Peter J. Carr, Conceptualization , Formal Analysis , Funding Acquisition , Investigation , Methodology , Project Administration , Resources , Supervision , Validation , Visualization , Writing – Original Draft Preparation , Writing – Review & Editing , a, 1 Laura O'Connor, Investigation , Methodology , Project Administration , Visualization , Writing – Original Draft Preparation , Writing – Review & Editing , 1 Georgina Gethin, Conceptualization , Investigation , Methodology , Resources , Visualization , Writing – Original Draft Preparation , Writing – Review & Editing , 1 John D. Ivory, Investigation , Methodology , Visualization , Writing – Original Draft Preparation , 1 Paul O'Hara, Investigation , Methodology , Writing – Original Draft Preparation , Writing – Review & Editing , 2 Orla O'Toole, Investigation , Methodology , Visualization , Writing – Original Draft Preparation , Writing – Review & Editing , 3 and Patricia Healy, Conceptualization , Investigation , Methodology , Validation , Visualization , Writing – Original Draft Preparation , Writing – Review & Editing 1
1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland
Find articles by Peter J. Carr1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland
Find articles by Laura O'Connor1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland
Find articles by Georgina Gethin1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland
Find articles by John D. Ivory2 University Hospital Galway, Galway, Ireland
Find articles by Paul O'Hara3 Clinical Trials Unit, HRB Clinical Research Facility, University Hospital Galway, Galway, Ireland
Find articles by Orla O'Toole1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland
Find articles by Patricia Healy 1 School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland 2 University Hospital Galway, Galway, Ireland 3 Clinical Trials Unit, HRB Clinical Research Facility, University Hospital Galway, Galway, Ireland No competing interests were disclosed. Accepted 2021 Apr 29. Copyright : © 2021 Carr PJ et al.This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
No underlying data are associated with this article.
Open Science Framework: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety? https://doi.org/10.17605/OSF.IO/U3JBW 15 .
Open Science Framework: PRISMA-P checklist 17 for “Study Protocol: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?”. https://doi.org/10.17605/OSF.IO/U3JBW 15 .
The latest revision of this protocol now incorporates feedback from both peer reviewers. A detailed breakdown of these revisions can be found in the responses to reviewers.
| Review date | Reviewer name(s) | Version reviewed | Review status |
|---|---|---|---|
| 2021 May 28 | Zane Robinson Wolf | Version 3 | Approved |
| 2021 May 12 | Ariane Ferreira Machado Avelar | Version 3 | Approved |
| 2021 Feb 10 | Ariane Ferreira Machado Avelar | Version 2 | Approved |
| 2021 Jan 22 | Zane Robinson Wolf | Version 2 | Approved with Reservations |
| 2020 Jul 9 | Ariane Ferreira Machado Avelar | Version 1 | Approved with Reservations |
Introduction: Intravenous therapy and medicines (IVTM) are the most common invasive interventions in use in healthcare. Prescribed IVTM play an essential role in the treatment of illness, management of chronic conditions and in maintaining health and wellbeing. The intravenous (IV) route is the administration of concentrated medications (diluted or undiluted) directly into peripherally or centrally inserted vascular access devices. Medication safety is a key priority and best practice standards are required to guide the safe preparation and administration of IVTM.
Methods: We will conduct a systematic review of the literature pertaining to the preparation and administration of intravenous therapy and medicines. Our search will include studies concerned with the preparation and/or administration of IVTM via peripheral or central vascular access devices. We will be guided by the preferred reporting items for systematic review and meta-analysis (PRISMA) in this review. Literature will include all trial designs, national/international guidelines, and expert consensus opinion made available in English from 2009 to present day.
Conclusions: We will synthesise the evidence concerning safe and effective preparation and administration of intravenous therapy and medicines to inform the development of a national guideline for healthcare professionals in Ireland. The availability of up-to-date, contemporaneous evidence-based practice standards will ensure quality and safety for service-users.
Registration: This study has been submitted to PROSPERO and we are awaiting confirmation of registration.
Keywords: intravenous therapy and medicine, review protocol, evidence synthesis, patient safety, practice standards
While the concept and practice of intravenous therapy is centuries old, with the first documented blood transfusion taking place in 1492, the key advancements that have made it a ubiquitous part of healthcare today largely occurred in the last two centuries 1 . The cholera epidemic in the early 19 th century led Dr William Brooke O'Shaughnessy to state “ I would not hesitate to inject some ounces of warm water in the veins. I would also, without apprehension, dissolve in that water the mild innocuous salts which nature herself is accustomed to combine with the human blood” 2 , a theory later tested by Dr Thomas Latta to great success 3 . Since then healthcare has witnessed a proliferation of new medicines requiring administration via the circulatory system.
Medication safety has been identified internationally by the World Health Organisation as a key area for improvement in all healthcare settings 4 . In Ireland, a number of medication-related errors appear in the top ten medical incidents reported to the State Claims Agency 5 (for example, incorrect dosages, missed medications, medications being incorrect/not reconciled for changes in care). Such medication incidents were reported from multiple services nationally 6 . Intravenous therapy and medicines (IVTM) safety can impact greatly on patient care. High profile medication errors have directly led to guidance being developed, as well as landmark legal rulings, both resulting in widespread changes to practice 7 .
With up to 90% of admitted patients now receiving IVTM at some point during their stay in hospital, relevant guidelines are more necessary than ever 8 . Additionally, while administration of IVTM was initially considered a role for the doctor alone, rapid developments in the field and the changing roles of healthcare professionals (HCPs) means that the majority of clinical staff will be responsible for the management, preparation, and administration of IVTM at some point. This highlights the various number of healthcare professionals involved in IVTM.
In 2018, the Irish Health Information and Quality Authority (HIQA) published its recommendations on the first phase of the Medication Safety Monitoring Programme. It recommends that hospitals provide clinical staff with easily accessible information such as policies, procedures, guidelines and/or protocols to guide the safe use of medicines at the point of prescribing, preparation and administration 9 .
A guideline is defined as “a principle of criterion that guides or directs action” 10 . The Irish Health Service Executive framework for developing guidelines emphasises using clear evidence from the existing literature, rather than expert opinion alone 10 . In systematically reviewing available literature, we can provide better knowledge and evidence for robust guideline for HCPs.
The aim of this review is to synthesise the evidence for a specific question: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?
This evidence synthesis will then feed into the development of new guidelines for the Irish Health Service Executive (HSE) and be disseminated to the wider research and clinical community. Our report will be guided by the PRISMA statement checklist (preferred reporting items for systematic review and meta-analysis) and the synthesis without meta-analysis (SWiM) extension 11, 12 .
Our primary research question, devised by the HSE to inform their guideline development, is “In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?”. The working group developing this national guideline have further identified the following areas as specific topics of interest:
Literature relating to independent double checking of IVTM Literature relating to the practices required to ensure complete administration of IVTM Literature relating to use of infusion pumps for the delivery of IVTM Literature relating to the standards required for labelling IVTMLiterature relating to the education preparation and competency requirements for healthcare professionals administering IVTM
Literature relating to the involvement of the following undergraduate students in the process of preparation and administration of IVTM: nurses, midwives, doctors, paramedics and radiographers.
To ensure that all relevant national and international peer reviewed evidence and policy literature is considered, this review will include randomised controlled trials (RCTs), systematic reviews, meta-analyses, cohort studies, observational studies, national/international guidelines, and expert consensus opinion made available from 2009 to current (See Table 1 for inclusion and exclusion criteria).
| Included | Excluded |
|---|---|
| RCTs, systematic reviews, meta-analyses, cohort studies, observational studies, national/international guidelines, and expert consensus opinion | Studies published before 2009 |
| Studies involving the preparation and/or administration of IV medicines via peripheral or central venous access devices | Studies focusing on needlefree devices or the introduction, care, or maintenance of access devices |
| Studies focusing on medical professionals, nurses, midwives, paramedics and radiographers, working within pre-hospital, acute hospital and community settings | Studies examining the administration of blood, blood products, or parenteral nutrition |
| Studies carried out in pre-hospital, acute hospital and community settings | Studies focusing on consent to IVT treatment or infection prevention |
RCTs, randomised controlled trials.
Literature must involve the preparation and/or administration of IV medicines via peripheral or central venous access devices.
Studies focusing on needlefree devices or the introduction, care, or maintenance of access devices will be excluded, as will studies examining the administration of blood, blood products, or parenteral nutrition. Studies focusing on consent or infection prevention will be also be excluded, owing to the robust guidelines already integrated into practice (e.g. Epic3 guidelines 13 and the Aseptic Non-Touch Technique (ANTT) framework 14 ). Work published before 2009 will be excluded, to ensure the synthesis reflects current best practices.
All patients receiving IV medicines (adults, children and neonates) in primary or secondary care settings (i.e. pre-hospital, acute hospital and community settings).
We will consider for inclusion any publication that details the preparation of IVTM for administration via peripheral or central venous access devices. This will include slow bolus IVTM injections, intermittent and continuous IV infusions. This review will include studies focusing on medical professionals, nurses, midwives, paramedics and radiographers, working within pre-hospital, acute hospital and community settings.
This review will gather safety and effectiveness outcome data. As these two terms underpin best clinical practice, we propose a broad definition of the following:
For safety outcomes, we will include papers with outcomes relating to incidences of errors in the preparation and/or administration of IVTM.
We will extract data relating to the effectiveness of the intervention in question, i.e. the outcomes as chosen within each study
For effectiveness outcomes:We will extract data relating to the effectiveness of the intervention in question, i.e. the primary outcomes as chosen within each study
We will extract data from studies which describe effectiveness of practiceWe will search the following databases for material published after 2009: Cochrane Library, PubMed, CINAHL, and Web of Science. Additionally, we will search OpenGrey and OAlster for grey literature. Searches are available in Extended data 15 . Searches will be designed by an appropriately experienced search methodologist team member (JDI).
Titles and abstracts will be imported into the systematic review software Covidence 16 . Two authors will screen the title and abstracts of the citations against the pre-specified eligibility criteria. Any discrepancies will be resolved by a content-expert author (PC) if consensus cannot be reached. The same process will be followed for full-text screening. We will record a rationale for exclusion for any papers deemed ineligible at full text. Both title and abstract and full-text screening processes will be piloted to ensure consistency across authors.
Data will be extracted from included studies by two reviewers (PC, LOC) independently using the data extraction tool within Covidence. Any discrepancies between reviewer’s extractions will be highlighted by Covidence, and consensus will be reached through discussion where necessary. The data extraction form will be piloted by two authors (PC, LOC).
Data extracted from each study (where provided) will include:
Primary outcome – All reported outcomes, primary and secondary relating to our defined outcomes of safety and effectiveness
Study/Article description: design, methodology (e.g RCT, cohort study), methods of analysis, data type (qualitative/quantitative), publication date, clinical trial registration and study protocol.
Health care personnel and study demographics: e.g role and treatment setting Care characteristics: primary disease, treatment(s), duration of care IVTM treatment details: drug administered, frequency, duration, access device usedAs our primary aim is to narratively synthesis the evidence, we will not be extracting data relating to risk of bias at this time. However, during data extraction, reviewers will extract data relating to methodology and study quality, to provide a rudimentary indication of evidence quality, and to inform potential further analyses.
There are two phases to our planned data synthesis. Firstly, we will synthesise the included fulltext papers. Data will be extracted under the headings given above into an Excel spreadsheet, and once complete papers will be organised by objective. Each grouping will be narratively reviewed with respect to key themes that appear in multiple papers, significant findings, and any contradictions which may appear, while also drawing attention to any clear gaps in the literature.
Data collected on the methodology of the included papers will be presented in tables for each section, and this data will also be used to give a basic judgement on the overall quality of evidence. Each section will also include a narrative summary of the types of literature being synthesised, and as individual items are discussed their format will also be described to ensure the strength of the evidence is clear.
As methodological data will be collected, should sufficient suitable studies be found, additional separate quantitative and qualitative analyses may be carried out.
We will produce a summary of findings addressing the focused objectives listed above. We anticipate high levels of heterogeneity in eligible studies thus ruling out the possibility of meta-analysis. Therefore, the Synthesis Without Meta-analysis (SWiM) extension to the PRISMA statement checklist will guide the optimal reporting of the work and results 12 .
A report summarising all major findings aligned with the focused objectives will be provided to the HSE to inform their guideline development. Some dissemination activities will be focused specifically on this audience (e.g. summary infographics, invited talks, etc.). Additionally, we plan to publish our findings in a peer reviewed journal. Should the data allow, we will separate qualitative and quantitative evidence and publish syntheses of both.
The search for this study was carried out in February 2020. Title and abstract screening was completed in early March, and full text screening is expected to be completed by early April.
This review will synthesise best available evidence for the preparation and administration of IVT as demonstrated in existing guidelines, peer-reviewed science, and expert consensus, forming an overview of the current state of the field. Ultimately, the findings will be used to inform the development of a Health Service Executive (HSE) national guideline for the administration of intravenous medications by healthcare professionals in Ireland. As such, a limitation of the study is the specificity of the inclusion and exclusion criteria, which are designed to allow this work to complement existing syntheses and minimise overlap with guidelines that are already integrated into clinical practice.
No underlying data are associated with this article.
Open Science Framework: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety? https://doi.org/10.17605/OSF.IO/U3JBW 15 .
Open Science Framework: PRISMA-P checklist 17 for “Study Protocol: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety?”. https://doi.org/10.17605/OSF.IO/U3JBW 15 .
[version 3; peer review: 2 approved]
This review was commissioned by the Health Service Executive (Office of Nursing and Midwifery Services).
1. Dutton WF: Intravenous therapy: Its application in the modern practice of medicine . F.A. Davis Co,1925. Reference Source [Google Scholar]
2. O’Shaughnessy WB: Report on the chemical pathology of the malignant cholera: containing analyses of the blood, dejections, &c. of patients labouring under that disease in Newcastle and London. Lond Highley. 1832. Reference Source [Google Scholar]
3. MacGillivray N: Dr Thomas Latta: the father of intravenous infusion therapy. J Infect Prev. 2009; 10 ( 1_suppl ):S3–S6. 10.1177/1757177409342141 [CrossRef] [Google Scholar]
4. Donaldson LJ, Kelley ET, Dhingra-Kumar N, et al.: Medication Without Harm: WHO’s Third Global Patient Safety Challenge. Lancet. 2017; 389 ( 10080 ):1680–1681. 10.1016/S0140-6736(17)31047-4 [PubMed] [CrossRef] [Google Scholar]
5. Slattery D, Walsh D, Maguire IOB, et al.: National Clinical Incidents, Claims and Costs Report: Lessons learned, a five year review 2010 - 2014 .2017. Reference Source [Google Scholar]
6. Kennedy M: Medication Incidents Reported In Irish Hospitals .2016. Reference Source [Google Scholar]
7. Sud A, Szawarski P: Classic cases revisited - Death of a nurse and the anatomy of error. J Intensive Care Soc. 2018; 19 ( 2 ):155–160. 10.1177/1751143717735203 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
8. Hadaway L: Short peripheral intravenous catheters and infections. J Infus Nurs. 2012; 35 ( 4 ):230–240. 10.1097/NAN.0b013e31825af099 [PubMed] [CrossRef] [Google Scholar]
9. Health Information and Quality Authority: Medication safety monitoring programme in public acute hospitals - An overview of findings . 131.2018. Reference Source [Google Scholar]
10. HSE: HSE National Framework for developing Policies, Procedures, Protocols and Guidelines (PPPGs) . Reader Information Title: HSE National Framework for developing Policies, Procedures, Protocols and Guidelines (PPPGs) HSE National Framework for developing Polic.2016. Reference Source [Google Scholar]
11. Moher D, Liberati A, Tetzlaff J, et al.: Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med. 2009; 151 ( 4 ): 264–9, W64. 10.7326/0003-4819-151-4-200908180-00135 [PubMed] [CrossRef] [Google Scholar]
12. Campbell M, McKenzie JE, Sowden A, et al.: Synthesis without meta-analysis (SWiM) in systematic reviews: reporting guideline. BMJ. 2020; 368 : l6890. 10.1136/bmj.l6890 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
13. Loveday HP, Wilson JA, Pratt RJ, et al.: epic3: national evidence-based guidelines for preventing healthcare-associated infections in NHS hospitals in England. J Hosp Infect. 2014; 86 ( Suppl 1 ):S1–S70. 10.1016/S0195-6701(13)60012-2 [PMC free article] [PubMed] [CrossRef] [Google Scholar]
14. Rowley S, Clare S, Macqueen S, et al.: ANTT v2: An updated practice framework for aseptic technique. Br J Nurs. 2010; 19 ( Sup 1 ):S5–S11. 10.12968/bjon.2010.19.Sup1.47079 [CrossRef] [Google Scholar]
15. O'Connor L, Carr P, Gethin G, et al.: In the preparation and administration of intravenous medicines, what are the best practice standards that healthcare professionals need to follow to ensure patient safety ?2020. 10.17605/OSF.IO/U3JBW [CrossRef]
16. Babineau J: Product Review: Covidence (Systematic Review Software). J Can Health Libr Assoc J Assoc Bibl Santé Can. 2014; 35 ( 2 ):68–71. 10.5596/c14-016 [CrossRef] [Google Scholar]
17. Moher D, Shamseer L, Clarke M, et al.: Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev. 2015; 4 ( 1 ): 1. 10.1186/2046-4053-4-1 [PMC free article] [PubMed] [CrossRef] [Google Scholar]