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The article focuses on the WHO's (World Health Organization) recommended International Nonproprietary Names (INN) for Pharmaceutical Substances. It announces the selection of new INNs according to established procedures, emphasizing that inclusion in these lists does not imply a recommendation for medical or pharmaceutical use. It is reported that the names are provided in multiple languages, along with chemical descriptions including molecular formulas and structural formulas.

This study aimed to characterize products using pharmacy-pharmacy benefit manager (PBM) discounts and to estimate the association among such discounts, prescription utilization, and out-of-pocket costs. This is a retrospective cohort study using IQVIA's Formulary Impact Analyzer, which contains anonymized, individual-level pharmacy claims representing US retail pharmacy transactions. We focused on 20 products with the greatest number of transactions using a pharmacy-PBM discount. Our unit of analysis was a treatment episode, defined as the length of time from an incident fill to no continuous use for 60 consecutive days after allowing for indefinite stockpiling. Outcome measures included products with greatest pharmacy-PBM discount use, characteristics of treatment episodes, and out-of-pocket costs with and without pharmacy-PBM discount. Across all products, 3.82% of transactions and 7.69% of treatment episodes were accompanied by a pharmacy-PBM discount. Commonly discounted products included generic treatments for chronic disease (lisinopril, levothyroxine, metformin) and neuropsychiatric conditions (alprazolam, amphetamine, buprenorphine, hydrocodone). The median postdiscount out-of-pocket cost was >2.5-fold higher during treatment episodes with a discount than those without ($15.15, interquartile range [IQR] $8.53-32.00, vs $5.88, IQR $1.40-15.00). Median treatment episode duration was 249 days (IQR 132-418) with discount use compared with 236 days (IQR 121-396) without discount use, although treatment episodes that began with a discount had fewer transactions per treatment episode and were shorter (median 212 days, IQR 114-360) than those that did not (313 days, IQR 178-500). Pharmacy-PBM discounts may foster market competition and improve access for under- and uninsured individuals; however, these programs may not generate savings for many insured individuals. • Approximately half of drug discounts originate from pharmacy-pharmacy benefit manager (PBM) programs rather than drug manufacturers, yet little is known regarding the use and impact of these programs. • In this retrospective cohort of individuals using anonymized, longitudinal, patient-level pharmacy claims, pharmacy-PBM discounts were used for 3.82% of transactions. Across all treatment episodes, the median postdiscount out-of-pocket cost was >2.5-fold higher during treatment episodes with a discount than those without. Treatment episodes that began with a discount had fewer transactions per treatment episode and were shorter than those that did not. • Pharmacy-PBM discounts may foster market competition and improve access for under- and uninsured individuals; nevertheless, these programs may not generate savings for many insured individuals. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To investigate the clinical outcomes of generic and original Levetiracetam tablets and the switching in children with epilepsy during hospitalization, so as to explore the switching and switching-back of generic and original Levetiracetam tablets in outpatient setting. METHODS: Retrospective cohort study was performed on 125 children with epilepsy admitted into the hospital and received 250 mg of Levetiracetam tablets from Jan. 2020 to Jun. 2022. The reduction rates of seizure frequency of children using generic and originator drugs were calculated, the characteristics of children who switched generic and original Levetiracetam tablets were summarized and analyzed, further follow-up was conducted on the switching and switching-back of original drugs in outpatient. RESULTS: Among the 125 children with epilepsy, the epilepsy control rate was 87. 50% (63 / 72) in the original drug group and 83. 02% (44 / 53) in the generic drug group, the difference was not statistically significant(P>0. 05), while the increase of number of drug combination would decrease the epilepsy control rate ( OR = 0. 333, 95% CI = 0. 114-0. 969, P = 0. 044). Four reports of adverse drug reactions were all from patients received monotherapy in the original drug group, which were respectively emotional lability (2 cases) and rash (2 cases). Fourteen cases of the enrolled children had variety switching between original and generic drugs, the number of hospital admissions (OR = 2. 7, 95%CI = 1. 506- 4. 791, P = 0. 001) and epilepsy control (OR = 0. 07, 95%CI = 0. 009-0. 555, P = 0. 012) were correlated with the drug variety switching when controlling gender, age and treatment characteristics. During outpatient follow-up, the cumulative switching rate was 50. 05% and the corrected cumulative switching-back rate was 20. 29% of the original drugs. CONCLUSIONS: There are no differences in efficacy and safety between original and generic Levetiracetam tablets in children with epilepsy in this study cohort, the drug variety switching occurs more frequently under increased hospital admissions and uncontrolled epilepsy. Despite the popularization of generic drugs in outpatient setting, there is still a fixed population using original drugs. [ABSTRACT FROM AUTHOR]

In this study, we compared the pharmacokinetics and safety of a new generic product and a branded reference product of amisulpride tablets. Additionally, we assessed the bioequivalence of the 2 products in healthy Chinese volunteers to acquire sufficient evidence for the marketing approval of the generic drug. Thirty volunteers under fasting and fed conditions were randomly administered a single dose of the test or reference drug orally, followed by a 7‐day washout period. The pharmacokinetic parameters were obtained by the concentration‐time profiles, including the area under the plasma concentration‐time curve (AUC) over the dosing interval, AUC from time zero to infinity, maximum plasma concentration, time to achieve maximum plasma concentration, and elimination half‐life. AUC from time zero to infinity of amisulpride in the postprandial group was reduced by approximately 25%, suggesting that a high‐fat diet can affect this parameter. In the aspect of safety, no serious adverse events occurred. This study demonstrated that generic and reference products of amisulpride tablets were bioequivalent in healthy Chinese volunteers under fasting and fed conditions. [ABSTRACT FROM AUTHOR]

Zidovudine/lamivudine tablets are nucleoside reverse transcriptase inhibitors that are used to treat human immunodeficiency virus. The objective of this study was to investigate the bioequivalence and pharmacokinetics (PKs) of test and reference preparations of zidovudine/lamivudine tablets in healthy Chinese subjects. We designed a randomized, open, single‐center, single‐dose, 2‐crossover experiment with a 7‐day washout period involving 20 healthy subjects. The subjects were given a single dose of the test or reference preparation after fasting overnight for 10 hours. Blood samples were subsequently collected at scheduled time points from 0 hour (preadministration) up to 24 hours postadministration. The plasma concentrations of zidovudine and lamivudine were determined by a validated ultra‐performance liquid chromatography‐tandem mass spectrometry method. Analysis of variance (ANOVA) was used to compare differences in the mean values of key PK parameters between the 2 preparations. Bioequivalence was evaluated by 2 one‐sided t‐tests and 90% confidence intervals (CIs) of the geometric mean ratio (GMR). In total, 19 of the 20 subjects completed the trial. Based on the analysis of PK parameters, the relative bioavailability of zidovudine and lamivudine was 101.1% ± 2.0% and 100.3% ± 1.5%, respectively. ANOVA found no significant difference in primary PK parameters when compared between the 2 formulations, and the 90% CIs of the GMR of the 2 formulations were within the bioequivalence margins of 80%–125%. No serious adverse events occurred. Thus, we confirmed that the 2 preparations were bioequivalent in healthy Chinese volunteers. Our analysis demonstrated that both products showed good tolerance in all subjects. [ABSTRACT FROM AUTHOR]

Companies have protected their products with large portfolios of patents. The drug company AbbVie, for example, has collected more than 100 patents on its blockbuster drug Humira. Many have raised concerns about such patent thickets" in the pharmaceutical industry, which have become a pressing concern given the increasingfrequency of thickets and effects on patients' lives. In response, some have downplayed concern by pointing to large patent portfolios in other industries, in particular, high technology. This Essay offers the jirst refutation of this argument. explaining why it fails on two basic levels. First, pharmaceutical companies have all of the patents they need to enter the market. As a result, they do not need to license, instead accumulating patents to block rivals. In contrast, because Of the presence of patents from multiple owners in products, high-technology firms need to engage in "cross licensing," which leads them to amass patents. Exclusion is exacerbated by the pharmaceutical industry's higher regulatory barriers and firm concentration. Second, we offer original empirical evidence supporting our hypothesis that pharmaceutical firms use duplicative patents to block market entry. We learn useful information from an analysis of continuation patents, which cannot disclose any new matter. Wejind that continuations have recently increased in the pharmaceutical industry, especially as compared to the high-technology industry. We also jind that the pharmaceutical industry litigates continuation patents at a much higher rate than the high-technology industries, which is consistent with keeping rivals off the market. We show similar results ®r "method-of-use patents," which drugfirms have used to delay generic entry, and.for the Humira patent thicket. [ABSTRACT FROM AUTHOR]

There is a constant interest in the study of drugs that are analogs of endogenous compounds. Guidelines for conducting bioequivalence studies are being updated. Official regulators are holding seminars on the development and study of generic drugs. The goal of the present study is to analyze approved protocols of clinical bioequivalence studies with an adaptive design for drugs that are analogs of endogenous compounds for the period 2015 – 2023. Nine bioequivalence protocols were analyzed. All protocols contained information on the determination of the endogenous background of the analyte being studied and the method for correcting it. An adaptive design did not need to be chosen because information was available on the variability of the studied endogenous compounds. Non-standard designs of the bioequivalence research could be considered for analogs of endogenous compounds, e.g., studies of the comparative pharmacokinetics with a detailed determination of the endogenous levels and with the use of pharmacodynamic endpoints. [ABSTRACT FROM AUTHOR]

Background. Schizophrenia is a public health burden and a severe type of mental disorder that has a significant distress to the individual and the society. Pharmacotherapy is the mainstay of the treatment, and the rational prescription is guided by World Health Organization (WHO) prescribing indicators developed to assess pharmaceutical prescribing practices by health providers. This study evaluated the pattern of health providers’ prescription of psychotropic drugs for schizophrenia patients from a tertiary mental health facility in Anambra State, southeastern part of Nigeria. Methodology. This was a one-year retrospective, descriptive, cross-sectional study of psychotropic medicines prescriptions for adult schizophrenia patients who were at least 18 years old, to assess the average number of drugs prescribed per encounter, the percentage of encounters with injection prescribed, the percentage of drugs prescribed by generic name, and the percentage of drugs prescribed from the Essential Medicines List. Results. A total of 338 encounters were assessed after random sampling, and the results show that the average number of prescriptions per encounter was 3.23, while 95.97% of the total number of drugs were prescribed by generic names, in 26.9% of the total number of encounters there were prescribed injections, while 100% of the prescribed drugs were from the Essential Medicines List. Other indicators reveal that fluphenazine was the most prescribed antipsychotic injection, while haloperidol and olanzapine were the most prescribed typical and atypical antipsychotics, respectively. Conclusions. There were issues of polypharmacy, some reluctance in prescribing drugs with generic names, and overuse of injections [ABSTRACT FROM AUTHOR]

Background: Given that peripheral arterial disease (PAD) disproportionately affects people of lower socioeconomic status, out-of-pocket expenses for preventive medications are a major barrier to their use. We carried out a cost comparison of drug therapies for PAD to identify prescribing strategies that minimize out-of-pocket expenses for these medications. Methods: Between March and June 2019, we contacted outpatient pharmacies in Hamilton, Ontario, Canada, to assess pricing of pharmacologic therapies at dosages included in the 2016 American College of Cardiology/American Heart Association guideline for management of lower extremity PAD. We also gathered pricing information for supplementary charges, including delivery, pill splitting and blister packaging. We calculated prescription prices with and without dispensing fees for 30-day brand-name and generic prescriptions, and 90-day generic prescriptions. Results: Twenty-four pharmacies, including hospital-based, independent and chain, were included in our sample. In the most extreme scenario, total 90-day medication costs could differ by up to $1377.26. Costs were affected by choice of agent within a drug class, generic versus brand-name drug, quantity dispensed, dispensing fee and delivery cost, if any. Conclusion: By opting for prescriptions for 90 days or as long as possible, selecting the lowest-cost generic drugs available in each drug class, and identifying dispensing locations with lower fees, prescribers can minimize out-of-pocket patient medication expenses. This may help improve adherence to guideline-recommended therapies for the secondary prevention of vascular events in patients with PAD. [ABSTRACT FROM AUTHOR]

Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir. [ABSTRACT FROM AUTHOR]

Objective: To determine the perception and concerns physicians and pharmacists have about generic drugs on three annual drug price lists in Trinidad. Method: Windows® Excel 2007 and Minitab® version 17 examined the price lists and a self-administered questionnaire was used to perform a non-randomized, cross-sectional study with a convenient sampling of physicians and pharmacists after obtaining written consent. Results: Physicians (78.6%) and pharmacists (87.1%) agreed and strongly agreed respectively that there are medical conditions for which brand name drugs are preferred including cardiovascular conditions and diabetes; which were comprised in the five major medication categories on the national drug price lists. Overall, physicians and pharmacists showed a 'Good'to 'Excellent' perception of generic drugs but had some safety and efficacy concerns. Lack of reporting of adverse drug reactions and quality issues by health professionals was also observed. Conclusion: Education and communication among patients, physicians and pharmacists can improve the perception of generic drugs; hence, increase confidence in prescribing, dispensing and patient management. [ABSTRACT FROM AUTHOR]

Herein, we aimed to formulate a novel oral disintegrating tablet (ODT) of aripiprazole (ARP) capable of rapid disintegration using a direct compression technique. Different ODTs were fabricated with directly compressible excipients, and their disintegration time, wettability (water absorption ratio and wetting time), and mechanical properties (hardness and friability) were evaluated. The optimized ODT comprised F-Melt® type C, Prosolv® SMCC HD90, and Na croscarmellose (10 mg of ARP in a 130 mg tablet). The ODT with 3.1–5.2 kp hardness exhibited rapid disintegration (14.1–17.2 sec), along with appropriate mechanical strength (friability < 0.24%). In a bioequivalent study in Korean healthy subjects (randomized, single-dose, two-period crossover design, n = 37), the novel ODT offered the equivalent pharmacokinetic profile to that of a conventional immediate release tablet (Otsuka, Abilify®, Japan), despite different disintegration and dissolution profiles. The 90% confidence intervals of the geometric mean test to reference ratios considering the area-under-the-curve and maximum plasma drug concentrations were 1.0306–11051 and 0.9448–1.1063, respectively, satisfying FDA regulatory criteria for bioequivalence. The novel ART ODT was physicochemically stable under the accelerated storage condition (40 °C, RH75%) for 24 weeks. Therefore, the novel ARP-loaded ODT is expected to be an alternative to oral ARP therapy, providing improved patient adherence. [ABSTRACT FROM AUTHOR]

The use of generic drugs reduces healthcare expenditures, especially for those of lower socio‐economic status. This research employs a descriptive research design and utilizes a cross‐sectional survey to investigate the behavioral intention of patients toward generic medicines, supported by the theory of planned behavior. A structured instrument was used to gather data from 410 respondents who were aware of and consuming generic medicines. A structural equation modeling (SEM) analysis was performed with the semopy library in Python programming. The results demonstrate that all the constructs, namely, attitude, subjective norm, and perceived behavioral control in relation to buying generic medicines, have a significant relationship with behavioral intention to purchase generic medicines. Among all three constructs, perceived behavioral control has the strongest link with behavioral intention. Furthermore, family monthly medical expenses moderate the relationship between all three constructs of planned behavior and behavioral intention. This study could help healthcare professionals and policymakers to understand consumer intention and design information and educational programs accordingly to increase the awareness and usage of generic medicines. The outcome indicates that consumers prefer to purchase generic medicines due to the similar active ingredients, dosage, side effects, and effectiveness, as well as the low cost compared to branded ones. [ABSTRACT FROM AUTHOR]

Background: Blockchain is expected to mitigate consumers' risk-aversion and quality uncertainty about generic drugs in medicine supply chains. This study investigates the effect of blockchain adoption for disclosing the quality information of generic drugs that compete with original drugs in the market and proposes legal measures accordingly. Methods: We employ a game-theoretic model to analyze a medicine supply chain including a generic drug manufacturer, an original drug manufacturer, and a retailer. We examine when should the supply chain members adopt blockchain for generic drugs and how blockchain affects the medicine supply chain. Results: Our results show that the quality information of generic drugs determines how blockchain adoption affects the price and sales quantity of generic and original drugs. Moreover, we observe that the generic drugs manufacturer and the retailer decide to adopt blockchain only if consumers' risk-aversion degree is sufficiently low. Also, a low risk-aversion degree can lead to higher whole supply chain's profitability with blockchain adoption, and generate a win-win-win situation of blockchain adoption for the consumers, the generic drug manufacturer, and the retailer. Conclusion: To mitigate consumers' risk aversion, the law should safeguard consumer rights. Blockchain adoption can benefit the medicine supply chain and consumers under certain conditions. However, it also requires the coordination of supply chain members' benefits and the disclosure of quality information. [ABSTRACT FROM AUTHOR]

Physicochemical properties (drug release, peel strength, adhesion, and stiffness) of Hokunalin® Tape (Hokunalin) and 13 generic transdermal bronchodilator patches containing tulobuterol were characterized and evaluated for comparison. Drug-release studies evaluating sustained release behavior demonstrated better performance by the drug Hokunalin, than the generics MED, YP, Sawai, and Teikoku. Hokunalin yield a 16.2% release 1 hour after initiation, 30.1% at 3 hours, 50.0% at 8 hours. In comparison, the generics MED, YP, Sawai, and Teikoku showed an intermediate release behavior to that of Hokunalin, with more than 80% release after 8 hours. A 90-degree peel adhesion test for tape peel strength demonstrated that the generic MED (4.99 N), YP (3.26 N), Sawai (4.17 N), and Teikoku (4.37 N) tapes yielded significantly higher values compared to Hokunalin (2.66 N). Probe tack tests, evaluating adhesive strength, yielded significantly higher values for the generics HMT (4.89 N) and Towa (4.25 N) compared to Hokunalin (3.66 N). Furthermore, for the stiffness-softness test, a significantly higher value was obtained for each generic yielded compared to Hokunalin (3.7-degree). These factors are important components of product qualities that affect treatment efficacy, including "ease of application" and other usability factors. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To estimate the comprehensive value of direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV) compared with peginterferon alfa and ribavirin (PEG/riba) employing a generalized cost-effectiveness analysis (GCEA). STUDY DESIGN: To assess the societal-level costeffectiveness of DAA treatment for HCV, we extended a previously published discrete-time Markov simulation model of HCV transmission and progression to include market dynamics and broader elements of value. METHODS: We followed a stepwise process to add novel value elements to a traditional CEA model for HCV treatments. For each additional element of value, we estimated incremental cost-effectiveness ratios (ICERs) of DAAs compared with PEG/riba. RESULTS: The health technology assessment (HTA)--style model yielded an ICER value of $64,512 per quality-adjusted life-year (QALY). Adding transmission dynamics resulted in an ICER value of $52,971 per QALY, whereas accounting for transmission dynamics and dynamic price and efficacy further decreased ICER values by 90% to $6406 per QALY. Incorporating genericization, productivity loss, caregiver spillover, and differential valuations of LYs vs quality of life, disease severity, and insurance value further decreased the ICER value to $4487 per QALY, a 93% reduction from the baseline HTA-style CEA to the fully realized GCEA. CONCLUSIONS: Our GCEA study results confirm that DAAs are a cost-effective treatment for HCV compared with PEG/riba even when using conventional cost-effectiveness approaches. Incorporating broader elements of value resulted in more than a 10-fold improvement in costeffectiveness, emphasizing the substantive impact of a generalized approach and the importance of incorporating GCEAs into decision-making. [ABSTRACT FROM AUTHOR]

Aim: For the successful approval and clinical prescription of insulin biosimilars, it is essential to show pharmacokinetic (PK) and pharmacodynamic (PD) bioequivalence to the respective reference products sourced from the European Union and the United States. Methods: Three phase 1, randomized, double‐blind, three‐period crossover trials compared single doses of the proposed biosimilar insulin analogues aspart (GL‐Asp, n = 36), lispro (GL‐Lis, n = 38) and glargine (GL‐Gla, n = 113), all manufactured by Gan & Lee pharmaceuticals, to the respective EU‐ and US‐reference products in healthy male participants (GL‐Asp and GL‐Lis) or people with type 1 diabetes (GL‐Gla). Study participants received 0.2 U/kg (aspart and lispro) or 0.5 U/kg (glargine) of each treatment under automated euglycaemic clamp conditions. The clamp duration was 12 h (aspart and lispro) or 30 h (glargine). Primary PK endpoints were the total area under the PK curves (AUCins.total) and maximum insulin concentrations (Cins.max). Primary PD endpoints were the total area under the glucose infusion rate curve (AUCGIR.total) and maximum glucose infusion rate (GIRmax). Results: Bioequivalence to both EU‐ and US‐reference products were shown for all three GL insulins. Least squares mean ratios for the primary PK/PD endpoints were close to 100%, and both 90% and 95% confidence intervals were within 80%–125% in all three studies. There were no noticeable differences in the safety profiles between test and reference insulins, and no serious adverse events were reported for the GL insulins. Conclusion: GL‐Asp, GL‐Lis and GL‐Gla are bioequivalent to their EU‐ and US‐reference products. [ABSTRACT FROM AUTHOR]

The use of physiologically based biopharmaceutics modeling (PBBM) and bioequivalence safe space is increasingly common for immediate-release drug products. However, for extended-release (ER) formulations there are only a few examples of this application. In this study, we developed ER formulations containing cyclobenzaprine 15 mg, supported by PBBM and bioequivalence safe space. Four formulations were prepared, F1, F2, F3 (ER mini-tablet formulations) and F4 (ER tablet formulation), and the dissolution profiles were evaluated. The dissolution profile of the reference drug product was also evaluated and used to set a bioequivalence safe space. A PBBM was set up, evaluated, and used to predict the in vivo behavior of the formulations. The bioequivalence safe space was calculated to be between – 25% and + 75% of the k1 and Tlag values of the dissolution profile of the reference drug product when applying the first-order dissolution kinetic model. All time points of the dissolution profile of the ER mini-tablet formulation F2, were within the safe space, and was approved in 10 of 10 trials of crossover virtual bioequivalence studies. Based on the PBBM strategy and bioequivalence safe space, it was possible to develop an ER mini-tablet formulation virtually bioequivalent to the reference drug product, even though this formulation failed the f2 test. [Display omitted] • Formulation development based on PBBM and bioequivalence safe space. • Failing similarity factor f2 but approved on virtual bioequivalence study. • Higher surface area from ER mini-tablets driving drug dissolution. [ABSTRACT FROM AUTHOR]

Background: Prescription writing error is a common phenomenon in the health sector. Appropriate handwritten prescription practices minimize medical errors during medical drug dispensing. Objectives: This project aimed to identify the extent to which clinicians adhere to handwritten drug prescription best practices and implement evidence-based strategies to improve compliance with handwritten prescription best practices in an outpatient department. Methods: The project was conceptually informed by the JBI Model of Evidence-Based Health care and the JBI Evidence Implementation Framework. Baseline and follow-up audit data were collected and analyzed using JBI's Practical Application of Clinical Evidence System (PACES) software. The JBI Getting Research into Practice (GRiP) program was used to identify potential barriers and design intervention strategies. The project was conducted in a public hospital outpatient department in Uasin Gishu County, Kenya. Results: There was a 100% improvement in compliance with the number of prescribers who had received education on essential features of a handwritten drug prescription. High compliance was observed in prescriptions that indicated the patient name (99%) and date of prescription (98%) in the follow-up audit. Approximately half of the prescriptions included a diagnosis of the disease in both the baseline and the follow-up audit. However, in the follow-up audit, only 21% of the prescriptions had legible handwriting and 27% prescribed drugs using the generic drug name. Conclusion: Regular audits and dissemination of audit findings through continuous medical education, hospital communication forums, and notices improved compliance with the number of prescriptions that contained the patient identifier and the date of prescription. [ABSTRACT FROM AUTHOR]

Fexofenadine hydrochloride (HCl) is a second‐generation, nonsedating, histamine H1‐receptor antagonist used to manage seasonal allergic rhinitis and chronic idiopathic urticaria. A new oral pediatric suspension of fexofenadine HCl has been developed, with the preservative potassium sorbate replacing parabens. The objective of this phase 1 single‐center, open‐label, randomized, 2‐treatment, full‐replicated, 4‐period, 2‐sequence crossover study in healthy adult volunteers was to assess the bioequivalence of 30 mg of the new oral suspension of fexofenadine HCl (test) versus 30 mg of the marketed pediatric oral suspension of fexofenadine HCl (reference). The replicate design was based on the high intra‐individual variability of fexofenadine (>30% on Cmax). The study comprised 68 randomized and treated volunteers. Plasma concentrations of fexofenadine were similar following the administration of a single dose of each formulation. Cmax, AUClast, AUC, median tmax, and mean t1/2z were similar between administrations of the same fexofenadine formulation and between formulations. A high intra‐individual variability was confirmed with both formulations. Bioequivalence of the test and reference fexofenadine HCl formulations was demonstrated as the 90% confidence intervals of the geometric least squares mean ratio for Cmax, AUClast, and AUC of fexofenadine were all within the bioequivalence range of 0.80‐1.25. There were no serious adverse events (AEs) or study discontinuations due to treatment‐emergent AEs with either fexofenadine HCl formulation. The new paraben‐free fexofenadine HCl 30‐mg oral suspension and marketed fexofenadine HCl 30‐mg pediatric oral suspension are bioequivalent under fasting conditions, with no safety concerns and a safety profile consistent with the known profile of fexofenadine. [ABSTRACT FROM AUTHOR]

This work aims to investigate bronchodilator delivery with the use of different vaping drug delivery systems (VDDS) by determining the dose equivalence delivered in relation to different references: a clinical jet nebulizer, a pMDI (pressurized metered dose inhaler) and a DPI (dry powder inhaler). Three different bronchodilators were used (terbutaline, salbutamol hemisulfate, ipratropium bromide). The e-liquids contained the active pharmaceutical ingredient (API) in powder form. Two different VDDS were tested (JUUL and a GS AIR 2 atomizer paired with a variable lithium-ion battery (i-stick TC 40 W), 1.5 ohm resistance, and 15 W power). Samples were collected using a glass twin impinger (GTI). High-performance liquid chromatography (HPLC) was used to quantify the drugs. A next-generation impactor (NGI) was used to measure the particle size distribution. Terbutaline emerged as the optimal API for bronchodilator delivery in both VDDS devices. It achieved the delivery of a respirable dose of 20.05 ± 4.2 µg/puff for GS AIR 2 and 2.98 ± 0.52 µg/puff for JUUL. With these delivered doses, it is possible to achieve a dose equivalence similar to that of a jet nebulizer and DPI, all while maintaining a reasonable duration, particularly with the GS AIR 2. This study is the first to provide evidence that vaping bronchodilators work only with appropriate formulation, vaping technology, and specific drugs, depending on their thermal degradation properties. [ABSTRACT FROM AUTHOR]

Summary of case law concerning generic medicine from the EU or EU contries. [ABSTRACT FROM AUTHOR]

Pre-exposure prophylaxis (PrEP) prevents HIV infection through the daily administration of anti-HIV drugs, such as Truvada combination tablets (a combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)). However, since PrEP is not approved in Japan, generic drugs sold overseas are imported and used by individuals. Then, the present study investigated the pharmaceutical equivalence of two generic drugs of Truvada (Generic A and Generic B). Tablet properties were examined by X-ray diffraction and differential scanning calorimetry. The dissolution behaviors and membrane permeabilities of FTC and TDF were assessed by the dissolution test using the paddle method and a membrane permeation experiment using Caco-2 cell monolayers, respectively. The dissolution behaviors of FTC and TDF differed between Truvada and its generic drugs. Furthermore, the membrane permeation rates of FTC and TDF in Generic B were slower than those in Truvada, and the AUC of FTC in Generic B was significantly smaller than that in Truvada. Differences were observed in the dissolution behaviors and membrane permeabilities of FTC and TDF in generic drugs (particularly Generic B) from those in Truvada. Since there are concerns regarding the clinical implications of these results, further studies, including in vivo experiments, are needed to ensure the safety of generic drugs. [ABSTRACT FROM AUTHOR]

Background: Pharmacists are crucial in lowering pharmaceutical expenditures by substituting brand-name drugs for generic drugs. They are expected to understand the principles and practices of generic drug substitution for high-quality patient care. Some key areas of knowledge include bioequivalence and therapeutic equivalence, regulatory requirements, drug interchangeability, and adequate patient counseling. Objectives: This study aims to assess the knowledge, perception, and practice of generic drug substitution among pharmacists in Lebanon following the crises and the factors affecting the prescription and selection of generic drugs. Methods: A pilot descriptive cross-sectional study targeting 80 Lebanese pharmacists was conducted over 2 months (September-October 2022), in which data were collected using a uniform survey. Results: Overall, pharmacists had a good knowledge of generic drugs in terms of active ingredients (97.5%), pharmaceutical form (85.0%), lower cost (88.7%), bioequivalence to the brand before (95.0%), and therapeutic equivalence. Nevertheless, 22.5% reported that generic drugs are less safe than brands, and 22.5% said they cause side effects or did not know. Among the possible factors that influence the prescription of generic drugs, 35.0% of pharmacists reported that the financial situation of the patient is among the least important factors, while the lack of possible alternatives (45.0%) and the difference in prices (40.0%) were the most important ones. The price of different generics on the market was among the most important factors (36.3%) affecting the selection of generic drugs, followed by the patient's. preference (26.3%). Only 11.2% considered the information given by pharmaceutical firms could affect their choice, and 10.0% considered the presence or not of excipients with known effects in the formulation. Conclusion: Most pharmacists in Lebanon were familiar with generic drugs and supported generic drug substitution. Factors affecting generic drug use and prescription should be further explored to clarify misconceptions and reduce possible adverse events. [ABSTRACT FROM AUTHOR]

Context: The perception of generic drugs may vary significantly between government and private doctors because physicians in the private sector have more prescribing choices and flexibility. Hence, this study was undertaken to analyse the knowledge, attitude and perception (KAP) of government and private physicians on generic drugs. Materials and Methods: This was a questionnaire-based cross-sectional study conducted among physicians working in public and private health sectors. The questionnaire had 25 closed-ended questions related to the KAP of generic medicine. The overall scores were categorised using Bloom's cut-off point. The Chi-square or Mann–Whitney U-test was used to compare the differences between the two groups. Results: About 80% of the participants in both groups agreed that generic medicines contain the same active ingredients as brand-name drugs, are less expensive and are available in the Indian market. Nearly 84% of government physicians and only 64% of private physicians believed that generic medicines are just as effective and secure as branded medicines (P - 0.003). The majority of physicians from both groups concurred that there is a lack of quality check in generic drug manufacturing, and they require more information about bioequivalence studies. In both categories, about 75% of participants preferred generic medications for their patients. However, in both groups, more than 50% of physicians were concerned about therapeutic failure and expressed reluctance to prescribe generic medications in life-threatening situations. Conclusions: Knowledge and acceptance of generic drugs regarding efficacy, safety, bioequivalence and therapeutic failure are low among both government and private physicians. [ABSTRACT FROM AUTHOR]

Research Question and Objective: While the number of pharmacoepidemiological studies on stimulant-based ADHD medications has expanded rapidly in recent years, likely due to the stimulant shortage, few studies have analyzed non-stimulant ADHD medications from a pharmacoepidemiological perspective. Such research is important because a significant number of individuals with ADHD have medical or psychiatric conditions that preclude stimulant use. Furthermore, no studies, to our knowledge, have analyzed atomoxetine exchanges on the black market. In this report, we seek to fill both these gaps in the research by analyzing black market diversions of atomoxetine, a non-stimulant medication for ADHD. As ADHD medication diversion is a growing issue, we also hypothesize the pharmacoepidemiologic contributors to and implications of such diversion. Method: This study analyzed black market atomoxetine purchases entered on the web-based platform StreetRx between January 2015 and July 2019. Data included the generic drug name, dosage, purchase price, date, and location in the United States. The mean price per milligram was determined and a heatmap was generated. Results: The average price per milligram of 113 diverted atomoxetine submissions was USD 1.35 (±USD 2.76 SD) (Median = USD 0.05, Min = USD 0.01, Max = USD 20.00). The states with the most submissions included Michigan (11), Pennsylvania (9), Indiana (8), and Ohio (8). Conclusion: The cost per milligram of atomoxetine on the black market is over 50 times the cost per milligram of the generic prescribed form. Future qualitative studies should investigate reasons why individuals are motivated to purchase atomoxetine, a non-stimulant medication, on the black market (recreational vs. nootropic vs. other clinical uses). [ABSTRACT FROM AUTHOR]

Objectives: The prescription errors and prescribing fault analysis was assessed, the rationality of the prescriptions was checked, and the medication error was categorized according to the NCC MERP Index. Materials and Methods: A cross-sectional, observational study was designed as per STROBE guidelines and conducted for 2 months in the pharmacy stores after approval of the Institutional Review Board. Patients' written informed consent was taken before getting their prescriptions, and each of the prescriptions procured in this way was photographed for record. The completeness of 320 prescriptions of outpatients of all age groups regarding the details about the doctor and the patient and clinical diagnosis/indication was analyzed. The rationality of prescription was based on WHO core drug use indicators. Descriptive analysis was done by using Microsoft Excel. Results: A total of 320 prescriptions were analyzed from eight departments. Information about patients and prescribers was mentioned in 100% of prescriptions. The diagnosis (40%), an indication was written in 195 prescriptions. Instructions for dispensing drugs (89%), instructions to patients (90%), duration of treatment (100%), follow-up visits (19%), and non-pharmacological instructions (13%) were mentioned. In total, 82% of prescriptions were legible. In a total of 1004 drugs, 92% of drugs were prescribed with a generic name, 100% from the essential drug list. The route and frequency of drug administration were mentioned for all drugs. According to NCCMERP, the category of medication errors falls under category B. Conclusion: To reduce medication errors, we can implement an electronic system, involve clinical pharmacologists, utilize prescription charts, and organize nationwide workshops on rational prescription writing. We should encourage regular prescription audits and reporting to improve the healthcare system in the country. [ABSTRACT FROM AUTHOR]

Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for generic products to their respective comparator products. In December 2022, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) published the first new draft guideline on BE for IR solid oral dosage forms (M13A). To support the development of ICH M13A, we comprehensively reviewed the landscape of oral IR products approved by the U.S. Food and Drug Administration (FDA) and compared BE recommendations for these products in the current U.S. FDA and European Medicines Agency (EMA) BE guidances. We utilized databases including Drugs@FDA, Orange Book, and product‐specific guidances (PSGs) published on the U.S. FDA and EMA websites to collect information. Oral IR products account for 46% of all FDA‐approved new drug applications currently listed in Orange Book with 82.5% solids, 0.9% semi‐solids, and 16.6% liquids. For all published U.S. FDA PSGs for solid oral IR products, in vivo BE studies with pharmacokinetic (PK) endpoints account for 88% of BE approaches recommended. Of these PK BE studies, 86.5% recommended fasting and fed BE studies, while only 15.9% EMA PSGs recommended both fasting and fed BE studies. This review helps clarify the scope of U.S. solid oral IR products impacted by the new ICH M13A draft guideline and demonstrates how recommendations in draft ICH M13A could significantly harmonize BE recommendations for IR oral products to facilitate global drug development. [ABSTRACT FROM AUTHOR]

The article examines the association between pharmaceutical patents and economic inequality. Topics discussed include how governments award and enforce 20-year product patents on pharmaceuticals, additional incentive provided by patents in the case of infectious diseases, and how universal access to new medicines could be achieved.

This article discusses a study conducted at a tertiary care hospital in Uttarakhand, India, to assess the prescribing practices and patterns of antibacterial agents. The study found that the prescribing practices deviated from the World Health Organization's (WHO) set standards, with polypharmacy, a smaller number of drugs prescribed with a generic name, and a majority of drugs prescribed from the Uttarakhand essential medicine list. The study also found that males were prescribed more antibiotics than females, younger patients were prescribed more antibacterials compared to older patients, and only 1.1% of prescriptions included injectables. The study suggests improving prescribing practices by adhering to local and national treatment guidelines, conducting regular prescription audits, and updating the essential medicine list. [Extracted from the article]

Drug shortages are becoming more frequent and severe in the United States, especially for generic drugs. A lack of economic incentives has been cited as a root cause. Only few firms choose to produce a such drugs, and, if they do, these firms do not allocate large levels of capacity. Hence, total industry supply is limited, increasing the odds of shortages. We develop and analyze a stylized game‐theoretic model of a generic drug market to understand the impact of various governmental interventions on the total industry equilibrium supply. We explicitly consider firm market entry and exit decisions and the participating firms' incentives to allocate productive capacity to the focal drug market. We first characterize sustainable numbers of active drug manufacturers and their equilibrium capacity allocation decisions for a given regulatory environment. We then analyze the effects of different possible policy interventions on these equilibrium decisions and total industry capacity. Finally, we consider the impact of combinations of different interventions and, importantly, the sequence in which such combined interventions are introduced. A key result of our analysis is that the sequence of policy interventions may have an important effect on the resulting equilibrium industry capacity. When changing the regulatory environment, policymakers should be careful never to lead a sequence of changes with an adjustment that adversely affects pharmaceutical firms' incentives to allocate capacity to the focal drug market; we show that starting with capacity‐supporting interventions always is a dominant strategy when aiming to increase total industry capacity. [ABSTRACT FROM AUTHOR]

Background and objectives: Generic medications are cost-effective without compromising therapeutic outcomes. Therefore, the goal of this study was to investigate, using a cross-sectional study design, the factors influencing Saudi Arabian consumers' preferences between innovator and generic medications. Methods: This cross-sectional study was carried out in Saudi Arabia using a Google survey form. For data collection, a simple random sampling strategy was used. The recruited participants were surveyed using a validated questionnaire that focused on six influencing domains: physician, pharmacist, perceived effectiveness, price, information availability, and confidence based on prior experience. The obtained data was used to analyze factors that have an association with any of the six domains using multinomial regression analysis. A correlation analysis was performed to examine the relationship between domains. Results: The 317 participants included 64.4 % females, 52 % aged ≥ 26, and a large proportion of Saudi nationals (82.6 %) and university graduates (78.9 %). Being employed (OR:3.029; P = 0.006; CI: 6.715–1.366), a healthcare providers (OR:2.298; P = 0.043; CI: 5.151–1.025), and having insurance coverage (OR:1.908; P = 0.017; CI: 3.245–1.122) had a greater influence on medication selection. Participants with linguistic and business educational backgrounds (OR:3.443; P = 0.022; CI: 9.950–1.191), those living in the northern region of Saudi Arabia (OR:3.174; P = 0.009; CI: 7.585–1.328), having chronic ailments (OR:3.863; P = 0.013; CI: 11.274–1.324), and possess insurance (OR:1.748; P = 0.039; CI: 2.971–1.028) get readily influenced by pharmacist. People who were married and lived in Saudi Arabia's southern region were influenced by perceived effectiveness when choosing medicine. Participants from the northern region were found to be influenced by the price of the medicines, information about the medicines, and confidence based on previous experience. The price of medicines has a significant impact on those suffering from chronic diseases. At a significant level of P = 0.01, all six influencing domains were found to be positively correlated with each other. Conclusion: The study shows that healthcare providers, drug prices, perceived efficacy, and information availability all have a big influence on the Saudi Arabian population's choice of medications. Educational background, location, and chronic disease status are associated with several influencing domains. Aside from public awareness campaigns, healthcare professionals should be involved in the implementation of the generic medication policy.

Introduction: The drugs approved by the Food and Drug Administration (FDA) in 2022, for the first time for any indication or under any brand, were studied under the contexts of indications, mechanism of action, and side effects. Primary care practitioners with considering patients as a composite whole will benefit by acquainting themselves with these drugs and their indications and adverse effects. Observations: The drugs were approved in all, 11 for the management of neoplasia, and 5 each for hematological, neurological, and dermatological conditions. 11 of the approved drugs are monoclonal antibodies and six are small molecule inhibitors. Conclusion: Although the FDA’s expedited approval program allows rapid market availability of drugs for difficult to treat conditions, a quarter of the globe does not have access to essential medicines, primarily due to cost. In light of this, approval agencies must reorient approval processes to improve accessibility.

This study evaluates the characteristics of generic active pharmaceutical ingredients (APIs) used to manufacture drugs with shortages in the US and facilities producing APIs worldwide. [ABSTRACT FROM AUTHOR]

This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition. [ABSTRACT FROM AUTHOR]

This study examines the accuracy of labeling for galantamine products formulated as both generic drugs and dietary supplements, as well as tests for contamination with microorganisms. [ABSTRACT FROM AUTHOR]