Transcript Introduction to Pharmacy Practice

Chapter 6: Specialty Pharmacy Practice
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
Key Terms
 Activity units (mCi)
 Assay
 Gamma photon
 Hazardous material
 Ligand
 Naturally occurring radioactive material (NORM)
Key Terms
 Nonrestricted
 Nuclear pharmacy
 Positron emission tomography (PET)
 Radioactive decay
 Radioactivity
 Radiopharmaceuticals
 Restricted areas
Nuclear Pharmacy
 Preparation & dispensing of radiopharmaceuticals
 Diagnosis & treatment of disease
 Involves considerable regulatory oversight
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
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
Nuclear Medicine-Diagnosis
 Nuclear medicine augments
 traditional imaging modalities
 x-ray
 computed tomography (CT)
 magnetic resonance imaging (MRI)
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
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
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
PET
 Positron emission tomography imaging
 Uses very short-lived radioactive materials
 More popular in recent years
 Dedicated facilities specialize in this area
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
Nuclear Pharmacy Operations
Unique aspects include:
 Location of nuclear pharmacies
 Workflow & staffing
 Restricted & nonrestricted areas
 Preparation & dispensing
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
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
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
Restricted Areas
 Order entry
 Compounding
 sterile product compounding
 Dispensing area
 Blood labeling area
 Packaging & transport area
 Radioactive material storage area
 Radioactive waste areas
USP 797
 Official public standards
 Primary dosage form for IV radiopharmaceuticals
 Topics specifically addressed
 equipment
 training
 appropriate attire
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
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
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
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
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
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
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
Specialized Instrumentation
 Geiger Mueller (GM) survey meter
 portable radiation detector clean
 Radionuclide dose calibrator
 Scintillation detector
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
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
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.”
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
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