1. Please can you provide a copy of your medicines management policies for the Trust which includes the policy of sharing medicines in vials and how the policy fulfils the requirements of the Nursing & Midwifery Council (NMC) with regards to vial sharing?
Copy of Medicines Prescribing & Administration procedure attached: Prescribing and Administering Medicines Procedure
Specific wording included in the relevant procedure is:
Multiple Doses from One Vial.
Only one single dose, for one single patient, on one occasion, should be taken from a drug vial unless the vial label/ package information indicates that it is for multiple dose use, or shows the presence of a preservative on the vial label, or is prepared in the Pharmacy Aseptic Dispensing Unit. Most vials and all intravenous fluid bags are for single use only. A notable exception is insulin in vials where multiple doses can be taken from one vial.
All ampoules are single use only.
Ref. NPSA Patient Safety Alert No. 20

2. As part of the Trust’s medicines management policy for vial-sharing. Please can you provide the names of the injectable monoclonal antibody medicines which are being vial shared?
None

3. Can you please provide the reasons for vial sharing, for each of the medicines you have listed in Q2, i.e. gain share, cost savings etc?
Not Applicable

4. If gain share is one of the reasons in Q3, please provide the details relating to the gain share for each medicine you have listed in Q2.
Not Applicable

5. If a cost saving is one of the reasons given in Q3 then please clarify what these cost savings are and the recipient of the cost saving.
Not Applicable

6. For each of the medicines you have outlined in Q2, please list the medicines that are vial shared and prepared in Aseptic Units under a sterile laboratory environment fulfilling the requirements of NHS Quality Control North West?
Not Applicable

7. Which hospitals in the Trust are vial sharing in this way. 

Not Applicable

8. What were the individual annual Service costs associated with preparing the medicines you have identified in Q2 via Aseptic preparation & were internal departments recharged these amounts? Please provide a list of the hospitals and departments that were recharged.
Not Applicable

9. For the medicines you have identified in Q6 prepared in Aseptic Units, please provide the Service costs for aseptic unit preparation for the following financial years: 15/16, 16/17 and current financial year 17/18, per hospital within the Trust.
Not Applicable

 
10. How do the drug acquisition costs of each of the medicines being prepared in Aseptic Units listed in Q6 compare to the Service Costs relating to Aseptic preparations for each of these medicines
Not Applicable

 
11. Of the medicines you have outlined in Q2 including those which you may not have mentioned so far, which monoclonal antibodies are being administered to patients via vial sharing practices not prepared in Aseptic Unit sterile conditions?
None

 
12. If vial sharing practice is taking place outside Aseptic Unit conditions, please can you provide reasons as to why this practice is taking place
Not Applicable

 
Patient Safety
13. According to the Centre for Disease Control and Prevention (CDCP):
https://www.cdc.gov/injectionsafety/cdcposition-singleusevial.html
Protect Patients Against Preventable Harm from Improper Use of Single–Dose/Single–Use Vials
It states that medications labelled as “single-dose” or “single-use” should be used for only one Patient
No comment to add

 
14. Please provide a list which of the medicines that are being vial shared not using Aseptic Lab conditions which include within their Summary of Product Characteristics (SPC), the following:
· That the solution for injection does not contain a preservative and
· Is for single use and should be administered immediately after drawing the dose into the syringe
Not Applicable

 
15. For medicines you have listed in Q14, can you explain why the recommendations of the CDCP and the SPC are not adhered to or implemented and thus patient safety is being compromised.
Not Applicable

 
16. For those medicines you have identified in Q14, which types of health care professionals (HCPs) are administering the medicines to patients?
Not Applicable

 
17. How does the Trust communicate with these HCPs the recommendations of the CDCP regarding medicines labelled for ‘single-dose’ or ‘single use?’
Not Applicable

 
18. Please provide a copy of this communication
Not Applicable

 
19. What is the Trust’s Vial sharing policy for medicines labelled for ‘single-dose’ or ‘single use’ and those medicines that don’t contain a preservative.
Duplication of Q1
The aseptics unit has a vial sharing SOP if and when it may be required.