A Drug Utilization Study of Anti-glaucoma Drugs in a Tertiary Care Hospital.

BACKGROUND AND OBJECTIVES: Today, branded medications and polytherapy are frequently prescribed for glaucoma, even without giving the patient the proper instructions. Hence, the safety, effectiveness, cost, and patient compliance of glaucoma medication must be weighed, and the anti-glaucoma medicine usage must be studied. Analysis of glaucoma patients' prescription usage was the objective of this study. MATERIAL AND METHODS: Between January 2021 and February 2022, this prospective and observational study was carried out at Andhra Medical College in Vishakhapatnam. One hundred prescriptions of those with primary open-angle and angle closure glaucoma were assessed. Age and gender-based subgroup analyses were conducted. R software (version 4.2.1) (The R Foundation for Statistical Computing, Vienna, Austria) was leveraged for data analysis. RESULTS: Out of 146 examined prescriptions, 100 (69%) were deemed suitable for analysis. Participants' mean age was 54.2 ± 10.8 years. Sixty-two were over 50 years old, and 36 were men. The mean intraocular pressure was 25.4 ± 1.7 mm of Hg. Per prescription, there were about 1.75 anti-glaucoma drugs. Fixed-dose combinations (FDC) were found in 43 prescriptions. Generic medications and patient instructions prevailed in most prescriptions (78%) and (84%). Timolol was used in each FDC with brimonidine, dorzolamide, or bimatoprost. CONCLUSION: The most often prescribed anti-glaucoma drug, timolol, was also identified as an essential component of the FDC. Doctors must prescribe generic medications with detailed directions for the patients.

Dapagliflozin Versus Vildagliptin as an Adjuvant to Metformin in Patients With Type 2 Diabetes Mellitus: A Randomized, Open-label Study.

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 (HbA1c), 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 HbA1c 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 HbA1c, 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.

Knowledge, attitude and practice (KAP) of pharmacovigilance among paediatricians of Odisha and factors related to poor reporting of adverse drug reactions.

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.

Adverse Drug Reactions in the Pediatric Population: Findings From the Adverse Drug Reaction Monitoring Center of a Teaching Hospital in Odisha (2015-2020).

Background and objective The incidence of adverse drug reactions (ADRs) in hospitalized children varies from 0.6-16.8%. There is a lack of uniformity and an absence of quality reporting with respect to the collection of data on ADRs worldwide, resulting in a scarcity of data regarding ADRs in children. In light of this, we aimed to analyze various factors related to ADRs in the pediatric population in the ADR Monitoring Center (AMC) of a teaching hospital in Odisha, India. Methods This was a record-based study conducted by the department of pharmacology in collaboration with the department of pediatrics. Detailed information regarding all ADR cases in children (<14 years of age) was collected in a format designed by the Indian Pharmacopoeia Commission (IPC). A total of 105 ADRs reported during a five-year period (2015-20) were subjected to analysis. Results The largest number of ADRs were reported in the age group zero to five years (41%). Males were affected more compared to females (1.7:1). Cutaneous ADRs were the most common type (86.5%) followed by the involvement of the gastrointestinal system (10%); 21% of cases were serious in nature, i.e., they required either hospitalization or led to a prolonged hospital stay. Antibiotics were the major drug category involved in causing drug reactions (66%) and among them, ceftriaxone (24.6%) was the most common causative agent. Conclusions One-fifth of the pediatric cases of ADRs were serious in nature. The most common causative agent was antibiotics, especially beta-lactams. There is an urgent need to raise awareness among healthcare professionals by conducting training programs to encourage the spontaneous reporting of ADRs, which will help to ensure drug safety in the pediatric population.

Analysis of Complications and Management After Self-Administration of Medical Termination of Pregnancy Pills.

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.

Cutaneous adverse drug reactions with fixed-dose combinations: Special reference to self-medication and preventability.

OBJECTIVES: To identify the association of cutaneous adverse drug reactions (CADRs) with use of fixed-dose combinations (FDCs) and to compare the occurrence of preventable CADRs between self-medication and prescribed medication of FDCs. PATIENTS AND METHODS: All cases of suspected CADRs with the use of FDCs were collected, and causality assessment was carried out using the WHO UMC scale. The burden of CADRs on self-medication and prescribed medication was found out. Preventability status was analyzed by Schumock and Thornton Criteria and compared between self-medication and prescribed medication. RESULTS: A total of 74 CADRs were detected; 68.91% were detected with antimicrobial and 31.09% with nonsteroidal anti-inflammatory drug-based FDCs. Fluoroquinolones + nitroimidazole was the most commonly suspected medications. Majority of CADRs (44.59%) were fixed-drug eruptions, which was significantly higher than others (P = 0.002). Analysis of preventability showed that there was a significantly higher occurrence of definitely preventable CADRs in self-medication group (40%) in comparison to prescribed group (6.81%), P = 0.028. CONCLUSIONS: Self-medication with FDCs is quite common and associated with a higher rate of preventable CADRs in comparison to that in prescribed medication.