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Objectives: To observe medication cost trends for 5 common neurologic conditions., Methods: We quantified annual out-of-pocket (OOP) and total medication costs for patients seen by a neurologist with epilepsy, multiple sclerosis (MS), Parkinson disease (PD), peripheral neuropathy (PN), and dementia/Alzheimer's disease in a commercial claims database cross-sectionally from 2012 to 2021., Results: We identified 186,144 patients with epilepsy, 54,676 with MS, 45,909 with PD, 169,127 with PN, and 60,861 with dementia/Alzheimer. OOP costs for MS medications increased each year, by 217% on average. Branded epilepsy medications had higher OOP costs than generics. Decreases ranging from 48% to 80% in annual OOP costs of duloxetine, pregabalin, rasagiline, rivastigmine, and memantine were observed in the years after generic introduction., Discussion: Preferentially selecting generic medications reduces OOP costs, other than for MS where costs continue to increase. Policy solutions, such as cost caps, are needed.

The increasing cost of prescription drugs has high concern and associated with medication nonadherence and adverse health outcomes. The use of generic prescription drugs by the patients depends on if recommended by competent healthcare providers. Generic medicines, which are cheaper and bioequivalent to brand-name drugs, offer an opportunity to reduce healthcare expenditures of Saudi Arabia's healthcare system as per the Vision 2030 plan. Therefore, the current study was conducted to assess the population awareness, attitude and perception towards the generic medications particularly those locally manufactured in Saudi Arabia. We managed a cross-sectional, questionnaire-based study and included indices like demographic sections, knowledge of generic medications, perception of generic medication use, and previous experience. Data was collected over 12 weeks from February 2022 to April 2022 using an online survey tool. A study of 462 participants found that the majority were male (54.97%), young (55.4%), with a graduate or post-graduate degree (73.5%) and employed (43.29%). The majority reported good health, with 75.5% reporting good health. The study found significant differences in knowledge about generic drugs, their country of origin, and their benefits and utility. Most participants had positive attitudes towards generic medications, with 45% believing they are as effective as those from other countries. The study also revealed a significant difference in participants' experience and usage of medications particularly satisfaction to health outcome. Enhancing healthcare professionals' perceptions of generics can positively influence patient/consumer opinions and trust in generic medicines. Patients' high trust in prescribing physicians also influences these opinions, as their opinions can influence patient/consumer opinions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Akhtar, Orayj. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Patient preferences for medications strongly correlate with adherence; one area of interest is the choice between branded and generic drugs. Despite extensive research about brand-versus-generic drug preferences, few studies have explored severe-illness patients like those with coronary heart disease (CHD). We could not locate studies measuring preference weights of branded drugs in different classes within guideline-recommended regimens using discrete choice experiments (DCE). We aimed to explore the preference for branded medications used for secondary prevention of CHD events among patients receiving treatment at one of the largest Egyptian health insurance clinics. Patients with CHD were interviewed to choose between various therapy regimens containing brand-name and generic versions of aspirin, beta-blockers, statins, and renin-angiotensin-aldosterone system blockers (RAAS blockers). The study employed a DCE technique and followed the recommendations of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR). Seventy-two percent (149) of the 208 patients questioned were dissatisfied with at least one of their generic medications. The majority of unsatisfied patients displayed brand preferences across the four medicine classes, primarily due to the notion that generics may be less effective. Patients preferred the RAAS blocker brand the most (adjusted odds ratio [AOR]: 3.14; 95% confidence interval [CI] 2.83 to 3.48), followed by beta-blockers (AOR: 2.06; 95% CI 1.88 to 2.27) and statins (AOR: 1.5; 95% CI 1.50 to 1.61). The relative importance of each class from the patient's perspective showed the highest importance with RAAS blockers (22.2%) and beta-blockers (14.1%), while statins and aspirin had minor importance (7.8% and 6.6%, respectively). In the present study, branded drugs for secondary CHD prevention were preferred over generic alternatives. This finding has two implications for clinical practice. Firstly, physicians and pharmacists need to assure patients about the quality of generics to insure patient satisfaction and adherence to medication. Secondly, health insurance providers need to confirm the effectiveness of generics through observational studies. Despite the well-proven protective effects of aspirin and statins, they had minor importance from the patient's perspective, highlighting the need to enhance patient knowledge. DCE was demonstrated to be a useful tool for eliciting the genuine preferences of patients treated within the setting of health insurance., (© 2024. The Author(s).)

Purpose: Although generic drugs are essential in reducing medical costs, their use in epilepsy therapy remains a subject of ongoing debate. In this study, we analysed prescription trends of generic drugs using data from the National Database of Health Insurance Claims and Specific Health Checkups (NDB) Open Data Japan., Methods: The number of generic drug prescriptions from 2017-2021 was extracted from the NDB Open Data Japan, with data for each medication stratified by prefectural region, sex, and age, allowing for the analysis of the impact of each factor. We analysed the correlation between the prescription volumes of generic antiseizure medications (ASMs) and the number of clinical epileptologists registered with the Japan Epilepsy Society per 100,000 population., Results: In 2021, the prescription volume of generic ASMs was 49 %, whereas that for other pharmacological agents was between 70-80 %. Notably, for children < 15 years of age, generics made up approximately 20 % of prescriptions, which was significantly less than that in other age groups. Analysis by prefecture revealed a negative correlation between prescription volumes of ASMs and the number of clinical epileptologists across prefectural regions in Japan (R = -0.47, p < 0.01)., Conclusion: Our findings indicate that the higher the proportion of clinical epileptologists in each prefecture, the lower the number of prescribed generic ASMs. Clinical epileptologists in Japan therefore prescribe antiseizure agents in accordance with the Japanese epilepsy treatment guidelines that do not recommend the use of generic agents., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Patient-reported outcomes (PROs) provide valuable insights into the impact of disease-modifying therapies (DMTs) on patients' daily lives and disease progression. This study evaluates treatment satisfaction and tolerability among patients using a brand-generic Teriflunomide (Tebazio®, 14 mg tablet) manufactured by Zistdaru Danesh Biopharmaceuticals., Materials and Methods: A Phase IV observational study was conducted on patients with Relapsing-Remitting Multiple Sclerosis (RRMS) who were either initiated on or switched to Teriflunomide 14 mg. The primary focus was on the medication's safety. Patient satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication [Version 1.4] (TSQM-14). Additionally, medication adherence and discontinuation rates were monitored., Results: Of the 235 RRMS patients enrolled, participated in this study, all received the Teriflunomide treatment orally on a daily basis. Over the 18-month follow-up period, 25.96 % of patients discontinued the treatment. Discontinuation was mainly due to adverse events (11 %), lack of patient willingness to continue (12.7 %), and disease progression (4.2 %). The most commonly reported adverse events included dermatologic disorders, elevated liver enzymes, and gastrointestinal issues. TSQM-14 scores demonstrated significant improvements over the 18-month period. A high medication adherence rate of 98.1 % was also recorded., Conclusion: Patients reported notable satisfaction with Teriflunomide, as reflected in their TSQM scores, which suggests a likelihood of improved patient adherence. The 14 mg brand-generic Teriflunomide was well-accepted by Iranian RRMS patients, with no significant concerns arising during the study. These findings also highlight the significance of patient-reported outcomes in DMTs, with potential benefits for adherence and clinical practice., Competing Interests: Declaration of Competing Interest All authors declare that they have no financial, personal, or other interests related to the subject matter of this paper that could create a potential conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Osteoporosis has been recognized as a significant health issue in Thailand. Pharmacological interventions are important way to prevent fracture. However, one of the main challenges in selecting a medication is high cost, particularly for brand-name drugs. Data on generic bisphosphonate use in Thai are still lacking. Therefore, our study aimed to assess the efficacy and safety of generic risedronate in postmenopausal Thai women with osteoporosis., Methods: This prospective study was conducted at King Chulalongkorn Memorial Hospital, Bangkok, Thailand, from December 2022 to January 2024. Serum C-terminal cross-linking telopeptide of type I collagen (CTX) and procollagen type I N-propeptide (P1NP) were measured at baseline. All participants subsequently received 35 milligrams of oral risedronate once weekly for 52 weeks. Serum CTX and P1NP were remeasured at different time points. BMD was reevaluated at 52 weeks after risedronate treatment initiation., Results: A total of 80 participants were included. The mean age was 65.2 ± 6.6 years. The mean body mass index (BMI) was 23.45 ± 3.49 kg/m 2 . The median (IQR) serum CTX level at 12 weeks was significantly lower than that at baseline (0.28 (0.16-0.46) ng/mL versus 0.44 (0.26-0.64) ng/mL, respectively; p value < 0.01). The suppression of serum CTX was confirmed at 52 weeks after treatment initiation. Compared with those at baseline, the serum P1NP levels were significantly lower at 24 weeks after treatment initiation (30.33 (19.19-39.58) ng/mL versus 41.90 (30.33-68.67) ng/mL, respectively; p value < 0.01). In terms of the BMD assessment at 52 weeks, significant improvements were observed in both areal BMD (g/cm 2 ) and T scores at all measured sites compared with baseline. The lumbar spine, femoral neck, and total hip BMD increased from baseline by 4.76%, 3.84% and 4.54%, respectively., Conclusion: Postmenopausal women with osteoporosis who were treated with generic risedronate demonstrated significant suppression of the bone remodelling process at 3, 6, and 12 months after treatment initiation. Additionally, significant improvements in the lumbar spine, femoral neck, and total hip BMD were observed at 12 months of therapy. These findings suggest that generic risedronate could be considered a reasonable and interesting option for treating postmenopausal women with osteoporosis in Thailand., (© 2024. The Author(s).)

Background: The prevalence of depression is gradually increasing worldwide with an increasing utilization of antidepressants. Nevertheless, despite their lower costs, generic-brand antidepressants were reported to be less prescribed. We aimed to examine the costs of reference- versus generic-brand antidepressant prescriptions in primary care practice., Methods: This cross-sectional study included electronic prescriptions for adult patients that contained antidepressants (World Health Organization's Anatomical Therapeutic Chemical (ATC) code: N06A), which were generated by a systematically selected sample of primary care doctors ( n = 1431) in Istanbul in 2016. We examined the drug groups preferred, the reference- versus generic-brand status, and pharmacotherapy costs., Findings: The majority of the prescriptions were prescribed for women (71.8%), and the average age of the patients was 53.6 ± 16.2 years. In prescriptions with a depression-related indication ( n = 40 497), the mean number and cost of drugs were 1.5 ± 1.0 and 22.7 ± 26.4 United States Dollar ($) per prescription, respectively. In these prescriptions, the mean number and cost of antidepressants per encounter were 1.1 ± 0.2 and $17.0 ± 13.2, respectively. Reference-brand antidepressants were preferred in 58.2% of depression-related prescriptions, where the mean cost per prescription was $18.3 ± 12.4. The mean cost per prescription of the generics, which constituted 41.8% of the antidepressants in prescriptions, was $15.1 ± 11.4. We found that if the generic version with the lowest cost was prescribed instead of the reference-brand, the mean cost per prescription would be $12.9 ± 11.2., Conclusions: Our study highlighted the substantial pharmacoeconomic impact of generic-brand antidepressant prescribing, whose preference over reference-brands could reduce the cost of antidepressant medication treatment by 17.5% in primary care, which could be approximately doubled if the cheapest generic antidepressant had been prescribed.

Background: Frailty and comorbidity influence the therapeutic approach in everyday clinical practice. The DOACs genericization opens a reflection on their differences from a pharmacological and bioavailability point of view, particularly in elderly frail patients. The aim of this project was to create a national Delphi consensus on the topic of the use of DOACs for atrial fibrillation (AF) in such patients, in light of the genericization of the class., Methods and Results: The consensus dealt with 3 main topics: a) efficacy and safety of DOACs in elderly and/or frail patients; b) therapeutic choice in specific frailty scenarios; c) DOACs genericization. 56 cardiologists, two internists and two neurologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: uncertain, 4: agree, 5: strongly agree). A positive consensus was reached if the percentage of agreement (vote 1-2, positive consensus) or disagreement (votes 4-5, negative consensus) was >66%; otherwise, no consensus was reached. Results are displayed accordingly., Conclusions: After 10 years of everyday clinical management of DOACs for AF, specific elements differentiating a molecule from another, either for efficacy or for safety, are consolidated. However, some uncertainties still exist in particular contexts, such as chronic kidney disease or cancer patients. Clinicians have an unsure attitude towards generic drugs, because clinical practice is lacking as well as a proper knowledge of the topic. Albeit being an alternative, the choice of the generic drug must remain the responsibility of the clinician., Competing Interests: Declaration of competing interest GLB declared speaker fees (small amount) from Bayer Healthcare, Boheringer, Daiichi-Sankyo, Pfizer/BMS, Sanofi. PCa has nothing to declare. PCo participates in Daiichi Sankyo, Inc.-funded research; is a coauthor of ESC guidelines on AF (versions 2010 and 2012) and received institutional research grants from Bayer, Boehringer, and Daiichi Sankyo, Inc.; and speaker honoraria from Bayer, Boehringer Ingelheim, Pfizer-BMS, and Daiichi Sankyo, Inc. In the last two years DMMF has received fees for partecipations as expert in Advisory Boards or as speaker in Congress and meeting or as consultant, from the following companies: Abiogen, Alfasigma, Angelini, Agave, Bayer, Daiichi-Sankyo, Grunenthal, Janssen, Lundbeck, Molteni, Sandoz, SPA, Zambon. ES has nothing to declare. LR is a speaker and a scientific research partner for Bayer, BMS/Pfizer, Boehringer Ingelheim and Daiichi-Sankyo; no fees are directly received personally., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The rising costs of drugs are putting health care systems under pressure. We report on the Bavarian Drug Agreement, which employs prescribing targets for preferred and generic drugs in ambulatory care. Under this agreement, providers are regularly profiled with individual feedback but also possible sanctions. We investigated the degree to which targets were being met (or not) and why failure occurred., Methods: We analysed prescribing data aggregated by practice for the quarter 1/2018. We chose eight specialisation groups and analysed their drug targets with a high prescribing volume, widely missed drug targets (<90%), and drugs preventing drug target achievement. Characterisation of drug targets and preventing drugs was undertaken., Results: Drug targets with a high prescribing volume are mostly achieved, while highly missed drug targets mostly do not affect the main indication area of the specialisation groups considered. Generic drug targets seem to be more easily achieved than recommended drug targets. Paediatrics accounts for the largest number of missed drug targets., Conclusions: The Bavarian tool implemented uses the prescribing volume (DDD) and price components to evaluate the prescription behaviour of physicians. Well-established drugs with demonstrated effectiveness, safety, and lower costs are preferred. Nevertheless, me-too drugs, combination drugs, costly innovations with unclear value, and drugs with application methods of variable convenience challenge the drug prescribers and are reasons for missed drug targets.

Background: Patients often use manufacturer-sponsored coupons to reduce their out-of-pocket spending. However, little is known whether coupon use is associated with medication-switching behaviors., Objective: To examine if using a manufacturer-sponsored coupon to initiate a medication is associated with patterns of medication-switching behaviors among patients with type 2 diabetes., Methods: Using IQVIA's retail pharmacy claims data from October 2017 to September 2019, we analyzed commercially insured patients with type 2 diabetes who had newly started taking the following noninsulin diabetes drugs: generic metformin (nearly no coupon use), Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors (SGLT2, high coupon use), and dipeptidyl peptidase IV inhibitors (DPP-IV inhibitors, moderate coupon use). We assessed if drug-switching behaviors, defined as no switching, switching to a same-class drug, or switching to a drug in a different class, differed among patients who did and did not use coupons to initiate treatments. We performed multinomial logistic regression to estimate the probability of each switching type associated with patients' initial coupon use., Results: Among 9,781 patients in our sample, 83.7% of them initiated treatments with metformin, 8.2% with SGLT2, and 8.1% with DPP-IV inhibitors. The overall switching rate was the lowest for generic metformin (40%) than brand-name drugs (56%-57%). Among the brand-name drug users, patients who used a coupon to initiate these drugs were less likely to switch to any drug compared with patients without coupon use (SGLT2 = -18% [95% CI = -24% to -13%]; DPP-IV inhibitors = -9% [-16% to -2%]). These patients were also less likely to switch to drugs in other competing classes (SGLT2 = -16% [95% CI = -22% to -10%]; DPP-IV inhibitors = -9% [-16% to -2%])., Conclusions: Patients who started their treatment with generic metformin had the lowest rate of drug switching. Using coupons to initiate brand-name drugs in classes with prevalent coupons was associated with reduced medication switching to other class drugs.

Background: The use of generic drugs is a way for healthcare systems to reduce costs, particularly in ambulatory care. Several studies suggest that the prescriber's speciality is associated with the use of generic drugs, and that substitutable drugs prescribed by General Practitioners (GPs) are more often generic, but this association has never been studied in France. In the French legislative context, except in rare situations, all substitutable drugs prescribed should be dispensed in generic form., Objectives: Compare the generic drugs dispensing rate among substitutable drugs dispensed in community pharmacies prescribed by French private GPs with that of other private specialists, all other specialities combined (first objective) or each other speciality taken individually (second objective)., Methods: We used a sample of an open available semi-aggregated database from the 2019 French health insurance system database. We compared with logistic regression models GPs to all other specialities combined, then GPs to the 19 other specialties taken individually, only on the substitutable drugs they prescribe in common., Results: In 2019, 53.4% of the drugs prescribed by French private ambulatory physicians were substitutable drugs, and 81.5% of them were dispensed in generic form. After adjustment, the generic dispensing rate for substitutable drugs was significantly higher for GPs than for other specialties (ORa 0.74 [IC95% 0.72-0.76]). Thirteen of the nineteen other specialities taken individually, such as endocrinologists (ORa 0.64 [IC95% 0.57-0.72]) and cardiologists (ORa 0.60 [0.56-0.63]) had significantly lower generic dispensing rates than GPs. No other speciality had a rate significantly higher than GPs., Conclusions: Substitutable drugs prescribed by French private GPs are more often dispensed in generic form than those from other private ambulatory specialties. To understand this result and optimise the use of generic drugs in outpatient settings, we need to study the different stages of drug use, from prescription by the physician to dispensing by the pharmacist and acceptance by the patient.

Background: Primary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2α analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05 mg/ml eye drops solution, in lowering IOP when compared to the originator Xalatan ® (latanoprost 0.005% ophthalmic solution, Pfizer)., Methods: This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18-75 years) with open-angle glaucoma or ocular hypertension., Results: Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55-8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61-8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events., Conclusions: Latanoprost Polpharma was shown to be non-inferior to Xalatan ® . Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life., Trial Registration: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39)., (© 2024. The Author(s).)

Objective: To identify the frequency and types of prescription errors, assess adherence to WHO prescribing indicators, and highlight the gaps in current prescribing practices of Junior dental practitioners in a tertiary care hospital in Karachi, Pakistan., Methods: This cross-sectional study was conducted from January 2021 to March 2021. The study included the prescriptions by house surgeons and junior postgraduate medical trainees for walk-in patients visiting the dental outpatient department. A total of 466 prescriptions were evaluated for WHO core drug prescribing indicators. The prescription error parameters were prepared by studying the WHO practical manual on guide to good prescribing and previous studies. Prescription errors, including errors of omission related to the physician and the patients, along with errors of omission related to the drug, were also noted. The statistical analysis was performed with SPSS version 25. Descriptive analysis was performed for qualitative variables in the study., Results: The average number of drugs per encounter was found to be 3.378 drugs per prescription. The percentage of encounters with antibiotics was 96.99%. Strikingly, only 16.95% of the drugs were prescribed by generic names and 23.55% of drugs belonged to the essential drug list. The majority lacked valuable information related to the prescriber, patient, and drugs. Such as contact details 419 (89.9%), date 261 (56%), medical license number 466 (100%), diagnosis 409 (87.8%), age and address of patient 453 (97.2%), form and route of drug 14 (3%), missing drug strength 69 (14.8%), missing frequency 126 (27%) and duration of treatment 72 (15.4%). Moreover, the wrong drug dosage was prescribed by 89 (19%) prescribers followed by the wrong drug in 52 (11.1%), wrong strength in 43 (9.2%) and wrong form in 9 (1.9%). Out of 1575 medicines prescribed in 466 prescriptions, 426 (27.04%) drug interactions were found and 299 (64%) had illegible handwriting., Conclusion: The study revealed that the prescription writing practices among junior dental practitioners are below optimum standards. The average number of drugs per encounter was high, with a significant percentage of encounters involving antibiotics. However, a low percentage of drugs were prescribed by generic name and from the essential drug list. Numerous prescription errors, both omissions and commissions, were identified, highlighting the need for improved training and adherence to WHO guidelines on good prescribing practices. Implementing targeted educational programs and stricter regulatory measures could enhance the quality of prescriptions and overall patient safety., (© 2024. The Author(s).)

Introduction: Chemotherapy in an integral part of cancer treatment, either administered alone or in combination with radiation. However, the cost of these drugs is often prohibitively high for most patients. To address this issue, the Government of India has established Jan Aushadhi (JAS) stores across the country, where affordable generic medicines are available. In the current study, we performed a cost minimization analysis comparing JAS drugs with branded chemotherapeutic drugs used in various cancer treatment regimens., Objectives: This study was to conduct a cost-minimization analysis by comparing the costs of different regimens when using JAS drugs, the most expensive branded drugs, and the least expensive branded drugs in the treatment of cancer in India., Materials and Methods: The study focused on conducting a cost minimization analysis of various chemotherapy drugs used in the treatment of different cancers, considering the availability of anticancer drugs at JAS stores. The costs for different chemotherapy regimens, including both anticancer and supportive drugs, were calculated for single and complete cycles. The costs of the most expensive and least expensive branded drugs were noted from the Current Index of Medical Stores. The cost difference (CD) was calculated by subtracting the cost of the cheaper drug from that of the costliest brand. The cost ratio (CR) and the percentage of cost variation (PCV) were calculated for India-specific conditions., Results: The study analyzed the CD for various regimens using JAS drugs for chemotherapy treatment of breast, esophagus, rectal, colon, stomach, prostate, ovary, endometrial, cervical, head and neck, lung, multiple myeloma, testicular, and lymphoma cancers. It also considered chemoirradiation regimens for brain, head and neck, anorectal, esophageal, and uterine cervical cancers. Significant CDs were observed when both anticancer and supportive drugs were obtained from JAS stores., Conclusion: To the best of the authors' knowledge, this is the first study to consider the CD, CR, and PCV for various regimens using JAS drugs, as well as the costliest and cheapest branded drugs in standard cancer treatment regimens. The results of this study are expected to assist healthcare professionals and pharmacists in understanding the cost-saving benefits of substituting expensive branded drugs with more affordable chemotherapeutic drugs for the treatment of cancer. This substitution can provide financial benefit for socioeconomically marginalized population., (Copyright © 2024 Copyright: © 2024 Journal of Cancer Research and Therapeutics.)

In the last decade there is an increasing frequency of sudden generic switches of antiseizure medications (ASMs) due to delivery problems. We here explored the patient's views toward generic substitution of ASMs and their experiences with delivery problems and switches of the manufacturer. A questionnaire already used in 2011 was updateded and published on the website of a patient's organisation from March 2022 until November 2022. 54.4 % of the responders reported delivery problems. Delivery problems were reported from Germany by a higher number of responders than from Switzerland. To 83.7 % of the responders the delivery problems were communicated by the pharmacists. In 41.9 % of these the delivery problems were coped by generic substitution. In 33 % of the latter breakthrough seizures occurred. 26 % of the respondents with experience of a change of the manufacturer not due to a delivery problem reported breakthrough seizures after being substituted. The majority of patients denied having been well informed about the possible consequences of a switch of the manufacturer. A thorough counselling on the low risks caused by change of the manufacturer and the need for good adherence to further reduce the risks should be part of the general information about their treatment with ASMs for people with epilepsy., Competing Interests: Declaration of Competing Interest Johannes Rösche received speaker’s honoraria from Eisai. Thomas Porschen has no conflicts of interest, Uwe Walter has received speaker honoraria and travel funds from Bristol-Myers Squibb, Daiichi Sankyo, Ipsen Pharma, Merz Pharma, and Pfizer, and a research grant from Merz Pharma. He has received royalties from Thieme and Elsevier Press. He serves as editor of the European Journal of Ultrasound., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

In a retrospective study conducted in three hospitals in Paris, generic antiretroviral accounted for 30.2% of all prescriptions. Tenofovir disoproxil/emtricitabine (TDF/FTC) was the most prescribed generic ART (82.3% of generic prescriptions). Generic ART (gART) was more likely to be prescribed to women, to patients less than 50 years, and with recent HIV diagnosis less than 3 years. Physicians prescribed more gART if they were men, older than 55 years or worked at a university teaching hospital., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Introduction and Objectives: Treatment of chronic hepatitis B (CHB) with nucelos(t)ide analogues (NA) can improve outcomes, but NA treatment is expensive for insurance plans., Materials and Methods: The Centers for Medicare & Medicaid Services database was assessed from 2012 to 2021 to assess the use of NA for CHB in patients on Medicaid. Data extracted included the number of claims, units, and costs of each agent stratified by originator and generic., Results: Over the study period, 1.9 billion USD was spent on NA, with spending peaking in 2016 at $289 million US, which has subsequently decreased. Lower expenditures since 2016 have been associated with increased use of generics. The use of generic tenofovir or entecavir led to savings of $669 million US over the study period., Conclusions: Increased generic use has significantly reduced expenditures for NA drugs; policy shifts towards generic drug use may help with sustainability., Competing Interests: Declaration of interests SEC reports grants from Gilead Sciences, Genfit, Allergan, Axcella Health, Inc, AstraZeneca, Merck, and Ipsen and personal fees from AstraZeneca and Novo Nordisk outside the submitted work. CSC reports investigator-initiated research grants/research materials from GlaxoSmithKline, Gilead Sciences, Inc., and Janssen Pharmaceutical; having served as a consultant for Gilead Sciences and Roche; and serving on an advisory board for Altimmune Pharmaceuticals with funds paid to the Canadian HBV Network, University of Calgary. MB has nothing to disclose., (Copyright © 2024 Fundación Clínica Médica Sur, A.C. Published by Elsevier España, S.L.U. All rights reserved.)

Objective: This study aims to determine whether the live birth rates were similar between GnRH antagonist original reference product Cetrotide ® and generic Ferpront ® , in gonadotropin-releasing hormone (GnRH) antagonist protocol for controlled ovarian stimulation (COS)., Methods: This retrospective cohort study investigates COS cycles utilizing GnRH antagonist protocols. The research was conducted at a specialized reproductive medicine center within a tertiary care hospital, spanning the period from October 2019 to October 2021. Within this timeframe, a total of 924 cycles were administered utilizing the GnRH antagonist originator, Cetrotide ® (Group A), whereas 1984 cycles were undertaken using the generic, Ferpront ® (Group B)., Results: Ovarian reserve markers, including anti-Mullerian hormone, antral follicle number, and basal follicular stimulating hormone, were lower in Group A compared to Group B. Propensity score matching (PSM) was performed to balance these markers between the groups. After PSM, baseline clinical features were similar, except for a slightly longer infertile duration in Group A versus Group B (4.43 ± 2.92 years vs. 4.14 ± 2.84 years, P = 0.029). The duration of GnRH antagonist usage was slightly longer in Group B than in Group A (6.02 ± 1.41 vs. 5.71 ± 1.48 days, P < 0.001). Group B had a slightly lower number of retrieved oocytes compared to Group A (14.17 ± 7.30 vs. 14.96 ± 7.75, P = 0.024). However, comparable numbers of usable embryos on day 3 and good-quality embryos were found between the groups. Reproductive outcomes, including biochemical pregnancy loss, clinical pregnancy, miscarriage, and live birth rate, did not differ significantly between the groups. Multivariate logistic regression analyses suggested that the type of GnRH antagonist did not independently impact the number of oocytes retrieved, usable embryos, good-quality embryos, moderate to severe OHSS rate, clinical pregnancy, miscarriage, or live birth rate., Conclusion: The retrospective analysis revealed no clinically significant differences in reproductive outcomes between Cetrotide ® and Ferpront ® when used in women undergoing their first and second COS cycles utilizing the GnRH antagonist protocol., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Cao, Hu, Xiao, Li, Lin, Liu and Liu.)

Background: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so., Methods: This study uses two scenarios to cost the impact the CPTPP would have had on Thailand's 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated., Results: Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%., Conclusions: Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand's hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs., (© 2024. The Author(s).)

Background: The global prevalence of hepatitis B virus (HBV) has presented a persistent challenge for public health prevention and treatment. However, studies that assess the public's access to anti-HBV drugs are absent., Aim: To examine the availability, pricing, and affordability of anti-HBV drugs in Jiangsu province, China and provide recommendations for improvement., Method: An enhanced methodology developed by the World Health Organization (WHO) and Health Action International was applied in a cross-sectional study that included 1026 healthcare facilities distributed in 13 prefectural-level cities in Jiangsu province., Results: Since almost all drugs had an availability of less than 30%, the accessibility of anti-HBV drugs was notably low. Primary healthcare facilities had the lowest availability, reporting 1.4% for Original Brands (OBs) and 1.7% for lowest-priced generics (LPGs). Furthermore, the northern Jiangsu region recorded the lowest availability at 0.7%. LPGs demonstrated higher availability than OBs, with median availability probabilities of 2.6% and 1.4%, respectively. The drugs listed on the WHO Essential Medicines List exhibited higher availability than those on other lists. The median price ratios for OBs, LPGs, and volume-based purchasing drugs were 0.83, 0.50, and 0.27, respectively, less than 1.5 times the international reference price. Despite favorable pricing, affordability rate was 23% for urban residents and 0% for rural residents, which was discouraging., Conclusion: Low availability and affordability of anti-HBV drugs were observed. Policy recommendations should emphasize the improvement of LPG availability by incentivizing priority prescribing. Healthcare subsidies should be provided more effectively and equitably., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: Atrial fibrillation (AF) is the most common abnormal heart rhythm in elderly patients. Rivaroxaban has been widely used for stroke prevention. The anticoagulant response to rivaroxaban increases with age, which may make elderly patients susceptible to adverse outcomes resulting from small differences in bioavailability between generic and brand products., Methods: We designed a cohort study of ≥65-year-old inpatients with AF. Sociodemographic and laboratory measures of qualified patients who received brand or generic rivaroxaban for at least 72 hours at the study hospital from January 2021 to June 2023 were collected retrospectively. The primary outcome was the incidence of bleeding., Results: A total of 1008 qualifying patients were included for analysis, with 626 (62.1%) receiving brand rivaroxaban and 382 (37.9%) receiving generic rivaroxaban. After propensity score matching and weighting to account for confounders, the odds ratios comparing brand vs generic rivaroxaban (95% confidence intervals) for the bleeding was 1.15 (0.72-1.82). Results from subgroup analyses of patients with age ≥85, HAS-BLED score ≥ 3, containment of antiplatelet drugs, and female patients were consistent with the primary analysis., Conclusion: It provides evidence regarding the clinical safety outcome of generic rivaroxaban in the elderly AF population that may be particularly susceptible to adverse outcomes resulting from small allowable differences in pharmacokinetics., Competing Interests: The authors have no conflicts of interest to declare., (© 2024 Chen et al.)

Background: The 2013 ACC/AHA Guideline was a paradigm shift in lipid management and identified the four statin-benefit groups. Many have studied the guideline's potential impact, but few have investigated its potential long-term impact on MACE. Furthermore, most studies also ignored the confounding effect from the earlier release of generic atorvastatin in Dec 2011., Methods: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow's test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow's test was used to discern trend changes between generic atorvastatin availability and guideline potential impact., Results: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release., Conclusions: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline., (© 2024. The Author(s).)

Background: Healthcare systems worldwide face escalating pharmaceutical expenditures despite interventions targeting pricing and generic substitution. Existing studies often overlook unwarranted volume increases in multisource markets due to differential physician perceptions of brand name and generics., Objective: This study aims to explain the outpacing of generic medicine use over brand name use in multisource markets and assess the regulatory role, specifically examining the impact of reference pricing on volume and intensity increases., Methods: Analyzing German multisource prescription medicine markets from 2011 to 2014, we evaluate regulatory mechanisms and explore whether brand name and generic medicines constitute separate market segments. Using an Oaxaca-Blinder decomposition approach, we divide the differential in brand name versus generic medicine use rates into market structure and unobserved segment effects., Results: Generic use rates surpass same-market brand name substitution by 3.87 prescriptions per physician and medicine, on average. Reference pricing mitigated volume increase, treatment intensity and expenditure. Disparities in quantity and expenditure dynamics between brand name and generic segments are partially explained by market structure and segment effects., Conclusion: Generic medicine use effectively reduces expenditures but contributes to increased net prescription rates. Reference pricing may control medicine use, but divergent physician perceptions of brand name and generics, revealed by identified segment effects, call for nuanced policy interventions., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Blankart, Vandoros. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: US adults often overpay for generic prescription medications, which can lead to medication nonadherence that negatively impacts cardiovascular outcomes. As a result, new direct-to-consumer online medication services are growing in popularity nationwide. Amazon recently launched a $5/month direct-to-consumer medication subscription service (Amazon RxPass), but it is unclear how many US adults could save on out-of-pocket drug costs by using this new service., Objectives: To estimate out-of-pocket savings on generic prescription medications achievable through Amazon's new direct-to-consumer subscription medication service for adults with cardiovascular risk factors and/or conditions., Methods: Cross-sectional study of adults 18-64 years in the 2019 Medical Expenditure Panel Survey., Results: Of the 25,280,517 (SE ± 934,809) adults aged 18-64 years with cardiovascular risk factors or conditions who were prescribed at least 1 medication available in the Amazon RxPass formulary, only 6.4% (1,624,587 [SE ± 68,571]) would achieve savings. Among those achieving savings, the estimated average out-of-pocket savings would be $140 (SE ± $15.8) per person per year, amounting to a total savings of $228,093,570 (SE ± $26,117,241). In multivariable regression models, lack of insurance coverage (adjusted odds ratio [OR] 3.5, 95%CI 1.9-6.5) and being prescribed a greater number of RxPass-eligible medications (2-3 medications versus 1 medication: OR 5.6, 95%CI 3.0-10.3; 4+ medications: OR 21.8, 95%CI 10.7-44.3) were each associated with a higher likelihood of achieving out-of-pocket savings from RxPass., Conclusions: Changes to the pricing structure of Amazon's direct-to-consumer medication service are needed to expand out-of-pocket savings on generic medications to a larger segment of the working-age adults with cardiovascular risk factors and/or diseases., Competing Interests: Disclosures D.A. Oddleifson reports no conflicts of interest. Z. Zheng reports no conflicts of interest. R.K. Wadhera reports receiving research support from the National Heart, Lung, and Blood Institute (R01HL164561, K23HL148525) and serving as a consultant for Abbott, CVS Health, and Chambercardio, outside the submitted work., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Despite efforts made to reduce morbidity and mortality associated with malaria, especially in sub-Saharan Africa, malaria continues to be a public health concern that requires innovative efforts to reach the WHO-set zero malaria agenda. Among the innovations is the use of artemisinin-based combination therapy (ACT) that is effective against Plasmodium falciparum. Generic artemether-lumefantrine (AL) is used to treat uncomplicated malaria after appropriate diagnosis. AL is metabolized by the cytochrome P450 family of enzymes, such as CYP2B6, CYP3A4 and CYP3A5, which can be under pharmacogenetic influence. Pharmacogenetics affecting AL metabolism, significantly influence the overall anti-malarial activity leading to variable therapeutic efficacy. This study focused on generic AL drugs used in malarial treatment as prescribed at health facilities and evaluated pharmacogenomic influences on their efficacy., Methods: Patients who have been diagnosed with malaria and confirmed through RDT and microscopy were recruited in this study. Blood samples were taken on days 1, 2, 3 and 7 for parasite count and blood levels of lumefantrine, artemisinin, desbutyl-lumefantrine (DBL), and dihydroartemisinin (DHA), the active metabolites of lumefantrine and artemether, respectively, were analysed using established methods. Pharmacogene variation analysis was undertaken using iPLEX microarray and PCR-RFLP., Results: A total of 52 patients completed the study. Median parasite density from day 1 to 7 ranged from 0-2666/μL of blood, with days 3 and 7 recording 0 parasite density. Highest median plasma concentration for lumefantrine and desbutyl lumefantrine, which are the long-acting components of artemisinin-based combinations, was 4123.75 ng/mL and 35.87 ng/mL, respectively. Day 7 plasma lumefantrine concentration across all generic ACT brands was ≥ 200 ng/mL which potentially accounted for the parasitaemia profile observed. Monomorphism was observed for CYP3A4 variants, while there were observed variations in CYP2B6 and CYP3A5 alleles. Among the CYP3A5 genotypes, significant differences in genotypes and plasma concentration for DBL were seen on day 3 between 1/*1 versus *1/*6 (p = 0.002), *1/*3 versus *1/*6 (p = 0.006) and *1/*7 versus *1/*6 (p = 0.008). Day 7 plasma DBL concentrations showed a significant difference between *1/*6 and *1/*3 (p = 0.026) expressors., Conclusions: The study findings show that CYP2B6 and CYP3A5 pharmacogenetic variations may lead to higher plasma exposure of AL metabolites., (© 2024. The Author(s).)

Context: Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organization has created suboptimal care of patients with endocrine disorders., Evidence Acquisition: This review is based on evidence obtained from several databases and search engines including PubMed, Google, and Google Scholar; reference searches; manual searching for web pages of international regulatory bodies; and the authors' experience from different healthcare settings., Evidence Synthesis: After the expiry of a patent, generic versions with the opportunity for increased availability and a price reduction are expected. There are access barriers worldwide for many off-patent endocrine drugs. The high price is the main issue for several medicines including insulin, hydrocortisone, testosterone, and gonadotropins. This is caused by several factors including the market monopoly due to the lack of registered generics or suppliers limiting the benefit of competition and a complex supply chain. Additionally, the lack of some medicines has been concerning due to market factors such as the relatively small number of patients, making it less attractive for the manufacturers. Commissioning of nonprofit manufacturers and state manufacturing as well as strict price control measures could alleviate this situation., Conclusion: Lack of availability and disproportionate price inflation affecting essential off-patent endocrine therapies is common due to several interrelated factors. Global collaboration among healthcare organizations with the support of policymaking bodies might be needed to mitigate this., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Endocrine Society.)

Background: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017., Methods: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence., Results: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%])., Conclusion: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia., (© 2024. The Author(s).)

Objectives: Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia., Design: Comparative cross-sectional study., Setting: The availability of essential, generic medicines for chronic diseases was assessed at two public pharmaceutical supply agency hubs., Participants: The current study included public supply agency hub managers, warehouse managers and forecasting officers at the study setting., Outcomes: The assessment encompassed the availability of chronic medicines on the day of data collection, as well as records spanning 8 months before the outbreak and 1 year during the pandemic. A total of 22 medicines were selected based on their inclusion in the national essential drug list for public health facilities, including 17 medicines for cardiovascular disease and 5 for diabetes mellitus., Results: The results of the study indicate that the mean availability of the selected basket medicines was 43.3% (95% CI: 37.1 to 49.5) during COVID-19, which was significantly lower than the availability of 67.4% (95% CI: 62.2 to 72.6) before the outbreak (p<0.001). Prior to COVID-19, the overall average line-item fill rate for the selected products was 78%, but it dropped to 49% during the pandemic. Furthermore, the mean number of days out of stock per month was 11.7 (95% CI: 9.9 to 13.5) before the outbreak of COVID-19, which significantly increased to 15.7 (95% CI: 13.2 to 18.2) during the pandemic, indicating a statistically significant difference (p<0.001). Although the prices for some drugs remained relatively stable, there were significant price hikes for some products. For example, the unit price of insulin increased by more than 130%., Conclusion: The COVID-19 pandemic worsened the availability of essential chronic medicines, including higher rates of stockouts and unit price hikes for some products in the study setting. The study's findings imply that the COVID-19 pandemic has aggravated already-existing medicine availability issues. Efforts should be made to develop contingency plans and establish mechanisms to monitor medicine availability and pricing during such crises., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objectives: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs., Materials and Methods: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range)., Results: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001)., Conclusion: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines., (Copyright © 2024 Copyright: © 2024 Indian Journal of Pharmacology.)

Purpose: Due to constantly rising therapy costs, biosimilars and generic drugs have gained tremendous importance through recent decades. Nevertheless, the acceptance among healthcare workers regarding biosimilars and generic drugs in previously published international studies is considerably lower than the scientific data on equivalent safety and efficacy would suggest. The aim of this questionnaire-based survey was to determine the perception and knowledge regarding generic drugs and biosimilars by medical professionals from different healthcare facilities in Vienna, Austria., Methods: The online questionnaire was sent to public and religious hospitals in Vienna, including the university hospital "Vienna General Hospital." In addition, doctors' offices were reached by sending out the questionnaire in the weekly news of the Vienna Medical Association., Results: A total of 282 physicians and 311 graduated nurses took part in the study. 63% and 62% of the participants were convinced that generic respective biosimilar drugs were clinically equivalent to the original reference drug. On average, 1.6 out of 4 knowledge questions were answered correctly about generics, while only 0.87 out of 4 questions were answered accurately about biosimilars., Conclusion: The results of this study support the outcome from previous surveys demonstrating that a large proportion of healthcare professionals is still skeptical about generics and biosimilars. According to the results of this study, better education of the medical staff might ensure greater acceptance of these types of drugs., (© 2023. The Author(s).)

Market drugs including brand or generic with poor quality, don't meet the acceptable standard guidelines. Vildagliptin is an important antidiabetic drugs used in monotherapy or in combinations protocols for treatment of diabetes mellites. The main goal of the current study is to assess the pharmaceutical equivalence of two marketed generics of vildagliptin 50 mg tablets compared to the branded product (Galvus 50 mg). The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drug. The results revealed that all tested samples showed dissolution behavior like standard drug. Whole samples dissolution reached after 15 min in accordance with the standard. According to the similarity factors records, tested vildagliptin samples showed a comparable dissolution to the reference drug. The current work presents an in vitro protocol for quality evaluation of recently released generic drugs., (© 2024. The Author(s).)

Over the past several years, advances in research, treatment, and market dynamics have impacted treatment strategies in chronic myeloid leukemia in chronic phase (CML-CP). They include the broader availability of cost-effective generic imatinib, and soon other generic second-generation tyrosine kinase inhibitors (TKIs). Access to affordable generics means that all patients with CML-CP should have access to safe and highly effective lifelong therapies. When overall survival is the treatment endpoint, imatinib provides a good treatment value. Second-generation TKIs may be the best frontline strategy when treatment-free remission is the goal. Recent studies have shown maintained efficacy and reduced toxicity when TKIs are used at reduced dosing. Reduced-dose schedules of second-generation TKIs (which are less toxic and induce faster deep molecular responses) may render generic second-generation TKIs a more attractive treatment option. Adjusting the dose of TKI in the presence of mild-to-moderate, or even severe but reversible, adverse events may be preferable to switching to a different TKI. The selection of second-line and beyond therapies depends on the evolving patterns observed with frontline treatment. Dose-adjusted ponatinib schedules have demonstrated improved efficacy and safety in patients resistant to second-generation TKIs or those with T315I-mutated disease. For asciminib, longer-term follow-up is needed to better evaluate its safety and efficacy compared with ponatinib. Allogeneic stem cell transplantation represents a valid alternative to newer-generation TKIs, with a better treatment value when TKIs are priced at >$40,000/year.

Purpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs., Patients and Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge. For each type of transplant and immunosuppressive agent, the benefit-risk profile of generic vs branded drugs in a two-year window was estimated by multivariate Cox models (HR; 95% CI). Furthermore, the potential cost savings per person associated with one year of treatment using generics were calculated., Results: The utilization of generic drugs showed a significant increase; over the study years, the proportion of users among kidney recipients ranged from 14.2% to 40.5% for TAC, from 36.9% to 56.7% for MYC, and from 18.2% to 94.7% for CsA. A great variability in generic uptake for region was found. A comparable risk-benefit profile between generic and branded formulations was shown for all immunosuppressors considered. Choosing generic immunosuppressants during maintenance could result in yearly savings of around 2000 euros per person for each therapy ingredient., Conclusion: The study shows an increasing proportion of patients using generic immunosuppressive drugs over time suggesting a growing acceptance of generics within the transplant community and reveals comparable risk-benefit profiles between the generic and branded formulations of TAC, CsA, and MYC. A significant variability in the use of generics immunosuppressive agents was found both at the regional level and among transplant centers and future research should delve into regional prescribing variations., Competing Interests: The authors report no conflicts of interest in this work., (© 2024 Finocchietti et al.)

Objective: The demand for generic tacrolimus is enormous. Our randomized trial was an open-label single-dose testing with four-periods and two-sequences; we aimed to evaluate the bioequivalence between a generic and branded tacrolimus by establishing their area under concentration-time curve (AUC) predictive equations. For better comparison, each tacrolimus served either as test vs. reference in sequence 1 or vice versa as reference vs. test in sequence 2., Methods: Forty healthy subjects were randomized into two groups, namely a sequence 1 group (N = 20 in test-reference-test-reference) or sequence 2 (N = 20, reference-test-reference-test) received a test tacrolimus (Ruibeirong®; Chengdu Shengdi Medicine Co., Ltd.) and a reference tacrolimus (Astagraf XL®, Astellas Ireland Co., Ltd.) under the fasting condition with a wash-out period of ≥14 days between every two phases. Blood samples were collected sequentially until 120 h after oral administration of tacrolimus., Results: A 95% upper confidence bound was -0.05% for the peak concentration (C max ), -0.02% for the AUC from 0 to the last time point (AUC 0-t ), and - 0.02% for the AUC from 0 to infinity (AUC 0-∞ ). The geometric least square means ratio (test/reference) with 90% of confidence interval (CI)) was 96.10% (90.58%-101.95%) for C max , 93.80% (88.52%-99.39%) for AUC 0-t , and 94.34% (89.20%-99.77%) for AUC 0-∞ . Meanwhile, the ratio of within-subject standard deviation of test/reference (σ WT/WR ) with 90% CI was 0.66 (0.50-0.86) for C max , 0.73 (0.55-0.96) for AUC 0-t , and 0.75 (0.57-0.98) for AUC 0-∞ . These results fulfilled the bioequivalence criteria by the Food and Drug Administration. Both products showed acceptable safety. Moreover, the AUC predictive equations (by linear regression plus limited sampling strategy) with 2-5 sampling time point showed the high performance (all R > 0.970, predictive error (PE) >0.5%, absolute PE <5.1%, which were interchangeable between test and reference products., Conclusion: Generic tacrolimus (Ruibeirong®) is bioequivalent to branded tacrolimus (Astagraf XL®) with tolerable safety, which AUC predictive equations work well and are interchangeable between the two products., Competing Interests: Declaration of Competing Interest None., (Copyright © 2023 Elsevier B.V. All rights reserved.)

Objectives: To assess the effectiveness of generic sofosbuvir (SOF) and branded daclatasvir (DCV) for the treatment of chronic hepatitis C virus (HCV)infected patients., Methods: This retrospective study, performed in a single center in Saudi Arabia between August 2017 and July 2022, we enrolled 140 consecutive patients with HCV who received generic SOF and branded DCV. The primary outcome was sustained virologic response at week 12 (SVR12)., Results: The majority of the patients were female (62.1%), infected with genotype 4 (57.9%), and treatment-naïve in 120 (85.7%) patients with baseline cirrhosis in 55 (39.3%). The mean patient age was 61±13.6 years. In the intention-to-treat analysis, 131 (93.6%) patients achieved SVR12. Moreover, 85.7%, 100%, 100%, 88.9%, and 96.3% of genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. In the per-protocol analysis, 131 (96.3%) patients achieved an SVR of 12. Additionally, 92.3%, 100%, 100%, 88.9%, and 98.7% of the patients with genotypes 1a, 1b, 2, 3, and 4, respectively, achieved SVR12. No HCV virologic breakthroughs occurred. In the subgroup analysis, SVR12 rates were comparable regardless of baseline characteristics, such as treatment history, cirrhosis, and hepatocellular carcinoma. Patients achieving SVR12 showed a significant improvement in post-treatment serum liver enzyme and total bilirubin levels., Conclusion: The findings of our study confirm the effectiveness of generic sofosbuvir as a treatment option for HCV infection., (Copyright: © Saudi Medical Journal.)

Background: South Africa is home to a multi-ethnic society with a large range of cultures and lifestyles. Cardiovascular disease is a major cause of morbidity and mortality. South Africa is known to have one of the highest incidence rates of hypercholesterolaemia in the world, especially among the Caucasian population., Aim: The aim of this retrospective chart review was to establish whether a multisource simvastatin (Simvotin ® , Ranbaxy, a Sun Pharma company) maintained the cholesterol-lowering effect after switching from the innovator brand Zocor ® (MSD South Africa) in the public-sector hospitals. Since prescribers often doubt the registration requirements of multisource products based on bioequivalence alone, this research was done to confirm similar clinical outcomes in a real-world setting., Methods: More than 200 charts were identified from patients treated for hyperlipidaemia. Patients were treated for at least six months prior to and again six months after the switching of brands in order to meet criteria to be eligible for inclusion. The lipid values at initiation of therapy as well as before switching (visit 1 and 2) had to be available and again six months after treatment on the multisource product (visit 3)., Results: No significant change was observed in the lipid control after switching, confirming similarity., Conclusion: This real-world evidence should allay any fears of generic inferiority of this important medicine in the treatment and prevention of high cardiovascular risk in patients requiring lipid-lowering therapy.

Objective: To describe the evolution in use and cost of antiseizure medications (ASM) in the United States of America (USA)., Methods: Retrospective descriptive study using the IBM MarketScan Commercial Database (data of privately-insured patients) for the years 2006 to 2021. We identified patients with epilepsy who were on ASM. We adjusted cost for inflation with the Gross Domestic Product Implicit Price Deflator., Results: We evaluated 347,158 patients (46.9 % males; median (p 25 -p 75 ) age: 33 (17-49) years; 28 % with pediatric-onset epilepsy and 72 % with adult-onset epilepsy) with a total of 1,385,382 person-years and 588,285,065 ASM prescription days. The most commonly prescribed (as percentage of prescription days) ASMs in 2006 were valproate (18 %) and lamotrigine (17 %) in pediatric-onset epilepsy and phenytoin (21 %) and carbamazepine (17 %) in adult-onset epilepsy, but starting in the 2010s, levetiracetam and lamotrigine became the most commonly prescribed ASMs in both pediatric-onset (in 2021, levetiracetam 25 %, lamotrigine 16 %) and adult-onset (in 2021, levetiracetam 27 %, lamotrigine 20 %) epilepsy. The proportion of generic ASM use increased 3.6-fold: from 23 % of prescription days in 2006 to 83 % of prescription days in 2021. The median (p 25 -p 75 ) average wholesale price (AWP) per person-year increased by 102 % from $2,684 ($990-$5,509) in 2006 to $5,417 ($2,858-$12,310) in 2021. The increases were greater in absolute terms for brand-name ASMs by 419 %: $3,109 ($1,564-$5,068 in 2006 and $16,149 ($12,950-$23,377) in 2021 than for generic ASMs by 462 %: $699 ($457-$1,678) in 2006 and $3,931 ($2,618-$6,081) in 2021. The costs directly borne by the patient (copay, coinsurance, deductibles, and pharmacy processing fees) increased by 69 % for brand-name ASMs from $393 ($246-$570) in 2006 to $665 ($335-$1,308) in 2021, but decreased by 37 % for generic ASMs from $147 ($98-$213) in 2006 to $92 ($51-$141) in 2021., Conclusions: The median cost of ASMs per person-year approximately doubled from 2006 to 2021. The increase in use of generic ASMs probably helped buffer the growing costs of ASMs. However, generic ASMs already represent 83 % of prescription days in 2021, with limited room to further contain costs by just increasing the proportion of generics., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest related to this manuscript., (Copyright © 2023. Published by Elsevier Ltd.)

Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication. Drug repurposing has important advantages including reduced development time and costs, and potentially large societal healthcare cost savings. However, current generic drug repurposing research faces a number of challenges in obtaining research funds. Furthermore, regardless of the success of a repurposing trial, commercial parties often lack interest in pursuing marketing authorisation for financial reasons, and academic researchers lack the knowledge, time and funding. Therefore, the new indication of a repurposed drug often does not make it 'on label'. We propose a large increase in public funding for generic drug repurposing research, including funds for the marketing authorisation process when a trial is successful, and a reduction in the regulatory burden of the marketing authorisation process for repurposed generic drugs., (© 2023. The Author(s).)

Purpose: Immediate-release forms of generic mixed amphetamine salts (MAS) have been the subject of passive surveillance reports signaling lack of effectiveness. We examined switching patterns that might suggest whether long-term users of specific MAS are more likely to switch away or switch back after use of the MAS of interest in the FDA's Sentinel Distributed Database., Methods: We required at least 60-day continuous supply of selected MAS grouped by Abbreviated New Drug Application (ANDA) to describe patterns of switching away from and to generics approved under the ANDAs of interest among individuals ages 15-64 years with attention deficit hyperactivity disorder or narcolepsy during 2013-2019., Results: We observed the greatest number of treatment episodes for ANDA 040422 (n = 525 771), followed by ANDA 202424 (n = 181 693), ANDA 040439 (n = 62 363), ANDA 040440 (n = 21 143), and ANDA 040480 (n = 8792). Of those with switches away from their original ANDA, episodes initiated on generic products under ANDA 040422 (48.6%) and ANDA 202424 (43.0%) were most likely to switch back, while those initiated on generic product under ANDA 040480 were least likely (24.1%). Of those episodes with switches to a generic under an ANDA of interest, about one-third (range 27.1% to 37.0%) switched back to the same product. These switches back had a median time to switch of about 30 days., Conclusions: These descriptive analyses, although subject to limitations, did not suggest increased switching away or switching back after use of the generics of interest. Continued post-marketing surveillance is warranted., (© 2023 John Wiley & Sons Ltd. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA.)

Background: Although generic drugs have been approved with the assurance of interchangeable applications with original drugs, some physicians, and patients still view their efficacy and interchangeability negatively. Using real-world data, we aimed to determine factors that impact switching between drugs that contain the same active ingredient, i.e., atorvastatin, and, in turn, whether this 'switch' could alter clinical outcomes., Methods: Using the National Health Insurance Service senior cohort, a retrospective cohort study was conducted to assess patients who had newly started atorvastatin 10 mg and had at least two records of national health examinations from 2010 to 2014. Drug switching, which was defined as a change in the atorvastatin product administered 90 days before the first and second examinations, was assessed. Greedy propensity score matching (1:2) was performed between switchers and non-switchers to control for potential confounders. Factors influencing switching were analyzed using multivariate logistic regression to estimate odds ratios and 95% confidence intervals (CIs). Changes in low-density lipoprotein-cholesterol (LDL-C) levels attributable to drug switching were evaluated using difference-in-differences regression., Results: A total of 1,588 patients were included, of whom 25.3% switched drugs (1,187 non-switchers and 401 switchers). Compared to patients taking generics before the first examination, those taking the original drugs had a lower odds ratio (0.31; 95% CI [0.21, 0.46]) for subsequent drug switching. A change in medical institution was associated with a significantly higher odds ratio (6.83; 95% CI [4.66, 10.02]). There were no significant differences in LDL-C alterations between switchers and non-switchers (0.42 mg/dL; 95% CI [-2.29, 3.13])., Conclusion: The type of first-time drug administered and changes in medical institution can influence drug switching. No significant changes in LDL-C values were observed in the various switching scenarios between the original and generic drugs, suggesting their interchangeable application in real-world clinical practice., (© 2023. BioMed Central Ltd., part of Springer Nature.)