We Go Monday, April 10, 2006 Registration Desk Open From Here? Open Forum and 5:45 - 6:45 PM 7 AM - 4:30 PM 8 - 9 AM Panel Discussion on the State New Member Seminar Registration Desk Open Continental Breakfast Boards of Pharmacy Role in 7 - 10 PM 7 - 8 AM 9 - 10:30 AM Emergency Preparedness and President’s Welcome NABP/USP Breakfast Executive Offi cer and Board Response Reception Sponsored by United States Member Programming Program #: 205-000-06-006-L04 Dinner will be served. Pharmacopeia, Inc (0.15 CEUs – 1.5 contact hours) Medical Gases, A Discussion Dress: business casual 8:15 - 10:15 AM 11:30 - 11:45 AM Joint CE Programming with Food and Drug Adminis- Sunday, April 9, 2006 tration Refreshment Break Public Policy Decisions: An (Lunch will be provided.) Program #: 205-000-06-003-L03 6:30 - 7:30 AM Analysis of Issues Which Have (0.15 CEUs – 1.5 contact hours) 12:30 - 1 PM Fun Run/Walk Dramatically Changed Health 9 - 10:30 AM Break 7:30 AM - 6 PM Care in the United States 1 - 4 PM Registration Desk Open Program #: 205-000-06-001-L04 Compliance Offi cer (0.2 CEUs – 2.0 contact hours) Programming Final Business Session 8 - 10 AM 2:30 - 2:45 PM Continental Breakfast 10:15 - 10:30 AM USP Chapter 797: Surveying for Refreshment Break Sterile Compounding Refreshment Break (in Presentation Area) Compliance 5:45 - 6:45 PM 8 AM - noon 10:30 AM - noon Program #: 205-000-06-004-L04 NABP/NACDS Reception Educational Presentation Joint CE Programming (0.15 CEUs – 1.5 contact hours) Sponsored by the National Area Open/Poster Session A Legislative Update for State 9 - 10:30 AM Boards of Pharmacy Association of Chain Drugs Stores 1 - 1:15 PM Professional Development 7 - 10:30 PM Welcome Remarks Program #: 205-000-06-002-L03 Programming (0.15 CEUs – 1.5 contact hours) Annual Awards Dinner Carmen A. Catizone, NABP Effective Communication and Dress: semiformal Executive Director/Secretary Noon - 12:15 PM Delivering Board Policy in Public Break Meetings and with the Media

Elections open officer and member installation ceremony will and the Nomination positions. follow for the new 2006- Procedures for Open (continued from page 27) The election will take place 2007 Executive Committee Positions, please visit the where the membership during the Final Business officers and members. Association’s Web site at will have an opportunity Session on Tuesday, April For updates to the list www.nabp.net or contact to interact with the 11, 2006. The results of the of nominations, NABP’s the Executive Office at candidates running for election will be announced Constitution and Bylaws, 847/391-4406, or e-mail immediately and the [email protected].

35 Feature News nabp newsletter states were permitting care professionals while the switch application passed Plan B women to obtain EC making an appearance on a through the normal review (continued from page 26) directly from pharmacists: news program. The American process, reviewers almost would serve as a beneficial Alaska, California, Hawaii, Pharmacists Association universally deemed the drug adjunct to FDA’s plan to Maine, Massachusetts, New (APhA) and the Illinois safe to market OTC. Two reclassify prescription drugs Hampshire, New Mexico, Pharmacists Association advisory committees met by ensuring that patients and Washington. Generally, (IPHA) strongly objected in a joint public meeting are properly educated states use either existing to his statements. “If the during the process; they in medication use. In collaborative practice Governor sincerely wants to voted 23 to 4 to recommend addition, it would serve as agreement protocols to allow expand access to emergency approving Plan B’s switch a means to implement any pharmacists to dispense contraception, he will act to to OTC status. The review subpopulation requirements EC on their own judgment, allow pharmacists working in staffs of the Offices of to risk manage specific or pass separate legislation collaboration with physicians Drug Evaluation relevant drugs. . . . If emergency that grants pharmacists to prescribe and dispense to the Plan B application contraceptives are placed independent prescribing emergency contraception also recommended the in a new counseling class authority to provide EC. under specific written switch to OTC marketing of drugs, pharmacists, the With EC available from protocols,” the associations status “without restriction.” nation’s most accessible pharmacists, women are said in a statement issued However, the acting director health care professionals, more often able to obtain shortly after the appearance. of the Center for Drug will be able to provide . . . the medication during “Since April 2005, when Evaluation and Research necessary information and evenings, weekends, or Governor Blagojevich (CDER), Steven Galson, assistance. Additionally, holidays. At the same time, issued his emergency order felt strongly that the studies this classification would the pharmacist can provide that requires pharmacies submitted in support of provide a mechanism for the patient counseling to ensure to dispense prescriptions the application did not verification of the patient’s that the medication is ‘without delay,’ both APhA adequately demonstrate that age, if necessary, or any other taken correctly and provide and the Illinois pharmacy young adolescents, due to subpopulation requirements.” referrals to family planning community have tried to their undeveloped cognitive work with and educate his skills, could safely use Plan B State Laws Facilitate resources or physicians – often giving previously administration about the as intended without adverse Access marginalized patients access critical role pharmacists effect on their behavior. Because of the positive to the health care system. play on the healthcare A “not approvable” letter public health and policy team. The Governor’s was sent with Galson’s implications of EC, and the Nonetheless, disagreements most recent statements signature in May 2004, to documented difficulty of over such issues as scope [equating the pharmacist’s Barr Laboratories, Inc, the women gaining access to EC of practice or liability can role as equivalent to a non- marketer of Plan B. within the 72-hour effective make it difficult for states healthcare professional] to adapt their collaborative After FDA sent this letter, window, several states have gravely insult the profession’s nearly 50 members of the moved to facilitate access practice agreements to contribution to health care permit pharmacists to US Senate and House of to ECs by allowing direct and the patient care services Representatives asked the dispensing by pharmacists, provide EC. Politics also plays pharmacists provide.” To a role, of course. And other Government Accountability with no physician’s some, misunderstandings Office (GAO) to investigate prescription required. (See concerns regarding a state such as this do not increase government’s perception of and report on FDA’s “States Increase Access to acceptance of state-mandated decision-making process. Emergency Contraception pharmacists’ competence pharmacist-facilitated access and role as health care In November 2005, the Through Pharmacists,” to EC. GAO issued its audit report. NABP Newsletter, March professionals were laid bare in a December 2005 incident FDA Under Fire In that report, the GAO 2003.) Washington state pointed to four aspects of in Illinois. That state’s In this highly politicized pioneered such a program the FDA review process that governor, Rod Blagojevich, atmosphere, FDA has come in the late 1990s. By the it found “unusual”: end of 2005, eight US made comments equating under fire for its handling pharmacists with non-health of the Plan B application. As

36 Feature News february 2006

1. The directors of than that of the review undisclosed but reportedly and OTC versions of the the Offi ces of Drug Divisions based on his view unrelated reasons in same active ingredient Evaluation III of the adequacy of the data September) announced on may be marketed in a and V, who would supporting the switch.” August 26, 2005, a 60-day single package.” normally have signed comment period, further The public comment a Plan B action letter, More Controversy postponing a decision. period ended November 1, disagreed with the While the GAO audit “The issues we were asked 2005, and FDA is currently not-approvable examined events only to resolve, and the proposal reviewing the results. The fi nding and did not leading up to the May that was put forward by public comments posted sign it, nor did the 2004 not-approvable letter, Barr Labs, presented us last fall revealed a variety director of the Offi ce Plan B’s switch application with many diffi cult and of opinions, including of New Drugs; process has continued to novel policy and regulatory those who viewed the dual 2. High-level FDA draw fi re since that time. issues,” Crawford said. OTC/prescription concept management was In the initial not-approvable “ . . . The answers to these as opening a Pandora’s more involved in the letter, Galson, the CDER’s questions can establish very Box, and others who saw Plan B application acting director, told Barr broad and far-reaching huge record-keeping than in other OTC Laboratories that, before policies that could have nightmares, particularly switch applications; the application could be a signifi cant effect on the if packaging is the same 3. The GAO received approved, Barr Laboratories way FDA regulates many for both, or logistical confl icting accounts would need to either different drugs.” nightmares if it is not. Many of whether or not the provide data demonstrating In his letter to Barr advocates of the switch to decision to deny the that Plan B could be used Laboratories denying a OTC pointed out that age switch application was safely by the younger change to OTC status for restrictions had been more made before or after adolescent population Plan B, Crawford outlined or less successfully carried the scientifi c reviews segment or, alternatively, the three major issues he out before for alcohol were completed; and could supply “additional identifi ed as well in his and tobacco or nicotine 4. The GAO felt that information in support of public announcement: products, and that bar codes the rationale used the revised indication to that trigger a request for  “While [FDA] has by the CDER acting allow for marketing of Plan identifi cation at the cash allowed the same director in denying B as a prescription-only register were easily added. active ingredient to the application product for women under be marketed both Rx Meanwhile, pressure was “novel and did the age of 16 years and a not follow FDA’s and OTC based on continued on FDA with nonprescription product for traditional practices.” indication, strength, at least one internal women 16 years and older.” FDA has publicly disputed dosage form and route staff resignation and a these fi ndings. In a Barr Laboratories took of administration, number of Congressional statement at the time of the latter approach, the Agency has never initiatives designed to the audit’s release, FDA resubmitting the application determined whether a force a decision on the stood by its rejection of in July 2004, asking for Plan drug may be both Rx Plan B application. the switch application, B’s switch to OTC status for and OTC based on the It remains to be seen maintaining that its women 17 years of age and age of the individual what FDA will decide actions were “typical for older; for women under using the drug”; in the Plan B switch high-profi le, controversial 17, the drug would remain  “A related concern application. Nonetheless, applications.” Ultimately, prescription-only. is how, as a practical if the controversy over according to FDA, “rather FDA did not take public matter, an age-based emergency contraception than introducing a ‘novel’ action on this revised distinction could be moves regulators closer approach to this OTC application until August enforced”; and to establishing a third, switch application, the 2005, when then-  “In addition, we have counseling class of drugs, Acting Director . . . reached Commissioner Lester M. never been confronted that in itself would provide a a different conclusion Crawford (who resigned for with whether the Rx victory for public health.

37 Feature News nabp newsletter Testimony scream out in pain. In drug distribution industry pedigree requirements, concluding his testimony, petitioned FDA to issue a Congress would have to (continued from page 31) Kevin Fagan asked the stay of a requirement for a amend the Food, Drug, transplant. What Fagan’s subcommittee members to written agreement with a and Cosmetic Act to make family purchased from vote in favor of Israel’s bill. manufacturer establishing the pedigree requirement a local chain pharmacy that a drug wholesaler is an universal and allow was low-dosage Epogen Status of Pedigrees authorized distributor, and “secondary wholesalers” to that was relabeled as During his introduction, for unauthorized distributors obtain the transaction history having a higher dose by Souder noted that FDA to provide a pedigree from all prior purchasers of a counterfeiter in Florida has been forced to delay showing all prior drug the drug, including those and resold within a loose a requirement for paper sales extending back to the currently designated as network of distributors. pedigrees until December manufacturer. authorized distributors. Amid 2006, in the hope that Radio Eban displayed a chart In response to these petitioning from wholesalers Frequency Identifi cation tracing the path of the concerns, FDA delayed the and the Small Business (RFID) track and trace medication from sale, effective date of certain Administration (SBA), and technology will be available repackaging, resale, and regulations relating to written in order to allow Congress for wholesale drug packaging fi nal sale – an indication of authorization agreements to consider the information by that time. During Lutter’s what can happen without and drug pedigrees until contained in the report, testimony, Souder asked why effective regulations and October 1, 2001. In June FDA has annually delayed FDA had not implemented pedigrees. 2001, FDA submitted a the effective date of the the regulations for universal Fagan’s father, Kevin, Report to Congress required authorization and pedigree pedigree requirements testifi ed about severe, by the FDA Appropriations requirements of the PDMA that it had published in painful cramping that Act for 2001. The report rule from 2001 to 2003. Then, 1999. Lutter replied that, Fagan experienced due noted that in order for in February 2004, when following publication of the to the insuffi cient dosage, secondary wholesalers FDA’s Counterfeit Drug Task regulations, the wholesale which caused Fagan to to comply fully with the Force Report was released, FDA further extended the stay of these provisions until San Francisco Facts December 2006. The Transamerica Pyramid Wholesalers and the SBA have claimed that pedigree nd NABP’s 102 Annual when then Transamerica requirements would add a Meeting President John R. Beckett signifi cant cost burden. Given April 8-11, 2006, Westin St noticed that all of the trees the uncertain prospects for Francis, San Francisco, CA in a city park, unlike the implementing electronic buildings, allowed natural Since 1972 the track and trace technology, light and fresh air to fi lter Transamerica Pyramid Israel’s bill would require down to the streets below. has been a signature paper pedigrees and would Becket wanted to achieve landmark of the San also set aside $300 million for

the same natural effect Photo Bureau Visitors & Convention San Francisco Francisco skyline. Located spot checks of drug supplies with Transamerica’s new in the heart of the and other measures. headquarters, so a pyramid Montgomery Financial (Sources: www. Whether or not federal design was chosen. District, at 48 fl oors, the transamerica.com/ legislation or regulations Transamerica Pyramid was According to Transamerica, company_profi le/ mandating paper or the tallest building in the The Transamerica Pyramid about_the_pyramid/ and electronic pedigrees, and/ United States west of the is now both a distinctive www.mustseesanfrancisco. or wholesale distributor Mississippi River from 1972 structure revered by San com/attractions/ authorization is passed, to 1974. The idea for the Franciscans and a landmark transamerica-pyramid. Catizone indicated that Pyramid was born in 1968 of international recognition. html) NABP and the state boards will continue working to uniformly implement these safeguards at the state level. 38 Association News february 2006 As More States Move Toward Pedigree Requirements, List of Counterfeit-susceptible Products Eliminated

Although many states Drug Advisory Coalition Committee in response to particularly prone to have begun to revise their (NDAC) and eliminate a recommendation from adulteration, counterfeiting, wholesale distributor the List and its inclusion the NABP Task Force on or diversion. The List, regulations based upon in the Model Rules on the Counterfeit Drugs and which contains products the Model State Pharmacy Licensure of Wholesale Wholesale Distributors, that are particularly prone Act and Model Rules of the Distributors (Model Rules) which released the Model to counterfeiting, was National Association of by mid-year 2006. NABP Rules in February 2004. In an attempt by NABP to Boards of Pharmacy and will also issue an updated March 2005, an updated assist states and reduce the concept of “Normal revision of the Model Rules revision of the Model redundancy and confusion Distribution Channel,” by midyear 2006. Rules was subsequently as state wholesale no state has adopted the The appointment of released. distributor regulations were National Specifi ed List of the NDAC – composed In addition to stricter updated and adopted. Susceptible Products (List) of representatives from licensing requirements such Currently, Florida is the only concept or recognized government agencies, as criminal background state that recognizes and the List as an interim various professional checks and due diligence maintains a “Specifi ed Drug approach until full pedigree organizations, and the procedures prior to List for Pedigree Papers,” implementation is required. wholesale distribution wholesale distribution which is expected to dissolve As a result, the NABP and pharmaceutical transactions, the Model in mid-year 2006 once its Executive Committee manufacturer industry – Rules mandated specifi c full pedigree requirements decided in December 2005 came at the direction pedigree requirements are implemented (see State to disband the National of the NABP Executive for products that are Board News, page 41).

Legal Briefs on the number of hours a pose a danger to the concluded that the pharmacist can work does, public health or safety. proposed rule was well (continued from page 29) in fact, concern the fi lling, within the authority of the refusal to rule on the The dissent argued that refi lling, and transfer of the proposed rule was Board of Pharmacy. constitutional claims prescriptions. He articulated and upheld the fi ndings merely a refinement of the This matter presents the the criticality of accurate existing rule. interesting perspective of that the proposed rule fi lling of prescriptions regarding limitations on Finally, the dissent argued rule-making procedures and the very basis for and the grant of authority the number of hours a the enactment of the that the welfare interests pharmacist may work and of the Wage and Hour Act to boards of pharmacy. practice act, emphasizing While the practice act establishing certain breaks the consequences of an is to balance the welfare of was beyond the statutory workers, through insuring may seem to broadly improperly fi lled script. In empower the Board to authority of the Board of fact, the North Carolina Board reasonable wages and Pharmacy. working hours, against regulate in the interest of Pharmacy adopted a rule of public protection, In a compelling dissent, effective in 1996 that states: any competing interests of business for the benefi t of not all activities may be one judge respectfully Pharmacists shall not interpreted as fulfi lling disagreed with the the workers. Conversely, dispense and permit the Pharmacy Practice such a mission. majority’s fi ndings that the holders shall not Board of Pharmacy lacked Act addresses the need for North Carolina Board of allow a pharmacist to regulation in the interest of Pharmacy v Rules Review the authority to adopt the dispense prescription proposed rule. The dissent protecting the consuming Commission, 620 S.E. 2d drugs at a rate per public. Thus, the dissent 893 (App. Ct. NC 2005) observed that setting limits hour or per day as to

39 Professional Affairs Update nabp newsletter

How FDA Reviews of Drug Marketing product to identify medication involved; Drug Names and Advertising areas of potential patient outcome; setting of Communications, improvement. the incident (eg, inpatient, By Carol Holquist, RPh, who rely on their  Overall risk evaluation. outpatient); relevant patient FDA, Office of Drug Safety clinical, regulatory, This final phase of the information (eg, age and Food and Drug and professional name review process gender); date of event; Administration (FDA) has experiences to decide weighs the results of manufacturer of the drug; received approximately on the acceptabililty of a each phase of the review dosage form and strength; 18,000 reports of actual or proprietary name. as well as additional and size of container. Finally, potential medication errors  Handwriting and risk factors such as you will need to check both since 1992 and continues verbal analyses. These overlapping strengths, “Product Problem and/or to improve the process are conducted within dosage forms, dosing Adverse Event” and “other” by which these errors are FDA to determine the recommendations, on the form. assessed. Over the past nine degree of confusion in indications for use, We also encourage you to years, FDA has increased the visual appearance or storage, labeling, and include your suggestions for safe use of drug products pronunciation between packaging, and important preventing errors. With your by minimizing user errors the proposed proprietary lessons learned from the contributions to increased attributed to nomenclature, name and names of other agency’s post-marketing reporting and the new labeling, and/or packaging United States drugs. experience. processes implemented by of drug products. The FDA health professionals Pharmacists and other health OPDRA, the agency can group in charge of these (nurses, pharmacists, and professionals can assist FDA provide effective intervention activities is the Office of physicians) are requested in minimizing medication strategies that will minimize Postmarketing Drug Risk to interpret both written errors by reporting any actual the risks associated with Assessment (OPDRA) under inpatient and outpatient or potential medication medication errors. FDA’s Center for Drug prescriptions and verbal errors to MedWatch, FDA’s Evaluation and Research. orders in an attempt to medical product reporting Safeguards for Severe Ten clinical pharmacists and simulate the Rx ordering and safety information Acne Medication physicians make up OPDRA’s process. program launched in June Announced medication error staff.  Computer-assisted analysis. 1993. All identification of Because isotretinoin Currently, OPDRA utilizes reporter, institution, and Since October 1999, (Accutane®) carries significant existing FDA databases patient are kept confidential OPDRA has reviewed risks of birth defects for to identify potential and are protected from approximately 400 drug women who are pregnant or soundalike and/or look- disclosure by the Freedom of products. Proprietary names might become pregnant, FDA alike proprietary names. Information Act. undergo a multifactorial has unveiled safeguards for In the future, OPDRA review designed to improve Medication errors can easily its distribution. (See related plans to use validated consistency and minimize be reported to MedWatch via article, March 2005 NABP computer software that risk with soundalike and telephone (1-800/332-1088), Newsletter, page 61.) The will improve the ability lookalike names. The process Web site manufacturers of isotretinoin to detect similarities in includes: (www.fda.gov/medwatch), are launching a program spelling and sound among and fax (1-800/FDA-0178). called iPLEDGE™ in which  Expert panel review. proprietary names. In addition, a standardized doctors and patients register An expert panel meets  Labeling and packaging MedWatch adverse event with the program and agree to weekly to exchange analysis. OPDRA reporting form (FDA Form accept certain responsibilities opinions on the safety of provides a safety 3500) is available to aid in as a condition of prescribing a new proprietary name. assessment of the submitting voluntary reports or using the drug. Wholesalers The panel comprises container labels, carton of medication errors. You and pharmacies must also OPDRA medication and package insert error prevention staff should provide a complete comply with the program labeling, and proposed description of the error; and representatives packaging of each from the Division level of staff (eg, pharmacist, nurse, physician) involved; (continued on page 43)

40 State Board News february 2006 Florida Law to Curb Counterfeiting Goes Into Effect in July

Beginning July 1, 2006, all the wholesaler’s facility The fi rst part of the law, of Record (ADR). If the wholesaler distributors to when it goes on the which took effect July 1, wholesaler is an ADR, it in Florida must provide shelves to be sold. But the 2003, has three components. does not have to provide a pedigree papers for each pedigrees do not have to be The requirements regarding pedigree for drugs not on the drug they sell. Verifying in paper form. According prescription wholesalers list of 34. If the wholesaler is pedigree papers will help to Stovall, “Wholesalers were enhanced to include (1) not an ADR, the wholesaler Florida close loopholes in the will be authorized to make more extensive wholesaler must provide a pedigree distribution chain that could the pedigree available in an forms; (2) a $100,000 bond when it distributes the drug otherwise allow illicit drugs electronic format and state requirement; and (3) a to another wholesaler. All this into the wholesale market. on the invoice specifi cally criminal background check changes July 1, 2006, when This component of the law how the pharmacy can obtain and fi ngerprinting. all wholesalers must provide will be enforced through that pedigree electronically.” Any wholesaler found guilty pedigrees to all of their department inspections and The requirement of the of selling counterfeit or customers, the end user, and the inspectors can request pedigree papers is a proactive diverted drugs now faces the the practitioner. pedigree documentation goal and the state is hoping tougher penalty of a second- The law was passed as a part of that inspection. these pedigree papers will or third-degree felony charge unanimously – it was realized Failure to comply with the help detect a counterfeit whereas before this law, that the law was developed pedigree requirements may or diverted drug before it these crimes were considered with patient safety in mind. result in criminal and/or reaches the hands of the misdemeanors. According to the Orlando administrative penalties. patient. A November 25, Until July 1, 2006, Florida Business Journal, there has According to Sandra R. 2005 Orlando Business will use its current list of 34 been a mixed response from Stovall, compliance manager Journal article states that commonly counterfeited or the wholesale prescription for the Florida Department “. . . The state’s wholesale diverted drugs that require drug distribution industry of Health, the key pharmaceutical industry pedigree papers. Other to the new legislation, but component of this bill is an ‘has been corrupted by the drugs that are currently the industry recognizes there authentication requirement – infi ltration of a criminal shipped from one wholesaler is a problem on both a state wholesalers must element, which is making a to another do not have to and a national level, and the authenticate each step of fortune while tainting our provide a pedigree unless law was passed to curtail the the distribution process drug supply,’ according to a the wholesaler is not an problem of counterfeiting from when a drug leaves 2003 report by a statewide Authorized Distributor and diverting drugs. grand jury.”

Register Now for the 102nd Annual Meeting

San Francisco, CA, will education programming, the Spouse/Guest Tour of Alcatraz are attending NABP’s 102nd be the place for “Unifying Meet the Candidates session, Island. Annual Meeting. Members, Candidates, and and the Annual Awards NABP has arranged a special Special air travel and rental the Profession – A Journey Dinner. meeting rate of $189 with car rates are available through to the Core of NABP,” during Registration is now available the Westin St Francis for NABP’s designated travel nd NABP’s 102 Annual Meeting on NABP’s Web site at single/double occupancy plus agency Options Travel at 1- April 8-11, 2006, at the Westin www.nabp.net or by returning applicable taxes. To guarantee 800/544-8785. When calling St Francis. You will see this the inserted registration the special rate, call Westin Options Travel, identify unifi cation theme come form. When registering, Hotel & Resorts’ reservation yourself as a registrant of to fruition through events please indicate if you plan offi ce toll-free at 1-800/937- NABP’s 102nd Annual Meeting that offer something for to participate in the Fun 8461 by March 3, 2006. Be and mention our special code, all attendees, including the Run/Walk and/or the optional sure to mention that you NABP102. business sessions, continuing

41 Association News nabp newsletter

Around the Scores Released for December 2005 Association FPGEE; June 2006 Date Announced

New Board On Saturday, December 3, NABP from educational or for the FPGEC Certifi cate. Members 2005, 1,753 candidates sat for licensure institutions that The FPGEC Certifi cate allows Keith W. Macdonald, NABP’s administration of the present their educational foreign graduates to partially RPh, has replaced Foreign Pharmacy Graduate backgrounds and licensure fulfi ll eligibility requirements Michael Triolo, PharmD, Equivalency Examination® and/or registration for licensure in the states that as a member of the (FPGEE®). The FPGEE to practice pharmacy. recognize the certifi cation. Nevada State Board of was administered in three Candidates are also required NABP continuously alerts Pharmacy. Macdonald’s United States locations: San to pass the FPGEE, the candidates that the FPGEC term expires on October Francisco, CA; Northlake Test of English as a Foreign Certifi cate is not a license 31, 2008. (Chicago, IL); and New York, Language™ (TOEFL®), and to practice pharmacy. NY. Candidates who sat for the Test of Spoken English™ Applicants who receive The Arizona State Board the December 3 examination (TSE®). Candidates who have the FPGEC Certifi cate are of Pharmacy has added received their scores in passed the FPGEE but have qualifi ed by the state boards Louanne Honeyestewa, January 2006. The next not satisfi ed the language of pharmacy that accept CPhT, as a new FPGEE is scheduled for June requirements for the portion the FPGEC Certifi cate to technician member. Her 24, 2006. required for the FPGEC continue the licensure process term expires on August Certifi cate need to be aware and take the North American 10, 2010. NABP provides the Foreign Pharmacy Graduate that the TOEFL and TSE will Pharmacist Licensure Board Examination Committee™ be phased out in 2006 and Examination™ and other replaced with the TOEFL required examinations in Reappointments (FPGEC®) Certifi cation Program as a means of Internet-based Testing (iBT), those jurisdictions that accept The Rhode Island an online version of the this certifi cation. To date, 50 Board of Pharmacy documenting the educational equivalency of a candidate’s TOEFL. During the phase- states recognize the FPGEC has reappointed two out period of the TOEFL and Certifi cate. members: foreign pharmacy education, as well as his or her license TSE and the phase in of the Candidates with questions  Felix M. Baez, RPh, and/or registration. During TOEFL iBT, either minimal about the FPGEE or Pre- whose term expires the FPGEC Certifi cation acceptable TOEFL iBT FPGEE®, the practice on November 30, process, candidates are scores or a combination of examination for the FPGEE, 2008; and required to submit certain minimal acceptable TOEFL may visit NABP’s Web site at  Public member documents or have the and TSE scores will satisfy www.nabp.net for updated Richard Hathaway, documents submitted to the language requirements information. whose term expires on May 31, 2008. The Utah Board of Pharmacy has reappointed Call for Committee, Task Force Volunteers Betty Yamashita, RPh, NABP is seeking volunteers curriculum vitae to NABP appointment to a committee who is also the Board’s from its active member Executive Director/Secretary or task force. chairperson. Her term boards of pharmacy to serve Carmen A. Catizone by expires on June 30, 2009. NABP President-elect on the Association’s 2006- Friday, May 26, 2006. Lawrence H. Mokhiber will Ray Seidlinger, PharmD, 2007 committees and task Letters should outline make the appointments when has been reappointed to forces. Interested executive the volunteer’s applicable he becomes NABP president the Nevada State Board offi cers and board members, experiences and following the 102nd Annual of Pharmacy. His new and staff are encouraged to accomplishments, along Meeting, to be held April 8-11, term expires on October submit a letter of interest with the reasons he or she 2006, at the Westin St Francis 31, 2008. and a current resume or wishes to be considered for in San Francisco, CA.

42 Professional Affairs Update

february 2006 (continued from page 40) and Health Care Provider promoted as natural or from prescription drug abuse to be able to distribute and Information Sheets that safer treatments that can for non-medical purposes. dispense the drug. detail the new patient and be substituted for approved It summarizes the growing In the wake of a February practitioner restrictions and hormone treatments. problem in the United States 2004 joint meeting between responsibilities under the In the letters, FDA advises the and the trend of non-medical FDA’s Drug Safety and Risk program. A reporting and fi rms that, under the federal use of prescription drugs. Management Advisory collection system for serious Food, Drug, and Cosmetic For more information on this Committee and Ophthalmic adverse events associated with Act, a product is considered bulletin visit www.nida.nih. Drugs Advisory Committee, the use of the drug has also to be a drug if it claims to gov/PrescripAlert/index.html. major improvements been established. Pregnancy diagnose, cure, mitigate, treat were recommended for exposures to isotretinoin must or prevent disease or, for FDA Announces the the restricted distribution be reported immediately to products other than foods Use of New Electronic program for isotretinoin, FDA at the MedWatch phone and dietary supplements, if it number (1-800/332-1088), Drug Labels which has proven effective claims to affect the structure Effective November 2, 2005, the iPLEDGE pregnancy in treating severe recalcitrant or function of the body. The FDA began requiring drug registry (866/495-0654), or on nodular acne. Under letters further state that FDA manufacturers to submit the iPLEDGE Web site. the recommendations, considers these products prescription drug label patients who could become Besides approving the “new drugs” that require FDA information to FDA in a pregnant are to have negative iPLEDGE program, FDA approval before marketing. new electronic format. This pregnancy testing and approved changes to the Partnering with FDA in this electronic format will allow birth control counseling existing warnings, patient enforcement effort is the health care providers and before receiving the drug. information, and informed Federal Trade Commission the general public to more In addition, patients must consent form to help patients (FTC), which has jurisdiction easily access the product complete an informed and prescribers better over advertising. FTC has sent information found in the consent form and obtain identify and manage the risks letters to 34 Web sites that FDA-approved package counseling about the risks of psychiatric symptoms and are promoting Alternative inserts (labels) for all and requirements for safe depression before and after Hormone Therapies and approved medicines in the use of the drug. Starting taking the medication. using similar claims without US. The new electronic December 31, 2005, all product labels will be the key FDA Warns Marketers reliable scientifi c evidence to patients and prescribers must support the claims. element and primary source register and comply with of ‘Alternative of medication information for requirements for offi ce visits, Hormone Therapies’ NIH Develops DailyMed – a new interagency counseling, birth control, and Food and Drug Community Drug Alert online health information other program components. Administration (FDA) Bulletin clearinghouse that will After October 31, 2005, has warned 16 fi rms that The National Institute on provide the most up-to-date wholesalers and pharmacies are marketing “Alternative Drug Abuse, as part of medication information were required to register Hormone Therapies” that the National Institutes of free to consumers, health with iPLEDGE in order to these therapies have not Health, has developed a new care providers, and health obtain isotretinoin from a been approved as safe Community Drug Alert care information providers. manufacturer. and effective drugs for Bulletin that addresses the This information can be Program information and treatment or prevention of latest scientifi c research accessed through the National registration is available at serious or life-threatening on the non-medical use of Library of Medicine at www.ipledgeprogram.com or health conditions. The prescription drugs of abuse http://dailymed.nlm.nih.gov. 866/495-0654. marketers represent dietary and addiction. This information will also be supplements or hormone provided through facts@fda. To increase available creams, which the marketers This bulletin is geared toward gov, an online resource to be information about claim can treat or prevent parents, teachers, counselors, launched in 2006 to give one- isotretinoin and its associated cancer, heart disease, school nurses, and health stop access to information risks, FDA also issued a arthritis, and osteoporosis. professionals who are about all FDA-regulated Public Health Advisory The products have been associated with those at risk products. and revised the Patient

43 Association Highlights nabp newsletter february 2006 Reminder Annual Meeting Travel Grant Program applications may be obtained by contacting NABP Headquarters and must be received at NABP Headquarters prior to the 102nd Annual Meeting, to be held at the Westin St Francis in San Francisco from April 8-11, 2006.

nabp newsletter

National Association of Boards of Pharmacy 1600 Feehanville Drive Mount Prospect, IL 60056

44