Pharmacist Expertise Is Critical to Combating Financial Toxicity for Patients With C difficile Infection
Pharmacists can also ensure proper education and selection of therapy before and after discharge.
Clostridioides difficile infection (CDI) has been identified as an urgent threat in the United States and is a common health care–associated infection.1 A patient with an initial episode of CDI has as much as a 25% chance of recurrent infection, whereas patients with multiply recurrent CDI (mrCDI) have an estimated 40% to 65% risk of recurrence.2 Moreover, mrCDI has a severe impact on patient quality of life, including mental and physical health.3
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New therapies have been recently approved by the FDA for the prevention of mrCDI, giving providers and patients more options. This also expands opportunities for pharmacists to serve an important role in transitions of care and patient follow-up. Pharmacists can offer education and insight into therapy selection, as well as access to solutions for improving patient care.
Pharmacist Impact in Transitions of Care
Transitions of care has been commonly identified as an area where pharmacists have significant impact. In a study by Rudawski and Patel, pharmacists were shown to significantly reduce hospital readmissions and improve patient satisfaction in transitions of care by offering education, medication reconciliation, and affordability review.4 In this study, interventions frequently included checking formulary coverage, savings programs, and ability to pay for medication prior to discharge.4
C difficile is a disease state that requires significant attention to transitions of care. Multidisciplinary teams are needed to improve patient-centered treatment and outcomes.5 In the infectious disease (ID) clinic at University of Illinois Chicago College of Pharmacy, our primary role is to provide medication counseling to patients and to address patient-specific barriers related to medication access.
Pharmacists have the knowledge and skills to address barriers to access. Implementing pharmacist evaluation of CDI discharge prescriptions at transitions of care could be helpful in ensuring patients can obtain and complete medications that were initiated in the inpatient setting. Patients unable to pick up a remaining prescription due to cost barriers may be at increased risk of recurrence due to incomplete treatment.
Additionally, prior authorizations may be necessary for some CDI therapies, depending on the insurance formulary. For some medications, patient assistance programs, including co-pay assistance, may be an option to aid in reducing cost burdens.
Financial Toxicity for Patients With CDI
Therapies for CDI can be highly expensive, and cost can pose a frequent barrier to patients receiving antibiotics, even for those medications generally regarded as inexpensive, such as oral vancomycin (Vancocin; ANI Pharmaceuticals).6 In our experience, some patients attempt multiple courses of vancomycin before obtaining fidaxomicin (Dificid; Merck) due to cost barriers. Although fidaxomicin is preferred to vancomycin in the 2021 Infectious Diseases Society of America CDI guidelines, the cost had prevented patients from attempting this therapy until they were desperate for a cure.7
A recent poster by Khaja et al examined the costs of first-line fidaxomicin at a single Veterans Affairs medical center and reported an average cost of $2400 for a 10-day fidaxomicin course.8 In this study, the inability to afford fidaxomicin was documented in 30% of patients as a reason for not completing therapy.8 Despite better efficacy in preventing recurrent infection, fidaxomicin continues to have cost barriers for patients, and prescribing patterns reflect this limitation in its use. Pharmacists can play a critical role in identifying cost-saving avenues and ensuring patients are able to access and complete their regimens.
Furthermore, cost-based restrictions on use are not limited solely to fidaxomicin; challenges exist with bezlotoxumab (Zinplava; Merck) and live biotherapeutic products as well. Pharmacists can aid in the identification of coverage status and prior authorization or assistance program enrollment for these medicines. The pharmacist can serve as a liaison between the ID clinicians, patients, and insurance companies to coordinate the approval and delivery of prescribed therapies.
Pharmacists’ Role in Education
Finally, pharmacists can play a critical role in educating providers and patients in the inpatient and outpatient settings. As medication experts,pharmacists can provide up-to-date information onthe rapidly changing CDI treatment and preventionlandscape to patients and other members ofthe patient care team. When treatment is discussedwith patients, education should also includepotential adverse effects, dosing instructions andexpectations, importance of adherence, and signs and symptoms of recurrence. Specifically, the use of taper and pulse regimens for the treatment of mrCDI can be particularly challenging, and patients may benefit from one-on-one education to explain the regimen.
However, the benefit of pharmacist involvement in patient counseling and education has been demonstrated for a variety of disease states, but there have been limited studies on this subject specifically for CDI.9,10 Regardless of the limited research available, we believe that this education should occur and may be performed by a pharmacist, which is based on our work in an ID clinic. Further research on this subject would be valuable to demonstrate the impact of the pharmacist in patient counseling and education for patients with CDI.
The arrival of new therapies for mrCDI heralds an exciting era in treating this debilitating disease. This presents an opportunity for pharmacists to aid in the education and the acquisition of a variety of unique therapies. In transitions of care, pharmacists can proactively address cost barriers to patients to ensure no interruptions in care. Overall, pharmacists serve a vital role in the management of initial CDI and mrCDI.
References
1. Clostridioides difficile infection (CDI) tracking. CDC. Updated February 24, 2022. Accessed November 13, 2023. https://www.cdc.gov/hai/eip/cdiff-tracking.html#:~:text=Clostridioides%20difficile%20infection%20(CDI)%20is,infections%20in%20the%20United%20States
2. Tsigrelis C. Recurrent Clostridioides difficile infection: recognition, management, prevention. Cleve Clin J Med. 2020;87(6):347-359. doi:10.3949/ccjm.87gr.20001
3. Garey KW, Jo J, Gonzales-Luna AJ, et al. Assessment of quality of life among patients with recurrent Clostridioides difficile infection treated with investigational oral microbiome therapeutic SER-109: secondary analysis of a randomized clinical trial. JAMA Netw Open. 2023;6(1):e2253570. doi:10.1001/jamanetworkopen.2022.53570
4. Rudawsky N, Patel HU. Impact of a transition of care pharmacist in a community hospital discharge model. J Healthc Qual. 2022;44(6):347-353. doi:10.1097/JHQ.0000000000000348
5. Khanna S, Lett J, Lattimer C, Tillotson G. Transitions of care in Clostridioides difficile infection: a need of the hour. Therap Adv Gastroenterol. 2022;15:17562848221078684. doi:10.1177/17562848221078684
6. Bunnell KL, Danziger LH, Johnson S. Economic barriers in the treatment of Clostridium difficile infection with oral vancomycin. Open Forum Infect Dis. 2017;4(2):ofx078. doi:10.1093/ofid/ofx078
7. Johnson S, Lavergne V, Skinner AM, et al. Clinical practice guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 focused update guidelines on management of Clostridioides difficile infection in adults. Clin Infect Dis. 2021;73(5):e1029-e1044. doi:10.1093/cid/ciab549
8. Khaja SF, Kuhn R, Ali S, Natesan SK. 2257. Cost-benefit analysis of fidaxomicin (FDX) as first line treatment for initial episode of Clostridioides difficile infection (CDI) during the COVID-19 pandemic: a quality control/improvement (QC/QI) project at a tertiary care Veterans Affairs medical center (VAMC) over a 4-year period. Open Forum Infect Dis. 2023;10(suppl 2):ofad500.1879. doi:10.1093/ofid/ofad500.1879
9. Ciminelli AM, Dupuis R, Williams D, et al. Patient education role of a pharmacist on a transplant service. Am J Health Syst Pharm. 2000;57(8):767-768. doi:10.1093/ajhp/57.8.767
10. Peveler R, George C, Kinmonth AL, Campbell M, Thompson C. Effect of antidepressant drug counselling and information leaflets on adherence to drug treatment in primary care: randomised controlled trial. BMJ. 1999;319(7210):612-615. doi:10.1136/bmj.319.7210.612
About the Authors
Aaron Hunt, PharmD, BCPS, is an infectious diseases fellow at University of Illinois Chicago College of Pharmacy.
Emily Drwiega, PharmD, BCIDP, BCPS, AAHIVP, is a visiting clinical assistant professor of pharmacy practice and a clinical pharmacist, infectious diseases/HIV at University of Illinois Chicago College of Pharmacy.
