Nuclear pharmacy compounding's impact on healthcare delivery

Objectives Nuclear Medicine clinicians are often uninformed about compounding in nuclear pharmacy. This "is a legal and accepted method of preparing customized medications, including radiopharmaceuticals, to meet unique physician identified patient needs," and fill supply gaps during times of product shortage.

Methods "Nuclear pharmacy compounding can be adding a radioactive liquid to a commercially available reagent kit, or the creation of a multi-component reagent kit or the synthesis of a radiolabeled compound via a multi-step preparation process. Compounding is different from manufacturing, which is guided by current good manufacturing practices (CGMP’s) [see United States Pharmacopeia (USP) <1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients (USPCI 1999i)] (2)." "Some of the characteristics or criteria that differentiate compounding from manufacturing include the existence of specific practitioner-patient-pharmacist relationships; the quantity of medication prepared in anticipation of receiving a valid prescription or prescription order; and the conditions of sale, which are limited to specific prescription orders."

Results Occasionally, a customized dose for a diagnostic test or treatment is needed. For example, a “physician may prescribe I-131 for treating thyroid cancer in a patient who requires a very small capsule to facilitate swallowing. A nuclear pharmacist can compound…” a small concentrated capsule to accommodate the needs of this patient. Recently, nuclear medicine departments have faced the challenge of keeping patient services available during severe isotope shortages. Nuclear pharmacists have bridged supply gaps by “…compounding radiopharmaceuticals from alternate isotope suppliers and making them available at the point of use.”

Conclusions Clinicians should be aware that this practice is an alternative for them to tailor services to patients and keep services available during times of chronic product shortages.

Research Support The Benefits of Nuclear Pharmacy Compounding. United Pharmacy Partners. Nuclear Compounding Guidelines. Radiopharmaceuticals in Nuclear Pharmacy and Nuclear Medicine