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ISSN 1561-2988 (Print)

2016, Number 1

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Rev Cubana Farm 2016; 50 (1)

Spontaneous reporting of suspected drug adverse reactions in 'Pedro Kouri' Institute of Tropical Medicine

Martínez RA, Duque VM, Castro PO, Alfonso OI, Jiménez LG, Acosta RED

Language: Spanish
References: 45
Page: 53-67
PDF size: 188.55 Kb.


ABSTRACT

Introduction: Adverse drug reactions are related to safety of pharmaceuticals, to high morbidity and mortality rates and to high economic burden upon the society. In "Pedro Kouri" Institute of Tropical Medicine, the adverse drug reaction notifications are inconsistent and there is no general analysis of reports.
Objectives: To characterize the adverse drug reactions reported in "Pedro Kouri" Institute in the period of 2011 through 2013.
Method: Observational, descriptive and cross-sectional pharmacovigilance study based on all the reports on adverse drug reactions by the professionals of the Institute during the selected period of time. They were classified according to attributable cause, frequency and type of reaction. Suspected drugs were identified and the patients who manifested these reactions were also studied.
Results: Seventy seven adverse reactions were reported and all of them were related to anti-infection drugs; antiretrovirals accounted for 75.3% and was the drug group mostly associated to them. The majority of reports were made on males (80.5%) and young people (51.9%). They were classified as probable in 66% of cases and definitive in 6.4%.
Conclusions: All the adverse drug reactions reported in the Institute in the 2011 to 2013 period were observed in HIV/aids patients and were severe ones.


REFERENCES

  1. Organización Mundial de la Salud. Comités de farmacoterapia: Guía práctica. Ginebra, Suiza: OMS. Departamento de Medicamentos Esenciales y Política Farmacéutica; 2003.

  2. Dirección de Medicamentos y Tecnologías Médicas. Departamento de Farmacoepidemiología. MINSAP. Balance anual 2013. Sistema cubano de farmacovigilancia. La Habana, Cuba: Minsap; 2013.

  3. Lazarou J, Pomeranz BH. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279(15):1200-5.

  4. Wiffen P, Gill M, Edwards J, Moore A. Adverse drug reactions in hospital patients: a systematic review of the prospective and retrospective studies. Bandolier Extra. 2002;101(4):1-15.

  5. Saladrigas MV. El sistema de clasificación ATC de sustancias farmacéuticas para uso humano (The Anatomical, Therapeutic, Chemical Classification System). Tribuna [Internet]. 2004 [citado 2015 jul 3]; 5(15). Disponible en: http://www.medtrad.org/panacea/IndiceGeneral/n15_tribuna-Saladrigas.pdf

  6. Claudio-Campos K, Duconge J, Cadilla CL, Ruaño G. Pharmacogenetics of drugmetabolizing enzymes in US Hispanics. Drug metabolism and personalized therapy. 2015;30(2):87-105.

  7. Jiménez G, Alfonso I, Calvo D.M, López M, Broche L, Lara C, et al. Normas y Procedimientos de Trabajo del Sistema Cubano de Farmacovigilancia. La Habana: Unidad Coordinadora Nacional de Farmacovigilancia. Departamento de Farmacoepidemiología. Dirección de Medicamentos. La Habana: Ministerio de Salud Pública; 2011.

  8. Cuba, Ministerio de Salud Pública. Antiinfecciosos. En: Clavo DM, Delgado I, editors. Formulario Nacional de Medicamentos. 2014. 4ta ed. La Habana: Editorial Ciencias Médicas; 2014. p. 91-208.

  9. Base de Datos Nacional de Farmacovigilancia. La Habana: Unidad Nacional Coordinadora de Farmacovigilancia, Minsap; 2003.

  10. Alfonso I, Jiménez G. Métodos de farmacovigilancia. En: Furones Mourrelle JA, Lara C, Calvo DM, Barbado, Cruz MA, editors. Farmacoepidemiología Uso racional de medicamentos. La Habana: Editorial Academia; 2010. p. 100-5.

  11. Hazell L, Shakir SAW. Under-Reporting of Adverse Drug Reactions. A Systematic Review. Drug Safety. 2006;29(5):385-96.

  12. Yunihastuti E, Widhani A, Karjadi TH. Drug hypersensitivity in human immunodeficiency virus-infected patient: challenging diagnosis and management. Asia Pacific Allergy. 2014;4(1):54-67.

  13. Micheli JE, Chinn LW, Shugarts SB, Patel A, Martin JN, Bangsberg DR, et al. Measuring the Overall Genetic Component of Nevirapine Pharmacokinetics and the Role of Selected Polymorphisms: Towards Addressing the Missing Heritability in Pharmacogenetic Phenotypes? Pharmacogenetics and genomics. 2013;23(11):591-6.

  14. Pavlos R, Mallal S, Ostrov D, Pompeu Y, Phillips E. Fever, rash and systemic symptoms: understanding the role of virus and HLA in severe cutaneous drug allergy. The journal of allergy and clinical immunology In practice. 2014;2(1):21- 33.

  15. Rieder MJ, Carleton B. Pharmacogenomics and adverse drug reactions in children. Front Genet [Internet]. 2014 [citado 2015 feb-12]; 5:[78 p.]. Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3997041/

  16. Vallano A, Cereza G, Pedros C, Agusti A, Danes I, Aguilera C, et al. Obstacles and solutions for spontaneous reporting of adverse drug reactions in the hospital. Br J Clin Pharmacol. 2015;60(7):653-8.

  17. Khan SA, Goyal C, Chandel N, Rafi M. Knowledge, attitudes, and practice of doctors to adverse drug reaction reporting in a teaching hospital in India: An observational study. Journal of Natural Science, Biology, and Medicine. 2013;4(1):191-6.

  18. Carr D, Bourgeois S, Chaponda M, Cornejo E, Panos Deloukas P, Pirmohamed M. Genome-wide association study of nevirapine hypersensitivity in a malawian HIV-infected population. Clinical and Translational Allergy. 2014;4(Suppl 3):125.

  19. Oshikoya KA, Awobusuyi JO. Perceptions of doctors to adverse drug reaction reporting in a teaching hospital in Lagos, Nigeria. BMC Clinical Pharmacology. 2009;9:14.

  20. Aragonés C, Sánchez L, Campos JR, J P. Antiretroviral Therapy Adherence in Persons with HIV/AIDS in Cuba. MEDICC Review. 2011;13(2):17-23.

  21. Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes. PLoS ONE. 2009;4(2):e4439.

  22. Lobo MG, Pinheiro SM, Castro JG, Momente VG, Pranchevicius MC. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacology & Toxicology. 2013;14:5.

  23. van Oosterhout J J, Jane Mallewa J, Kaunda K, Chagoma N, Njalale Y, Kampira E, et al. Stavudine Toxicity in Adult Longer-Term ART Patients in Blantyre, Malawi. PLoS ONE [Internet]. 2012 [citado 2015 feb-25]; 7(7):[e42029 p.]. Disponible en: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0042029

  24. Menezes CN, Maskew M, Sanne I, Crowther NJ, Raal FJ. A longitudinal study of stavudine-associated toxicities in a large cohort of South African HIV infected subjects [Internet]. 2011. [citado 2015 feb-25]. Disponible en: http://www.biomedcentral.com/1471-2334/11/244

  25. Palmer M, Chersich M, Moultrie H, Kuhn L, Fairlie L, Meyers T. Frequency of stavudine substitution due to toxicity in children receiving antiretroviral treatment in sub-Saharan Africa. Aids. 2013;27(5):781-5.

  26. WHO. Antiretroviral therapy for HIV infection in adults and adolescents: Recommendations for a public health approach (2010 version). [citado 2015 feb- 25]. Disponible en: http://whqlibdocwhoint/publications/2010/9789241599764_engpdf.

  27. AIDSinfo. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents 2013 [citado 2015 feb 10]. Disponible en: http://aidsinfo.nih.gov/guidelines .

  28. Tilles S. Practical issues in the management of hypersensitivity reactions: sulfonamides. South Med J. 2001;94:817-24.

  29. Haas DW, Kuritzkes DR, Ritchie MD, Amur S, Gage BF, Maartens G, et al. Pharmacogenomics of HIV Therapy: Summary of a Workshop Sponsored by the National Institute of Allergy and Infectious Diseases. HIV Clin Trials. 2011;12(5):277-85.

  30. Bannaga A, Rahama O, Barlow G. Nevirapine-induced Stevens-Johnson syndrome following HIV postexposure prophylaxis. BMJ Case Rep [Internet]. 2013 Apr. [citado 2015 feb-10] . Disponible en: http://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23625676/

  31. Sweetman SC, editor. Martindale: The Complete Drug Reference. Thirty-sixth ed. London: Pharmaceutical Press; 2009.

  32. Knight L, Muloiwa R, Dlamini S, Lehloenya RJ. Factors Associated with Increased Mortality in a Predominantly HIV-Infected Population with Stevens Johnson Syndrome and Toxic Epidermal Necrolysis. PLoS One [Internet]. 2014 [citado 2015 feb-11]; 9(4):[e93543 p.]. Disponible en: http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0093543

  33. Creed R, Morrison LK, Ravanfar P, Mendoza N, Tyring S. Skin complications of HIV infection. Expert Review of Dermatology. 2009;4(5):509-21.

  34. Haas DW, Mootsikapun P, Ruxrungtham K, Podzamczer D. Clinical perspectives on human genetic screening to prevent nevirapine toxicity. Personalized medicine. 2012;9(7):773-82.

  35. Namayanja GK, Nankya JM, Byamugisha JK, Ssali FN, Kityo CM, Rwambuya S, et al. Stevens - Johnson syndrome due to nevirapine. Afr Health Sci. 2005;5(4):338-40.

  36. Tansuphaswadikul S, Aung SE, Phonrat B, Kaewkungwal J, Pitisuttithum P, Maek-a-nantawat W. Predisposing factors for nevirapine toxicity among AIDS patients with low baseline CD4 count. Asian Pac J Allergy Immunol. 2007;25(2- 3):147-54.

  37. Brown KC, Hosseinipour MC, Hoskins JM, Thirumaran RK, Tien HC, Weigel R, et al. Exploration of CYP450 and drug transporter genotypes and correlations with nevirapine exposure in Malawians. Pharmacogenomics. 2012;13(1):113-21.

  38. Mahasirimongkol S. ClinicalTrial.gov Identifier: NCT00986063: Genotype Based Personalized Prescription of Nevirapine (GENPART) Thailand: Food and Drug Administration2012 [citado 2014 mar 7]. Disponible en: www.clinicaltrials.gov/ct2/show/NCT00986063?term=NCT00986063&rank=1

  39. IPK. Pautas cubanas para el tratamiento y manejo de los pacientes VIH/sida sometidos a terapéutica antirretroviral. La Habana: IPK; 2009.

  40. Kiertiburanakul S, Sungkanuparph S, Malathum K, Watcharananan S, Sathapatayavongs B, Charoenyingwattana A, et al. A Model and Risk Score for Predicting Nevirapine-Associated Rash among HIV-infected Patients: En Settings of Low CD4 Cell Counts and Resource Limitation. Open AIDS J. 2009;3:24-30.

  41. Havlir D, Cheeseman SH, Mclaughlin M, Murphy R, Erice A, Spector SA, et al. High-dose nevirapine: safety, pharmacokinetics, and antiviral effect in patients with human immunodeficiency virus infection. Journal of Infectious Diseases. 1995;171(3):537-45.

  42. Ratanasuwan W, Jariyasethpong T, Anekthananon T, Intalapaporn P, Kongpatanakul S, Pongnarin P, et al. Association of Nevirapine Levels with Rash or Hepatotoxicity Among HIV-Infected Thai Women. Open AIDS J. 2012;6:266-73.

  43. Moseley RH. Vancomycin. Hepatotoxicity of antimicrobials and antifungal agents. In: Kaplowitz N, DeLeve LD, editors. Drug-induced liver disease. 3rd ed. Amsterdam: Elsevier; 2013. p. 469.

  44. Sorrell TC, Collignon PJ. A prospective study of adverse reactions associated with vancomycin therapy. J Antimicrob Chemother 1985;16:235-41.

  45. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) NLoMN. LIVERTOX (LiverTox.nih.gov). [actualizado 2014-02-5; citado 2014 13-02]. Disponible en: http://livertox.nih.gov/aboutus.html.




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