A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital

Background: No pharmacotherapeutic agent is completely free from noxious and unintended effects and thus adverse drug reactions (ADRs) are inevitable consequences of drug therapy. Incidence of ADRs in Indian population ranges between 1.8% and 25.1%. However, ADR reporting in India is inadequate. Developing awareness inpatients and healthcare professionals (HCPs) will help in reducing the ADRs, its suffering and socioeconomic impact. Hence, the present study of ADR monitoring in the outpatients and inpatients of the medicine department in a tertiary care hospital is undertaken. The main objective of this study was to assess the ADR reporting patterns in outpatient and inpatient of medicine department. The study was also aimed to assess the causality, severity, and preventability of these ADRs and comparison between spontaneous reporting by HCP and patient self-reporting of suspected ADRs.Methods: This study was a prospective observational study conducted in 111 consecutive patients who experienced ADRs in the department of medicine. The study plan included analysis and assessment of the clinical pattern, spectrum of ADRs reported based on causality, severity, preventability factors. The impact of ADRs on emotional, occupational, and social life of patients was evaluated. The assessments were compared between patient reporting and HCP reporting of ADRs.Results: The clinical spectrum of ADRs ranged from the more common mild reactions such as skin rashes, itching, nausea, and vomiting to moderately severe reactions prolonging the hospital stay. The predominant causative drugs were antimicrobials, antiretrovirals, non-steroidal anti-inflammatory drugs and antihypertensives. The majority of ADRs were probable in causality assessment, moderate in severity and probably preventable. Comparison of ADR reporting between patient and HCP revealed that ADRs reported by patient’s been less in incidence, similar in qualitative analysis to HCP with very elaborative narration and highlighted emotional and occupational impact due to ADRs than HCP reports.Conclusion: A wide range of ADRs are possible in medicine department. Adequate awareness of ADR reporting and precautions, while prescribing drugs are essential. Including patients as additional reporters of suspected ADR may add to the benefit of pharmacovigilance

Impact of educational session on knowledge and attitude towards teratogenicity among undergraduate medical students: a comparative study

Background: Teratogenicity is a major cause of abortion, still birth and can result in longterm disability with a significant impact on individuals, families, societies and healthcare systems. Drugs being one of the causes of teratogenicity, creating awareness among medical students, the future prescribing physicians, the rate of teratogenicity can be decreased. The objective was to compare the attitude and knowledge about teratogenicity among the medical undergraduates before and after an educational session on teratogenicity.Methods: A pre-validated semi structured questionnaire on attitude and knowledge about teratogenicity was distributed to 2nd year medical students (147) before and after teratogenicity educational session. Results obtained were compared within the group. Paired t test was used for within the group comparison. P-Value <0.05 was considered to be statistically significant.Results: Improvement in knowledge showed statistically significant improvement following teratogenicity educational session (P-Value=0.0003). Improvement was there in post session attitude scores as well, however, it was not significant (P-Value=0.64).Conclusions: Early reinforcement about teratogenicity in medical students enables them to decide appropriate drug therapy while prescribing for females of reproductive age group

Adverse drug reactions in paediatric patients in a tertiary care hospital in India: a prospective observational single centre study

Background: Adverse drug reactions (ADRs) are a major source of concern in adult and paediatric population. Monitoring ADRs in children is vital as they differ from adults in pharmacokinetic and pharmacodynamics responses. Strict ethical guidelines in clinical trials result in extrapolation of data from studies done in adults. Further, ADRs reported in adults do not predict those in children. Incidence of ADRs in children is 2.9% emphasizing the need for systematic monitoring. Studies at institutional level can generate valuable data among paediatric population. Hence, the current study was taken up to assess the clinical pattern of ADRs, their causality, severity and preventability.Methods: This is a prospective observational single centre study. Suspected cases of ADRs were collected and assessed for the clinical pattern, causality, severity and preventability factors along with gender-wise distribution.Results: A total of 118 ADRs were reported in our study. Most of the ADRs (46.67%) occurred below 1 year of age with male preponderance (53.4%). Skin was the most common organ involved (91.5%). Majority (78.8%) of ADRs were due to anti-infectives for systemic use (J). Vaccines were the most commonly implicated agents (55.9%) followed by antibiotics (22.9%). Severe reaction like DRESS syndrome was reported due to antiepileptics (including levetiracetam) requiring hospitalisation. Majority of ADRs were probable (92.4%), moderate (73.7%) and definitely preventable (61%).Conclusions: A wide range of ADRs are possible in paediatric population. Adequate knowledge about ADRs is essential and caution has to be exercised even while prescribing drugs which are considered safe in children