Incidence of adverse drug reactions in patients taking anti-tuberculosis treatment

Background: High incidence of infection has caused a large number of morbidity and mortality which is partly due to serious adverse reactions induced by Anti-Tuberculosis (Anti-TB) drugs. In present prospective study an attempt is made to estimate the incidence and risk factor for ADRs among patients treated for tuberculosis.Methods: All the new patients starting their treatment with selected six DOT center were enrolled in study. All patient's complete clinical history was recorded. They were followed regularly for occurrence of ADR till end of their treatment.Results: Total of 108 patients (67 male and 41 female) had taken and completed their treatment during the study period (March 2007 - April 2008) and were observed for occurrence of ADR during their treatment period. Out of total108, 28 patients (25.9%) experienced one of the ADR, out of 28 patients, 12 (42.85%) patients developed GIT intolerance, and hepatitis was seen in 8 (28.57%) patients, while 4 (14.48%) patients developed skin reactions. Only 3 (7.14%) patient developed dizziness and loss of balance, which was relieved by reduction of dose of streptomycin.Conclusions: With close monitoring and on time action, RNTCP DOTs regimens can be safely and successfully administrated.

A study of prescribing pattern of antihypertensive drugs in hypertensive patients with co morbid diabetes in a tertiary care teaching hospital

Background: Hypertension and diabetes mellitus are among the commonest non-communicable diseases. Co-existence of hypertension and diabetes increases morbidity and mortality. So co-existence of these diseases requires attention and rational management. Studying current prescribing pattern of drugs provide data for recommendations and decisions regarding rational practice. We undertook this study to study prescribing pattern.Methods: It was cross sectional, observational, descriptive study in outdoor patients suffering from hypertension and type 2 diabetes mellitus for duration of one year. Data of 601 patients were analyzed using descriptive statistics to determine prescribing pattern of drugs.Results: In this study, 71.55% patients were above 50 years age. Female patients were 56.57%. Average duration of hypertension was 4.08 years. Commonly prescribed antihypertensive drug groups were angiotensin converting enzyme (ACE) inhibitors (85.36%) followed by ? receptor blockers (33.44%) and calcium channel blockers (29.95%). Enalapril (85.36%) followed by amlodipine (29.95%) and atenolol (21.46%) were commonly prescribed antihypertensive drugs. Single antihypertensive drug was prescribed in 292 (48.59%) prescriptions. The most common monotherapy drug was enalapril (82.19%). Two antihypertensive drugs were prescribed in 231 (38.43%) prescriptions. The most common two drug combination was ACE inhibitors + ? receptor blockers (40.69%). Four antihypertensive drugs were prescribed in only 1.50% prescriptions.Conclusions: From this study, the results suggest that the prescribing pattern of antihypertensive drugs reflects recommendations of current guidelines and practices. However, ? receptor blockers were prescribed more commonly. There is room for improvement in choice of drugs.

A study of utilization pattern of drugs in HIV positive patients at antiretroviral therapy centre of a tertiary care teaching hospital

Background: Infection with human immunodeficiency virus (HIV) and subsequent acquired immunodeficiency syndrome (AIDS) continues to be a major public health problem. Treatment and therapeutic guidelines have evolved over a period of time. Drug utilization study helps to evaluate changing pattern of drug use, compliance with national guidelines and rational use of drugs.Methods: Authors conducted observational, non interventional, descriptive study in outdoor HIV positive patients for one year. We have analysed collected data using descriptive statistics to determine drug use indicators and utilization pattern of drugs.Results: Study showed that average number of drugs per encounter was 3.96. The most commonly prescribed antiretroviral therapy (ART) regime was combination of zidovudine, lamivudine with nevirapine (51.92%). Among antiretroviral drugs prescribed, nucleoside reverse transcriptase inhibitors (49.45%) were the most common drug subclass and lamivudine (33.33%) was the most common antiretroviral drug. Second most common medication class was antibacterial agents (18.77%) and co-trimoxazole (10.11%) was the most common antibacterial agent. The third most commonly prescribed drug class was vitamins namely folic acid and multivitamins (2.63 %). Percentage of encounters with an antibiotic prescribed was 41.46%. Tuberculosis was the most common opportunistic infection. In 90.05% of encounters with ART prescriptions, adherence was more than 95%.Conclusions: Overall the results suggest that the prescribing pattern to be in accordance with national guidelines and reflect changing patterns of drug usage in HIV positive patients in World. Drug use indicators reflect rational approach to prescribing pattern.

Adverse drug reaction monitoring on antiretroviral therapy in human immunodeficiency virus patients in a tertiary care hospital.

Background: The aim of current study was to assess the pattern of adverse drug reactions (ADRs) in patients receiving antiretroviral (ARV) therapy. Methods: A prospective, observational study was carried out for duration of 15 months. Clinical and treatment data were collected from patients, who underwent ARV therapy during the study period. CDSCO forms were used to record the ADRs. Causality, severity and preventability were assessed by suitable scales. Result: Out of 216 patients 165 (76%) patients develop ADRs. Total of 274 ADRs were noted among 165 patients (1.66 ADR/patient). Out of them 100 (60.60%) were males and 65 (39.39%) were females. The most common ADR was gastrointestinal disorders (83, 30.29%). The most numbers of ADRs were observed in ZLN (Zidovudine + Lamivudine + Nevirapine) regimen (54%) followed by SLN (Stavudine + Lamivudine + Nevirapine) regimen (26%). According to WHO causality assessment scale most ADRs were possible (236, 86.13%). Hartwig and Siegel severity scale show 243 (88.69%) ADRs were moderate. Schumock and Thornton scale show all, ADRs were “not preventable.” Conclusion: Early detection of drug toxicity helps to treat the patient and modify the drug regimen to minimize toxic effects.

Drug utilization pattern of antiseizure drugs and their adverse effects in the pediatric population, in a tertiary care hospital attached to a medical college.

Background: Epilepsy is “a condition characterized by recurrent (two or more) seizure, unprovoked by any immediate identifi ed cause.” The desired outcome of antiseizure drug (ASD) therapy is to be seizure-free throughout the rest of life. The objective was to study the utilization pattern and adverse drug reactions (ADRs) associated with the use of ASDs in pediatric outpatients in epilepsy clinic. Methods: This cross-sectional, observational and single center study was carried out over a period of 1 year in 430 pediatric patients. Analyzed data included demographic details and drugs prescribed in respective seizure types along with ADRs due to ASDs. Results: In a total 430 patients analyzed, seizure were most commonly observed in boys (69.8%) in 6-10 year of age (45.3%), with a positive family history in (16%), with no specifi c cause of seizure in (71.6%), with most common type was focal seizure in (62.3%), which was mainly treated with carbamazepine (73.8%). Most common ADR was irritability (32.2%) with Valproate being main drug. 87.3% ADRs were in “ possible” as per World Health Organization causality assessment scale, 94.9% ADRs were “mild” as per Hartwig and Siegel severity assessment scale and 98.3% ADRs were “preventable” as per Schumock and Thornton preventability scale. Conclusion: Focal seizure was most common type of seizure observed mainly in boys of 6-10 year with carbamazepine as mainly prescribed drug. Use of appropriate ASDs in the majority of patients as per guidelines, has decreased number of ADRs in our study. Prescribing drugs were mainly from essential drug list and by generic names.

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.

Pattern of adverse events following immunization in an Indian teaching hospital.

Background: Vaccination is an essential component of the public health programs and among most cost effective medical intervention. Vaccines like other pharmaceutical product are not entirely risk free; while most known side effects are mild and non-serious. But some vaccines have been associated with very rare but serious side effect. So, there is a need of a surveillance program to monitor and record such events. Aims & Objective: To detect adverse events following immunizations (AEFI) in children and find vaccine responsible for them. Material and Methods: A one year, prospective, vaccine safety study was undertaken in 2011 covering a pediatric population who were administered vaccines. A two-phase telephone survey of all patients was conducted, comprising of an initial call at 1 week and a follow-up call at 30 days after the vaccine administration date. All AEFI were recorded in Vaccine Adverse Event Reporting System (VAERS) form. Results: Of a total sample of 4320 children, ranging in age from 0 to 14 years, 10110 vaccine doses were given. Each child received 2.34 vaccines on an average. Out of 4320 children, 899 children (20.8%) suffered 1003 AEFI. The most frequent types of adverse reactions to vaccines were fever (34.33 per 1000 doses), excessive crying (30.95 per 1000 doses) and injection site swelling (18.57 per 1000 doses). AEFI rate per 1000 doses was 99.2%. Conclusion: Most of the adverse events reported were mild and non-serious. Establishment of national AEFI database can be a worthy long term goal in Indian context.