Review
Health Care Sciences & Services
Lucia Gozzo, Filippo Caraci, Filippo Drago
Summary: The prescription of generic drugs is an important cost-containment strategy in health systems. Regulatory authorities encourage or require the use of generic drugs due to their lower price compared to brand-name alternatives. However, drug substitution can be critical, especially for drugs with a narrow therapeutic index. Additionally, generics cannot be automatically considered bioequivalent due to the biocreep phenomenon.
Review
Clinical Neurology
Reem Odi, Valentina Franco, Emilio Perucca, Meir Bialer
Summary: The safety of switching between generic products of antiseizure medications remains a hot topic in epilepsy management due to concerns about bioequivalence, statistical testing, regulatory requirements, and intra-subject variability. Analysis of generic products in Europe showed that most products had good bioequivalence with narrow 90% confidence intervals for AUC. The risk of clinically relevant changes in plasma drug exposure due to switching across generic products is small, with gabapentin generics showing the greatest potential for variability.
Article
Pharmacology & Pharmacy
Sarah Elmer, Doodipala Samba Reddy
Summary: This article discusses the issue of generic substitution of antiseizure medications (ASMs) and highlights the critical pharmacotherapeutic issues associated with generic ASMs. It emphasizes the need for considering therapeutic equivalence and other clinical factors when interchanging generic ASMs.
JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS
(2022)
Article
Cardiac & Cardiovascular Systems
Iris Ma, Rebecca L. Tisdale, Daniel Vail, Paul A. Heidenreich, Alexander T. Sandhu
Summary: Generic medications cost less than brand-name medications and have similar efficacy, but there are still substantial cost savings to be had by increasing the utilization of generics in cardiovascular therapies. States with laws related to mandatory pharmacist generic substitution and patient consent for substitution showed higher rates of generic utilization.
CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES
(2021)
Article
Pharmacology & Pharmacy
Sura Al Zoubi, Lobna Gharaibeh, Batool Al-Masri, Ahmad B. Alsahele, Buthainah AL-Masaeid
Summary: This study aimed to assess medical students' experience, knowledge, and attitude towards generic switching as patients, students, and future prescribers and policymakers. The survey results showed that about half of the participants believed that pharmacists should not have the right to independently switch drugs, and only 16% stated that they would choose generic drugs for treatment in the future.
FRONTIERS IN PHARMACOLOGY
(2022)
Review
Pharmacology & Pharmacy
Sam Habet
Summary: This study discusses the identification of drugs with Narrow Therapeutic Index (NTI), pointing out that the current definitions are controversial, the lists are arbitrary, and variability may affect safety and efficacy. The objectives include facilitating consensus on NTI definition, identifying characteristics, and developing criteria for identification. The FDA should consider PK studies as well as comparative efficacy and safety studies for NTI drugs.
JOURNAL OF PHARMACY AND PHARMACOLOGY
(2021)
Article
Chemistry, Medicinal
Changhee Ha, Hyun-Seung Lee, Eun Yeon Joo, Young-Min Shon, Seung Bong Hong, Dae-Won Seo, Soo-Youn Lee
Summary: The study investigated the therapeutic drug monitoring of Levetiracetam in Korean epilepsy patients, revealing a large inter-individual difference in its pharmacokinetics and its susceptibility to EIAEDs. There was a strong correlation between weight-adjusted Levetiracetam dosage and concentrations.
Article
Economics
Benjamin N. Rome, Ameet Sarpatwari, Aaron S. Kesselheim
Summary: Substituting brand-name drugs with cheaper, equally effective generic alternatives is an important strategy to promote adherence and control prescription drug spending. This study found that states with laws requiring patient consent or notification for pharmacist substitution of generics had lower use of generics, while mandating substitution and protecting pharmacists from liability did not appear to have significant effects.
Article
Medicine, General & Internal
Grzegorz Grzesk, Wioleta Stolarek, Michal Kasprzak, Elzbieta Grzesk, Daniel Rogowicz, Michal Wicinski, Marek Krzyzanowski
Summary: The retrospective analysis of 710 patients treated with Carbamazepine revealed that patients between 3 and 17 years of age were more likely to be within the therapeutic range, despite receiving higher doses per kilogram of body weight. Patients aged ≥18 were more likely to experience drug overdose, while suicide attempts only occurred in elderly patients.
JOURNAL OF CLINICAL MEDICINE
(2021)
Review
Pharmacology & Pharmacy
Bruno Charlier, Albino Coglianese, Federica De Rosa, Ugo de Grazia, Francesca Felicia Operto, Giangennaro Coppola, Amelia Filippelli, Fabrizio Dal Piaz, Viviana Izzo
Summary: Epilepsy is a complex neurological disorder with various syndromes and treatments, including the use of antiseizure medications (ASMs) that act on synaptic levels. Monitoring ASMs levels in biological fluids is crucial to minimize risks, and measuring the free drug fraction is increasingly important for better correlation with pharmacological and toxicological effects. Validated methodologies exist for separating and quantifying different drug forms, but further validation studies are needed to connect pharmacokinetic monitoring with clinical outcomes in real-world settings.
Review
Chemistry, Analytical
Omid Heydari Shayesteh, Reza Mahjub, Akram Ranjbar, Katayoun Derakhshandeh, Mahdi Jamshidi
Summary: Accurate determination of narrow therapeutic index drugs is crucial for clinicians to make clear judgments regarding drug therapy for patients. Traditional analytical techniques have limitations, leading to high interest in nano/(bio)sensing technology.
Review
Medicine, General & Internal
P. Lechat
Summary: Therapeutic impact following replacement of reference medicines with generic products may depend on the bioequivalence between the two. While it is generally accepted that a 20% difference in exposure between reference and generic has no therapeutic impact, drugs with narrow therapeutic index require stricter bioequivalence limits. Regulatory agencies have proposed narrowing the acceptance limits to ensure interchangeability, but individual exposure differences can still affect the therapeutic impact. Considering the 95% confidence intervals of the individual generic/reference exposure ratios as an additional criterion for interchangeability may be necessary, especially for drugs with narrow therapeutic index.
BULLETIN DE L ACADEMIE NATIONALE DE MEDECINE
(2023)
Article
Pharmacology & Pharmacy
Fuquan Li, Akhilesh Vikram Singh
Summary: Epilepsy is a complex neurological disorder characterized by recurrent seizures, and the treatment of epilepsy involves balancing the efficacy, safety, and tolerability of antiepileptic drugs. Novel drug delivery techniques aim to enhance drug efficacy and reduce side effects for more effective treatment.
ACTA PHARMACEUTICA
(2021)
Article
Clinical Neurology
Roro Rukmi Windi Perdani, Wawaimuli Arozal, Irawan Mangunatmadja, Nastiti Kaswandani, Setyo Handryastuti, Bernie Endyarni Medise, Harri Hardi, Rajarajan Amirthalingam Thandavarayan, Hanifah Oswari
Summary: Despite the availability of many anti-seizure medications (ASMs), a significant number of children with epilepsy, approximately 30%, still experience treatment failure, known as drug-resistant epilepsy (DRE). There is currently no international consensus on the use of second-line ASMs as substitution therapy for DRE. Previous studies mainly focused on comparing ASMs as add-on or substitution therapy in newly diagnosed epilepsy, but there is a lack of research on comparing first-line and second-line ASMs as substitution therapy, particularly in DRE children. A randomized controlled trial will be conducted in three referral hospitals in Indonesia, enrolling 102 participants aged 1-18 and dividing them into an intervention group receiving first-line ASMs and a control group receiving second-line ASMs. The primary outcome measure will be the difference in the proportion of responders between the two groups after 14 weeks of intervention.
FRONTIERS IN NEUROLOGY
(2023)
Article
Clinical Neurology
Samuel Waller Terman, Chun C. Lin, Wesley T. Kerr, Lindsey B. DeLott, Brian C. Callaghan, James F. Burke
Summary: From 2008 to 2018, there was a decrease in the use of first-generation and enzyme-inducing antiseizure medications, while the cost of brand name medications increased.
Article
Behavioral Sciences
Thomas Johnstone, Maria Isabel Barros Guinle, Gerald A. Grant, Brenda E. Porter
Summary: The study aimed to evaluate the safety and impact of Dexmedetomidine Hydrochloride (DH) administration during pediatric invasive intracranial electroencephalography (IEEG). The results showed that DH administration was not associated with adverse events and did not significantly affect the frequency of seizures captured on the IEEG and the duration of hospitalization.
EPILEPSY & BEHAVIOR
(2024)
Article
Behavioral Sciences
Sabra Zaraa, H. Steve White, Andy Stergachis, Edward Novotny Jr, Chris Protos, Grant Simic, Jennifer L. Bacci
Summary: This study used design thinking to develop a community pharmacist-led intervention for people living with epilepsy. Four features - pharmacist-patient consultations, care plan development, regular check-ins, and care coordination with other health care providers - were identified as desirable, feasible, and viable for the intervention. The study highlights the importance of involving pharmacists in epilepsy care and provides evidence-based features for such interventions.
EPILEPSY & BEHAVIOR
(2024)
Article
Behavioral Sciences
Bofei Tan, Qiang Liu, Yameng Qin, Qiuyan Chen, Rong Chen, Yanzi Jin, Mengyun Li, Xiaodan Jia, Xianrui Xu, Qing Zhang
Summary: The purpose of this study was to identify factors associated with insomnia in patients with epilepsy. The results showed that nocturnal seizures and anxiety were independently associated with insomnia in these patients. Patients with epilepsy and insomnia were more likely to experience depression and excessive daytime sleepiness.
EPILEPSY & BEHAVIOR
(2024)
