Case Study in Radiopharmaceutical Use


November 2012 - Vol.9 No. 11 - Page #90

At Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, the nuclear pharmacy is part of the molecular imaging and therapy services/radiology department, which in turn falls under the auspices of nuclear medicine. The processes of nuclear pharmacy are governed by an authorized nuclear pharmacist (ANP) as defined by the United States Nuclear Regulatory Commission (NRC) (see Figure 1). To be certified as a nuclear pharmacist, a state registered pharmacist takes part in a structured program comprising additional education, examination, and training or experience in nuclear pharmacy practices equaling or exceeding 4,000 hours.

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At MSKCC, the selection and use of specific radiopharmaceuticals are reviewed by authorized nuclear physicians, along with the coordinating ANP. Likewise, most radiopharmaceuticals gain approved use status via a collaborative group, such as the committee on radiation (COR), the radioactive drug research committee (RDRC), the institutional review board, or the research council. These groups are also responsible for risk quality assurance and quality control measures. Product approval is based on how much of a radioactive drug should be given per radiation dose, exposure, and absorption in the body. These factors are broken down as follows:

  • Effective Dose Equivalent (EDE)—The sum of the products of the dose equivalent to the organ or tissue and the weighting factors applicable to each of the body organs or tissues that are irradiated
  • External Dose—That portion of the dose equivalent received from radiation sources outside the body
  • Eye Dose Equivalent (LDE)—The external exposure of the lens of the eye taken as the dose equivalent at a tissue depth of 0.3 cm

(All doses are calculated based on body surface area, which is especially important in pediatric patients.)

Functions of the Reviewing Committee
Establishing and formalizing governing guidelines for committees that regulate radiopharmaceutical-related activities is an important aspect of nuclear medicine.

All activities are performed under a radioactive material (RAM) license issued by the COR/RDRC agencies. These committees must:

  1. Be familiar with all pertinent NRC regulations
  2. Review the training and experience of proposed authorized users and the radiation safety officer (RSO) to determine whether their qualifications are sufficient to enable them to perform their duties safely, and in accordance with regulations and licensure
  3. Review, on the basis of safety, and approve or deny, consistent with the limitations of regulations and licenses, all requests for authorization to use radioactive materials within the institution
  4. Review the RSO’s periodic summary report on the occupational radiation exposure records for all personnel
  5. Review programs to ensure that all employees whose duties may require them to work in, or frequent, areas where radioactive materials are used (eg, security, housekeeping, physical plant staff) are appropriately instructed as required by NRC regulations
  6. Review, at a minimum annually, the RSO’s report on the radiation safety program to determine whether activities are being conducted safely and in accordance with NRC regulations and the conditions of the license
  7. Recommend remedial action to correct deficiencies identified in the radiation safety program
  8. Maintain written minutes of all committee meetings

Exposure Protection
To protect staff and patients from radiation, the goal is to limit exposure through the principle of limiting radiation exposure to as low as reasonably achievable (ALARA) when scheduling staff. Sharing the radiation burden to limit the exposure of each employee handing these materials is key.  
When working with radioactive, volatile substances, such as I-131 liquid, proper handling is paramount. The hood must be monitored, and thus a computer system measures the derived air concentration, ie, the concentration of a given radionuclide in the air. Derived air concentration is monitored by the department of environmental control, and periodic bioassays of the thyroid are performed on all staff handling volatile substances.

Radioactive Waste Disposal Policies
Each authorized user is responsible for the secure and safe storage of radioactive waste generated. Radioactive waste must always be handled by the radiation safety department in a facility. This waste must be categorized, segregated, and shielded in waste bins according to the energy and decay time half-life of the product. The NRC requires that all licensees maintain written records of the disposal of radioactive waste, and in order to meet these requirements individual users and principal investigators are required to complete and retain records. Based on these records, the radiation safety department generates a summary of the following information:

  • Names of isotopes and quantities on hand (mCi)
  • Activities (mCi) of waste
  • Activities disposed 

The radiation safety department compiles the appropriate records and regularly presents this data to the NRC, state, or department of health radiological division.

To view NRC’s Backgrounder on Radioactive Waste, go to
http://www.nrc.gov/reading-rm/doc-collections/fact-sheets/radwaste.html .


Rashid Ghani, PharmD, MBA-MIM, ANP, is the clinical coordinator of nuclear pharmacy in the molecular imaging & therapy services-radiology nuclear medicine department at Memorial Sloan-Kettering Cancer Center in New York City.

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