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Analysis of adverse drug reactions in hospitalized patients reported to pharmacovigilance center in a teaching hospital

Year 2020, Volume: 45 Issue: 2, 556 - 561, 30.06.2020
https://doi.org/10.17826/cumj.671198

Abstract

Purpose: This study was carried out to assess the rate and pattern of adverse drug reactions (ADRs) reporting in hospitalized patients at a teaching hospital.
Materials and Methods: A retrospective cross-sectional study was conducted in Balcalı Hospital at Adana, Turkey for one year. The reports were examined on the basis of demographics, ADRs type, causality, severity, seriousness, drug characteristics, and outcomes. WHO-UMC/ Naranjo algorithm scale, Hartwig and Siegel severity scale and pharmacovigilance contact point (PVCP) criteria were used to assess the causality, severity, and seriousness of ADRs respectively.
Results: A total of 61105 hospitalized patients were admitted to the hospital and only 20 spontaneous ADRS were submitted to (PVCP) with an incidence rate of 0.03%. Of these, 18 eligible ADRs reporting forms were reviewed according to inclusion criteria. ADRs related to antibiotics (38.8%) were most frequently reported followed by antineoplastic agents (22.2%). Most of the ADRs were related to skin (33.3%). In causality assessment, almost 50% of the reported ADRs were possible and 55.5% were moderate in severity. Moreover, about 83.3% of the ADRs were found to be serious according to PVCP criteria. Among the total patients, 55.5% have recovered from the reactions. ADRs were reported by physicians (66.7%) followed by an assistant doctor (16.7%).
Conclusion: This study shows that ADRs are a significant problem in hospitalized patients. Monitoring and management of severe and serious types of ADRs would be valuable for improved patient care.

References

  • 1. Giardina C, Cutroneo PM, Mocciaro E et al. Adverse drug reactions in hospitalized patients: results of the FORWARD (facilitation of reporting in hospital ward) study. Front Pharmacol. 2018; 9:350.
  • 2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
  • 3. Ozcan G, Aykac E, Kasap Y, et al. Adverse drug reaction reporting pattern in Turkey: analysis of the national database in the context of the first pharmacovigilance legislation. Drugs Real World Outcomes. 2016;3(1):33-43.
  • 4. Pathak AK, Kumar M, Dokania S, et al. A retrospective analysis of reporting of adverse drug reactions in a tertiary care teaching hospital: one year survey. J Clin Diagn Res. 2016;10(8):FC01.
  • 5. Lazorou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA, 1998. 279: p. 1200-5.
  • 6. Venkatasubbaiah M, Reddy PD, Satyanarayana SV. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria journal of medicine. 2018;54(4):597-603.
  • 7. Hussain R, Hassali MA. Current status and future prospects of pharmacovigilance in Pakistan. Journal of pharmaceutical policy and practice, 2019. 12(1): p. 14.
  • 8. World Health Organization (WHO) Pharmacovigilance: Ensuring the Safe Use of Medicines - WHO Policy Perspectives on Medicines. 2004. https://apps.who.int/medicinedocs/en/d/Js6164e/. Accessed 12 November 2019.
  • 9. 18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018. Drug Safety. 2018;41(11):1103-273.
  • 10. World Health Organization (WHO) Pharmacovigilance.2004. https://www. who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/. Accessed 15 November 2019.
  • 11. 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.
  • 12. World Health Organization (WHO) The use of the WHO-UMC system for standardized case causality assessment. Uppsala: The Uppsala Monitoring Centre. 2005:2-7.
  • 13. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32.
  • 14. World Health organization (WHO) ATC/DDD methodology. 2019-2020. https://www.whocc.no/atc_ddd_index/. Accessed 15 November 2019.
  • 15. Carrasco-Garrido P, de Andrés LA, Barrera VH, et al. Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006). BMC health services research 2010; 10: 287.
  • 16. Bordet R, Gautier S, Le Louet H, et al. Analysis of the direct cost of adverse drug reactions in hospitalised patients. European journal of clinical pharmacology 2001; 56: 935-941.
  • 17. Dequito AB, Mol PG, van Doormaal JE, et al. Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands. Drug Saf 2011; 34: 1089-1100. 2011/10/11. DOI: 10.2165/11592030-000000000-00000.
  • 18. Nobili A, Licata G, Salerno F, et al. Polypharmacy, length of hospital stay, and in-hospital mortality among elderly patients in internal medicine wards. The REPOSI study. European journal of clinical pharmacology 2011; 67: 507-519.
  • 19. Soldin OP, Chung SH and Mattison DR. Sex differences in drug disposition. BioMed Research International 2011; 2011.
  • 20. Sai NP. Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India. Int J Basic Clin Pharmacol. 2019; 8: 934.
  • 21. Walter SR, Day RO, Gallego B, et al. The impact of serious adverse drug reactions: a population‐based study of a decade of hospital admissions in New South Wales, Australia. British journal of clinical pharmacology 2017; 83: 416-426.
  • 22. Fasipe OJ, Akhideno PE and Owhin OS. The observed effect of adverse drug reactions on the length of hospital stay among medical inpatients in a Nigerian University Teaching Hospital. Toxicology Research and Application 2019; 3: 2397847319850451.
  • 23. Kim D-W, Choi Y-C, Lee Y-S, et al. Analysis of pediatric adverse drug reactions reported to regional pharmacovigilance center of a single university hospital. Allergy Asthma Respir Dis. 2018; 6: 263-269.
  • 24. Vlahovic-Palcevski V, Morovic M and Palcevski G. Antibiotic utilization at the university hospital after introducing an antibiotic policy. European journal of clinical pharmacology 2000; 56: 97-101.
  • 25. Trifirò G, Calogero G, Ippolito FM, et al. Adverse drug events in emergency department population: a prospective Italian study. Pharmacoepidemiology and drug safety 2005; 14: 333-340.
  • 26. Güner MD and Ekmekci PE. Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. Journal of drug assessment 2019; 8: 13-20.
  • 27. Abdel-Latif MM and Abdel-Wahab BA. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi pharmaceutical journal 2015; 23: 154-161.
  • 28. Kumar B, Nayak K, Singh H, et al. A pharmacovigilance study in medicine department of tertiary care hospital in Chhattisgarh (Jagdalpur), India. Journal of young pharmacists 2010; 2: 95-100.
  • 29. Van den Bemt P, Egberts A, Lenderink A, et al. Adverse drug events in hospitalized patients A comparison of doctors, nurses and patients as sources of reports. European journal of clinical pharmacology 1999; 55: 155-158.
  • 30. Schutte T, van Eekeren R, Richir M, et al. The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study. Naunyn-Schmiedeberg's archives of pharmacology 2018; 391: 17-26.

Bir eğitim hastanesinde farmakovijilans merkezine yönlendirilen yatan hastalardaki advers ilaç reaksiyonlarının analizi

Year 2020, Volume: 45 Issue: 2, 556 - 561, 30.06.2020
https://doi.org/10.17826/cumj.671198

Abstract

Amaç: Bu çalışma, bir eğitim hastanesinde yatan hastalarda rapor edilen advers ilaç reaksiyonlarının (ADR) oranını ve şeklini değerlendirmek için yapılmıştır.
Gereç ve Yöntem: Adana, Balcalı Hastanesi'nde bir yıllık retrospektif kesitsel bir çalışma yapıldı. ADR'lerin nedensellik, şiddet ve ciddiyetini değerlendirmek için WHO-UMC / Naranjo algoritma skalası, Hartwig ve Siegel şiddet skalası ve farmakovijilans temas noktası (PVCP) kriterleri kullanıldı.
Bulgular: Toplam 61105 yatan hastadan 20 spontan ADRS vakası PVCP’ye sunulmuş olup insidansı %0.03’ e denk düşmektedir. Bunlardan 18 tanesi ADR bildirim formu dahil edilme kriterlerine göre uygun bulunmuştur. Antibiyotiklerle ilişkili ADR'ler (% 38.8) en sık bildirilirken antineoplastik ajanlar (% 22.2) idi. ADR'lerin çoğu deri ile ilişkiliydi (% 33.3). Nedensellik değerlendirmesinde, bildirilen ADR'lerin neredeyse %50'si mümkündür ve % 55.5'i orta ciddiyettedir. Ayrıca, ADR'lerin yaklaşık % 83.3'ünün PVCP kriterlerine göre ciddi olduğu bulunmuştur. Toplam hastalar arasında% 55.5'i reaksiyonlardan iyileşmiştir. ADR'ler doktorlar (% 66.7) ve ardından asistan doktor (% 16.7) tarafından rapor edilmiştir.
Sonuç: Bu çalışma hastanede yatan hastalarda ADR'lerin önemli bir problem olduğunu göstermektedir. Şiddetli ve ciddi tipte ADR'lerin izlenmesi ve yönetimi, daha iyi hasta bakımı için değerli olacaktır.

References

  • 1. Giardina C, Cutroneo PM, Mocciaro E et al. Adverse drug reactions in hospitalized patients: results of the FORWARD (facilitation of reporting in hospital ward) study. Front Pharmacol. 2018; 9:350.
  • 2. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356(9237):1255-9.
  • 3. Ozcan G, Aykac E, Kasap Y, et al. Adverse drug reaction reporting pattern in Turkey: analysis of the national database in the context of the first pharmacovigilance legislation. Drugs Real World Outcomes. 2016;3(1):33-43.
  • 4. Pathak AK, Kumar M, Dokania S, et al. A retrospective analysis of reporting of adverse drug reactions in a tertiary care teaching hospital: one year survey. J Clin Diagn Res. 2016;10(8):FC01.
  • 5. Lazorou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients. JAMA, 1998. 279: p. 1200-5.
  • 6. Venkatasubbaiah M, Reddy PD, Satyanarayana SV. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria journal of medicine. 2018;54(4):597-603.
  • 7. Hussain R, Hassali MA. Current status and future prospects of pharmacovigilance in Pakistan. Journal of pharmaceutical policy and practice, 2019. 12(1): p. 14.
  • 8. World Health Organization (WHO) Pharmacovigilance: Ensuring the Safe Use of Medicines - WHO Policy Perspectives on Medicines. 2004. https://apps.who.int/medicinedocs/en/d/Js6164e/. Accessed 12 November 2019.
  • 9. 18th ISoP Annual Meeting “Pharmacovigilance without borders” Geneva, Switzerland, 11–14 November, 2018. Drug Safety. 2018;41(11):1103-273.
  • 10. World Health Organization (WHO) Pharmacovigilance.2004. https://www. who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/. Accessed 15 November 2019.
  • 11. 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.
  • 12. World Health Organization (WHO) The use of the WHO-UMC system for standardized case causality assessment. Uppsala: The Uppsala Monitoring Centre. 2005:2-7.
  • 13. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49(9):2229-32.
  • 14. World Health organization (WHO) ATC/DDD methodology. 2019-2020. https://www.whocc.no/atc_ddd_index/. Accessed 15 November 2019.
  • 15. Carrasco-Garrido P, de Andrés LA, Barrera VH, et al. Trends of adverse drug reactions related-hospitalizations in Spain (2001-2006). BMC health services research 2010; 10: 287.
  • 16. Bordet R, Gautier S, Le Louet H, et al. Analysis of the direct cost of adverse drug reactions in hospitalised patients. European journal of clinical pharmacology 2001; 56: 935-941.
  • 17. Dequito AB, Mol PG, van Doormaal JE, et al. Preventable and non-preventable adverse drug events in hospitalized patients: a prospective chart review in the Netherlands. Drug Saf 2011; 34: 1089-1100. 2011/10/11. DOI: 10.2165/11592030-000000000-00000.
  • 18. Nobili A, Licata G, Salerno F, et al. Polypharmacy, length of hospital stay, and in-hospital mortality among elderly patients in internal medicine wards. The REPOSI study. European journal of clinical pharmacology 2011; 67: 507-519.
  • 19. Soldin OP, Chung SH and Mattison DR. Sex differences in drug disposition. BioMed Research International 2011; 2011.
  • 20. Sai NP. Analysis of adverse drug reactions in a tertiary care teaching hospital in Southern India. Int J Basic Clin Pharmacol. 2019; 8: 934.
  • 21. Walter SR, Day RO, Gallego B, et al. The impact of serious adverse drug reactions: a population‐based study of a decade of hospital admissions in New South Wales, Australia. British journal of clinical pharmacology 2017; 83: 416-426.
  • 22. Fasipe OJ, Akhideno PE and Owhin OS. The observed effect of adverse drug reactions on the length of hospital stay among medical inpatients in a Nigerian University Teaching Hospital. Toxicology Research and Application 2019; 3: 2397847319850451.
  • 23. Kim D-W, Choi Y-C, Lee Y-S, et al. Analysis of pediatric adverse drug reactions reported to regional pharmacovigilance center of a single university hospital. Allergy Asthma Respir Dis. 2018; 6: 263-269.
  • 24. Vlahovic-Palcevski V, Morovic M and Palcevski G. Antibiotic utilization at the university hospital after introducing an antibiotic policy. European journal of clinical pharmacology 2000; 56: 97-101.
  • 25. Trifirò G, Calogero G, Ippolito FM, et al. Adverse drug events in emergency department population: a prospective Italian study. Pharmacoepidemiology and drug safety 2005; 14: 333-340.
  • 26. Güner MD and Ekmekci PE. Healthcare professionals’ pharmacovigilance knowledge and adverse drug reaction reporting behavior and factors determining the reporting rates. Journal of drug assessment 2019; 8: 13-20.
  • 27. Abdel-Latif MM and Abdel-Wahab BA. Knowledge and awareness of adverse drug reactions and pharmacovigilance practices among healthcare professionals in Al-Madinah Al-Munawwarah, Kingdom of Saudi Arabia. Saudi pharmaceutical journal 2015; 23: 154-161.
  • 28. Kumar B, Nayak K, Singh H, et al. A pharmacovigilance study in medicine department of tertiary care hospital in Chhattisgarh (Jagdalpur), India. Journal of young pharmacists 2010; 2: 95-100.
  • 29. Van den Bemt P, Egberts A, Lenderink A, et al. Adverse drug events in hospitalized patients A comparison of doctors, nurses and patients as sources of reports. European journal of clinical pharmacology 1999; 55: 155-158.
  • 30. Schutte T, van Eekeren R, Richir M, et al. The adverse drug reaction reporting assignment for specialist oncology nurses: a preliminary evaluation of quality, relevance and educational value in a prospective cohort study. Naunyn-Schmiedeberg's archives of pharmacology 2018; 391: 17-26.
There are 30 citations in total.

Details

Primary Language English
Subjects Allergy, Forensic Medicine, Health Care Administration
Journal Section Research
Authors

Zakir Khan 0000-0003-1365-548X

Emine Öz 0000-0002-6600-9177

Olcay Kıroğlu 0000-0003-3182-2122

Yusuf Karataş 0000-0002-2892-5625

Publication Date June 30, 2020
Acceptance Date March 25, 2020
Published in Issue Year 2020 Volume: 45 Issue: 2

Cite

MLA Khan, Zakir et al. “Analysis of Adverse Drug Reactions in Hospitalized Patients Reported to Pharmacovigilance Center in a Teaching Hospital”. Cukurova Medical Journal, vol. 45, no. 2, 2020, pp. 556-61, doi:10.17826/cumj.671198.