BOARD OF PHARMACY SPECIALTIES

NUCLEAR PHARMACY CERTIFICATION

CONTENT OUTLINE/CLASSIFICATION SYSTEM
FINALIZED DECEMBER 2013 / FOR USE ON FALL 2014 EXAMINATION AND FORWARD

The following domains, tasks, and knowledge statements were identified by the BPS Specialty Council on Nuclear Pharmacy
and validated through a role delineation study, most recently updated in 2013. The proportion of examination items allotted to
each domain was determined through analysis and discussion of the results of the role delineation study by the Specialty Council.

Each of the major areas/domains of Nuclear Pharmacy practice noted below will be tested. Questions will not be grouped by
domain. Items testing each domain are distributed throughout the total examination. Please note that this examination will SAMPLE
a candidates knowledge rather than trying to test all of his/her knowledge.

Here is a brief primer to understand the structure of the content outline/ classification system.

Domains: A domain is a major responsibility or duty. You can think of a domain as a major heading in an outline format. You will see
the domains displayed as black bars on the outline. Five domains are included in the content outline and are noted below.

1. Procurement, Storage, and Handling (16 percent of examination)

2. Preparation, Compounding, and Dispensing (38 percent of examination)
3. Quality Assurance (17 percent of examination)
4. Health and Safety (19 percent of examination)
5. Drug Information and Professional Consultation (10 percent of examination)

Tasks: A task statement defines an activity that elaborates on the domain. The set of task statements in a domain offer a
comprehensive and detailed description of the domain. You will see the tasks are gray bars on the outline.

Knowledge Statement: For each task, it is valuable to understand what knowledge and skills are essential to competent
performance. The set of knowledge statements clarifies the expectations for newly certified pharmacists. You will find the
knowledge statements under each task statement.

DESCRIPTION
Domain 1: Procurement, Storage, and Handling (16 percent of examination)
Task 1: Define product specifications such as quantity, concentration, availability, calibration, expiration, and manufacturer.
Knowledge of:
1. Product specifications such as quantity, concentration, availability, calibration, expiration, manufacturer, contaminants,
ingredients, and cost
2. USP standards and other regulations governing materials
3. Products, supplies, and other materials needed for nuclear pharmacy practice
4. Inventory control of radiopharmaceuticals
Task 2: Confirm appropriate condition of products upon receipt such as temperature, light sensitivity, and humidity.
Knowledge of:
1. Appropriate condition of products upon receipt such as temperature, light sensitivity, and humidity
2. Receipt requirements for radioactive and non-radioactive drugs, components, and supplies
3. Consequences of improper shipping
Task 3: Assess product attributes such as pedigree, traceability, and drug classification.
Knowledge of:
1. Confirm acceptability of products for use
2. Required documentation and record retention (e.g., certificates of analysis, drug classification)
3. Record-keeping procedures to ensure traceability of all drugs and related components
Task 4: Store materials under appropriate conditions.
Knowledge of:
1. Storage and shielding requirements for radiopharmaceuticals, adjunct agents, components, and supplies, including the
consequences of improper storage

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DESCRIPTION
Domain 2: Preparation, Compounding, and Dispensing (38 percent of examination)
Task 1: Review orders for radiopharmaceuticals, devices, and adjunct agents for appropriateness.
Knowledge of:
1. Indications, dosage recommendations, and route of administration for radiopharmaceuticals and adjunct agents
2. Patient preparatory requirements and techniques to improve the safety and efficacy of nuclear medicine procedures (e.g.,
fasting, hydration, sedation, thyroid blockade)
3. Factors that may interfere with the outcome of nuclear medicine procedures (e.g., drug interactions, allergies)
Task 2: Select products, components, supplies, and equipment needed to prepare and compound prescription orders.
Knowledge of:
1. Ingredients and components of reagent kits and radiopharmaceuticals, including the purpose of each
2. Physiochemical and kinetic properties, mechanisms of localization, and pharmacologic and therapeutic effects of
radiopharmaceuticals and adjunct agents
3. Half-lives, modes of decay, and emission energies associated with radiopharmaceuticals
4. Appropriate documentation supplied by the vendor (e.g., COA, COC, COQ)
Task 3: Elute radionuclide generators.
Knowledge of:
1. Physical and chemical characteristics of available generators
2. Generator kinetics and elution techniques
3. Proper storage and use environment
Task 4: Prepare sterile and non-sterile medications and devices using appropriate aseptic and hazard control techniques.
Knowledge of:
1. Factors that affect the stability and shelf life of reagent kits and radiopharmaceuticals, including radionuclidic
contamination
2. Formulation factors that may adversely affect preparation performance
3. Concepts, techniques, and parameters required for optimal preparation of radiopharmaceuticals (e.g., package insert
recommended volumes, activities, pH, temperature, order of mixing, excipients, specific activity)
4. Professional standards for preparing sterile and non-sterile medications and devices (e.g., USP General Chapter 795, USP
General Chapter 797)
5. Blood labeling procedures and precautions for blood-borne pathogens
Task 5: Compound sterile and non-sterile preparations according to professional standards and regulations.
Knowledge of:
1. General synthesis and radiolabeling methods (e.g., redox reactions, chelation, substitution, radioiodination) as well as
methods for optimizing yield of radiolabeled compounds
2. Containers, closures, and other packaging materials used in the compounding and dispensing of radiopharmaceuticals
3. Standards for compounding sterile and non-sterile medications and devices (e.g., USP General Chapter 795, USP General
Chapter 797, USP General Chapter 823)
4. Physical and chemical incompatibilities
5. Preparation verification methods and applications
Task 6: Verify the identity, integrity, concentration, container labeling, and proper storage of the final preparation.
Knowledge of:
1. USP standards for drugs, pharmaceutical ingredients, reagents, tests and assays, and other materials
2. Product labeling of manufacturer package insert
3. Regulations for container labeling of radiopharmaceuticals and adjunct agents
Task 7: Determine proper dosage based on patient history, age, weight, and other factors.
Knowledge of:
1. Factors that affect dosage selection as well as methods used to calculate and determine dosages of radiopharmaceuticals
and adjunct agents for specific patients (e.g., pediatrics, breast-feeding, and pregnant patients)
Task 8: Dispense radiopharmaceuticals and adjunct agents.
Knowledge of:
1. Situations when pharmacologic interventions are clinically indicated
2. Proper sequencing when multiple imaging procedures or clinical factors are required as part of a patients diagnostic
workup (e.g., dialysis)

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DESCRIPTION
3. Mechanisms by which selected interventions can enhance the utility, safety, or efficacy of specific nuclear medicine
procedures
4. Applicable rules and regulations pertaining to radiopharmaceutical and adjunct agents record keeping and traceability
Domain 3: Quality Assurance (17 percent of examination)
Task 1: Perform appropriate quality assurance procedures for nuclear pharmacy instrumentation, equipment, environment, and
devices.
Knowledge of:
1. Regulations and standards regarding the possession, use, and quality control and testing of the instruments, equipment,
and devices (e.g., dosimeter, dose calibrator, survey meter, well counter)
2. Regulations and standards regarding environmental quality (e.g., viable particle air monitoring, non-viable particle air
monitoring, contact plate testing, contamination controls)
Task 2: Perform appropriate product release tests for radiopharmaceutical preparations.
Knowledge of:
1. Testing methods and release criteria for radiopharmaceuticals (e.g., radiochemical purity, radionuclidic purity, chemical
purity, sterility, pyrogenicity)
Task 3: Ensure appropriate processes are in place for sterility of aseptic preparations.
Knowledge of:
1. Regulations and standards regarding personnel training and qualification (e.g., media fill testing, fingertip sampling, garbing
assessment)
Task 4: Maintain applicable quality assurance records to identify trends and document compliance.
Knowledge of:
1. Procedures for the review of quality assurance documentation
Domain 4: Health and Safety (19 percent of examination)
Task 1: Ensure compliance with radioactive materials regulations and license requirements for radiation and radiopharmaceuticals.
Knowledge of:
1. Radiation protection principles, techniques, and standards (e.g., NRC)
2. Appropriate shielding techniques as well as attenuation coefficients and HVLs
3. Applicable regulations and standards related to the receipt, storage, handling, and clinical application of radioactive
materials
4. Regulations governing the storage, possession, testing, and use of sealed sources
5. Principles for the operation of equipment or devices used to measure radioactivity and radiation exposure rates
Task 2: Ensure compliance with regulations concerning handling, packaging, labeling, and transporting radioactive, biohazardous,
and hazardous substances and waste.
Knowledge of:
1. Regulations concerning packaging, labeling, and transportation of radioactive, biohazardous, and hazardous materials,
including knowledge and use of appropriate equipment
2. Rules and regulations governing the storage and disposal of waste materials
Task 3: Apply policies and procedures for a safe working environment.
Knowledge of:
1. Standards for providing a safe working environment (e.g., CDC, OSHA, NFPA)
2. Regulations for effluent release (e.g., NRC, EPA)
Task 4: Apply policies and procedures for regulatory and medical events.
Knowledge of:
1. Rules governing regulatory and medical events, including notification
2. Procedures used in response to spills or other incidents involving radioactive materials
Task 5: Apply policies and procedures for security of the facility, radioactive materials, medications, and supplies.
Knowledge of:
1. Regulations and standards governing the security of the facility, radioactive materials, medications, and supplies (e.g., NRC,
accrediting agencies)
Domain 5: Drug Information and Professional Consultation (10 percent of examination)
Task 1: Evaluate factors affecting patient outcomes in nuclear medicine procedures.
Knowledge of:
1. Normal radiopharmaceutical kinetics, biodistribution, and image acquisition or therapy application
January 2014, Board of Pharmacy Specialists. All rights reserved. This document is the copyrighted property of Board of Pharmacy Specialists
and is shared subject to a limited revocable license for the sole use of BPS volunteers in exam development activities. All other uses and disclosure
to non-essential persons are expressly prohibited. Page 3
DESCRIPTION
2. Clinical significance of factors that alter normal radiopharmaceutical kinetics, biodistribution, and image acquisition or
therapy such as radiopharmaceutical impurities, concomitant medication use, and disease or pathology
3. Study selection factors such as patient specific parameters and study sequencing
4. Requirements and techniques for the administration of radiopharmaceuticals and adjunct agents
5. Parameters that should be monitored when a patient is receiving a specific medication or drug regimen, or when a patient
undergoes a specific surgical intervention or receives some other specific therapeutic measure
6. Pediatric dosing
Task 2: Consult with practitioners to ensure optimal utilization of radiopharmaceuticals and adjunct agents in patient care.
Knowledge of:
1. Organ systems and pathophysiologic disorders in patients administered radiopharmaceuticals and adjunct agents
2. Role of nuclear medicine procedures relative to other modalities in the diagnosis or management of specific disorders
3. Nuclear medicine procedures used to monitor the safety and efficacy of therapeutic drug regimens or other therapeutic,
surgical, or interventional procedures
4. Mechanisms by which selected medications can enhance the utility, safety, or efficacy of specific nuclear medicine
procedures
5. Economic ramifications of radiopharmaceutical care
6. Design and interpretation of drug use evaluation studies
7. Rational radiopharmaceutical and ancillary medication usage
8. Normal and atypical performance parameters (e.g., radiopharmaceutical biodistribution, image quality, dosimetry,
therapeutic effect, likelihood of untoward effects) associated with the therapeutic use of radiopharmaceuticals
9. Patient factors that may interfere with the outcome of the nuclear medicine procedure
10. Preparatory requirements and techniques to improve the safety or efficacy of the nuclear medicine procedure (e.g., fasting,
hydration, sedation, thyroid blockade)
11. Pregnancy and breast-feeding guidelines for nuclear medicine procedures
12. Patient education needs, requirements, methods, and aids
13. Availability and interpretation of nuclear medicine procedures used to monitor drug efficacy and toxicity
Task 3: Provide information on the prevention, recognition, treatment, reporting, and analysis of adverse drug events.
Knowledge of:
1. Nature and incidence of previously reported adverse drug events to radiopharmaceuticals and adjunct agents
2. Mechanisms and symptomology associated with adverse drug events to radiopharmaceuticals and adjunct agents
3. Methods to treat or alleviate adverse drug events
4. Adverse reaction investigation and reporting systems
5. Troubleshooting and identification of the source of adverse drug events such as patient variable, disease state or condition,
medication therapy, or formulation error
6. Image presentation of radiopharmaceutical quality or drug administration issues
Task 4: Report information regarding drug defects or clinical issues associated with the use of radiopharmaceuticals and adjunct
agents.
Knowledge of:
1. Factors and mechanisms that cause product defects or clinical problems with radiopharmaceuticals and adjunct agents
2. Reporting systems that can be used to document product problems and clinical problems associated with
radiopharmaceuticals and adjunct agents
Task 5: Provide information about health physics and radiation safety compliance.
Knowledge of:
1. Patient release conditions post radionuclide administration
2. Concepts of radiation safety (e.g., dose, exposure, time, pharmacokinetics, routes of excretion, pregnancy, breast-feeding)
3. Regulations to effectively address concerns of individuals, families, and community organizations
4. Radiation biology, nuclear physics, instrumentation, and radiation safety to educate concerned patients, employees, and
administration staff

January 2014, Board of Pharmacy Specialists. All rights reserved. This document is the copyrighted property of Board of Pharmacy Specialists
and is shared subject to a limited revocable license for the sole use of BPS volunteers in exam development activities. All other uses and disclosure
to non-essential persons are expressly prohibited. Page 4