Nuclear Pharmacy Practice Guidelines                                                           Return to Home

Nuclear pharmacy is-a specialized pharmaceutical care service that has been defined as follows:

Nuclear pharmacy is a patient-oriented service that embodies the scientific knowledge and professional judgement required to improve and promote health through assurance of the safe and efficacious use of radioactive drugs for diagnosis and therapy.

A nuclear pharmacist shall possess an active pharmacist license and shall have received didactic instruction and/or supervised professional experience in the practice of nuclear pharmacy. The practice of nuclear pharmacy is composed of the following general domains related to the provision of nuclear pharmacy services:

1. Procurement

2. Compounding

3. Quality Assurance

4. Dispensing

5. Distribution

6. Health and Safety

7. Provision of Information and Consultation

8. Monitoring Patient Outcome

9. Research and Development

To aid in the further description and interpretation of the practice guidelines, each guideline is followed by a list of tasks and their related knowledge statement. This document was created by nuclear pharmacists as a guide for other pharmacists interested in nuclear pharmacy practice. While it may appear to be quite detailed, it is not intended to be an all-inclusive document. This is a dynamic field and the pharmacist's professional judgement should be used when interpreting or applying the following guidelines.

*Guideline Validation completed in Fall 1995

Guideline 1. The nuclear pharmacist is responsible for the procurement of radiopharmaceuticals and other drugs, supplies, and materials necessary for his/her practice.

1.1 Determines product specifications (such as quantity, concentration, date and time of delivery, calibration time, and specific delivery instructions) an initiates purchase order for both radioactive and nonradioactive materials essential to the practice of nuclear pharmacy, demonstrating knowledge of:

1.1.1 USP/NF standards for drugs, pharmaceutic ingredients, reagents, tests and assays, and other materials.

1.1.2 radiopharmaceutical classes and or individual products, including regulatory status, vendors, availability/delivery, amounts, concentrations, calibration, formulation, components (e.g., antioxidants, stabilizing agents, buffers), shelf-life, storage, compounding parameters (e.g., activity, volume), stability, expiration, and cost.

1.1.3 pharmaceutical classes and individual drug products used in Conjunction with nuclear medicine studies.

1.1.4 analytical supplies (e.g., solvents, chromatography strips/columns), sterility test media, endotoxin test media, and other materials needed for radiopharmaceuticals quality control procedures.

1.1.5 other components used in radiopharmaceutical compounding including precursors, reagents, target solutions and gases, containers and closures, and transfer lines and membrane filters.

1.1.6 other supplies needed to practice nuclear pharmacy including needles and syringes, disinfectants, gloves, sharps containers, and other disposable/consumable supplies.

1.2 Receives radiopharmaceutical shipments and other orders, following applicable regulatory procedures for opening packages. Maintains records as appropriate. The pharmacist should have knowledge of:

1.2.1 regulations for receipt of radioactive packages.

1.2.2 record-keeping procedures to ensure traceability of all drugs and related components (e.g., reagents, containers, and closures) and testing materials (e.g., sterility test media, endotoxin test media).

1.2.3 procedures to verify the identity of reagents and components (e.g., manufacturer certification, physical/chemical tests of identity).

1.3 Maintains inventory and/or orders materials as appropriate to provide necessary services. The pharmacist should have knowledge of:

1.3.1 shelf-life, expiration, availability/delivery of radioactive and nonradioactive drugs, components and supplies.

1.3.2 use patterns (e.g., amounts/rate of use) of radioactive and nonradioactive drugs, components and supplies

1.4 Stores both radioactive and nonradioactive material in compliance with light, temperature, humidity, segregation, and shielding requirements, demonstrating knowledge of:

1.4.1 light, temperature, and humidity storage requirements for radioactive and nonradioactive drugs, components, and supplies.

1.4.2 the consequences of improper storage conditions on the physical and/or chemical integrity of the material.

1.4.3 requirements for segregation of drugs, biologicals, supplies and other materials.

1.4.4 shielding requirements for radioactive materials.

1.5 Inspects storage areas at appropriate intervals for temperature controls, expired materials, inventory (e.g., controlled substance), etc. Main@ns records as appropriate. The pharmacist should have knowledge of:

1.5.1 JCAHO standards, ASHP standards, and NABP recommendations or relevant federal or state law regarding inspections of drug storage areas.

Guideline 2. The nuclear pharmacist is responsible for the compounding of radiopharmaceuticals necessary to his/her practice.

2.1 Reviews the prescription orders for diagnostic and therapeutic procedures to be performed in the nuclear medicine departments being serviced, demonstrating knowledge of:

2.1.1 indications and dosage recommendations for radiopharmaceuticals.

2.1.2 methods of dosage calculation based on patient characteristics and diagnostic and therapeutic goals.

2.1.3 potential drug interactions and alternative or corrective measures available.

2.2 Selects the radiopharmaceuticals from commercially produced or individually formulated products to be used for the scheduled procedures in accordance with the physician's prescription,

demonstrating knowledge of-

2.2.1 radiopharmaceutical classes and of individuals products, including regulatory status,. vendors, availability/delivery, amounts, concentrations, calibration, shelf-life, storage, expiration, and cost.

2.2.2 formulation components (e.g., antioxidants, stabilizing agents, buffer), compounding parameters (e.g., activity, volume), stability, and appropriate time of use.

2.3 Maintains an appropriate and safe compounding environment. Employs appropriate equipment, supplies and devices in the preparation of products.

2.4 Provides for an aseptic environment for the compounding and dispensing of sterile dosage forms, demonstrating knowledge of:

2.4.1 aseptic technique and available standards for compounding of sterile products.

2.4.2 good compounding practices.

2.5 Verifies the identity, integrity, package labeling, and proper storage of each component and final product, demonstrating knowledge of:

2.5.1 USP/NF standards for drugs, pharmaceutic ingredients, reagents, tests and assays, and other materials.

2.5.2 proper storage conditions for each component and final product.

2.6 Develops procedures for extemporaneous compounding of radiopharmaceuticals or other dosages forms as needed. Prior to implementation, validates that radiopharmaceuticals compounded meet USP or other appropriate specifications, demonstrating knowledge of:

2.6.1 USP or other standards regarding the proper compounding of radiopharmaceuticals.

2.6.2 components used in radiopharmaceutical compounding including precursors, reagents, target solutions and gases, containers and closures, and transfer lines and membrane filters.

2.6.3 physical and chemical characteristics of components including incompatibilities.

2.6.4 product validation methods and applications.

2.7 Maintains a radiopharmaceutical record containing appropriate information for each lot of material to ensure traceability. The pharmacist should have knowledge of:

2.7.1 applicable rules and regulations.

2.8 When compounding radiopharmaceuticals from generator-produced radionuclides, elutes generator and determines and records the radionuclidic, radiochemical, and chemical purity of generator eluate as appropriate. The pharmacist should have knowledge of:

2.8.1 physical and chemical characteristics of available generators.

2.8.2 generator kinetics, elution techniques, and quality assurance techniques.

2.9 Produces radionuclides and determines and records the radionuclidic, radiochemical, and chemical purity of the product as appropriate, demonstrating knowledge of-

2.9.1 components used in radiopharmaceutical compounding including precursors, reagents, target solutions and gases, containers and closures, transfer lines and membrane filters, and their availability.

2.9.2 production methods and nuclear reactions.

2.9.3 production parameters and quality assurance techniques.

2.10 Compounds products pursuant to or in anticipation of prescriptions, demonstrating knowledge of:

2.10.1 compounding techniques, formulation components (e.g., antioxidants, stabilizing agents,

buffers), compounding parameters (e.g., activity, volume), stability, storage, and shelf life.

Guideline 3. The nuclear pharmacist is responsible for the quality assurance of radiopharmaceuticals and of instruments, equipment, and devices necessary for his/her practice.

3.1 Establishes criteria, develops and implements procedures, and maintains records for each of the following as appropriate: -

3.1.1 radionuclidic purity, requiring knowledge of:

3.1.1.1 physics of radionuclides.

3.1.1.2 analytical methods (e.g., gamma spectroscopy) for detecting and quantitating radionuclidic impurities in a given radiopharmaceutical.

3.1.2 radiochemical purity, requiring knowledge of:

3.1.2.1 chemistry of radiopharmaceuticals.

3.1.2.2 analytical methods (e.g., chromatographic methods, electrophoresis, ion exchange, solvent extraction, and distillation) for detecting and quantitating radiochemical impurities in a given radiopharmaceutical.

3.1.3 chemical purity and pH, requiring knowledge of.

3.1.3.1 analytical methods for detecting chemical impurities (e.g., colorimetric spot test for aluminum ion in Tc-99 eluate).

3.1.3.2 analytical methods for determining pH

3.1.4 pharmaceutical integrity (e.g., particle size, isotonicity, sterility, apyrogenicity), requiring knowledge of:

3.1.4.1 analytical methods for estimating particle size and number (i.e., use of microscope and hemacytometer grid).

3.1.4.2 calculations and analytical methods for determining isotonicity.

3.1.4.3 USP tests for sterility and apyrogenicity.

3.1.5 biology integrity (e.g., leukocytes, platelets, antibodies, etc.) requiring knowledge of:

3.1.5.1 Analytical methods of determining biological integrity.

3.1.6 other characteristics (e.g., specific activity, isomeric purity), requiring knowledge of:

3.1.6.1 calculations and analytical methods for determining other characteristics.

3.2 Checks the function of instruments, equipment, and devices and maintains records as appropriate, demonstrating knowledge of:

3.2.1 radiation physics.

3.2.2 principles of operation and procedures for quality control of the nuclear pharmacy instruments, equipment, and devices.

3.2.3 NRC or state regulations and standards regarding the possession, use, calibration, and quality control of the instruments, equipment, and devices used in the nuclear pharmacy.

Guideline 4. The nuclear pharmacist is responsible for the dispensing of radiopharmaceuticals and other drugs necessary to his/her practice.

4.1 Recommends dosage levels based on patient history, age, weight, surface area, and/or other factors, demonstrating knowledge of:

4. 1. I indications and dosage recommendations for radiopharmaceuticals.

4.1.2 methods of dosage calculation based on patient characteristics.

4.2 Dispenses prescriptions in conjunction with applicable pharmacy law and keeps appropriate records, demonstrating knowledge of-.

4.2.1 current pharmacy law for the state in which he/she is practicing

4.3 Develops policies and procedures to ensure that the correct drug in the correct dosage and dosage form is received by the correct patient at the correct time via the correct route of administration.

4.4 Develops policies and procedures, supervises, and reviews the activities of nonpharmacist personnel under the pharmacist's supervision.

Guidelines 5. The nuclear pharmacist is responsible for the distribution of radiopharmaceuticals, other drugs, and other materials necessary to his/her practice.

5. 1 Complies with all applicable regulations concerning packaging, labeling, and transportation of radioactive and other materials (e.g., biohazards), demonstrating knowledge of-

5.1.1 DOT regulations concerning packaging, labeling, and transportation of radioactive and other materials.

5.1.2 proper procedures and use of equipment necessary to verify that package meet DOT requirements.

Guideline 6. The nuclear pharmacist is responsible for the health and safety of him/herself, coworkers, patients, and the public as related to his/her practice.

General

6.1 Complies with applicable rules and license requirement regulating radiation and radiopharmaceuticals, demonstrating knowledge of:

6.1.1 federal, state, and local rules and regulations governing the transportation, storage, and use of radiopharmaceuticals.

6.1.2 facility license requirements regulating the handling of radiopharmaceuticals.

6.2 Develops radiation protection policies and procedures consistent with the principles of ALARA.

Safety

6.3 Develops policies and procedures to provide a safe working environment with respect to health risks other than radiation (e.g., chemical or biohazard risks), demonstrating knowledge of:

6.3.1 the types of risk involved and accepted techniques for minimizing such risks.

6.3.2 OSHA and CDC standards for providing a safe working environment.

Equipment

6.4 Develops policies and procedures to ensure the proper calibration, maintenance, and use of equipment and maintains appropriate records, demonstrating knowledge of-.

6.4.1 calibration techniques for equipment used in the nuclear pharmacy.

6.4,2 maintenance requirements and resources to provide maintenance unavailable in the pharmacy.

6.4.3 the proper storage and use of equipment used in the nuclear pharmacy.

Sealed Sources

6.5 Develops policies and procedures to ensure proper storage, testing, and use of sealed sources and maintains appropriate records, demonstrating knowledge of:

6.5.1 federal, state, and l@ rules and regulations governing the storage, testing, and use of sealed sources.

Waste

6.6 Develops policies and procedures to ensure proper storage, disposal, and transport of waste material and maintains appropriate records, demonstrating knowledge of:

6.6.1 federal, state, and local rules and regulations governing the storage, disposal, and transport of waste materials.

Misadministration

6.7 Develops policies and procedures concerning investigation of misadministration, implementation of corrective actions, notification of proper authorities, and maintenance of appropriate records,

demonstrating knowledge of:

6.7.1 proper compounding and dispensing procedures, including documentation of prescription orders received and subsequently filled.

6.7.2 federal, state, and local regulations governing misadministration and notification of proper authorities.

Guideline 7. The nuclear pharmacist is responsible for provision of information and consultation related to his/her practice.

7.1 Provides information and consultation on the biological effects of radiation, demonstrating knowledge of:

7.1.1 the biological effects of ionizing radiation, particularly the effects of radiation exposure from radiopharmaceuticals.

7.1.2 stochastic and nonstochastic risks associated with exposure to low-level radiation.

7.1.3 radiation doses to specific organs which results from the administration of radiopharmaceuticals.

7.1.4 methods used to determine/estimate radiation absorbed doses, dose equivalents, and effective dose equivalents.

7.2 Provides information and consultation on radiation physics, demonstrating knowledge of:

7.2.1 half-lives, modes of decay, gamma ray constants, etc., associated with clinically-used radionuclides.

7.2.2 appropriate shielding techniques as well as attenuation coefficients, half-value layers, etc.

7.2.3 radiation protection principles, techniques, and standards (e.g., those issued by NRC, NCRP, ICRP, OSHA, EPA, DOT, or state agencies).

7.2.4 operation, calibration, and quality control of instrumentation used to measure radioactivity and radiation exposure rates.

7.2.5 radioactive and biohazardous waste disposal policies and methods.

7.2.6 the procedures used in response to spills or other accidents involving radioactive material.

7.3 Provides information and consultation on radiopharmaceutical chemistry, demonstrating knowledge of:

7.3.1 general synthetic and radiolabeling methods (e.g., redox reactions, chelation,

radioiodination, template synthesis, etc.) as well as methods for optimizing yield of radiolabeled product.

7.3.2 the physicochemical properties of radiopharmaceuticals (e.g., pH, specific activity, oxidation state, etc.)

7.3.3 factors which affect the stability and shelf-life of reagent kits and radiopharmaceuticals.

7.3.4 (a) the principles of chemical, radiochemical, and radionuclidic purity; (b) details regarding chemical, radiochemical, and radionuclidic contamination of specific radiopharmaceuticals; and (c) analytical methods used to assess the chemical, radiochemical, and radionuclidic purity of radiopharmaceuticals.

7.4 Provides information and consultation on radiopharmaceutical compounding and quality assurance, demonstrating knowledge of-

7.4.1 aseptic technique.

7.4.2 the ingredients/components of reagent kits and radiopharmaceuticals, including the purpose of each.

7.4.3 the principles of pharmaceutical product formulation and drug dosage for design and evaluation.

7.4.4 compounding concepts and techniques required for optimal preparation of radiopharmaceuticals (e.g., minimum/maximum volumes and activities, duration of incubation, pH and temperature considerations, order in which components should be added/mixed, use of appropriate diluents, use of radionuclides with suitable specific activity, etc.)

7.4.5 containers, closures, and other packaging materials used in the compounding of radiopharmaceuticals.

7.4.6 formulation factors that might adversely affect product performance.

7.4.7 the principles and proper techniques for assuring the quality of radiopharmaceuticals.

7.4.8 the significance of quality control procedures and the interpretation of test results as they relate to product performance.

7.5 Provides information and consultation on radiopharmaceutical products, demonstrating knowledge of:

7.5.1 the cost, source, and availability of radiopharmaceuticals, ancillary medications, and related products and services.

7.5.2 specifications and requirements related to placement of product orders.

7.5.3 storage conditions required for radiopharmaceuticals.

7.5.4 physicochemical and kinetic properties, mechanisms of localization, and pharmacologic and/or therapeutic effects (if any) of radiopharmaceuticals and ancillary medications.

7.6 Provides information and consultation on the clinical applications of radiopharmaceuticals, demonstrating knowledge of.

7.6.1 organ systems and pathophysiologic disorders evaluated and/or treated with radiopharmaceuticals.

7.6.2 the role of nuclear medicine in the diagnosis or management of specific disorders (relative to other diagnostic and therapeutic modalities).

7.6.3 factors influencing the selection of a radiopharmaceutical for a specific patient/nuclear medicine procedure (e.g., product performance, kinetics, availability, cost, stability, regulatory status, as well as the patient's health status, cooperativeness, idiosyncrasies, etc.).

7.6.4 factors that affect dosage selection as well as methods used to calculate/determine dosages of radiopharmaceuticals for specific patients.

7.6.5 nuclear medicine procedures used to monitor the safety and efficacy of therapeutic drug regimens or other therapeutic, surgical, or interventional procedures.

7.6.6 proper sequencing when multiple imaging studies (e.g., x-ray, ultrasound, magnetic resonance, nuclear medicine) are required as part of a patient's diagnostic workup.

7.7 Provides information and consultation on pharmacologic interventions used in nuclear medicine and drug interactions involving radiopharmaceuticals, demonstrating knowledge of..

7.7.1 the mechanisms by which selected medications can enhance the utility, safety, or efficacy of specific nuclear medicine procedures.

7.7.2 situations when pharmacologic interventions are clinically indicated.

7.7.3 the mechanisms by which medications can alter the kinetics of radiopharmaceuticals, the biodistribution patterns which result from these altered kinetics, and the clinical significance of the resulting alterations.

7.8 Provides information on the type and incidence of adverse reactions and assists in developing guidelines for the prevention, recognition, treatment, and reporting of adverse reactions to radiopharmaceuticals and pharmacologic interventional drugs (i.e., adenosine, captopril, etc.), demonstrating knowledge of:

7.8.1 the nature and incidence of previously-reported adverse reactions to radiopharmaceuticals and ancillary medications.

7.8.2 mechanisms and symptomatology associated with adverse reactions to medications in general and radiopharmaceuticals specifically.

7.8.3 methods to treat or alleviate adverse drug reactions.

7.8.4 existing adverse reaction reporting systems.

7.9 Analyzes records, and reports information regarding product defects or clinical problems associated with the use of radiopharmaceuticals and ancillary medications, demonstrating knowledge of:

7.9.1 factors that cause product defects and/or clinical problems with radiopharmaceuticals and ancillary medications, and the mechanisms involved.

7.9.2 existing reporting systems which can be used to document product problems and/or clinical problems associated with radiopharmaceuticals and ancillary medications.

7.10 Provides information and consultation on regulations which affect the practice of nuclear pharmacy and nuclear medicine, demonstrating knowledge of.

7.10.1 applicable federal, state, and local regulations and standards related to the receipt, storage, handling, transportation, clinical application and disposal of radioactive materials used in medical and pharmacy practice.

7.10.2 methods which allow nuclear pharmacies and nuclear medicine departments/clinics to comply with pertinent regulations in the most efficient manner.

Guideline 8, The nuclear pharmacist is responsible for provision of pharmaceutical care to patients and for assuring optimal patient outcomes within the scope of his/her practice.

8.1 Assisting in assuring that patients throughout the institutions(s) are appropriately referred to nuclear medicine, i.e., makes recommendations as to when nuclear medicine imaging or therapy is/is not

required for provision of optimal pharmaceuticall care of specific patients, demonstrating knowledge of:

8.1.1 organ systems and pathophysiologic disorders evaluated and/or treated with radiopharmaceuticals and ancillary medications.

8.1 .2 the role of nuclear medicine in the diagnosis or manapement of specific disorders (relative to other diagnostic and therapeutic modalities).

8.1.3 factors influencing the selection of a radiopharmaceutical and ancillary medication for a specific patient/nuclear medicine procedure.

8.1.4 proper sequencing when multiple imaging procedures or modalities are required as part of a patient's diagnostic workup.

8.1.5 the economic ramifications of pharmaceutical care.

8.2 Assists in developing institutional standards for the national use of radiopharmaceuticals and ancillary medications, and conducts drug use evaluations for radiopharmaceuticals and ancillary medications to help determine the extent to which these drugs are being used rationally in the institution, demonstrating knowledge of:

8.2.1 the various patient specific factors which are considered in the selection of radiopharmaceuticals and ancillary medications.

8.2.2 the design and interpretation of drug use evaluations studies.

8.3 Assists in screening patients referred to nuclear medicine in order to prospectively assure that radiopharmaceuticals and ancillary medications are used appropriately and the patient does not experience a drug related problem, demonstrating knowledge of:

8.3.1 rational radiophannaceutical and ancillary medication usage.

8.3.2 factors unique to each special patients population (e.g., degree of patient cooperativeness, organ size and ftinction, overall health status, stage of fetal development, preference of breast feeding vs. formula feeding, etc.) that may affect outcome (performance) parameters of the nuclear medicine procedure (e.g., radiopharmaceutical biodistribution, image quality, dosimetry, therapeutic effect, likelihood of untoward effects, etc.).

8.4 Assists in evaluating the in vivo performance of radiopharmaceuticals and ancillary medications by monitoring patients who receive these drugs, i.e., monitors the safety and efficacy of radiopharmaceutical and ancillary medication usage through patient follow-up and review of images and data obtained from nuclear medicine procedures, demonstrating knowledge of:

8.4.1 normal or expected as well as atypical or unanticipated outcome (performance) parameters (e.g., radiopharmaceutical biodistribution, image quality, dosimetry, therapeutic effect, likelihood of untoward effects, etc.) associated with the clinical use of radiopharmaceuticals and ancillary medications, as well as the interpretation of these parameters.

8.5 Assures that patients are prepared properly for diagnostic and therapeutic nuclear medicine procedures in older to obtain optimal results from the use of radiopharmaceuticals and ancillary medications. Assists with the education of (a) patients who are to receive these drugs and (b) nuclearmedicine personnel who will be administering the radiopharmaceutical and any ancillary medications to the patients, demonstrating knowledge of:

8.5.1 patient preparation requirements and techniques, including (a) patient interview and/or chart review in order to ascertain the patient's medical history and medication usage for the purpose of assessing whether factors exist that may interfere with the outcome of the nuclear medicine procedure and (b) determination of these patients who require bowel cleansing, fasting, hydration, sedation, thyroid blockade, or other preparatory steps to improve the safety or efficacv of the nuclear medicine procedure.

8.5.2 patient education needs, requirements, methods, and aids.

8.5.3 requirements and techniques for the administration of radiopharmaceuticals and ancillary, medications.

8.6 Recognizes and makes appropriate recommendations when interventional (pharmacologic,

physiologic, physical) studies are indicated for the management of specific patients, demonstrating knowledge of:

8.6.1 the mechanisms by which selected interventions can enhance the utility, safety, or efficacy of specific nuclear medicine procedures.

8.6.2 situations when interventions are clinically indicated.

8.7 Prevents or alternatively recognizes, investigates, initiates actions to rectify, and reports clinical problems (e.g., adverse reactions, unanticipated or unusual imaging or therapy results,

misadministrations, medication errors, or other quality assurance failures, etc.) associated with the use of radiopharmaceuticals. Whenever possible, screens patients prior to diagnostic or therapeutic procedure to determine if there are any factors that may interfere with or alter the outcome/results of the procedure, demonstrating knowledge of:

8.7.1 type, incidence, mechanism/cause, and methods for the prediction, recognition, investigation, and reporting of factors that may cause unusual or unanticipated nuclear medicine imaging or therapy results, e.g., (a) imaging artifacts caused by patient motion, urine contamination, imaging with poorly calibrated instruments, improper sequencing of diagnostic tests, etc.; and (b) factors that can alter radiopharmaceutical biodistribution such as radiopharmaceutical formulation problems, drug-radiopharmaceutical interactions, improper route/technique of radiopharmaceutical administration, surgical interventions, dialysis, blood transfusions, radiation therapy, unanticipated or atypical pathophysiologic pathologic conditions beyond those for which the study was originally indicated, etc.

8.7.2 type, incidence, mechanism, and methods for prevention, recognition, investigation, reporting, and correction or treatment of any of the following: adverse reaction, untoward effects, misadministrations, medication errors, and/or other quality assurance failures associated with the clinical use or radiopharmaceuticals and ancillary medications.

8.8 Assists in monitoring the safety and efficacy or outcomes of individual patients' drug regimens, surgical interventions, and other therapeutic measures using imaging modalities and radiometric technology, i.e., makes appropriate recommendations when it is recognized that a specific patient's drug regimen,surgical intervention, or other therapeutic measures can be effectively monitored using techniques available in nuclear medicine, demonstrating knowledge of:

8.8.1 parameters that can and/or 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.

8.8.2 the availability and interpretation of nuclear medicine and radioimmunoassay procedures used to monitor (a) drug efficacy and toxicity and (b) the outcome of various survical interventions or other therapeutic measures.

8.8.3 subtherapeutic, therapeutic, and toxic drug serum concentration ranges.

8.9 Assists with the administration of therapeutic and diagnostic radiopharmaceuticals and ancillary medications and the performance of nuclear medicine procedures, demonstrating knowledge of:

8.9.1 the requirements and techniques for the administration of radiopharmaceuticals and ancillary medications.

8.9.2 technical and procedural aspects involved in performing/completing a nuclear medicine diagnostic study or therapeutic procedure.

8.10 Facilitates the process of assuring that information gained through the use of diagnostic pharmaceuticals is included as an integral component of a patient's therapeutic care plan, demonstrating knowledge of:

8.10.1 methods for the development of a comprehensive and effective therapeutic care plan.

8.10.2 methods for sharing of patient-specific information with other health care providers, e.g., hospital pharmacist, physicians, nurses, etc.

Guideline 9. The nuclear pharmacist is responsible for RESEARCH and DEVELOPMENT as necessary for his/her practice.

9.1 Participates in the design of new radiopharmaceuticals, demonstrating knowledge of:

9.1.1 structure-activity relationships.

9.1.2 pharmacology including localization, metabolism,and excretion.

9.1.3 pharmaceutical chemistry and radiochemistry.

9.2 Participates in the laboratory evaluation of new radiopharmaceuticals or new uses of existing radiopharmaceuticals, demonstrating knowledge of:

9.2.1 experimental design

9.2.2 experimental data collection and analysis.

9.3 Participates in the formulation of new radiopharmaceuticals or the new formulation (e.g., modified preparation or compounding procedures) of existing radiopharmaceuticals, demonstrating knowledge of:

9.3.1 physical and chemical properties of radiopharmaceuticals.

9.3.2 dosage form characteristics.

9.3.3 formulation components (e.g., precursors, realents, target solutions and gases, containers and closures, transfer lines and membrane filters, antioxidants, stabilizing agents, buffers), compounding parameters (e.g., activity, volume), stability, storage, and shelf-life.

9.4 Participates in the quality control testing of new radiopharmaceuticals or the new formulations of existing radiopharmaceuticals, demonstrating knowledge of:

9.4.1 principles of quality control testing.

9.4.2 potential radiochemical, chemical, and pharmaceutical impurities.

9.5 Participates in the clinical trials of new radiopharmaceutic-als or the new formulations of existing radiopharmaceuticals, including the preparation and submission or radiopharmaceutical INDs to FDA and applications to local committees (e.g., IRB), demonstrating knowledge of:

9.5.1 experimental design.

9.5.2 requirements for IND submission.

9.5.3 requirements for local committee (e.g., IRB) approval.

9.5.4 applicable record-keeping requirements.

Key to Acronyms:

ALARA As Low As Reasonably Achieveable

ASHP American Societv of Health-System Pharmacists (formerly the American Society of Hospital Pharmacist)

CDC Center for Disease Control

DOT Department of Transportation

EPA Environmental Protection Agency

FDA Food and Drug Administration

ICRP International Commission on Radiological Protection

IND Investigational New Drug

IRB Institutional Review Board

JCAHO Joint Commission on Accreditation of Healthcare Organizations

NABP National Association of Boards of Pharmacy

NRC Nuclear Regulatory Commission

NCRP National Council on Radiation Protection and Measurements

OSHA Occupational Safety and Health Administration

USP United States Pharmacopeia

USP/NF United States Pharmacopeia/National Formulary

 

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