Skip to main content
SpringerLink
Log in

Availability of Data on Adverse Reactions to Antiretroviral Drugs in Medical Charts According to the Naranjo Algorithm: An Example of a Brazilian Historical Cohort

  • Original Research Article
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Background and Objective

Although not designed for research purposes, medical charts can be a unique source for obtaining information on long-term adverse drug reactions. This study aimed to assess the availability of key information on paper-based patient medical records needed to detect long-term adverse reactions to antiretroviral therapy (ART).

Methods

This is an ongoing historical cohort study carried out in three public HIV/AIDS referral centers in Belo Horizonte, Brazil. Medical charts of treatment-naïve HIV-infected adult patients initiating ART between 2001 and 2005 were reviewed for a follow-up period of up to 5 years after the first ART prescription. Descriptive analysis was performed by estimating the absolute and relative frequencies of selected variables. The Naranjo algorithm was employed to assess the availability of data on long-term adverse outcomes in medical charts.

Results

A total of 233 medical charts were eligible for study and 26.1 % contained at least one long-term adverse reaction, corresponding to 45 cases of dyslipidemia (19.3 %), 16 (6.9 %) of lipodystrophy and 5 of type 2 diabetes mellitus (2.1 %). Temporal relationship and ART switch could be better documented from medical charts. Information on reasons for ART switching and alternative causes for adverse reactions was very lacking.

Conclusions

Specific tools should be developed and included in medical routines to improve adverse reaction reporting by physicians and other health professionals. This could be implemented simultaneously with the transition from paper to electronic medical charts in Brazil, facilitating the identification of long-term adverse reactions to antiretroviral drugs in epidemiological studies and in clinical practice.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. De Waal R, Cohen K, Maartens G. Systematic review of antiretroviral-associated lipodystrophy: lipoatrophy, but not central fat gain, is an antiretroviral adverse drug reaction. PLoS ONE. 2013;8(5):e63623.

    Article  PubMed Central  PubMed  Google Scholar 

  2. De Wit S, Sabin CA, Weber R, Worm SW, Reiss P, Cazanave C, et al. Incidence and risk factors for new-onset diabetes in HIV-infected patients: the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study. Diabetes Care. 2008;31(6):1224–9.

    Article  PubMed Central  PubMed  Google Scholar 

  3. Härmark L, van Grootheest AC. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol. 2008;64(8):743–52.

    Article  PubMed  Google Scholar 

  4. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.

    Article  PubMed  Google Scholar 

  5. Olsen J. Using secondary data. In: Rothman K, Greenland S, editors. Modern epidemiology. 2nd ed. Philadelphia: Lippincott-Raven; 1998. p. 481–91.

    Google Scholar 

  6. Murff HJ, Patel VL, Hripcsak G, Bates DW. Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inf. 2003;36(1–2):131–43.

    Article  Google Scholar 

  7. Gearing RE, Mian IA, Barber J, Ickowicz A. A methodology for conducting retrospective chart review research in child and adolescent psychiatry. J Can Acad Child Adolesc Psychiatry. 2006;15(3):126–34.

    PubMed Central  PubMed  Google Scholar 

  8. Agbabiaka TB, Savovic J, Ernst E. Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008;31(1):21–37.

    Article  PubMed  Google Scholar 

  9. Greco DB, Simão M. Brazilian policy of universal access to AIDS treatment: sustainability challenges and perspectives. AIDS. 2007;21(Suppl 4):S37–45.

    Article  PubMed  Google Scholar 

  10. Guimarães MDC, Acúrcio FA, Machado CJ, Possas CA. Adesão ao Tratamento Antirretroviral no Brasil: Coletânea de estudos do Projeto ATAR. Ministério da Saúde Brasília, 2010. http://www.aids.gov.br/sites/default/files/atar-web.pdf. Acessed 5 Nov 2013.

  11. Ministério da Saúde. Recomendações para Terapia Anti-retroviral em Adultos Infectados pelo HIV: 2008. Ministério da Saúde, Brasília; 2008. http://www.aids.gov.br/sites/default/files/consensoAdulto005c_2008montado.pdf. Accessed 05 Nov 2013.

  12. Third Report of the National Cholesterol Education Program (NCEP) Expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III); 2002. http://www.nhlbi.nih.gov/guidelines/cholesterol/. Accessed 20 Oct 2013.

  13. Standards of Medical Care in Diabetes. 2013. Diabetes Care. 2013;36(Suppl 1):S11–66.

    Google Scholar 

  14. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239–45.

    Article  CAS  PubMed  Google Scholar 

  15. Heath KV, Hogg RS, Singer J, Chan KJ, O’Shaughnessy MV, Montaner JS. Antiretroviral treatment patterns and incident HIV-associated morphologic and lipid abnormalities in a population-based cohort. J Acquir Immune Defic Syndr. 2002;30(4):440–7.

    Article  CAS  PubMed  Google Scholar 

  16. Pinto Neto LFS, Neves MB, Ribeiro-Rodrigues R, Page K, Miranda AE. Dyslipidemia and fasting glucose impairment among HIV patients three years after the first antiretroviral regimen in a Brazilian AIDS outpatient clinic. Braz J Infect Dis. 2013;17:438–43.

    Article  PubMed  Google Scholar 

  17. Carr A, Cooper DA. Adverse effects of antiretroviral therapy. Lancet. 2000;356(9239):1423–30.

    Article  CAS  PubMed  Google Scholar 

  18. White AJ. Mitochondrial toxicity and HIV therapy. Sex Transm Infect. 2001;77(3):158–73.

    Article  CAS  PubMed Central  PubMed  Google Scholar 

  19. Carr A. HIV lipodystrophy: risk factors, pathogenesis, diagnosis and management. AIDS. 2003;17(Suppl 1):S141–8.

    Article  CAS  PubMed  Google Scholar 

  20. Masia-Canuto M, Bernal-Morell E, Gutierrez-Rodero F. Alteraciones lipidicas y riesgo cardiovascular asociado a la terapia antirretroviral. Enferm Infecc Microbiol Clin. 2006;24(10):637–48.

    Article  PubMed  Google Scholar 

  21. Brown TT, Glesby MJ. Management of the metabolic effects of HIV and HIV drugs. Nat Rev Endocrinol. 2012;8(1):11–21.

    Article  CAS  Google Scholar 

  22. Ministério da Saúde. Síndrome lipodistrófica em HIV. Ministério da Saúde., Brasília; 2011. http://www.aids.gov.br/sites/default/files/anexos/publicacao/2011/50427/vers_o_final_63134.pdf. Accessed 05 Nov 2013.

  23. Silva FG, Tavares-Neto J. Avaliação dos prontuários médicos de hospitais de ensino do Brasil. Rev Bras Educ Med. 2007;31:113–26.

    Article  Google Scholar 

Download references

Acknowledgments

The authors are grateful to Prof. Sérgia Starling Magalhães for the valuable contributions to the discussion of this paper.

Sponsors: Fundação de Amparo à Pesquisa do Estado de Minas Gerais—FAPEMIG (Grant Number APQ0043-10); Conselho Nacional de Desenvolvimento Científico e Tecnológico—CNPq (Grant Number 484865/2011-0); Pró-Reitoria de Pesquisa—PRPq—Universidade Federal de Minas Gerais. C. A. Menezes de Pádua and C. S. Moura have no conflicts of interest that are directly relevant to the content of this study.

Author information

Authors and Affiliations

  1. Department of Social Pharmacy, Faculty of Pharmacy, Federal University of Minas Gerais, Avenida Antônio Carlos 6627, Pampulha, Belo Horizonte, MG, Brazil

    Cristiane A. Menezes de Pádua

  2. Division of Clinical Epidemiology, McGill University Health Center, McGill University, Montreal, Canada

    Cristiano S. Moura

Authors
  1. Cristiane A. Menezes de Pádua
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Cristiano S. Moura
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Cristiane A. Menezes de Pádua.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Menezes de Pádua, C.A., Moura, C.S. Availability of Data on Adverse Reactions to Antiretroviral Drugs in Medical Charts According to the Naranjo Algorithm: An Example of a Brazilian Historical Cohort. Clin Drug Investig 34, 395–402 (2014). https://doi.org/10.1007/s40261-014-0187-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40261-014-0187-0

Keywords

Search

Navigation