A pharmacovigilance study of anti-depressant agents in psychiatric patients at a tertiary care teaching hospital

Background: Anti-depressant drugs have great benefit in treating a many psychiatric disorders, including schizophrenia and bipolar disorder, although all these drugs are associated with many potential adverse effects. In this study, the occurrence of adverse effects like weight gain, sleep disturbances, dry mouth were assessed and reported in drug naïve patients Anti-depressant drugs.Methods: It is a prospective observational study of patients attending Psychiatry department in NRI General Hospital of age 10 to 80 years who were prescribed with anti-depressant drugs. The study was conducted for a period of 8 months from June 2018 to February 2018.Results: Among 86 patients prescribed with antidepressants, the occurrence of adverse drug reactions due to antidepressants was 60.78% with Selective serotonin reuptake inhibitors being the most common class of drugs implicated for adverse drug reactions followed by 24.49% with Tricyclic antidepressants. A total of 51 adverse drug reactions were noted of which weight gain was most common, closely followed by sleep disturbances and drowsiness. Out of 52 adverse drug reactions assessed for causality, 88.2% of the adverse drug reactions cases were probable, while 11.7% were possible. According to Hartwig and Siegel’s Scale 84.3% of the cases are found to be mild, 15.68% moderate.Conclusions: The study allows knowing information about the occurrence and pattern of adverse drug reactions associated with Anti-depressant drugs in the population thus reducing its incidence and protecting the user population from available harm.

Medication Therapy Management Services and Pharmacovigilance Studies in Tuberculosis Patients: A Patient Care Aspect in the Pulmonology Department in a Tertiary Care Hospital

Background: Tuberculosis is fundamentally a disease of the lungs, however, it can influence any organ in the body. Objectives: Primary objective was to improve the patient compliance or medication adherence and to identify, detect, monitor ADRs induced by anti-tubercular drugs and report them. A secondary objective was to prevent the emergence of drug resistance and treatment of prolongation/failure in TB patients. Methods: A prospective, observational, cohort study was carried out for 6-months in tertiary care hospital. There were 60 patients included in the study. The data were evaluated for patients’ demographic profile, type of TB, medication adherence and occurrence of ADRs. Adverse drug reactions were observed and recorded. The causality of ADRs was assessed using WHO-causality assessment scale and Naranjo causality assessment scale. The severity of ADRs was determined using Hartwig’s severity assessment scale. Results and Discussion: Total of 60 patients were included in the study. Results showed that among 60 patients included in the study, 44 patients experienced ADRs. Among all age groups, the highest numbers of ADRs were seen in the age group 19-30 (43.1%) years. The occurrence of ADRs was noticed more in females (77.7%). The majority of ADRs occurred in patients was general (28.4%), and gastrointestinal effects (23.8%). Conclusion and Scope of the Study: Adherence to treatment is crucial for the cure of individual patients, controlling the spread of infection, minimizing the development of drug resistance and to reduce the chances of re-infection. Proper therapeutic monitoring of regimen, dose management, and pharmacovigilance activities are necessary. Such approaches will not only improve the treatment outcomes but also minimizes the chances of treatment prolongation/failure. All the health care professionals should interpret their responsibility in this domain of the health care profession.

A retrospective analysis of adverse drug reactions in a tertiary care teaching hospital at Dehradun, Uttarakhand.

Background: Adverse drug reactions (ADRs) are one of the major causes of hospital admissions. The objective of this study was to ascertain the various ADRs occurring in a tertiary care teaching hospital at Dehradun, Uttarakhand. Methods: The ADRs were collected from January 2010 to June 2014 by the Department of Pharmacology in Shri Guru Ram Rai Institute of Medical & Health Sciences, Dehradun, Uttarakhand. A total of 123 ADRs were collected, analyzed and assessed on WHO causality assessment scale. Results: A total of 123 ADRs were assessed. Male:female ratio was 1.5:1. Age-wise distribution of ADRs was done: 0-15 years had 15 (12.19%), 16-30 had 50 (40.65%), 31-45 showed 25 (20.32%), 46-60 years 22 (17.88%) and >60 years had 11 (8.94%). 112 (91.05%) ADRs were serious, and 11 (8.94%) were non-serious. As per the WHO causality assessment scale, 91 (73.98%) ADRs were probable, 30 (24.39%) were possible, and 2 (1.62%) were certain. Most commonly occurring ADRs were fixed drug eruption in 42 (34.14%) patients, erythematous maculopapular rash in 20 (16.26%) patients and urticarial rash in 15 (12.19%) patients, followed by others. The drugs most frequently associated with ADRs were non-steroidal antiinflammatory drugs (NSAIDs), fluoroquinolones, penicillins, cephalosporins and phenytoin sodium, followed by others. Conclusions: Majority of ADRs were probable according to WHO causality assessment scale. Most common ADR was fixed drug eruption. Most frequent drugs associated with ADRs were NSAIDs. ADRs contribute to increased morbidity and mortality in patients; thereby pose a huge burden on the society.

Adverse drug reaction monitoring in psychiatric outpatient department of a Tertiary Care Hospital.

Background:Pharmacovigilance in psychiatry units can play vital role in detecting adverse drug reactions (ADRs) and alerting physician to such events, thereby protecting the user population from avoidable harm. Objective: To assess the suspected ADRs profile of psychotropic drugs in psychiatry OPD of a tertiary care hospital and its comparison with available literature data as well as to create awareness among the consultant psychiatrists to these ADRs profile. Materials and Methods: A prospective study was conducted in the psychiatry OPD. Thirty five consecutive patients per day were screened irrespective of their psychiatric diagnosis for suspected ADRs on 3 fixed days in a week from January 2011 to December 2011. CDSCO form was used to record the ADRs. Causality was assessed by WHO causality assessment scale while severity was assessed using Hartwig and Siegel scale. Results: Out of 4410 patients were screened, 383 patients were suspected of having at least one ADR. Thus, 8.68 % of our study population reported ADRs. Of 407 events recorded, 369(90.60%) were “probable” and rest “possible” according to WHO-UMC causality assessment scale. According to Hartwig and Siegel scale, 268 ADRs (65.85%) were “moderate” category. Twenty one different kinds of ADRs were noted. Conclusion: This study enables to obtain information on the incidence and frequency of ADRs in the local population that allows opportunity for education to the physicians to improve the patient’s quality of life.