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International Journal of Clinical Pharmacy

, Volume 38, Issue 6, pp 1457–1463 | Cite as

Development and content validation of an assessment tool for medicine compounding on hospital wards

  • Eeva Suvikas-PeltonenEmail author
  • Eija Granfors
  • Ercan Celikkayalar
  • Raisa Laaksonen
  • Joni Palmgren
  • Marja Airaksinen
Research Article

Abstract

Background Medicines should be compounded by using an aseptic technique to assure patient safety. The parenteral administration of microbiologically contaminated doses can result in bacteriaemia, other morbidity and even death. Objective The purpose was to develop and content validate an assessment tool for medicine compounding on hospital wards suitable for self-assessment and external audit to ensure the safety of medicine compounding on wards. Setting Finland as setting. Method The first draft of the tool was based on ISMP “Guidelines for safe preparation of sterile compounds” and a systematic literature search. The tool was validated by using a two-rounded Delphi-method with a panel of 19 experts. Suitability and feasibility of each item was evaluated. Main outcome measure An agreement of ≥70% on each item was required. Results The final tool comprises of 64 items under the following topics: (1) general principles of good compounding practices (23 items), (2) recording and confirming medicine orders on the wards (5 items), (3) storage of medicines on the wards (7), (4) aseptic compounding of intravenous medicines (25 items) and (5) quality assurance (4 items). Most items related to General principles of good compounding practices and Compounding of IV medicines (36 and 38% of the items, respectively). Conclusion It was possible to develop and content validate, by the Delphi method, an assessment tool for safe aseptic compounding on hospital wards. A two-round Delphi process yielded consensus on 64 items for this purpose.

Keywords

Aseptic technique Tool Audit Medicine compounding Finland Quality assessment 

Notes

Acknowledgements

Corresponding author was supported by the state research funding granted by Satakunta Hospital District when completing this manuscript.

Funding

None.

Conflicts of interest

None.

Supplementary material

11096_2016_389_MOESM1_ESM.xlsx (19 kb)
Supplementary material 1 (XLSX 20 kb)

References

  1. 1.
    Noskin GA, Rubin RJ, Schentag JJ, Kluytmans J, Hedblom EC, Smulders M, et al. The Burden of Staphylococcus aureus infections in hospitals in the United States: an analysis of the 2000 and 2001 nationwide inpatient sample database. Arch Intern Med. 2005;165:1756–61.CrossRefPubMedGoogle Scholar
  2. 2.
    National Nosocomical Infections Surveillance System. National nosocomical infections surveillance (NNIS) system report, data summary from January 1992 through June 2004, issued October 2004. Am J Infect Control. 2004;32:470–85.CrossRefGoogle Scholar
  3. 3.
    Institute for Safe Medication Practices (ISMP): guidelines for safe preparation of sterile compounds, 2013. http://www.ismp.org/tools/guidelines/IVSummit/IVCGuidelines.pdf. Accessed 29 Feb 2016.
  4. 4.
    Olivier LC, Kendoff D, Wolfhard U, Nast-Kolb D, Nazif Yazici M, Esche H. Modified syringe design prevents plunger-related contamination-results of contamination and flow rate tests. J Hosp Infect. 2003;53:140–3.CrossRefPubMedGoogle Scholar
  5. 5.
    Sharp J. Quality in the manufacture of medicines and other healthcare products. London: Pharmaceutical Press; 2000. p. 331–60.Google Scholar
  6. 6.
    Farwell J. Aseptic dispensing for NHS patients (Farwell report). London: Department of Health; 1995.Google Scholar
  7. 7.
    The Finnish Medicines Agency (Fimea). Määräys 6/2011, Apteekkien lääkevalmistus (Requirement 6/2011: preparation of medicines in pharmacies). http://www.fimea.fi/documents/160140/764653/20675_FINAL_Apteekkien_laakevalmistus_maarays_SUOMI_2011-12-16.pdf. Accessed 29 Feb 2016.
  8. 8.
    The Finnish Medicines Agency (Fimea). Määräys 6/2012, Sairaala-apteekin ja lääkekeskuksen toiminta (Requirement 6/2012: Function of hospital pharmacies and dispensaries). http://www.fimea.fi/documents/160140/764653/22690_Maarays_6_2012.pdf. Accessed 29 Feb 2016.
  9. 9.
    Garqiulo DA, Sheridan J, Webster CS, Swift S, Torrie J, Weller J, et al. Anaesthetic drug administration as a potential contributor to healthcare-associated infections: a prospective simulation-based evaluation of aseptic techniques in the administration of anaesthetic drugs. BMJ Qual Saf. 2012;21:826–34.CrossRefGoogle Scholar
  10. 10.
    Hsu C-C, Sandford BA. The Delphi technique: making sense of consensus. Pract Assess Res Eval. 2007;12(10):1–7.Google Scholar
  11. 11.
    Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther. 2001;26:5–14.CrossRefPubMedGoogle Scholar
  12. 12.
    Definition of Webropol. http://www.webropol.fi/. Accessed 29 Feb 2016.
  13. 13.
    Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Hoboken: Wiley; 2010.Google Scholar
  14. 14.
    European commission. EU guidelines to good manufacturing practice medicinal products for human and veterinary use. 2008; 4 Annex 1: manufacture of sterile medicinal products (corrected version) http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf. Accessed 29 Feb 2016.
  15. 15.
    Dougherty L, Lister S. The Royal Marsden Hospital Manual of Clinical Nursing procedures. 8th ed. Chichester: Wiley; 2012.Google Scholar
  16. 16.
    Koskinen T, Ojala R, Puirava A, Puirava P, Sälimäki J. Lääketietoa ammattilaisille (Drug information for professionals). 1st ed. Helsinki: Sanoma Pro Oy; 2012.Google Scholar
  17. 17.
    Nurminen ML. Lääkehoito (Medication). 9th ed. Helsinki: Sanoma Pro Oy; 2008.Google Scholar
  18. 18.
    Taam-Ukkonen M, Saano S. Turvallisen lääkehoidon perusteet (Principles of Safe Medication). 8th ed. Helsinki: Sanoma Pro Oy; 2016.Google Scholar
  19. 19.
    Saano S, Naaranlahti T, Helin-Tanninen M, Järviluoma E. Sairaalafarmasia (Hospital Pharmacy). 1st ed. Kuopio: Farmasian opiskelijayhdistys Fortis ry; 2005.Google Scholar
  20. 20.
    Veräjänkorva O, Huupponen R, Huupponen U, Kaukkila H-S, Torniainen K. Lääkehoito hoitotyössä (Pharmacotherapy in Nursing). 1st ed. Helsinki: WSOY; 2006.Google Scholar
  21. 21.
    Saano S, Taam-Ukkonen M. Lääkehoidon käsikirja (Handbook of Pharmacotherapy). 1st ed. Helsinki: Sanoma Pro Oy; 2013.Google Scholar
  22. 22.
    Karhumäki E, Jonsson A, Saros M. Mikrobit hoitotyön haasteena (Microbes challenge for nursing). 2nd ed. Helsinki: Edita Prima Oy; 2009.Google Scholar
  23. 23.
    Austin P, Elia M. Improved aseptic technique can reduce variable contamination rates of ward-prepared parenteral doses. J Hosp Infect. 2013;83:160–3.CrossRefPubMedGoogle Scholar
  24. 24.
    De Smet B, Veng C, Kruy L, Kham C, van Griensven C, Peeters C, et al. Outbreak of Burkholderia cepacia bloodstream infections traced to the use of Ringer lactate solution as multiple-dose vial for catheter flushing, Phnom Penh, Cabodia. Clin Microbiol Infect. 2013;19:832–7.CrossRefPubMedGoogle Scholar
  25. 25.
    Cousins DH, Sabatier B, Beque D, Schmitt C, Hoppe-Tichy T. Medication errors in intravenous drug preparation and administration: a multicentre audit in the UK, Germany and France. Qual Saf Health Care. 2005;14:190–5.CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    Frean JA, Arntzen L, Rosekilly I, Isaäcson M. Investigation of contaminated parenteral nutrition fluids associated with an outbreak of serratia odorifera septicaemia. J Hosp Infect. 1994;27:263–73.CrossRefPubMedGoogle Scholar
  27. 27.
    McCrea MK. No excuse for unsafe injection practices. AORN J. 2013;97:132–5.CrossRefPubMedGoogle Scholar
  28. 28.
    Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther. 2001;26:5–14.CrossRefPubMedGoogle Scholar
  29. 29.
    Fick DM, Cooper JW, Wade WE, Waller JL, Maclean JR, Beers MH. Updating the Beers criteria for potentially inappropriate medication use in older adults: results of US consensus panel of experts. Arch Intern Med. 2003;163:2716–24.CrossRefPubMedGoogle Scholar
  30. 30.
    Laroche ML, Charmes JP, Merle L. Potentially inappropriate medications in the elderly: a French consensus panel list. Eur J Clin Pharmacol. 2007;63:725–31.CrossRefPubMedGoogle Scholar
  31. 31.
    Dimitrow MS, Mykkänen SI, Leikola SN, Kivelä SL, Lyles A, Airaksinen MS. Content validation of a tool for assessing risks for drug-related problems to be used by practical nurses caring for home-dwelling clients aged ≥65 years: a Delphi survey. Eur J Clin Pharmacol. 2014;70:991–1002.CrossRefPubMedGoogle Scholar
  32. 32.
    Teinilä T, Halmepuro-Jaatinen S, Yritys K, Manni K, Airaksinen M. Adapting the US Institute for Safe Medication Practices’ Medication Safety Self-Assessment tool for community pharmacies in Finland. Int J Pharm Pract. 2012;20:15–24.CrossRefPubMedGoogle Scholar
  33. 33.
    Celikkayalar E, Myllyntausta M, Grissinger M, Airaksinen M. Adapting and remodelling the US Institute for Safe Medication Practices’ Medication Safety Self-Assessment tool for hospitals to be used to support natuonal medication safety initiatives in Finland. Int J Pharm Pract. 2016;24(4):262–70.CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing 2016

Authors and Affiliations

  1. 1.Satakunta Central HospitalPoriFinland
  2. 2.PoriFinland
  3. 3.Helsingin yliopistoHelsinkiFinland

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