Pharmacovigilance started about 170 years ago, although it was not yet named as such at that time. It is structured activity in the professional health field, with important social and commercial implications aimed at monitoring the risk/benefit ratio of drugs, improving patient’s safety and the quality of life. In this commentary we report the milestones of pharmacovigilance up to the present day, in order to understand all the steps that have characterized the historical evolution; from the first reports, which were essentially letters or warnings sent by clinicians to publishers of important and famous scientific journals, up to today’s modern and ultrastructured electronic registries. The historical phases also help us to understand why pharmacovigilance helped us to achieve such important results for man’s health and for pharmacology itself, and to identify the challenges that await Pharmacovigilance in future years.
Adverse drug reactions (ADRs) are a major concern in clinical practice. Reporting of ADRs either through health care professionals or the patients themselves is of utmost importance to give an accurate estimate of the prevalence, severity and preventability of ADRs. Present study was conducted to evaluate the prevalence of adverse drug reactions in a tertiary care hospital in Hyderabad, Telangana, India. This was a retrospective observational study, extending over 3 months (December 2020 to February 2021). A total of 41 cases comprising patients of either sex or age group were studied. The data was collected using CDSCO ADR reporting form. A total of 41 ADRs were reported during the three months period of study. During the study period a total of 41 ADR reports were received from various departments of the hospital. We observed 25 ADRs in females and 16 ADRs in males from our study. Among the age groups, 3 ADRs in age group 0 – 19 Yrs., 28 ADRs were seen in age group 20 – 59 Yrs., and 10 ADRs were seen in age group >60 Yrs. Maximum number of ADRs came from General Medicine department 17 (41.46%). Drug therapy 41 (100%) and diseases 19 (46.34%) were the most prominent predisposing factors of ADRs seen in our hospital. Causality assessment of suspected drugs was assessed using Naranjo scale. According to Naranjo scale most of the reported ADRs were found to be probable 23 (56.9%) followed by possible 16 (39.02%) and definite 2 (4.8%). The severities of the reactions were done using Hart Wig Scale. Majority of the reactions were mild 25 (60.97%). Withdrawal of the drug 5 (12.19%) was the main line of the management of the adverse drug reactions in the present study. Majority of serious ADRs were preventable in our study. ADRs are a major cause of morbidity worldwide. Frequency of ADRs can be reduced by careful follow up and a robust hospital-based pharmacovigilance setup. A measure to improve detection and reporting of adverse drug reactions by all health care professi
Background. Current pharmacological management for patients with chronic obstructive pulmonary disease (COPD) focuses on inhaled long-acting bronchodilators, which are considered as the recommended first-line treatment option for such patients.Methods. A prospective study was conducted in 70 patients with moderate to severe COPD. Thirty-five patients (Group A) were administered daily glycopyrronium bromide (50μg) and 35 (Group B) received tiotropium bromide (18μg). Patients were assessed for forced expiratory volume in one second (FEV 1 ) score, COPD assessment scale (CAT), modified Medical Research Council (mMRC) scale, body-mass index, airflow obstruction, dyspnoea and exercise (BODE) index for COPD survival for two consecutive follow-ups after every three months of drug use. Results.Group A showed a significant improvement with respect to different evaluation methods compared to group B. Significant results were observed for group A parameters were mMRC (0.0001), CAT (0.01), BODE (0.0001) and FEV 1 (0.03). Conclusions.In patients with moderate to severe COPD, glycopyrronium bromide (50μg) once daily is found to be more beneficial than tiotropium bromide (18μg).
Background: Perioperative pain is an outcome of inflammation produced by tissue trauma or direct nerve injury. Approximately 70% of patients suffer from moderate to severe pain during the perioperative period. The purpose of this study was to compare the effect of NSAIDs with opioids and NSAIDs with TCAs in the perioperative pain management of orthopedic patients. Method: This was a prospective observational study conducted for six months at the Inpatient Unit Department of Orthopedics of tertiary care Hospital. The participants were randomly divided into two groups each consisting of 40 patients. Group I treated with opioids and Group II treated with TCAs. The pain intensity of perioperative patients was assessed using the visual analogue scale (VAS). Pain outcome was evaluated using the pain outcome questionnaire (POQ). Results: A total of 80 participants were enrolled in this study, of which 54% were males and 46% were females. No significant differences in gender and age were observed between two groups (P>0.05). Each group have shown notable improvement in the pain outcome. Both the study groups have disclosed similar levels of patient satisfaction. Combination regimen proved to be more efficacious in both groups compared to individual regimen (p<0.05). Conclusion: We conclude that both opioids and TCAs have similar potential to manage perioperative pain. Frequency of adverse events was more in patients receiving opioids than TCAs. Addition of NSAID in postoperative management should be increased to reduce the dose of opioids. Hence TCAs are of better choice.
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