Retrospective Analysis of Potential Adverse Drug Interactions in the Drugs Prescribed to the Elderly at a Tertiary Health Care Center in Raipur, Chhattisgarh, Central India.

Background The elderly population differs from adults in having various physiological changes and multiple diseases, which demand the use of multiple medications. The practice of polypharmacy in the elderly leads to numerous harmful effects like adverse drug reactions, adverse drug-drug interactions (DDIs), poor compliance, etc. Methodology This study collected 295 case files of elderly patients retrospectively in the Departments of General Medicine, Cardiology and Nephrology after obtaining Institute Ethics Committee approval to look for the potential adverse DDIs with their severity according to the clinical significance. Results and interpretation The total number of adverse DDIs identified was 156, the maximum in Category 'C.' Salbutamol plus carvedilol/propranolol, ramipril plus telmisartan and ivabradine plus diltiazem were the adverse DDIs categorized under severity 'X'. The identified DDIs were categorised according to the mechanism such as increased bleeding risk, hypokalemia, hyperkalaemia, reduced effect of drugs and increased effect of drugs.  Conclusion Polypharmacy can lead to several adverse consequences in the elderly, of which adverse DDIs play a crucial role in harmful health outcomes. This study brings out the significance of predicting drug interactions beforehand which can reduce the risk of bleeding and other risks of hyper/hypokalaemia, hyponatremia and hypoglycaemia.

Analysis of Drugs Prescribed to Elderly Patients in a Tertiary Health Care Center in Raipur, Central India: An Observational Study.

Background Most elderly patients suffer from multiple diseases and are on multiple drugs for treatment. Polypharmacy in the elderly, physiological changes with old age, changes in the pharmacokinetics and pharmacodynamic effects of many drugs, and newer drug prescription trends for diseases like diabetes and cardiovascular disease make drug prescribing in the elderly more difficult. There are many chances of drug-drug interactions with easily available over-the-counter (OTC) medications. To prevent the irrational use of drugs in the elderly, there is a need for prescription analysis studies. Prescription analysis studies will help in finding errors in prescriptions and also change trends in the use of medication among the elderly. Methodology This cross-sectional observation study was conducted on 234 elderly patients to investigate medicine use patterns among the geriatric patients attending the Medicine Outpatient Department in a tertiary care teaching hospital. Drug data were collected from the study participants after obtaining written informed consent and analysed, including demographic details, personal history, disease history, and details of the drug, including the generic name of the drug, dose and duration of therapy, and prescription pattern. The proportions of drugs prescribed for different diseases were analysed. Also, the drugs were analysed as per their pharmacological profiles. Results and interpretation A total of 1298 drug prescriptions were analysed in this study. Of the total participants, 60.26% were male, 35% were unemployed, 53% were retired, and 27% were taking OTC herbal medications. Most of the patients included in this study were suffering from diabetes, hypertension, and other comorbidities. Telmisartan and telmisartan in combination with other drugs were the most commonly encountered prescription drugs, i.e., 24% among the cardiovascular drugs. Aspirin and statins alone or in combination were the most commonly encountered prescriptions, i.e., 27.88% of the drugs used for prophylaxis of cardiovascular diseases. Conclusion This study showed a prescription pattern for the elderly and highlighted precautions to be taken with some of the prescribed drugs. As polypharmacy is observed with elderly prescriptions, possible drug interactions must be taken into account. Regular prescription analysis of drugs prescribed to the elderly will help in the appropriate and rational use of drugs.

Ten-Year Cardiovascular Risk as Predicted by the QRISK®3 Calculator in Diabetic Patients Attending a Tertiary Care Teaching Hospital in Central India and Its Application to Stratify Statin Over-Users and Under-Users.

BACKGROUND: Cardiovascular disease (CVD) is an important cause of morbidity and mortality in diabetic patients. As such, risk stratification is essential to identify the risk factors of CVD and provide early intervention. The QRISK®3 tool, recommended by the National Institute for Health and Care Excellence (NICE) guidelines, has the option to choose the patient's ethnicity, which is not available in other tools. However, there is a paucity of data regarding the use of this tool in the Indian population. Therefore, this study was planned to predict 10-year CVD risk using the QRISK®3 tool and to determine statin eligibility in diabetic patients. METHODS: We enrolled diabetic patients visiting our general medicine outpatient department and diabetic clinic in the study. We collected data from clinical and prescription records, as well as through patient interviews. We analyzed the data to determine the 10-year CVD risk using the QRISK®3 risk tool, which is available online. A cut-off QRISK score of 10%, as recommended by the NICE guidelines (2014), was used to stratify patients as "over-users" and "under-users." We also analyzed the data to determine any correlation between other risk factors and QRISK scores. RESULTS: Of the 134 diabetic patients recruited in this study, 43 (32.09%) had a CVD risk score of <10%, of which 16 (37.21%) were categorized as "over-users." Of the patients, 91 had a CVD risk score of ≥10%, of which 17 (18.68%) were categorized as "under-users." Risk factors showing a positive correlation with QRISK score included duration of diabetes, age, blood pressure treatment, waist circumference, and non-high-density lipoprotein cholesterol level. CONCLUSION: QRISK score can be useful to predict 10-year CVD risk in the Indian population and to stratify patients as statin over-users and under-users. This tool can be used in the Indian set-up to identify potential candidates for statin initiation.

Appropriateness of Surgical Antibiotic Prophylaxis in a Tertiary Care Teaching Hospital in Central India: A Retrospective Analysis.

Surgical antibiotic prophylaxis (SAP) has been a boon in the prevention of surgical site infections (SSIs). This study was conducted to assess and evaluate the selection, timing, and duration of administration of SAP and their compliance with national and international guidelines in a tertiary care teaching hospital in India. This retrospective study included the data collected from the central records department in a tertiary care teaching hospital on major surgeries conducted between January 1, 2018, and December 31, 2018, from the departments of ENT, general surgery, orthopedic surgery, and obstetrics and gynecology. The data was analyzed for the appropriateness of their indication for SAP administration, choice, timing, and duration of antibiotics, and compliance with the American Society of Health-System Pharmacists (ASHP) and Indian Council of Medical Research (ICMR) guidelines. Results and interpretation Out of the total 394 case records included, only 2.53% (n = 10) of the cases were given an appropriate antibiotic. The duration of SAP was appropriate only in 6.53% (n = 24), and the timing of SAP administration was appropriate only in 50.76% (n = 204). The most commonly used antibiotic was ceftriaxone (pre-operative 58.12% (n = 229) and post-operative 43.14% (n = 170)). Major inappropriateness was observed in the selection of antibiotics which may be attributed to the non-availability of cefazolin in the institute. The inappropriateness of the duration of the SAP may be attributed to the extra precautions taken by the treating physicians to prevent SSIs. The overall compliance of the surgical cases with respect to the ASHP and ICMR guidelines was less than 1%. Conclusion This study identified the lacuna between the guidelines for SAP and the clinical application of the same. It also identified the areas where quality improvement was needed which can be improved by implementing antimicrobial stewardship, especially the choice and the duration of SAP administration.

Assessment of Reporting Quality of Drug-Related Randomized Controlled Trials Conducted in India and Published in MEDLINE-Indexed Indian Journals Over a Decade: A Systematic Review.

Poorly published trials may result in biased and erroneous healthcare decisions. We conducted this systematic review to evaluate the reporting quality of drug-related randomized controlled trials (RCTs) conducted in India and published in MEDLINE-indexed Indian journals over a decade (between January 1, 2011, and December 31, 2020), as per the Consolidated Standards of Reporting Trials (CONSORT) Checklist 2010. An extensive literature search was conducted using the terms "Randomized controlled trial AND India." The full-length papers were extracted for RCTs related to drugs. Two independent investigators assessed each article against the checklist containing 37 criteria. Each article was scored 1 or 0 against each criterion which was finally summed up and evaluated. None of the articles fulfilled all 37 criteria. A compliance rate of >75% was seen in only 15.5% of articles. More than 75% of articles fulfilled a minimum of 16 criteria. Major checklist points observed to be deficient were "important changes to methods after trial commencement" (7%), "interim analysis and stopping guidelines" (7%), and "description of similarity of interventions while blinding" (4%). There remains ample room for improvement regarding research methodology and manuscript preparation in India. Moreover, journals should stringently implement the CONSORT Checklist 2010 to enhance the standard and quality of publications.

Usefulness of STOPP/START criteria and Beers criteria for prescribing in geriatric patients in a tertiary health care center, Raipur, Central India.

Background: Polypharmacy and inappropriate prescribing are risk factors for adverse clinical outcomes in older people. Screening tools can identify potential medicine-related patient safety incidents for the elderly on multiple medicines and with chronic diseases. Methods: In this prospective observational study, details of demography, diagnosis, history of constipation/peptic ulcer disease, over-the-counter medications, and clinical and laboratory findings were noted. Information obtained was reviewed and analyzed with the help of STOPP/START and Beers 2019 criteria. At 1 month follow-up, improvement was assessed with the help of a structured questionnaire. Results: As per the criteria, modification in drugs was recommended for 213 drugs; it was actually performed for 27.73% and 48.71% drugs as per Beers and STOPP/START criteria, respectively. Glimepiride was replaced with short-acting sulfonylureas because of hypoglycemia, and angiotensin receptor blockers were stopped because of hyperkalemia as per Beers criteria. Statins were started in 19 patients by START criteria. Overall general health improvement was observed at 1 month, but an increase in anxiety, tension, worry, depressed feel, and insomnia was observed in initial days of the coronavirus disease 2019 pandemic. Conclusions: In view of polypharmacy in the prescriptions, the combination of prescribing criteria need to be considered while prescribing medications to the elderly to get optimum therapeutic benefits and improvement in the quality of life. The quality of primary care of the elderly can also be improved by use of screening tools such as STOPP/START and Beers criteria by a primary/family physician. Prescription evaluation by a trained pharmacologist/physician for possible drug/food/disease interactions and for therapy modification can be incorporated for routine geriatric care at a tertiary care center. Clinical trial registry of India registration number: CTRI/2020/01/022852.

Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh: A retrospective analysis.

BACKGROUND AND OBJECTIVES: Adverse Drug Reactions (ADRs) can lead to significant morbidity, rarely mortality and financial burden over the patient. ADRs that can be prevented can be considered as form of medication error sometimes. This study assessed the preventability, predictability and severity of ADRs using different assessment scales. METHODS: ADR Monitoring Centre under newly established teaching hospital in Chhattisgarh collected ADR reports from different healthcare professionals during the period from November 2016 to November 2018. Analysis of the reported ADRs was done for their causality assessment, demographic details of patients, most common drug class responsible for the ADR. Seriousness and preventability of ADRs were analysed by using WHO Causality Scale and Modified Schumock and Thornton Scale respectively. Severity of ADRs was assessed by Modified Hartwig and Siegel Scale. RESULTS: Totally 288 ADRs were reported in a 2-year period. 92.01% ADRs were non serious. 44.8% were mild, 53.81% moderate and 1.39% were severe ADRs. Causality assessment showed: 5.21% certain, 54.86% probable, 39.24% possible and 0.69% unlikely ADRs. Around 26% ADRs were definitely and probably preventable and 27.78% ADRs were predictable. The highest number (32.29%) of ADRs were reported to antimicrobials. 11.15% ADRs were reported to NSAIDs, in that 37.5% ADRs were due to NSAIDs combination. CONCLUSION: Many ADRs in this study are non-serious, preventable and predictable. Management of such ADRs through therapeutic interventions would be beneficial in a better patient outcome. Multidisciplinary strategies involving physicians, pharmacists, other healthcare professionals and patient education and awareness about ADRs are needed for prevention of ADRs.

Evaluation of the Prescribed Drugs to Elderly in a Tertiary Healthcare Center for Possible Drug Interactions with Investigational Drugs for COVID-19 Treatment.

OBJECTIVE: Earlier identifying drug interactions may help in risk reduction in elderly patients. METHODS: Drug prescription data of 212 elderly patients of tertiary health care center had been analyzed for possible drug interactions with investigational drugs for COVID-19 treatment. Drug interaction had been checked from Stockley's Drug Interaction 2019 and Martindale the Complete Drug Reference 2017 and standard reference books of Pharmacology. FINDINGS: Different types of drugs prescribed in the elderly were 260 and out of which 68 (26.36%) were in the category of fixed-dose combinations. Around 150 (70.75%) elderly patients were having one or more associated comorbidities. Thirty-five drugs prescribed to elderly had been found to cause drug interaction with investigational drugs for COVID-19. Possible drug interactions are mediated through CYP3A4 (eighteen patients), CYP2D6 (seven patients) isoenzymes, or P glycoproteins transporters (three patients). CONCLUSION: Possible drug interactions predicted in this study suggested need for modification of dose of drug or watchfulness for adverse effects. If these drug interactions are considered beforehand, complications can be prevented on account of these drug interactions in elderly who are suffering from COVID-19.

Bromocriptine mesylate: Food and Drug Administration approved new approach in therapy of non-insulin dependant diabetes mellitus with poor glycemic control.

Food and Drug Administration (FDA) approved bromocriptine mesylate, a quick release formulation, 0.8 mg tablets, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Bromocriptine products were previously approved by the FDA for the treatment of pituitary tumors and Parkinson's disease. Bromocriptine is thought to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in insulin-resistant patients. Adverse events most commonly reported in clinical trials of bromocriptine included nausea, fatigue, vomiting, headache, and dizziness. These events lasted a median of 14 days and were more likely to occur during initial titration of the drug. Due to novel mechanism of action, single daily dose, and lower incidence of stroke, myocardial infarction and vascular events, bromocriptine may act as landmark in treatment of type 2 diabetes.

Efficacy and safety of livwin (polyherbal formulation) in patients with acute viral hepatitis: A randomized double-blind placebo-controlled clinical trial.

OBJECTIVES: The study was planned to evaluate the efficacy and safety of Livwin (polyherbal formulation) in acute viral hepatitis. MATERIALS AND METHODS: In this study, there were 29 patients in each group, receiving either Livwin (containing Ashwagandha, Arjuna, Bhumyamalaki, Daruharidra, Guduchi, Kutki and Punarnava) or placebo capsules containing lactose powder (500 mg). Both drugs were given orally two capsules two times a day for eight weeks followed by treatment free period of four weeks. Recovery of patients was assessed by noting symptomatic recovery and by measuring levels of serum bilirubin, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), alkaline phosphatase at baseline, 2, 4, 8 and 12 weeks. RESULTS: Significant earlier recovery of weakness was observed with Livwin as compared to placebo at 2, 4 and 8 weeks. Serum bilirubin and ALT was observed in normal range in significantly more number of patients with Livwin treatment as compared to placebo at 2, 4 and 8 weeks. AST was observed in normal range in significantly more number of patients with Livwin treatment as compared to placebo at 2 and 4 weeks. CONCLUSIONS: Livwin is found effective in uncomplicated patients of acute viral hepatitis. Epigastric pain and diarrhea were reported with Livwin treatment.