Perioperative Recommendations for Medication Safety

NCT04240301 | Not Yet Recruiting

• 1 other identifier: 2019P003567
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the proposed research is to create and disseminate expert-based recommendations for perioperative medication safety that are tailored to country income level, using the World Bank's four country income groups: high, upper-middle, lower-middle, and low income. The specific aims of the research are to: 1) Develop consensus-based perioperative medication safety recommendations, 2) Prioritize the recommendations by their level of clinical importance for implementation in high, upper-middle, lower-middle and low income countries, and disseminate the recommendations; and 3) Evaluate the initial adoption of the recommendations in each country income group.

Conditions

Perioperative Medication Safety

Keywords

medication safety; anesthesiology; perioperative

Outcome Measures

Primary Outcomes (1)

• Expert-based medication safety recommendations.

  Four tiers of stepwise recommendations, corresponding to each of the World Bank's four country income groups.

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Our expert panel will consist of 120 members, 30 from each of the World Bank's four county country income groups: high, upper-middle, lower-middle, and low income. Expert panel members will be anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts.

You may qualify if:

• Anesthesiologists, surgeons, operating room nurses, nurse anesthetists, pharmacists and patient safety experts

You may not qualify if:

• None

Sponsors & Collaborators

• Karen C. Nanji,M.D.,M.P.H.: lead
• World Federation of Societies of Anesthesiologists: collaborator
• University of California, San Francisco: collaborator
• Aga Khan University: collaborator
• University of Toronto: collaborator
• University of Minnesota: collaborator
• University of Auckland, New Zealand: collaborator

Related Publications (10)

• Merry AF, Webster CS, Hannam J, Mitchell SJ, Henderson R, Reid P, Edwards KE, Jardim A, Pak N, Cooper J, Hopley L, Frampton C, Short TG. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation. BMJ. 2011 Sep 22;343:d5543. doi: 10.1136/bmj.d5543.

  PMID: 21940742 BACKGROUND

• Nanji KC, Patel A, Shaikh S, Seger DL, Bates DW. Evaluation of Perioperative Medication Errors and Adverse Drug Events. Anesthesiology. 2016 Jan;124(1):25-34. doi: 10.1097/ALN.0000000000000904.

  PMID: 26501385 BACKGROUND

• Llewellyn RL, Gordon PC, Wheatcroft D, Lines D, Reed A, Butt AD, Lundgren AC, James MF. Drug administration errors: a prospective survey from three South African teaching hospitals. Anaesth Intensive Care. 2009 Jan;37(1):93-8. doi: 10.1177/0310057X0903700105.

  PMID: 19157353 BACKGROUND

• Orser BA, Chen RJ, Yee DA. Medication errors in anesthetic practice: a survey of 687 practitioners. Can J Anaesth. 2001 Feb;48(2):139-46. doi: 10.1007/BF03019726.

  PMID: 11220422 BACKGROUND

• Shridhar Iyer U, Fah KK, Chong CK, Macachor J, Chia N. Survey of medication errors among anaesthetists in Singapore. Anaesth Intensive Care. 2011 Nov;39(6):1151-2. No abstract available.

  PMID: 22165377 BACKGROUND

• Webster CS, Merry AF, Larsson L, McGrath KA, Weller J. The frequency and nature of drug administration error during anaesthesia. Anaesth Intensive Care. 2001 Oct;29(5):494-500. doi: 10.1177/0310057X0102900508.

  PMID: 11669430 BACKGROUND

• Wahr JA, Abernathy JH 3rd, Lazarra EH, Keebler JR, Wall MH, Lynch I, Wolfe R, Cooper RL. Medication safety in the operating room: literature and expert-based recommendations. Br J Anaesth. 2017 Jan;118(1):32-43. doi: 10.1093/bja/aew379. Epub 2016 Dec 30.

  PMID: 28039240 BACKGROUND

• Whitaker D, Brattebo G, Trenkler S, Vanags I, Petrini F, Aykac Z, Longrois D, Loer SA, Gaszynski T, Sipylaite J, Copaciu E, Cerny V, Akeson J, Mellin-Olsen J, Abela C, Stecher A, Kozek-Langenecker S, Ratsep I; European Section and Board of Anaesthesiology of the UEMS. The European Board of Anaesthesiology recommendations for safe medication practice: First update. Eur J Anaesthesiol. 2017 Jan;34(1):4-7. doi: 10.1097/EJA.0000000000000531.

  PMID: 27548778 BACKGROUND

• Utley M, Gallivan S, Mills M, Mason M, Hargraves C. A consensus process for identifying a prioritised list of study questions. Health Care Manag Sci. 2007 Feb;10(1):105-10. doi: 10.1007/s10729-006-9003-6.

  PMID: 17323658 BACKGROUND

• Nanji KC, Merry AF, Shaikh SD, Pagel C, Deng H, Wahr JA, Gelb AW, Orser BA. Global PRoMiSe (Perioperative Recommendations for Medication Safety): protocol for a mixed-methods study. BMJ Open. 2020 Jun 30;10(6):e038313. doi: 10.1136/bmjopen-2020-038313.

  PMID: 32606066 DERIVED

Study Officials

• Karen C. Nanji, M.D., M.P.H.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen C. Nanji, M.D., M.P.H.

CONTACT

(617) 724-8544; KNANJI@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia at Harvard Medical School

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share