Search

Background & Objectives: Drug-induced diseases (DIDs) are well known but least studied. Data on DIDs from India are not available. Hence, this retrospective cross-sectional study was undertaken using suspected adverse drug reaction (ADR) data collected form Pharmacovigilance Programme of India (PvPI) to evaluate profile of DIDs over two years, in a tertiary care teaching hospital from north India., Methods: The suspected ADRs in the form of DID were evaluated for drug and disease related variables and were classified in terms of causality., Results: DID rate was 38.80 per cent. Mean duration of developing DIDs was 26.05 ± 9.6 days; 25.16 per cent had more than one co-morbid condition. Geriatric population (53.99%) accounted for maximum DIDs followed by adult (37.79%) and paediatric (8.21%). Maximum events were probable (93.98%) followed by possible (6.04%). All DIDs required intervention. Gastritis (7.43%), diarrhoea (5.92%), anaemia (4.79%), hypotension (2.77%), hepatic dysfunction (2.69%), hypertension (1.51%), myalgia (1.05%), and renal dysfunction (1.01%) were some of the DIDs. Anti tubercular treatment (ATT), anti retroviral treatment (ART), ceftriaxone injection, steroids, non-steroidal anti-inflammatory drugs, antimicrobials and anticancer drugs were found as commonly offending drugs., Interpretation & Conclusions: Our findings show that DIDs are a significant health problem in our country, which need more attention.

Aim of Study: To evaluate adverse drug reaction (ADR) profile of antimicrobials over 3-year period., Material and Methods: A retrospective cross-sectional study was undertaken using suspected adverse drug data collection form available under Pharmacovigilance Programme of India (PvPI)., Results: A total of 2,586 ADR events were recorded in 3 years, out of which 392 (15.15%) were because of antimicrobials. Male: female was 1.02:1. Medicine department contributed maximally (98.97%). The intravenous (IV) route of drug administration accounted maximum ADRs (53.32%), followed by oral route (45.41%). Monotherapy was responsible for 80.87%, whereas combination therapy for 19.13%. Combinations therapy was irrational in 79.67%. The most common antibiotic resulting in ADRs was injection ceftriaxone (35.71%), followed by tab. azithromycin (7.39%), tab. ofloxacin+ornidazol (5.35%), ofloxacin (3.57%), ciprofloxacin (2.29%), amoxicillin (2.55%), tab. cefixime (2.29%), inj. linezolid (2.04%). Rash remained the most common ADR, followed by diarrhoea and gastritis. Most common organ system involved was dermatological (47.44%), followed by gastrointestinal (GI) (39.28%), central nervous system (CNS) (5.35%), cardiovascular system (CVS) (3.57%) and renal and genitourinary (1.78%). While 47.96% ADR's were latent, 26.785% were acute and 25.26% were sub-acute. Moreover, 89.79% of ADRs were moderate in nature, whereas 26.88% were severe and 3.33% mild in nature. Furthermore, 92.86% were non-serious and 7.14% serious in nature. Also, 65.06% of antimicrobial caused ADRs were type A and 34.64% were type B reactions. As per World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) scale, 73.98% of ADRs were probable/likely and 26.02% as possible. However, 99.47% of ADRs required intervention., Conclusion: The current study suggest that ADRs due to antimicrobials is a significant health problem.

Aim: The aim was to evaluate the extent and factors responsible for underreporting (UR) of adverse drug reactions (ADRs) in India., Materials and Methods: A retrospective observational, cross-sectional prospective questionnaire-based analysis was undertaken to evaluate the extent and factors for UR of ADRs in pharmacovigilance., Results: At the time, this report was prepared, 90 ADR Monitoring Centers (AMC) were operational in India. Indian AMC functional rate was 56.45%. The average number of Individual Case Safety Reports reported by our center via VigiFlow per month was 48.038. In a period of the 3 years the total number of ADRs reported was 3024. The average number of reports per month was 80.08. Active surveillance versus spontaneous reporting contributed 66.13% versus 33.86% of the total ADRs (P < 0.0001). Outpatient Department (OPD) contribution was 76.05% and indoor contribution was 23.94% of total reports (P < 0.0001). Department of Medicine (33%), followed by oncology (19.27%) and chest disease (13.49%) contributed maximally. The contribution of Pharmacology ADR monitoring OPD was 16.20%. Eye, ear, nose and throat and surgery, private Medical Colleges, hospitals in periphery, sub-district and district contributed no ADRs. ADR detection rates by clinical presentation, biochemical investigation and diagnostic tools were 84.33%, 14.57%, and 1.09% respectively (P < 0.0001). Reporting by postgraduate, registrars, consultants and nurses were 72.65%, 6.58%, 16.56% and 4.19% respectively (P < 0.0001). PG students in Pharmacology contributed an average number of 5.61 ADR reports/month. The lack of knowledge and awareness about Pharmacovigilance Programme of India (PvPI), lethargy, indifference, insecurity, complacency, workload, lack of training were the common factors responsible for UR. Major academic activity, exams, thesis and synopsis submission time influenced reporting of ADRs by postgraduate students., Conclusion: UR is a matter of concern PvPI. Multiple interventions are needed to improve ADR reporting.