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1.
Indian J Med Res ; 159(2): 130-141, 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38528817

RESUMO

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.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Prescrições , Humanos , Estudos Transversais , Centros de Atenção Terciária , Índia/epidemiologia , Antibacterianos/efeitos adversos , Prescrições de Medicamentos
2.
Indian J Psychiatry ; 65(5): 526-533, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37397838

RESUMO

According to the Global Burden of Disease (GBD) Study conducted in 2019, smoking tobacco leads to over 8 million deaths each year. Hence, it is crucial to identify optimal smoking cessation therapy. To compare the efficacy of varenicline versus bupropion for smoking cessation by performing a meta-analysis of randomized controlled trials (RCTs). Protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO). The Patient intervention comparison outcome time (PICOT) format is used in the study. Patients having nicotine use disorder treated with varenicline or bupropion were included, and the continuous abstinence rate (CAR) was assessed at 12, 24, and 52 weeks. The PubMed and Google Scholar databases were systematically searched, and after the screening, RCTs involving a comparison of varenicline and bupropion in smoking cessation were included. We performed a meta-analysis of three RCTs (10110 patients) by RevMan 5.4.1 statistical software to determine the efficacy of varenicline compared with bupropion in smoking cessation. The CAR at 9- to 12-week follow-up of varenicline is superior to bupropion (OR = 1.79, CI range: 1.59-2.02, P < 0.001). Similarly, the CAR of varenicline is superior to bupropion for weeks 9-24 (1.51, 1.32 to 1.72) and weeks 9-52 (1.60, 1.22 to 2.12), suggesting the absolute advantage of varenicline over bupropion for smoking cessation in terms of efficacy. Both varenicline and bupropion are efficacious therapies for smoking cessation. Compared with bupropion, varenicline can significantly improve the CAR at the end of treatment, at 24 weeks, and at 52 weeks of follow-up.

3.
J Assoc Physicians India ; 71(2): 11-12, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37354468

RESUMO

AIM: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. METHODS: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. RESULTS: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. CONCLUSION: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.


Assuntos
Hospitais , Estudos Transversais , Estudos Prospectivos , Combinação de Medicamentos , Índia
4.
Cureus ; 15(5): e38485, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37273298

RESUMO

Background Healthcare workers (HCWs) were compelled to use personal protective equipment (PPE) during the COVID-19 pandemic to prevent cross-transmission. One of the most significant challenges in responding to the COVID-19 pandemic is the consistent and effective use of PPE to avoid staff exposure and infection. This study aimed to detect and evaluate the adverse effects of PPE and determine the associated risk factors. Methodology This cross-sectional study included 186 randomly selected HCWs at Civil Hospital, Ahmedabad, from May 2022 to July 2022. An anonymous self-administered questionnaire was used for data collection, and data analysis was done using descriptive statistics. Results PPE-related adverse effects were noted among 147 HCWs, with a prevalence of 79.03%. Data analysis showed that factors significantly associated with PPE adverse effects in HCWs were age group 20-40 years (chi-squared (χ2) = 4.119, p = 0.04) and female gender (χ2 = 7.153, p = 0.007). Overall, 30.8% of participants had tested positive while on duty during the pandemic. Similarly, adverse effects were associated with PPE use of more than four hours per day and more than three days per week (χ2 = 5.477, p = 0.02 and χ2 = 6.488, p = 0.01, respectively). The majority of HCWs expressed indentation and pain on the back of the ear (52.7%) and pressure-related injury (39.8%) as adverse effects after wearing masks; skin soaking in sweat (54.83%) due to gloves; profuse sweating due to gown (64.28%); fogging (65.26%) due to googles and face-shield; and discomfort (61.29%). Conclusions The prevalence of adverse effects related to wearing PPE was alarmingly high among HCWs. The major risk factors were age, female sex, and duration of use. Although the majority of healthcare personnel have received vaccinations, the use of PPE has not altered, and severe skin reactions continue to be a global issue with no known solution. To further understand the problem, national data for the impacted healthcare professionals could be helpful. Furthermore, workplace prevention programs are necessary.

5.
Cureus ; 15(2): e35095, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36938207

RESUMO

BACKGROUND: The COVID-19 pandemic along with its treatment has brought myriad potential complications including the heightened risk of secondary fungal infections like mucormycosis. Mucormycosis is a rare angioinvasive fungal infection that has traditionally been highly fatal despite surgical intervention and antifungal medications. AIM: To re-evaluate the risk factors, epidemiology, and possible COVID-19-associated conditions on a larger sample size than the existing data. METHODOLOGY: We studied the possible risk factors, clinical presentations, treatment, and outcome of 203 patients with mucormycosis in a single-center retrospective-prospective observational study for three months at a tertiary care hospital after obtaining due permission from the institutional ethics committee. RESULTS: The mean age of patients was 52 ± 11.5 years, and 92.61% had a history of COVID-19 infection. Around 86.7% of patients were suffering from diabetes mellitus with 50% being already known cases whereas the other 50% developed post-COVID-19 infection; 65.02% of patients were administered corticosteroids during their COVID-19 treatment. About 51.72% of patients required hospital admission and among them, 16.25% of patients required ICU support. The mean oxygen saturation (SpO2) levels on admission were 84.61 ± 12.96%, and 38.92% of patients required mechanical respiratory support. The mean duration between COVID-19 infection and the onset of mucormycosis was 18.80 ± 16.61 days. The most common clinical presentations were facial pain and swelling (26.6%) and ophthalmic symptoms including eye swelling, pain, and ptosis (25.12%). Antifungal treatment was given to all the patients and 89.36% of the patients underwent surgical debridement of fungal mass. At the end of three months, 60.59% of the 188 patients survived with improvement, 13.30% had no improvement and/or deterioration of health, and 18.72% succumbed to mucormycosis. Intracranial involvement and leukocytosis were positively associated with mortality whereas surgical intervention was significant for positive outcomes at the end of three months in patients with mucormycosis (p<0.05). CONCLUSION: The sudden rise of mucormycosis during the second wave of COVID-19 can be attributed to uncontrolled blood sugar levels along with high corticosteroid usage as well as various nosocomial factors during the COVID-19 treatment. Early and aggressive treatment with surgical intervention and antifungal drugs can improve disease outcomes.

6.
Cureus ; 14(11): e31220, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-36514560

RESUMO

BACKGROUND: An epidemic of Mucorales was reported following the second wave of COVID-19 in India, and intracranial extension of the same was one of the most dreadful complications. METHODS: A total of 62 patients with cerebral mucormycosis were recruited and followed up till 12 weeks to evaluate the risk factors, incidence, clinical manifestations, management, and prognosis of cerebral mucormycosis. FINDINGS: A median age of 51.5 years with male predominance (74%) was noted. The majority of subjects reported a history of COVID infection (93.5%) and diabetes mellitus (83.87%). The first symptom of mucormycosis appeared after a mean period of 17.63 ± 8.9 days following COVID. Facial swelling and ptosis were the most common symptoms. Only 55% of patients had neurological presentations, and hemiparesis was the most common neurological sign (30.6%). Radiologically, the involvement of maxillary sinus (90.32%) and ethmoid sinus (87.10%) was commonly noted. Cerebral findings included temporal lobe (50%) and parietal lobe (30.06%) involvement, cavernous sinus thrombosis (30.06%), and internal carotid artery thrombosis (22.58%). Acute cerebral infarction was notable in 37% of subjects (p-value=0.0015, significant association with the outcome). Conventional and liposomal amphotericin B were used in 91.94% and 53.23% of patients, respectively. Retrobulbar amphotericin injections used in 11.3% of subjects significantly affected the outcome (p-value=0.03, significant). Posaconazole step-down therapy was used in 72.5% of subjects (p-value=0.0005, significant). Surgical interventions were performed in 53 (85.48%) subjects (p-value=0.004, significant). Functional endoscopic sinus surgery was the most common (in 64.52% of subjects), followed by maxillectomy (20.97% of subjects) and craniotomy (17.7% of subjects). At the end of 12 weeks, 33.87% of patients died and 59.68% were alive; the rest (6.45%) were lost to follow-up. INTERPRETATION: The absence or late presentation of neurological symptoms led to a delayed diagnosis of cerebral mucormycosis. The presence of acute cerebral infarction indicated a worse prognosis. However, there was a significant influence of step-down posaconazole therapy, retrobulbar amphotericin injections, and surgical intervention on the prognosis of cerebral mucormycosis.

7.
Indian J Pharmacol ; 54(1): 19-23, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35343203

RESUMO

OBJECTIVE: Trigger tool method (TTM) is an active surveillance method for adverse drug reaction (ADR) monitoring. The study aimed to evaluate TTM for ADR monitoring in indoor patients of the surgery department. MATERIALS AND METHODS: This prospective, observational study was conducted at the Department of Surgery of a Tertiary Care Teaching Hospital in Gujarat. Patients of either gender and more than 18 years of age admitted to two selected surgery units were enrolled with prior informed consent. Preliminary trigger tool list (PTTL) comprising 13 drug triggers (DTs), 13 patient triggers (PTs), 9 laboratory triggers (LTs), and 12 surgical module triggers (STs) were used. Patients were followed up till discharge to monitor the occurrence of triggers and adverse events. RESULTS: A total of 400 patients were included (male: female ratio of 2.3:1; mean age: 43.07 ± 16.4 years; and mean length of hospital stay: 5.75 ± 3.12 days). Of 400 patients, triggers were present in 359 patients (89.75%) and no trigger was observed in 41 patients (10.25%). Of the 47 triggers in PTTL, 24 triggers were observed 1155 times, of these 14 triggers lead to the detection of 49 ADRs in 43 patients. The rate of adverse drug events was 12.25/100 patients. DT was the most common trigger identified (81.64%). Positive predictive values (PPV) for PTs, STs, DTs, LTs were 26.88%, 23.07%, 10.3%, and 5.55%, respectively. The comprehensive PPV of PTTL was 11.97%. Modified trigger tool list consists of 14 triggers. CONCLUSION: TTM is an effective method of ADR monitoring in the surgery department. An awareness of TT helps better detection of ADRs.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Hospitalização , Hospitais de Ensino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Atenção Terciária à Saúde
8.
Indian J Pharmacol ; 54(6): 407-416, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-36722552

RESUMO

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.


Assuntos
Pesquisa Biomédica , Medicamentos Essenciais , Centros de Atenção Terciária , Índia , Prescrições
9.
Perspect Clin Res ; 12(1): 33-39, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33816207

RESUMO

OBJECTIVES: The objective of this study is to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs) at Civil Hospital Ahmedabad, India. MATERIALS AND METHODS: A prospective, single-center, observational cum intervention study was conducted in two phases in the Department of Medicine over 15 months. In phase I, preliminary trigger tool list (PTTL) comprising 55 triggers was evaluated by pharmacologist in terms of detection of ADR in 400 patients and then, modified trigger tool list (MTTL) was prepared. In Phase II, the TTM using MTTL was compared with the spontaneous method of ADR monitoring after educational interventions in resident doctors of the two units of medicine department. RESULTS: Of the 55 triggers in PTTL, 34 triggers were observed in 327 patients, of which 19 triggers lead to the detection of 66 ADRs. The rate of ADEs was 16.5%/100 patients. Positive predictive value (PPV) of each trigger ranged from 0% to 100%. PPV for drug trigger, laboratory trigger, and PT was 14.4%, 4.5%, and 23.3%, respectively. Overall, PPV of PTTL was 19.27%. Sensitivity and specificity were 100% and 21.66%, respectively. MTTL consists of these 19 triggers. In Phase II, resident doctors reported 16 ADRs, using spontaneous method and 23 ADRs using MTTL. The rate of ADEs per 100 patients was 1.63 and 2.13, respectively, with these methods. A total of 105 ADRs were reported during both phases. CONCLUSION: TTM is an effective method of ADR reporting if it is utilized by a trained person. This method could be used as add-on method to spontaneous method to improve ADR reporting.

10.
Indian J Med Res ; 153(1 & 2): 219-226, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33818480

RESUMO

BACKGROUND & OBJECTIVES: Hydroxychloroquine (HCQ), reported to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replication in in vitro studies, has been recommended for prophylaxis of COVID-19 in healthcare workers (HCWs). The objective of this study was to assess short-term adverse events (AEs) of HCQ in HCWs. METHODS: This cross-sectional study among consenting HCWs taking prophylaxis and working in hospitals with COVID-19 patients used online forms to collect details of HCWs, comorbidities, prophylactic drugs used and AEs after the first dose of HCQ. Verification of dose and AEs was done by personal contact. Multivariate logistic regression analysis was done to determine the effect of age, gender and dose of HCQ on AE. RESULTS: Of the 1303 HCWs included, 98.4 per cent (n=1282) took HCQ and 66 per cent (n=861) took 800 mg as first day's dose. Among the 19.9 per cent (n=259) reporting AEs, 1.5 per cent (n=20) took treatment for AE, none were hospitalized and three discontinued HCQ. Gastrointestinal AEs were the most common (172, 13.2%), with less in older [odds ratio (OR) 0.56, 95% confidence interval (CI) 0.35-0.89], with more in females (OR 2.46, 95% CI 1.78-3.38) and in those taking a total dose of 800 mg on day one compared to a lower dose. Hypoglycaemia (1.1%, n=14), cardiovascular events (0.7%, n=9) and other AEs were minimal. INTERPRETATION & CONCLUSIONS: HCQ prophylaxis first dose was well tolerated among HCWs as evidenced by a low discontinuation. For adverse effects, a small number required treatment, and none required hospitalization. The study had limitations of convenience sampling and lack of laboratory and electrocardiography confirmation of AEs.


Assuntos
Tratamento Farmacológico da COVID-19 , COVID-19/prevenção & controle , Pessoal de Saúde , Hidroxicloroquina , Estudos Transversais , Feminino , Humanos , Hidroxicloroquina/efeitos adversos , Hidroxicloroquina/uso terapêutico , Masculino , Profilaxia Pré-Exposição
11.
Perspect Clin Res ; 9(2): 108-109, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29862207
12.
J Clin Pharmacol ; 58(11): 1406-1417, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29799622

RESUMO

This observational, prospective, single-center study was conducted to evaluate the efficacy and safety of commonly prescribed drugs for zoster-associated pain and their impact on quality of sleep at a tertiary care hospital in western India. Patients ≥18 years of age, newly diagnosed with zoster-associated pain were evaluated on days 0, 7, 14, 30, 60, 90, 120, 150, and 180 or until resolution of pain, whichever was earlier, using the Wong Baker FACES Pain Rating Scale, Neuropathic Pain Scale, and Insomnia Severity Index for intensity of pain, quality of pain, and quality of sleep, respectively. A total of 78 patients (46.0 [16.3] years) completed the study. They received nonsteroidal anti-inflammatory drugs (65), gabapentin (30), amitriptyline (27), and amitriptyline + gabapentin (21) for mean durations of 7.7 (3.0), 89.2 (7.2), 107.6 (46.3), and 104.5 (46) days, respectively. Improvement in the Wong Baker FACES Pain Rating Scale and Neuropathic Pain Scale score was similar among treatment groups except for a greater fall in Wong Baker FACES Pain Rating Scale score at days 7 and 120 and that in deep pain score at day 7 in combination treatment group vs the amitriptyline group. Clinically significant insomnia was detected in 35 patients at baseline and demonstrated progressive and similar improvement among groups. Treatment modification was required in 20 patients. Zoster-associated pain resolved in 69 patients. Nine adverse drug reactions, mostly mild, nonserious, and nonpreventable, were reported. To conclude, drugs commonly used for zoster-associated pain are effective and well tolerated. These have a similar effect on pain and quality of sleep, except for a possible greater effect of combination treatment in the early phase of intense and deep pain.


Assuntos
Amitriptilina/uso terapêutico , Anti-Inflamatórios não Esteroides/uso terapêutico , Gabapentina/uso terapêutico , Neuralgia/tratamento farmacológico , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Amitriptilina/efeitos adversos , Anti-Inflamatórios não Esteroides/efeitos adversos , Quimioterapia Combinada , Feminino , Gabapentina/efeitos adversos , Herpes Zoster/complicações , Humanos , Índia , Masculino , Pessoa de Meia-Idade , Medição da Dor , Estudos Prospectivos , Sono , Resultado do Tratamento
13.
Perspect Clin Res ; 9(1): 15-22, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29430413

RESUMO

AIMS: This study aims to measure the quality of life (QOL), treatment satisfaction, and tolerability of antidiabetic drugs in patients suffering from type 2 diabetes mellitus (DM). METHODS: The prospective, observational study was conducted in consenting patients of type 2 DM attending the outpatient department of a tertiary care hospital in Western India. The QOL instrument for Indian diabetes (QOLID) patients questionnaire and the Diabetes Treatment Satisfaction Questionnaire were administered to all patients at baseline, 3 months, and 6 months of treatment. Tukey-Kramer comparison test was used to analyze the difference in QOLID scores in various domains at baseline, 3 months, and 6 months. WHO-UMC scale, Naranjo's probability scale, Hartwig and Siegel, and Schumock and Thornton modified criteria were used to analyze the adverse drug reactions. RESULTS: A male preponderance was observed in 200 patients enrolled in the study. The mean duration of diabetes was 10.96 ± 5.99 years. The patients received metformin alone (40), metformin and glipizide (47), metformin, glipizide and other oral hypoglycemic agents (OHAs) (78), and OHAs and insulin (35). A significant improvement in fasting and postprandial blood sugar was observed at 6 months as compared to the baseline (P < 0.05). A total of 39 (19.5%) patients suffered from adverse effects to metformin and insulin. Physical health and physical endurance improved in patients receiving metformin alone or in combination with glipizide as compared to patients receiving other OHAs and/or insulin. Treatment satisfaction, highest in patients receiving metformin and least in those receiving insulin, was unaltered during the study period. CONCLUSIONS: While polypharmacy is evident, using lesser medicines offers better treatment satisfaction and QOL in DM. Periodic assessment of QOL and treatment satisfaction are recommended in DM.

14.
Indian J Med Paediatr Oncol ; 38(2): 103-110, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28900315

RESUMO

OBJECTIVE: To evaluate efficacy, safety and utilization pattern of deferasirox in paediatric patients of transfusion dependant ß Thalassemia Major at a tertiary care teaching hospital in Gujarat. MATERIALS AND METHODS: This observational, prospective-retrospective, single centre, continuous study was conducted in a tertiary care teaching hospital among paediatric patients of transfusion dependent ß Thalassemia Major. Patients treated with deferasirox for not more than 12 weeks were enrolled. Details of blood transfusions, relevant investigations performed every 3 weeks and 3 months and drugs used were recorded in a pretested case record form. Parents were provided with a diary to record the details of ADRs. Data were analyzed for demographic characteristics, number and mean volume of blood transfusions, changes in serum ferritin and iron levels, number and types of ADRs and progression, causality, severity and preventability of ADRs. RESULTS: Of the 60 patients enrolled, one patient was lost to follow up and four withdrew their consent. Of the remaining 55 patients, 36 were boys and 19 were girls (mean age: 6 ± 3.14 years), including patients of 1-3 years (11), 4-6 years (24), 7-10 years (12) and 11-12 years (8). Thirty six patients were born of consanguineous marriages. Adherence to blood transfusion guidelines and deferasirox prescribing and administration guidelines was observed. A serial and significant decrease in mean serum ferritin and serum iron at 3 weeks and 3 months with deferasirox treatment was observed in all age groups except that of 11-12 years. A total of 117 ADRs were observed in 52 patients from 19498 doses, most common being diarrhea (24), raised serum creatinine (15), raised hepatic enzymes (14), abdominal pain (14) and rashes (14). A reduction in dose was required in 32 cases, while a temporary stoppage was indicated in 41 cases. Deferasirox was the possible and probable cause of 65 and 51 ADRs respectively as assessed by WHO-UMC scale. Majority of ADRs were definitely preventable and mild in nature. CONCLUSION: ß Thalassemia Major is more common in males. A rational prescribing of deferasirox was observed. Deferasirox effectively reduced serum ferritin and serum iron levels in these patients.

15.
Indian J Pharmacol ; 49(1): 1, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28458413
16.
17.
Indian J Pharmacol ; 48(Suppl 1): S5-S9, 2016 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-28031599

RESUMO

Competency-based medical education (CBME) is gaining momentum across the globe. The Medical Council of India has described the basic competencies required of an Indian Medical Graduate and designed a competency-based module on attitudes and communication. Widespread adoption of a competency-based approach would mean a paradigm shift in the current approach to medical education. CBME, hence, needs to be reviewed for its usefulness and limitations in the Indian context. This article describes the rationale of CBME and provides an overview of its components, i.e., competency, entrustable professional activity, and milestones. It elaborates how CBME could be implemented in an institute, in the context of basic sciences in general and pharmacology in particular. The promises and perils of CBME that need to be kept in mind to maximize its gains are described.


Assuntos
Educação Baseada em Competências , Educação Médica , Farmacologia/educação , Currículo , Humanos
18.
Indian J Pharmacol ; 48(5): 571-575, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27721545

RESUMO

BACKGROUND: Most of the academic teachers use four or five options per item of multiple choice question (MCQ) test as formative and summative assessment. Optimal number of options in MCQ item is a matter of considerable debate among academic teachers of various educational fields. There is a scarcity of the published literature regarding the optimum number of option in each item of MCQ in the field of medical education. OBJECTIVES: To compare three options, four options, and five options MCQs test for the quality parameters - reliability, validity, item analysis, distracter analysis, and time analysis. MATERIALS AND METHODS: Participants were 3rd semester M.B.B.S. students. Students were divided randomly into three groups. Each group was given one set of MCQ test out of three options, four options, and five option randomly. Following the marking of the multiple choice tests, the participants' option selections were analyzed and comparisons were conducted of the mean marks, mean time, validity, reliability and facility value, discrimination index, point biserial value, distracter analysis of three different option formats. RESULTS: Students score more (P = 0.000) and took less time (P = 0.009) for the completion of three options as compared to four options and five options groups. Facility value was more (P = 0.004) in three options group as compared to four and five options groups. There was no significant difference between three groups for the validity, reliability, and item discrimination. Nonfunctioning distracters were more in the four and five options group as compared to three option group. CONCLUSION: Assessment based on three option MCQs is can be preferred over four option and five option MCQs.


Assuntos
Avaliação Educacional/métodos , Inquéritos e Questionários , Educação Médica , Humanos , Distribuição Aleatória , Estudantes de Medicina
20.
J Basic Clin Pharm ; 8(1): 4-7, 2016 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28104967

RESUMO

OBJECTIVES: To evaluate the knowledge, attitude and practice of consumers in India about disposal of unused medicines. MATERIALS AND METHODS: A questionnaire comprising 11 questions evaluating the Knowledge (2), Attitude (3) and Practice (6) of unused medicines was prepared and pre validated before administering to 200 consumers of medicines attending the outpatient department of Civil Hospital Ahmedabad, a tertiary care teaching hospital in Western India. Requisite permissions from Institutional Ethics Committee and informed consent were obtained prior to recruiting them for the study. Responses were recorded, in Microsoft Excel® spreadsheet and evaluated for percentage response. RESULTS: Majority of the respondents (136, 68%) stored unused medicines at home. Analgesics (26.5%) were the most common unused medicine stored. Safe disposal of medicine was considered necessary by majority respondents (160, 80%) for different reasons like prevention of illegal/unintended use (84, 42%), prevention of environmental pollution (32, 16%) or possible ADR caused by old drugs (54, 27%). Only 78 (39%) respondents were aware of appropriate methods of disposal. Disposal in household trash (61, 30.5%) was the most common method used. Majority of respondents felt the need for a facility or programme to collect unused medicines (152, 76%) and an increased awareness among consumers regarding hazards and methods of disposal of unused medicines (154, 77%). CONCLUSION: Majority of consumers are aware about the need for safe disposal of unused medicines. But the right attitude for and practice of safe disposal of medicines is lacking. A need for increased awareness regarding safe disposal of medicines is acknowledged by majority of consumers.

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