N a t i o n a l A s s o c i a t i o n o f N u c l e a r P h a r m a c i e s N E W S L E T T E R SPRING 2006 INSIDE THIS ISSUE : A LETTER FROM THE EXECUTIVE DIRECTOR REPORT ON NANP S CONTINUING PARTICIPATION IN CORAR MEETINGS INCREASING JCAHO INFLUENCE ON NUCLEAR PHARMACY? NRC PETITIONED TO PARTIALLY RESCIND PATIENT RELEASE RULE USP CHAPTER <797> UPDATE INDUSTRY PRESENTERS AT THE UPCOMING NANP GENERAL BUSINESS MEETING
Page 2 A LETTER FROM THE EXECUTIVE DIRECTOR To NANP members and fellow nuclear pharmacists, I am writing on behalf of the NANP Board of Directors to update you on our activities since March of 2005, and to invite you to the NANP General Business Meeting. I am pleased to report that NANP is healthy and actively working on behalf of over 450 nuclear pharmacies in the US. As of this writing, there are currently 323 NANP members including large chains and independents, academics/hospital-based, as well as both PET and traditional nuclear pharmacies. The support of Cardinal Health NPS, Tyco/Mallinckrodt, GE Healthcare, PETNet, as well as over 35 independent and institutional members allows us to continue NANP activities in three areas: 1) regulatory and government affairs, 2) professional education to promote the best business practices in nuclear pharmacy, and 3) interaction with commercial manufacturers to bring you information regarding new products and services. We are pleased to welcome several new NANP members, including independent pharmacies and institutions, IBA/Eastern Isotopes (17 pharmacies) and two Associate Members- Molecular Insight Pharmaceuticals and International Isotopes Inc.- to our membership in 2005. Over the last year, we have participated in several regulatory and rule-making initiatives and monitored other issues. Chris Ondeck and I continue to participate in the Council on Radionuclides and Radiopharmaceuticals (CORAR) meetings representing NANP. The CORAR has reorganized their Manufacturing and Quality Standards, and Transportation Committees, and established the Nuclear Pharmacy Committee (NPC) to specifically address radiopharmaceutical distributors and manufacturers issues related to nuclear pharmacy. I am a non-voting member of the NPC representing NANP. This relationship with CORAR, and their manufacturer members, has allowed NANP to provide input directly to the manufacturers and regulators from the perspective of nuclear pharmacies. This interaction with CORAR is a tremendous opportunity for NANP to leverage our relatively small budget and organization to influence regulatory and government affairs on behalf of our member nuclear pharmacies. Discussions are ongoing to refine the NANP strategic plan and to increase our effectiveness in representing the unique needs of nuclear pharmacies and bring value to our members. The NANP is working to maintain our regulatory and government affairs activities at the national level, and to increase our activities at the state and regional levels. The NANP is continuing to develop our interactions with distributors and manufacturers to bring them into our organization as Associate Members to support our activities. We are also working to improve communications among NANP members. Plans are underway to bring enhanced utility to the NANP website in order to improve member access to timely information and to maintain links to useful materials. We continue to work closely with the APhA and Society of Nuclear Medicine to identify and support their efforts that may impact nuclear pharmacies and to ensure the consistency of their message to others regarding our business. The NANP was established in 1984 as a trade association representing nuclear pharmacies and maintains its unique place within the various professional organizations with which we often collaborate. Over the last 22 years, NANP has worked effectively to influence regulatory and legislative actions, to promote the business of nuclear pharmacies, and to educate commercial distributors and manufacturers of radiopharmaceuticals and radionuclides regarding the needs of nuclear pharmacies. Since our incep-
Page 3 tion in 1984, dues have remained $100 per pharmacy. At this time, some adjustment to correct for 20 years of inflation is necessary. The Board of Directors is now considering an increase in the annual dues in order to increase our level of activities at both local and national levels to achieve our objectives. I anticipate that NANP membership will continue to grow following enhancement of our member relations, timely communications, and the higher profile of our activities. Below is a partial list of issues on which NANP has taken action on behalf of our member nuclear pharmacies since March 2005: Monitoring and comment on the USP Sterile Compounding Committee continued activities related to USP <797>. Participation in the NRC stakeholders meeting on rulemaking to establish a regulatory framework for the expanded definition of byproduct material established by the Energy Policy Act of 2005 to discourage expansion of NRC Regulation of Naturally Occurring and Accelerator Produced Radioactive Materials or NARM. Letters to Congress and meetings with Rep. Wilson to remove the sunset clause from the Energy Bill that would have disallowed the export of highly-enriched uranium necessary for 99Molybdenum production by MDS Nordion. Letters to Congress in support of restoring funds earmarked for nucelar medicine research to the DOE budget. Participation in the Society of Nuclear Medicine activities: cgmp Working Group; Coding and Reimbursement Working Group, Committee on Radiopharmaceuticals, Committee on Pharmacopeia, and the Radiopharmaceutical Sciences Council. Continued interaction with APhA Section on Nuclear Pharmacy committees and leadership The NANP General Business Meeting and New Products/Regulatory Update will be held in conjunction with the APhA Annual Meeting, 9-11AM on Saturday, March 18 at Moscone-West Convention Center, Room 3022. I am very excited about our program and the opportunity to update you on NANP activities over the last year. We will hear presentations on new products by representatives from Molecular Insight, International Isotopes, and MDS Nordion. The results of the National Institutes of Standards and Technologies (NIST) Radiopharmaceutical Measurement Quality Program 90Y intercomparison test conducted in collaboration with NANP, will also be reported. This is a forum for NANP members to communicate with one another to identify priorities for the next year. I look forward to seeing you at the NANP and APhA meetings and to learning more about what NANP can do to benefit you, our members. Thank you for your continued support and for the opportunity to serve the NANP. Best wishes for safe travels. Jeff Norenberg Executive Director and Chairman
Page 4 REPORT ON NANP S CONTINUING PARTICIPATION IN CORAR MEETINGS By Chris Ondeck, Legal Counsel for NANP Partner, Crowell & Moring LLP This past year, NANP continued its relationship with the Council on Radionuclides and Radiopharmaceuticals (CORAR), to work on common interests in nuclear pharmacy issues. In particular, Chris Ondeck attended the December 7, 2006 CORAR meetings as NANP s counsel and representative. The summary of issues addressed at those meetings, and their relevance to NANP, follows. CORAR s Committee of Manufacturing, Quality and Standards discussed several issues relevant to NANP: (a) the OSHA request for information on Ionizing Radiation CORAR submitted a response, and OSHA needs to update its antiquated standard; (b) NRC regulation of NARM CORAR questioned the OSHA representative (Scott Moore) as to what materials produced in an accelerator is considered to be NARM, and the response was that everything made radioactive, including targets and activated materials could be considered NARM the current status is that OSHA is in the drafting stage and is not requesting input currently; and (c) NRC Extremity Dose Monitoring CORAR has requested NANP input and assistance in creating a draft guidance document the NRC rulemaking could have significant impact on NANP members. CORAR s Committee of Nuclear Pharmacy similarly discussed issues relevant to NANP: (a) Revisions to USP Chapter 797 CORAR has submitted comments on the revisions, and the comments were shared with Jeff Norenberg; (b) FDA PET Rulemaking PETNET has submitted comments; and (c) discussion of mission and role of this CORAR committee whether the Committee should be continued was discussed, and the agreement was to recommend to CORAR that the Committee continue for at least one more year if the Committee is discontinued, NANP may need to assume additional industry advocacy. INCREASING JCAHO INFLUENCE ON NUCLEAR PHARMACY? By Richard A. Nickel, MS, RPh Mallinckrodt Inc. The Joint Commission for Accreditation of Healthcare Organizations is the principle accreditation body for customers of commercial nuclear pharmacies. Presently, the Commission has no accreditation pathway for nuclear pharmacies, but they do influence the nuclear pharmacy community. When preparing for an upcoming survey, Directors of Pharmacy may request information on USP Chapter <797> compliance with all outsourced sterile compounding, including radiopharmaceuticals. In addition, the Medication Management (MM) Standard which requires a pharmacist to review all medication orders is interpreted by the Commission to apply to contract nuclear pharmacies. NRC PETITIONED TO PARTIALLY RESCIND PATIENT RELEASE RULE by James A. Ponto, MS, RPh, BCNP Chief Nuclear Pharmacist and Professor (Clinical) University of Iowa Hospitals and Clinics An individual recently petitioned the NRC to rescind its patient release rule which allows patients treated with more than 30 mci I-131 to be released
Page 5 based on calculations that each member of the general public will receive no more than 500 mrem from the patient. The NRC received the petition for rulemaking submitted by Peter G. Crane (petitioner) entitled Re: Petition for Partial Revocation of the Patient Release Criteria Rule. The petitioner is an attorney who was formerly employed in the NRC s Office of the General Counsel from 1975 until his retirement from the NRC in 1999. The petitioner requests that the NRC partially revoke 10 CFR 35.75, Release of Individuals Containing Radiopharmaceuticals or Permanent Implants (Patient Release Criteria Rule). The petitioner believes the Patient Release Criteria Rule is defective on both legal and policy grounds. The petitioner recommends that 10 CFR 35.75 be amended to prohibit the release of patients from radioactive isolation with more than the equivalent of 30 millicuries of radioactive iodine-131 in their systems. The NRC is soliciting public comment on the petition for rulemaking. For more information, see the Federal Register notice: http://ruleforum.llnl.gov/cgi-bin/downloader/ crane_lib/1660-0001.htm and the petition: http://ruleforum.llnl.gov/cgi-bin/ downloader/crane_lib/1660-0002.pdf Comments regarding the petition must be submitted by March 6, 2006. Although the proposed revision to 10 CFR 35.75 expressed in the petition does not directly affect nuclear pharmacy practice, it does affect many of our nuclear medicine colleagues and customers. Accordingly, the NANP, as on organization, and several NANP members, individually, have submitted comments to the NRC urging denial of the petition. Some of the points discussed in these comments included: release of patients containing 30 mci is permitted only when calculations demonstrate acceptable exposure to members of the public AND the patient is willing and able to comply with radiation protection instructions; thus, release is allowed for most patients, but some patients still require hospitalization; the limit of 500 mrem for radiation exposure to members of the public is consistent with NCRP recommendations for infrequent exposure, and doses at this level are not considered hazardous; compliance with the current release rule requires that the patient be given written instructions; thus, the patient has this information readily available in case of confusion or forgetfulness; the guidance for current release rule incorporates conservative assumptions and calculations; several published articles and unpublished experience all demonstrate that actual exposures to family members, as determined by having them wear dosimeters, is substantially lower than anticipated exposures based on release calculations. Purported instances of excessive exposure to others are generally the result of non-compliance with the current release rule and associated guidance, rather than a problem with the rule itself; and ALARA, as defined in 10 CFR 20, includes the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations, and in relation to utilization of nuclear energy and licensed materials in the public interest. The current release rule is beneficial in minimizing hospitalization costs and is generally in the best interests of the patients and their family members.
Page 6 In summary, a large body of evidence exists supporting the reasonableness, appropriateness, and positive value of the current release rule. USP CHAPTER <797> UPDATE By Richard A. Nickel, MS, RPh Mallinckrodt Inc. Pharmacy Compounding-Sterile Preparations (USP Chapter <797>) became official on January 1, 2004 and has not yet been revised. Since that time, USP has received comments from a variety of sources and it is expected that the proposed revision will be in the next Pharmacopeial Forum. State Board of Pharmacy response has been very uneven, varying from virtually complete adoption to no response at all. Many states are considering revising their rules to adopt or acknowledge the Chapter, but may be waiting for the next revision. The National Association of Boards of Pharmacy may be introducing their newly revised Model Rules at their upcoming April meeting. It is expected that the new Model Rules, if introduced, will adopt the recommendations of their Task Force on Standards for Compounding. If they do, the pace of activity by each State Board may increase in this area. INDUSTRY PRESENTERS AT THE UPCOMING NANP GENERAL BUSINESS MEETING Wendy Graham-Coco, Molecular Insight Pharmaceuticals, Inc. Zemiva (Iodofiltic acid I 123): Rapid assessment of low to intermediate risk chest pain patients with possible acute coronary syndrome (myocardial infarction or unstable angina) is an important diagnostic challenge. Over 3 million chest pain patients are hospitalized each year however, only 15% of these patients are ultimately diagnosed with ACS. A rapid and accurate assessment for ACS could potentially decrease unnecessary hospitalizations while improving chest pain triage. Zemiva (Iodofiltic acid I 123) is a radiolabeled fatty acid analog that is currently in Ph 2 clinical investigation for localization of myocardial ischemia utilizing SPECT imaging technology up to 30 hours after the ischemic event. SPECT imaging with Zemiva can be completed within 45 minutes of injection and does not require a stress test. Wendy s presentation will focus on the key properties of Zemiva including basic chemistry, pharmacology, dosing, handling and early clinical studies. Steve Laflin, International Isotopes Inc. International Isotopes Inc. (INIS) is a ten year old company that supplies iodine-131 radiochemical and manufactures a wide range of reference and calibration standards for nuclear pharmacy (flood source, dose calibrators, rod sources etc.). INIS imports its iodine-131 from South Africa and then custom packages and dispenses quantities tailored to pharmacy orders. INIS has demonstrated the quality and reliability of its products through thousands of shipments over the past several years. The presentation will be made by Steve T. Laflin the President and CEO of the company. Steve has been the President and CEO of International Isotopes Inc. since 2001 and involved in the nuclear industry in various radiological engineering positions for over 25 years beginning with the U.S. nuclear Navy and including commercial nuclear and government nuclear laboratory experience. He has a Bachelors degree in Health Physics from Idaho State University and is a Director for the Council on Radionuclides and Radiopharmaceuticals (CORAR).
Page 7 Colyn Steeves, MDS Nordion Inc. I-123 The Future is Now: Colyn will focus on the growth of I-123 usage by the pharmacy segment in the US as well as the growth of I-123 labeled radiopharmaceuticals. He will address actions that MDS Nordion has taken to reliably supply I-123 to nuclear pharmacies in the United States. N A T I O N A L A S S O C I A T I O N O F N U C L E A R P H A R M A C I E S O F F I C E R S Executive Director and Chairman Jeff Norenberg University of New Mexico Secretary/Treasurer Jerry Costanzo Cardinal Health NPS Legal Counsel Chris Ondeck B O A R D O F D I R E C T O R S Jerry Costanzo Cardinal Health NPS Rich DeVeau GE Medical Systems Rich Nickel Mallinckrodt DIS Michael Mosley PETNet Pharmaceuticals Danny R. Allen Independent NuTech Timothy M. Quinton Independent Radiopharmacy Inc James Ponto Institutional/Academic University of Iowa
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