Preparation and administration of androgen deprivation therapy products: Retrospective survey results

Abstract

Leuprolide acetate (LA) is a gonadotropin-releasing hormone agonist used as androgen deprivation therapy for advanced prostate cancer. LA is available in formulations intended for intramuscular (IM-LA) or subcutaneous (SC-LA) administration. Post-marketing reports have noted handling errors associated with the preparation and administration of SC-LA. This study gathered real-world evidence on administration and management of IM-LA and SC-LA in large, urology- or oncology-based practices. Over 200 staff were invited; 151 participated in an online survey. Main outcomes were time for each step of the ordering, inventory, mixing and administration processes. Mean values and standard errors are reported for continuous variables, and frequency and percentage are reported for categorical variables. Comparisons between groups were made with t tests and chi-square tests as appropriate. For IM-LA and SC-LA, ease of ordering and time to place an order (10.8 ± 1.3 vs. 10.6 ± 1.4 min, respectively) were similar. IM-LA was associated with a shorter time to complete preparation (2.5 ± 0.2 vs. 6.1 ± 0.6 min, P < 0.001) compared with SC-LA. This difference of 3.6 min per preparation could result in substantial time savings annually ranging from 120 h per year to 240 h per year in clinical practices administering 2000 injections per year or 4000 injections per year, respectively. For IM-LA vs. SC-LA, greater ease of preparation was reported by 64% vs. 43% of respondents, respectively. Over 15% of respondents used injection sites inconsistent with prescribing information, regardless of the type of injection. This study found that it takes a significantly shorter time to prepare and administer IM-LA than SC-LA in large urology- and oncology-based practices. The time saved could be utilized for other tasks such as seeing additional patients. Use of injection sites inconsistent with prescribing information suggests a need for more training of nursing staff in the proper administration of these drugs to ensure adequate testosterone suppression and patient safety.