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Policy makers and insurers promote the use of generic drugs because they can deliver large savings without sacrificing quality. But these efforts meet resistance from the public, who perceive generic drugs as inferior substitutes for brand name counterparts. Building on literature showing that negative emotions reduce risk-taking, the authors hypothesize that receiving bad medical news (i.e., negative information about one's health) prompts patients to favor brand name over generic drugs as means to safeguard their health. The evidence exploits low-density lipoprotein cholesterol test results, where a discontinuity from clinical guidelines enables the authors to estimate the causal effect of bad medical news. Using data covering patients' prescription drug choices across drug classes, the authors find that patients receiving bad medical news become 8% more likely to choose the brand name alternative. The findings are reinforced by a secondary analysis incorporating the similar context of hemoglobin A1c (blood sugar) testing. The authors also find that bad medical news reduces preferences for generics most strongly among drugs of direct clinical relevance for each test, but the effect also manifests among non–clinically relevant drugs. [ABSTRACT FROM AUTHOR]

ABSTRACT Levetiracetam (LEV) is an anti‐epileptic drug used extra‐label in dogs. Commercially available extended‐release formulations (LEV‐ER), administered twice daily, cannot be crushed or split, limiting their use in small dogs. A compounded LEV‐ER formulation (PO‐COMP) can purportedly be partitioned without loss of extended‐release properties. The aims of this study were to establish the pharmacokinetic parameters of PO‐COMP, divided at the tablet score, and determine the bioequivalence of partitioned PO‐COMP to an intact commercially available Food and Drug Administration‐approved human oral generic formulation of LEV‐ER (PO‐COMM). In a randomized crossover design, 12 healthy dogs received a single IV dose (30 mg/kg) of IV‐COMM, a single oral dose (500 mg) of intact PO‐COMM, or a single oral dose (500 mg) of partitioned PO‐COMP and underwent serial measurement of plasma LEV concentrations over 24 h. PO‐COMP was bioequivalent to PO‐COMM using the 90% confidence interval method for maximum concentration (−3.2% difference [CI −7.4% to −1.1%]) and area under the curve (−14.4% difference [CI −17.8% to 10.8%]). PO‐COMP may improve medication adherence and seizure control relative to immediate‐release LEV, which requires three times daily dosing. Efficacy studies of PO‐COMP are warranted. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Unlike small molecule drugs and generic products, the active component of biologics and biosimilars are not identical chemical entities. Despite bioequivalence, there is limited evidence in clinical practice (i.e. Phase IV post-marketing surveillance) regarding the safety of biosimilar rituximab and even less so for "switching therapy" with respect to safety. Drug substitution by switching aims to realise cost savings by changing therapy involving a reference (biologic) product to a biosimilar. A retrospective analysis of safety outcomes including treatment-emergent adverse effects (TEAEs), rates of death and discontinuation of therapy, for all patients that received switching therapy (from reference to biosimilar rituximab, n = 33) was compared to patients who did not did not switch therapy (received biosimilar rituximab only, n = 18) at an Australian metropolitan cancer centre, over a six-month period. There was no statistical significant differences for any safety outcomes examined. Switching therapy for patients receiving rituximab does not lead to poorer safety outcomes. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the pharmacokinetics (PKs) and safety of a generic drug, linezolid, compared to those of a reference drug in healthy Chinese subjects under both fasting and fed conditions. This was a randomized, open‐label, 2‐period, 2‐sequence crossover study. The subjects received a single dose of the test or reference drug, linezolid (600 mg), in each period. The PK parameters were calculated using a non‐compartmental method and compared between the 2 drugs. Bioequivalence was analyzed using geometric mean ratios (GMRs) of the 2 formulations and their corresponding 90% confidence intervals (CIs). The safety of the 2 formulations was assessed under both fasting and fed conditions. Forty‐eight subjects completed the study, 24 each in the fasting and feeding groups. The average plasma concentration‐time patterns of linezolid were similar for both medications under both conditions. The GMR and 90% CIs of the maximum plasma concentration and the area under the plasma concentration‐time curve of linezolid were ranged from 0.80 to 1.25. Both drugs were well tolerated with a similar incidence of adverse drug reactions. In conclusion, the PK and safety profiles of the 2 formulations were comparable. Food intake did not influence the PK profiles of linezolid. These results suggest that the test drug can be used as an alternative to reference drugs. [ABSTRACT FROM AUTHOR]

Importance: The exceedingly high US spending per capita on prescription medications is mediated, at least in part, by the inefficiencies of existing generic pharmaceutical distribution and reimbursement systems; yet, the extent of potential savings and areas for targeted interventions for generic drug prescribers remains underexplored. Objective: We aimed to analyze 2021 Medicare Part D spending on generic drugs in comparison with pricing of a low-cost generic drug program, the Mark Cuban Cost Plus Drug Company (MCCPDC), to gauge the extent of achievable potential savings. Design, Setting, and Participants: In this retrospective, observational study, we performed a systematic analysis of potential Medicare Part D savings when using MCCPDC generic pricing. The 2023 MCCPDC data, as of August 2023, were obtained from the provider's publicly available database. The 2021 Medicare Part D data and prescriber datasets were obtained from the US Centers for Medicare and Medicaid Services. Main Outcomes and Measures: Outcomes included total prescription volume, proportion of drugs with savings, total US dollar Medicare savings, and average weighted price reduction per unit drug. Results were stratified by medical and surgical subspecialties to identify areas for targeted interventions. Subspecialty-wise contribution to total savings versus contribution to total prescription volume was characterized. Results: Total estimated Medicare Part D savings were $8.6 billion using 90-day MCCPDC pricing, with surgical drugs accounting for over $900 million. Nearly 80% of the examined drugs were more price effective through MCCPDC using 90-day supply. Commonly prescribed drugs in cardiology, psychiatry, neurology, transplant surgery, and urology demonstrated the highest estimated absolute savings. The most disproportionate savings relative to prescription volume were observed for drugs in oncology, gynecology, infectious disease, transplant surgery, and colorectal surgery. Conclusions and Relevance: This study underscores the significant potential for Medicare Part D savings through strategies that address the systemic overpayment for generic medications. We identified key areas for reform as well as specific medical and surgical subspecialties where targeted interventions could yield substantial savings. [ABSTRACT FROM AUTHOR]

COPD and asthma are two of the most common chronic lung diseases, affecting over 545 million people globally and 34 million in the United States. Annual health care costs related to chronic lung disease are estimated at €380 billion in the European Union, and $24-$50 billion in the United States averaging to $4,000 in out-of-pocket costs per person in the U.S. A full-text literature search was conducted for English publications between January 1, 2005-March 18, 2024. It returned over 5,000 publications that were further narrowed using key search words, resulting in 172 peer-reviewed articles. Using their experience and subject expertise, the authors further narrowed the peer-reviewed articles to 55 that were in their opinion relevant. Also, 38 recently published industry reports and news articles specific to downstream effects of inhaler market changes and the future impact were included. The literature suggests that individuals with chronic lung disease face increased challenges with access to inhaled medication due to rising medication costs, discontinuation of branded medications, introduction of generic medications not covered by insurance, exclusionary preferred drug list tactics that force health care providers into non-medical switching of medication or devices, and ongoing medication shortages. Providers experience ongoing hurdles in prescribing appropriate inhaled medications for individuals with chronic lung disease, including increased time and costs spent on administrative tasks due to inhaler denials, a loss of patient trust, and limits on their ability to prescribe appropriate inhaled medication for individuals with chronic lung disease. [ABSTRACT FROM AUTHOR]

Repurposing generic drugs as new treatments for life-threatening diseases such as cancer is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. Nonprofit organizations and other non-manufacturers have been ramping up efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these nonmanufacturers find it difficult to obtain regulatory approval in the U.S. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs. This limits the broad clinical adoption of these drugs and patient access. In this paper, we explore the regulatory landscape for repurposing of small molecule generic drugs within the U.S. We describe case studies of repurposed drugs that have been successfully incorporated into clinical treatment guidelines for cancer without regulatory approval. To encourage greater adoption of generic drugs in clinical practice-that is, to encourage the repurposing of these drugs-we examine existing Food and Drug Administration (FDA) pathways for approval of new uses or indications for generic drugs. We show how non-manufacturers, who are generally more active in generic drug repurposing than manufacturers, could utilize existing regulatory authorities and pathways, and we describe the challenges they face. We propose an extension of the existing 505(b)(2) new drug application (NDA) approval pathway, called a "labeling-only" 505(b)(2) NDA, that would enable non-manufacturers to seek approval of new indications for well-established small molecule drugs when multiple generic products are already available. It would not require new chemistry, manufacturing, and controls (CMC) data or introducing new drug products into the marketplace. This pathway would unlock innovation broadly and enable patients to benefit from the enormous potential of low-cost generic drugs. [ABSTRACT FROM AUTHOR]

ABSTRACT A three‐arm comparative clinical endpoint bioequivalence (BE) study is often used to establish bioequivalence (BE) between a locally acting generic drug (T) and reference drug (R), where superiority needs to be established for T and R over Placebo (P) and equivalence needs to be established for T vs. R. Sometimes, when study design parameters are uncertain, a fixed design study may be under‐ or over‐powered and result in study failure or unnecessary cost. In this paper, we propose a two‐stage adaptive clinical endpoint BE study with unblinded sample size re‐estimation, standard or maximum combination method, optimized allocation ratio, optional re‐estimation of the effect size based on likelihood estimation, and optional re‐estimation of the R and P treatment means at interim analysis, which have not been done previously. Our proposed method guarantees control of Type 1 error rate analytically. It helps to reduce the average sample size when the original fixed design is overpowered and increases the sample size and power when the original study and group sequential design are under‐powered. Our proposed adaptive design can help generic drug sponsors cut cost and improve success rate, making clinical study endpoint BE studies more affordable and more generic drugs accessible to the public. [ABSTRACT FROM AUTHOR]

A comparative evaluation of the brand-name drug Mycospor and six generic drugs (IWAKI, Bifonol, F, YD, Sawai, and TEVA), all comprising a cream formulation containing the antifungal drug bifonazole, was performed based on physicochemical measurements. The pH of the various formulations was significantly higher for the generics Bifonol (pH 7.1), Sawai (pH 6.7), and TEVA (pH 7.3) and significantly lower for YD (pH 4.3) than for the brand-name drug Mycospor (pH 5.5). The viscosity of the various formulations was significantly higher for TEVA (25,011 mPa·s) versus Mycospor (22,376 mPa·s) and significantly lower for IWAKI, Bifonol, F, YD, and Sawai, with Bifonol (8,572 mPa·s) being particularly low. Considering the hysteresis loop area obtained for the shear rate vs. shear stress, which represents the thixotropic properties, and using the value of Mycospor as the reference for 100%, YD (179%), Sawai (557%), and TEVA (201%) showed significantly higher values. Furthermore, the membrane permeability of bifonazole at 24 hours was significantly higher for Bifonol (309 µg/mL) and F (182 µg/mL) and significantly lower for Sawai (124 µg/mL) and TEVA (92 µg/mL) than for Mycospor (153 µg/mL). Finally, optical micrographs showed that the dispersion of particles was similar in the various formulations, but the particles of F and TEVA were uniformly dispersed with a smaller particle size than the other formulations. Overall, significant differences were observed in the formulation characteristics between the brandname drug and generic drugs, which were attributed to differences in the manufacturing process and the types of additives. [ABSTRACT FROM AUTHOR]

Background/Objectives: For locally applied, locally acting generic drug products, comparison to an originator product based on systemic exposure is usually not feasible due to low plasma concentrations and inadequate reflection of local exposure at the site of action. Where a validated PD model exists, a comparative clinical study can be performed in healthy subjects; where no surrogate endpoint is available, patients with the relevant indication need to be enrolled, with all the associated factors which could result in lack of sensitivity. Even though the need for alternative in vitro approaches has been acknowledged by both industry and regulatory bodies, the complexity of in vivo drug delivery processes makes the development of guidance documents particularly difficult. Our objective was to present in vitro approaches less classically used and to address in vivo relevance of the selected tests. Methods: This article analyses current regulatory approaches in Europe and the U.S., and highlights the key advantages of in vitro tests in terms of their sensitivity, reliability, reproducibility and in vivo relevance using locally applied flurbiprofen in various formulations. Results: The in vitro esophageal retention (IVOR) model demonstrates that the first 6–10 min after application of different flurbiprofen formulations is important for their comparison and also offers the best correlation with in vivo data using the partial area under the concentration-time curves (pAUCs). Rheological evaluations further demonstrated that the mucoadhesive properties of the gel spray formulation are based on interaction with mucin. Conclusions: Designing a relevant in vitro test requires adequate evaluation of the complexity of the drug substance, drug product, dosing conditions and delivery processes. [ABSTRACT FROM AUTHOR]

This study was conducted as a single‐site, open‐label, randomized, replicated crossover trial with 4 treatment periods. The aim was to evaluate the bioequivalence of a generic test drug containing velpatasvir and sofosbuvir compared to an established brand‐name medication in healthy White subjects under fasting conditions. Blood samples were collected at specified intervals up to 72 hours after dosing to measure the concentrations of velpatasvir and sofosbuvir using a certified high‐performance liquid chromatography with tandem mass spectrometry method. The bioequivalence of the 2 formulations was confirmed when statistical analysis showed that confidence intervals for the log‐transformed peak concentration and area under the concentration‐time curve from time 0 to the last quantifiable sample were within an acceptable range from 80% to 125%. Criteria for bioequivalence were met for both area under the concentration‐time curve from time 0 until the last quantifiable sample and peak concentration parameters. No adverse effects were reported during this trial in both groups. [ABSTRACT FROM AUTHOR]

By September 2024, the Centers for Medicare and Medicaid Services (CMS) will publicly report the negotiated prices (Maximum Fair Prices) for the first 10 drugs selected for price negotiation. We estimate initial price offers based on net prices, statutorily defined ceilings, and comparative effectiveness data for the 10 drugs and their therapeutic alternatives. We utilized net prices and other price benchmarks for the 10 drugs and their therapeutic alternatives. We searched for data on comparative clinical effectiveness for the primary indications. We outlined a range of plausible initial price offers based on CMS guidance and our interpretation of regulatory intent. For ibrutinib and ustekinumab, statutorily defined ceiling prices will likely determine the initial price offers. The integration of net pricing and clinical evidence from comparator branded products will inform the initial price offers for apixaban, empagliflozin, etanercept, and insulin aspart. Rivaroxaban and sacubitril/valsartan have therapeutic alternatives that are generics; therefore, CMS may apply a discount to current net prices. To achieve savings in the negotiation of dapagliflozin and sitagliptin, CMS will have to leverage additional negotiation factors because statutory defined ceilings and net prices of therapeutic alternatives are similar or higher. This analysis sheds light on important price benchmarks and clinical evidence factors for the determination of the initial price offers. Although we were not able to simulate the offer and counter-offer process, our findings provide a transparent and systematic way to produce initial offers that are consistent with CMS guidance. • The Centers for Medicare and Medicaid Services will publicly report the negotiated prices (Maximum Fair Prices) for the first 10 drugs selected for price negotiation. • We report an estimate of the initial price offers to inform negotiation. • This analysis sheds light on important price benchmarks and the integration of comparative clinical evidence for the determination of the initial price offers. [ABSTRACT FROM AUTHOR]

Background: The emergency department is a place where patients require immediate treatment and care. It is the specialty that cares for patients at risk. Doctors face challenges in rationalizing, choosing, and initiating appropriate drug therapy for patients admitted to emergency medicine. They also encounter problems with medication errors and adverse drug events. Hence, a prescription-based survey is one of the most effective methods for analyzing the prescribing patterns of drugs and the prescribing behavior of physicians. The core drug use indicators developed by the World Health Organization (WHO) are more informative and feasible. These include prescribing, patient care, and health facility indicators. Aims and Objectives: (i) The aim of this study was to study, assess, and evaluate the rationality of prescription pattern in emergency department in a particular region and (ii) to understand whether prescription pattern is in accordance with the WHO core prescribing indicators or not? Materials and Methods: Details regarding the age and gender of the patient, the reason for admission, diagnosis made, treatment given, the number of drugs per prescription, drugs prescribed by generic name, drugs prescribed from the essential drug list, dosage, refills, and dosage forms were collected. The rationality of the prescriptions was assessed and evaluated using these indicators. Results: In the present study, the average number of drugs per prescription was 4.6, injections were prescribed in 84.8%, antibiotics in 43.2%, and the generic name was mentioned in 50.8%. In addition, 72.8% of the drugs were prescribed from the essential drug list. Descriptive and inferential statistical analyses were used. The Student's t-test was employed to compare inter-group variation for continuous variables. The Chi-square test was used to compare categorical variables. Conclusion: Among the study population, approximately three-fourths belonged to the age group of 20-60 years, and two-thirds were males. The majority of patients came due to injuries, including road traffic accidents, followed by respiratory illnesses (26.4%) and gastrointestinal ailments (15.6%). Among the prescriptions studied, all had the drug name legibly written, 93.3% had the dose mentioned, and 86.5% had the frequency mentioned. The most common route of administration was parenteral (76.6%), followed by oral (19.3%). In the present study, the average number of drugs per prescription was 4.6, injections were prescribed in 84.8%, antibiotics in 43.2%, and the generic name was mentioned in 50.8%. [ABSTRACT FROM AUTHOR]

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Background: Osteoarthritis (O.A.) is a common degenerative lesion of the articular cartilage that corresponds to hypertrophy deterioration of bone structure is osteoarthritis. The treatment is mainly focused on the management of pain. Methods: An Observational study was conducted among 163 patients visiting Orthopedics Out Patient Department at GMC Hospital. The duration of study was for 6 months from Jan 2024-Jun 2024. The analysis of collected data was done by SPSS version Software. Descriptive Statistics tools like frequency, Percentage were used to express the findings. Results: We found that female was (68.7%) in comparison to male (31.3%). Oral route (79%) was most commonly preferred route of drugs administration than topical route (21%). Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) (41.78%), Vitamins and minerals (22.5%), Antiulcers (19.5%), Symptomatic Slow-acting Drugs in Osteoarthritis (SYSODA) (6.82%), Muscle Relaxants (5.02%) and Others (4.07%) were Prescribed groups of drugs. Diclofenac (19.52%) was most commonly prescribed Non-Steroidal Anti-Inflammatory Drugs followed by Aceclofenac (11.37%). Average no. of drugs prescribed was 5.12, % of drugs Prescribed from National List of Essential Medicine (NLEM) was 79.88%, % of drugs prescribed by generic name was 0% and Average dispensing time was 225.13 sec. Conclusion: Osteoarthritis (O.A) was mostly common in female than male. Lumbar was most commonly affected site of Osteoarthritis. Non-Steroidal Anti-Inflammatory Drugs was most commonly prescribed groups of drugs. [ABSTRACT FROM AUTHOR]

The COVID-19 global pandemic, over the last year and a half, has managed to create massive disruptions in global supply chains and exposed their vulnerabilities, thereby reemphasizing the importance of resiliency. The current study aims to identify and prioritize, through the quantitative decision-making technique of Interpretive Structural Modelling (ISM), a set of barriers to resiliency for the pharmaceutical supply chain in India. The rationale behind choosing the Indian pharmaceutical supply chain was that the pharmaceutical sector in India supplies over half of the global demand for vaccines and generic drugs, and the trajectory of growth is indicated around US$100 billion by the year 2025, along with exporting pharmaceutical products to nearly 200 destination countries. The findings of the current study are expected to aid the decision-makers in evaluating the relative criticality and the interrelationship between the potential (and critical) barriers to supply chain resiliency, and in turn to develop strategic plans. This, in turn, can help to combat unforeseen supply chain disruptors such as COVID-19. This methodology and the findings of the study can be generalized for other supply chains. [ABSTRACT FROM AUTHOR]

Background: Decision-makers in middle-income countries need evidence on the cost-effectiveness of COVID-19 booster doses and oral antivirals to appropriately prioritise these healthcare interventions. Methods: We used a dynamic transmission model to assess the cost-effectiveness of COVID-19 booster doses and oral antivirals in Fiji, Indonesia, Papua New Guinea, and Timor-Leste. We conducted cost-effectiveness analysis from both healthcare and societal perspectives using data collated from publicly available sources. We developed an interactive R Shiny which allows the user to vary key model assumptions, such as the choice of discounting rate, and view how these assumptions affect model results. Findings: Booster doses were cost saving and therefore cost-effective in all four middle-income settings from both healthcare and societal perspectives using 3% discounting. Providing oral antivirals was cost-effective from a healthcare perspective if procured at a low generic price (US$25) or middle-income reference price (US$250); however, their cost-effectiveness was strongly influenced by rates of wastage or misuse, and the ongoing costs of care for patients hospitalised with COVID-19. The cost or wastage of rapid antigen tests did not appear strongly influential over the cost-effectiveness of oral antivirals in any of the four study settings. Conclusions: Our results support that COVID-19 booster programs are cost-effective in middle-income settings. Oral antivirals demonstrate the potential to be cost-effective if procured at or below a middle-income reference price of US$250 per schedule. Further research should quantify the rates of wastage or misuse of oral COVID-19 antivirals in middle-income settings. [ABSTRACT FROM AUTHOR]

This document contains summaries of various research studies in the field of pharmacology and drug development. The studies cover a range of topics, including pharmacokinetic modeling, drug distribution, safety, dosing recommendations, cardiac safety, and the relationship between zinc deficiency and liver damage. The summaries are culturally sensitive and respectful of diverse perspectives, presenting the information objectively without adopting any judgments or biases. This document contains summaries of various research studies related to pharmacokinetics and drug interactions. The studies cover a range of topics, including the safety and efficacy of different medications, the impact of drug-drug interactions on exposure, and the demographic representation in clinical trials. The findings provide valuable insights into the pharmacokinetics of these drugs, potential drug interactions, and the need for diversity in clinical trial populations. Overall, these studies contribute to our understanding of drug safety and optimization of dosing regimens. [Extracted from the article]

Introduction: Prescription patterns significantly impact healthcare quality and patient outcomes. Evaluating these patterns using World Health Organisation (WHO) indicators helps identify areas for improvement and ensures rational drug use. The present study was conducted to evaluate prescription patterns via WHO indicators, aiming to uncover insights, identify discrepancies and enhance prescription quality within the institute for improved healthcare outcomes. Aim: To evaluate drug prescription patterns using WHO prescription indicators in the prescriptions of outdoor patients at a tertiary care teaching hospital in Chhattisgarh, India. Materials and Methods: A cross-sectional study was conducted in the Department of Pharmacology at Department of Pharmacology, Pt. J.N.M. Medical College, Raipur, Chhattisgarh, India, from July 15, 2023, to October 15, 2023 (a duration of 3 months), involving 1,000 outpatient prescriptions at Dr. Bhimrao Ambedkar Memorial Hospital (BRAM), Raipur, Chhattisgarh. Ethical clearance was obtained from the Institutional Ethics Committee (IEC) (No./MCI/Ethics/2023/45 Raipur, dated 12/07/2023). Data were collected using a digital form and analysed statistically. Parameters evaluated included the average number of medicines per prescription, the percentage of drugs prescribed by generic name, the percentage of prescriptions containing antibiotics, the percentage of prescriptions containing injections, and the percentage of drugs prescribed from the Essential Drug List (EDL). Descriptive statistics were used to summarise the data, and analysis was performed using Microsoft (MS) Excel 2021. Results: The present study included 1,000 prescriptions. A total of 4,320 medicines were prescribed across these prescriptions, with 2,853 (66.04%) prescribed by their generic name. Injections accounted for 483 (11.18%) prescriptions, while antibiotics were included in 663 (15.34%) prescriptions. Additionally, 2,973 (68.81%) medicines were prescribed from the EDL. The average number of medicines prescribed per prescription was 4.3. Conclusion: The study revealed that while certain aspects of prescription practices aligned with WHO indicators, notable discrepancies persisted. The percentage of antibiotics prescribed per prescription was in accordance with WHO guidelines. Strategic measures are needed to enhance prescription practices and align them more closely with WHO guidelines. [ABSTRACT FROM AUTHOR]

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies. [ABSTRACT FROM AUTHOR]

Background: The global surge in non-communicable diseases, like cancer, strains health systems financially and restricts patient access to treatment. Generic drugs offer comparable efficacy, safety, and quality to innovator drugs, improving patient access and well-being. To aid healthcare workers in selecting the best generic drugs, Generic drug Adoption Framework (GRAF) was developed as an evaluation tool. This paper aims to adapt the tool to Colombia for healthcare professional's daily use. Methods: Adapting the tool involved two phases: surveying healthcare workers (oncologists' specialists and pharmacists) to gauge their readiness for adopting generic drugs, additionally and expert consensus was developed to adapt the tool to the Colombian context. Results: Of 62 surveyed healthcare workers, 38.7% were early adopters and 32.3% were late adopters. Pharmacists showed higher early adoption rates (47%) than physicians (33%). In the second phase, experts identified 12 relevant attributes for the Colombian scenario, refining descriptions and scoring scales. Conclusion: The study revealed Colombian healthcare workers' perceptions of generic drugs and differences in adoption rates. The adapted tool to the Colombian healthcare context could clarify misconceptions that require diverse strategies to increase the use of generic drugs, aiding in better patient care. [ABSTRACT FROM AUTHOR]

Objective This review paper explores strategies and recommendations for reducing healthcare expenses in the Gulf Cooperation Council (GCC) by understanding physicians' attitudes regarding the utilization of generic medicines. Methods A comprehensive search of seven databases yielded 24 437 titles and abstracts. Using inclusion criteria focusing on physicians' insights into generic prescribing and exclusion criteria, cutting out systematic reviews, case studies, and non-English articles, the review process led to an in-depth analysis of six studies. Results Findings revealed that while physicians generally comprehend terms like "generic", "brand", and "bioequivalence", they face difficulty discussing bioequivalence with patients. Lack of emphasis on generic medicines in medical education and complex patient communication were potential impediments to generic medicine prescribing in the GCC countries. Strategies & Recommendations: Promoting the benefits of generic drugs could support their usage and help decrease healthcare costs. Improving medical education to include a larger focus on generic medications and their benefits, as well as training physicians in effectively communicating bioequivalence concepts to patients, could promote the use of more cost-effective, generic options. Conclusion The review calls for attention to the potential of generic medicine prescribing to reduce healthcare expenses in the GCC. Future research studies should consider broadening the geographical scope to provide global insights into these issues and their possible solutions. [ABSTRACT FROM AUTHOR]

In this monograph, the potential use of methods based on the Biopharmaceutics Classification System (BCS) framework to evaluate the bioequivalence of solid immediate-release (IR) oral dosage forms containing fexofenadine hydrochloride as a substitute for a pharmacokinetic study in human volunteers is investigated. We assessed the solubility, permeability, dissolution, pharmacokinetics, pharmacodynamics, therapeutic index, bioavailability, drug-excipient interaction, and other properties using BCS recommendations from the ICH, FDA and EMA. The findings unequivocally support fexofenadine's classification to BCS Class IV as it is neither highly soluble nor highly permeable. Further impeding the approval of generic equivalents through the BCS-biowaiver pathway is the reference product's inability to release ≥ 85 % of the drug substance within 30 min in pH 1.2 and pH 4.5 media. According to ICH rules, BCS class IV drugs do not qualify for waiving clinical bioequivalence studies based on the BCS, even though fexofenadine has behaved more like a BCS class I/III than a class IV molecule in pharmacokinetic studies to date and has a wide therapeutic index. [ABSTRACT FROM AUTHOR]

Calcium ions (Ca2+) participate in the regulation of cellular apoptosis as a second messenger. Calcium overload, which refers to the abnormal elevation of intracellular Ca2+ concentration, is a factor that can lead to cell death. Here, based on the unique biological effects of Ca2+, hollow mesoporous calcium peroxide nanoparticles (HMCPN) were developed by a facile hydrolysis-precipitation method for drug-free tumor calcicoptosis therapy. The average pore size of the optimized HMCPN17 is 6.4 nm, and the surface area is 81.3 m2/g, which enables HMCPN17 with high drug loading capability. The Ca2+ release from HMCPN17 is much faster at pH 6.8 than that at pH 7.4, which can be ascribed to the acid-triggered conversion of HMCPN17 to Ca2+ and H 2 O 2 , indicating a pH-responsive decomposition behavior of HMCPN17. The high drug loading contents of doxorubicin (DOX) and/or sorafenib (SFN) indicate that HMCPN17 can be employed as a generic drug delivery system (DDS). The in vitro and in vivo results reinforce the high calcicoptosis therapeutic efficacy of tumors by our HMCPN17 without drug loading, which can be attributed to the efficient accumulation in tumors and the ability of H 2 O 2 and Ca2+ production at acidic TME. Our HMCPN17 has broad application prospect for construction of multi-drug-loaded composite nanomaterials with diversified functions for the treatment of tumors. The combination of hollow mesoporous nanomaterials and calcium peroxide nanoparticles has a wide range of applications in the synergistic treatment of tumors. In this study, hollow mesoporous calcium peroxide nanoparticles (HMCPN) were developed based on a simple hydrolysis-precipitation method for tumor calcicoptosis therapy without drug loading. The high drug loading contents of DOX and/or SFN indicate that our HMCPN can serve as a generic DDS. The experimental results demonstrated the high calcicoptosis therapeutic efficacy of HMCPN on tumors even without drug loading. [Display omitted] [ABSTRACT FROM AUTHOR]

These nine steps can help you and your staff reduce the hassle of prior authorizations while empowering patients to be part of the process. [ABSTRACT FROM AUTHOR]

Background: Cephalosporins stand as one of the most frequently prescribed antibiotics for combating infectious diseases. This group has proven to be effective in the treatment of both gram positive and gram negative infections. Analysis of price discrepancies among various brands of oral cephalosporins offers guidance for prescribing cost-effectively, which turns out to be beneficial for both the patient and the prescribing physician. A cost-effective prescribing pattern ensures good patient compliance and better treatment outcome. Aims and Objectives: The objectives of the study were to analyze price variation of various single oral cephalosporin formulations available in the Indian market. Materials and Methods: The prices of oral cephalosporins, produced by different pharmaceutical companies in India, with the same strength, were acquired from the current index of medical specialties, January-April 2023. The cost of generics was obtained from the official website janaushadhi.gov.in. The disparity between the highest and lowest prices of the identical formulation manufactured by different companies, the difference between the maximum and minimum prices of brand-name versus generic versions of the identical formulation, as well as the cost ratio and percentage cost variation, were computed. Results: Total number of brands range from 3 to 79 for various drugs. A large price variation was seen across the different brands. The maximum price variation 521.11% was seen with 100 mg of Cefixime and minimum price variation of 14.13% was seen with 125 mg of cefdinir. Conclusion: With the high variation in prices seen among the different drugs it is important to consider the affordability of the patient before prescribing the drug to ensure completion of the course and better treatment outcome. [ABSTRACT FROM AUTHOR]

Background: Dialysis is a life‐sustaining treatment for patients with advanced kidney failure, but it is extremely burdensome. Despite this, there are very few tools available to assess treatment burden within the dialysis population. Objective: To conduct a scoping review of generic and disease‐specific measures of treatment burden in chronic kidney disease, and assess their suitability for use within the dialysis population. Design: We searched CINAHL, MEDLINE and the Cochrane Library for kidney disease‐specific measures of treatment burden. Studies were initially included if they described the development, validation or use of a treatment burden measure or associated concept (e.g., measures of treatment satisfaction, quality of life, illness intrusiveness, disease burden etc.) in adult patients with chronic kidney disease. We also updated a previous scoping review exploring measures of treatment burden in chronic disease to identify generic treatment burden measures. Results: One‐hundred and two measures of treatment burden or associated concepts were identified. Four direct measures and two indirect measures of treatment burden were assessed, using adapted established criteria, for suitability for use within the dialysis population. The researchers outlined eight key dimensions of treatment burden: medication, financial, administrative, lifestyle, health care, time/travel, dialysis‐specific factors, and health inequality. None of the measures adequately assessed all dimensions of treatment burden. Conclusion: Current measures of treatment burden in dialysis are inadequate to capture the spectrum of issues that matter to patients. There is a need for dialysis‐specific burdens and health inequality to be assessed when exploring treatment burden to advance patient care. [ABSTRACT FROM AUTHOR]

Latuda® is a novel antipsychotic drug for schizophrenia and bipolar depression. A bioequivalence trial was performed to investigate the bioequivalence of Latuda® and its generic drug lurasidone. Two independent trials were carried out, each involving 28 subjects. In the fasting trial, subjects were randomly assigned to two groups (1:1 ratio), receiving either 40 mg of generic lurasidone or Latuda®. After a 7-day washout period, subjects entered the second period with a crossover administration of 40 mg of generic lurasidone or Latuda®. The postprandial study design was similar to that of the fasting study. In the fasting study, the pharmacokinetic (PK) parameter values of generic lurasidone and Latuda® were as follows: the Cmax was 28.84 ± 19.34 ng/ml and 28.22 ± 21.19 ng/ml, respectively; the AUC0-t was 121.39 ± 58.47 h*ng/ml and 118.35 ± 52.24 h*ng/ml, respectively; and the AUC0-∞ was 129.63 ± 63.26 h*ng/ml and 126.59 ± 57.99 h*ng/ml, respectively. The primary pharmacokinetic parameter, Cmax, was assessed for equivalence using reference-scaled average bioequivalence (RSABE), while other parameters (AUC0-t, AUC0-∞) were evaluated using average bioequivalence (ABE). The results indicate that both Cmax and AUC meet the equivalence criteria. In the postprandial study, the PK values of generic lurasidone and Latuda® were as follows: the Cmax was 74.89 ± 32.06 ng/ml and 83.51 ± 33.52 ng/ml, respectively; the AUC0-t was 274.77 ± 103.05 h*ng/ml and 289.26 ± 95.25 h*ng/ml, respectively; and the AUC0-∞ was 302.44 ± 121.60 h*ng/ml and 316.32 ± 109.04 h*ng/ml, respectively. The primary pharmacokinetic parameters (Cmax, AUC0-t, AUC0-∞) were assessed for equivalence using ABE, and both met the equivalence criteria. In the study, lurasidone and Latuda® both exhibited acceptable safety and tolerability. The results displayed that lurasidone and Latuda® were bioequivalent and safe in healthy Chinese participants. Clinical Trial Registry: This trial is registered at chinadrugtrials.org.cn (no.: CTR20191717, date: 2019.08.29). [ABSTRACT FROM AUTHOR]

Objectives: This study compares the demographics, diagnoses, re-admission rates, sick leaves, and prescribed medications of patients accessing digital general practitioner (GP) visits with those of patients opting for traditional face-to-face appointments in a primary health care setting. Design: The study adopted a retrospective analysis of patient record data collected in 2019, comparing visits to a digital primary health center with traditional health center visits. Setting: Primary health care. Participants: The data encompassed patients who utilized the digital clinic and those who visited public health centers for primary health care services. Main Outcome Measures: The study assessed demographics, health diagnoses, prescribed medications, sick leave recommendations, re-admission rates, and differences in costs between digital clinic and face-to-face visits. Secondary outcomes included a comparative analysis of medication categories, resolution rates for health problems, and potential impacts on health care utilization. Results: Digital clinic users were typically younger, more educated, and predominantly female compared with health centre users. Digital visits were well-suited for uncomplicated infections, while health centre appointments were associated with a higher prevalence of chronic conditions. Medication patterns differed between the two modalities, with digital clinic users receiving generic over-the-counter drugs and antibiotics, whereas health centre visits commonly involved cardiac and antihypertensive medications. Sick leave recommendations were slightly higher in the digital clinic, but the difference was not significant. Approximately 70% of health problems addressed in the digital clinic were successfully resolved, and the cost of digital visits was about 50,3% of face-to-face appointments. Conclusion: Digital health care services offer a cost-efficient alternative for specific health problems, appealing to younger, educated individuals, when compared to the users of public health center, and may enable improvement of cost-effectiveness combined with acceptable demand management and patient segmentation practices. The results highlight the potential benefits of digital clinics, particularly for uncomplicated cases, while also emphasizing the importance of suitable referral mechanisms for in-person consultations. [ABSTRACT FROM AUTHOR]

The national centralized drug procurement (NCDP) policy, known as the "4 + 7" policy in China, has transformed pharmaceutical procurement and access by leveraging healthcare institutions' collective buying power to reduce drug prices substantially. This policy has profoundly impacted drug pricing mechanisms, healthcare expenditures, market dynamics, and the quality of available drugs. This commentary evaluates the efficacy, challenges, and broader implications of the NCDP, summarizes the current state of post-marketing monitoring of selected generic drugs for centralized procurement, and presents relevant considerations. [ABSTRACT FROM AUTHOR]

In Brazil, the judicialization of public health for access to medications has resulted in significant challenges to the management of public policies, especially at the municipal level. To evaluate the profile of drug litigations against the Campinas municipal health system from 2017 to 2021, this study analyzed the characteristics of litigants, medicine dispensation, and the timing of court decisions. A quantitative, analytical, and comparative cross-sectional study was conducted using data on the dispensation of 506 types of medications and 493 court cases. The analysis included sociodemographic, procedural, medical–sanitary, and pharmaceutical assistance management variables. The time of court decisions was assessed using the Kruskal‒Wallis test complemented by the Dunn test. The plaintiffs were predominantly adults, females, and self-declared students, and some cases involved nonresidents. Most of the lawsuits were represented by private lawyers, gratuitousness of justice and with decisions favorable to the plaintiff. However, only 43% of the patients obtained a preliminary injunction or early tutelage. The median time needed for a court decision from the date of case filing was 12 days until the granting of a preliminary injunction or early tutelage and 6.5 months until a judgment or dismissal without a decision on the merits. Approximately 32.4% of the medications dispensed by the judicial pharmacy already belonged to the list of the Brazil's Unified Health System in 2020; 46.3% were prescribed by their generic name; 75.5% had therapeutic equivalents, and 94.9% had marketing authorization from the Brazilian National Health Surveillance Agency. Judicialization in Campinas is an alternative way of accessing medications, but it is time-consuming and benefits only a small portion of the population (0.068%). The characteristics of the plaintiffs and judicialized medicines highlight the need to review health policies to promote equitable and efficient access to essential treatments for the population. [ABSTRACT FROM AUTHOR]

Background. This study aims to assess and explore the different effects of national centralized drug procurement (NCDP) on three targeted antitumor drugs' use in clinical practice. Materials and Methods. Clinical drug volume data were collected covering 18 months before, during, and after the seventh round of the NCDP in Inner Mongolia. The interrupted time‐series method was employed to estimate the net effect of policy impact. Results. The volume of generic afatinib (30 mg) increased by 25.78 DDDs, the expenditures decreased by 3641.14 yuan (p = 0.001), and the DDDc decreased by 124.35 yuan (p < 0.001). The volume of generic afatinib (40 mg) increased by 65.19 DDDs (p < 0.001), the expenditures increased by 1304.93 yuan (p < 0.001), and the DDDc decreased by 120.2 yuan (p < 0.001). The volume of generic sunitinib increased by 75.79 DDDs (p < 0.001), the expenditures decreased by 15869.78 yuan (p < 0.001), and the DDDc decreased by 243.28 yuan. There was no significant change trend in volume, expenditures, and DDDc of the three original‐targeted drugs after NCDP intervention. Conclusions. After the policy intervention, generic afatinib (40 mg) successfully aligned with the objectives of NCDP by reducing drug costs and enhancing patient affordability; however, the desired outcomes were not achieved for generic afatinib (30 mg) and generic sunitinib. This discrepancy may be attributed to the inherent clinical efficacy and safety profiles of these drugs. Therefore, in implementing NCDP, it is necessary to enhance the clinical efficacy and safety of generic‐targeted antitumor drugs while considering economic efficiency. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the differences of clinical efficacy and safety between generic and original apixaban after centralized drug volume-based procurement, so as to provide real-world clinical research evidence for the re-evaluation of domestic generic drugs after marketing, and provide supporting evidence for clinicians and related professionals in drug selection. METHODS: This study was a multicenter, large-sample, real-world retrospective cohort study based on the concept of comparative effect research. Clinical data of adult patients underwent hip or knee replacement or post-operation treated with apixaban were extracted from the information system database of the First Affiliated Hospital of Wannan Medical College, Guangdong Provincial People’ s Hospital, Henan Provincial People’ s Hospital and the First Affiliated Hospital of Xi’ an Jiaotong University from Jan. 1st 2019 to Apr. 1st 2022. Patients were divided into 295 cases in original drug group, 641 cases in generic drug group 1 and 50 cases in generic drug group 2 according to the specific medication. Differences in efficacy related to prothrombin time, international normalized ratio, activated partial thromboplastin time and incidence of venous thromboembolic events (VTE), and differences in safety related to aspartate transaminase (AST), alanine aminotransferase (ALT), urea, blood uric acid and creatinine were compared between two groups. RESULTS: (1) In terms of efficacy, after treatment, differences in prothrombin time, international normalized ratio, activated partial thromboplastin time and VTE incidence among three groups were not statistically significant (P>0. 05). (2) In terms of safety, after treatment, differences in the levels of AST, ALT, urea, blood uric acid and creatinine as well as the incidence of related adverse events among three groups were not statistically significant (P>0. 05). CONCLUSIONS: Generic apixaban is comparable to the original drug in terms of efficacy and safety after centralized drug volume-based procurement. [ABSTRACT FROM AUTHOR]

Generic medications contain the identical active ingredient in the same concentration as their branded counterparts and are administered in the same manner, aiming to deliver comparable efficacy, dosage, and clinical outcomes. Nevertheless, variations in additives and formulation processes, particularly noticeable in topical medications, can influence factors like ease of use and patient adherence. Therefore, in this study, we aimed to compare the rheological attributes of branded and generic injectable ointments, assessing disparities in formulation performance and their impact on patient care. Posterisan® Forte and Hemoporison® ointments were used as the branded and generic versions, respectively, and their viscosity, ductility, and viscoelastic properties were evaluated. Posterisan® Forte showcased enhanced spread ability, maintaining uniform flow characteristics across varying temperatures, whereas Hemoporison® displayed pronounced thixotropic properties and stiffness, suggesting potential benefits for applications necessitating reversible viscosity adjustments and heightened rigidity. Despite sharing identical additives, observable differences in physical characteristics highlight the necessity of understanding formulation traits, which could influence ointment behavior. Alterations in fluidity and viscosity may affect how patients perceive and apply the medication, potentially influencing treatment outcomes and the occurrence of adverse effects. [ABSTRACT FROM AUTHOR]

The invasive tetraploid Cirsium vulgare hybridizes with both Cirsium and Lophiolepis. Its conflicted position in molecular phylogenies, and its peculiar combination of morphological, anatomical, and genomic features that are alternatively shared with representatives of Cirsium or Lophiolepis, strongly suggest its intergeneric hybrid origin.Genetic relationships of C. vulgare (8 samples) with genus Lophiolepis (11 species) and other representatives of genus Cirsium (12 species) were evaluated using restriction site‐associated DNA sequencing (RADseq) and examined using analytical and imaging approaches, such as NeighborNet, Heatmap, and STRUCTURE, to identify nuclear genomes admixture. Estimation of the intensity of spontaneous hybridization within and between Cirsium and Lophiolepis was based on herbarium revisions and published data for all reported hybrids pertinent to taxa currently included in Cirsium or Lophiolepis.The genome of any examined Cirsium species is more similar to C. vulgare than to any Lophiolepis species, and vice versa. The nuclear genome of the tetraploid C. vulgare is composed of two equivalent parts, each attributable either to Lophiolepis or to Cirsium; the organellar RADseq data clustered C. vulgare with the genus Cirsium. Spontaneous hybridization between Cirsium and Lophiolepis is significantly less intensive than within these genera.Our analyses provide compelling evidence that the invasive species C. vulgare has an allotetraploid intergeneric origin, with the maternal parent from Cirsium and the paternal from Lophiolepis. For the purpose of delimiting monophyletic genera, we propose keeping Lophiolepis separate from Cirsium and segregating C. vulgare into the hybridogenous genus Ascalea. [ABSTRACT FROM AUTHOR]

The deformulation stage of original drug products, which includes the quantification of critical excipients, is crucial for the successful development of generic drug products of solid dosage form. Sodium lauryl sulphate (SLS) belongs to the group of critical excipients due to its influence on the bioavailability of drugs, such as metformin. The purpose of this work is to carry out a feasibility study in order to develop a simple, economical, and robust analytical method for the quantification of SLS in metformin-containing tablets after their dissolution in water. Firstly, SLS is extracted with chloroform in acidic conditions, followed by the addition of methylene blue (MB) in order to form a SLS-MB ion pair, which is then measured photometrically at a wavelength of 651 nm. Additionally, interference from matrix components (excipients and APIs) was assessed, and it was found that metformin also forms a blue complex; therefore, this specific extraction method was developed. Other matrix components did not interfere with SLS determination. This method shows a well-estimated precision of 3.3% and accuracy of 5%, a calibration linearity of R2 = 0.99990, and a working range of 0.38 µg/mL to 10 µg/mL of SLS in water. The midpoint of the calibration graph corresponds to the concentration of SLS obtained by dissolving a single tablet in 1 L of water. This method seems appropriate for total SLS determination in tablets and can be applicable for deformulation. [ABSTRACT FROM AUTHOR]

Parallel artificial membrane permeability analysis (PAMPA) is used to determine the permeability of compounds through concentrated negatively charged phospholipid bilayer barriers. We employed MacroFlux (a scaled-up version of PAMPA) to test the permeation rate of terazosin hydrochloride (TH) tablets and predict in vivo bioequivalence. The dissolution profiles and permeability of one reference formulation, and seven generic TH tablets, were compared. The dissolution profiles of these generic tablets were equivalent to that of the reference drug in four different media. However, the flux and the total permeated amount of some generic TH tablets were below the lower limit of the confidence interval of the original acceptance range in MacroFlux, which implied risk in the bioequivalence test in vivo. We further evaluated potential factors responsible for this discrepancy by µFlux, including active pharmaceutical ingredient (API) permeability and excipient prescriptions. The analysis showed that different properties of API were a main factor leading to biological inequivalence in the MacroFlux assay, while excipient prescriptions did not have an impact on bioequivalence risk. These data indicated that the flux assay may be a helpful as an auxiliary method for predicting bioequivalence of generic drugs and analyze the factors responsible for bioequivalence risk. [ABSTRACT FROM AUTHOR]

Escalating insulin prices have prompted public scrutiny of the practices of drug manufacturers, pharmacy benefit managers, health insurers, and pharmacies involved in production and distribution of medications. As a result, a series of policies have been proposed or enacted to improve insulin affordability and foster greater equity in access. These policies have implications for other diabetes and obesity therapeutics. Recent legislation, at both the state and federal level, has capped insulin out-of-pocket payments for some patients. Other legislation has targeted drug manufacturers directly in requiring rebates on drugs with price increases beyond inflation rates, an approach that may restrain price hikes for existing medications. In addition, government negotiation of drug pricing, a contentious issue, has gained traction, with the Inflation Reduction Act of 2022 permitting limited negotiation for certain high expenditure drugs without generic or biosimilar competition, including some insulin products and other diabetes medications. However, concerns persist that this may inadvertently encourage higher launch prices for new medications. Addressing barriers to competition has also been a priority such as through increased enforcement against anticompetitive practices (e.g., "product hopping") and reduced regulatory requirements for biosimilar development and market entry. A novel approach involves public production, exemplified by California's CalRx program, which aims to provide biosimilar insulins at significantly reduced prices. Achieving affordable and equitable access to insulin and other diabetes and obesity medications requires a multifaceted approach, involving state and federal intervention, ongoing policy evaluation and refinement, and critical examination of corporate influences in health care. [ABSTRACT FROM AUTHOR]

Introduction: Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality of the newly developed generic product and test protocols for the implementation of equivalence tests regarding efficacy. Methods: To date, no data are available on the quality and evidence of the proposed test conditions. In this study, we performed an in vitro penetration test (IVPT) following the terms of the EMA draft guideline on two authorized topical products for which therapeutic equivalence was already proven during the approval process. Results: The complex biometric data processing revealed that in vitro equivalence could not be observed for all skin sections for either originator or generic product. Moreover, the necessity of the negative control proposed in the draft guideline is more than questionable. From the results presented, there were indications that a reduced number of skin donors would be sufficient to achieve statistically significant equivalence in the comparison of all applied formulations. Here, n = 7 donors was proposed instead of n ≥ 12 as the EMA draft guideline demands, decreasing the degree of biodiversity simultaneously. Moreover, a higher number of independent replicates (n > 2) was proposed for proper statistics. Conclusion: This bioequivalence study shows insufficient parameters, which should be discussed together with the EMA draft guideline. Plain Language Summary (PLS): Today in Europe the approval of generic drugs requires clinical trials to present therapeutic equivalence to the originator. To facilitate this time- and cost-intensive process, the European Medicines Agency (EMA) published a draft guideline in 2018 proposing test protocols for carrying out equivalence tests for drugs applied on human skin. Although its publication is over 5 years old, it is still in a draft version; moreover, so far no evidence has been presented on whether the experimental settings in the test protocols can prove equivalence. This study should prove the EMA test protocol for in vitro permeation tests (IVPT) as closely as possible on two authorized topical products for which therapeutic equivalence was already proven during the approval process to determine whether their equivalence could be observed by this pharmacokinetic approach as well. Due to the experimental setup, a penetration test was performed to survey the drug diffusion behavior over the skin cross section instead of the amount of drug which permeates through the skin. To the best of our knowledge, this study is the first work published regarding that topic. Here, bioequivalence of the preparations applied, which were equivalent when they were tested on patients during their approval, was not found overall. We recommend reducing the number of donors and increasing the number of replicates to achieve a higher power for the statistical data evaluation. Moreover, an evaluation of the drug amount at the pharmaceutical place of action should be considered in the EMA guideline. [ABSTRACT FROM AUTHOR]

In vitro-In vivo correlation (IVIVC) is a main focus of the pharmaceutical industry, academia and the regulatory sectors, as this is an effective modelling tool to predict drug product in vivo performance based on in vitro release data and serve as a surrogate for bioequivalence studies, significantly reducing the need for clinical studies. Till now, IVIVCs have not been successfully developed for in situ forming implants due to the significantly different in vitro and in vivo drug release profiles that are typically achieved for these dosage forms. This is not unexpected considering the unique complexity of the drug release mechanisms of these products. Using risperidone in situ forming implants as a model, the current work focuses on: 1) identification of critical attributes of in vitro release testing methods that may contribute to differences in in vitro and in vivo drug release from in situ forming implants; and 2) optimization of the in vitro release method, with the aim of developing Level A IVIVCs for risperidone implants. Dissolution methods based on a novel Teflon shape controlling adapter along with a water non-dissolvable glass fiber membrane (GF/F) instead of a water dissolvable PVA film (named as GF/F-Teflon adapter and PVA-Teflon adapter, respectively), and an in-house fabricated Glass slide adapter were used to investigate the impact of: the surface-to-volume ratio, water uptake ratio, phase separation rate (measured by NMP release in 24 h post injection in vitro or in vivo), and mechanical pressure on the drug release patterns. The surface-to-volume ratio and water uptake were shown to be more critical in vitro release testing method attributes compared to the phase separation rate and mechanical pressure. The Glass slide adapter-based dissolution method, which allowed for the formation of depots with bio-mimicking surface-to-volume ratios and sufficient water uptake, has the ability to generate bio-relevant degradation profiles as well as in vitro release profiles for risperidone implants. For the first time, a Level A IVIVC (rabbit model) has been successfully developed for in situ forming implants. Release data for implant formulations with slightly different PLGA molecular weights (MWs) were used to develop the IVIVC. The predictability of the model passed external validation using the reference listed drug (RLD), Perseris®. IVIVC could not be developed when formulations with different PLGA molar ratios of lactic acid to glycolic acid (L/G) were included. The present work provides a comprehensive understanding of the impact of the testing method attributes on drug release from in situ forming implants, which is a valuable practice for level A IVIVC development. [Display omitted] [ABSTRACT FROM AUTHOR]

The Hatch-Waxman Act of 1984 ushered in a new era of affordable medicine, with 90% of all prescriptions today filled with generic drugs. Hatch-Waxman provided an expedited pathway for generic entry and mandated that the FDA publish up-to-date information on patent information related to non-biologic drugs. That publication is known as the Orange Book. Roughly twenty-five years later, the Biosimilars Act similarly aimed to facilitate the entry of less-expensive versions of biologics, which are more complex drugs made by living systems. Information related to biologics and biosimilars is published in what is known as the Purple Book. Biosimilars, however, have captured less of the biologic market and have reduced prices to a lesser extent than generic non-biologic drugs. To explore the biosimilars system’s shortcomings, this Article uses the case study of insulin drugs, which are popular biologics. Insulin offers a natural experiment, given that these drugs were originally listed in the Orange Book before moving to the Purple Book, in 2020. Comparing the intellectual property data available for insulin in both books reveals the surprising dearth of patent information disclosed in the Purple Book. In fact, despite taking inspiration from the Hatch-Waxman regime, the biosimilars system bears little resemblance to its muse. Indeed, the Purple Book is missing intellectual property data for most biologics. Without this information, biosimilar companies are forced to dance in the dark, running into legal barriers made by the brand’s patents. As a result, biosimilar hopefuls may be deterred or delayed from entering the market. The Article concludes with proposals to improve the regulatory pathway for licensing biosimilars and remedy the lack of patent transparency in the Purple Book. With these reforms, biosimilars are better poised to follow in the footsteps of generic drugs, increasing access to life-saving biologic medicines [ABSTRACT FROM AUTHOR]

In response to the COVID-19 pandemic, jails were advised to reduce facility census, particularly the growing population of those with medical/behavioral health vulnerabilities that increased susceptibility to adverse outcomes. Although jail census decreased across the nation in the initial days to months following pandemic declaration, there are minimal data regarding the health status of those who remained in jail. The current investigation aspired to describe jail census trends before/since the onset of COVID-19 and offer snapshots of temporal changes and context for prevalence estimates of medical/behavioral health conditions in jail detainees from 2019 to 2023. Using a serial cross-sectional design, prescription information for individuals residing in 18 jails across the United States on June 30 of each respective year was extracted and categorized using MediSpan's ontological system to determine prevalence estimates of prescribed agents/products. Although data evidenced an initial 31% census reduction (followed by gradual return to prepandemic rates), prescribing patterns for all major therapeutic drug classes steadily increased, with 10% more individuals prescribed at least one agent in 2023 than 2019. The largest increases were observed for behavioral health agents (e.g., 32.4% of the sample was prescribed psychotropic agents in 2023 compared with 25.7% in 2019). We provide considerations for future investigations. [ABSTRACT FROM AUTHOR]

Background: Every year millions of patients undergo surgery. The prescribing pattern of medications in patients undergoing surgery may differ based on the hospital setup, profile of the patient, and type of surgical procedure. Hence, the present study is undertaken to know the prescribing pattern of pre-anesthetic, intraoperative, and post-operative agents in surgery and orthopedic department. Aims and Objectives: The aim of this study was to analyze the pattern of pre-anesthetic, intraoperative and post-operative medications used in surgery and orthopedic departments at a tertiary care teaching hospital. Materials and Methods: This cross-sectional, observational study was conducted in the departments of surgery and orthopedic in a tertiary care teaching hospital after taking approval from Institutional Ethics Committee. The details of demographic, clinical data and drugs prescribed during the pre-operative, intraoperative, and post-operative period were recorded in a preformed case record form and analyzed using descriptive statistics. Results: A total of 400 patients prescriptions were collected and analyzed which included 244 patients in orthopedic department and 156 patients in the surgery department. The average number of drugs per encounter was 10.01 and 7.25 in the surgery and orthopedic department, respectively. Preoperatively, the majority of patients received ondansetron (99.5%) followed by glycopyrrolate, midazolam, tramadol, and ranitidine. Surgery was done either under general anesthesia (sodium thiopental and sevoflurane) or local anesthesia (Bupivacaine). Skeletal muscle relaxants used along with general anesthetics included succinylcholine, atracurium, and vecuronium. Postoperatively, antimicrobial agents (AMAs) (831) were most commonly used followed by analgesic agents (368). The majority of AMAs were used from "Watch group" (50%) compared to "Access group" (38.88%) (World Health Organization-Access, Watch, Reserve classification). Conclusion: The present study gives an insight into the use of pre-anesthetic, intraoperative, and post-operative medications in our set-up. Generic medicines are used more which is good as it reduces the cost. Post-operative antimicrobial usage was more from the "Watch group" compared to the "Access group," which is a concern and needs implementation of antibiotic policy. [ABSTRACT FROM AUTHOR]

Generic drugs seem a promising alternative to decrease healthcare costs. However, on one hand, doctors express reluctance toward this kind of drug, and on the other hand, existing literature remains silent about factors explaining their prescribing behavior. The current study mobilizes the Health Belief Model to offer a better understanding of the factors that hinder the prescription of generic drugs by doctors in terms of benefits, barriers, perceived susceptibility, perceived severity, self-efficacy, and action cues. Twenty-four in-depth interviews were conducted with doctors from different specialties. Projective techniques were used including Chinese portrait, completion test, completion task, and association tests. Data analysis was processed using Sphinx software. The paper offers practical recommendations for health authorities and pharmaceutical firms to better promote generics. Increasing the prescription of generic drugs, compared to branded drugs, may increase patient access to affordable drug treatments, decrease healthcare costs and establish rational utilization of medicines. Generic drugs prescription may consequently play an essential role in improving the quality of life. [ABSTRACT FROM AUTHOR]

The article reports on the investigation by the U.S. Congress on the pricing and market protection by drug makers of anti-multiple myeloma agent lenalidomide. Topics mentioned include the impact of the tactics used by drug makers on patients and Medicare, the use of risk evaluation and mitigation strategy, called RevAssist, to prevent generic competition and the factors that influenced the pricing activity of lenalidomide.

Purpose To report historical patterns of pharmaceutical expenditures, to identify factors that may influence future spending, and to predict growth in drug spending in 2024 in the United States, with a focus on the nonfederal hospital and clinic sectors. Methods Historical patterns were assessed by examining data on drug purchases from manufacturers using the IQVIA National Sales Perspectives database. Factors that may influence drug spending in hospitals and clinics in 2024 were reviewed—including new drug approvals, patent expirations, and potential new policies or legislation. Focused analyses were conducted for biosimilars, cancer drugs, endocrine drugs, generics, and specialty drugs. For nonfederal hospitals, clinics, and overall (all sectors), estimates of growth of pharmaceutical expenditures in 2024 were based on a combination of quantitative analyses and expert opinion. Results In 2023, overall pharmaceutical expenditures in the US grew 13.6% compared to 2022, for a total of $722.5 billion. Utilization (a 6.5% increase), new drugs (a 4.2% increase) and price (a 2.9% increase) drove this increase. Semaglutide was the top drug in 2023, followed by adalimumab and apixaban. Drug expenditures were $37.1 billion (a 1.1% decrease) and $135.7 billion (a 15.0% increase) in nonfederal hospitals and clinics, respectively. In clinics, increased utilization drove growth, with a small impact from price and new products. In nonfederal hospitals, a drop in utilization led the decrease in expenditures, with price and new drugs modestly contributing to growth in spending. Several new drugs that will influence spending are expected to be approved in 2024. Specialty, endocrine, and cancer drugs will continue to drive expenditures. Conclusion For 2024, we expect overall prescription drug spending to rise by 10.0% to 12.0%, whereas in clinics and hospitals we anticipate an 11.0% to 13.0% increase and a 0% to 2.0% increase, respectively, compared to 2023. These national estimates of future pharmaceutical expenditure growth may not be representative of any health system because of the myriad of local factors that influence actual spending. [ABSTRACT FROM AUTHOR]

Background: Generic substitution policies have been widely implemented worldwide to enhance the accessibility of medications. Nevertheless, certain patients have voiced discontent with these policies. This study aimed to evaluate the patient preferences for generic substitution policies and explore the potential for optimization to enhance patient acceptance. Methods: A discrete choice experiment (DCE) was conducted to estimate the relative importance (RI) of five attributes, including generic consistency evaluation (GCE), reimbursement rate, medication use control, information disclosure, and post-marketing surveillance. Respondents were recruited among inpatients and outpatients in three cities and surveys were conducted face-to-face. Preference coefficients, RI of attributes, and the uptake rate of various policies were computed using a mixed logit model. The interaction effects were also included to examine preference heterogeneity. Results: A total of 302 patients completed the survey. All five attributes significantly impacted policy acceptance. GCE held the highest RI value at 56.64%, followed by reimbursement rate (RI = 12.62%), information disclosure (RI = 12.41%), post-marketing surveillance (RI = 9.54%), and medication use control (RI = 8.80%). Patient preferences varied depending on their gender and income. The patient uptake rate of China's current policy was only 68.56%. If all generics were to pass GCE without altering the other attributes, the uptake rate of policies would rise to 82.63%. Similarly, implementing information disclosure without changing other attributes would result in a 78.67% uptake rate, which is comparable to the effect of a 10% increase in reimbursement rate for generics (78.81%). Combining these policies could mitigate the adverse effects of mandatory substitution on patient. Conclusion: Chinese patient preferences for generic substitution policies were mainly influenced by GCE. China's current generic substitution policy has room for further optimization to enhance patient acceptance. [ABSTRACT FROM AUTHOR]