RESUMO
Background: Adverse drug reactions (ADR) are the leading cause of mortality and morbidity in all health care systems. Hospital based ADR monitoring and reporting programmes can throw some light upon the profile of ADRs and ways to prevent them, facilitating rational drug use. An attempt has been made in this study to analyse the seriousness, predictability, preventability, severity and outcome of ADRs occurring in a tertiary care hospital.Methods: This was a retrospective observational study based on the data collected from ADRs reported to an approved ADR monitoring centre (AMC). Data collected was evaluated for seriousness, predictability, preventability, severity and outcome using appropriate scales. Simple descriptive statistics was used for analysis.Results: The total number of ADRs reported was 300. Among this 39% reactions were serious. The commonest reason for considering as serious reaction was prolongation of hospitalization. The overall predictability was 40.4%. Total preventability was found to be 18.3%. Assessment of severity showed 55.3 %, 41.7%, 3% reactions in mild, moderate and severe grades respectively. 64.3% patients had recovered from the reaction and 30% were recovering at the time of reporting ADR. Only 0.3% ADRs caused death.Conclusions: Authors hope this study will foster the culture of reporting and analysing ADRs among health care professionals and students. The findings from the study can create awareness among health care professionals regarding the impact of ADRs on the treatment course.
RESUMO
Background: Adverse drug reactions (ADRs) are an important concern in modern therapeutics. Due to limitations in identifying ADRs during research phase, organized post marketing studies are essential. However, there are only few recent studies on this subject available in India. Hence this study was done in a tertiary care hospital in South Kerala to evaluate the profile and causality of ADRs.Methods: The details of patients who developed ADRs during the period from October 2016 to November 2017 were collected. Data collection was done using the suspected drug reactions monitoring form by CDSCO used under PvPI and a retrospective observational cross-sectional analysis was done. The profile and causality of ADRs were evaluated.Results: The total number of ADR events reported was 300. 179 ADRs were hypersensitivity reactions (Aronson Type B) and the remaining 121 reactions were Type A reactions. The individual drug class causing majority of the ADRs was antibiotics (36%). Commonest significant dose related ADR was bleeding (7%) caused by combined use of antiplatelets and anticoagulants. The organ system most affected as per SOC classification was skin and appendages (56%). Causality assessment revealed that majority (76%) belonged to “probable” category, whereas 23.6% were of “possible” type.Conclusions: The development of ADRs can significantly affect treatment course – interruption of drug therapy, use of additional drugs and prolonged hospital stay. Employing monitors dedicated to ADR detection and education of prescribers to closely monitor patients can help manage ADRs effectively.