PHARMACOVIGILANCE STUDY OF ANTIRETROVIRAL THERAPY IN HUMAN IMMUNODEFICIENCY VIRUS/ACQUIRED IMMUNODEFICIENCY SYNDROME PATIENTS AT ANTIRETROVIRAL THERAPY CENTRE, JABALPUR
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i9.26747Keywords:
Pharmacovigilance, Adverse drug reaction, Antiretroviral therapy, Acquired immunodeficiency syndromeAbstract
Objective: The objective of the study was to assess the adverse drug reactions (ADRs) of antiretroviral therapy along with its causality, severity, and preventability.
Method: A prospective as well as a retrospective observational study with a sample size of 260, jointly conducted in the Department of Pharmacology and antiretroviral therapy (ART) center of N.S.C.B. Medical College Jabalpur, India, from March 2016 to July 2017. We observed various ADRs to ART in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients and assessed causality, severity, and preventability of the reported ADRs as per the standard scales.
Results: A total of 260 patients were enrolled of which 220 (84.6%) patients developed a total of 425 ADRs. Maximum 51.7% of ADRs were caused by TLE followed by 37% with ZLN regimen. Most common ADRs were dizziness 18.6%, rashes 14.6%, anemia 10.6%, and vomiting 6.6%. Dizziness and rashes are mainly caused by TLE and ZLN regimen, respectively. Management of ADRs with a change in the regimen was applied as an interventional tool in 40% of the patients. Causality assessment as per the WHO-UMC scale showed that 55.5% of ADR were probable and 45.5% were possible. 84.5% of ADR was not preventable, while 15.5% of ADRs were probably preventable. 38% of ADRs were mild, 56% were moderate, and 6% were severe in nature.
Conclusion: Antiretrovirals, however, the milestone for the treatment of HIV/AIDS have very high potential for developing ADRs. Hence, active pharmacovigilance is needed for not only safety of the patients but also compliance to the treatment which is necessary for optimal therapeutic outcomes and to improve quality of life.
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References
Pharmacovigilance. Internet Home Page. Available from: https://www. en.wikipedia.org/wiki/Pharmacovigilance.
World Health Organization. The Importance of Pharmacovigilance- Safety Monitoring of Medicinal Products. Geneva: WHO; 2002. p. 40-43. Available from: http://www.apps.who.int/medicinedocs/pdf/ s4893e/s4893e.pdf.
Uppsala Reports/72â€. WHO-Uppsala Monitoring Centre. 2016 April; Issue 72: Page 14. Available from: https://www.who-umc.org/ media/1237/uppsalareports-may-2016.pdf#page=14.
Shah RR, Masatkar V, Bohra S, Malek N, Ghose G, Pandya HP. has HAART won heart of HIV/AIDS patients? World J Pharm Life Sci 2017;3:184-98.
UNAIDS. Fact Sheet July. 2017. Available from: http://www.unaids. org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf.
UNAIDS. Global AIDS Update; 2016. Available from: http://www. unaids.org/sites/default/files/media_asset/global-AIDS-update-2016_ en.pdf.
UNAIDS AIDS info. Country Factsheets India; 2016. Available from: http://www.aidsinfo.unaids.org.
Bhuvana KB, Hema NG, Sangeetha. A prospective observational study of adverse drug reactions to antiretroviral therapy: Type and risk factors in a tertiary care teaching hospital. Int J Basic Clin Pharmacol 2014;3:380-4.
Kumar P. Sexually transmitted disease: Acquired immune deficiency syndrome: A review. J Appl Pharm Sci 2011;1:35-43.
HIV Medications-mTatva Health-PIE. Available from: https://www. mtatva.com/en/spl-health/hiv-medications/.
Rathod PS, Patil PT, Lohar RP, Patil AW Current trends in highly active antiretroviral therapy in an anti-retroviral therapy centre attached to a remote government medical college of Maharashtra, India: a retrospective study. Int J Basic Clin Pharmacol 2016;5:1011-6.
The use of the WHO-UMC System for Standardised Case Causality Assessment. Available from: https://www.who-umc.org/media/2768/ standardised-case-causality-assessment.pdf.
Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm 1992;27:538.
Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm 1992;49:2229-32.
Sharma A, Vora R, Modi M, Sharma A, Marfatia Y. Adverse effects of antiretroviral treatment. Indian J Dermatol Venereol Leprol 2008;74:234-7.
Nagpal M, Tayal V, Kumar S, Gupta U. Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study. Indian J Med Sci 2010;64:245-52.
Sadiq S, Gupta S, Khajuria V, Tandon VR, Mahajan A, Gupta M. Adverse drug events due to antiretroviral therapy in a northern Indian tertiary care institution. Natl J Physiol Pharm Pharmacol 2016;6:205-8.
Khan K, Khan AH, Sulaiman SA, Soo CT, Akhtar A. Adverse drug reactions in HIV/AIDS patients at a tertiary care hospital in Penang, Malaysia. Jpn J Infect Dis 2016;69:56-9.
Sehgal R, Gupta MC, Ghalaut PS. Adverse event monitoring of antiretroviral drugs -A pharmacovigilance perspective. Int J Pharmacol Res 2017;7:65-70.
Kumar A, Majhee L, Gari M. Causality, severity and preventability assessment of adverse drug reactions in patients received anti-retroviral therapy in a tertiary care hospital: A retrospective study. Natl J Physiol Pharm Pharmacol 2017;7:178-82.
Jain A, Lihite RJ, Lahkar M, Baruah SK. A study on adverse drug reactions to first-line antiretroviral therapy in HIV infected patients at a tertiary care hospital in Northeast India. HIV AIDS Rev 2016;15:131-5.
Singh H, Dulhani N, Tiwari P, Singh P, Sinha T. A prospective, observational cohort study to elicit adverse effects of antiretroviral agents in a remote resource-restricted tribal population of Chhattisgarh. Indian J Pharmacol 2009;41:224-6.
Reddy AK, Lihite RJ, Lahkar M, Choudhury U, Baruah SK. A study on adverse drug reactions in HIV infected patients at a ART centre of tertiary care hospital in Guwahati, India. Asian J Pharm Clin Res 2013;6:102-4.
Kumari R, Chandra S, Gari M, Kumari A. An assessment of adverse drug reaction patterns among HIV positive patients receiving antiretroviral therapy in a tertiary care hospital. Int J Pharmacol Res 2017;7:88-93.
Weldegebreal F, Mitiku H, Teklemariam Z. Magnitude of adverse drug reaction and associated factors among HIV-infected adults on antiretroviral therapy in Hiwot Fana specialized university hospital, Eastern Ethiopia. Pan Afr Med J 2016;24:255.
Rather ZA, Chowta MN, Raju GJ, Mubeen F. Evaluation of the adverse reactions of antiretroviral drug regimens in a tertiary care hospital. Indian J Pharmacol 2013;45:145-8.
Masenyetse LJ, Manda SO, Mwambi HG. An assessment of adverse drug reactions among HIV positive patients receiving antiretroviral treatment in South Africa. AIDS Res Ther 2015;12:6.
Abdissa SG, Fekade D, Feleke Y, Seboxa T, Diro E. Adverse drug reactions associated with antiretroviral treatment among adult Ethiopian patients in a tertiary hospital. Ethiop Med J 2012;50:107-13.
Namme Luma H, Doualla MS, Choukem SP, Temfack E, Ashuntantang G, Achu Joko H, et al. Adverse drug reactions of highly active antiretroviral therapy (HAART) in HIV infected patients at the general hospital, Douala, Cameroon: A cross sectional study. Pan Afr Med J 2012;12:87.
Anwikar SR, Bandekar MS, Smrati B, Pazare AP, Tatke PA, Kshirsagar NA, et al. HAART induced adverse drug reactions: A retrospective analysis at a tertiary referral health care center in India. Int J Risk Saf Med 2011;23:163-9.
Modayil RR, Harugeri A, Parthasarathi G, Ramesh M, Prasad R, Naik V, et al. Adverse drug reactions to antiretroviral therapy (ART): An experience of spontaneous reporting and intensive monitoring from ART centre in India. Pharmacoepidemiol Drug Saf 2010;19:247-55.
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