Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

Background: All drugs profoundly modify our biological processes and may manifest as adverse drug reactions (ADRs), which are unpredictable and inevitable consequences. Antibiotics are a common cause of ADR, necessitating stopping or change of antibiotics. The incidence of ADRs increases with the number of drugs prescribed in a prescription, and antibiotics are rarely prescribed as monotherapy.Aim: The study aimed to assess frequency, class of antibiotics, symptoms, causality, the severity of antimicrobial-associated ADRs, and see the demographic distribution.Methods: ADRs were collected and filled in suspected ADR forms and sent via vigiflow to the National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI). These ADR reports, termed individual case safety reports (ICSRs), were analyzed from Jan 2016 to Dec 2019.Results: A total of 414 (54.33%) ICSRs of 762 were identified as antimicrobial-associated. Adults in the age group 19–65 years accounted for 345 (83.09%) of ADRs. A total of 192 (46.38%) were males, and 222 (53.14%) were females. Skin and subcutaneous tissue System organ class was involved in 54% of cases. In the causality assessment, 268 (64.49%) were “probable,” 123 (29.71%) were “possible,” and 23 (5.56%) were “certain.” On severity assessment, 256 ADRs (61.83%) were mild, 133 (32.12%) were moderate, and 25 (6.03%) were severe. A total of 54 antimicrobial agents, excluding anti-tubercular drugs, were identified, and antibacterial accounted for 268 (64.73%) ADRs, followed by antiviral 90 (21.73%), antiprotozoal agents 33 (7.97%) antimalarials anti-scabicidal, antifungal accounting for the remaining.Conclusion: Antimicrobials play a crucial role in treating infections, and utmost vigilance during antimicrobials prescription reduces the frequency and severity of the ADRs, thereby reducing the morbidity and mortality and the pharmacoeconomic burden to the health care system. Pharmacovigilance must be boosted to ensure the safe and effective use of antibiotics and reduce the occurrence of ADRs

A study to assess the knowledge and attitude of parents of children with epilepsy

Objective: The objective was to evaluate the knowledge and attitude of parents of children with epilepsy toward the disease. Methods: Inthis cross-sectional, descriptive study, parents of 60 children with epilepsy from pediatric neurology clinic of All India Institute ofMedical Sciences were enrolled. Data on epilepsy were collected using pre-tested and validated self-developed knowledge, belief, andattitude questionnaire (α=0.85, 0.89). Results: The mean knowledge and attitude scores of parents of the children with epilepsy were9.82±3.9 (2-22) and 31.25±9.27 (0-40), respectively. Parents of the children with epilepsy had poor 50 (83.3%, scores <60%) to fairknowledge scores (60-70%). Majority of the parents 33 (55%) had excellent attitude (≥80%), while 11 (18.3%), 6 (10%), and 10 (16.7%)parents had good, fair, and poor attitude, respectively. Correlation between knowledge and attitude was found to be very weak andnegative (r=−0. 039, p=0.77) with few misconception related to disease and clear idea about the activities to be performed with/withoutcaution. Conclusion: There is a need for developing informational booklet and conducting educational sessions on epilepsy for theparents in particular and public in general

Dentists’ Knowledge, Attitudes and Practices Regarding Hepatitis B, C and Human Immunodeficiency Virus / Acquired Immunodeficiency Syndrome In Northeast Part of Rajasthan

Introduction: Healthcare professionals including surgeons, dentists and paramedical personnel’s belong to high risk group of transmitting blood borne pathogens. Keeping this in view a study was proposed to assess the Knowledge, Attitude, and Practices (KAP) of dental professionals towards different viral diseases in northeast part of Rajasthan. Materials and Method: A cross-sectional, descriptive study was conducted among 500 randomly selected dentists in Jaipur district. Questions regarding KAP of hepatitis B (HBV), Hepatitis C (HCV) and Human immunodeficiency virus (HIV) / Acquired immunodeficiency syndrome (AIDS) were included in the questionnaire. Statistical analysis was done through SPSS Ver. 20.0. software using chi-square test, independent t-test and analysis of variance (ANOVA) to evaluate the differences between parameters. Results: The result indicates that the majority of the study subjects (60%) were female. The mean (+Standard Deviation) for age and work experience was 35.5+8.85 and 5.6+8.76 respectively. The mean value of KAP was 38.4+3.23, 21.5+4.34 and 23.05+5.67 respectively. It was observed that knowledge regarding HBV, HCV and HIV/AIDS was statistically significant with work experience (>10 Years; p<0.001), year of graduation (after 2006; p<0.001). Attitude of study subjects for HBV, HCV and HIV/AIDS was significantly inclined by age group (< 30 years: P = 0.011), work experience (≥10 years: P < 0.001), and place of work (dental clinic: P = 0.013). Conclusions: The observations of the study highlighted a reasonable level of knowledge and attitude of dental practitioners for HBV, HCV and HIV/AIDS infections. However there is a need of improvement in the knowledge level which can alter their attitude and practice towards patients with HBV, HCV and HIV/AIDS infection

Status of package insert guidelines for drugs accessible as over the counter drugs

Background: As per Indian pharmacopoeia, package inserts are part of a label that provides information on the article. It may be the sole source of information for drugs, which are available in the pharmacies without the prescription and it may include both prescription and over the counter (OTC) drugs. So, to aid in safety and efficacy of these drugs, package inserts must follow the standard guidelines (The Drugs and Cosmetics rule, 1945). The objective of this study was to observe the status of the standard guidelines for package insert in drugs accessible as OTC drugs.Methods: Based on the inquiries made with pharmacies, list of drugs commonly bought without prescription was made. 256 drugs were evaluated. Their package inserts were observed for the extent to which the guidelines given by The Drugs and Cosmetics rule 1945, section 6.2 and 6.3 are being followed. Secondary objectives were made to assess if package inserts are physician friendly or patients friendly.Results: Package inserts were missing in 180 (70%) of the drugs.  Therapeutic indications were present in 71% of the available package inserts (76). Pharmaceutical information was given in 57% of the package inserts. English was the preferred language and medicinal terms were used. Only one package insert was patient friendly.Conclusions: Package inserts should be made available in every drug. There should be a separate patient oriented package insert guideline, as per US food and drug administration (FDA), in India as well. This will aid in their safe and effective use

Efficacy of Pre-Operative Submucosal Injection of Dexamethasone in Mandibular Third Molar Surgery: A Randomized Control Trial

INTRODUCTION: Surgical extraction of third molar irrespective of any technique results in postoperative pain, swelling of face and limited mouth opening. The aim of the present study was to assess and compare the effects of Dexamethasone (4mg) administered prior to surgery.MATERIALS AND METHOD: A randomized control trial was conducted which included a total of fifty patients. All the patients were randomly put in two groups of twenty five each. Group I patients underwent transalveolar extraction of third molar under local anesthesia and standard oral drug regime. Group II patients received an additional submucosal injection of dexamethasone 4 mg, thirty minutes prior administration of local anaesthesia. Pain, swelling and mouth opening was recorded on second, seventh and tenth post-operative days after surgery.RESULTS: The difference in pain scores on second post-operative day between two groups were found statistically non-significant. However, there was significant reduction in pain scores on seventh and tenth day in both groups. Mouth opening showed statistically significant difference between the two groups.CONCLUSION: The observations of the present study provide a fundamental basis for the use of corticosteroids such as dexamethasone sodium phosphate in the form of submucosal administration in lower than usual doses to decrease postoperative inflammation when compare to other routes of drug administration

Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M.  Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate. 

Knowledge, Attitude and Practice on Biologicals and Biosimilars among Clinicians in Radiotherapy Department

Background: The decoding of human genome helped to design pharmacological agents like Biologicals and Biosimilars which can target the affected etiological aberrations. Biological agents are large complex molecules produced by recombinant techniques in a living system for therapeutic or diagnostic uses and have revolutionized treatment of many diseases. Patent expiry of Biologicals has led to the development of Biosimilars which are similar in efficacy & safety and have no clinically meaningful differences, but are not identical to Biologicals and undergo fewer clinical trials than their reference biologicals. Clinicians’ in- depth knowledge of these agents is important to optimize the use of cost-effective & easily accessible options. Methods: This is a cross sectional observational study conducted between Feb-March 2020 in Radiotherapy/Chemotherapy Oncology Department of Dr B.R.A.M. Hospital & Pt. J. N. M. Medical College, Raipur, Chhattisgarh, using a self-administered, structured questionnaire consisting of 15-question among 30 clinicians prescribing Biologicals and Biosimilars. Results: 83.3% of clinicians were familiar with the term ‘Biologicals’ & ‘Biosimilars’. 60% believed that Biosimilars are same as Generic Medicines and have the same potency as Biologicals. 53% assumed that Biologicals & Biosimilars can be switched. 50% were able to explain the difference or similarity between Biologicals and Biosimilars. Conclusion: The findings reveal that the clinicians had good knowledge about Biologicals and Biosimilars but lacked application of this knowledge in clinical practice. This highlights a need for regular educational initiative to reduce the knowledge deficit & its application in clinical practice. Further, there must be a National Treatment Guidelines on use of Biologicals  and Biosimilars

Introduction, transmission and aggravation of malaria in desert ecosystem of Rajasthan, India

Background & objectives: Malaria is an important public health problem in northwestern desert partof Rajasthan. Since desert malaria is seasonal or unstable, there is a need to study its epidemiology inthe totality to address factors like how malaria is introduced into desert every year and what are desertspecifictransmission risk factors leading to epidemics?Methods: Twenty-six villages in irrigated, semi-irrigated and non-irrigated settings of the desert havebeen selected. Periodic investigations were undertaken in all the seasons from 2001 through 2002 todetermine causes of introduction of disease, the factors involved in its transmission and the epidemicrisk factors. Standard methods/procedures for mosquito collection, preservation and identification andfor parasitological studies were employed. Rainfall data were analysed and correlated.Results: Importation of malaria infection through individuals was the major cause of introduction ofdisease in all the 12 villages showing some initial load of infection. Areas having higher populationof cattle in relation to humans (human to cattle ratio of 1:25) had less transmission of disease (ratioof primary to secondary cases 1:3) as compared to relatively less cattle (human to cattle ratio 1:3)resulting into high transmission of disease with 1:47 ratio of primary to secondary cases. Introducedthrough migration, prospective transmission of malaria was observed as a resultant interaction ofdensity of three components namely malaria cases, vector density and cattle to human ratio. Rainfallmore than average when coupled with more cases of imported malaria leads to the eruption of malariaepidemics.Interpretation & conclusion: Importation of malaria cases was the major cause of seasonal introductionof malaria in the desert. This initial or primary parasitic load available in a village leads to aparticular transmission quantum depending upon the density of vectors, human and cattle populationat a particular time. Areas with more imported cases when coupled with profuse vector population leadto epidemic malaria situations in the desert

Fishery, biology and dynamics of dogtooth tuna, Gymnosarda unicolor (Rüppell, 1838) exploited from Indian seas

Dogtooth tuna, Gymnosarda unicolor (Rüppell, 1838) (Fig. 1) is a pelagic tuna preferring waters of temperature between 21 and 26 oC. It is one of the principal species exploited by hook and line (recreational as well as commercial fishery) operated in the oceanic region. Meat of dogtooth tuna is white and so it has great demand and fetch high price (IUCN, 2011). However, occasional ciguatera fish poisoning in humans has been reported on consumption of dogtooth tuna. It is exported in fresh and frozen state and is used for the production of sashimi, canned tuna, and pouch products. Most of the world landings of dogtooth tuna during 1963 -2006 was from the Indian Ocean. Small scale tuna long lines for the species operating in the Indian Ocean belong to Taiwan, Srilanka, Maldives, Japan or Pakista