Identification of priorities for medication safety in the neonatal intensive care unit via failure mode and effect analysis

Document Type: Original Article


1 Associate Professor, Health Services Management, Health Sciences Research Center, Department of Health and Management, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran

2 MSc, Health Services Management, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran

3 MSc, Health Services Management, Imam Reza Hospital Administrator, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran

4 MD, Internist, Clinical Toxicologist, Assistant Professor, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran


Prevention of medication errors in neonatal intensive care units (NICUs) is of paramount importance due to age-specific and physiological conditions of neonates. This study aimed to evaluate the risk of medication prescription and administration via failure mode and effects analysis (FMEA), which was carried out at the Research and Medical Teaching Center of Imam Reza Hospital in Mashhad, Iran.
Methods: In this study, we adopted qualitative (action research) and quantitative (descriptive cross-sectional research) methods. The FMEA of the prescribed and administered medications in the NICU was performed using the nine-step FMEA by the National Center for Patient Safety. A diagram was plotted to determine the potential failure modes and effects of an error by the brainstorming team and to evaluate factors leading to errors. It was suggested to determine improvement strategies via interviews with team members and consider the requirements of the study units. Quantitative analysis of descriptive statistics (total points) was used to assess the content and qualitative data and reach expert consensus.
Results: In this study, two processes, including prescription and use of drugs in the pediatric intensive care unit, were used. In this regard, seven activities, 29 sub-processes 29, and 68 failure modes were identified by FMEA technique, five of which were identified as high-risk modes using prioritization matrix. Moreover, a risk priority number (RPN) of 100 was considered critical for the possible errors in drug prescription by physicians and was proposed as a method to reduce or eliminate failure modes.
Conclusion: FMEA is an effective proactive risk-assessment tool, used to help multidisciplinary teams to understand the healthcare process and identify the possible errors. In addition, it helps prioritize remedial interventions for patients and enhance the safety of drug prescription in neonates.


  1. Keers RN, Williams SD, Cooke J, Ashcroft DM. Causes of medication administration errors in hospitals: a systematic review of quantitative and qualitative evidence. Drug Saf. 2013; 36(11):1045-67.
  2. Ferner RE, Aronson JK. Clarification of terminology in medication errors: definitions and classification. Drug Saf. 2006; 29(11):1011-22.
  3. McLeod M, Barber N, Franklin BD. Facilitators and barriers to safe medication administration to hospital inpatients: a mixed methods study of nurses’ medication administration processes and systems (the MAPS Study). PLoS One. 2015; 10(6):e0128958.
  4. Keers RN, Williams SD, Cooke J, Ashcroft DM. Prevalence and nature of medication administration errors in health care settings: a systematic review of direct observational evidence. Ann Pharmacother. 2013; 47(2):237-56.
  5. Kaufmann J, Laschat M, Wappler F. Medication errors in pediatric emergencies: a systematic analysis. Dtsch Arztebl Int. 2012; 109(38):609-16.
  6. Zakharov S, Tomas N, Pelclova D. Medication errors--an enduring problem for children and elderly patients. Ups J Med Sci. 2012; 117(3):309-17.
  7. Neuspiel DR, Taylor MM. Reducing the risk of harm from medication errors in children. Health Serv Insights. 2013; 6:47-59.
  8. Moyen E, Camire E, Stelfox HT. Clinical review: medication errors in critical Care. Crit Care. 2008; 12(2):208.
  9. Kruer RM, Jarrell AS, Latif A. Reducing medication errors in critical care: a multimodal approach. Clin Pharmacol. 2014; 6:117-26.
10. Rahimi S, Seyyed-rasouli A. Nurse’s drug precautions awareness. Iran J Nurs. 2004; 16(36):53-6.

11. MUSAREZAIE A, MOMENI GGT, ZARGHAM BA, HAJ SE. Survey of the medication errors and refusal to report medication errors from the viewpoints of nurses in hospitals affiliated to isfahan university of medical sciences, IRAN. 2013; 9(1):76-85.

12. Thornton E, Brook OR, Mendiratta-Lala M, Hallett DT, Kruskal JB. Application of failure mode and effect analysis in a radiology department. Radiographics. 2011; 31(1):281-93.

13. Shebl NA, Franklin BD, Barber N. Failure mode and effects analysis outputs: are they valid? BMC Health Serv Res. 2012; 12:150.

14. Shebl N, Franklin B, Barber N, Burnett S, Parand A. Failure mode and effects analysis: views of hospital staff in the UK. J health Serv Res Policy. 2012; 17(1):37-43.

15. Dean Franklin B, Shebl NA, Barber N. Failure mode and effects analysis: too little for too much? BMJ quality & safety. 2012; 21(7):607-11.

16. Alba Mesa F, Sanchez Hurtado MA, Sanchez Margallo FM, Gomez Cabeza de Vaca V, Komorowski AL. Application of failure mode and effect analysis in laparoscopic colon surgery training. World J Surg. 2015; 39(2):536-42.

17. Rosen MA, Sampson JB, Jackson EV Jr, Koka R, Chima AM, Ogbuagu OU, et al. Failure mode and effects analysis of the universal anaesthesia machine in two tertiary care hospitals in Sierra Leone. Br J Anaesth. 2014; 113(3):410-5.

18. Sawant A, Dieterich S, Svatos M, Keall P. Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems. Med Phys. 2010; 37(12):6466-79.

19. Ozilgen S, Bucak S, Ozilgen M. Improvement of the safety of the red pepper spice with FMEA and post processing EWMA quality control charts. J Food Sci Technol. 2013; 50(3):466-76.

20. Chiozza ML, Ponzetti C. FMEA: a model for reducing medical errors. Clin Chim Acta. 2009; 404(1):75-8.

21. Lisby M, Nielsen LP, Mainz J. Errors in the medication process: frequency, type, and potential clinical consequences. Int J Qual Health Care. 2005; 17(1):15-22.

22. Weingart SN, Spencer J, Buia S, Duncombe D, Singh P, Gadkari M, et al. Medication safety of five oral chemotherapies: a proactive risk assessment. J Oncol Pract. 2011; 7(1):2-6.

23. Rosen MA, Chima AM, Sampson JB, Jackson EV Jr., Koka R, Marx MK, et al. Engaging staff to improve quality and safety in an austere medical environment: a case-control study in two Sierra Leonean hospitals. Int J Qual Health Care. 2015; 27(4):320-7.

24. Zeleke A, Chanie T, Woldie M. Medication prescribing errors and associated factors at the pediatric wards of Dessie Referral Hospital, Northeast Ethiopia. Int Arch Med. 2014; 7:18.

25. Krahenbuhl-Melcher A, Schlienger R, Lampert M, Haschke M, Drewe J, Krahenbuhl S. Drug-related problems in hospitals: a review of the recent literature. Drug Saf. 2007; 30(5):379-407.

26. Berdot S, Sabatier B, Gillaizeau F, Caruba T, Prognon P, Durieux P. Evaluation of drug administration errors in a teaching hospital. BMC Health Serv Res. 2012; 12:60.

27. Fahimi F, Abbasi Nazari M, Abrishami R, Sistanizad M, Mazidi T, Faghihi T, et al. Transcription errors observed in a teaching hospital. Arch Iran Med. 2009; 12(2):173-5.

28. Lan YH, Wang KW, Yu S, Chen IJ, Wu HF, Tang FI. Medication errors in pediatric nursing: assessment of nurses' knowledge and analysis of the consequences of errors. Nurse Educ Today. 2014; 34(5):821-8.

29. Lago P, Bizzarri G, Scalzotto F, Parpaiola A, Amigoni A, Putoto G, et al. Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open. 2012; 2(6):e001249.

30. Zeraatchi A, Talebian MT, Nejati A, Dashti-Khavidaki S. Frequency and types of the medication errors in an academic emergency department in Iran: the emergent need for clinical pharmacy services in emergency departments. J Res Pharm Pract. 2013; 2(3):118-22.

31. 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.

32. Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009; 67(6):599-604.

33. Paredes-Atenciano JA, Roldan-Avina JP, Gonzalez-Garcia M, Blanco-Sanchez MC, Pinto-Melero MA, Perez-Ramirez C, et al. Failure mode and effects analysis on computerized drug prescriptions. Rev Calid Asist. 2015; 30(4):182-94.