RESUMEN
Background: The balance between reducing patient wait time and mitigating waste of parenteral products has not been well described in literature. Objective: Evaluate the patient wait times and cost-effectiveness of employing a premix versus an on-demand workflow model for compounding parenteral admixtures in a hematology/oncology infusion setting. Methods: This single center, retrospective cost analysis compiled manually documented monthly waste reports and estimated drug pricing for the institution to calculate the cost of waste during both premix and on-demand compounding workflows. Time to administration was audited for one week with both models. Results: Over a period of 28.5 months following the premix model, 564 products were documented as wasted ($1,196,014.01 in estimated drug purchasing cost). Over a period of 3 months following the on-demand model, 12 products were wasted ($34,823.98 in estimated drug purchasing cost). Switching models reduced the monthly average number of wasted products from 20 to 4 per month; the average cost of waste was reduced from $41,965.40 to $11,607.99 per month (P < .0001). Overall patient wait time from clearance until administration, excluding any recommended wait times after premedication administration (if applicable), was similar in both models: an average of 38.26 minutes in the premix model and 40.97 minutes in the on-demand model. Conclusion: Premixing parenteral admixtures was not cost effective at our institution. After resuming an on-demand compounding model, the monthly cost of waste (based on drug pricing alone) was reduced by over 70%. The wait time from clearance to treatment administration was similar in both models.
RESUMEN
OBJECTIVE: To report a case of a woman who continued erenumab for migraine prophylaxis throughout her pregnancy and to review the literature for pregnancy safety data for the calcitonin gene-related peptide (CGRP) receptor and ligand-directed therapies currently approved for migraine prophylaxis in the United States. BACKGROUND: Migraine is a common headache disorder that can be significantly disabling. Many people experiencing migraine seek out preventative therapies to improve their quality of life. Unfortunately, currently approved prophylactic agents may not be safe to use during pregnancy, potentially limiting the use of these agents in women of childbearing potential. As the newest class of prophylactic agents for migraine, CGRP agents have limited pregnancy safety data in humans. METHODS: A review of the literature was conducted through the PubMed database using the terms pregnancy and either erenumab, fremanezumab, galcanezumab, eptinezumab, rimegepant, or atogepant. Additional sources of information such as prescribing information, assessment reports submitted to the European Medicines Agency (EMA), and manufacturer data were sought. RESULTS: One case report was found in the literature documenting a human pregnancy with no adverse effects in the baby after exposure to erenumab. However, the last dose was administered in the second week of pregnancy and discontinued thereafter. The evaluation of 92 safety reports describing maternal exposure prior to or during pregnancy to either erenumab, galcanezumab, or fremanezumab was located. Incidence of miscarriage and congenital anomalies appear to be similar to rates in the general population. CONCLUSIONS: The use of erenumab during pregnancy in our patient resulted in no known harm to the child. This case is unique in that the mother continued to receive erenumab throughout the pregnancy. Safety data is lacking regarding the use of these agents during pregnancy, despite their frequent use in women of childbearing potential.