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NAT I O N A L A S S O C I AT I O N O F B O A R D S O F P H A R M A CY A I D T O G O V E R N M E N T – T H E P R O F E S S I O N – T H E P U B L I C – 1 9 0 4 TO 2 0 0 0 NABP Begins Transmitting Disciplinary Information to HIPDB Reporting to the Healthcare the data entry module was month’s activities, as well as a Integrity and Protection Data given to the boards pre-loaded comprehensive summary of Bank (HIPDB) is now an easy, with disciplinary information activity from all reporting seamless process for those state dating back to 1982. As state states. boards that choose to use NABP boards receive disciplinary as an authorized reporting action information, it is agent. NABP recently completed entered into the Data Entry the Disciplinary Clearinghouse Module. Pop-up windows and Data Entry Module, and has pick lists help users navigate successfully transmitted data the program, and each month to HIPDB. the board e-mails the file to As part of the advanced clearinghouse program, NABP created the Disciplinary Clearinghouse Data Entry Module, an Access-based software program, for participating member boards. Simple to use, NABP. From this file, NABP updates the Disciplinary Clearinghouse records, con- “To avoid hardship on the state boards of pharmacy, NABP developed the Data Entry Module to be user friendly and to accommodate reporting of disciplinary action to the NABP Clearinghouse and HIPDB,” says Jerry Moore, NABP president. verts the data into the required NABP began working on the format and sends the informa- software program for reporting tion to the HIPDB. Each disciplinary actions last participating state board summer. Participating state receives a report of its previous (continued on page 82) 83 International VIPPS Program to be Launched by NABP 87 NABP’s VIPPS Elected to ASAE “Honor Role” 88 The Prescription Drug Marketing Act: Final Regulations NABP Completes Build-out 90 NABP Completes Headquarters Remodeling Project ION OF BOA AT R CI DS PHARM OF AC Y TIONAL ASS O NA The remodeling of NABP’s first level, including the addition of three managerial offices, 15 staff cubicles, and a file room, was completed in mid-June. See story on page 90. 19 0 4 ® VOLUME 29 - NUMBER 6 - JUNE/JULY 2000 in this issue NABP Begins Transmitting Disciplinary Information to HIPDB (continued from page 81) boards received and installed module are umbrella boards. In actions taken against health the Data Entry Module (the these cases, disciplinary action care providers, suppliers, and software program for reporting) reporting is usually done by an practitioners. Federal and state in January and February 2000, agency other than the board of agencies and health plans are and NABP began routine pharmacy. required to report to the data transmissions of data to HIPDB in March 2000. “We try very hard to accommodate the boards regarding what bank, and are permitted access to the system for a fee. Health care suppliers, providers, and The Data Entry Module does information they give us and not require the boards to have how they are able to provide it the full Access software pro- to us,” notes Moore. “If a state gram on their computer system. board is required to submit Though some functions are information directly to the limited, the run-time version HIPDB, we will accept a hard (Access Light) accepts all copy of disciplinary informa- information required by HIPDB tion as a submission to NABP’s For more information or to and the NABP Clearinghouse. clearinghouse; and the data make NABP your board’s NABP staff works with each will be entered manually by reporting agent, contact Glenn state to create a version that NABP staff.” Detweiler, Licensure Applica- HIPDB was developed by the Currently, 24 states have US Department of Health and received, and are using, the Human Services to create a software, which is provided at comprehensive data collection no charge. Most of those states program for the reporting and who are not using NABP’s data disclosing of most final adverse Representatives of eGovNet team continues to work with presented the RAP system to eGovNet.com, a provider of the executive officers and Web-based solutions for online members of the state boards of transactions, to customize the pharmacy at a special session Renewal and during NABP’s Annual Application Meeting in May 2000. Process Once completed, the (RAP) system system will allow for each pharmacists and participating pharmacies to submit state board. their initial licensure Since each application and board’s database systems are renewal via the Internet. When unique, their link to the RAP fully operational, NABP’s RAP system must be refined to system will feature credit and produce an effective end result. debit card payment for fees, and The analysis and creation of provide licensees with easy each link is going smoothly, access to their professional and the project is moving along information on file with partici- as planned. pating boards of pharmacy. 82 ary Reporting to National Data Bank” in the January 1999 NABP Newsletter). tion Database Programs Director, by telephone at 847/698-6227, or by e-mail, [email protected]. ION OF BOA AT R CI PHARM OF AC Y NABP’s Information Technology Proposes Mandatory Disciplin- DS Renewal and Application Process Update to “self-query” (see “HHS TIONAL ASS O NA meets all the state’s needs. practitioners are only allowed 19 0 4 ® The NABP Newsletter (ISSN 0027-5700) 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 68 member boards of pharmacy to the profession and the public. The opinions and views expressed in this publication do not necessarily reflect the official views, opinions, or policies of NABP or any board unless expressly so stated. The subscription rate is $35 per year. National Association of Boards of Pharmacy 700 Busse Highway Park Ridge, Illinois 60068 847/698-6227 www.nabp.net [email protected] Carmen A. Catizone Executive Director/Secretary Mark E. Paulson Editorial Manager © 2000 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. NABP NEWSLETTER International VIPPS Program to be Launched by NABP In order to help meet the growing threat endorsed a plan to work with the licensing authori- Practice Sites™ (VIPPS™) program, the new International VIPPS program will ties in partici- utilize the same core criteria rogue pating foreign and policies to certify candi- Internet countries to date Web sites. However, the certify online review of relevant licensure, posed by pharmacy sites operating from outside the United States, the Association’s Executive Committee has pharmacies located within their jurisdictions. Based on NABP’s successful Verified Internet Pharmacy site inspections, and other criteria verification performed by NABP in the US will be conducted by the participating foreign licensing authority. (continued on page 95) Fee Increase for NAPLEX, MPJE, Licensure Transfer Effective January 1 In 1999, the NABP Executive Also effective January 2001, Committee approved fee the fee for processing a Pre- increases for the NAPLEX® liminary Application for (North American Pharmacist Pharmaceutic Licensure Licensure Examination™), the Transfer will increase from Multistate Pharmacy Jurispru- $250 to $300 per state for the dence Examination™ first state to which the appli- (MPJE™), and transfer of cant is requesting licensure pharmaceutic licensure. transfer. This increase is the Effective January 1, 2001, candidates sitting for the NAPLEX and MPJE will be required to pay an additional administrative fee. The administrative fee for the NAPLEX first since 1996, when the Electronic Licensure Transfer Program™ (ELTP™) was implemented, and is set to absorb the average annual cost of living between 1996 and 2003. NAPLEX Score Transfer Fee Increase Beginning September 1, 2000, NABP will increase the score transfer fee for the NAPLEX® (North American Pharmacist Licensure Examination™) from $50 to $75. Although the Executive Committee approved this increase for the Fiscal Year beginning January 1, 2000, NABP will not implement the change until the beginning of September 2000. Those will be $110, and the adminis- The fee to request licensure requests received from trative fee for the MPJE will be transfer to additional states on candidates postmarked after $45. This new charge will be the same application form as September 1, 2000, without implemented to offset higher the first state will remain at the appropriate fee adjust- seating fees charged to NABP $50 per state. In addition, the ment included, will be by the Chauncey Group current $50 fees for changing returned. NABP will be International, LTD, testing the transferring state, referred notifying appropriate schools vendor of both examinations. to as Change of State, and of pharmacy. The base testing fees for both the NAPLEX and MPJE are not expected to increase for the next several years. The NAPLEX fee will remain $250, and the extending the life of an Official Application for Transfer of Pharmaceutic Licensure, known as Extension of Time, will remain unchanged. For additional information about the NAPLEX, please call NABP at 847/698-6227, or visit the Association’s Web site at www.nabp.net. MPJE fee will stay at $85. JUNE/JULY 2000 83 LegalBriefs How Do You Stop a Charging Pharmacist? By Dale Atkinson, JD pharmacy’s records were not adequately notify him of Perhaps one of the inaccurate and disorganized. the standard for evaluating most effective tools The investigator recommended compliance with the law. In for a board of continuing the investigation to rejecting this argument, the pharmacy in the Board, and eventually Supreme Court of New Hamp- carrying out its conducted an audit on the shire cited numerous statutes mission of public pharmacy. Based upon this that authorized the Board to protection is the audit, the Board commenced enforce the practice act and ability to enter an disciplinary proceedings provide for the protection of administrative against the pharmacist. the public. Such authorization also provided for the authority order that prohibits or limits The pharmacist was charged the rights of a licensee to with 10 counts of failing to practice. Whether the board maintain accurate and com- has the authority to “limit” the plete controlled drug records, practice privileges of a licensee four counts of dispensing must be interpreted through controlled drugs in unlawful the practice act, which legisla- quantities, and one count of Incredibly, the pharmacist tively creates and empowers the dispensing incorrect medica- argued that since perfect regulatory entity. Many prac- tion. The Board also ques- compliance with the laws is tice acts do not specifically tioned the pharmacist’s impossible, express standards provide for the authority of the competence, both generally and are necessary to inform him as board to limit the license of a as a pharmacist-in-charge. to what degree of noncompli- practitioner as part of an After a formal hearing and ance will subject him to administrative disciplinary upon rehearing the matter due penalties under applicable law. proceeding. The following case to a petition by the pharma- The court quickly disposed of provides an interesting judicial cist, the board restricted the this argument, stating that analysis of board orders under practice privileges of the pharmacists and pharmacies disciplinary proceedings, pharmacist’s license by pre- have an unequivocal duty to including the limitation placed cluding him from serving as a comply with pharmacy and upon the license of a pharma- pharmacist-in-charge for an drug laws. Therefore, any cist-in-charge. Additional indefinite period of time and noncompliance with such laws interesting issues involving imposing a $1,000 fine. The will potentially subject a administrative searches are pharmacist, however, was not licensee to investigation and also discussed. precluded from practicing prosecution. The court contin- A pharmacist duly licensed in pharmacy in a capacity other ued, stating that while perfect New Hampshire purchased a than as a pharmacist-in-charge. compliance may not be pos- pharmacy. Thereafter, he The pharmacist appealed the became the pharmacist-in- ruling of the Board on numer- charge under the applicable ous grounds. First, the phar- statute. While visiting the macist contended that the pharmacy in the course of an statutes governing the Board’s unrelated matter, a New authority and procedures to Hampshire Board investigator inspect pharmacy were imper- observed that a number of the missibly vague because they did 84 of the Board, or its designated representatives, to enter pharmacies and investigate possible violations of applicable laws. sible, decisions to investigate and prosecute are committed to the sound discretion of the Board. By virtue of its specialized knowledge and authority, the Board alone is empowered to develop enforcement policies best calculated to achieve the NABP NEWSLETTER ends contemplated by the accurate records of sales of Finally, and because access is Legislature and must allocate certain drugs. Thus, the state limited to normal business available funds and personnel clearly has a recognized hours and to original records or in a way to execute these substantial interest in regulat- prescriptions, the statutory policies effectively and ing the sale and distribution of scheme is sufficiently limited in efficiently. drugs to deter their illicit use time, place, and scope as to whenever possible and trace constitute an adequate substi- their movement through the tute for a warrant. Based upon channels of commerce. the foregoing, the court held The pharmacist next argued that the audit conducted by the Board constituted an that the audit was lawfully illegal administrative search under the federal and state constitutions. In addressing these arguments, the court first stated the general rule that absent a recognized exception, a warrantless search by a government body is, per se, unreasonable and invalid. However, New Hampshire has explicitly recognized an administrative search exception. In order to satisfy this exception, three criteria must be met: 1. There must be a substantial government Incredibly, the pharmacist argued that since perfect compliance with the laws is impossible, express standards are necessary to inform him as to what degree of noncompliance will subject him to penalties under applicable law. Next, the licensee argued that the Board disclosed the contents of prescriptions during the proceedings in violation of applicable confidentiality statutes. Such statutes prohibit Board officials or representatives from divulging prescription orders and records inspected in the course of their duties “except in connection with a prosecution or adminislicensing board to which prosecution or proceeding of ment, requiring a warrant the person to whom such before inspection would impede prescriptions, orders or records The warrantless the abilities of the inspectors relate is a party.” The pharma- inspection must be to deter faulty records and cist argued that the person to necessary to further the illegal dispensation of drugs. whom such prescriptions regulatory scheme; and Requiring a warrant would also “relate” refers to the customer, The implementation of inhibit the ability of the Board and therefore the customer’s the statutory inspec- to quickly investigate wrongdo- consent must be obtained tion program must ing that may pose a threat to before the prescriptions can be provide a constitution- public safety. Accordingly, disclosed during the disciplin- ally adequate substi- warrantless access to records is ary hearings. The court de- tute for a warrant. necessary to ensure that the clined to accept this argument inspection is made; 3. administrative proceedings. Addressing the second require- pursuant to which the 2. uncovered was admissible in the trative proceeding before a interest that informs the regulatory scheme conducted, and the information mere prospect of inspections based upon the unreasonable Regarding the first require- will prompt otherwise ques- result that could occur when ment, New Hampshire has long tionable licensees to comply the pharmacist and customer required pharmacists to keep with the law. act in concert and refuse to authorize disclosure. (continued on page 86) JUNE/JULY 2000 85 NABP Awards VIPPS Certification to Tel-Drug Rx Tel-Drug Rx®, of Sioux Falls, SD, a wholly-owned subsidiary of CIGNA HealthCare and located at Finally, the licensee argued case and, thus, the court that there was no evidence would not substitute its presented that he personally judgment for that of the Board failed to enter data which under these circumstances. gave rise to the current Based upon the foregoing, the charges. In effect, the phar- court upheld the sanction macist argued that he could imposed upon the licensee. not be personally responsible www.teldrug.com, has for the alleged wrongdoings. become the most recent The court rejected this online pharmacy to receive argument, stating that the the Verified Internet Phar™ LegalBriefs (continued from page 85) ™ macy Practice Sites (VIPPS ) certification from NABP. licensee was the pharmacistin-charge and responsible for the practice of pharmacy in and by that pharmacy, including, but not limited to, compliance with all local, state, and federal pharmacy and drug laws. Hence, the licensee’s status as a pharmacist-in-charge imposed upon Boards of pharmacy must be aware of the legislative authority that empowers the regulatory agency to investigate and discipline licensees. Understanding the relationship of the investigative process to the eventual sanction should wrongdoing be substantiated is essential in avoiding appeals and ultimately protecting the public. Board members and inspectors must understand the necessity of and process for Tel-Drug Rx is a mail order him heightened responsibili- pharmacy program offered by ties under the law compared Tel-Drug, Inc, especially for to those imposed on a phar- maintenance medications macist. Related to this prescribed for long-term argument, the licensee argued treatment of chronic condi- that indefinitely prohibiting tions. Tel-Drug Rx also him from serving as a phar- provides toll-free customer macist-in-charge unfairly and service and 24-hour refill disproportionately imposed a ordering and emergency sanction in violation of the pharmacy services. state constitution. Participation in the VIPPS Recognizing that the licensee macist-in-charge while certification program is was able to continue practic- allowing the authority to voluntary. The program was ing pharmacy and was also continue the practice generally. developed to provide consum- able to petition the Board From a practical standpoint, ers with reliable means to anytime to lift the restriction boards which limit the practice identify those online pharma- upon a showing that he is privileges of a licensee must cies that have proven their capable of assuming the also be prepared to monitor ability and authorization to duties of a pharmacist-in- and enforce such limitations. dispense pharmaceuticals to charge, the court rejected the the public in the jurisdictions arguments of the pharmacist. listed on the VIPPS Web site. Applying appropriate deference For more information about to the decision of the Board, Attorney Dale J. Atkinson is a the VIPPS program, call the court recognized that partner in the law firm of NABP at 847/698-6227 or go sanctions are necessarily Atkinson & Atkinson, counsel for to NABP’s Web site at tailored to the facts of each NABP. obtaining a warrant prior to performing inspections. Boards must also understand their authority in crafting an appropriate sanction under certain circumstances. Interestingly, this opinion did not address the authority of the board to “limit” a license, and in this case, prohibit a practitioner from acting as a phar- Appeal of William H. Morgan, RPh 742 A.2d 101 (NH 1999). www.nabp.net. 86 NABP NEWSLETTER Professional AffairsUpdate HRSA Announces Clinical Pharmacy Initiative ethnic and racial groups,” states nology tools by 2003 to help Dr Marilyn Gaston, HRSA’s prevent medication errors Associate Administrator for resulting from poorly handwrit- The US Health Resources and Primary Health Care. “A clinical ten prescriptions. The paper, Services Administration’s pharmacist is a key member of a entitled “A Call to Action: (HRSA) Bureau of Primary health delivery team. In addi- Health Care (BPHC) recently tion to dispensing drugs, the announced its Clinical Phar- pharmacist consults with macy Initiative, a program that patients, monitors their use of emphasizes clinical pharmacy prescribed drugs, and checks for services as a necessary part of potential drug interactions. A the delivery of primary health clinical pharmacist prevents care. HRSA is the agency problems caused by drug within the US Department of interactions, inappropriate Health and Human Services doses, and failure to adhere to responsible for improving the prescribed therapy.” access to health care. Through the Clinical Pharmacy Initia- For more information on OPA tive, the BPHC’s Office of activities, visit their web site at Pharmacy Affairs (OPA) will www.hrsa.gov/odpp. develop working relationships ISMP Calls for Elimination of Handwritten Rxs with BPHC programs to help them implement and maintain clinical pharmacy services. “The Initiative’s emphasis on comprehensive pharmacy services is consistent with HRSA’s strategy for achieving 100% access to health care and zero health disparities among Eliminate Handwritten Prescriptions Within 3 Years,” is the first in a series of “White Papers” planned by ISMP to address the topic of medication errors. It describes the benefits, drawbacks, costs, and techno- The Institute for Safe Medica- logical considerations of using tion Practices (ISMP) has this kind of technology published a discussion paper to address medication errors. that calls for the elimination of handwritten prescriptions and advocates the widespread use of handheld prescribing tech- “Technology can’t solve all the medication error problems in the world,” states ISMP President Michael R. Cohen, MS. “In fact, we often see that NABP’s VIPPS Elected to ASAE “Honor Roll” technology can actually introduce a whole new set of problems if we don’t use it NABP has been elected to efforts to inform consumers the Associations Advance about those online pharma- America Honor Roll, a cies that have met the national awards competition rigorous 17-point VIPPS sponsored by the American criteria, and are in compli- Society of Association ance with the licensure laws Executives (ASAE), Washing- of the jurisdictions in which ton, DC, in recognition they practice pharmacy. By of its Verified Internet clicking on the VIPPS seal Pharmacy Practice Sites™ found on the home pages of (VIPPS™) program. program-certified online The document is available on pharmacies, consumers are ISMP’s Web site at instantly hyperlinked to (continued on page 92) www.ismp.org. Specifically, ASAE recognized NABP’s VIPPS program for its JUNE/JULY 2000 appropriately. Still with proper systems design, implementation, and maintenance, the benefits of handheld prescribing far outweigh the drawbacks. There’s simply no good reason why we can’t begin using this technology now to make prescribing a lot safer.” 87 The Prescription Drug Marketing Act: Final Regulations Editor’s Note: Following is a composed wholly or partially of of the charity, or by special column, submitted by insulin, whether prescription personal delivery by the the US Food and Drug Adminis- or over-the-counter (OTC), are donor. Samples must tration, to further explain final subject to the reimportation be placed in a sealed regulations concerning the restrictions of section 801(d) of carton by the donor for Prescription Drug Marketing Act the Federal Food, Drug, and delivery to or collection (PDMA). Cosmetic Act (the Act). Section by the recipient charity. The final regulations implementing the Prescription Drug Marketing Act (PDMA) amendments to the Federal Food, Drug, and Cosmetic Act were published in the December 3, 1999 Federal Register (Docket Nos. 92N-0297 and 88N-0258). The regulations become final December 4, 2000. The final rule covers: 801(d) of the Act prohibits the reimportation of any prescription drug that was originally manufactured in the United States back into the US unless the importation is by the manufacturer of the drug or, in the case of a medical emergency, with the permission of the FDA. Drug Donation of Samples (3) A donated sample cannot be dispensed to a patient or be distributed to another charitable institution until it has been examined by a licensed practitioner or registered pharmacist at the recipient charity to confirm that the donation record Prescription drug samples may accurately describes the wholesale distribution be donated provided there is drug sample delivered, of prescription (Rx) accountability and oversight of and that the drug drugs; such donations that will serve sample is not adulter- to minimize the potential for ated or misbranded for diversion of the samples. Even any reason. (1) the reimportation and (2) the distribution of Rx drugs purchased by hospitals or other health care entities; (3) drugs donated to though no comments were received on this section in the proposed rule (F.R. Vol. 59, No. 49, March 14, 1994), several of charitable organiza- the proposed requirements tions; have been eliminated as too (4) the distribution of Rx drug samples; and (5) certain sections of the “Guidelines for State Licensing of Wholesale Prescription Drug Distributors” (21 CFR Part 205). Reimportation burdensome. Prescription drug samples may be donated provided the following rules are observed: (4) The recipient charity must dispose of any drug sample found to be unsuitable by destroying it or returning it to the manufacturer for destruction. The charity shall maintain complete records of the disposi- (1) Donated drug samples are packaged in their tion of all destroyed or returned samples. original, unopened packaging with intact labeling. (5) The recipient must prepare a complete and accurate donation (2) Donated drug samples record at the time of The reimportation section of may be delivered by the collection or the PDMA was amended by the mail or common carrier delivery of the drug US Food and Drug Administra- to the recipient chari- samples. A copy of this tion (FDA) Modernization Act table organization, donation record must to include drugs composed collected by an autho- be kept for at least wholly or partially of insulin. rized agent or employee three years. Therefore, drug products 88 NABP NEWSLETTER (6) Each recipient must (3) unsuitable drugs are keep complete and destroyed or returned accurate records of to the supplier for drug sample donation destruction; and sufficient for complete accountability and (4) there are adequate may be used in place of paper records to comply with PDMA. Paper Records Part 11 does not apply to paper inventory, accountabil- records that are transmitted by ity, and security electronic means, such as systems to prevent loss, faxing. Since Part 11 does not theft, or diversion of apply to paper documents that conduct, at least the donated drugs. For are photocopied, microfiched, annually, an inventory the FDA, the bottom or faxed, the final regulations of prescription drug line on donations is contain revised security and sample stocks and that if a drug cannot authentication requirements prepare a report be sold in the United for paper records. reconciling the results States, it cannot be of each inventory with donated. The Agency Mid-Level Practitioners the most recent prior advises that previously When there is a question inventory. dispensed prescription concerning whether a mid-level drugs may not be practitioner may request, donated. In addition, receive, or dispense prescrip- since such donation is tion drug samples, one must distribution of a look to the laws of the state auditing of drug sample stocks. (7) Each recipient must (8) Drug samples must be stored under appropriate conditions. (9) A recipient shall notify prescription drug to a where the practitioner prac- the FDA within five party other than a tices. It is state law that working days of discov- consumer or patient, determines the practices and ering a significant loss the Agency considers authorities granted to such or known theft of this to be wholesale practitioners. If a mid-level prescription drug distribution. practitioner is permitted to samples. Drug Donation of Non-Samples Electronic Records and Electronic Signatures 21 CFR Part 11, Electronic prescribe prescription drugs but is prohibited by state law from receiving samples, that mid-level practitioner may not be sampled. Although no specific controls Records; Electronic Signatures are established in this regula- (F.R. March 20, 1997) super- tion for the donation of non- sedes the requirements con- sample prescription drugs, the cerning electronic systems and All drug shipments sent back Agency (FDA) recommends that: records in the proposed PDMA to the manufacturer or supplier regulations. by hospitals and other health (1) the donor verify that care entities are categorized as the charity is legiti- Part 11 applies to any records mate; created, modified, archived, (2) all donated drugs are retrieved, or transmitted to the screened by a physician agency under all laws and or pharmacist to regulations administered by the eliminate drugs that FDA. Provided the requirements are recalled, outdated, of Part 11 are met, electronic or otherwise unsuitable records, electronic signatures, for human use; handwritten signatures executed to electronic records JUNE/JULY 2000 Drug Returns returns. A credit memo containing information specified in the regulation must be prepared by the hospital, health care entity, or charitable organization, and a copy must be sent to the manufacturer. Any drugs returned to a manufacturer or wholesale (continued on page 93) 89 NABP Completes Headquarters Remodeling Project Construction of the remodeling of the first level at NABP’s headquarters in Park Ridge, Ill, was completed in early June. Construction began on April 17, 2000. “This build-out will help NABP provide more efficient service to the boards by centralizing customer service and application data processing,” says Jerry Moore, JD, RPh, NABP president. “In the long run, this will help NABP control costs by using the current Consruction workers near completion of the final phase of the build-out. This main row of cubicles is now the home of the Foreign Pharmacy department and Office Services. space available to its maximum capability. As the Association continues to expand its programs and services, this to be the most cost-effective construction, we are pleased project will also allow NABP to choice. with the results and looking plan for its future needs.” “The general idea was to create forward to moving in.” In order to provide expanded a suite of offices on the first The newly transformed first member services, NABP began level that was as pleasant a level includes three managerial to explore its options to working atmosphere as the offices, 15 staff cubicles, and accommodate additional staff existing second level,” says an updated file room. Also part early this year. After much Margaret Gould, NABP office of the expansion, NABP has consideration, remodeling the services manager, who has installed a new phone system. first level of its Park Ridge overseen the entire remodeling Staff moved into the first level headquarters was determined project. “After seven weeks of in late June. NABP Accepting Inspector DSA Nominations NABP is cur- health and welfare. A 2000. Letters should be ad- rently accepting special luncheon will dressed to Executive Director/ nominations for be held to honor the Secretary Carmen A. Catizone, recipient of NABP’s and should include a written 2000 DSA for Inspec- narrative that explains why the Hosto Distin- tors on Monday, nominee should be considered. guished Service November 13, 2000 The list of nominees will be Award (DSA) for during NABP’s Health reviewed by the Executive Inspectors. The Law Officers Confer- Committee. the Association’s 2000 Lester E. DSA Nomination award honors those board compliance officers who have been acknowledged by NABP’s Executive Committee for their efforts in furthering NABP’s objectives to protect the public 90 ence in Biloxi, Miss. Nomination letters should be All letters of nomination for sent to NABP headquarters at the award must be received at 700 Busse Highway, Park NABP headquarters no later Ridge, IL 60068, or faxed to than Friday, September 1, 847/698-0124. NABP NEWSLETTER State Board News Washington Board that get into trouble with drugs NABP Seeks Item Writers for Testing Programs or alcohol. We send these Pharmacy practitioners, individuals to treatment . . . educators, and regulators Pharmacy is expanding its and allow them to return to who are interested in definition of the legal use of the practice of their respective serving as an item writer for needles and syringes to include profession. However, we take a the North American Phar- the prevention of blood borne different, less kindly, view of macist Licensure Examina- in the rehabilitation of the Expands the Legal Use of Needles and Syringes licensed health professionals The Washington State Board of diseases. Although the state other drug tion™ (NAPLEX®), Multistate of Washington does not abusers, particu- Pharmacy Jurisprudence require a prescription to sell larly intravenous Examination™ (MPJE™), syringes, they can only be drug users. By or the Disease State sold for legal use. increasing the Management (DSM) exami- Currently, the law in Wash- availability of nations should send or fax ington states “the retailer syringes, we have a letter of interest and a shall satisfy himself or an opportunity to current resume or curricu- herself that the device will be help these lum vitae to NABP’s Execu- used for the legal use intended.” unfortunate individuals while tive Director/Secretary By redefining legal use, pharma- preventing the overall spread Carmen A. Catizone at 700 cists would have more legal of disease at the same time.” Busse Highway, Park Ridge, discretion to sell syringes to Many pharmacies stopped IL 60068; fax 847/698-0124. intravenous drug users, thus selling needles and syringes Item writers will receive helping to slow the spread of after passage of the 1998 State training materials describ- HIV and hepatitis. Drug Paraphernalia Law, which ing the skills necessary for After reviewing the evidence made the distribution of their designated examina- presented at a program spon- needles and syringes a civil tion, and may be asked to sored by NABP, the Centers for offense when they are used to attend a weekend workshop Disease Control and Prevention inject illegal controlled sub- at NABP headquarters or (CDC), and the American stances. An exception exists, an area hotel, with appli- Pharmaceutical Association however, when injection syringe cable expenses paid by (APhA) in the Spring of 1999, equipment is distributed NABP. Item writers will Washington State Board of through public health and receive periodic requests to Pharmacy Executive Director community-based HIV preven- develop new test items that Donald H. Williams drafted a tion programs. While the will be considered for resolution for the Board to exception was placed in the law inclusion in NABP’s consider, which is now moving to allow needle exchange assessment programs. through the rulemaking programs to continue to process. “I believe that if the operate, the Board recommends Board could reinterpret the that pharmacists use the syringe law, we might find a way exception to sell needles and for our pharmacists to partici- syringes after establishing a pate in another public health relationship with their local program,” says Williams. public health agency. Such a relationship could be created “I find it interesting that the by contract or by obtaining a boards of pharmacy, medicine, letter of support from the nursing, etc, are very interested health agency. JUNE/JULY 2000 State board of pharmacy members and staff are particularly encouraged to participate in the item writing process. Questions about item writing should also be directed to Carmen A. Catizone at NABP headquarters. 91 Expanded ELTP Training Session Offered to Boards of Pharmacy Staff A more extensive Electronic computer. Some state board to-date information available Licensure Transfer Program offices already have the appro- from all the boards,” says Moore. (ELTP) training session for priate hardware and will only “We frequently find disciplinary boards of pharmacy staff receive the new software. information in the database members will be held late this summer at the NABP headquarters in Park Ridge, Ill. This “The upgrades will allow state boards to use more features of that an applicant has not disclosed in the application.” our system,” says Information Besides showcasing the quick Technology Manager Andrew and effective methods to obtain Duda, “and to use the current that necessary information, communications channels to training has other pluses. The training session will focus contact our server and use the “Training provides the opportu- on features of the latest version World Wide Web in the future. nity to discuss what NABP can of Lotus Notes board offices will We will be processing data over do for boards in very specific use to communicate with NABP. the Internet instead of through terms,” says Moore. “Past According to NABP President dial-up connections.” attendees said it was beneficial year’s training is delayed because more time is needed to prepare the program training. Jerry Moore, JD, RPh, “This year’s training session will also include the new Clearinghouse/ HIPDB program and some new ELTP is a rapid and accurate method for licensure transfer. Within 24 to 48 hours from the to gain an overview of NABP and how the data they submit is used to benefit the boards.” time NABP recives a preliminary The Licensure and Application application, a Requests for Database Programs department Verification is e-mailed to the will issue notices when train- state boards, and their response ing dates are finalized. Board to NABP can be returned almost staff members interested in Along with the expanded instantaneously. The program attending will fill out a simple training, NABP is providing also verifies disciplinary infor- registration form. Questions hardware and software for the mation, competency assessment can be directed to Licensure ELTP system to those board scores, and Foreign Pharmacy and Application Database offices that require it. The Graduate Equivalency Certifica- Programs Director Glenn hardware is a Pentium III 500 tion. “NABP’s disciplinary Detweiler at 847/698-6227, or MHz, or faster, personal clearinghouse has the most up- e-mailed to [email protected]. areas suggested by last year’s participants. It is applicable to both new and established board staff members.” NABP’s VIPPS Elected to ASAE “Honor Roll” (continued from page 87) NABP’s VIPPS Web site, where Associations Advance America ation, citizenship, and commu- they may access specific Honor Roll is, indeed, an nity service. information that will assist honor for NABP.” them in choosing an online pharmacy they can trust with their family’s health care needs. th “Your program is a perfect Now in its 10 year, the example of how associations Associations Advance America play a vital role in helping the awards program recognizes nation adapt to complex and “We are pleased that the ASAE associations that propel changing times,” says Michael has recognized NABP and the America forward with innova- S. Olson, CAE, ASAE president VIPPS certification program,” tive projects in education, and CEO, in regards to the comments Jerry Moore, JD, skills training, standards- VIPPS program. “Contributions RPh, NABP president. “To have setting, business and social such as yours are vital, and been included on ASAE’s innovation, knowledge cre- add real value to society.” 92 NABP NEWSLETTER PDMA: Final Regulations (continued from page 89) distributor must be kept under proper conditions for storage, Bulk Drugs/Pharmacy Compounding handling, and shipping, and drugs, including those imported for pharmacy compounding, the importer of record is engaged in written documentation show- Under PDMA, the term “bulk ing the proper conditions were drugs” refers to Bulk Drug maintained must be provided Substances (BDS), which is to the manufacturer or whole- defined as drugs or drug sale distributor with the components, furnished in returned drug products. forms other than finished wholesale distribution and must be state licensed. Any agent that subsequently distributes the BDS must also be state licensed. Since the Agency does not Controlled Room Temperature/21 CFR Part 205 regard starter packs as drug The proposed regulations Starter Packs samples under the Act, use of modified section 205.50(c) of the term “starter” on drug the wholesaler licensing sample labeling is inappropri- regulations to require, in the ate and should not be used. absence of labeled storage Indigent Patient Programs conditions on a prescription The Agency has determined to be stored according to the that drug products distributed definition of Controlled Room to indigent patients programs drug, that the drug would have dosage form, that are intended Temperature (CRT) as stated in to furnish pharmacological the revised edition of the US activity or other direct effect in Pharmacopeia (USP). The the diagnosis, cure, mitigation, Agency agreed that this proposal treatment, or prevention of is substantive rather than disease, or to effect the struc- technical since the definition of ture or any function of the CRT changed significantly from body of humans. Because the the edition of the USP in effect statute makes all drugs subject at the time of the original to section 503(b)(1) of the Act drafting of the proposed regula- Samples in Retail Pharmacies subject to PDMA, a bulk drug tions and the current USP that is intended to furnish edition. Therefore, this proposal pharmacological activity or has been withdrawn. The proposal to consider the other direct effect when it Questions about the Prescrip- presence of a drug sample in a becomes a finished dosage form tion Drug Marketing Act retail pharmacy as a violation that is a prescription drug is (PDMA) and the final regula- of the Act has been withdrawn. subject to the PDMA. Require- tions may be directed to: However, the agency continues ments concerning the whole- Margaret O’Rourke, senior to interpret the presence of sale distribution of prescription regulatory expert, Division of samples in a retail pharmacy drugs also apply to bulk drugs Prescription Drug Compliance as probative that samples are because similar concerns exist, and Surveillance (HFD-330), being distributed in violation of as with finished dosage form Center for Drug Evaluation the Act and would consider products, involving personnel and Research, US Food and opening an investigation if and facilities through which Drug Administration. Phone: prescription drug samples are bulk drugs are distributed and 301/827-7296; e-mail: found in a retail pharmacy. how they are stored and [email protected]. are not samples under the PDMA when distributed through manufacturer-sponsored indigent patient programs. Such programs generally include appropriate controls, documentation, and verification of the distribution and use of these products. handled. For imported bulk JUNE/JULY 2000 93 Survey Shows State Boards Gain Autonomy More state boards of pharmacy Permit and licensing fees bring the 1997 Survey. The respond- are working independently of in the most revenue for the ing state boards also showed central agencies than in years boards. Of the states that gains in responsibility for past, according to NABP’s responded, five boards each setting and collecting fees, at biennial Resources and awarded more than 15,000 69.5% and 67.4%, respectively. Responsibilities Survey. In registered pharmacist licenses. 1999, 47 boards of pharmacy California granted the greatest responded to the Survey, number, with 29,423 licenses. which covers such topics as Alaska granted the fewest, board organization, responsi- awarding only 478 pharmacist bilities, procedures, budget licenses. processes, and computer Almost all of the boards have made use of NABP’s Electronic Licensure Transfer Program™ (ELTP™) computer system. Only two states use a central computer system in conjunc- California, with its $5 million tion with another state depart- budget, reported the largest ment, while 43 of the boards Since the 1997 Survey, three annual budget. Three states make use of the ELTP computer boards have begun functioning have a budget of $2.5 million or system. The ELTP system is as autonomous agencies, more, and 10 states have a also used by the boards for bringing the total members of yearly budget of $1 million. word processing (44%), finan- capabilities. boards that function independently of other state agencies to 27. Seventeen boards function As the number of autonomous boards has increased, so has cial/budgeting (7%), and database management (30%). the state boards’ power to set Copies of the 1999 Resources budgets. Currently, 56.5% of and Responsibilities Survey the boards of pharmacy develop may be obtained by contacting budgets, while 30.4% report the office of NABP’s executive that a central agency controls director/secretary at Regardless of whether they budget development. This is 847/698-6227. function independently or not, down from the 35% recorded in as part of a central agency, and the remaining three fall into both categories, depending on the task involved. every state board of pharmacy has the power to license and discipline pharmacists. Nearly all of the boards, 43, perform pharmacy inspections. Only 27 boards are responsible for Central Agency vs. Autonomous Board Operations enforcing the Federal Food, 6% Drug, and Cosmetic Act, while 36% 31 have responsibility for the Controlled Substances Act. In terms of fines, only seven of the boards do not impose fines, which is down by two 58% from the 1997 Survey. Of the 40 boards that can impose fines, 12 boards did not collect any fines, while New York and New Jersey collected more Central Agency Both Autonomous than $200,000 each. The average annual revenue from fines was $36,410. 94 NABP NEWSLETTER Around theAssociation Warren New Executive of Colorado Board New Board Members Susan L. Warren, MS, JD, Pharmacy announces two new assumed the position of members, Stan Haywood, program administrator of the RPh, and Wallace E. Nelson, Colorado State Board of RPh. Both Haywood and Pharmacy effective April 10, Nelson began their five-year 2000. She replaces Kent terms in May. on the Governor’s The North Carolina Board of Council on Alcohol and Other Drug Abuse and the Mount, who retired in March. Haywood is Institute on Alcohol and Most recently, Ms Warren was the owner Other Drug Studies board of manager of medical services and chief directors. Also involved in delivery for the Colorado pharmacist education, Mr Nelson is the Department of Labor and of Prevo chairman of the Perquimans Employment and was respon- Drugs in County Board of Education. sible for three medical service Asheboro, programs. She has also held NC. A graduate of positions with the Colorado Moné Serves on APhA Board of Trustees Department of Public Health the University of North Caro- Kentucky Board of Pharmacy and Environment, the Colo- lina School of Pharmacy, he Executive Director Michael rado Department of Regulatory serves on the Mutual Drugs Moné, JD, RPh, was elected Agencies, and the Colorado Legislative Affairs, and is a to the American Pharmaceuti- Attorney General’s Office. member of the Asheboro City cal Association (APhA) Board Board of Education. of Trustees as the 2000 – public health from Harvard Nelson is the director of 2001 speaker-elect for the School of Public Health, a Chowan Hospital Pharmacy in house of delegates. Moné is juris doctorate from the Edenton, and is a graduate of currently a member of NABP’s University of Nebraska Law the University of North Caro- Multistate Pharmacy Juris- School, and a degree from the lina – Chapel Hill. He was prudence Examination™ University of Nebraska. chosen by the governor to serve Review Committee. Warren has a masters of International VIPPS Program to be Launched (continued from page 83) The new program will also offer about that country’s specific interest in participating in the a separate interface to foreign requirements, and about VIPPS program. It is expected Internet users from the exist- online pharmacies certified in the new VIPPS program will go ing VIPPS pages, located at that particular nation. Inter- live on the Internet during the http://vipps.nabp.net. Users national VIPPS Web pages are fourth quarter of this year. For wishing to verify an interna- currently under development more information regarding tional certified Web site will by NABP. VIPPS, please call NABP’s click on the VIPPS “Click To Verify” seal, and be instantly linked to a series of VIPPS Web site pages that list information JUNE/JULY 2000 So far, licensing authorities from Australia, Canada, and New Zealand have expressed Licensure Programs Department at 847/698-6227, or email via [email protected]. 95 NABP Meeting Dates Saturday-Sunday, July 29-30, 2000 Executive Committee Meeting, NABP Headquarters, Park Ridge, Ill Sunday-Tuesday, August 6-8, 2000 District III Meeting, Grove Park Inn, Asheville, NC Thursday-Saturday, August 10-12, 2000 District V Meeting, Sheraton Hotel, Winnipeg, Manitoba, Canada Thursday-Sunday, September 21-24, 2000 District VII & VIII Meeting, Hilton Tucson East, Tucson, Ariz Thursday-Sunday, October 5-8, 2000 District VI Meeting, Arkansas Excelsior Hotel, Little Rock, Ark Thursday-Saturday, October 19-21, 2000 District II Meeting, Hilton Shorts Hotel, Short Hills, NJ Friday-Sunday, November 10-12, 2000 District IV Meeting, Radisson Hotel & Suites, Chicago, Ill Saturday-Sunday, November 11-12, 2000 Executive Committee Meeting, Beau Rivage Casino-Hotel, Biloxi, Miss Sunday-Tuesday, November 12-14, 2000 Health Law Officers Conference, Beau Rivage Casino-Hotel, Biloxi, Miss Thursday-Saturday, October 12-14, 2000 District I Meeting, Sheraton Hotel, Burlington, Vt ION OF BOA AT R CI DS PHARM OF AC Y TIONAL ASS O NA Sunday-Wednesday, October 15-18, 2000 Fourth International Conference of Pharmaceutical Competencies, Ottawa, Ontario, Canada 19 0 4 96 ® newsletter National Association of Boards of Pharmacy 700 Busse Highway Park Ridge, Illinois 60068 NABP NEWSLETTER