Introduction to Pharmacy Practice

1. Introduction to Pharmacy Practice Chapter 6: Specialty Pharmacy Practice

2. Learning Outcomes • Describe development of nuclear pharmacy practice • Explain basic concepts of nuclear medicine • Explain role in patient diagnosis & treatment • Describe aspects of nuclear pharmacy practice • Identify areas for technicians in nuclear pharmacy • Explain role of technicians in compounding specialties

3. Key Terms • Activity units (mCi) • Assay • Gamma photon • Hazardous material • Ligand • Naturally occurring radioactive material (NORM)

4. Key Terms • Nonrestricted • Nuclear pharmacy • Positron emission tomography (PET) • Radioactive decay • Radioactivity • Radiopharmaceuticals • Restricted areas

5. Nuclear Pharmacy • Preparation & dispensing of radiopharmaceuticals • Diagnosis & treatment of disease • Involves considerable regulatory oversight

6. Basic Concepts • Radioactivity • transfer of excess energy into radioactive emission • Half-life • time for ½ material to give up its excess energy • NORM • example: radon gas • Medical applications • radioactive materials from nuclear reactor / accelerator

7. Nuclear Medicine-Diagnosis • Diagnostic nuclear medicine • attach ligand to compound • ligand moves through patient’s body • gives off radioactive emission called gamma photon • emissions are mapped • Renal imaging • blood flow to kidneys • assesses kidney function • urine flow from kidney into bladder

8. Nuclear Medicine-Diagnosis • Nuclear medicine augments • traditional imaging modalities • x-ray • computed tomography (CT) • magnetic resonance imaging (MRI)

9. Nuclear Medicine-Treatment • Destructive effects of radioactive emissions • radioactive form of iodide-treatment of thyroid diseases • overactive thyroid • thyroid cancer • thyroid gland takes up radioactive iodide molecule • radioactive emissions from molecule damage thyroid • overactive thyroid returns to normal levels • thyroid cancer-dose is substantially higher

10. Historical Perspective • Development of nuclear pharmacy • Dr. John Christian • Purdue University School of Pharmacy, • Captain William H. Briner • 1978-nuclear pharmacy recognized by APhA • first specialty area of pharmacy practice • BCNP-board certification specialty • > 500 BCNP nuclear pharmacists

11. Nuclear Pharmacy • 3 major chain nuclear pharmacies • more than 200 locations • More than 100 independently owned nuclear pharmacies • PTCB certification-often required to work in nuclear pharmacy

12. PET • Positron emission tomography imaging • Uses very short-lived radioactive materials • More popular in recent years • Dedicated facilities specialize in this area

13. Nuclear Pharmacy Operations • Pharmacy technician • integral part of almost every aspect of nuclear pharmacy • essential member of nuclear pharmacy team • role based on state board of pharmacy regulations

14. Nuclear Pharmacy Operations Unique aspects include: • Location of nuclear pharmacies • Workflow & staffing • Restricted & nonrestricted areas • Preparation & dispensing

15. Nuclear Pharmacy Location • Close to hospitals in geographic area • within 2-3 hour travel distance • quick access to major transportation routes • Nuclear pharmacies located • strip malls • medical office complexes • as freestanding buildings • Few outward signs of pharmacy • Restricted access

16. Workflow and Staffing • 24 hours a day, 7 days a week, 365 days a year • “night shift” • most important/productive time in nuclear pharmacy • prepare, dispense, and deliver agents to their customers before the first patient seen in nuclear medicine • en route to hospitals or clinics before 6 A.M. each day • “add-on” doses needed throughout day

17. Restricted & Nonrestricted • Nonrestricted areas • staff & visitor access • limited to no contact with radioactive materials • monitored regularly for inadvertent contamination • Restricted area • radioactive materials are stored, handled , dispensed

18. Restricted Areas • Order entry • Compounding • sterile product compounding • Dispensing area • Blood labeling area • Packaging & transport area • Radioactive material storage area • Radioactive waste areas

19. USP 797 • Official public standards • Primary dosage form for IV radiopharmaceuticals • Topics specifically addressed • equipment • training • appropriate attire

20. Preparation • Prescription processing • Orders called to pharmacy in evening • Add-on doses- “STAT” throughout day • Amount of radioactivity • Assay describes # activity units as mCi/mL • Challenge-assay constantly changing • radioactive decay

21. Rx Order for Radiopharmaceuticals Order includes: 1. agent to be administered 2. amount of radioactivity (mCi) to be dispensed 3. time of administration to patient 4. patient name

22. Production & Acquisition • Radiopharmacist -attach radioactivity to ligand • Ligands-“kit” formulations • More than 40 different radiopharmaceutical “kits” • On-site production • Radionuclide generator system • Continual production of radioisotope Tc-99m

23. Quality Control Tests • Generally less than 1 minute to complete • No doses should leave the pharmacy before quality control checks • Quality control testing is pharmacy technician task

24. Dispensing • Unit dose • Usually dispensed in a 3 or 5 mL syringe • When dispensing radioactive materials • small variance (usually 10-20%) is allowed • Appropriate container made of lead/shielding material • to prevent loss of material during shipping • minimizes radiation exposure to • delivery staff • public

25. Handling Radioactive Materials • Hazardous • Regulatory requirements • Nuclear Regulatory Commission (NRC) • Part 10 of Code of Federal Regulations (10 CFR). • Department of Transportation (DOT) • shipping & receiving of radioactive materials

26. 10 CFR, Part 20 • Standards for Protection from Radiation.10 • Women can safely work in nuclear pharmacy • pregnant or nursing • Additional monitoring & safety precautions are used • ALARA—As Low As Reasonably Achievable • time, distance, shielding

27. Specialized Instrumentation • Geiger Mueller (GM) survey meter • portable radiation detector clean • Radionuclide dose calibrator • Scintillation detector

28. Future Directions • Nuclear pharmacy technician is integral part of team • Changing roles of nuclear pharmacist & technician • mandated clinical pharmacy services • requiring greater role for nuclear pharmacy technician

29. Compounding Specialties • Lack of commercially available products • to meet the specific needs of an individual • Pediatrics • Women’s health • Fertility • Pain management • Ophthalmology • Veterinary pharmacy practice

30. Veterinary Pharmacy Practice • Veterinary medicine as long as human medicine • > 45,000 veterinarians in United States • Center for Veterinary Medicine (CVM) of the FDA • regulates food additives & drugs for animals • Food, Drug and Cosmetic Act • subsection specific to veterinary medicine • “Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

31. AVMA • American Veterinary Medical Association • FDA “Green Book” • animal drug products approved for safety/effectiveness • available electronically • Veterinarians authorized to utilize human drugs • “Human” drug Rx can be filled at any licensed pharmacy

32. Unique Aspects • Pharmacists at animal hospitals • veterinary medicine schools • Position statement on compounding practices • flavored medications • standard “recipes” • Bioavailability, biodistribution, kinetics of drugs • metabolism • gastric transit • absorption • pH