RESUMEN
The pharmacovigilance program of India (PvPI), after its inception, has been reliably acquiring force in bringing issues to light among the masses, healthcare professionals, the pharma industry, and clinical staff at hospitals. Adverse drug reactions are unintended events that occur after exposure to a drug, biological product, or medical device, and they may result in morbidity and mortality. It is critical to monitor the safety of drugs during the post-marketing phase to find long-term and rare ADRs, as well as ADRs in special populations and patients with co-morbidities that are not usually included during clinical trials. The definitive objective of pharmacovigilance is to collate data and analyze it. Assessing the causality between ADRs and drugs is necessary to decrease the occurrence of ADRs and to reduce the risk of drug-related ADRs. ADRs may lead to increased morbidity, increased hospital stays, and increased cost of treatment, resulting in compromised patient safety. Causality assessment is the evaluation of the likelihood that a particular treatment is the cause of an observed adverse event and establishing a causal association between a drug and a drug reaction is necessary to prevent further recurrences. Numerous methods available for establishing a causal association between the drug and adverse events have been broadly classified into clinical judgment or global introspection, algorithms, and probabilistic methods. These include the Swedish method, World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, Naranjo's algorithm, Kramer algorithm, Jones algorithm, Karch algorithm, Bégaud algorithm, Adverse Drug Reactions Advisory Committee guidelines, Bayesian Adverse Reaction Diagnostic Instrument, and so on. Despite various methods available, none of the causality assessment tools have been universally accepted as the gold standard. Naranjo's algorithm and WHO-UMC scales are, however, the most commonly used. Similarly, for preventability and severity assessment of ADRs, the Schumock and Thornton scale and Hartwig and Siegel's scale are most commonly used. Hence, we reviewed different tools and methods available to assess the causality, preventability, and severity of ADRs.
RESUMEN
Background Preeclampsia is a major factor in both maternal and fetal morbidity and mortality. The most widely investigated preeclampsia prevention medication is low dose Aspirin. However, guidelines differ considerably regarding the prophylactic dose of Aspirin for preeclampsia. Objective The objective is to compare the efficacy of 150mg versus 75mg Aspirin for the prevention of preeclampsia in pregnant women at high risk of preeclampsia. Methodology This was a parallel, open-label, randomized control trial carried over a period of one year and three months at a tertiary care center of Eastern India. Block randomization was done and block sizes of 2 and 4 were used to ensure balanced distributions within the study arms. Primary outcome was the development of preeclampsia and secondary outcomes were fetomaternal complications in both groups. Results The present clinical trial was conducted on 116 pregnant women with a risk factor of preeclampsia and they were randomly assigned to receive either 150mg or 75mg of Aspirin daily beginning from 12 to 16 weeks of gestation till 36 weeks' gestation. A significantly greater number of pregnant females who received Aspirin 75mg (33.92%) developed preeclampsia in contrast to those who received Aspirin 150mg (8.77%), p=0.001, OR = 5.341, 95%CI = 1.829-15.594. There was an insignificant difference in fetomaternal outcome among both the groups of women. Conclusion Among women who are at high risk of developing preeclampsia, Aspirin 150 mg once a day at bedtime is more effective than Aspirin 75 mg once a day at bedtime in preventing preeclampsia with similar fetomaternal outcomes (NICU admission, IUGR, neonatal death, still birth, eclampsia, HELLP syndrome, placental abruption and pulmonary edema).