RESUMEN
PURPOSE: We examined the efficacy of topical capsaicin in reducing delayed chemotherapy-induced nausea and vomiting (CINV). METHODS: Adults on highly emetogenic chemotherapy regimens applied 2 g of capsaicin ointment (0.075%) or matching placebo four times a day to the abdomen for 5 days in addition to standard antiemetic regimen in this blinded randomized controlled trial. Patients were monitored for nausea and vomiting in the immediate (day 1), delayed (days 2-5), and extended phases (days 2-15). Self-reported incidence and daily episodes of CINV were compared between the groups. Onset, severity, need for rescue antiemetics, cumulative vomiting episodes, and safety were also compared. RESULTS: In total, 160 patients were enrolled. The final modified intention-to-treat population included 75 patients each in the capsaicin and placebo groups. Fewer patients experienced nausea (36.0% [n = 27] v 53.3% [n = 40]; P = .033) and vomiting (28.0% [n = 21] v 42.7% [n = 32]; P = .060) in the capsaicin arm during the delayed phase. During the extended phase, there was a significantly lower incidence of nausea (44% v 64.0%; P = .014) in the capsaicin arm. No difference in nausea (26.7% v 25.3%) or vomiting (22.7% v 18.7%) was evident in the immediate phase. The average daily episodes of nausea and vomiting were significantly fewer in the capsaicin arm during the delayed and extended phases. With capsaicin, no grade 3 nausea (9.3% v 0.0%; P = .007) was observed, and the time to first nausea and vomiting was significantly prolonged. There were no differences between the groups with respect to rescue antiemetics, unscheduled hospital visits, and adverse events. CONCLUSION: Topical capsaicin reduced the incidence of nausea and the average number of vomiting episodes during delayed and extended phases without increasing adverse effects.
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Capsaicina , Náusea , Vómitos , Humanos , Capsaicina/administración & dosificación , Capsaicina/efectos adversos , Vómitos/inducido químicamente , Vómitos/prevención & control , Vómitos/epidemiología , Náusea/inducido químicamente , Náusea/prevención & control , Náusea/epidemiología , Masculino , Femenino , Persona de Mediana Edad , Adulto , Administración Tópica , Anciano , Antineoplásicos/efectos adversos , Antineoplásicos/administración & dosificación , Antieméticos/administración & dosificación , Antieméticos/uso terapéutico , Neoplasias/tratamiento farmacológicoRESUMEN
OBJECTIVES: India has taken several initiatives to provide health care to its population while keeping the related expenditure minimum. Since cardiovascular diseases are the most prevalent chronic conditions, in the present study, we aimed to analyze the difference in prices of medicines prescribed for three cardiovascular risk factors, based on (a) listed and not listed in the National List of Essential Medicines (NLEM) and (b) generic and branded drugs. MATERIALS AND METHODS: Outpatient prescriptions for diabetes mellitus, hypertension, and dyslipidemia were retrospectively analyzed from 12 tertiary centers. The prices of medicines prescribed were compared based on presence or absence in NLEM India-2015 and prescribing by generic versus brand name. The price was standardized and presented as average price per medicine per year for a given medicine. The results are presented in Indian rupee (INR) and as median (range). RESULTS: Of the 4,736 prescriptions collected, 843 contained oral antidiabetic, antihypertensive, and/or hypolipidemic medicines. The price per medicine per year for NLEM oral antidiabetics was INR 2849 (2593-3104) and for non-NLEM was INR 5343 (2964-14364). It was INR 806 (243-2132) for generic and INR 3809 (1968-14364) for branded antidiabetics. Antihypertensives and hypolipidemics followed the trend. The price of branded non-NLEM medicines was 5-22 times higher compared to generic NLEM which, for a population of 1.37 billion, would translate to a potential saving of 346.8 billion INR for statins. The variability was significant for sulfonylureas, angiotensin receptor blockers, beta-blockers, diuretics, and statins (P < 0.0001). CONCLUSION: The study highlights an urgent need for intervention to actualize the maximum benefit of government policies and minimize the out-of-pocket expenditure on medicines.
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Hipoglucemiantes , India , Humanos , Estudios Retrospectivos , Hipoglucemiantes/economía , Hipoglucemiantes/uso terapéutico , Enfermedades Cardiovasculares/tratamiento farmacológico , Enfermedades Cardiovasculares/economía , Medicamentos Genéricos/economía , Medicamentos Genéricos/uso terapéutico , Hipolipemiantes/economía , Hipolipemiantes/uso terapéutico , Factores de Riesgo de Enfermedad Cardiaca , Costos de los Medicamentos , Hipertensión/tratamiento farmacológico , Hipertensión/economía , Diabetes Mellitus/tratamiento farmacológico , Diabetes Mellitus/economía , Dislipidemias/tratamiento farmacológico , Dislipidemias/economía , Antihipertensivos/economía , Antihipertensivos/uso terapéutico , Costos y Análisis de CostoRESUMEN
BACKGROUND OBJECTIVES: Irrational prescribing practices have major consequences on patient safety and also increase the economic burden. Real-life examples of impact of irrational prescription have potential to improve prescribing practices. In this context, the present study aimed to capture and evaluate the prevalence of deviations from treatment guidelines in the prescriptions, potential consequence/s of the deviations and corrective actions recommended by clinicians. METHODS: It was a cross-sectional observational study conducted in the outpatient departments of tertiary care hospitals in India wherein the 13 Indian Council of Medical Research Rational Use of Medicines Centres are located. Prescriptions not compliant with the standard treatment guidelines and incomplete prescriptions with respect to formulation, dose, duration and frequency were labelled as 'prescriptions having deviations'. A deviation that could result in a drug interaction, lack of response, increased cost, preventable adverse drug reaction (ADR) and/or antimicrobial resistance was labelled as an 'unacceptable deviation'. RESULTS: Against all the prescriptions assessed, about one tenth of them (475/4838; 9.8%) had unacceptable deviations. However, in 2667/4838 (55.1%) prescriptions, the clinicians had adhered to the treatment guidelines. Two thousand one hundred and seventy-one prescriptions had deviations, of which 475 (21.9%) had unacceptable deviations with pantoprazole (n=54), rabeprazole+domperidone (n=35) and oral enzyme preparations (n=24) as the most frequently prescribed drugs and upper respiratory tract infection (URTI) and hypertension as most common diseases with unacceptable deviations. The potential consequences of deviations were increase in cost (n=301), ADRs (n=254), drug interactions (n=81), lack of therapeutic response (n=77) and antimicrobial resistance (n=72). Major corrective actions proposed for consideration were issuance of an administrative order (n=196) and conducting online training programme (n=108). INTERPRETATION CONCLUSIONS: The overall prevalence of deviations found was 45 per cent of which unacceptable deviations was estimated to be 9.8 per cent. To minimize the deviations, clinicians recommended online training on rational prescribing and administrative directives as potential interventions.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Prescripciones , Humanos , Estudios Transversales , Centros de Atención Terciaria , India/epidemiología , Antibacterianos/efectos adversos , Prescripciones de MedicamentosRESUMEN
BACKGROUND: The concept of listing essential medicines can lead to improved supply and access, more rational prescribing, and lower costs of drugs. However, these benefits hinge on the prescription of drugs from an Essential Medicines List (EML). Several studies have highlighted the problem of underutilization of EMLs by prescribers. Therefore, as part of prescription research by the Indian Council of Medical Research-Rational Use of Medicines Centres Network, we evaluated the extent of prescription of drugs not listed in the National List of Essential Medicines (NLEM). MATERIALS AND METHODS: Prescriptions of outpatients from participating centers were included after obtaining verbal/written informed consent as approved by the Ethics Committee, and evaluated for prescription of drugs from the NLEM 2015. RESULTS: Analysis of 4838 prescriptions from 13 tertiary health-care institutes revealed that 2677 (55.33%) prescriptions had at least one non-NLEM drug prescribed. In all, 5215 (31.12%) of the total 16,758 drugs prescribed were not in NLEM. Of these, 2722 (16.24%) were single drugs and 2493 (14.88%) were fixed-dose combinations (FDCs). These comprised 700 different drug products - 346 single drugs and 354 FDCs. The average number of non-NLEM drugs prescribed per prescription was 1.08, while the average number of all drugs prescribed was 3.35 per prescription. It was also found that some of the non-NLEM drugs prescribed had the potential to result in increased cost (for example, levocetirizine), increased adverse effects (dextromethorphan), and less effectiveness (losartan) when compared to their NLEM counterparts. Nonavailability of an essential drug (oral hydroxocobalamin) was another important finding of our study. CONCLUSION: This study highlights the extent and pattern of drugs prescribed from outside the NLEM at the tertiary health-care level and the need for training and enhanced awareness among prescribers for greater utilization of the NLEM.
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Investigación Biomédica , Medicamentos Esenciales , Centros de Atención Terciaria , India , PrescripcionesRESUMEN
BACKGROUND: Cisplatin is a commonly used chemotherapy agent known to induce serious adverse reactions that may require hospital readmission. We aimed to analyze the extent and factors associated with unplanned hospital admissions due to cisplatin-based chemotherapy regimen-induced adverse reactions. METHODS: Retrospective review of medical records of those patients who received at least one cycle of chemotherapy with cisplatin-based regimen during a six-month period from March to August 2017. RESULTS: Of the 458 patients who received cisplatin during the study period, 142 patients did not meet inclusion criteria. The remaining 316 patients had a total of 770 episodes of primary admissions for chemotherapy administration. Overall, 187 episodes (24%) of intercycle unplanned hospital admission were recorded of which a major proportion (n=178; 23%) was due to chemotherapy-induced adverse reactions. Underweight patients had higher odds of unplanned admission (OR 1.77, 95% confidence interval [CI] 1.11 to 1.77). Significantly, more number of patients with cancers of head and neck and cancers of musculoskeletal were readmitted (p<0.001). Compared to high-dose cisplatin, low- and intermediate-dose cisplatin had lesser odds of unplanned admission (OR 0.52 and 0.77; 95% CI, 0.31 to 0.88 and 0.41 to 1.45, respectively). Patients without concomitant radiotherapy, drug-drug interaction and initial chemotherapy cycles had lesser odds of unplanned admission (OR 0.38, 0.50 and 0.52; 95% CI, 0.26 to 0.55, 0.25 to 0.99 and 0.32 to 0.84 respectively). Unplanned admissions were mainly due to blood-related (31%) and gastrointestinal (19%) adverse reactions. Among chemotherapy regimens, cisplatin monotherapy (34%) and cisplatin with doxorubicin (20%) regimens resulted in a major proportion of unplanned admissions. CONCLUSION: These findings highlight risk factors that help identify high-risk patients and suggest that therapy modifications may reduce hospital readmissions due to cisplatin-based chemotherapy-induced adverse reactions.