Current pattern of adverse drug reactions to anti-retroviral therapy in an antiretroviral therapy centre attached to a government medical college of Maharashtra, India: a retrospective study

Background: Adverse drug reactions (ADR) are rated as fifth leading cause of death and accounts for approximately 5% of all hospital admissions. Under reporting of ADR from healthcare professional is considered as the contributing factor for increased morbidity and mortality. India has taken well appreciated step to launch Pharmacovigilance Programme of India (PvPI) to safeguard heath care of Indian population. This study looks into the detailed analysis of ADR reported to adverse drug reaction monitoring centre (AMC), Government Medical College, Trivandrum to assess its pattern, causality, severity and seriousness of ADR. Primary objectives of this study are the pattern of adverse drug reactions reported to ADR monitoring centre (AMC) and secondary objective is to assess causality, severity.Methods: A record based descriptive study was conducted in the ADR monitoring centre of government medical college, Trivandrum, Kerala from September 1st 2016 to February 2017(6 months). The data were collected from the all reported case records/ ADR report form of CDSCO. The details of the various adverse drug reactions were identified and analysed to find the pattern of adverse drug reactions including distribution of age, gender, causal drug group, system organ class. Also, an attempt is made to do causality assessment using WHO UMC scale and severity by using Heart wig Seigel Scale.Results: Out of 320 ADR cases, majority of reports were due to cutaneous manifestations. Most common ADRs were erythema, induration, and rash, itching. Females were 56% and males were 44%. Majority cases were of adult age group. Causality 91.88% were probably related, 75.6% were mild reaction. 25% of cases were serious. 77.5% were recovered. Antibacterial implicated 25(7.8%) followed by anti-epileptics 24 (7.5%) ADR.Conclusions: The pattern of adverse drug reactions reported to this AMC is comparable to the studies done in other parts of country. A strong need for streamlining of ADR monitoring system and reporting reemphasized by this study, which will promote the ADR reporting in healthcare professionals.

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Retrospective clinical analysis of adverse drug reactions associated with antiretroviral therapy in Tlokwe district, South Africa

South African Family Practice ◽

10.1080/20786190.2017.1364013 ◽

2017 ◽

Vol 60 (1) ◽

pp. 31-36

Author(s):

Rentia van Graan ◽

Michelle Viljoen ◽

Malie Rheeders ◽

Fadeela Motara

Keyword(s):

South Africa ◽

Antiretroviral Therapy ◽

Adverse Drug Reactions ◽

Clinical Analysis ◽

Drug Reactions

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Frequency and nature of adverse drug reactions in elderly in-patients of two Indian medical college hospitals

Journal of Postgraduate Medicine ◽

10.4103/0022-3859.85201 ◽

2011 ◽

Vol 57 (3) ◽

pp. 189 ◽

Cited By ~ 16

Author(s):

G Parthasarathi ◽

S Guido ◽

A Harugeri ◽

M Ramesh ◽

H Basavanagowdappa

Keyword(s):

Adverse Drug Reactions ◽

Drug Reactions ◽

Medical College ◽

Indian Medical

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A prospective observational pharmacovigilance study of adverse drug reaction monitoring in patients of MDR-TB at tertiary care hospital

International Journal of Basic & Clinical Pharmacology ◽

10.18203/2319-2003.ijbcp20182671 ◽

2018 ◽

Vol 7 (7) ◽

pp. 1291

Author(s):

Mirza Shiraz Baig ◽

Monali Raghunath Kale ◽

Avinash Lamb

Keyword(s):

Adverse Drug Reactions ◽

Health Care Professionals ◽

Tertiary Care Hospital ◽

Tertiary Care ◽

Public Health Problem ◽

Treatment Withdrawal ◽

Care Hospital ◽

Drug Reactions ◽

Medical College ◽

Mdr Tb

Background: The emergence of drug resistant mycobacteria has become a significant public health problem world over creating an obstacle to effective TB control. ADRs are common in patients of MDR-TB on DOTs-Plus drug regimen. Present study was carried out in tertiary care hospital. Identification of types and frequency of adverse drug reactions in Intensive and continuation phase of MDR-TB Patients.Methods: It was a prospective observational study conducted in Department of TB- Chest and Medicine, Govt. Medical College, Aurangabad, Maharashtra, India. All the MDR-TB patients admitted at the directly observed treatment, short course plus (DOTS plus) Center at Medical College Hospital were enrolled and were monitored for ADRs. The causality and severity of the reactions were determined using Naranjo algorithm and Hartwig questionnaire, respectively.Results: A total of 121 tuberculosis patients of MDR-TB on DOTS therapy were enrolled for the study. Out of 121 patients, 13 were dropouts, 6 died, 7 defaulted so 108 patients assessed for ADRs, 48 patients developed 61 (56.48%) adverse drug reactions. The higher numbers of ADRs were observed in age group 31-40yrs followed by 21-30yrs which were more common in men. Majority of adverse drug reactions were Gastrointestinal (GI) problems 32 (52.45%), followed by Ototoxicity 7 (11.48%) and Psychiatric Manifestations 6 (9.84%) and skin problems 3 (4.92%). On evaluation of the causality of ADRs, majority were found to be Possible (59.02%). The severity assessment showed that most of the patients ADRs were of moderate level (50.82%).Some patients required treatment withdrawal and replacement with other drug and most of the patients were managed with supportive medication without removing anti-tubercular drug from their treatment regimen.Conclusions: ADRs are major factor limiting completion of drug therapy under RNTCP and occurrence of drug resistance which requires attention of all health care professionals.

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PIN102 - IMPACT OF DEPRESSION AND ITS ASSOCIATION TO HIGHLY ACTIVE ANTIRETROVIRAL THERAPY ADHERENCE AND ADVERSE DRUG REACTIONS IN PEOPLE LIVING WITH HIV IN INDIA

Value in Health ◽

10.1016/j.jval.2018.09.1420 ◽

2018 ◽

Vol 21 ◽

pp. S237

Author(s):

R. Rajesh ◽

R. Radhakrishnan ◽

D.V. Muralidhar ◽

V. Sudha

Keyword(s):

Antiretroviral Therapy ◽

Adverse Drug Reactions ◽

Highly Active Antiretroviral Therapy ◽

People Living With Hiv ◽

Drug Reactions ◽

Therapy Adherence ◽

Highly Active ◽

Antiretroviral Therapy Adherence ◽

Living With Hiv

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Adverse Events Associated with Nifurtimox Treatment for Chagas Disease in Children and Adults

Antimicrobial Agents and Chemotherapy ◽

10.1128/aac.01135-20 ◽

2020 ◽

Author(s):

A. J. Berenstein ◽

N. Falk ◽

G. Moscatelli ◽

S. Moroni ◽

N. González ◽

...

Keyword(s):

Retrospective Study ◽

Adverse Events ◽

Chagas Disease ◽

Adverse Drug Reactions ◽

Drug Tolerance ◽

Drug Reactions ◽

Safety Concerns ◽

Scarce Data

BACKGROUND: Nifurtimox (NF) is one of the only two drugs currently available for Chagas disease (ChD) treatment. However, there is scarce data on NF safety, and many physicians defer or refuse NF treatment because of concerns about drug tolerance. METHODS: Retrospective study of adverse drug reactions (ADRs) associated with NF treatment of ChD. Children received NF doses of 10-15 mg/kg/day for 60-90 days, and adults 8-10 mg/kg/day for 30 days. Results: 215 children (median age: 2.6yrs, range 0-17) and 105 adults (median age: 34yrs, range 18-57) were enrolled. Overall, 127/320 (39.7%) patients developed ADRs, with an incidence of 64/105 in adults, and 63/215 in children (OR = 3.7, 95%CI [2.2;6.3]). We observed 215 ADRs, 131 in adults (median: 2 events/patient (IQR25-75= 1-3) and 84 in children (median: 1 event/patient (IQR25-75= 1-1.5) (PAdjusted < 0.001). ADRs were mainly mild and moderate. Severe ADRs were infrequent (1.2% in children and 0.9% in adults). Nutritional, central nervous and digestive systems were the most frequently affected, without differences between both groups. Treatment was discontinued in 31/320 (9.7%) patients without differences between groups. However, ADR-related discontinuations occurred more frequently in adults than in children (OR = 5.5, 95%CI = [1.5;24]). CONCLUSIONS: Our study supports the safety of NF for ChD treatment. Delaying NF treatment due to safety concerns does not seem to be supported by the evidence.

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Pattern of adverse drug reactions reported to the regional Pharmacovigilance center at Nepal Medical College and Teaching Hospital, Kathmandu

Journal of Nepal Pharmaceutical Association ◽

10.3126/jnpa.v26i1.6633 ◽

2012 ◽

Vol 26 (1) ◽

pp. 54-61 ◽

Cited By ~ 1

Author(s):

Durga Bista ◽

Bal Ram Shrestha ◽

Prakash Rai ◽

Akhilesh Chandra Jauhari ◽

Vishnu Kant Kulshrestha

Keyword(s):

Adverse Drug Reactions ◽

Teaching Hospital ◽

Causality Assessment ◽

Age Group ◽

Drug Reactions ◽

Preliminary Stage ◽

Medical College ◽

Probable Relationship ◽

Pharmacovigilance Center ◽

Inflammatory Drugs

The Pharmacovigilance program in Nepal is at very preliminary stage. Present study analyzed the pattern, causality, severity and preventability of the reported adverse drug reactions (ADRs) to the Pharmacovigilance center at Nepal Medical College and Teaching Hospital (NMCTH), from June 2007 to July 2011. A total of 40 ADR cases were reported, among which 23 (57.5%) were in males and 17 (42.5%) in females. Nineteen (47.5%) ADRs were reported in the age group between 21-40 years. Department of Medicine reported 12(30%) ADRs. Among the total ADRs, antibiotics [n=17, (42.5%)] were responsible for most of the reactions followed by non steroidal anti-inflammatory drugs [n=5, (12.5%)]. Most of the drugs were found to affect dermatological system [n=14, (35%)]. Carbamazepine accounted for 5 (12.5%) ADRs. The causality assessment showed 34 (85%) of the ADRs to have a ‘probable’ relationship with the suspected reaction.DOI: http://dx.doi.org/10.3126/jnpa.v26i1.6633JNPA. XXVI(1) 2012 54-61

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