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A descriptive analysis of drug related problems identified when prescribing the COVID-19 antiviral drug Paxlovid®

Stoiber et al., Research Square, doi:10.21203/rs.3.rs-4973191/v1
Oct 2024  
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Retrospective 140 hospitalized COVID-19 patients in Austria showing that pharmacist review identified a high rate of drug-related problems (DRPs) with paxlovid prescribing, including drug-drug interactions (DDIs) and inappropriate dosing based on renal function. In 87% of cases, pharmacist interventions were required to prevent DRPs.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid1. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid"2.
Use may promote the emergence of variants that weaken host immunity and potentially contribute to long COVID3.
Kamo et al. show significantly increased risk of acute kidney injury. Resistant variants are likely5,6.
Stoiber et al., 17 Oct 2024, retrospective, Austria, preprint, mean age 75.2, 5 authors, study period September 2022 - March 2023.
This PaperPaxlovidAll
A descriptive analysis of drug related problems identified when prescribing the COVID-19 antiviral drug Paxlovid®
Alina Stoiber, Gwen Gray, Gudrun Sailer, Wolfgang Huf, Antonella Tonna
doi:10.21203/rs.3.rs-4973191/v1
Background Paxlovid® is the only licensed oral COVID - 19 antiviral containing nirmatrelvir and ritonavir. Ritonavir is a potent inhibitor of cytochrome P450 enzymes resulting in clinically signi cant drug-drug interactions (DDIs). Aim To describe the frequency, type, and severity of detected drug related problems (DRPs) with Paxlovid® Method This study involved a retrospective, quantitative data analysis. All patients prescribed Paxlovid® in a public hospital in Vienna, were included. Data was collected from the patients' records and recorded on a customised and piloted data collection form. Any DRPs were also noted. The severity of DDIs was classi ed using an established checker tool. Results 122 of 140 (87.1%) patients required interventions to prevent DRPs; 63.6% of cases required intervention by the pharmacist at dispensing. The most common DRPs were DDIs (57.1%). In 24.3% of cases both renal impairment and DDIs were noted. 313 DDIs were recorded in 114 patients; in 24 patients, the interactions recorded were severe. In 3 patients (2.1%), Paxlovid® was prescribed despite being contraindicated due to severe renal impairment requiring pharmacist intervention. Conclusion This study demonstrated that numerous DRPs involving Paxlovid® were identi ed by the pharmacist following prescribing. Pharmacists' involvement in prescribing highly interacting drugs such as Paxlovid® is bene cial to enhance patient safety. Impact on Practice Pharmacist screening for drug related problems at the point of dispensing is likely to increase patient safety and mitigate risk associated with high-risk drugs. The study con rms that a strong focus needs to be placed on reviewing the patients´ renal function and adjusting dosing accordingly both as part of the prescribing and screening processes.
Con ict of Interests The authors declare that they have no con ict of interest. Characteristics Supplementary Files This is a list of supplementary les associated with this preprint. Click to download. Appendices.docx
References
Doogue, Polasek, Drug Dosing in Renal Disease, The Clinical Biochemist Reviews
Hassan, Al-Ramahi, Aziz, Impact of a renal drug dosing service on dose adjustment in hospitalized patients with chronic kidney disease, The Annals of Pharmacotherapy, doi:10.1345/aph.1M187
Hull, Montaner, Ritonavir-boosted protease inhibitors in HIV therapy, Annals of Medicine, doi:10.3109/07853890.2011.572905
Igho-Osagie, Puenpatom, Williams, Prevalence of potential drug-drug interactions with ritonavir-containing COVID-19 therapy, J Manag Care Spec Pharm, doi:10.18553/jmcp.2023.22366
Kieck, Mahalick, Vo, Medication-Related Problems Identi ed and Addressed by Pharmacists Dispensing COVID-19 Antivirals at a Community Pharmacy, Pharmacy, doi:10.3390/pharmacy11030087
Kucukarslan, Peters, Mlynarek, Pharmacists on rounding teams reduce preventable adverse drug events in hospital general medicine units, Arch Intern Med, doi:10.1001/archinte.163.17.2014
Mahase, Covid-19: NICE plans to expand Paxlovid eligibility to 1.4 million more people, BMJ, doi:10.1136/bmj.q59TablesTable1:Characteristicsofpatients
Mchugh, Interrater reliability: the kappa statistic, Biochemia Medica
Portman, Scolese, Facilitating oral COVID-19 therapy utilization through a pharmacy consult service, JAPhA, doi:10.1016/j.japh.2023.04.010
Roblek, Deticek, Leskovar, Clinical-pharmacist intervention reduces clinically relevant drug-drug interactions in patients with heart failure: A randomized, double-blind, controlled trial, International Journal of Cardiology, doi:10.1016/j.ijcard.2015.10.206
Tanne, Covid-19: FDA authorises pharmacists to prescribe Paxlovid, BMJ, doi:10.1136/bmj.o1695
Tasaka, Tanaka, Yasunaga, Potential drug-related problems detected by routine pharmaceutical interventions: safety and economic contributions made by hospital pharmacists in Japan, Journal of Pharmaceutical Health Care and Sciences, doi:10.1186/s40780-018-0125-z
Traynor, Québec authorizes pharmacists to prescribe Paxlovid, American Journal of Health-System Pharmacy, doi:10.1093/ajhp/zxac163
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Ritonavir is a potent inhibitor of cytochrome P450 enzymes resulting in clinically ' 'significant drug-drug interactions (DDIs).\n' '<bold>Aim</bold>\n' 'To describe the frequency, type, and severity of detected drug related problems (DRPs) with ' 'Paxlovid®\n' '<bold>Method</bold>\n' 'This study involved a retrospective, quantitative data analysis. All patients prescribed ' 'Paxlovid® in a public hospital in Vienna, were included. Data was collected from the ' 'patients’ records and recorded on a customised and piloted data collection form. Any DRPs ' 'were also noted. The severity of DDIs was classified using an established checker tool.\n' '<bold>Results</bold>\n' '122 of 140 (87.1%) patients required interventions to prevent DRPs; 63.6% of cases required ' 'intervention by the pharmacist at dispensing. The most common DRPs were DDIs (57.1%). In ' '24.3% of cases both renal impairment and DDIs were noted. 313 DDIs were recorded in 114 ' 'patients; in 24 patients, the interactions recorded were severe. In 3 patients (2.1%), ' 'Paxlovid® was prescribed despite being contraindicated due to severe renal impairment ' 'requiring pharmacist intervention.\n' '<bold>Conclusion</bold>\n' 'This study demonstrated that numerous DRPs involving Paxlovid® were identified by the ' 'pharmacist following prescribing. 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