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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.
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Background: Painful diabetic neuropathy is a common complication of long standing diabetes mellitus. Amitriptyline is commonly used to treat painful diabetic neuropathy. Pregabalin has been shown to be effective in the treatment of painful diabetic neuropathy with lesser adverse effects. Sustained release (SR) of pregabalin has the advantage of once daily dosing and a better patient compliance. Hence, this study was planned to compare the efficacy and safety of pregabalin-SR with amitriptyline in painful diabetic neuropathy.Methods: It is a prospective, open labelled, randomized controlled study. A total of 80 patients diagnosed with painful diabetic neuropathy based on Diabetic neuropathy symptom score and Michigan neuropathy screening instrument, were randomized into two groups to receive amitriptyline and pregabalin SR. Amitriptyline was started at 25mg OD and pregabalin SR 75mg OD for 6 weeks with optional dose titration. Patients were assessed for pain relief by using visual analogue scale and an overall improvement in their general condition by patient’s global impression of change scale. Adverse drug reactions were recorded on each follow up.Results: All patients had significant improvement in pain relief in both the treatment groups. The median VAS (visual analogue scale) score was slightly higher in pregabalin SR group (25 vs 22) however it was not statistically significant. Intergroup comparison did not show any significant differences between the treatment groups. Good and moderate pain relief were noted in 37(92.5%) and 3(7.5%) patients on amitriptyline and 36 (90%) and 4 (10%) patients on pregabalin SR respectively. The common adverse effects reported in amitriptyline group were drowsiness (27.5%) and dry mouth (17.5%) and in pregabalin-SR group were drowsiness (15%) and dizziness (5%). No serious adverse event was reported in either of the groups.Conclusions: In patients with painful diabetic neuropathy both amitriptyline and pregabalin-SR are equally effective in alleviating pain and improving the patient’s general condition, but pregabalin-SR has the advantage of fewer adverse effects and convenient dosage timing.
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Background: Adverse drug reactions (ADRs) have become frequent cause for hospitalization and are coming up as an economic burden on health systems. Identification of ADRs and their reporting pattern can provide useful information for their management. Hence, this study was planned to evaluate causality and pattern of ADRs in a tertiary care hospital.Methods: The present study was undertaken in a tertiary care teaching hospital. A total of 200 ADRs reports collected in the ADR monitoring centre were analysed. The WHO definition of an ADR was adopted as well as WHO scale for causality assessment was used. Evaluation of the data was done for various parameters which included drug groups causing ADRs, body systems affected in ADRs, reporters and seriousness of reactions.Results: Overall occurrence of ADRs was slightly more in males (58%). Skin (72%) was the most commonly affected organ system. Antimicrobials (47%) were the drug group most commonly involved in ADRs. The causative drug was withdrawn for the management of the ADR in the majority (86%) of the patients. Upon causality assessment, majority of the ADRs were rated as probable (83.5%). Almost all of the reports were contributed by clinicians (99%).Conclusions: The causality assessment and pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.
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The present study was conducted to evaluate the spontaneous ADR monitoring in a tertiary care hospital. A total of 150 ADRs reports were collected. The WHO definition of an ADR was adopted. Evaluation of the data was done for various parameters which included types, severity and seriousness of reactions. Naranjo score was used for causality assessment. Overall occurrence of ADRs was more in males. Type A reactions (77%) accounted for majority of the reports. Gastrointestinal system (33%) was the most commonly affected organ system. Antibiotics (32%) were the drug class most commonly involved in ADRs. The suspected drug was withdrawn for the management of the ADR in the majority (82%) of the reports. Upon causality assessment, majority of the ADRs were rated as possible (64%). Mild and moderate reactions accounted for 23 and 65% of ADRs, respectively. The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.
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A number of medical schools throughout the world have tried to downsize the basic sciences, but studies have shown that teaching of basic sciences is of importance for the clinical years that lie ahead. While some students endorse this finding, others want instruction in these sciences to be limited in terms of content and time. With the increasing cost of medical education and healthcare, medical schools the world over are trying to contain expenditure on the teaching of the basic sciences. In India, too, instruction in these sciences has been curtailed. This trend may need to be reviewed and the new challenges in this area must be addressed. Natl Med J India 2015;28:137–40
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The purpose of the present study was to comparatively evaluate the effect of newer antihistamines on psychomotor functions in Indian population. Seventy five patient volunteers were included in the study. Volunteers were put into 5 groups based on the type of antihistamine prescribed. Group-1 volunteers included those who were prescribed no antihistamine, group-2 were prescribed first generation antihistamines, group 3, 4 & 5 were prescribed second generation antihistamines cetrizine, fexofenadine and loratadine respectively. A battery of four psychomotor function tests: critical flicker fusion threshold (CFFT), digit symbol substitution test (DSST), finger tapping (FT) and visual analogue scale (VAS) for day time sedation was used in the study. First generation antihistamines impaired psychomotor functions establishing the validity of psychomotor function tests chosen for the study. Second generation antihistamines did not significantly affect CFFT frequency, but DSST score was significantly reduced. Fexofenadine significantly reduced FT score. All antihistamines produced sedation except loratadine on VAS. Second generation antihistamines impaired psychomotor performance in Indian patients, however there were individual differences evident in respect to the effect of drugs.
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The incidence of fungal infections has increased dramatically over the past few decades. Newer antifungal agents have increased the therapeutic options thereby leading to the demand for in vitro determination of antifungal susceptibility. The sensitivity pattern of Candida species isolated from samples collected in a tertiary care hospital was studied. Isolates were tested against amphotericin B, clotrimazole, fluconazole and nystatin. The susceptibility pattern of these isolates revealed that most of the isolates were sensitive to amphotericin B, fluconazole and nystatin. Candida species were most sensitive to amphotericin B. Prevalence of resistance to amphotericin B was lowest followed by nystatin and azoles. Candida has shown high level of resistance to clotrimazole. Resistance has increased to these antifungal drugs as compared to earlier data. Fungal infections are often challenging to manage, caution has to be exercised in the use of antifungal drugs to arrest any further increase in the resistance.
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The objective of the study was to compare the efficacy and safety of duloxetine and venlafaxine in major depressive disorder. The study was conducted in 26 patients suffering from major depressive disorder as per DSM-IV criteria. Patients were randomized to two groups and were given duloxetine (20,40,60mg BD) and venlafaxine (75,150,225mg OD) for 6 weeks. The primary efficacy parameter was the Hamilton Depression Rating Scale (HDRS-17). Secondary efficacy parameters included the Montgomery and Asberg depression rating scale (MADRS) and clinical global impression (CGI) scale. Safety evaluation was based on treatment emergent adverse effects and laboratory investigations. There was significant decrease in HDRS, MADRS, CGI scores from baseline to endpoint (p<0.05) in both the groups. However the difference in scores between two groups was not statistically significant. Total mean HDRS score decreased from 27(SD=2.5) to 4 (SD=1.2) in duloxetine group and from 29(SD=2.3) to 4 (SD=1.0) in venlafaxine group at the end of therapy. Response and remission rate was 96% and 69% in duloxetine group as compared to 92% and 62% in venlafaxine group respectively. There was no significant difference in adverse effects and laboratory investigation in two groups. The findings of this study indicate that duloxetine may be an effective and safe antidepressant in Indian patients of major depressive disorder. It is equally effective to venlafaxine in patients of depression.