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FOI Request

Disclosure ID
FOI/02763
Request Date
October 12, 2018
Subject
Unlicensed Medicines
Description
1 Does your Trust have a policy on the use of unlicensed medicines? Please Answer Yes or No. If yes, please provide a copy of the policy and all other relevant documentation
2 Does your Trust have a policy or protocol on obtaining informed consent from patients when an unlicensed medicine is used? Please answer Yes or No. If yes, please provide copies of all relevant documentation including copies of template informed consent materials used to consent patients where an unlicensed medicine is to be administered
3 Please state which Board level job role(s) is (are) responsible for patient safety and consenting?
4 Does your Trust have, or intend to introduce, a policy that makes compounded bevacizumab routinely available to treat wet age-related macular degeneration? If yes please supply a copy of your policy.
5 Does your Trust currently have a wholly NHS owned pharmacy with an aseptic unit for compounding/aliquotting medicines?

If yes, is this NHS pharmacy the same legal entity as that of your hospital Trust?

6 Does your Trust currently host on its premises a privately owned pharmacy with an aseptic unit for compounding/aliquotting medicines?
7 Over the past two years has your Trust, on more than one occasion, used compounded Avastin (bevacizumab) for ophthalmic use?
8 Is the pharmacy referred to above in Q5 or Q 6 currently providing, or potentially able to provide, compounded Avastin (bevacizumab) for ophthalmic use?
9 If you answered yes to Q5 or Q6:

 

Does the pharmacy referred to above in Q5 or Q6 currently hold an MHRA license for the manufacture of specials?

10 If you answered yes to Q5 or Q6 but no to Q9:

 

When was the pharmacy referred to above in answer to Q5 or Q6 last inspected by the CQC?

11 If you answered no to questions Q5 or Q6 above, but yes to question Q7:

 

Please provide information regarding from whom your Trust has or obtained/purchased   compounded Avastin (bevacizumab). If you cannot provide the name of any commercial supplier, please provide as much information as possible.

Response
1 Does your Trust have a policy on the use of unlicensed medicines? Please Answer Yes or No. If yes, please provide a copy of the policy and all other relevant documentation Yes, please see attached policy
2 Does your Trust have a policy or protocol on obtaining informed consent from patients when an unlicensed medicine is used? Please answer Yes or No. If yes, please provide copies of all relevant documentation including copies of template informed consent materials used to consent patients where an unlicensed medicine is to be administered Referred to in attached policy

 

3 Please state which Board level job role(s) is (are) responsible for patient safety and consenting? Professor Mark O’Donnell – Medical Director – Consenting

Marie Thompson – Director of Nursing & Quality – Safety

4 Does your Trust have, or intend to introduce, a policy that makes compounded bevacizumab routinely available to treat wet age-related macular degeneration? If yes please supply a copy of your policy. No policy and no discussions about an intended policy have taken place
5 Does your Trust currently have a wholly NHS owned pharmacy with an aseptic unit for compounding/aliquotting medicines?

If yes, is this NHS pharmacy the same legal entity as that of your hospital Trust?

Yes

 

 

Yes

6 Does your Trust currently host on its premises a privately owned pharmacy with an aseptic unit for compounding/aliquotting medicines? No
7 Over the past two years has your Trust, on more than one occasion, used compounded Avastin (bevacizumab) for ophthalmic use? No
8 Is the pharmacy referred to above in Q5 or Q 6 currently providing, or potentially able to provide, compounded Avastin (bevacizumab) for ophthalmic use? Currently does not provide and no discussions have taken place about being able to in the future
9 If you answered yes to Q5 or Q6:

 

Does the pharmacy referred to above in Q5 or Q6 currently hold an MHRA license for the manufacture of specials?

 

 

No

10 If you answered yes to Q5 or Q6 but no to Q9:

 

When was the pharmacy referred to above in answer to Q5 or Q6 last inspected by the CQC?

 

 

CQC don’t inspect, QCNW under EL97(52) do. The last inspection was on 19/7/18

11 If you answered no to questions Q5 or Q6 above, but yes to question Q7:

 

Please provide information regarding from whom your Trust has or obtained/purchased   compounded Avastin (bevacizumab). If you cannot provide the name of any commercial supplier, please provide as much information as possible.

 

 

 

N/A

Attachment 1
ratified_corp-proc-312.pdf
Attachment 2
Attachment 3
Attachment 4
Attachment 5
Attachment 6