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Profile of adverse drug reactions in patients admitted to general surgical wards of a rural tertiary-care hospital in India

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Abstract

Aim

To find the incidence rate of adverse drug reactions (ADRs) and investigate its various aspects in patients admitted to surgery wards of a rural tertiary-care hospital in India.

Methodology

A prospective observational study, involving 800 patients over a period of 1.5 years, was carried out to find the incidence rate of ADRs, and various aspects of such events (e.g. causality, severity, preventability, causative drugs, organs/systems involved, and management strategy with outcome). A structured and pre-tested form was used to compile the data.

Results

An ADR was reported in 3.9 % of patients. Neither the age nor gender of the patients influenced incidence rate. Type A (augmented) reactions accounted for 83.9 % of ADRs. Causality assessment, using the WHO-UMC method, revealed that 58.1 and 41.9 % of ADRs fell into the ‘probable’ and ‘possible’ categories, respectively, whereas the corresponding proportions were 71.0 and 29.0 % using the Naranjo ADR probability scale. As the number of drugs per patient increased, the incidence of ADRs also increased. The majority (77.4 %) of ADRs were associated with antimicrobial drugs, followed by analgesics, with 71 % of ADRs involving the gastrointestinal system. No ADRs were fatal. Suspected drugs were discontinued in 64.5 % of patients and 96.8 % patients had fully recovered at the time of discharge.

Conclusion

Identification and monitoring of ADRs among various patient groups, including those admitted to general surgical wards of a hospital, along with meticulous reporting thereof, can help provide better and more rational patient care. Few studies that monitored ADRs in surgical patients are available. The incidence rate of ADRs amongst surgical patients in this Indian hospital appears to be much lower than commonly reported (3.9 vs. 10–25 %).

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References

  1. Nebeker JR. Clarifying adverse drug events: a clinician’s guide to terminology, documentation, and reporting. Ann Intern Med. 2005;140(10):795–801.

    Article  Google Scholar 

  2. Tripathi KD. Essentials of medical pharmacology. 6th ed. New Delhi: Jaypee Publications.

  3. ASHP guidelines on adverse drug reaction monitoring and reporting. American Society of Hospital Pharmacy. Am J Health Syst Pharm. 1995;52(4) 417–9.

  4. Bates DW, Leape LL, Cullen DJ, et al. Effects of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280(15):1311–6.

    Article  CAS  PubMed  Google Scholar 

  5. Rodrigues GS, Khan SA. Pharmacovigilance among surgeons and in surgical wards: overlooked or axiomatic? Indian J Surg. 2011;73(1):4–8.

    Article  PubMed Central  PubMed  Google Scholar 

  6. Farrokhi S, Nahvi H, Pourpak Z, et al. Adverse drug reactions in a department of pediatric surgery. J Trop Pediatr. 2006;52(1):72–3.

    Article  PubMed  Google Scholar 

  7. Davies EC, Green CF, Taylor S, et al. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One. 2009;4(2):e4439.

    Article  PubMed Central  PubMed  Google Scholar 

  8. Boeker EB, de Boer M, Kiewiet JJ, et al. Occurrence and preventability of adverse drug events in surgical patients: a systematic review of literature. BMC Health Serv Res. 2013;13:364.

    Article  PubMed Central  PubMed  Google Scholar 

  9. World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. Geneva: Office of Publications, World Health Organization; 2002.

    Google Scholar 

  10. Naranjo CA, Busto U, Sellers EM, 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 

  11. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229–32.

    CAS  PubMed  Google Scholar 

  12. Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538.

    CAS  PubMed  Google Scholar 

  13. Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health & Family Welfare Government of India in collaboration with Indian Pharmacopoeia Commission. Pharmacovigilance programme of India (PvPI) for assuring drug safety. Ghaziabad: Central Drugs Standard Control Organization; 2011.

  14. Gor AP, Desai SV. Adverse drug reactions (ADR) in the inpatients of medicine department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol. 2008;40(1):37–40.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  15. Sriram S, Ghasemi A, Ramasamy R, et al. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci. 2011;16(1):16–25.

    PubMed Central  PubMed  Google Scholar 

  16. Rao PGM, Archana B, Jose J. Implementation and results of an adverse drug reaction reporting programme at an Indian teaching hospital. Indian J Pharmacol. 2006;38(4):293–4.

    Article  Google Scholar 

  17. Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008;65(2):210–6.

    Article  PubMed Central  CAS  PubMed  Google Scholar 

  18. Classen DC, Pestotnik SL, Evans RS, et al. Adverse drug events in hospitalized patients-excess length of stay, extra costs and attributable mortality. JAMA. 1997;277(4):301–6.

    Article  CAS  PubMed  Google Scholar 

  19. Laurence DR, Bennett PN, Brown MJ. Clinical pharmacology. 8th ed. New York: Churchill Livingstone; 1997.

    Google Scholar 

  20. Sharma M, Gupta SK, Gupta VB. A comparative study of causality assessment scale used in the analysis of spontaneously reported events. J Pharmacovigil Drug Saf. 2009;6(1):5–9.

    Google Scholar 

  21. Hoigné R, Lawson DH, Weber E. Risk factor for adverse drug reactions: epidemiological approaches. Eur J Clin Pharmacol. 1990;39(4):321–5.

    Article  PubMed  Google Scholar 

  22. Holland EG, Degruy FV. Drug-induced disorders. Am Fam Physician. 1997;56(7):1791–2.

    Google Scholar 

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Authors and Affiliations

  1. Department of Pharmacology, Smt. B. K. Shah Medical Institute and Research Centre, Sumandeep Vidyapeeth, Piparia, Vadodara, Gujarat, India

    Nirav Patel & Sagun Desai

Authors
  1. Nirav Patel
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  2. Sagun Desai
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Correspondence to Nirav Patel.

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Funding

No sources of funding were used to conduct the study or prepare this report.

Conflict of interest

Nirav N. Patel and Sagun V. Desai declare that they have no conflicts of interest relevant to the content of this manuscript.

Ethical approval

Ethical approval was obtained from the Institutional Ethics Committee before the commencement of the study. Written informed consent obtained from all the patients.

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Patel, N., Desai, S. Profile of adverse drug reactions in patients admitted to general surgical wards of a rural tertiary-care hospital in India. Drugs Ther Perspect 31, 402–406 (2015). https://doi.org/10.1007/s40267-015-0231-z

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