Background:
Children are very much vulnerable to adverse drug reactions (ADRs) and also tend to have more severe form of adverse effects compared to adults. Though ADR is a significant problem in children, paediatricians seem to neglect this aspect. Knowledge, attitude and practice (KAP) studies related to pharmacovigilance among paediatricians are lacking in literature. Hence, this study was planned to know the gaps in KAP among paediatricians of Odisha and factors related to underreporting of ADR.
Materials and Methods:
Google Form containing the questions was shared to paediatricians of Odisha state working in both private and government organisations. The questionnaire was prepared based on previous studies and some new questions relevant to our scenario were added. The questionnaire contained six questions based on knowledge, four on attitude and three on practice of ADR. Apart from that, it contained questions to know their response regarding the factors that discourage paediatricians to report ADRs. There were 60 responses.
Results:
Among the paediatricians, 70%–80% were aware of the pharmacovigilance programme running in India. Also, 80%–90% agreed that ADR reporting is crucial in paediatric health care, while most of them were trained regarding ADR reporting. But only 50% of them had reported an ADR in their clinical practice, which clearly indicates towards underreporting.
Conclusion:
The motivation for voluntary reporting of ADRs among paediatricians for preventing the morbidity and mortality in this vulnerable population could be of immense importance, and hence, various workshops and CMEs should be conducted to improve the KAP of these doctors, so that the problem of underreporting could be minimised.
Background
Medical abortion up to seven weeks of pregnancy by using a combination of mifepristone and misoprostol with careful follow-up is approved by WHO guidelines. But due to the counter sale of medical termination of pregnancy (MTP) pills, in our country, pregnant women have easy access to use them landing upon serious complications. The present study aims to assess the outcome of self-medicated MTP pills in pregnant women.
Method
This prospective observational study includes pregnant women who presented to our hospital for medical assistance due to complications after using the counter of MTP pills without medical consultation. Findings of ultra-sonographic and physical examination were noted along with analysis of subsequent management.
Results
The major complaint at presentation was excessive bleeding (78%). Out of 100 patients, 66% of cases were diagnosed as incomplete abortion, 6% as missed abortion, and 6% as unaffected pregnancy. Ectopic pregnancy was detected in 12% of cases. Sixty patients of incomplete abortion were managed with suction and evacuation and six were supplemented with misoprostol. All patients with ectopic pregnancies were managed surgically.
Conclusion
The majority of the pregnant women who took MTP pills presented with serious complications in the form of bleeding, incomplete/missed abortion, and ectopic pregnancy. Restriction of the over-the-counter dispensation of abortion pills needs to be strictly implemented and knowledge of women regarding the unfavourable outcome of MTP pill intake without proper consultation needs to be improved.
Fixed drug eruption (FDE) is one of the common manifestations of cutaneous drug induced reactions. These are mainly caused by antibiotic and analgesic preparations. Many of the fixed dose combinations available in the market are mostly used as self medication and patients suffer from drug reactions. We present a rare case of recurrent FDE and lip swelling in a patient after taking fixed dose combination of Norfloxacin and Tinidazole.
Introduction: The rising burden of diabetes mellitus led to the development of novel drugs like dapagliflozin and vildagliptin. Their efficacies in chronic diabetic patients have been thoroughly studied. However, there is a paucity of comparative studies on these drugs in newly diagnosed diabetic patients. The endpoints of our study were changes in glycated hemoglobin (HbA
1c
), fasting blood glucose (FBG), and postprandial blood glucose (PPBG) at 24 weeks from baseline.
Methods: This randomized, open-label, 24-week study was conducted at Kalinga Institute of Medical Sciences, Bhubaneswar, India, from January 2021 to November 2022. The participants were randomized in a 1:1 ratio to receive tablets of either dapagliflozin 10mg once daily or vildagliptin 50mg once daily as an add-on to metformin 500-2000 mg. The analyses were performed in the per-protocol population. We used R software v. 4.1.1 (R Foundation, Indianapolis, IN) for data analysis.
Results: 114 (83.8%) of 136 enrolled participants completed this study. The mean age of the study population was 41.08±5.17 years. Additionally, 52 (45.6%) of them were females. The mean changes in HbA
1c
from baseline were -1.19 (95% CI: -1.36 to -1.03) and -1.28 (95% CI: -1.37 to -1.18) in dapagliflozin and vildagliptin groups, respectively (p=0.21). The median changes in FBG and PPBG in both groups were -38.76, -46.13 (p=0.07), and -51.84, -53.56 (p=0.14), respectively.
Conclusions: Reductions in HbA
1c
, FBG, and PPBG with add-on treatment of vildagliptin were more pronounced than dapagliflozin after a 24-week intervention. However, the differences were not statistically significant.
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