RESUMO
BACKGROUND: US adults often overpay for generic prescription medications, which can lead to medication nonadherence that negatively impacts cardiovascular outcomes. As a result, new direct-to-consumer online medication services are growing in popularity nationwide. Amazon recently launched a $5/month direct-to-consumer medication subscription service (Amazon RxPass), but it is unclear how many US adults could save on out-of-pocket drug costs by using this new service. OBJECTIVES: To estimate out-of-pocket savings on generic prescription medications achievable through Amazon's new direct-to-consumer subscription medication service for adults with cardiovascular risk factors and/or conditions. METHODS: Cross-sectional study of adults 18-64 years in the 2019 Medical Expenditure Panel Survey. RESULTS: Of the 25,280,517 (SE ± 934,809) adults aged 18-64 years with cardiovascular risk factors or conditions who were prescribed at least 1 medication available in the Amazon RxPass formulary, only 6.4% (1,624,587 [SE ± 68,571]) would achieve savings. Among those achieving savings, the estimated average out-of-pocket savings would be $140 (SE ± $15.8) per person per year, amounting to a total savings of $228,093,570 (SE ± $26,117,241). In multivariable regression models, lack of insurance coverage (adjusted odds ratio [OR] 3.5, 95%CI 1.9-6.5) and being prescribed a greater number of RxPass-eligible medications (2-3 medications versus 1 medication: OR 5.6, 95%CI 3.0-10.3; 4+ medications: OR 21.8, 95%CI 10.7-44.3) were each associated with a higher likelihood of achieving out-of-pocket savings from RxPass. CONCLUSIONS: Changes to the pricing structure of Amazon's direct-to-consumer medication service are needed to expand out-of-pocket savings on generic medications to a larger segment of the working-age adults with cardiovascular risk factors and/or diseases.
Assuntos
Doenças Cardiovasculares , Custos de Medicamentos , Fatores de Risco de Doenças Cardíacas , Humanos , Adulto , Pessoa de Meia-Idade , Masculino , Feminino , Estudos Transversais , Doenças Cardiovasculares/economia , Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/tratamento farmacológico , Adulto Jovem , Custos de Medicamentos/estatística & dados numéricos , Adolescente , Gastos em Saúde/estatística & dados numéricos , Estados Unidos , Medicamentos sob Prescrição/economia , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Redução de Custos , Assistência Farmacêutica/economiaRESUMO
Over the past several years, advances in research, treatment, and market dynamics have impacted treatment strategies in chronic myeloid leukemia in chronic phase (CML-CP). They include the broader availability of cost-effective generic imatinib, and soon other generic second-generation tyrosine kinase inhibitors (TKIs). Access to affordable generics means that all patients with CML-CP should have access to safe and highly effective lifelong therapies. When overall survival is the treatment endpoint, imatinib provides a good treatment value. Second-generation TKIs may be the best frontline strategy when treatment-free remission is the goal. Recent studies have shown maintained efficacy and reduced toxicity when TKIs are used at reduced dosing. Reduced-dose schedules of second-generation TKIs (which are less toxic and induce faster deep molecular responses) may render generic second-generation TKIs a more attractive treatment option. Adjusting the dose of TKI in the presence of mild-to-moderate, or even severe but reversible, adverse events may be preferable to switching to a different TKI. The selection of second-line and beyond therapies depends on the evolving patterns observed with frontline treatment. Dose-adjusted ponatinib schedules have demonstrated improved efficacy and safety in patients resistant to second-generation TKIs or those with T315I-mutated disease. For asciminib, longer-term follow-up is needed to better evaluate its safety and efficacy compared with ponatinib. Allogeneic stem cell transplantation represents a valid alternative to newer-generation TKIs, with a better treatment value when TKIs are priced at >$40,000/year.
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Antineoplásicos , Leucemia Mielogênica Crônica BCR-ABL Positiva , Leucemia Mieloide de Fase Crônica , Humanos , Mesilato de Imatinib/uso terapêutico , Antineoplásicos/efeitos adversos , Inibidores de Proteínas Quinases , Leucemia Mieloide de Fase Crônica/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Leucemia Mielogênica Crônica BCR-ABL Positiva/genética , Medicamentos Genéricos/uso terapêutico , Proteínas de Fusão bcr-abl/genéticaRESUMO
BACKGROUND: Despite efforts made to reduce morbidity and mortality associated with malaria, especially in sub-Saharan Africa, malaria continues to be a public health concern that requires innovative efforts to reach the WHO-set zero malaria agenda. Among the innovations is the use of artemisinin-based combination therapy (ACT) that is effective against Plasmodium falciparum. Generic artemether-lumefantrine (AL) is used to treat uncomplicated malaria after appropriate diagnosis. AL is metabolized by the cytochrome P450 family of enzymes, such as CYP2B6, CYP3A4 and CYP3A5, which can be under pharmacogenetic influence. Pharmacogenetics affecting AL metabolism, significantly influence the overall anti-malarial activity leading to variable therapeutic efficacy. This study focused on generic AL drugs used in malarial treatment as prescribed at health facilities and evaluated pharmacogenomic influences on their efficacy. METHODS: Patients who have been diagnosed with malaria and confirmed through RDT and microscopy were recruited in this study. Blood samples were taken on days 1, 2, 3 and 7 for parasite count and blood levels of lumefantrine, artemisinin, desbutyl-lumefantrine (DBL), and dihydroartemisinin (DHA), the active metabolites of lumefantrine and artemether, respectively, were analysed using established methods. Pharmacogene variation analysis was undertaken using iPLEX microarray and PCR-RFLP. RESULTS: A total of 52 patients completed the study. Median parasite density from day 1 to 7 ranged from 0-2666/µL of blood, with days 3 and 7 recording 0 parasite density. Highest median plasma concentration for lumefantrine and desbutyl lumefantrine, which are the long-acting components of artemisinin-based combinations, was 4123.75 ng/mL and 35.87 ng/mL, respectively. Day 7 plasma lumefantrine concentration across all generic ACT brands was ≥ 200 ng/mL which potentially accounted for the parasitaemia profile observed. Monomorphism was observed for CYP3A4 variants, while there were observed variations in CYP2B6 and CYP3A5 alleles. Among the CYP3A5 genotypes, significant differences in genotypes and plasma concentration for DBL were seen on day 3 between 1/*1 versus *1/*6 (p = 0.002), *1/*3 versus *1/*6 (p = 0.006) and *1/*7 versus *1/*6 (p = 0.008). Day 7 plasma DBL concentrations showed a significant difference between *1/*6 and *1/*3 (p = 0.026) expressors. CONCLUSIONS: The study findings show that CYP2B6 and CYP3A5 pharmacogenetic variations may lead to higher plasma exposure of AL metabolites.
Assuntos
Antimaláricos , Combinação Arteméter e Lumefantrina , Artemisininas , Combinação de Medicamentos , Etanolaminas , Fluorenos , Humanos , Antimaláricos/uso terapêutico , Antimaláricos/farmacocinética , Combinação Arteméter e Lumefantrina/uso terapêutico , Feminino , Etanolaminas/uso terapêutico , Etanolaminas/farmacocinética , Adolescente , Fluorenos/uso terapêutico , Fluorenos/farmacocinética , Fluorenos/farmacologia , Artemisininas/uso terapêutico , Artemisininas/farmacocinética , Masculino , Gana , Adulto , Adulto Jovem , Criança , Pré-Escolar , Pessoa de Meia-Idade , Malária Falciparum/tratamento farmacológico , Malária Falciparum/parasitologia , Medicamentos Genéricos/uso terapêutico , Resultado do Tratamento , Farmacogenética , Idoso , LactenteRESUMO
BACKGROUND: This retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017. METHODS: This was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence. RESULTS: A total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]). CONCLUSION: This comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.
Assuntos
Medicamentos Genéricos , Humanos , Equivalência Terapêutica , Medicamentos Genéricos/uso terapêutico , Arábia Saudita , Estudos Retrospectivos , Tamanho da AmostraRESUMO
PURPOSE: Due to constantly rising therapy costs, biosimilars and generic drugs have gained tremendous importance through recent decades. Nevertheless, the acceptance among healthcare workers regarding biosimilars and generic drugs in previously published international studies is considerably lower than the scientific data on equivalent safety and efficacy would suggest. The aim of this questionnaire-based survey was to determine the perception and knowledge regarding generic drugs and biosimilars by medical professionals from different healthcare facilities in Vienna, Austria. METHODS: The online questionnaire was sent to public and religious hospitals in Vienna, including the university hospital "Vienna General Hospital." In addition, doctors' offices were reached by sending out the questionnaire in the weekly news of the Vienna Medical Association. RESULTS: A total of 282 physicians and 311 graduated nurses took part in the study. 63% and 62% of the participants were convinced that generic respective biosimilar drugs were clinically equivalent to the original reference drug. On average, 1.6 out of 4 knowledge questions were answered correctly about generics, while only 0.87 out of 4 questions were answered accurately about biosimilars. CONCLUSION: The results of this study support the outcome from previous surveys demonstrating that a large proportion of healthcare professionals is still skeptical about generics and biosimilars. According to the results of this study, better education of the medical staff might ensure greater acceptance of these types of drugs.
Assuntos
Medicamentos Biossimilares , Humanos , Medicamentos Biossimilares/uso terapêutico , Medicamentos Genéricos/uso terapêutico , Pessoal de Saúde , Atitude do Pessoal de Saúde , PercepçãoRESUMO
BACKGROUND: The 2013 ACC/AHA Guideline was a paradigm shift in lipid management and identified the four statin-benefit groups. Many have studied the guideline's potential impact, but few have investigated its potential long-term impact on MACE. Furthermore, most studies also ignored the confounding effect from the earlier release of generic atorvastatin in Dec 2011. METHODS: To evaluate the potential (long-term) impact of the 2013 ACC/AHA Guideline release in Nov 2013 in the U.S., we investigated the association of the 2013 ACC/AHA Guideline with the trend changes in 5-Year MACE survival and three other statin-related outcomes (statin use, optimal statin use, and statin adherence) while controlling for generic atorvastatin availability using interrupted time series analysis, called the Chow's test. Specifically, we conducted a retrospective study using U.S. nationwide de-identified claims and electronic health records from Optum Labs Database Warehouse (OLDW) to follow the trends of 5-Year MACE survival and statin-related outcomes among four statin-benefit groups that were identified in the 2013 ACC/AHA Guideline. Then, Chow's test was used to discern trend changes between generic atorvastatin availability and guideline potential impact. RESULTS: 197,021 patients were included (ASCVD: 19,060; High-LDL: 33,907; Diabetes: 138,159; High-ASCVD-Risk: 5,895). After the guideline release, the long-term trend (slope) of 5-Year MACE Survival for the Diabetes group improved significantly (P = 0.002). Optimal statin use for the ASCVD group also showed immediate improvement (intercept) and long-term positive changes (slope) after the release (P < 0.001). Statin uses did not have significant trend changes and statin adherence remained unchanged in all statin-benefit groups. Although no other statistically significant trend changes were found, overall positive trend change or no changes were observed after the 2013 ACC/AHA Guideline release. CONCLUSIONS: The 2013 ACA/AHA Guideline release is associated with trend improvements in the long-term MACE Survival for Diabetes group and optimal statin use for ASCVD group. These significant associations might indicate a potential positive long-term impact of the 2013 ACA/AHA Guideline on better health outcomes for primary prevention groups and an immediate potential impact on statin prescribing behaviors in higher-at-risk groups. However, further investigation is required to confirm the causal effect of the 2013 ACA/AHA Guideline.
Assuntos
Fidelidade a Diretrizes , Inibidores de Hidroximetilglutaril-CoA Redutases , Análise de Séries Temporais Interrompida , Guias de Prática Clínica como Assunto , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , Estados Unidos , Fatores de Tempo , Estudos Retrospectivos , Masculino , Feminino , Idoso , Pessoa de Meia-Idade , Resultado do Tratamento , Fidelidade a Diretrizes/normas , Biomarcadores/sangue , Dislipidemias/tratamento farmacológico , Dislipidemias/sangue , Dislipidemias/diagnóstico , Dislipidemias/mortalidade , Dislipidemias/epidemiologia , Atorvastatina/uso terapêutico , Atorvastatina/efeitos adversos , Doenças Cardiovasculares/mortalidade , Doenças Cardiovasculares/prevenção & controle , Doenças Cardiovasculares/sangue , Bases de Dados Factuais , Padrões de Prática Médica/normas , Colesterol/sangue , Adesão à Medicação , Medicamentos Genéricos/uso terapêutico , Medicamentos Genéricos/efeitos adversos , Medição de RiscoRESUMO
BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. METHODS: This study uses two scenarios to cost the impact the CPTPP would have had on Thailand's 2020 hepatitis C treatment regime if Thailand joined the CPTPP and suspended clauses were reinstated. RESULTS: Joining the CPTPP could have increased the cost more than tenfold if suspended CPTPP clauses were reinstated and Thailand was not willing or able to issue compulsory licenses. Based on the 2020 budget, the price for this possible scenario could have reduced hepatitis C treatment coverage by 90%. CONCLUSIONS: Acceding to trade agreements such as the CPTPP that require increasing intellectual property protection, could compromise Thailand's hepatitis C program and other national treatment programs reliant on affordable generic medicines. The CPTPP could also prevent Thailand from relying on its own pharmaceutical capabilities to manufacture medicines needed to sustain its treatment programs.
Assuntos
Hepatite C , Cooperação Internacional , Tailândia , Humanos , Hepatite C/tratamento farmacológico , Estados Unidos , Propriedade Intelectual , Antivirais/uso terapêutico , Medicamentos Genéricos/uso terapêuticoRESUMO
BACKGROUND: Primary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2α analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05 mg/ml eye drops solution, in lowering IOP when compared to the originator Xalatan® (latanoprost 0.005% ophthalmic solution, Pfizer). METHODS: This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18-75 years) with open-angle glaucoma or ocular hypertension. RESULTS: Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04 ± 2.14 mmHg or 7.17 ± 2.11 mmHg was found after treatment with test or reference product, respectively (N = 44). In the intention to treat analysis, the reduction was 7.29 ± 2.53 mmHg (95% CI: 6.55-8.04) or 7.43 ± 2.78 mm Hg (95%CI: 6.61-8.24) after treatment with test or reference product, respectively (N = 47). There were no serious adverse events. CONCLUSIONS: Latanoprost Polpharma was shown to be non-inferior to Xalatan®. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life. TRIAL REGISTRATION: The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI/41,779- 11/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642/25.12.2018) (clinical trial identification number: 848,300,144/0103/1 - POP03; IND number/EudraCT number: 2018-001727-39).
Assuntos
Anti-Hipertensivos , Estudos Cross-Over , Glaucoma de Ângulo Aberto , Pressão Intraocular , Latanoprosta , Hipertensão Ocular , Soluções Oftálmicas , Humanos , Latanoprosta/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Glaucoma de Ângulo Aberto/fisiopatologia , Masculino , Feminino , Pessoa de Meia-Idade , Pressão Intraocular/efeitos dos fármacos , Hipertensão Ocular/tratamento farmacológico , Anti-Hipertensivos/uso terapêutico , Anti-Hipertensivos/efeitos adversos , Idoso , Adulto , Medicamentos Genéricos/uso terapêutico , Medicamentos Genéricos/efeitos adversos , Resultado do Tratamento , Conservantes Farmacêuticos/uso terapêutico , Método Simples-Cego , Tonometria Ocular , Método Duplo-CegoRESUMO
INTRODUCTION AND OBJECTIVES: Treatment of chronic hepatitis B (CHB) with nucelos(t)ide analogues (NA) can improve outcomes, but NA treatment is expensive for insurance plans. MATERIALS AND METHODS: The Centers for Medicare & Medicaid Services database was assessed from 2012 to 2021 to assess the use of NA for CHB in patients on Medicaid. Data extracted included the number of claims, units, and costs of each agent stratified by originator and generic. RESULTS: Over the study period, 1.9 billion USD was spent on NA, with spending peaking in 2016 at $289 million US, which has subsequently decreased. Lower expenditures since 2016 have been associated with increased use of generics. The use of generic tenofovir or entecavir led to savings of $669 million US over the study period. CONCLUSIONS: Increased generic use has significantly reduced expenditures for NA drugs; policy shifts towards generic drug use may help with sustainability.
Assuntos
Antivirais , Custos de Medicamentos , Medicamentos Genéricos , Gastos em Saúde , Hepatite B Crônica , Medicaid , Humanos , Estados Unidos , Medicaid/economia , Antivirais/uso terapêutico , Antivirais/economia , Hepatite B Crônica/tratamento farmacológico , Hepatite B Crônica/economia , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Nucleosídeos/uso terapêutico , Nucleosídeos/economia , Tenofovir/uso terapêutico , Tenofovir/economia , Guanina/análogos & derivados , Guanina/uso terapêutico , Guanina/economiaRESUMO
This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition.
Assuntos
Medicamentos Genéricos , Patentes como Assunto , Medicamentos sob Prescrição , Avaliação de Risco e Mitigação , Custos de Medicamentos , Indústria Farmacêutica , Medicamentos Genéricos/uso terapêutico , Competição Econômica , Avaliação de Risco e Mitigação/legislação & jurisprudência , Estados Unidos , Patentes como Assunto/legislação & jurisprudênciaRESUMO
This study examines formulary coverage of brand-name adalimumab and biosimilars across Medicare Part D plans.
Assuntos
Adalimumab , Medicamentos Biossimilares , Formulários Farmacêuticos como Assunto , Cobertura do Seguro , Medicare Part D , Humanos , Adalimumab/economia , Adalimumab/uso terapêutico , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Cobertura do Seguro/economia , Cobertura do Seguro/estatística & dados numéricos , Medicare Part D/economia , Medicare Part D/estatística & dados numéricos , Estados Unidos/epidemiologiaRESUMO
Market drugs including brand or generic with poor quality, don't meet the acceptable standard guidelines. Vildagliptin is an important antidiabetic drugs used in monotherapy or in combinations protocols for treatment of diabetes mellites. The main goal of the current study is to assess the pharmaceutical equivalence of two marketed generics of vildagliptin 50 mg tablets compared to the branded product (Galvus 50 mg). The in vitro dissolution test was used as a quality control tool to obtain the dissolution profile of vildagliptin compared to the reference drug. The results revealed that all tested samples showed dissolution behavior like standard drug. Whole samples dissolution reached after 15 min in accordance with the standard. According to the similarity factors records, tested vildagliptin samples showed a comparable dissolution to the reference drug. The current work presents an in vitro protocol for quality evaluation of recently released generic drugs.
Assuntos
Medicamentos Genéricos , Hipoglicemiantes , Vildagliptina , Medicamentos Genéricos/uso terapêutico , Controle de Qualidade , ComprimidosRESUMO
BACKGROUND: Healthcare systems worldwide face escalating pharmaceutical expenditures despite interventions targeting pricing and generic substitution. Existing studies often overlook unwarranted volume increases in multisource markets due to differential physician perceptions of brand name and generics. OBJECTIVE: This study aims to explain the outpacing of generic medicine use over brand name use in multisource markets and assess the regulatory role, specifically examining the impact of reference pricing on volume and intensity increases. METHODS: Analyzing German multisource prescription medicine markets from 2011 to 2014, we evaluate regulatory mechanisms and explore whether brand name and generic medicines constitute separate market segments. Using an Oaxaca-Blinder decomposition approach, we divide the differential in brand name versus generic medicine use rates into market structure and unobserved segment effects. RESULTS: Generic use rates surpass same-market brand name substitution by 3.87 prescriptions per physician and medicine, on average. Reference pricing mitigated volume increase, treatment intensity and expenditure. Disparities in quantity and expenditure dynamics between brand name and generic segments are partially explained by market structure and segment effects. CONCLUSION: Generic medicine use effectively reduces expenditures but contributes to increased net prescription rates. Reference pricing may control medicine use, but divergent physician perceptions of brand name and generics, revealed by identified segment effects, call for nuanced policy interventions.
Assuntos
Medicamentos Genéricos , Medicamentos Genéricos/economia , Medicamentos Genéricos/uso terapêutico , Humanos , Alemanha , Custos de Medicamentos , Gastos em Saúde , Médicos/economiaRESUMO
Purpose: This study evaluates the use, benefit-risk profile, and economic impact of generic immunosuppressants (tacrolimus-TAC, cyclosporine-CsA, and mycophenolate-MYC) in kidney and liver transplant recipients compared to brand-name drugs. Patients and Methods: A retrospective multicentre observational study, involving four Italian regions, was conducted based on the national transplant Information system and regional healthcare claims data. The analysis focused on incident patients who received kidney and liver transplants between 2013 and 2019 and evaluated the use of generic of CsA, TAC, and MYC during the 30-day period following discharge. For each type of transplant and immunosuppressive agent, the benefit-risk profile of generic vs branded drugs in a two-year window was estimated by multivariate Cox models (HR; 95% CI). Furthermore, the potential cost savings per person associated with one year of treatment using generics were calculated. Results: The utilization of generic drugs showed a significant increase; over the study years, the proportion of users among kidney recipients ranged from 14.2% to 40.5% for TAC, from 36.9% to 56.7% for MYC, and from 18.2% to 94.7% for CsA. A great variability in generic uptake for region was found. A comparable risk-benefit profile between generic and branded formulations was shown for all immunosuppressors considered. Choosing generic immunosuppressants during maintenance could result in yearly savings of around 2000 euros per person for each therapy ingredient. Conclusion: The study shows an increasing proportion of patients using generic immunosuppressive drugs over time suggesting a growing acceptance of generics within the transplant community and reveals comparable risk-benefit profiles between the generic and branded formulations of TAC, CsA, and MYC. A significant variability in the use of generics immunosuppressive agents was found both at the regional level and among transplant centers and future research should delve into regional prescribing variations.
Assuntos
Transplante de Rim , Humanos , Ciclosporina , Medicamentos Genéricos/uso terapêutico , Rejeição de Enxerto , Terapia de Imunossupressão , Imunossupressores/efeitos adversos , Fígado , Tacrolimo/uso terapêutico , Estudos RetrospectivosRESUMO
In a retrospective study conducted in three hospitals in Paris, generic antiretroviral accounted for 30.2% of all prescriptions. Tenofovir disoproxil/emtricitabine (TDF/FTC) was the most prescribed generic ART (82.3% of generic prescriptions). Generic ART (gART) was more likely to be prescribed to women, to patients less than 50âyears, and with recent HIV diagnosis less than 3âyears. Physicians prescribed more gART if they were men, older than 55âyears or worked at a university teaching hospital.
Assuntos
Medicamentos Genéricos , Infecções por HIV , Humanos , Estudos Retrospectivos , Feminino , Masculino , Medicamentos Genéricos/uso terapêutico , Pessoa de Meia-Idade , Paris , Infecções por HIV/tratamento farmacológico , Adulto , Antirretrovirais/uso terapêutico , Prescrições de Medicamentos/estatística & dados numéricos , Idoso , Uso de Medicamentos/estatística & dados numéricos , Fármacos Anti-HIV/uso terapêuticoRESUMO
BACKGROUND: Frailty and comorbidity influence the therapeutic approach in everyday clinical practice. The DOACs genericization opens a reflection on their differences from a pharmacological and bioavailability point of view, particularly in elderly frail patients. The aim of this project was to create a national Delphi consensus on the topic of the use of DOACs for atrial fibrillation (AF) in such patients, in light of the genericization of the class. METHODS AND RESULTS: The consensus dealt with 3 main topics: a) efficacy and safety of DOACs in elderly and/or frail patients; b) therapeutic choice in specific frailty scenarios; c) DOACs genericization. 56 cardiologists, two internists and two neurologists from Italy expressed their level of agreement on each statement by using a 5-point Likert scale (1: strongly disagree, 2: disagree, 3: uncertain, 4: agree, 5: strongly agree). A positive consensus was reached if the percentage of agreement (vote 1-2, positive consensus) or disagreement (votes 4-5, negative consensus) was >66%; otherwise, no consensus was reached. Results are displayed accordingly. CONCLUSIONS: After 10 years of everyday clinical management of DOACs for AF, specific elements differentiating a molecule from another, either for efficacy or for safety, are consolidated. However, some uncertainties still exist in particular contexts, such as chronic kidney disease or cancer patients. Clinicians have an unsure attitude towards generic drugs, because clinical practice is lacking as well as a proper knowledge of the topic. Albeit being an alternative, the choice of the generic drug must remain the responsibility of the clinician.
Assuntos
Fibrilação Atrial , Técnica Delphi , Medicamentos Genéricos , Idoso Fragilizado , Humanos , Idoso , Fibrilação Atrial/tratamento farmacológico , Medicamentos Genéricos/uso terapêutico , Inibidores do Fator Xa/uso terapêutico , Inibidores do Fator Xa/administração & dosagem , Feminino , Masculino , Idoso de 80 Anos ou mais , Consenso , Itália/epidemiologia , Acidente Vascular CerebralRESUMO
In the last decade there is an increasing frequency of sudden generic switches of antiseizure medications (ASMs) due to delivery problems. We here explored the patient's views toward generic substitution of ASMs and their experiences with delivery problems and switches of the manufacturer. A questionnaire already used in 2011 was updateded and published on the website of a patient's organisation from March 2022 until November 2022. 54.4â¯% of the responders reported delivery problems. Delivery problems were reported from Germany by a higher number of responders than from Switzerland. To 83.7â¯% of the responders the delivery problems were communicated by the pharmacists. In 41.9â¯% of these the delivery problems were coped by generic substitution. In 33â¯% of the latter breakthrough seizures occurred. 26â¯% of the respondents with experience of a change of the manufacturer not due to a delivery problem reported breakthrough seizures after being substituted. The majority of patients denied having been well informed about the possible consequences of a switch of the manufacturer. A thorough counselling on the low risks caused by change of the manufacturer and the need for good adherence to further reduce the risks should be part of the general information about their treatment with ASMs for people with epilepsy.
Assuntos
Anticonvulsivantes , Substituição de Medicamentos , Epilepsia , Humanos , Anticonvulsivantes/uso terapêutico , Alemanha , Inquéritos e Questionários , Suíça , Epilepsia/tratamento farmacológico , Feminino , Masculino , Adulto , Pessoa de Meia-Idade , Medicamentos Genéricos/uso terapêutico , Indústria Farmacêutica , IdosoRESUMO
Objective: This study aims to determine whether the live birth rates were similar between GnRH antagonist original reference product Cetrotide® and generic Ferpront®, in gonadotropin-releasing hormone (GnRH) antagonist protocol for controlled ovarian stimulation (COS). Methods: This retrospective cohort study investigates COS cycles utilizing GnRH antagonist protocols. The research was conducted at a specialized reproductive medicine center within a tertiary care hospital, spanning the period from October 2019 to October 2021. Within this timeframe, a total of 924 cycles were administered utilizing the GnRH antagonist originator, Cetrotide® (Group A), whereas 1984 cycles were undertaken using the generic, Ferpront® (Group B). Results: Ovarian reserve markers, including anti-Mullerian hormone, antral follicle number, and basal follicular stimulating hormone, were lower in Group A compared to Group B. Propensity score matching (PSM) was performed to balance these markers between the groups. After PSM, baseline clinical features were similar, except for a slightly longer infertile duration in Group A versus Group B (4.43 ± 2.92 years vs. 4.14 ± 2.84 years, P = 0.029). The duration of GnRH antagonist usage was slightly longer in Group B than in Group A (6.02 ± 1.41 vs. 5.71 ± 1.48 days, P < 0.001). Group B had a slightly lower number of retrieved oocytes compared to Group A (14.17 ± 7.30 vs. 14.96 ± 7.75, P = 0.024). However, comparable numbers of usable embryos on day 3 and good-quality embryos were found between the groups. Reproductive outcomes, including biochemical pregnancy loss, clinical pregnancy, miscarriage, and live birth rate, did not differ significantly between the groups. Multivariate logistic regression analyses suggested that the type of GnRH antagonist did not independently impact the number of oocytes retrieved, usable embryos, good-quality embryos, moderate to severe OHSS rate, clinical pregnancy, miscarriage, or live birth rate. Conclusion: The retrospective analysis revealed no clinically significant differences in reproductive outcomes between Cetrotide® and Ferpront® when used in women undergoing their first and second COS cycles utilizing the GnRH antagonist protocol.
Assuntos
Hormônio Liberador de Gonadotropina , Antagonistas de Hormônios , Indução da Ovulação , Humanos , Hormônio Liberador de Gonadotropina/antagonistas & inibidores , Hormônio Liberador de Gonadotropina/análogos & derivados , Feminino , Estudos Retrospectivos , Indução da Ovulação/métodos , Gravidez , Adulto , Antagonistas de Hormônios/uso terapêutico , Antagonistas de Hormônios/administração & dosagem , Antagonistas de Hormônios/efeitos adversos , Taxa de Gravidez , Coeficiente de Natalidade , Medicamentos Genéricos/uso terapêutico , Reserva Ovariana/efeitos dos fármacosRESUMO
OBJECTIVES: Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia. DESIGN: Comparative cross-sectional study. SETTING: The availability of essential, generic medicines for chronic diseases was assessed at two public pharmaceutical supply agency hubs. PARTICIPANTS: The current study included public supply agency hub managers, warehouse managers and forecasting officers at the study setting. OUTCOMES: The assessment encompassed the availability of chronic medicines on the day of data collection, as well as records spanning 8 months before the outbreak and 1 year during the pandemic. A total of 22 medicines were selected based on their inclusion in the national essential drug list for public health facilities, including 17 medicines for cardiovascular disease and 5 for diabetes mellitus. RESULTS: The results of the study indicate that the mean availability of the selected basket medicines was 43.3% (95% CI: 37.1 to 49.5) during COVID-19, which was significantly lower than the availability of 67.4% (95% CI: 62.2 to 72.6) before the outbreak (p<0.001). Prior to COVID-19, the overall average line-item fill rate for the selected products was 78%, but it dropped to 49% during the pandemic. Furthermore, the mean number of days out of stock per month was 11.7 (95% CI: 9.9 to 13.5) before the outbreak of COVID-19, which significantly increased to 15.7 (95% CI: 13.2 to 18.2) during the pandemic, indicating a statistically significant difference (p<0.001). Although the prices for some drugs remained relatively stable, there were significant price hikes for some products. For example, the unit price of insulin increased by more than 130%. CONCLUSION: The COVID-19 pandemic worsened the availability of essential chronic medicines, including higher rates of stockouts and unit price hikes for some products in the study setting. The study's findings imply that the COVID-19 pandemic has aggravated already-existing medicine availability issues. Efforts should be made to develop contingency plans and establish mechanisms to monitor medicine availability and pricing during such crises.
Assuntos
COVID-19 , Medicamentos Essenciais , Humanos , COVID-19/epidemiologia , Etiópia/epidemiologia , Controle de Doenças Transmissíveis , Estudos Transversais , Pandemias , Medicamentos Genéricos/uso terapêutico , Doença CrônicaRESUMO
OBJECTIVE: To identify the frequency and types of prescription errors, assess adherence to WHO prescribing indicators, and highlight the gaps in current prescribing practices of Junior dental practitioners in a tertiary care hospital in Karachi, Pakistan. METHODS: This cross-sectional study was conducted from January 2021 to March 2021. The study included the prescriptions by house surgeons and junior postgraduate medical trainees for walk-in patients visiting the dental outpatient department. A total of 466 prescriptions were evaluated for WHO core drug prescribing indicators. The prescription error parameters were prepared by studying the WHO practical manual on guide to good prescribing and previous studies. Prescription errors, including errors of omission related to the physician and the patients, along with errors of omission related to the drug, were also noted. The statistical analysis was performed with SPSS version 25. Descriptive analysis was performed for qualitative variables in the study. RESULTS: The average number of drugs per encounter was found to be 3.378 drugs per prescription. The percentage of encounters with antibiotics was 96.99%. Strikingly, only 16.95% of the drugs were prescribed by generic names and 23.55% of drugs belonged to the essential drug list. The majority lacked valuable information related to the prescriber, patient, and drugs. Such as contact details 419 (89.9%), date 261 (56%), medical license number 466 (100%), diagnosis 409 (87.8%), age and address of patient 453 (97.2%), form and route of drug 14 (3%), missing drug strength 69 (14.8%), missing frequency 126 (27%) and duration of treatment 72 (15.4%). Moreover, the wrong drug dosage was prescribed by 89 (19%) prescribers followed by the wrong drug in 52 (11.1%), wrong strength in 43 (9.2%) and wrong form in 9 (1.9%). Out of 1575 medicines prescribed in 466 prescriptions, 426 (27.04%) drug interactions were found and 299 (64%) had illegible handwriting. CONCLUSION: The study revealed that the prescription writing practices among junior dental practitioners are below optimum standards. The average number of drugs per encounter was high, with a significant percentage of encounters involving antibiotics. However, a low percentage of drugs were prescribed by generic name and from the essential drug list. Numerous prescription errors, both omissions and commissions, were identified, highlighting the need for improved training and adherence to WHO guidelines on good prescribing practices. Implementing targeted educational programs and stricter regulatory measures could enhance the quality of prescriptions and overall patient safety.