Adverse drug reaction monitoring in patients on antiretroviral therapy in a tertiary care hospital in Eastern India

Background: Fixed dose combinations are widely used in India, they are either irrational or prescribed irrationally. Moreover, the government has recently banned over 300 fixed dose combinations (FDCs) because of a lack of therapeutic justification. This study was conducted to study the prescribing pattern of FDCs in a tertiary care teaching hospital and to highlight the rationality of FDCs, and adverse drug reactions (ADRs) associated with them.Methods: In the present prospective observational study, a total of 500 inpatients were evaluated for prescribing pattern, cost analysis, and adverse drug reactions (ADRs) of FDCs. The FDCs were assessed for their rationality. The ADRs and severity were assessed using the WHO causality scale, Hartwig severity scale respectively.Results: Out of total 103 FDCs, 58 were approved, 86 were rational and 17 were irrational. 5 FDCs were banned and irrational. 48.54% of rational FDCs had rationality score from 7 to 9. The most commonly prescribed FDCs belonged to the anatomic therapeutic and chemical class of respiratory system, followed by the in younger age group and cardiovascular FDCs in the elderly. The 886 ADRs occurred in 500 patients with a mean of 1.81±1.9. Banned FDCs contributed to 76 ADRs. According to causality and severity assessment, most of the ADRs were possible (62.53%) and mild (70.77%) respectively.Conclusions: Although FDCs were rational in most cases but banned FDCs were also prescribed. As these FDCs were associated with ADRs, monitoring of patients is necessary. Knowledge and attitude of healthcare professionals can be assessed through awareness programs.

Section: Discussionsupporting

confidence: 86%

Evaluation of prescribing pattern and rationality of fixed dose combinations in patients of general medicine department

Joshi¹,

Falke²,

Saji³

et al. 2019

“…Tenofovir based regimen was found to be milder with regard to Haematological ADRs compared to Zidovudine based regimens (ZLN /ZLE). 3 Present study has also reported renal adverse events as renal failure, acute kidney injury and nephrotoxicity and also gastrointestinal ADRs. The ADRs due to efavirenz were largely nonspecific with some patients showing raised serum transaminase levels suggestive of hepatotoxicity.…”

Section: Figure 4: Severity Assessment Of Reported Adverse Drug Reactmentioning

confidence: 52%

“…2 Antiretroviral drugs mainly suppress viral load and thus restoring the immune function. 3 In India, NACO has made efforts to make generic HAART available which is very economical due to which many HIV infected individuals are receiving the therapy. 4 Many studies in the developing countries have demonstrated the safety tolerability and efficacy of generic HAART.…”

Section: Introductionmentioning

confidence: 99%

“…The incidence of ADRs among patients on antiretrovirals from both developing and developed countries is ranging between 11% and 35.9% with incidence being as high as 54% co-existent with opportunistic infections. 3 So continuous evaluation will benefit the ART that helped to achieve ultimate goal of making treatment more safe and effective to the patients and early modification of drug regimen to improve patient compliance and tolerability to the therapy.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of adverse drug reactions of first line antiretroviral drugs in a tertiary care centre of Telangana, India

Gabbita

Jillapegu

Vangala

et al. 2018

Background: The introduction of highly active anti-retroviral therapy (HAART) has led to a significant reduction in AIDS related morbidity and mortality. Most of the adverse drug reactions are preventable. So continuous evaluation will benefit Antiretroviral treatment that helped to achieve ultimate goal of making treatment safer and more effective to patients. The present study was designed to monitor and analyse the incidence, type and nature of adverse events to first line Antiretroviral drugs.Methods: A cross sectional observational study was conducted at Antiretroviral treatment center of Gandhi Hospital, Secunderabd, Telangana. The study was conducted over a period of 6 months involving all HIV patients. After initiation of 1st line regimen- tenofovir 300mg + lamivudine 300mg + efavirenz 600mg (TLE), patients were followed for any adverse event. Descriptive statistics was used for analysis of data.Results: Out of 453 studied, 47 patients developed adverse events. A total of 79 adverse events were reported. The assessment of total adverse drug reaction profile revealed cutaneous 44.30%, hematological 40.50%, renal 11.39%, gastrointestinal 3.79%. WHO-UMC causality assessment scale showed 76.5% and 23.4% Adverse events as probable and possible respectively. Hartwig and Siegel severity scale revealed 93.6%, 2.1% and 4.3% as mild, moderate and severe cases respectively.Conclusions: The TLE regimen found with lower adverse events in this study. The study focuses the importance of active adverse event monitoring to detect early toxicities and to support safe use of anti-retroviral treatment.

“…1 The presentation of this treatment in the created nations in the late 90s and the ensuing advancement in giving its availability all around has been related with a striking abatement in AIDS-related mortality, which has changed the standpoint of HIV infection from being a quickly lethal to an incessantly reasonable infection. 2,3 Antiretrovirals mainly suppress viral load, in this way re-establishing the insusceptible capacity. Declining expenses of antiretrovirals alongside the generation of medications by bland producers has helped tertiary care centers in resource limited territories cook better antiretroviral care to HIV-seropositive population.…”

Section: Introductionmentioning

confidence: 99%

A study on adverse drug reactions in patients on antiretroviral therapy in a tertiary care hospital

Gungam

Yadav

Junapudi³

2018

Background: Besides unparalleled advantages, exceptionally dynamic antiretroviral treatment is additionally connected with extensive variety of potential adverse drug reactions (ADRs), which prevents treatment adherence. The present study is intended to screen and monitor the event of ADRs to different antiretroviral treatment (ART) regimens in a tertiary care ART setup.Methods: A prospective, longitudinal observational study was done in the outpatient setting of nodal ART center, Osmania General Hospital. A sum of 525 patients on different ART regimens were examined for ADRs more than year and a half. Adverse event history, prescription history and other significant subtle elements were captured. Causality and seriousness of each announced ADR were surveyed.Results: 37.33% patients of aggregate members gave a sum of 330 ADRs. Patients from zidovudine-based regimens presented with majority of ADRs such as anemia, central nervous system (CNS), and gastrointestinal (GI) side effects. Tenofovir-based regimens were, be that as it may, observed to be somewhat more secure. The blend with Efavirenz was related with significant CNS reactions while that of Nevirapine was related with rash and pigmentation of nails. Atazanavir supported second-line regimens were quite connected with expanded serum lipid levels taken after by other GI and CNS unfavourable impacts. Expanded liver compounds were found in atazanavir-based second-line ART.Conclusions: The study enables to obtain in sequence on the incidence and pattern of ADRs associated with various antiretroviral regimens, thereby reducing its occurrence and protecting the patient population from avoidable harm. Need of intensive monitoring for ADRs in ARTs along these lines is by all accounts an order.