Skip to main content

Advertisement

Log in

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

  • Research Article
  • Published:
International Journal of Clinical Pharmacy Aims and scope Submit manuscript

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.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  Google Scholar 

  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. 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.

    Article  CAS  PubMed  Google Scholar 

  5. Sharp J. Quality in the manufacture of medicines and other healthcare products. London: Pharmaceutical Press; 2000. p. 331–60.

    Google Scholar 

  6. Farwell J. Aseptic dispensing for NHS patients (Farwell report). London: Department of Health; 1995.

    Google Scholar 

  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. 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. 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.

    Article  Google Scholar 

  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. Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther. 2001;26:5–14.

    Article  CAS  PubMed  Google Scholar 

  12. Definition of Webropol. http://www.webropol.fi/. Accessed 29 Feb 2016.

  13. Keeney S, Hasson F, Mckenna H. The Delphi technique in nursing and health research. Hoboken: Wiley; 2010.

    Google Scholar 

  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. Dougherty L, Lister S. The Royal Marsden Hospital Manual of Clinical Nursing procedures. 8th ed. Chichester: Wiley; 2012.

    Google Scholar 

  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. Nurminen ML. Lääkehoito (Medication). 9th ed. Helsinki: Sanoma Pro Oy; 2008.

    Google Scholar 

  18. Taam-Ukkonen M, Saano S. Turvallisen lääkehoidon perusteet (Principles of Safe Medication). 8th ed. Helsinki: Sanoma Pro Oy; 2016.

    Google Scholar 

  19. Saano S, Naaranlahti T, Helin-Tanninen M, Järviluoma E. Sairaalafarmasia (Hospital Pharmacy). 1st ed. Kuopio: Farmasian opiskelijayhdistys Fortis ry; 2005.

    Google Scholar 

  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. Saano S, Taam-Ukkonen M. Lääkehoidon käsikirja (Handbook of Pharmacotherapy). 1st ed. Helsinki: Sanoma Pro Oy; 2013.

    Google Scholar 

  22. Karhumäki E, Jonsson A, Saros M. Mikrobit hoitotyön haasteena (Microbes challenge for nursing). 2nd ed. Helsinki: Edita Prima Oy; 2009.

    Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  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.

    Article  CAS  PubMed  Google Scholar 

  27. McCrea MK. No excuse for unsafe injection practices. AORN J. 2013;97:132–5.

    Article  PubMed  Google Scholar 

  28. Campbell SM, Cantrill JA. Consensus methods in prescribing research. J Clin Pharm Ther. 2001;26:5–14.

    Article  CAS  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

  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.

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

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

Funding

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Eeva Suvikas-Peltonen.

Ethics declarations

Conflicts of interest

None.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary material 1 (XLSX 20 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Suvikas-Peltonen, E., Granfors, E., Celikkayalar, E. et al. Development and content validation of an assessment tool for medicine compounding on hospital wards. Int J Clin Pharm 38, 1457–1463 (2016). https://doi.org/10.1007/s11096-016-0389-z

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11096-016-0389-z

Keywords

Navigation