In this letter to the editor, we report 82 persons with CF (PwCF) self‐reported changes in mental and physical health and potential attribution with either the COVID‐19 pandemic and the initiation elexacaftor/tezacaftor/ivacaftor (ETI). Emerging evidence has shown an association with ETI and mental health adverse events. The close proximity of ETI FDA approval and prescribing in PwCF and the COVID‐19 pandemic present a challenge in determining the cause of mental health decline. We report 33 (40%) of respondents felt that COVID‐19 contributed to a worsening of either their anxiety, depression, or both and 7 (9%) of respondents felt that ETI contributed to a worsening in their anxiety, depression, or both. Eighteen (23%) of respondents felt that ETI had contributed to improvement their mental health. This letter highlights multiple factors that could be impacting mental health beyond ETI. As the COVID‐19 pandemic is moving toward an endemic phase, future studies may have more success in deciphering ETI effects on mental health.
Background: Cystic fibrosis (CF) patients who grow Pseudomonas aeruginosa on respiratory culture are commonly prescribed inhaled tobramycin (TIS) to eradicate the organism. The objective of this study was to determine the impact of a pharmacy technician/pharmacist team, in conjunction with an integrated health-system specialty pharmacy (IHSSP), on the time from positive culture to prescribing and access to TIS in a pediatric CF clinic.Methods: A retrospective study of CF patients positive for P. aeruginosa who were prescribed TIS for eradication.
Results:The study included 20 patients in the pregroup and 42 patients in the postgroup. Total median (interquartile range) days from positive culture to TIS being shipped to the patient from the pharmacy was significantly different: 15 (10. days in the pregroup and 9 (7-14) days in the post groups (p = .005). The time from positive culture to TIS prescribing was significantly different: 6 (5-12.75) days in the pregroup and 5 (3.75-6) days in the postgroup (p = .01). In the postgroup median time from prescription to the patient receiving the TIS was significantly different between the two groups 2 (2-5) days IHSSP group versus 6 (3-9) external specialty pharmacy group (p = .003). Time from prescription to prior authorization approval was the same in both groups.Conclusions: The addition of the pharmacy team reduced time from culture to TIS being received by the patient. Patients able to fill at the IHSSP received their medication sooner than an external specialty pharmacy. The study shows the benefit of an integrated pharmacy model in conjunction with an IHSSP.
While our survey showed that PwCF felt that the COVID-19 pandemic had
impacted their mental health more than ETI therapy, around 9% of survey
responders felt that ETI did cause an increase in either anxiety or
depression. This finding was similar to the numbers Spoletini and
colleagues found in their adult clinic. They also found that a dose
reduction of ETI improved or resolved mental health adverse events for
most patients. [2] A recently published study by Guimbellot and
colleagues studied ivacaftor levels in PwCF who were on ivacaftor
monotherapy and showed many patients had levels higher than the
published minimum effective concentrations.[6] Thus, there may be a
correlation between ETI levels and mental health adverse events that
should be further explored in a prospective manner.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.