Before 2004, radiopharmaceuticals weren’t considered part of the hospital pharmacy’s domain. Traditionally, these products were handled by the nuclear pharmacy department, and all policies and procedures regarding radiopharmaceuticals were dictated as such.
But when The Joint Commission (TJC) reclassified them as medication, it placed responsibility in the realm of hospital pharmacy management. A recent article in Pharmacy Practice News looked at the oversight required by the hospital pharmacy.
Under the United States Pharmacopeia (USP) chapters <797> and <795> as well as other accreditation standards, radiopharmaceuticals must now be handled using the same systems, protocols and procedures as other medications to ensure quality and safety. Note, however, that radiopharmaceuticals are not stored in automated dispensing cabinets such as those provided by Omnicell.
Because of their radioactivity, hospitals are required to have policies in place that are both robust enough to manage radiopharmaceutical use and in line with hospital-wide medication standards.
Radiopharmaceutical management presents a number of unique challenges. Because these medications have abbreviated half-lives of approximately six hours, they must be delivered each day and prepared near the point of use for every patient. In addition to this particular requirement, radiopharmaceuticals must also be compliant with radiation exposure regulations, further affecting the way they are handled.
Addressing Safety Concerns
The first step in handling safety concerns regarding nuclear medicine is to use only FDA-approved radiopharmaceuticals, as this helps ensure patient well-being. There are currently 47 FDA-approved radiopharmaceuticals on the market.
The hospital should have in place a policy that allows a courier to gain entrance to the nuclear department, transfer and store the drugs. But using a licensed nuclear pharmacy does not always go hand in hand with FDA-approved products, so keep in mind that extra diligence and precaution may be needed. Maintaining an updated list of radiopharmaceuticals verified by the agency can be helpful in being aware of knockoff products.
A Detailed Formulary
Due to the recent re-categorization of radiopharmaceuticals, few healthcare institutions have included these products on their formulary. However, this is a key step in the safety process surrounding nuclear medicine. As legend drugs, accreditation agencies hold that the director of pharmacy has oversight authority for radiopharmaceutical use based on medication management standards.
In addition to updating the formulary to accurately reflect the pharmacy’s stock, it should be reviewed regularly by pharmacy directors as well. Keeping pharmacy staff up to date concerning medication use protocols is another essential element of radiopharmaceutical management and safety.
Radiopharmaceuticals necessitate specific protocols for preparation, storage and use. It’s critical that both pharmacy and nursing are involved in review of the protocol process, and that any protocol is first approved by a medical staff committee. For a diplomatic approach, a pharmacy liaison can be appointed to the nuclear medicine department to further boost inclusion and to ensure drug use protocols are properly reviewed.
What strategies have you found effective in managing radiopharmaceuticals? Leave a comment below to share your ideas.