ABSTRACT
Background: The World Health Organization (WHO) declared Coronavirus disease-19 (COVID-19) caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) a pandemic on March 11, 2020. On 16th January 2021, India began its vaccination programme using two COVID-19 vaccines (Covishield and Covaxin). Precautionary dose (booster shots) was administered to health and front-line workers in the beginning and then to all eligible populations. Material and Methods: This was a descriptive observational study conducted in the COVID-19 vaccination centres of Karnal district and the ADR monitoring centre, KCGMC, Karnal. During the visits to vaccination centres, all beneficiaries of the precautionary third dose of COVID-19 vaccines as well as healthcare workers were sensitized to report in case of any adverse event following vaccination as part of the policy of the vaccination programme run by the government and Pharmacovigilance Programme of India. The data were collected in suspected adverse drug reaction (ADR) reporting form version 1.4, and causality assessment was done as per the WHO-UMC scale. The data were analysed as simple proportions and percentages. Results: The booster dose was administered to 72,853 individuals, while the 1st dose and 2nd dose were given to 13,30,042 and 10,73,050, respectively. Only three ADRs were reported with the booster dose in 34 vaccination centres in the Karnal district. These three ADRs were classified as unlikely on causality assessment and hence not included in the analysis. Conclusion: The booster dose administered for the prevention of COVID-19 has been found to be reasonably safe. The population who received COVID-19 booster doses was significantly less than the populations who received the first and second doses, which suggests a low acceptance rate.
ABSTRACT
CONTEXT: Hypoglycemia is a well-recognized adverse effect in the treatment of type 1 diabetes mellitus. For patients of type 2 diabetes mellitus (T2DM) on stabilized treatment with the current oral antidiabetic drugs, occurrence of hypoglycemia is considerably less well studied. The current study was undertaken to understand the extent of this problem in elderly Indian patients. OBJECTIVES PRIMARY OBJECTIVE: Assessment of incidence of hypoglycemia in patients of T2DM on stable treatment. SECONDARY OBJECTIVES: 1. Estimation of incidence of episodes of severe hypoglycemia in patients. 2. Correlation of presence of hypoglycemia with treatment modality. SETTINGS AND DESIGN: This study was conducted as an open label, single-center observational study at a multispecialty tertiary care hospital. MATERIALS AND METHODS: The study participants consisted of 50 elderly confirmed patients of either gender suffering from T2DM undergoing treatment and follow-up in the hospital for at least 12 weeks. After a brief training session and enrolment, the patients were asked to report to study site every month for next 2 months. Parameters recorded were plasma glucose levels, HbA1c levels, treatment regimen, body mass index, possible hypoglycemic episode based on symptoms and self-monitoring of blood glucose, and quality of life based on questionnaire score. STATISTICAL ANALYSIS: Descriptive and other statistics were used to analyze the hypoglycemic episodes experienced by the patients for correlation with medicines and the effect of hypoglycemia on their quality of life. RESULTS: Total of nine hypoglycemic episodes were recorded. Severe hypoglycemia did not occur in any patient. Patient on insulin reported significantly more hypoglycemia. Quality of life is not much different in patients using insulin in T2DM.
ABSTRACT
A very large part of India's population fulfils its healthcare needs from government run healthcare delivery system which is free, contributory or highly subsidised. Use of medicines forms a large part of healthcare facility. As the number of medicines and brands are ever increasing in today's market, it is usual for pharmacy to substitute a generic instead of the prescribed brand or a different brand if the prescribed brand is not available. Depending on the type of substitute, it could fall under 'generic' or 'therapeutic' substitution. For any condition, there may be numerous medicines existing, some of which probably got introduced more recently, may be more expensive and erroneously perceived to act better than the earlier known medications for the same ailment. Also, due to very high number of medicines that are approved and available for use in the market, it is impossible to stock all the medicines in any pharmacy. Generic and therapeutic substitutions should be formalised and implemented by institutions, with the consent and cooperation of all the stake holders as guided by World Health Organisation. The advantages and limitations of medicine substitutes are discussed in the review.
