Needle free systems

NHS PASA Purchasing for Safety - injectable medicines project Pilot Site: Derby Hospitals NHS Foundation Trust

Phase 2 workstream report 1 of 7 February 2008 Needle free Ver 1

Needle free systems 1 Summary: Needles free systems are widely employed in the Trust for safe administration of injectable medicines and to reduce infection risks. Needle free systems are also available for the preparation of hazardous injections (e.g. cytotoxic chemotherapy), reducing the risk of operator injury and environmental contamination. The workstream was identified from issues raised by the Chemotherapy focus group in phase 1 of the project. The workstream will evaluate the Teva ‘Tevadaptor’™ and Baxter ‘Chemo-Aide’™ products within specialist pharmacy aseptic dispensing services using qualitative and quantitative techniques to rate ease of use, time saving, staff safety etc and to make national recommendations for safe aseptic dispensing practice. 2 Background: 2.1 Aim and key benefits

One of the main issues identified from Phase 1 of the project was the potential for needle stick injuries whilst aseptically preparing cytotoxic products. The aim of this particular workstream was to evaluate current local practice for cytotoxic preparation and also identify and evaluate needle-free devices, available on the market, for cytotoxic preparation and administration. Key benefits include: • Safe for operators (eliminates the risk of needle stick injuries). • Ease of use (less manipulations required). • Safer administration (decreases the risk of spillage) • Reduced risk of cytotoxic exposure for both preparation and administration. • Reduced preparation time

2.2 Workstream summary (see Appendix A) 3 Objectives: • Review current practice / techniques in local units and identify key issues • Establish accident rate from needle-stick injuries and other operator risks • Agree quantitative and qualitative criteria for evaluation of these products • Evaluate each product against existing practice for defined period • Undertake risk: benefit analysis; identify strengths & weaknesses of each product • Develop rationale and business case for routine use of these products in NHS • Maintain progress plan and complete workstream report to present to Pilot Team



4 Methods and measures 4.1 Workstream design

The needle-free pilot was to be taken forward by a multidisciplinary team of Pharmacists, Nurses and Pharmacy Technicians. The evaluation of the needle free devices would take place on the chemotherapy day case unit at the Derbyshire Royal Infirmary as this is the area with the highest demand for aseptically prepared cytotoxic products. The two needle-free devices selected for the pilot were the ‘Chemo-Aide’™ marketed by Baxter and the ‘Tevadaptor’™ marketed by Teva. Both products had the benefit of being needle-free for both preparation and administration purposes.

4.2 Evaluation(s)

Evaluations would take place on both the Baxter ‘Chemo-Aide’™ and Teva ‘Tevadaptor’™. The devices would be piloted separately, for one week each. During the evaluation week, each device will be used for aseptic preparation and administration purposes.

4.3 Measures

Each device will be measured indifferently. Quantitative measures would include • Preparation timings • Incident rates • Cost of consumables

Qualitative measures would include

• An assessment questionnaire for both pharmacy and nursing staff discussing advantages/disadvantages of each product and current practice.

5 Workstream outputs 5.1 Literature review

At this present time there are no published guidelines to support the use of needle-free systems in the UK, although there is a study ongoing by Teva. According to Dr E. Walters, medical director of Teva Hospitals1, ‘the study will take place over a 5-week period looking at environmental exposure using both current practice and the ‘Tevadaptor’™ system.’ The study hopes to demonstrate the benefits of the ‘Tevadaptor’™ system. Hopefully the findings will be published in the future.



Most literature available refers to safe handling of cytotoxics but does include reference to needle-free systems. Professor G. Sewell and S. Roberts2 document that ‘cytotoxic contamination issues arise even when protective measures are in place. ’The risks posed by cytotoxic drugs to the operator and environment may be reduced, if not eliminated, by considering additional approaches: firstly, the application of effective decontamination methods, and secondly, the use of intervention (ie, a closed-system drug transfer device).’ The paper then goes on to state the recommendation made by the US National Institute for Occupational Safety (NIOSH)3 for the use of a closed–system drug transfer device to prepare cytotoxic drugs which has been acknowledged by international guidelines and relevant European directives. Within the US, research has been conducted to evaluate different transfer devices and their containment of hazardous drug vapours and also their potential for contamination due to leakage or spillage of hazardous drugs.4−5 Results showed that the Phaseal® system was the closest to a true closed system and reduced the potential amount of contamination.

5.2 Focus groups

Discussions took place with Baxter and Teva on separate occasions in order to:

• View the needle-free system • Demonstrate use of the needle-free system • Raise any issues concerning preparation or administration with needle-

free systems • Discuss pricing of the needle-free system • Train staff in the use of the system for preparation or administration

Discussions also took place with risk services to review any in-house Incident reports that related to cytotoxic needle stick injuries or any other risk to operators.

5.3 Evaluation(s) (see Appendix B)

The first evaluation was devised to review local practice for preparation. Six local hospital aseptic units were sent questionnaires, four replied. The findings were as follows:

• All units used needles for manipulations • Two units used chemotherapy mini spikes/dispensing pins where

appropriate • Mini-spikes/dispensing pins were the only needle-free devices used for

manipulations



• Advantages for using Mini-spikes/dispensing pins included reduction in number of manipulations involving needles, therefore decreasing risk of needle stick injuries

• Cost was deemed the biggest disadvantage of using a needle-free device • In the past 12 months, three units had two cytotoxic needle stick injuries

whilst one unit did not have any • In the past 12 months, two units had two cytotoxic spillages within the

isolator whilst two units did not have any • Compared to the number of items prepared, locally, needle stick injuries

happened less than 0.5% of the time.

A questionnaire produced by Exodus Market Research was used at the end of the two week pilot period to retrieve qualitative data, for both the ‘Tevadaptor’™ and ‘ChemoAide’™, from a pharmacy preparation and a nursing administration perspective.

Pharmacy evaluations Current practice evaluation

• Needles were most advantageous for use with cytotoxic preparation due to their ease of use.

• The factor most influential on use of needles for cytotoxic reconstitution was size.

• The highest risk associated with use of needles was needle stick injuries • Other advantages for use of needles stated by operators included

adequately packaged and can be used with any vial or infusion bag.

‘ChemoAide’™ Evaluation

• Operators found quite easy to use • Cytotoxic spillage was deemed to be the highest risk • Another possible risk stated was cross contamination • The most advantageous factor was ease of use • The least advantageous factor was cost • No incidents occurred during pilot

‘Tevadaptor’™ Evaluation

• Operators found very easy to use • Contamination of environment and disposal were deemed the highest risk • The most advantageous factor, compared to current practice, was how

safe the device was to use.



• The least advantageous factor was cost • No incidents occurred during the pilot

Nursing evaluation

Current practice

• Needles only used for pre-meds when the set has no ‘clear link™’ (integral

needle-free) device. • Needles were deemed most advantageous for use due to low cost. • The least advantageous factor was the risk of needle stick injury

‘ChemoAide’™ Evaluation

• Nursing staff found quite difficult to use • Contamination of the nurse was deemed the highest risk • The most advantageous factor, compared to current practice, was how

safe the device was to use • The two least advantageous factors included cost and complexity of use. • Three incidents occurred during the pilot

‘Tevadaptor’™ Evaluation

• Nursing staff found very easy to use • Nursing staff felt there was little to no risk during administration • The most advantageous factors, compared to current practice, included

safe and easy to use • The least advantageous factor, compared with current practice, was cost. • No incidents occurred during the pilot

6 Discussion

Analysing the evaluation forms has shown that a needle-free system for cytotoxic therapy is more advantageous than current practice for both administration and preparation. One device was preferred over the other due to facts documented in the evaluation. The same device was preferred from a preparation and administration perspective. There is potential to eradicate needle stick injuries with hazardous injections for operators. Nursing staff perceived problems with two administration sets, low absorption and light sensitive sets, due to the fact that neither set has the ‘clear link™’ system in place. Both sets still have an additive port which requires use of a needle.



Timings for the preparation of trays and manipulations were variable throughout the week which could be down to several factors. The operators had to become used to a new system and some operators worked part time and did not start to use the products until mid week hence some operators were quicker than others. Unfortunately due to staff shortage, timings were not recorded from an administration point of view but anecdotally, the feed back was positive and patients did not appear to be delayed. Due to time restraints, only the leading two devices on the market were chosen to trial. Other devices are available which could have possibly been included. Also it would have been beneficial to have a longer time frame for pharmacy and nursing staff to adapt to the different practice and get a real flavour of how each device worked. Neither company could supply stability or sterility information therefore all products had to be used immediately, limiting preparation in advance of patient presentation. Environmental monitoring of each device would have been ideal, as it would have truly proven how ‘closed’ a needle-free system is and to what extent an operator is exposed to hazardous material. The benefits of a needle-free system are quite clear from the point of manufacture to the point of administration. However, due to low incident rates, cost of needle-free systems and current cost savings having to be met within each NHS Trust, is it possible for NHS Trusts to invest in such systems? That then begs the question should we be putting a price on safety? 7 Recommendations Replace current practice with a specific needle-free system that works well from both a nursing and pharmacy perspective. With the data available on certain systems and with the likelihood of more data becoming available in the future, like NIOSH, national recommendations should be made by the Health and Safety Executive (HSE) and endorsed by NHS PASA, patient safety and health regulators, for the use of closed needle-free systems for the safety of the pharmacy staff, nursing staff and patients. The evaluation demonstrated that a system which is easy to use and can be generically applied to a wide range of different products and presentations will be of greatest value to the NHS. Industry should undertake stability studies to demonstrate that needle-free products remain inert when in contact with cytotoxic chemotherapy drugs; this will further



encourage their use and allow preparation in advance of patient attendance, reducing waiting times. There is opportunity to use such needle-free devices for preparation and administration of a wide range of higher risk injectable medicine products. 8 Conclusions The overall aims of the work stream were met although the time frame to achieve objectives was short. In order to take this pilot forward, more in depth evaluations could be done nationally to collate information about cytotoxic needle stick and spillage incidents throughout the UK to help support the use of needle-free devices. More research is also required from the pharmaceutical industries who supply such devices, with regards to the stability and sterility of products when needle-free devices are in situ. The more data that becomes available, like NIOSH, will support national recommendations from regulators such as HSE. 9 Acknowledgements

Baxter Healthcare Teva Pharmaceuticals Pharmacy and Nursing staff based on the chemotherapy day unit at the Derbyshire Royal Infirmary. 7 References 1 Walters.E. Reducing risk with Tevadaptor™ , Presentsed at the MARCH annual conference 14th June 2007, London 2 Sewell G, Roberts S. Safe handling of cytotoxics. Hospital Pharmacy Europe 2007;34:17-19 3 US National Institute for Occupational Health and Safety. Preventing occupational exposure to antineoplastic drugs in healthcare settings. Available at www.cdc.gov/niosh/docs/2004-165 4 Au C, Jorgenson J, Smith B. Evaluation of Vial Transfer Devices for Containment of Hazardous Drug Vapors, Presented at the Oncology Nursing Society, 32nd Annual Congress, April 24–27, 2007, Las Vegas, NV 5 Spivey S, Jorgenson J. Contamination Comparison of Transfer Devices Intended for Handling Hazardous drugs, presented at the Oncology Nursing Society, 32nd Annual Congress, April 24–27, 2007, Las Vegas, NV


Phase 2 workstream brief – Appendix A October 2007 Needle free Ver 1

Workstream 2: Needle free Purpose: Needles free systems are widely employed in the Trust for safe administration of injectable medicines and to reduce infection risks. Needle free systems are also available for the preparation of hazardous injections (e.g. cytotoxic chemotherapy), reducing the risk of operator injury and environmental contamination. Aim: This workstream aims to evaluate the Teva ‘Tevadaptor’ and Baxter ‘Chemo-Aide’ products within specialist pharmacy aseptic dispensing services using qualitative and quantitative techniques to rate ease of use, time saving, staff safety etc and to make national recommendations for safe aseptic dispensing practice. Objectives: 1. Review current practice / techniques in local units and identify key issues 2. Establish accident rate from needle-stick injuries and other operator risks 3. Agree quantitative and qualitative criteria for evaluation of these products 4. Evaluate each product against existing practice for defined period 5. Undertake risk: benefit analysis; identify strengths & weaknesses of each product 6. Develop rationale and business case for routine use of these products in NHS 7. Maintain progress plan and complete workstream report to present to Pilot Team Stakeholders: Lead: Amanda Hewitt, Chief Pharmacy Technician, Cancer Services Tom Gray, Chief Pharmacist, Project Lead (facilitator) Team: Colin Ward, Directorate Pharmacist, Cancer Services Leslie McKenna and Elaine Barrett (Chemotherapy Sisters) Milestones: Oct 2007 Set up work stream, identify stakeholders, agree brief and action plan Nov 2007 Objectives 1-2; meet industry representatives, progress report Dec 2007 Objectives 3-4; agree criteria, start evaluation, analysis, rationale Jan 2008 Objectives 4-7; complete evaluation, analysis, rationale and report Measures: • Input measures Risk assessment, Incident rate, capacity, staff perception • Output measures risk: benefit analysis, capacity, incident rate


Phase 2 workstream brief - Appendix A Updated 25/04/2008 Needle free Action Plan

Workstream 2: Needle free Summary action plan and progress report Lead: Amanda Hewitt Chief Pharmacy Technician, Cancer Services Pharmacy: Emma Dyson Chief Pharmacy Technician, Cancer Services Colin Ward Directorate Pharmacist, Cancer Services Nursing: Leslie McKenna Elaine Barrett Chemotherapy Sisters Industry: Representatives Teva UK and Baxter Healthcare Others: Tom Gray Chief Pharmacist, Project Lead and Facilitator Ref Issue Action(s) Date

started Date due Lead

1 Workstream setup Agree Workstream team, brief, action plan and

maintain progress report for monthly Pilot Boards Oct 2007 Amanda Hewitt

2 Current practice Review current practice and techniques in local

chemotherapy services. Identify risks. Oct 2007 Amanda Hewitt

3 Incident rate Review Trust incidents relating to needle-stick injury

or spillage in preparation and administration Oct 2007 Workstream team

4 Identify local practices Questionnaire to review local and regional practices

in chemotherapy preparative services Oct 2007 Dec 2007 Amanda Hewitt and

Workstream team

5 Criteria for evaluation of needle-free systems for preparation (and administration)

Agree quantitative and qualitative criteria for evaluation of needle-free products with Industry

Nov 2007 Dec 2007 Amanda Hewitt and Workstream team

6 Evaluate products Evaluate Tevadaptor™ with syringes

Evaluate ChemoAide™ with infusions (Viaflo™) Dec 2007 Jan 2008 Amanda Hewitt and

Chemo Sisters

7 Final report Write up work stream in report template provided

and report back to Pilot Board 13.2.08 Dec 2007 Feb 2008 Amanda Hewitt and

Workstream team


Phase 2 workstream brief – Appendix A Updated 25/04/2008 Needle free Progress Report

Workstream 2: Needle free Monthly progress report: Oct 2007 Nov 2007 Dec 2007 Jan 2008 Ref Action(s) Date

started Progress B G A R

Date complete

Comments

1 Agree Workstream team, brief, action plan and maintain progress report for monthly Pilot Boards

Oct 2007 G Ongoing Monthly progress report to Pilot Board meetings

2 Review current practice and techniques in local chemotherapy services. Identify risks.

Oct 2007 G Obtain information from local centres –Nottingham,

Leicester, Lincoln and Burton hospitals

3 Review Trust incidents relating to needle-stick injury or spillage in preparation and administration

Oct 2007 G Obtain data from Datix and identify root causes from

interviews with staff and review of techniques

4 Questionnaire on local / regional practices Identify best practice recommendations

Oct 2007 G Identify best practice recommendations from current literature and risk assess local practices

5 Develop and agree quantitative and qualitative criteria with sponsors for evaluation of systems

Nov 2007 A Simple criteria for evaluation of needle-free systems e.g. time, ease of use, safety (in-use, spillage, protection)

6 Evaluation plan for Tevadaptor / ChemoAide to include: Brief, training, assessment and feedback

Dec 2007 G Recommend 1 week of each product Obtain cost: benefit analyses from industry sponsors

7 Final workstream report Dec 2007 G Pilot Board meeting 13 February 2008. Final project review scheduled for March 2008

Key: Blue - fully implemented; Green - good progress / on target; Amber - some progress / issues; Red - No progress / major issues Issues for escalation: Ref Issue Options 5 Difficulty obtaining meeting with Teva Pursue Daniel Green for early meeting

6 No sponsorship from NHS PASA project Obtain sponsorship from Baxter / Teva. Peter Fox to raise with representatives


Phase 2 workstream Findings – Appendix B January 2008 Needle free

Workstream 2: Needle free Appendix B – Evaluation findings Timings: Timings were recorded for actual manipulations for regimens which are shown below.

Comparison of manipulation Timings

05

10152025

Hercepti

nFEC

Docetax

ol

Gemcit EC

Gem/C

arbo

Oxalip

latin CE

Irinote

can AC

Regimens

Tim

e (m

ins) Tevadaptor

Local PracticeChemoAide

Even though more time was generally taken to complete regimens using needle-free devices compare to using needles, on the whole, the average time was decreased using the needle-free devices.

Overall time taken for Manipualtion of Regimens

020406080

100120

Tevadaptor Local Practice ChemoAide

Device

Tim

e (m

ins)

Cost: Looking at all practices, a cost comparison was completed for an average week and the results are shown below:



Cost comparison of local practice V Needlefree Devices

0

200

400

600

800

1000

Local practice Tevadaptor ChemoAide

Cos

t (£)

This is of no surprise as the cost of needles is relatively cheap in comparison to that of using needle-free devices. The sample questionnaires (below) were sent to both Pharmacy and Nursing staff who had taken part in the two week trial to evaluate both needle free systems against the current practice used within the chemotherapy day unit. NHS Purchasing and Supply Agency Derbyshire Hospitals NHS Foundation Trust Purchasing for patient safety: Assessment of safety of needle free systems – NURSING STAFF Dear Colleague, We are conducting this research amongst nursing staff to assess the needle free systems ChemoaideTM and TevadaptorTM. If you have not used these devices, please forward this document on to a colleague that has done so. Your views are of great value to us and completion of the questionnaire should take around 20 minutes of your time. The research is being conducted by an independent market research agency, Exodus Research which is a full member of the Market Research Society and abides strictly by its Code of Conduct. Your individual answers will not be revealed to the project team or any other individual/ organisation and will be reported collectively with all other respondents. To complete this document electronically, please use your mouse to select the box against the answers that best meet your views or by typing in your answer. Alternatively, to complete the questionnaire manually, please print this document. Please return your completed form by 18 February 2008 (information on how to return the document is provided at the end of the questionnaire). Thank you in advance for your invaluable help.

If you would like a copy of the anonymised results of this research please give your email or name & postal address opposite

Section 1: Current practice using needles

No (please describe the system used below) 1 Yes (please explain how these are used below) 2

1. Do you currently use needles to administer chemotherapy? If so, how are these used? If not, what system (type, brand, etc.) do you use?



2. The following is a list of risks that may be associated with the current use of needles to administer cytotoxic chemotherapy. Please rank these to show which you believe to be the highest risk, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5

Contamination of nurse 1 2 3 4 5

Disposal 1 2 3 4 5 Needle stick injury 1 2 3 4 5

Harm to patient 1 2 3 4 5 Comments:

No 1

Yes (please specify below) 2 3. Are you aware of any other risks associated with the use of needles for administration of cytotoxic chemotherapy?

4. The following is a list of possible advantages of using needles for administration. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each advantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantages Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5

Easy to use 1 2 3 4 5

Safe 1 2 3 4 5 Quick (time taken) 1 2 3 4 5 Comments:

No 1

Yes (please specify below) 2 5. Are you aware of any other possible advantages of using needles for administration?

6. The following is a list of possible disadvantages of using needles for administration. Please rank these to show which you believe to be most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th

disadvantageous Least

disadvantageous Costs of consumables 1 2 3 4 5

Complex technique 1 2 3 4 5

Needle stick injury 1 2 3 4 5 Time taken 1 2 3 4 5 Comments:

No 1

Yes (please specify below) 2 7. Are you aware of any other possible disadvantages of using needles for administration?

Section 2: ChemoaideTM Device

Very easy 1 Quite easy 2 Quite difficult 3 Very difficult 4

8. How easy was the Chemoaide needle free system to use? Please tick one box. If you wish to comment further please write in the box opposite



Less than 10

seconds 1 10 to under 30 seconds 2 30 to under

60 seconds 3 1 to 5 minutes 4 More than five minutes 5

9. How long did it usually take to administer cytotoxic drugs using the Chemoaide device? If you wish to comment further please write in the box opposite

10. The following is a list of risks that may be associated with the use of Chemoaide compared to current practice for administration of chemotherapy. Please rank these to show which you believe to be the highest risk associated with the use of Chemoaide, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5




No 1

Yes (please specify below) 2 11. Are you aware of any other risks associated with the use of Chemoaide for administration of cytotoxic chemotherapy?

12. The following is a list of advantages that may be associated with the use of Chemoaide compared to current practice for administration of chemotherapy. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantage Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5



No 1

Yes (please specify below) 2 13. Are you aware of any other possible advantages of using Chemoaide for cytotoxic reconstitution?

14. The following is a list of disadvantages that may be associated with the use of Chemoaide compared to current practice for administration of chemotherapy. Please rank these to show which you believe to be the most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th







No 1 Yes (please specify below) 2

15. Are you aware of any other possible disadvantages of using Chemoaide for administration of chemotherapy?

No 1

Yes (please specify below) 2 16. Did any problems occur during the use of the Chemoaide device (including device failure, difficulty handling or connecting, etc.)?

No 1

Yes (please specify below) 2 17. Did any incidents occur during the use of Chemaide that resulted in an IR1 form being completed (e.g. major spillage, needle-stick injury, etc.)?

No (please specify below) 1

Yes (please specify below) 2 18. Do you think the use of Chemoaide offers ‘value for money’ for the trust? Please explain why you say this.

Section 3: TevadaptorTM Device


19. How easy was the Tevadaptor needle free system to use? Please tick one box. If you wish to comment further please write in the box opposite

Less than 10 seconds 1 10 to under 30 seconds 2 30 to under


20. How long did it usually take to administer cytotoxic drugs using the Tevadaptor device? If you wish to comment further please write in the box opposite

21. The following is a list of risks that may be associated with the use of the Tevadaptor system compared to current administration of chemotherapy. Please rank these to show which you believe to be the highest risk associated with the use of Tevadaptor, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If write any further comments in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5




No 1

Yes (please specify below) 2 22. Are you aware of any other risks associated with the use of Tevadaptor for administration of chemotherapy?

23. The following is a list of advantages that may be associated with the use of Tevadaptor compared to current practice for administration of chemotherapy. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantage Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5



23. The following is a list of advantages that may be associated with the use of Tevadaptor compared to current practice for administration of chemotherapy. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantage Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Easy to use 1 2 3 4 5


No 1

Yes (please specify below) 2 24. Are you aware of any other possible advantages of using Tevadaptor for administration of chemotherapy?

25. The following is a list of disadvantages that may be associated with the use of the Tevadaptor system compared to current practice of administration of chemotherapy. Please rank these to show which you believe to be the most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th





No 1

Yes (please specify below) 2 26. Are you aware of any other possible disadvantages of using Tevadaptor for administration of chemotherapy?

No 1

Yes (please specify below) 2 27. Did any problems occur during the use of the Tevadaptor device (including device failure, difficulty handling or connecting, etc.)?

No 1

Yes (please specify below) 2

28. Did any incidents occur during the use of Tevadaptor that resulted in an IR1 form being completed (e.g. major spillage, needle-stick injury, etc.)?


Yes (please specify below) 2 29. Do you think the use of Tevadaptor offers ‘value for money’ for the trust? Please explain why you say this.

Section 4: Overall perceptions of devices and additional comments



30. Please rank the following devices in terms of their overall benefits, and what would you say is the single greatest benefit of each Please tick one box for each device and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Device Best overall

benefits 2nd best overall

benefits 3rd best overall

benefits Single greatest benefit

Current needle administration (if applicable)

1 2 3

Current needle free administration (if applicable)

1 2 3

Chemoaide device 1 2 3

Tevadaptor device 1 2 3

Comments:

Current needle administration (if applicable) 1

Current needle free administration (if applicable) 2 Chemoaide device 3 Tevadaptor device 4

31. Which of the following devices would you prefer to use and why? Please tick one box and give reason for preference in the box opposite Reason:

Please write any further comments on needle free systems that may affect patient safety, in the space opposite.

THANK YOU FOR YOUR TIME.

Please save your completed questionnaire as a Word document and return it by 18 February 2008 in one of the following ways:

1. Send it as an attachment (otherwise the selected boxes will be deselected in transmission) to [email protected]. OR

2. Print and fax your form to 01934 750176 OR 3. Print and free-post (no stamp required) to the following address:

Exodus Market Research Ltd FREEPOST (SWB1735) WESTON SUPER MARE BS24 0ZZ

NHS Purchasing and Supply Agency Derbyshire Hospitals NHS Foundation Trust Purchasing for patient safety: Assessment of safety of needle free systems - PHARMACY Dear Colleague, We are conducting this research amongst pharmacy staff to assess the needle free systems ChemoaideTM and TevadaptorTM. If you have not used these devices, please forward this document on to a colleague that has done so. Your views are of great value to us and completion of the questionnaire should take around 20 minutes of your time. The research is being conducted by an independent market research agency, Exodus Research which is a full member of the Market Research Society and abides strictly by its Code of Conduct. Your individual answers will not



be revealed to the project team or any other individual/ organisation and will be reported collectively with all other respondents. To complete this document electronically, please use your mouse to select the box against the answers that best meet your views or by typing in your answer. Alternatively, to complete the questionnaire manually, please print this document. Please return your completed form by 18 February 2008 (information on how to return the document is provided at the end of the questionnaire). Thank you in advance for your invaluable help.

If you would like a copy of the anonymised results of this research please give your email or name & postal address opposite

Section 1: Current practice using needles 1. The following is a list of factors that may influence the ‘ease of use’ of needles for cytotoxic reconstitution. Please rank these to show which you believe to be most influential on ease of use, next most influential and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Factor Most influential 2nd most influential 3rd most influential 4th most influential Least influential Size 1 2 3 4 5

Packaging (ease of removal) 1 2 3 4 5

Shape (ease of handling) 1 2 3 4 5 Complexity of use 1 2 3 4 5

Disposal after use 1 2 3 4 5 Comments:

2. The following is a list of risks that may be associated with the current use of needles. Please rank these to show which you believe to be the highest risk, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5

Contamination of operator 1 2 3 4 5


Spillage 1 2 3 4 5 Comments:

No 1

Yes (please specify below) 2 3. Are you aware of any other risks associated with the use of needles for preparation of cytotoxic chemotherapy?

4. The following is a list of possible advantages of using needles for reconstitution. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each advantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantages Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5




5. Are you aware of any other possible advantages of using needles for reconstitution?



6. The following is a list of possible disadvantages of using needles for reconstitution. Please rank these to show which you believe to be most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th





No 1

Yes (please specify below) 2 7. Are you aware of any other possible disadvantages of using needles for reconstitution?

Section 2: ChemoaideTM Device


8. How easy was the Chemoaide needle free system to use? Please tick one box. If you wish to comment further please write in the box opposite

Less than 10

seconds 1 10 to under 30 seconds 2 30 to under


9. How long did it usually take to reconstitute cytotoxic drugs using the Chemoaide device? If you wish to comment further please write in the box opposite 10. The following is a list of risks that may be associated with the use of Chemoaide compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the highest risk associated with the use of Chemoaide, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5




No 1

Yes (please specify below) 2 11. Are you aware of any other risks associated with the use of Chemoaide for preparation of cytotoxic chemotherapy?

12. The following is a list of advantages that may be associated with the use of Chemoaide compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantage Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5




13. Are you aware of any other possible advantages of using Chemoaide for



cytotoxic reconstitution?

14. The following is a list of disadvantages that may be associated with the use of Chemoaide compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th





No 1

Yes (please specify below) 2 15. Are you aware of any other possible disadvantages of using Chemoaide for cytotoxic reconstitution?

No 1

Yes (please specify below) 2 16. Did any problems occur during the use of the Chemoaide device (including device failure, difficulty handling or connecting, etc.)?

No 1

Yes (please specify below) 2 17. Did any incidents occur during the use of Chemaide that resulted in an IR1 form being completed (e.g. major spillage, needle-stick injury, etc.)?


Yes (please specify below) 2 18. Do you think the use of Chemoaide offers ‘value for money’ for the trust? Please explain why you say this.

Section 3: TevadaptorTM Device


19. How easy was the Tevadaptor needle free system to use? Please tick one box. If you wish to comment further please write in the box opposite

Less than 10 seconds 1 10 to under 30 seconds 2 30 to under


20. How long did it usually take to reconstitute cytotoxic drugs using the Tevadaptor device? If you wish to comment further please write in the box opposite

21. The following is a list of risks that may be associated with the use of the Tevadaptor system compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the highest risk associated with the use of Tevadaptor, the next highest and so on. Please tick one box for each risk and ensure overall only one box in each column is selected. If write any further comments in the last row Risk Highest risk 2nd highest risk 3rd highest risk 4th highest risk Least risk Contamination of environment 1 2 3 4 5







22. Are you aware of any other risks associated with the use of Tevadaptor for preparation of cytotoxic chemotherapy?

23. The following is a list of advantages that may be associated with the use of Tevadaptor compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the most advantageous, the next most advantageous and so on. Please tick one box for each factor and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Advantage Most advantageous 2nd advantageous 3rd advantageous 4th advantageous Least advantageous Cheap 1 2 3 4 5



No 1

Yes (please specify below) 2 24. Are you aware of any other possible advantages of using Tevadaptor for cytotoxic reconstitution?

25. The following is a list of disadvantages that may be associated with the use of the Tevadaptor system compared to current practice of using needles for cytotoxic reconstitution. Please rank these to show which you believe to be the most disadvantageous, the next most disadvantageous and so on. Please tick one box for each disadvantage and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Disadvantage Most

disadvantageous 2nd

disadvantageous 3rd

disadvantageous 4th





No 1

Yes (please specify below) 2 26. Are you aware of any other possible disadvantages of using Tevadaptor for cytotoxic reconstitution?

No 1

Yes (please specify below) 2 27. Did any problems occur during the use of the Tevadaptor device (including device failure, difficulty handling or connecting, etc.)?

No 1

Yes (please specify below) 2 28. Did any incidents occur during the use of Tevadaptor that resulted in an IR1 form being completed (e.g. major spillage, needle-stick injury, etc.)?


Yes (please specify below) 2 29. Do you think the use of Tevadaptor offers ‘value for money’ for the trust? Please explain why you say this.

Section 4: Overall perceptions of devices and additional comments 30. Please rank the following devices in terms of their overall benefits, and what would you say is the single greatest benefit of each Please tick one box for each device and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Device Best overall






30. Please rank the following devices in terms of their overall benefits, and what would you say is the single greatest benefit of each Please tick one box for each device and ensure overall only one box in each column is selected. If you wish to comment further, please write in the last row Device Best overall




Current administration 1 2 3

Chemoaide device 1 2 3

Tevadaptor device 1 2 3

Comments:

Current administration 1

Chemoaide device 2 Tevadaptor device 3

31. Which of the following devices would you prefer to use and why? Please tick one box and give reason for preference in the box opposite

Reason:

Please write any further comments on needle free systems that may affect patient safety, in the space opposite.

THANK YOU FOR YOUR TIME.

Please save your completed questionnaire as a Word document and return it by 18 February 2008 in one of the following ways:

4. Send it as an attachment (otherwise the selected boxes will be deselected in transmission) to [email protected]. OR

5. Print and fax your form to 01934 750176 OR 6. Print and free-post (no stamp required) to the following address:

Exodus Market Research Ltd FREEPOST (SWB1735) WESTON SUPER MARE BS24 0ZZ


Phase 2 workstream Findings – Appendix C January 2008 Needle free

Workstream 2: Needle free Appendix C - Detailed evaluation findings:

Needle free systems

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