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