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1.
Cureus ; 16(4): e57939, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38738059

RESUMO

BACKGROUND: The Clinical Trials Registry - India (CTRI) database is a registry of various trials conducted in India and this study scrutinized the studies registered for COVID-19 from the database to detect patterns in trial design, appraising the target regions of therapies and comprehending the terrain of research endeavors. METHOD: This was a cross-sectional study that analyzed the registered trials for COVID-19 between March 2020 and September 2023. A trial search was conducted on the CTRI database to include all types of studies registered for COVID-19 with keywords like "COVID" and "coronavirus" and studies conducted on conditions other than COVID-19 were excluded. The data regarding study characteristics were noted under various sections in a preformed proforma. RESULTS: A total of 807 trials were taken for final analysis and there were about 344 prospective and 260 retrospective interventional trials, 35 prospective and 165 retrospective observational studies, and two prospective and one retrospective post-marketing surveillance study. The majority of the studies had duration under 12 months (91%). The maximum number of studies were registered from AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homeopathy) and allied therapies (n = 283), with about 104 types of interventions, followed by the drug category having 119 trials registered and about 57 types of interventions. Kabasura Kudineer and yoga in the AYUSH category, molnupiravir, colchicine, and favipiravir in the drug category, and tocilizumab and convalescent plasma among biologics were some common interventions used. The majority of trials did not mention the trial phase and declared it as not applicable (54%), whereas 15% were registered as phase 2 and 13% as phase 3. About 54% of the studies were randomized and randomized parallel-group design (20%) was the most common study design. Only 6% of the trials were post-graduate thesis and the majority of the trials (n = 535) denied sharing their individual participant data. Only 0.86% and 0.61% of the trials were terminated and suspended, respectively, denoting proper design and conduct of the trials. CONCLUSION: In the CTRI database, the majority of trials were prospective interventional studies, with a predominance of AYUSH therapies and drug interventions. Common interventions included Kabasura Kudineer and yoga in AYUSH, and molnupiravir, colchicine, and favipiravir in drugs. Most studies had durations under 12 months and randomized parallel-group design was the most common study design. The intention to use and promote an indigenous system of medicine looks promising in the absence of any definite therapy. A minute number of registered suspended and terminated trials might be a positive picture of meticulously designed and executed trials even during a pandemic situation in India.

2.
Indian J Med Res ; 159(2): 143-152, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38577855

RESUMO

BACKGROUND OBJECTIVES: Expenditure on healthcare is a major concern in the geriatric age group. The current study was carried out to assess the expenditure patterns on medicines utilized in geriatric inpatients. METHODS: An observational study was conducted on 1000 geriatric inpatients, aged ≥60 yr, admitted to the medicine unit. Data were collected regarding demographic characteristics, prescribed medicines, expenditure incurred on medicines, appropriateness of medicines prescribed and adverse drug reactions (ADRs). Appropriateness of the prescribed medicines was determined using the American Geriatrics Society 2015 Updated Beers Criteria. RESULTS: Geriatric inpatients comprised 41.3 per cent of the total individuals admitted in the ward during the study period. A total of 8366 medicines were prescribed in 127 formulations. The total expenditure on prescribed medicines was INR 1,087,175 with a per capita expenditure of INR 1087.17. Parenteral medicines accounted for 91 per cent of the expenditure on medicines. Maximum expenditure (70%) was incurred on 11.9 per cent of the medicines prescribed. The per capita expenditure was significantly higher in individuals with comorbidities (P=0.03) and those who had a longer duration of hospital stay (P<0.0001). About 28.1 per cent prescriptions were inappropriate. ADRs (140) were observed in 139 (13.9%) inpatients. Individuals with inappropriate medicines prescriptions and ADRs had a longer duration of hospital stay and more number of medicines prescribed. INTERPRETATION CONCLUSIONS: Comorbidities, prolonged hospitalization, polypharmacy, inappropriate medicines and parenteral medicines being prescribed contribute to increased expenditure on medicines in geriatric inpatients. In view of the rising number of geriatric inpatients, there is a need to frame a drug policy for them along with surveillance of expenditure on prescribed medicines. This needs to be treated as a priority.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacoeconomia , Humanos , Idoso , Centros de Atenção Terciária , Hospitalização , Prescrição Inadequada , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Índia/epidemiologia
3.
Expert Opin Drug Saf ; 23(2): 187-198, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38063346

RESUMO

BACKGROUND: Dyslipidaemia is a crucial risk factor for cardiovascular morbidity and mortality. A short interfering RNA called inclisiran diminishes circulating levels of PCSK9 and LDL-C by hindering PCSK9 translation in the liver. METHODS: RCTs were electronically searched on PubMed, Cochrane Central, and Clinicaltrials.gov to assess the safety and efficacy of inclisiran. Cochrane Review Manager 5 was used to conduct the pooled analysis. Risk of bias was assessed and GRADE pro-GDT was utilized, respectively, to estimate the methodological quality and overall quality of evidence. RESULTS: Of 218 records screened, four studies were included with 2203 participants in inclisiran and 1949 participants in the placebo group. Inclisiran was related to non-significant elevated risk of total adverse events[RR = 1.05(0.98,1.12), p = 0.16; I2 = 53%], non-serious adverse events[RR = 1.09(0.97,1.22),p = 0.15;I2 = 61%] and all-cause mortality[RR = 1.01(0.60,1.70),p = 0.97;I2 = 0%] whereas a lower risk of serious adverse events[RR = 0.94(0.70,1.25),p = 0.67;I2 = 73%], cardiac disorders [RR = 0.87(0.66,1.15),p = 0.33;I2 = 42%] and Major adverse cardiovascular events(MACE)[RR = 0.79(0.62,1.00),p = 0.05; I2 = 0%] as compared to placebo. Inclisiran was also linked to a substantial decline in the percentage of LDL-C, PCSK9, total cholesterol, and Apo B. CONCLUSION: The pooled analysis of the existing evidence shows that inclisiran showed reduced risk of MACE along with excellent efficacy in managing dyslipidemia. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifiers are NCT03399370, NCT03397121, NCT03400800, and NCT02597127.


Elevated cholesterol levels have been found to be associated with a high risk of heart disease and associated deaths. There are various classes of drugs used to control high low-density lipoprotein cholesterol (LDL-C) levels in blood yet appropriate control and patient compliance, to regular cholesterol-lowering drugs have been an issue. Inclisiran, a novel drug for reducing the LDL-C levels in serum can be given every six months as an effective therapy to minimize the levels of LDL-C in serum. This study was designed to assess the safety and effectiveness of inclisiran in patients with hyperlipidemia. Inclisiran was found to have a non-significant elevated risk of total adverse events, non-serious adverse events, and all-cause mortality. The majority of the adverse events seem to be non-serious and tolerable. There was an observed non-significant lower risk of serious adverse events, cardiac disorders, and significantly reduced risk of major adverse cardiovascular events when compared to placebo. Inclisiran was also linked to a significant decline in the percentage of LDL-C, PCSK9, total cholesterol, and Apo B in patients with hyperlipidemia. With the evidence available at present, inclisiran seems an efficacious and well-tolerated therapeutic strategy to manage elevated cholesterol and LDL-C levels. However, long-term, large cardiovascular outcome trials are required to conclude on the drug's cardiovascular and overall safety.


Assuntos
Anticolesterolemiantes , Doenças Cardiovasculares , Dislipidemias , Hiperlipidemias , Humanos , Doenças Cardiovasculares/induzido quimicamente , LDL-Colesterol , Dislipidemias/induzido quimicamente , Hiperlipidemias/tratamento farmacológico , Pró-Proteína Convertase 9 , RNA Interferente Pequeno
4.
Expert Opin Drug Saf ; 22(12): 1237-1251, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37526060

RESUMO

BACKGROUND: Insomnia is a multi-factorial disorder with conventional treatment options that are not satisfactory for many patients. This metaanalysis analyzed the safety and efficacy of daridorexant. METHODS: An electronic database search for RCTs was conducted on Medline via PubMed, Cochrane, and Clinicaltrials.gov using the terms 'Daridorexant,' 'RCT,' 'Insomnia' trials evaluating the efficacy and/or safety of daridorexant for insomnia were included. The data were synthesized using Cochrane review manager version 5.4.1. Cochrane risk of bias 2.0 tool and GRADEpro-GDT were used to assess the methodological and evidence quality, respectively. RESULTS: Of 109 searched studies, four trials were included. The risk of treatment-emergent adverse events with 25 mg daridorexant [risk ratio (RR) = 1.12 (0.88, 1.43), p = 0.36; I2 = 0%] and 50 mg daridorexant [RR = 1.25 (0.88, 1.79), p = 0.22; I2 = 28%] and serious adverse events with 25 mg [RR = 0.86 (0.23, 3.19), p = 0.82, I2 = 56%] and 50 mg [RR = 1.32 (0.29, 6.08), p = 0.72, I2 = 52%] was comparable to placebo [Moderate quality evidence]. Risk of nasopharyngitis was also comparable to placebo. The efficacy parameters like wake after sleep onset, latency to persistent sleep, and subjective total sleep time showed significant improvement with daridorexant. The risk of bias is low for three studies and some concern for one. CONCLUSION: Daridorexant is a safer and efficacious agent for induction and maintenance of sleep for chronic insomnia. PROSPERO: The registration number is CRD42022335233. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov identifiers are NCT03575104, NCT03545191, NCT03679884, and NCT02839200).


Assuntos
Distúrbios do Início e da Manutenção do Sono , Humanos , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Imidazóis , Pirrolidinas/efeitos adversos
5.
J Family Med Prim Care ; 12(7): 1399-1405, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37649754

RESUMO

Background: Package inserts (PIs) serve detailed information on drug products to the users and primary care physicians, so information should be accurate, reliable, and as per the regulatory guidelines. The study aims to analyze the information adequacy of the PIs available in the Indian market as per Drug and Cosmetic Rule 1945 and US Food and Drug Administration criteria. Materials and Methods: A cross-sectional study was conducted on PIs collected from accessible pharmacy stores. Information provided was recorded as per criteria, and total information adequacy score (IAS) and information deficiency (IDS) score were calculated. The association of factors like single-drug/FDCs, a company of origin Indian/multinational, and route of administration (ROA) with IDS was statistically analyzed. Results: Of 120 PIs, 60%, 86.66%, and 73% were single-drug, prescription-drug, and drugs by Indian manufacturers, respectively. Most PIs provided generic names, ROA, and indications for use. 85%, 12%, 29.16%, and 3.33% provided information on PIs on the ability to drive, drug-food interactions, drug-drug interactions, and addiction potential, respectively. Lacking area was information on use in pediatrics-geriatrics (30%), excipients (28.3%), preclinical (15.83%), post-surveillance data (18.33%), and approval date (2.5%). There was a statistically significant difference between pharmaceutical score (3.22 vs 4.12), therapeutic score (11.5 vs 13.18), and total IAS (14.78 ± 3.39 vs 17.31 ± 2.33) of Indian and multinational companies. IDS was statistically significantly different in both pharmaceutical and therapeutic categories for single-drug vs FDCs (P = 0.00001), OTC vs prescription drugs (P < 0.05), and Indian vs multinational companies' PIs (P = 0.00001). Conclusion: Numerous facets of information are lacking in PIs, and they do not impart whole information, especially of Indian origin, as per objective IDS.

6.
Drug Des Devel Ther ; 17: 1907-1932, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37397787

RESUMO

Metformin has been designated as one of the most crucial first-line therapeutic agents in the management of type 2 diabetes mellitus. Primarily being an antihyperglycemic agent, metformin also has a plethora of pleiotropic effects on various systems and processes. It acts majorly by activating AMPK (Adenosine Monophosphate-Activated Protein Kinase) in the cells and reducing glucose output from the liver. It also decreases advanced glycation end products and reactive oxygen species production in the endothelium apart from regulating the glucose and lipid metabolism in the cardiomyocytes, hence minimizing the cardiovascular risks. Its anticancer, antiproliferative and apoptosis-inducing effects on malignant cells might prove instrumental in the malignancy of organs like the breast, kidney, brain, ovary, lung, and endometrium. Preclinical studies have also shown some evidence of metformin's neuroprotective role in Parkinson's disease, Alzheimer's disease, multiple sclerosis and Huntington's disease. Metformin exerts its pleiotropic effects through varied pathways of intracellular signalling and exact mechanism in the majority of them remains yet to be clearly defined. This article has extensively reviewed the therapeutic benefits of metformin and the details of its mechanism for a molecule of boon in various conditions like diabetes, prediabetes, obesity, polycystic ovarian disease, metabolic derangement in HIV, various cancers and aging.


Assuntos
Diabetes Mellitus Tipo 2 , Metformina , Neoplasias , Feminino , Humanos , Metformina/farmacologia , Metformina/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/farmacologia , Hipoglicemiantes/uso terapêutico , Neoplasias/tratamento farmacológico , Glucose/metabolismo , Proteínas Quinases Ativadas por AMP/metabolismo
7.
Cureus ; 15(2): e35340, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36974248

RESUMO

BACKGROUND: The majority of the under five mortality rate (U5MR) in India were due to treatable causes and could have been prevented by providing quality medicines. Availability and affordability of medicine can be improved by the introduction of essential medicine concepts. PURPOSE: The current study was carried out to compare the latest edition of the WHO essential medicine list for children (EMLc) with that of Indian EMLc to determine the need to update the Indian EMLc. METHODS: A descriptive observational study was carried out in the Department of Pharmacology of a tertiary care hospital. The latest edition of WHO EMLc (8th) was compared with the latest edition of Indian EMLc (1st) in terms of inclusion of categories or subcategories, the number of medicines in each category or subcategories, medicines which are present in WHO EMLc but missing in Indian EMLc and vice versa. RESULTS: In total 134 medicines are present in Indian EMLc as compared to 350 medicines in WHO EMLc. The important categories which are completely missing in Indian EMLc are medicines for reproductive health and perinatal care, peritoneal dialysis solution, medicines for mental and behavioral disorders, and medicines for diseases of joints. The important medicines which are not included in Indian EMLc are bedaquilline, delaminid, cefixime, piperacillin+tazobactum, vancomycin, acyclovir, azathioprine, cisplatin, and filgrastim. Important vaccines including rotavirus, cholera, hepatitis, and typhoid vaccine are not mentioned in Indian EMLc. CONCLUSION: There is an urgent need to update the Indian EMLc in order to promote access to pediatric medicine and facilitate the rational use of medicines.

8.
Indian J Ophthalmol ; 70(11): 3791-3796, 2022 11.
Artigo em Inglês | MEDLINE | ID: mdl-36308098

RESUMO

Cataract causes bilateral blindness in 20 million people globally, the vast majority of whom live in developing countries. Manual small-incision cataract surgery (MSICS) has emerged as an efficient and economical alternative to phacoemulsification, giving comparable results in terms of final visual gain. One of the important determinants of postoperative visual gain is the status of the corneal endothelium. Multiple factors such as corneal distortion, irrigation solution turbulence, mechanical trauma by instruments, nuclear fragments, intraocular lens contact, and free oxygen radicals, all have been implicated in causing corneal damage during cataract surgery. MSICS with posterior chamber intraocular lens implantation has been reported to cause an endothelial cell loss of 15.83%, which is comparable with other modes of cataract surgery like extracapsular cataract extraction and phacoemulsification. Thorough preoperative assessment of endothelial status and taking necessary steps for endothelial protection during surgery can decrease the endothelial cell loss and overall burden of pseudophakic bullous keratopathy. In addition to surgical techniques, the type of irrigating solutions, ocular viscoelastic devices, intracameral dyes, and drugs all affect the endothelial cell status. This review presents a summary of available literature on the protection of endothelial cells during different steps of MSICS. This is especially relevant for developing countries where large-scale MSICS cataract surgeries are performed to decrease the cataract blindness burden.


Assuntos
Extração de Catarata , Catarata , Lentes Intraoculares , Facoemulsificação , Ferida Cirúrgica , Humanos , Endotélio Corneano , Células Endoteliais , Extração de Catarata/efeitos adversos , Extração de Catarata/métodos , Facoemulsificação/métodos , Cegueira
9.
Crit Rev Oncog ; 27(4): 23-37, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-37199300

RESUMO

Oral cancers (OCs), being one of the frequent malignancies in the head and neck region, need prompt diagnosis and treatment. Apart from basic therapeutic modalities, immunotherapy has now been utilized as a novel approach to combat the disease. With the comprehension of the strategies adopted by cancer cells to evade the immune elimination by the body's immune system, targeted immunotherapies have now become the core area of research. The immune expression of epidermal growth factor receptor (EGFR), programmed cell death protein ligand-1 (PDL-1), etc., are enhanced in OC and have been associated with evasion of the immune system. Targeted immunotherapies now include monoclonal antibodies targeting EGFR like cetuximab and panitumumab, programmed cell death-1 (PD-1) inhibitors like pembrolizumab, cemiplimab, and nivolumab, and PD-L1 inhibitors like atezolizumab, avelumab, and durvalumab. Targeted immunotherapies like chimeric antigen receptor T-cell treatment and small molecule inhibitors are in several clinical trials tried as monotherapy and adjuvant immunotherapy and have shown promising results. Other immunothera-peutic approaches such as cytokines like interferons or interleukins, vaccines, and gene therapy have also been an area of research for the management of OC. However, the cautious selection of appropriate patients with specific immune characteristics as a candidate for immunotherapeutic agents is a crucial component of targeted immunotherapy. This article elaborates on the immune contexture of oral cancer cells, the mechanism of immune evasion by cancer cells, targets for immunotherapies, existent immunotherapeutic agents, and prospects in the field of immunotherapy.


Assuntos
Neoplasias Bucais , Nivolumabe , Humanos , Imunoterapia/métodos , Neoplasias Bucais/tratamento farmacológico , Receptores ErbB
10.
Indian J Med Microbiol ; 39(4): 439-445, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34511310

RESUMO

PURPOSE: This paper explores inclusion of topics on antimicrobial resistance (AMR) and antimicrobial stewardship (AMS) in pre-service human and animal healthcare professional curricula as mandated in the first strategic objective of National Action Plan on Antimicrobial Resistance. METHODS: Online versions of pre-service medical [Bachelor of Medicine, Bachelor of Surgery (MBBS)], dental [Bachelor of dental sciences (BDS)], pharmacy [Bachelor of Pharmacy (B Pharm)], veterinary [Bachelor of veterinary science and animal husbandry (B.V.Sc. & A.H.)] and post graduate medical [Doctor of medicine (MD), Master of surgery (MS) and post graduate (PG) medical diploma courses] curricula and hardcopy of nursing (Bachelor of science (BSc) Nursing-Basic) curricula were assessed. Validated search terms were used for identifying individual learning topics, domains of learning and number of hours of learning related to AMS and AMR. Recent edition of commonly referred medical textbooks were manually checked for inclusion of chapters or separate sections on AMR and AMS. RESULTS: Low coverage and poor depth with no mention of required duration of learning for AMR and AMS was observed across the majority of curricula. MS, BDS, B Pharm and BSc nursing curricula did not include AMR and AMS. Out of twenty-three textbooks assessed, only six textbooks included AMS. Gynecology, Obstetrics, Orthopedic and Surgery textbooks did not include separate section on AMR or AMS. CONCLUSIONS: Our study documented inadequate inclusion of AMR and AMS in pre-service medical, dental, nursing, pharmacy and veterinary curricula and post graduate medical curriculum. Standardized education regarding AMR and AMS in multi-professional curricula by educational councils across sectors and updating of medical textbooks of all the subjects by authors/publishers for adequate emphasis on these topics is urgently needed for success of 'One health' in combating AMR.


Assuntos
Antibacterianos , Gestão de Antimicrobianos , Currículo , Educação em Veterinária , Pessoal de Saúde/educação , Animais , Antibacterianos/uso terapêutico , Atenção à Saúde , Farmacorresistência Bacteriana , Humanos , Médicos Veterinários
11.
Trials ; 22(1): 105, 2021 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-33516238

RESUMO

BACKGROUND: To compare the efficacy and safety of bioavailable turmeric extract versus paracetamol in patients with knee osteoarthritis (OA). METHODS: In this randomized, non-inferiority, controlled clinical study, patients of knee OA were randomized to receive bioavailable turmeric extract (BCM-95®) 500 mg capsule two times daily or paracetamol 650 mg tablet three times daily for 6 weeks. The primary outcome measure was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. The secondary outcome measures were WOMAC total, WOMAC stiffness, and WOMAC physical function scores. Responder analysis of individual patients at different levels (≥ 20%, ≥ 50%, and ≥ 70%) for WOMAC score was calculated. TNF alpha and CRP levels were evaluated and adverse events (AE) were also recorded. RESULTS: Seventy-one and seventy-three knee OA patients, respectively in bioavailable turmeric extract and paracetamol groups, completed the study. Non-inferiority (equivalence) test showed that WOMAC scores were equivalent in both the groups (p value < 0.05) in all the domains within the equivalence limit defined by effect size (Cohen's d) of 0.5 whereas CRP and TNF-α were better reduced with turmeric extract than paracetamol. After 6 weeks of treatment, WOMAC total score, pain, stiffness, and function scores got a significant improvement of 23.59, 32.09, 28.5, and 20.25% respectively with turmeric extract. In the turmeric extract group, 18% of patients got more than 50% improvement and 3% of patients got more than 70% improvement in WOMAC pain and function/stiffness score and none of the patients in the paracetamol group met the criteria. CRP and TNF-α got significantly reduced (37.21 and 74.81% respectively) in the turmeric extract group. Adverse events reported were mild and comparatively less in the turmeric extract group (5.48%) than in the paracetamol group (12.68%). CONCLUSION: The results of the study suggest that bioavailable turmeric extract is as effective as paracetamol in reducing pain and other symptoms of knee osteoarthritis and found to be safe and more effective in reducing CRP and TNF-α. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2017/02/007962 . Registered on 27 February 2017.


Assuntos
Acetaminofen/uso terapêutico , Osteoartrite do Joelho/tratamento farmacológico , Extratos Vegetais/uso terapêutico , Acetaminofen/efeitos adversos , Adulto , Curcuma/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Medição da Dor , Extratos Vegetais/efeitos adversos , Estudos Prospectivos , Resultado do Tratamento
12.
Indian J Gastroenterol ; 40(1): 65-71, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33481172

RESUMO

Publication of scientific paper is critical for modern science evolution, and professional advancement. However, it comes with many responsibilities. An author must be aware of good publication practices. While refraining from scientific misconduct or research frauds, authors should adhere to Good Publication Practices (GPP). Publications which draw conclusions from manipulated or fabricated data could prove detrimental to society and health care research. Good science can blossom only when research is conducted and documented with complete honesty and ethics. Unfortunately, publish or perish attitude has led to unethical practices in scientific research and publications. There is need to identify, acknowledge, and generate awareness among junior researchers or postgraduate students to curb scientific misconduct and adopt GPP. This article discusses various unethical publication practices in research. Also, the role and responsibilities of authors have been discussed with the purpose of maintaining the credibility and objectivity of publication.


Assuntos
Autoria , Pesquisa Biomédica/ética , Ética em Pesquisa , Editoração/ética , Má Conduta Científica/ética , Humanos , Papel Profissional
13.
Indian J Pediatr ; 88(3): 227-234, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-32086758

RESUMO

OBJECTIVES: To assess the availability of pediatric formulations in Essential Medicines Lists and public health care facility in India. METHODS: Availability of pediatric formulations in the public health sector was evaluated by assessing inclusion of pediatric formulations in the National List of Essential Medicines (NLEM), Delhi Essential Medicine List (DEML), Indian Academy of Pediatrics (IAP) Essential Medicines Lists (EML) and comparing it with the World Health Organization's list of essential medicines for children (WHO, EMLc). In addition, availability of 30 essential medicines in a public, tertiary care hospital was assessed over a period of 1 y. RESULTS: Many medicines present in WHO EMLc were not there in NLEM and DEML. The number of pediatric medicines formulations not available in pediatric doses as compared to WHO EMLc was 98,97 and 97 in NLEM, DEML and IAP respectively. Palliative care was the most neglected area in all the lists. In the public health care facility, only 53% of the tracer pediatric medicines were available. CONCLUSIONS: There is less availability of pediatric formulations in the Indian NEML and state DEML. Availability of key tracer pediatric medicine formulations in public health facility is poor. A separate pediatric EML is required in the country to improve focus on availability of child-specific formulations.


Assuntos
Medicamentos Essenciais , Pediatria , Criança , Atenção à Saúde , Acessibilidade aos Serviços de Saúde , Humanos , Índia , Setor Público , Organização Mundial da Saúde
14.
Eur J Pediatr ; 179(9): 1435-1443, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32185474

RESUMO

Lack of availability of age-appropriate dosage forms for children often results in use of adult dosage forms, which are administered to children after crushing or breaking. This can result in inappropriate doses being given to the children. This study was done to assess the prescribing pattern of use of medicines that had to be fragmented or crushed for use in relation to the age of the child. A prescription audit of 1200 outpatients and 400 inpatient records was done in the pediatric department of Lok Nayak tertiary care teaching hospital in the National Capital New Delhi, India. A structured pro forma was used for collecting the data. The total medicines prescribed, use of adult formulations, and number of adult medicines that had to be fragmented or broken for administration to pediatric patients were assessed. A total of 880 medicines were prescribed among inpatients and 2701 in outpatients. In inpatients, 230 (26.1%) medicines and in outpatients, 1013 (37.5%) medicines were fragmented before use. Some of these medicines were available in liquid oral dosage forms in Delhi Essential Medicine List (DEML) and should be available in the hospital. Medicines for use for common conditions were fragmented. Maximum use of fragmented medicines was in the age group of 6-9 years, both among inpatients and outpatients. Association of fragmentation with age was significant (p value < 0.05).Conclusion: Children are being prescribed dosage forms, requiring manual fragmentation or crushing. Policy changes and measures to make available age-appropriate pediatric dosage formulations need to be taken to improve pediatric pharmacotherapy in the hospital and health system. What is Known: • The dosage formulation prescribed to a patient can impact the patient's compliance with the therapy, accuracy of dosing, and patient and care providers' safety. • Lack of availability of age-appropriate dosage forms is common for children and often results in administration of adult dosage forms after crushing or breaking. What is New: • Some regularly prescribed medicines (14) including amoxicillin, albendazole, chloroquine, carbamazepine, valproate, and phenytoin that had to be fragmented were available in liquid oral dosage forms in the Delhi Essential Medicine List (DEML). • Despite being included in the EML, the patient has been denied access to appropriate medicines. It indicates a lack of concern and sensitivity about what is required for rational prescribing to children.


Assuntos
Hospitais de Ensino , Adulto , Criança , Humanos , Índia , Atenção Terciária à Saúde
15.
J Integr Med ; 16(2): 113-119, 2018 03.
Artigo em Inglês | MEDLINE | ID: mdl-29526234

RESUMO

OBJECTIVE: To assess the knowledge, attitude, perception and practice of Ayurveda, yoga, Unani, Siddha, homeopathy and naturopathy (AYUSH) among allopathic doctors and interns and determine their opinion regarding integration of AYUSH education within the allopathic curriculum. METHODS: This prospective, cross sectional study was conducted in a tertiary care teaching Hospital, New Delhi, India, from March 2016 to March 2017. A survey of 500 allopathic doctors and 150 interns was performed using a structured questionnaire. RESULTS: A majority of doctors (95.2%) were aware of the term AYUSH and had knowledge of yoga (70.6%), homeopathy (55.6%), Ayurveda (50.3%), Siddha (47.8%), naturopathy (32.9%) and Unani (28.9%). Most of the participants (63.0%) felt that therapies under AYUSH are effective. A majority (84.0%) of the doctors were of the view that more research is required in the field of AYUSH. While homeopathy (44.0%) was the most common system used by doctors for themselves, yoga was the therapy most commonly (60.0%) recommended to patients. Nearly half of the doctors (46.7%) recommended AYUSH to their patients, mainly for chronic illness (74.0%). A majority (77.5%) of the respondents agreed that students of allopathic medicine should be familiarized with AYUSH. The modes of incorporation of AYUSH into the medical curriculum most commonly suggested by respondents were optional courses (54.5%) and introductory lectures (42.3%). CONCLUSION: Doctors and interns of allopathic medicine are aware of AYUSH systems. They use it for themselves and recommend it to patients. They believe that familiarization of Bachelor of Medicine and Bachelor of Surgery students with AYUSH therapies and their integration with allopathic medicine may help in improving patient care.


Assuntos
Pessoal de Saúde/psicologia , Homeopatia , Internato e Residência , Ayurveda/psicologia , Adulto , Conscientização , Currículo , Feminino , Homeopatia/educação , Homeopatia/psicologia , Hospitais de Ensino , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica , Estudos Prospectivos , Inquéritos e Questionários , Recursos Humanos , Adulto Jovem
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