In 2004, The Joint Commission (TJC) expanded the definition of medications to include radiopharmaceuticals. Since then, accreditation agencies categorize them as legend drugs subject to medication management standards.
Since radiopharmaceuticals are radioactive, nuclear medicine departments have historically managed their use by complying with Nuclear Regulatory Commission (NRC) regulations. However, as legend drugs, accreditation agencies denote that the director of pharmacy has oversight responsibility for their use based on medication management standards. A key element in managing medications is the hospital formulary.
Has your Pharmacy and Therapeutics (P&T) committee, or similar review board, approved the use of radiopharmaceuticals used in your hospital? Are they included on formulary?
The Cardinal Health compliance resource library can help with your collaborative efforts to ensure that your facility uses FDA-approved radiopharmaceuticals and that they are included on formulary.
Ensure patient safety
- One of the first steps to help ensure patient safety is to use FDA-approved radiopharmaceuticals.
- Using a licensed nuclear pharmacy does not always guarantee the use of FDA-approved radiopharmaceuticals.
- If your nuclear medicine department uses radiopharmaceuticals that originate from sources other than the approved manufacturer(s) they may be administering unapproved copies of commercially available FDA-approved drugs.