Pub Date : 2026-02-23DOI: 10.1016/j.clinthera.2026.01.014
Wei Wang, Jun Guo, Bo Chen, Zhijian Lan, Yongjin Fang
Purpose: To assess the effect of etomidate injection on succinylcholine-induced fasciculations through a randomized controlled trial.
Methods: Intravenous succinylcholine (2 mg/kg) was administered to 100 adult patients undergoing elective vocal cord surgery, with allocation to two groups: immediate group, where succinylcholine was administered immediately, and delayed group, where succinylcholine was administered 15 sec after injection of etomidate 0.2 mg/kg. The two groups were compared in terms of the severity and duration of muscle fasciculation caused by succinylcholine and the incidence of postoperative myalgia.
Findings: The severity of fasciculations graded on a 4-point scale was considered the primary outcome. Compared with the delayed group, the immediate group exhibited substantially reduced fasciculation severity scores (P = 0.005). A lower incidence of postoperative myalgia was observed in the immediate group than in the delayed group (P = 0.031). Furthermore, in the delayed group, the heart rate after intervention decreased more significantly (P = 0.014). No differences in other adverse effects were observed.
Implications: The severity of succinylcholine-induced fasciculations and the incidence of postoperative myalgia were significantly reduced without adversely affecting intubation conditions or hemodynamics by injecting a 0.2 mg/kg dose of etomidate immediately before administering 2 mg/kg succinylcholine.
{"title":"Effects of Etomidate Injection on Succinylcholine-Induced Fasciculation.","authors":"Wei Wang, Jun Guo, Bo Chen, Zhijian Lan, Yongjin Fang","doi":"10.1016/j.clinthera.2026.01.014","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.01.014","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the effect of etomidate injection on succinylcholine-induced fasciculations through a randomized controlled trial.</p><p><strong>Methods: </strong>Intravenous succinylcholine (2 mg/kg) was administered to 100 adult patients undergoing elective vocal cord surgery, with allocation to two groups: immediate group, where succinylcholine was administered immediately, and delayed group, where succinylcholine was administered 15 sec after injection of etomidate 0.2 mg/kg. The two groups were compared in terms of the severity and duration of muscle fasciculation caused by succinylcholine and the incidence of postoperative myalgia.</p><p><strong>Findings: </strong>The severity of fasciculations graded on a 4-point scale was considered the primary outcome. Compared with the delayed group, the immediate group exhibited substantially reduced fasciculation severity scores (P = 0.005). A lower incidence of postoperative myalgia was observed in the immediate group than in the delayed group (P = 0.031). Furthermore, in the delayed group, the heart rate after intervention decreased more significantly (P = 0.014). No differences in other adverse effects were observed.</p><p><strong>Implications: </strong>The severity of succinylcholine-induced fasciculations and the incidence of postoperative myalgia were significantly reduced without adversely affecting intubation conditions or hemodynamics by injecting a 0.2 mg/kg dose of etomidate immediately before administering 2 mg/kg succinylcholine.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147282691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-14DOI: 10.1016/j.clinthera.2026.01.008
Yi Cai
{"title":"Letter to the Editor: Commending the Feasibility of CYP2C19 Pharmacogenetic Testing in Personalized Antiplatelet Therapy-Insights and Perspectives.","authors":"Yi Cai","doi":"10.1016/j.clinthera.2026.01.008","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.01.008","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146200472","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-03DOI: 10.1016/j.clinthera.2026.01.002
Mona M Makhamreh, Stephanie M Rice, Kavya Shivashankar, Casey J Brewer, Rodney A McLaren, Seth I Berger, Huda B Al-Kouatly
Purpose: Hereditary anemias are a cause of nonimmune hydrops fetalis (NIHF). Our objective was to review the spectrum of hereditary anemia genes in NIHF diagnosed by exome sequencing (ES).
Methods: We performed a systematic review of ES studies in NIHF from January 1, 2000 to August 1, 2024 with emphasis on genes causing fetal anemia as a primary phenotype.
Findings: Forty-one ES studies with 207 genetically diagnosed NIHF cases met our inclusion criteria; 6 cases within 6 studies involved NIHF and hereditary anemia. Among the six cases, five had definitive diagnosis or likely diagnosis supported by pathogenic or likely pathogenic variants, while one case harbored only variants of uncertain significance and was classified as a possible diagnosis. The six different hereditary anemia genes included SEC23B, SPTA1, KLF1, RPL11, UNC13D, and RFWD3.
Implications: Overall, ES confirmed the etiology of hereditary anemia in 2.4% (5/207) of genetically diagnosed NIHF cases. Hereditary anemias, therefore, represent a distinct and clinically relevant subset of ES-diagnosed NIHF cases. ES should be considered first line in fetuses with NIHF, as common non-genetic causes such as fetomaternal hemorrhage, infectious etiologies, and alloimmunization are excluded. It is also indicated when fetal anemia is suspected, particularly in the setting of elevated MCA Dopplers with a negative evaluation for common hemoglobinopathies and nongenetic etiologies.
{"title":"Hereditary Anemias as a Monogenic Etiology for Nonimmune Hydrops Fetalis.","authors":"Mona M Makhamreh, Stephanie M Rice, Kavya Shivashankar, Casey J Brewer, Rodney A McLaren, Seth I Berger, Huda B Al-Kouatly","doi":"10.1016/j.clinthera.2026.01.002","DOIUrl":"https://doi.org/10.1016/j.clinthera.2026.01.002","url":null,"abstract":"<p><strong>Purpose: </strong>Hereditary anemias are a cause of nonimmune hydrops fetalis (NIHF). Our objective was to review the spectrum of hereditary anemia genes in NIHF diagnosed by exome sequencing (ES).</p><p><strong>Methods: </strong>We performed a systematic review of ES studies in NIHF from January 1, 2000 to August 1, 2024 with emphasis on genes causing fetal anemia as a primary phenotype.</p><p><strong>Findings: </strong>Forty-one ES studies with 207 genetically diagnosed NIHF cases met our inclusion criteria; 6 cases within 6 studies involved NIHF and hereditary anemia. Among the six cases, five had definitive diagnosis or likely diagnosis supported by pathogenic or likely pathogenic variants, while one case harbored only variants of uncertain significance and was classified as a possible diagnosis. The six different hereditary anemia genes included SEC23B, SPTA1, KLF1, RPL11, UNC13D, and RFWD3.</p><p><strong>Implications: </strong>Overall, ES confirmed the etiology of hereditary anemia in 2.4% (5/207) of genetically diagnosed NIHF cases. Hereditary anemias, therefore, represent a distinct and clinically relevant subset of ES-diagnosed NIHF cases. ES should be considered first line in fetuses with NIHF, as common non-genetic causes such as fetomaternal hemorrhage, infectious etiologies, and alloimmunization are excluded. It is also indicated when fetal anemia is suspected, particularly in the setting of elevated MCA Dopplers with a negative evaluation for common hemoglobinopathies and nongenetic etiologies.</p>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2026-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146118174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-26DOI: 10.1016/j.clinthera.2025.12.003
Rania Abdel-latif PhD , Wadha Al Muftah MD , Shaban Mohammed MD , Toka AlHsson BPharmSc , Daoud Al-Badriyeh PhD , Radja Badji PhD , Awad Al-Qahtani MD , Abdul Rahman Arabi MD , Said Ismail PhD , Moza Al Hail BPharmSc , Jassim Al Suwaidi MD
Purpose
CYP2C19 loss-of-function (LoF) alleles are associated with increased cardiovascular risk in clopidogrel-treated percutaneous coronary intervention (PCI) patients. Despite the guidelines recommendation for newer P2Y12 inhibitors, clopidogrel remains widely prescribed. The study the potential impact and feasibility of implementing pharmacogenetics (PGx) testing to guide antiplatelet therapy and develop strategies for its clinical integration to improve patient management.
Methods
A pilot study following a prospective cohort design was conducted within the largest community healthcare provider in Qatar using point-of-care (POC) CYP2C19 genotyping in tailoring antiplatelet therapy for PCI patients. Eligible patients underwent CYP2C19 genotyping, and P2Y12 inhibitor prescriptions were adjusted based on genetic results. The study measured antiplatelet prescribing patterns and identified clinically significant gene-drug interactions.
Findings
Out of 376 patients tested, 283 patients received PGx-guided recommendations for anti-platelet therapy. Actionable CYP2C19 alleles were detected in 22% of those patients, prompting a change in drug therapy. PGx-guided recommendations were adopted at a rate of 80%, and CYP2C19 genotyping was a significant predictor of antiplatelet therapy adjustments. A sub-analysis of the cost impact revealed an estimated reduction of 300 QR (82.41 $) per patient annually for ACS patients who underwent PCI with stent placement.
Implications
This real-world study highlights the feasibility and clinical impact of CYP2C19 genotyping in guiding antiplatelet therapy for ACS and PCI patients, supporting broader PGx testing implementation in routine cardiovascular care.
{"title":"Implementing CYP2C19 Pharmacogenetic Testing for Personalized Antiplatelet Therapy: Findings From the QPGx-CARES Initiative","authors":"Rania Abdel-latif PhD , Wadha Al Muftah MD , Shaban Mohammed MD , Toka AlHsson BPharmSc , Daoud Al-Badriyeh PhD , Radja Badji PhD , Awad Al-Qahtani MD , Abdul Rahman Arabi MD , Said Ismail PhD , Moza Al Hail BPharmSc , Jassim Al Suwaidi MD","doi":"10.1016/j.clinthera.2025.12.003","DOIUrl":"10.1016/j.clinthera.2025.12.003","url":null,"abstract":"<div><h3>Purpose</h3><div>CYP2C19 loss-of-function (LoF) alleles are associated with increased cardiovascular risk in clopidogrel-treated percutaneous coronary intervention (PCI) patients. Despite the guidelines recommendation for newer P2Y12 inhibitors, clopidogrel remains widely prescribed. The study the potential impact and feasibility of implementing pharmacogenetics (PGx) testing to guide antiplatelet therapy and develop strategies for its clinical integration to improve patient management.</div></div><div><h3>Methods</h3><div>A pilot study following a prospective cohort design was conducted within the largest community healthcare provider in Qatar using point-of-care (POC) CYP2C19 genotyping in tailoring antiplatelet therapy for PCI patients. Eligible patients underwent CYP2C19 genotyping, and P2Y12 inhibitor prescriptions were adjusted based on genetic results. The study measured antiplatelet prescribing patterns and identified clinically significant gene-drug interactions.</div></div><div><h3>Findings</h3><div>Out of 376 patients tested, 283 patients received PGx-guided recommendations for anti-platelet therapy. Actionable CYP2C19 alleles were detected in 22% of those patients, prompting a change in drug therapy. PGx-guided recommendations were adopted at a rate of 80%, and CYP2C19 genotyping was a significant predictor of antiplatelet therapy adjustments. A sub-analysis of the cost impact revealed an estimated reduction of 300 QR (82.41 $) per patient annually for ACS patients who underwent PCI with stent placement.</div></div><div><h3>Implications</h3><div>This real-world study highlights the feasibility and clinical impact of CYP2C19 genotyping in guiding antiplatelet therapy for ACS and PCI patients, supporting broader PGx testing implementation in routine cardiovascular care.</div></div><div><h3>Trail registration</h3><div>HMC-IRB Registration: IRB-HMC-2021-011, IRB-MoPH Assurance: IRB-A-HMC-2019-0014. ISRCTN registration: ISRCTN15110009, <span><span>https://www.isrctn.com/ISRCTN15110009</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 170-178"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2025-12-16DOI: 10.1016/j.clinthera.2025.11.013
Siyi Liu
{"title":"Comment on “Pharmacists’ Knowledge and Perceptions of Buprenorphine at New York State Pharmacies: Identifying the Extent of Pharmacy-Level Barriers to Access Buprenorphine”","authors":"Siyi Liu","doi":"10.1016/j.clinthera.2025.11.013","DOIUrl":"10.1016/j.clinthera.2025.11.013","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 206-207"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773897","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-24DOI: 10.1016/j.clinthera.2026.01.005
Paul Beninger MD, MBA
{"title":"Trending: The Critical Importance of Public Databases to Public Health","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2026.01.005","DOIUrl":"10.1016/j.clinthera.2026.01.005","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 135-137"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-29DOI: 10.1016/j.clinthera.2026.01.003
Renee R. Eger MD, FACOG, MSCP
{"title":"Expanding Nonhormonal Options for Menopausal Vasomotor Symptoms: Clinical Impact of Elinzanetant","authors":"Renee R. Eger MD, FACOG, MSCP","doi":"10.1016/j.clinthera.2026.01.003","DOIUrl":"10.1016/j.clinthera.2026.01.003","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 210-212"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146092274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-08DOI: 10.1016/j.clinthera.2025.12.009
Seunghoon Han MD, PhD , Dong-Seok Yim MD, PhD , Sungpil Han MD, PhD , Suein Choi MD, PhD , Sung-Yeon Cho MD, PhD , Raeseok Lee MD, PhD , Dukhee Nho MD , Hye-Jeong Baek MS , Dong-Gun Lee MD, PhD
Purpose
This study evaluated the bioequivalence of a newly developed liposomal amphotericin B (LAmB) formulation (DKF-5122, Amphosom™) relative to AmBisomeⓇ and mechanistically characterized the pharmacokinetic property.
Methods
The two-period crossover trial included a patient cohort receiving once-daily infusions for 5 days per period and a healthy-adult cohort receiving a single dose per period. Both cohorts received 3 mg/kg intravenously, and plasma concentrations of LAmB and free drug (fAmB) were analyzed. Bioequivalence in healthy adults was evaluated using conventional criteria. A joint population model was developed based on healthy-adult data, linking LAmB and fAmB through first-order liposomal release and linear disposition. Model adequacy was assessed by goodness-of-fit diagnostics, prediction-corrected visual predictive checks, and bootstrap analysis.
Results
Thirty-one participants contributed to the dataset (six patients and twenty-five healthy adults). In healthy adults, Test-to-Reference geometric mean ratios (90% confidence intervals) were 1.08 (1.04–1.12) for the maximum concentration of LAmB and 1.01 (0.94–1.08) for the area under the curve; for fAmB, the corresponding values were 1.00 (0.91–1.10) and 1.01 (0.95–1.07), meeting conventional bioequivalence criteria. Both LAmB and fAmB were well described by 3-compartment models, and the only formulation-related difference was a statistically significant reduction in the central compartment volume of LAmB for the Test formulation. However, this difference was not of a magnitude that would meaningfully affect the BE outcome. Covariate effects were not clinically relevant.
Conclusions
Amphosom™ achieved pharmacokinetic bioequivalence to AmBisomeⓇ, and the joint model explained the observed similarity by quantifying liposomal release and systemic disposition of LAmB and fAmB. ClinicalTrials.gov identifier: NCT05749380.
{"title":"Pharmacokinetic Equivalence of AmphosomTM, a Newly Developed Liposomal Amphotericin B, to AmbisomeⓇ","authors":"Seunghoon Han MD, PhD , Dong-Seok Yim MD, PhD , Sungpil Han MD, PhD , Suein Choi MD, PhD , Sung-Yeon Cho MD, PhD , Raeseok Lee MD, PhD , Dukhee Nho MD , Hye-Jeong Baek MS , Dong-Gun Lee MD, PhD","doi":"10.1016/j.clinthera.2025.12.009","DOIUrl":"10.1016/j.clinthera.2025.12.009","url":null,"abstract":"<div><h3>Purpose</h3><div>This study evaluated the bioequivalence of a newly developed liposomal amphotericin B (LAmB) formulation (DKF-5122, Amphosom™) relative to AmBisome<sup>Ⓡ</sup> and mechanistically characterized the pharmacokinetic property.</div></div><div><h3>Methods</h3><div>The two-period crossover trial included a patient cohort receiving once-daily infusions for 5 days per period and a healthy-adult cohort receiving a single dose per period. Both cohorts received 3 mg/kg intravenously, and plasma concentrations of LAmB and free drug (fAmB) were analyzed. Bioequivalence in healthy adults was evaluated using conventional criteria. A joint population model was developed based on healthy-adult data, linking LAmB and fAmB through first-order liposomal release and linear disposition. Model adequacy was assessed by goodness-of-fit diagnostics, prediction-corrected visual predictive checks, and bootstrap analysis.</div></div><div><h3>Results</h3><div>Thirty-one participants contributed to the dataset (six patients and twenty-five healthy adults). In healthy adults, Test-to-Reference geometric mean ratios (90% confidence intervals) were 1.08 (1.04–1.12) for the maximum concentration of LAmB and 1.01 (0.94–1.08) for the area under the curve; for fAmB, the corresponding values were 1.00 (0.91–1.10) and 1.01 (0.95–1.07), meeting conventional bioequivalence criteria. Both LAmB and fAmB were well described by 3-compartment models, and the only formulation-related difference was a statistically significant reduction in the central compartment volume of LAmB for the Test formulation. However, this difference was not of a magnitude that would meaningfully affect the BE outcome. Covariate effects were not clinically relevant.</div></div><div><h3>Conclusions</h3><div>Amphosom™ achieved pharmacokinetic bioequivalence to AmBisome<sup>Ⓡ</sup>, and the joint model explained the observed similarity by quantifying liposomal release and systemic disposition of LAmB and fAmB. ClinicalTrials.gov identifier: NCT05749380.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 186-195"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145942776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2026-02-01Epub Date: 2026-01-22DOI: 10.1016/j.clinthera.2025.12.012
Tais Uliana MBA , Zeineb Lassoued MSc , Sergio Moreno Restrepo MBA , Shahper Rahman MSc , Sambasiva Kolati MPharm , Aritz Ateka MSc , Kristie Sourial MRPharmS
Purpose
Prescription-to-over-the-counter (Rx-to-OTC) switch applications face significant barriers, with many experiencing rejections despite potential public health benefits. The purpose of this article was to investigate the regulatory landscape and challenges associated with Rx-to-OTC switches, focusing on the reasons behind rejections and withdrawals across various countries. By examining unsuccessful switches and identifying potential solutions, this article aimed to provide insights into improving regulatory frameworks and enhancing access to safe and effective self-care options.
Methods
A qualitative analysis of 19 International Nonproprietary Names spanning 10 therapeutic areas was conducted across eight countries to identify and categorize the reasons for rejection of the switch of these medicines from prescription to nonprescription status.
Findings
The study identified concerns leading to the rejection of Rx-to-OTC switch applications, including safety issues, challenges in diagnoses and self-management, and behavioral risks. Inconsistencies in regulatory decisions were observed across different countries.
Implications
The analysis identified opportunities to improve regulatory frameworks through risk-balanced approaches, innovative technologies, pharmacist-led models, and harmonized standards across regions. These opportunities could enhance access to self-care options while easing healthcare system burdens and ensuring safety.
{"title":"Analyzing Prescription Drug to Over-the-Counter Drug Switch Rejections: Understanding Regulatory Concerns, A Global Overview","authors":"Tais Uliana MBA , Zeineb Lassoued MSc , Sergio Moreno Restrepo MBA , Shahper Rahman MSc , Sambasiva Kolati MPharm , Aritz Ateka MSc , Kristie Sourial MRPharmS","doi":"10.1016/j.clinthera.2025.12.012","DOIUrl":"10.1016/j.clinthera.2025.12.012","url":null,"abstract":"<div><h3>Purpose</h3><div>Prescription-to-over-the-counter (Rx-to-OTC) switch applications face significant barriers, with many experiencing rejections despite potential public health benefits. The purpose of this article was to investigate the regulatory landscape and challenges associated with Rx-to-OTC switches, focusing on the reasons behind rejections and withdrawals across various countries. By examining unsuccessful switches and identifying potential solutions, this article aimed to provide insights into improving regulatory frameworks and enhancing access to safe and effective self-care options.</div></div><div><h3>Methods</h3><div>A qualitative analysis of 19 International Nonproprietary Names spanning 10 therapeutic areas was conducted across eight countries to identify and categorize the reasons for rejection of the switch of these medicines from prescription to nonprescription status.</div></div><div><h3>Findings</h3><div>The study identified concerns leading to the rejection of Rx-to-OTC switch applications, including safety issues, challenges in diagnoses and self-management, and behavioral risks. Inconsistencies in regulatory decisions were observed across different countries.</div></div><div><h3>Implications</h3><div>The analysis identified opportunities to improve regulatory frameworks through risk-balanced approaches, innovative technologies, pharmacist-led models, and harmonized standards across regions. These opportunities could enhance access to self-care options while easing healthcare system burdens and ensuring safety.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"48 2","pages":"Pages 148-158"},"PeriodicalIF":3.6,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146028619","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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