A study of adverse vaccine events among pediatric age group in a tertiary medical college hospital

Background: Vaccines are pivotal health products that are used and administeredprophylactically to a large number of healthy individuals. A significant proportion ofvaccines are administered to the pediatric age group, particularly to the neonates andinfants as part of the national immunization programmes. As with any drug, untowardreaction can occur with the administration of vaccines. Most of the clinical trials withthe vaccines are conducted and validated in a relatively small sample size. Activemonitoring as part of the Pharmacovigilance programme is imperative to identifyrare or deferred adverse vaccine events (AVE).Methods: A prospective, single center, observational, naturalistic study on reportforms in pediatric age group, who may develop AVE in Sapthagiri Institute ofMedical Sciences and Research Center, Bengaluru, was conducted during the studytime widow, from February 20, 2014, to April 20th, 2014. Children under 5 years ofage were included in the study. All children more than 5 years of age were excludedfrom the study. The causality assessment were attempted to be recorded as per theNaranjo score, which is used to quantitatively evaluate the association between AVEand vaccines.Results: 19.04% of children aged 1-5 years of age documented with adverse eventfollowing immunization (AEFI) (p=0.036). It was found that either a naïve or thefully immunized children suffered from the AEFI most of which was trivial. Feverwas the most common AEFI reported followed by an excess cry. The incidence offever reported was substantially high following the DPT vaccine.Conclusions: All the AEFI received through the telephonic calls were documented.There was no mortality or a major adverse event reported. Maximum AEFI weredocumented in the neonates and the children 1-5 years of age which was statisticallysignificant. In addition, the study provides a scope for further research with referenceto the inter-age group variability. The immune mechanism behind such a differencealso needs to be explored

Drug disposing behavior and awareness of the concept of ecopharmacovigilance among the medical faculty

Background: The ever-increasing impact of drugs on the environment has added an altogether new dimension of monitoring, assessing and documenting the known and unknown drug effects on our fragile environment in the form of ecopharmacovigilance. This study was carried out to document the drug disposing behavior and awareness of the concept of ecopharmacovigilance among the medical faculty of a tertiary care Medical Hospital.Methods: A detailed, structured, anonymous questionnaire consisting of both open and close ended essential queries on drug disposal practices was prepared and response obtained from the participants which included an agglomeration of teaching faculty and the clinicians of various disciplines of the Institute.Results: 97.87% of the participants obtained drugs in excess which included a majority of solid (68.12%) and liquid (31.88%) dosage forms. The maximum medicines obtained in excess included analgesics and antipyretics (89.36%), anti-asthmatics (15.22%), and anti-emetics (13.48%). 82.8% of the respondents were unaware of the proper drug disposal technique and 94.7 % of the respondents practiced open disposal of the drugs.Conclusions: An abysmally low level of awareness about ecopharmacovigilance and unhealthy, irrational method of drug disposal was documented in our study. Appropriate training of those who handle drugs in hospitals and healthcare establishments is the need of the hour

Adverse drug reaction monitoring of antitubercular drugs at tertiary care medical college hospital: prospective study

Background: To study the socio-demographic profile of patients receiving DOTS and to estimate the prevalence of adverse drug reaction and casualty in patients receiving DOTS.Methods: This is a self reporting prospective study , trained personnel instructed patients about treatment and possible adverse drug reaction and patient telephone number was noted and pamphlet with information about possible ADR’S and containing contact number of the staff in-charge was distributed among the patients and they were instructed to contact staff if any mild or severe ADR’S was noticed and also staff in-charge himself contacted patients regularly for update of neglected ADR’S and noted information was tabulated ,analyzed using and frequency table with percentage and chi-square test of significance was calculated and causality was assessed using Noranjo scale and severity using modified Hartwig and Siegal scale.Results: The commonest ADRs received were gastritis in 32 (20%) patients, followed by myalgia in 25 (15.6%) and fatigue in 21(13.12%) patients. Major adverse events included chest pain, joint pain, edema, blurring of vision and mental depression. It was surprising that none of the patients reported with any untoward skin reactions. In a small sample of 64 subjects, 160 ADRs were noted and among the ADRs there by received, the statistically significant value obtained was only with that of gastritis (p= 0.025).Conclusions: Incidence of fatal ADR’s in DOTS is none with extremely low incidence of severe ADR’s with only mild to moderate ADR’S reported DOTS is relatively safe in treatment of tuberculosis

A comparative study of the effect of supplementing citicoline with fluoxetine and amitriptyline on learning and memory in albino rats

Background: The prevalence of psychosomatic complaints in children and adolescents has been reported to be between 10% and 25%. In addition, these problems present in a wide range of people across different age groups. Complaints of impaired learning and memory are common in patients treated with drugs acting on the central nervous system including the prototypical antidepressant drugs (AAD) such as fluoxetine and amitriptyline. Concomitant administration of the nootropic drug citicoline may help in the maintenance of cognition through the retention of memory and learning capacity.Methods: Albino rats were used for this study as they are the most standardized of all experimental animals and divided into five groups of six rats each including the control group. The test apparatus used was the Morris water maze which is one of the most widely used tasks in behavioral neuroscience for studying the psychological processes and neural mechanisms of spatial learning and memory. The drugs used in the study were fluoxetine amitriptyline and citicoline. All the rats received respective treatment for the period of 20 days. The experiment was conducted during the last week. During this period, the rats were simultaneously trained and tested for 4 days for learning behavior (i.e. from 14th to 17th day of the study) designated as day 1, day 2, day 3, and day 4. After a gap of 2 days, i.e. on day 20, the rats were tested for the retention of memory on Morris water maze (designated as day 6).Results: There was a statistically significant impairment in learning behavior of the rats in fluoxetine and amitriptyline group when compared to control group (p<0.01 is highly significant) but no such significance was obtained when the groups containing the AADs was supplemented with citicoline. In addition, fluoxetine caused more impairment than amitriptyline and supplemental citicoline was beneficial in retaining the memory and preventing learning impairment, but the combination is more beneficial in the amitriptyline group as compared to the fluoxetine group.Conclusions: Cognition in individuals with depression may be influenced by several factors, including basic neuropathology and the frequency and severity of depressive episodes. The major finding of the present study is that learning was impaired by both the antidepressants, i.e., fluoxetine and amitriptyline but was reversed by citicoline which has a novel mechanism of action