Academy of Pharmacy Practice and Management- Nuclear Pharmacy Practice Section APPM-NPPS

1. Academy of Pharmacy Practice and Management-Nuclear Pharmacy Practice Section(APPM-NPPS) Business Meeting Sunday March 16, 2008

2. Sponsor Perry Polsinelli President/CEO United Pharmacy Partners Inc (UPPI)

3. Welcome from the Chair Rich Nickel 2007-2008 Chair APPM-NPPS American Pharmacists Association Academy of Pharmacy Practice and Management Nuclear Pharmacy Practice Section

4. Agenda Meeting Sponsor - Opening Remarks Welcome from the Chair Academy Information Officer Information Dr. Richard Bertin, BPS George Hinkle, BPS Update Jeff Norenberg, NANP Update Robert Mach, SNM-RPSC Update Committee Updates Incoming Chair Wrap-up & Committee Huddles

5. Academy Information

6. Nuclear Pharmacy Practice Section (NPPS)

7. Officer Information

8. Officer Information

9. Officer Information

10. BPS

11. BPS Update

12. NUCLEAR PHARMACY SPECIALTY COUNCIL - 2007 Nuclear Specialists Wendy Galbraith, PharmD, BCNP Fred Gattas, PharmD, BCNP Richard Hammes, MS, BCNP Walter Miller, PharmD, BCNP John Sterzinger, BS, BCNP George Hinkle, MS, BCNP Non-nuclear members Carmen Blumenthal, MS Carolyn Brackett, PharmD, BCPS Norm Tomaka

13. BOARD OF PHARMACEUTICAL SPECIALTIES STATISTICS � 2007 Almost 7,000 pharmacist specialists are currently certified by B.P.S. 507 BCNP (Nuclear) 419 BCNSP (Nutrition Support) 757 BCOP (Oncology) 4,523 BCPS (Pharmacotherapy) 509 BCPP (Psychiatric)

14. BPS NUCLEAR SPECIALTY CERTIFICATION EXAM-2007 Thirty (30) took the Nuclear Pharmacy Specialty Certification Examination on October 6, 2007 with 23 (77%) passing.

15. NPSC Activities-2007 Review of Professional Development Program for Recertifcation-UNM Completion of Role Delineation-new Content Outline for NUSPEX Passing Point Study

16. Contact Information bps@aphanet.org www.bpsweb.org

17. NANP Update Jeff Norenberg MS,PharmD,BCNP,FASHP,FAPHA Executive Director, National Association of Nuclear Pharmacies (NANP) Associate Professor and Director, Radiopharmaceutical Sciences College of Pharmacy University of New Mexico Health Sciences Center

18. 2-4 PM Saturday, 15 March 2008 NANP General Business MeetingRegulatory and New Product Update

19. 2007 NANP Business Report NANP is a trade association representing ~450 nuclear pharmacies in US whose mission includes: Regulatory and government affairs - local, state, and federal Professional education to promote the best business practices in nuclear pharmacy Interaction with commercial manufacturers to bring you information regarding new products and services Established 1984

20. 2007 Membership Update ~300 NANP member nuclear pharmacies Cardinal Health NPS, Covidien, GE Healthcare, IBA Molecular, PETNet Solutions New Member = Triad Isotopes Independents, Academic/Institutional BOD representation >10 locations Associate Members Molecular Insight Pharmaceuticals, Inc. (MIP)

21. 2007-2008 Activity Summary CMS/HOPPS/APC Task Force FDA PET User Fees NANP.net Interactions with Professional Orgs NANP Scholarship

23. 2008 Goals and Objectives FDA Drug Pedigree Compounding JACHO Med Management NANP Scholarship

24. NANP Scholarship NANP will award a $2000 scholarship in recognition of academic excellence and contributions to Nuclear Pharmacy First award April 2008 Awarded at NANP Business Meeting Application materials available at NANP.net

25. Jeff Norenberg - Executive Director (505) 272-8101 jpnoren@unm.edu Chris Ondeck - Legal Counsel (202) 624-2855 COndeck@crowell.com Bibiana Collier - Member Services (202) 508-8810 BCollier@crowell.com Visit us at www.nanp.net NANP Contacts

26. SNM-RPSC Update Robert Mach, PhD President, Radiopharmaceutical Sciences Council, Society of Nuclear Medicine

29. 10:00 AM-11:30 AM � 211-213 Radiochemistry: Nuts and Bolts I - SAM Session SNM Radiopharmaceutical Sciences Council � SummaryThis session is designed for those clinicians, scientists, pharmacists and technologists wishing to gain experience in rapidly evolving field of molecular imaging, especially pertaining to PET imaging. Role of Nuclear Medicine imaging and constraints involved in developing new and novel imaging agents will be discussed. Differences in developing C-11 and F-18 labeled compounds will be discussed. Special emphasis will be placed on quality control issues relating to these imaging agents and their impact on translational research. A basic knowledge in nuclear medicine imaging and/or radiopharmaceuticals is highly desirable. Educational ObjectivesUpon completion of this session, attendees will be able to: 1. Discuss the basic issues in quality control of PET radiopharmaceuticals. 2. Describe issues pertaining to F-18 and C-11 labeled PET imaging agents. 3. Construct constraints and guidelines to develop novel PET radiopharmaceuticals labeled with F-18 and C-11 isotopes. 4. Recognize issues pertaining to translational research using PET radiopharmaceuticals. 5. Review promising PET radiopharmaceuticals. � Organizers: Pradeep Garg, PhD; Robert Henry Mach, PhD � � 10:00 AM - 10:20 AM F-18 Radiopharmaceuticals: Tricks of the Trade Robert H. Mach � 10:20 AM - 10:40 AM C-11 Radiopharmaceuticals: Tricks of the Trade Pradeep K. Garg � 10:40 AM - 11:00 AM The Importance of Chelator for radiometal-based Radiopharmaceuticals in PET imaging. Carolyn J. Anderson � 11:00 AM - 11:20 AM Quality Control Issues in PET and SPECT Radiopharmaceuticals: Technical and Regulatory Sally Schwarz 11:20 AM - 11:30 AM Question for the speakers Robert H. Mach, Pradeep K. Garg, Carolyn Anderson, and Sally Schwartz

30. 12:30 PM-2:00 PM � 211-213 Radiochemistry: Nuts and Bolts II - SAM Session SNM Radiopharmaceutical Sciences Council � SummaryThis session is designed for those clinicians, scientists , pharmacists and technologists wishing to gain experience in rapidly evolving field of molecular imaging, especially pertaining to PET and SPECT imaging. Role of Nuclear Medicine imaging and constraints involved in developing new and novel imaging agents will be discussed. Differences in developing traditional radiopharmaceuticals labeled with metal isotopes will be discussed. Special emphasis will be placed on various chemistries involved in the production and quality controls pertaining to this class of radiopharmaceuticals and their impact on translational research. A basic knowledge in nuclear medicine imaging and/or radiopharmaceuticals is highly desirable. Educational ObjectivesUpon completion of this session, attendees will be able to: 1. Discuss the basic issues in quality control of SPECT and PET radiopharmaceuticals. 2. Describe issues pertaining to chelating chemistry to incorporate SPECT and PET imaging isotopes. 3. Construct constraints and guidelines to develop novel imaging agents. 4. Identify issues pertaining to translational research using radiopharmaceuticals incorporating metals. � Organizers: Pradeep Garg, PhD; Alan B. Packard, PhD � � 12:30 PM - 12:50 PM SPECT Radiopharmaceuticals (Iodine and Tc-99m) Michael Adam � 12:50 PM - 1:10 PM Cu labeled PET Radiopharmaceuticals. Carolyn Anderson � 1:10 PM - 1:30 PM Radiopharmaceuticals incorporating metals: Diagnostic and therapeutic applications Cara Ferreira � 1:30 PM - 1:50 PM Therapeutics: Molecular Biology Aided Engineered Macromolecules for radiotherapy Surinder Batra � 1:50 PM - 2:00 PM Questions for the speakers Michael Adam, Carolyn Anderson, Cara Ferreira, Surinder Batra

31. APhA-APPM NPPS Section Charges MTM New APhA Membership Awards Elections Annual Meeting: Poster Judges/Moderators e-Communities Model Rules Update

32. NPPS Committees

33. Awards Committee

34. Awards Committee

35. Daniel B. Smith Practice Excellence Award

36. Daniel B. Smith Practice Excellence Award

37. William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice

38. William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice

39. Honorary APhAMembership

40. Honorary APhAMembership

41. APPM Policy Standing Committee

42. Policy Standing Committee

43. Policy Standing Committee List of recommended topics for assignment to 2007-08 APhA Policy Committee: MTM Documentation and Billing Standards Clinical Benchmarks Pharmacy Compounding Student Pharmacists� Experiential Training in Light of Increasing Number of Pharmacy Schools Role of Pharmacist in Smoking Cessation Pharmacy Technician Education & Training To see status of recommended topics, go to www.pharmacist.com/HOD

44. Policy Standing Committee Currently, the 2007-08 APhA Policy Committee was charged with researching and determining proposed APhA policies: Experiential Education and Residency Training for Pharmacists Pharmacy Compounding Accreditation and Pharmacy Technician Education and Training Open hearing is on Sunday at 1PM

45. Education Committee

46. Education Committee

47. Education Committee

48. Reviewers for Contributed Papers Michele Beauvais Garcia Simon-Clarke Wendy Galbraith Richard Green Nicki Hilliard Vivian Loveless Brigette Nelson Eric Smith Mark Soffing Duann Vanderslice Kristina Wittstrom

49. Poster Sessions Initial Evaluation of a Microbiostatic Coating as an Adjunct in Aseptic Handling. Ponto J. University of Iowa Hospitals and Clinics/University of Iowa College of Pharmacy (82) Pharmacist Review of Medication Orders in a Clinical Nuclear Medicine Setting. DePietro A, Rice P, Callahan R, Massachusetts General Hospital (83)

50. Professional Affairs Committee

51. Professional Affairs Committee

52. Model Rules UpdateTask Force

53. Model Rules UpdateTask Force

54. Regulatory Affairs Committee

55. Nuclear Regulatory Commission Updates Authorized Nuclear Pharmacist (ACMUI) Inclusion of Accelerated Produced Radionuclides

56. 10 CFR 35.55 Training for an authorized nuclear pharmacist Is certified by a specialty board whose certification process has been recognized by the Commission/or Has completed 700 hours in a structured educational program consisting of: and Has obtained written attestation, signed by a preceptor authorized nuclear pharmacist

57. The New, Expanded Definition of Byproduct Material (October 1,2007) Includes: discrete sources of radium-226, accelerator-produced radioactive materials, and discrete sources of naturally occurring radioactive material, as required by the Energy Policy Act of 2005 (EPAct), which was signed into law on August 8, 2005.

58. FDA/Radiopharmaceuticals Sestamibi � BMS (Avista) patent extended until July 2008 Covidien DraxImage (GE) Cardinal Health CIS-US Mebrofenin CIS-US Bracco

59. PDUFAFDA Prescription Drug User Act (PDUFA), a program through which drug makers pay the FDA to review new products. PDUFA (1992) was set to expire on Sept. 30, 2007. The bill was sponsored by Sen. Edward Kennedy, D-Mass., chairman of the Health, Education, Labor and Pensions Committee and Sen. Michael Enzi, R-Wyoming. Hours before the expiration of the Prescription Drug User Fee Act, the Senate approved legislation renewing the program, thus averting imminent FDA layoffs. 

60. Summary of the FDA Amendments Act of 2007 Public Law No. 110-85 Revitalization ActPDUFA IV, PDARA PET Compounded Products Creates new annual establishment fee program (to help cover costs for FDA inspections) for certain compounded positron emission tomography (PET) drugs Each person who is named as the applicant in an approved human drug application for a PET drug is subject to one-sixth of an annual establishment fee for each establishment identified in the application as producing PET under the approved application

61. FDARA would also exempt from all annual establishment user fees those PET drug sponsors who certify to FDA that they are not-for-profit medical centers with only a single PET drug manufacturing establishment, and provided at least 95% percent of the total number of doses of each PET drug produced by that establishment will be used within the medical center itself.

62. The Safe Drug Compounding Act of 2007 Facing mounting opposition since introducing the legislation into the Senate, Sens. Kennedy, D-Mass., Roberts, R-Kan., and Burr, R-N.C., have backed off the bill that would allow the FDA to intervene as to when a patient requires a compounded medication. The bill also would call for the FDA to establish federal requirements for sterile compounding that duplicate and supersede those already established by the U.S. Pharmacopeia and give wider authority over compounded medications to the FDA, thereby removing the current authority of state boards of pharmacy. In addition, the bill would severely restrict interstate distribution of compounded medications.

63. CMS(HOPPS) The House and Senate finalized legislation on Wednesday, December 20, 2007 to extend the 2007 reimbursement methodology for therapeutic radiopharmaceuticals through June 30, 2008. On January 27, 2008 the SNM sent a letter to CMS stating: We believe that the continuation of separate payment for all radiopharmaceuticals (following the same criteria as other drugs and biologics) is critical to enable hospitals to account for the complex combinations of radiopharmaceuticals used with nuclear medicine procedures.

64. USP 797 General Chapter <797> Pharmaceutical Compounding Sterile Preparations is revised and finalized. Once the chapter becomes official in June of 2008, the current version in USP 31 � NF 26 will no longer be the official chapter. Regulatory Update today 2-5pm Room 29 A/B

65. NIOSH NPPS Comments to the Proposed Updates to Appendix A of NIOSH Alert on Hazardous Drugs (NIOSH Docket #105) 1. Metastron (strontium-89 chloride) 2. Quadramet (samarium-153) Revised list has not been published

66. 2008 National Patient Safety GoalsJCAHO Goal 1 Improve the accuracy of patient identification. Goal 2 Improve the effectiveness of communication among caregivers. ask and respond to questions. Goal 3 Improve the safety of using medications. Goal 7 Reduce the risk of health care-associated infections. Goal 8 Accurately and completely reconcile medications across the continuum of care. Goal 9 Reduce the risk of patient harm resulting from falls. Goal 11 Reduce the risk of surgical fires. Goal 13 Encourage patients� active involvement in their own care as a patient safety strategy. Goal 15 The organization identifies safety risks inherent in its patient population. Goal 16 Improve recognition and response to changes in a patient�s condition.

67. 2007 Medication Reconciliation the Pharmacists� Responsibility APhA recognizes pharmacists as the health care team member responsible for the medication reconciliation process when patients move between practice settings within the continuum of care. (JAPhA NS45(5):580 September-October 2007)

68. 2009 Implementation Expectations for JCAHO Requirement 8 In settings where medications are not used, are used minimally, or prescribed for a short duration, modified medication reconciliation processes are performed. Examples of these include areas outpatient radiology, ambulatory care, etc. In these settings obtaining a list of the patient�s known medications currently taken at home is still important but it does not necessarily require obtaining information on the dose, route and frequency for use of the patient�s current medications. A new list of the known, current medications does not need to be provided to patients when they leave these setting, unless the patient is assessed to be confused or unable to comprehend adequately.

69. Medication ReconciliationJCAHO Website New�[8B] If a patient comes in for an outpatient test such as an imaging study with contrast or to have a procedure such as endoscopy with sedation, but there is no change in their home medication regimen, is it required to give the patient a written list of their home medications? If the patient already has the list and it hasn�t changed, you don�t need to provide another copy of it. However, if the patient doesn�t have a current list of his/her medications, a copy of the list should be provided. [New, 1/07]

70. Pharmacist Review of Medication OrdersJCAHO 2007 Standard MM.4.10 Preparing and Dispensing All prescriptions or medication orders are reviewed for appropriateness. Elements of Performance for MM.4.10 1. Before dispensing, removal from floor stock, or removal from an automated storage and distribution device, a pharmacist reviews all prescription or medication orders unless a licensed independent practitioner controls the ordering, preparation, and administration of the medication; or in urgent situations when the resulting delay would harm the patient, including situations in which the patient experiences a sudden change in clinical status(for example, new onset of nausea).

71. Incoming Chair

72. APhA-APPM Nuclear Section 2008-2009Goals MTM Self-Assessment Task Force to update the Model Rules Increase communication on nuclear e-community website Awards Membership campaign Section Officer Candidate Recruitment

73. Wrap-Up