A cross sectional study of knowledge, attitude and practices related to fixed dose combinations use among clinicians and resident doctors at a tertiary care teaching hospital in India

Background: In the year 2016, Government of India had banned 350 fixed dose combinations (FDCs) for the safety and efficacy purpose. The present study was conducted to assess the knowledge, attitude and practices of the clinicians and residents about the use of FDCs at a tertiary care hospital.Methods: A questionnaire based study was conducted at a tertiary care hospital after getting approval from institutional ethics committee. A pre-validated questionnaire comprising of 30 items was distributed to 100 participants. The questionnaire focused on the prescribing behaviour, knowledge on therapeutic efficacy, advantages and limitations of FDC use, clinician perception regarding FDC use and the strategies to improve the awareness about the regulatory updates of the marketed drugs.Results: Total 52/100 clinicians responded. Out of these, 88% prescribed FDCs in their practice, 62% prescribed FDCs only after ensuring therapeutic efficacy and 50% prescribed WHO approved FDCs. 64% were aware of the recent ban on some FDCs by DCGI. Internet was the most common source of latest updates on the regulatory status of the drug, as stated by 55% clinicians. All clinicians agreed that efforts are needed to ensure that prescribers remain up to date about the post-marketing regulatory status of the drugs.Conclusions: Even though many clinicians prescribe FDCs regularly, they appreciated the step of banning some FDCs; however, the clinicians need to be trained to update themselves regularly. The source and relevance of these updates should be taught to the undergraduate students during their training period which can be reemphasized during post graduate training period

A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India

Background: The present study was undertaken to evaluate the incidence and pattern of adverse drug reaction (ADRs), causality, severity and preventability of ADRs.Methods: Data was collected and analyzed with the information such as patients’ demographic details, associated co-morbid conditions and detailed drug related information gathered from ADR reporting forms. World Health Organization (WHO) scale was used for assessing causality, modified Hartwig scale was used for assessing severity and modified Schumock and Thorntons scale were used for assessing preventability of ADRs. Data was analyzed using descriptive statistics.Results: Total 154 ADRs were reported in a period of one year (August 2016- July 2017). Out of 154 ADRs analyzed, 120 (77.9%) were in adults, 33 (21.4%) pediatric and 01 (0.7%) in geriatric patients. The most common ADR recorded was cutaneous reactions (43.5%) and the most common causative class of drugs for the same was found to be antimicrobials (46.7%) followed by non-steroidal anti-inflammatory drugs (15.6%). Causality assessment scale indicated 68.8% ADRs possible and 24% ADRs as probable. Severity assessment revealed that 45.5 % were mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 84.4% of the cases were probably non-preventable.Conclusions: In this study it was found that, most of the ADRs were of possible category with mild to moderate severity and majority being non-preventable. Antimicrobial drugs being the most common offending drug class causing ADRs. Strategies targeting appropriate and cautious use of this class of drugs may benefit in reducing the number of ADRs and therefore the cost involved in the treatment

Evaluation of prescribing pattern of drugs use in patients of coronary artery disease at a tertiary care hospital

Background: Coronary artery disease (CAD) is a major cause responsible for mortality more in younger age group than in elderly. Studies have reported underuse of four evidence based medicines namely aspirin, β-blockers, angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), and statins in patients with CAD, particularly in developing countries. Therefore, this study was planned to analyse the prescriptions of patients with CAD to determine the appropriateness of the prescriptions.Methods: After obtaining the Institutional ethics committee permission, a cross sectional observational study was conducted at a tertiary care hospital. Total 150 patients were enrolled from the outpatient department, wards and intensive care unit of medicine department. Total 150 patients’ prescriptions presenting with varied category of CAD were screened and analysed.Results: The most common categories of CAD encountered was ST segment elevated myocardial infarction (N=50, 33%) followed by chronic stable angina (N=29, 20%). Among the drugs prescribed, antiplatelet drugs were prescribed to 135 (90%), hypolipidemics to 134 (89%), nitrates to 114 (76%), beta blockers to 97 (65%), ACE inhibitors to 94 (64%), anticoagulants to 60 (40%) and miscellaneous drugs to 52 (35%), patients. Of 68 (45%) patients with type 2 diabetes mellitus, 15 (22%) were prescribed only metoprolol and others were given ACE-I or ARBs.Conclusions: Among four evidence based drugs, use of 3 drugs, antiplatelets, beta blockers and hypolipidemics was apparent in 90% of prescriptions. Use of ACE inhibitors and ARBs was observed in type 2 diabetic patients with CAD, reflecting rational prescribing behavior of clinicians

Ethics reporting practices in clinical research publications: A review of four Indian journals

Background: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals. Materials and Methods: Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants. Results: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent. Conclusion: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals