Medication Errors Associated With Adverse Drug Reactions in Iran (2015-2017): A P-Method Approach

Document Type: Short Communication

Authors

1 Department of Assessment and Control on Prescribing and Use of Medicines and Health-Related Products, Iran Food and Drug Administration, Ministry of Health and Medical Education, Tehran, Iran

2 Department of Pediatrics, Iran University of Medical Sciences, Tehran, Iran

3 Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands

4 Department of Pharmaceutics, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Abstract

Medication errors are the second most common cause of adverse patient safety incidents and the single most common preventable cause of adverse events in medical practice. Given the high human fatalities and financial burden of medication errors for healthcare systems worldwide, reducing their occurrence is a global priority. Therefore, appropriate policies to reduce medication errors, using national data and valid statistics are required. The primary objective of this study was to provide a national ‘characteristic profile’ of medication error-associated adverse drug reactions (ADRs), which are also known as preventable ADRs (pADRs). A retrospective study of pADR reports submitted to the national pharmacovigilance center (PCV) within Iran’s Food and Drug Administration was conducted over a 2-year period (2015-2017). Preventability Method (P-Method), which is a standardized tool developed and recommended by the World Health Organization (WHO), was used for preventability assessment. The results of the analyses revealed that while the number of pADRs increased from year one to two (601 to 630), their proportion out of all ADRs per year decreased (7.32% to 6.44%). The percentage of pADRs was higher in females (61.01%) and adults (83.27%), and the highest number of reports were received by nurses (71.57%). Having ‘a documented hypersensitivity to an administered drug or drug class’ was the most common preventable factor in both years (61.23% and 54.29% respectively), and ‘anti-infectives used systemically’ were the medication class which primarily contributed to both serious (53.29%) and non-serious pADRs (39.19%). The specific characteristics of medication errors associated with ADRs from this study, especially the preventable criteria which led to their occurrence, can help devise more specific preventative policies.

Highlights

Supplementary File 1 (Download)

Keywords

Main Subjects


  1. Ferner RE, Aronson JK. Clarification of terminology in medication errors: definitions and classification. Drug Saf. 2006;29(11):1011-1022. doi:10.2165/00002018-200629110-00001
  2. Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009;67(6):599-604. doi:10.1111/j.1365-2125.2009.03415.x
  3. Taxonomy of Medication Errors. National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP). http://www.nccmerp.org/types-medication-errors.  Accessed April 2017. Published 1996.
  4. Hartwig SC, Denger SD, Schneider PJ. Severity-indexed, incident report-based medication error-reporting program. Am J Hosp Pharm. 1991;48(12):2611-2616.
  5. Aronson JK. Medication errors: what they are, how they happen, and how to avoid them. QJM. 2009;102(8):513-521. doi:10.1093/qjmed/hcp052
  6. Good practice guide on recording, coding, reporting and assessment of medication errors. European Medicines Agency (EMA); 2015. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196979.pdf.  Accessed May 2017.
  7. World Health Organization. Reporting and learning systems for medication errors: the role of pharmacovigilance centres. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/emp_mes/en.  Accessed May 2017. Published 2014.
  8. Sixty-ninth World Health Assembly Addressing the Global Challenge of Medication Safety to Improve Patient Safety and Quality of Care, Side Event on Wednesday 25 May 2016. http://www.portal.pmnch.org/patientsafety/campaigns/wha_69_side_event_agenda_25_may_2016.pdf.  Accessed May 2017.
  9. Wittich CM, Burkle CM, Lanier WL. Medication errors: an overview for clinicians. Mayo Clin Proc. 2014;89(8):1116-1125. doi:10.1016/j.mayocp.2014.05.007
  10. Bayazidi S, Zarezadeh Y, Zamanzadeh V, Parvan K. Medication Error Reporting Rate and its Barriers and Facilitators among Nurses. J Caring Sci. 2012;1(4):231-236. doi:10.5681/jcs.2012.032
  11. World Health Organization. Medication Without Harm - Global Patient Safety Challenge on Medication Safety. Geneva: World Health Organization; 2017. http://apps.who.int/iris/bitstream/10665/255263/1/WHO-HIS-SDS-2017.6-eng.pdf?ua=1&ua=1.  Accessed May 2017.
  12. Mansouri A, Ahmadvand A, Hadjibabaie M, Kargar M, Javadi M, Gholami K. Types and severity of medication errors in Iran; a review of the current literature. Daru. 2013;21(1):49. doi:10.1186/2008-2231-21-49
  13. Mansouri A, Ahmadvand A, Hadjibabaie M, et al. A review of medication errors in iran: sources, underreporting reasons and preventive measures. Iran J Pharm Res. 2014;13(1):3-17.
  14. Guidelines on Good Pharmacovigilance Practices (GVP): Annex I -  Definitions. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500143294.pdf.  Accessed May 2017. Published October 9, 2017.
  15. ICH Harmonaised Tripartite Guideline -- Clinical Safety Data Management; Definitions and Standards for Expedited Reporting E2A (version 4). International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use; 1994. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2A/Step4/E2A_Guideline.pdf.  Accessed May 2017. 
  16. Contemporary View of Medication– Related Harm. A New Paradigm. National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP); 2015. http://www.nccmerp.org/sites/default/files/nccmerp_fact_sheet_2015-02-v91.pdf.  Accessed June 2017.
  17. Goedecke T, Ord K, Newbould V, Brosch S, Arlett P. Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error Prevention. Drug Saf. 2016;39(6):491-500. doi:10.1007/s40264-016-0410-4
  18. Alj L, Touzani MDW, Benkirane R, Edwards IR, Soulaymani R. Detecting medication errors in pharmacovigilance database: capacities and limits. Int J Risk Saf Med. 2007;19(4):187-194.
  19. World Health Organization (WHO). Reporting and learning systems for medication errors: the role of pharmacovigilance centres. http://apps.who.int/medicinedocs/documents/s21625en/s21625en.pdf.  Accessed May 2017. Published 2014.
  20. Hutton B, Kanji S, McDonald E, et al. Incidence, causes, and consequences of preventable adverse drug events: protocol for an overview of reviews. Syst Rev. 2016;5(1):209. doi:10.1186/s13643-016-0392-4
  21. Guidelines for ATC classification and DDD assignment, 2018. Oslo: WHO Collaborating Centre for Drug Statistics Methodology; 2017. https://www.whocc.no/atc_ddd_index_and_guidelines/guidelines/.  Accessed June 2017.
  22. Benkirane R, Soulaymani-Bencheikh R, Khattabi A, et al. Assessment of a new instrument for detecting preventable adverse drug reactions. Drug Saf. 2015;38(4):383-393. doi:10.1007/s40264-014-0257-5
  23. The use of the WHO-UMC system for standardised case causality assessment. http://www.who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf.  Accessed May 2017.
  24. Bencheikh RS, Benabdallah G. Medication errors: pharmacovigilance centres in detection and prevention. Br J Clin Pharmacol. 2009;67(6):687-690. doi:10.1111/j.1365-2125.2009.03426.x
  25. Hakkarainen KM, Gyllensten H, Jonsson AK, Andersson Sundell K, Petzold M, Hagg S. Prevalence, nature and potential preventability of adverse drug events - a population-based medical record study of 4970 adults. Br J Clin Pharmacol. 2014;78(1):170-183. doi:10.1111/bcp.12314
  26. Hakkarainen KM, Hedna K, Petzold M, Hagg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions--a meta-analysis. PLoS One. 2012;7(3):e33236. doi:10.1371/journal.pone.0033236
  27. Specialist centres supporting WHO and the International Drug Monitoring programme; Uppsala Monitoring Center (UMC). https://www.who-umc.org/global-pharmacovigilance/specialist-centres/.  Accessed May 2017.
  28. Irrational Use of Medicine. Financial Tribune - First Iranian English Economic Daily. May 27, 2016. https://financialtribune.com/articles/people/42319/irrational-use-of-medicine.  Accessed May 2017.
  29. Thompson AE, Anisimowicz Y, Miedema B, Hogg W, Wodchis WP, Aubrey-Bassler K. The influence of gender and other patient characteristics on health care-seeking behaviour: a QUALICOPC study. BMC Fam Pract. 2016;17:38. doi:10.1186/s12875-016-0440-0
  30. Aagaard L, Strandell J, Melskens L, Petersen PS, Holme Hansen E. Global patterns of adverse drug reactions over a decade: analyses of spontaneous reports to VigiBase. Drug Saf. 2012;35(12):1171-1182. doi:10.2165/11631940-000000000-00000
  31. Abdel-Latif MM, 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 Pharm J. 2015;23(2):154-161. doi:10.1016/j.jsps.2014.07.005
  32. Shamim S, Sharib SM, Malhi SM, et al. Adverse drug reactions (ADRS) reporting: awareness and reasons of under-reporting among health care professionals, a challenge for pharmacists. Springerplus. 2016;5(1):1778. doi:10.1186/s40064-016-3337-4
  33. Abolhassani N, Akbari Sari A, Rashidian A, Rastegarpanah M. Assessment of orthographic similarity of drugs names between Iran and overseas using the solar model. Iran J Public Health. 2017;46(12):1652-1658.