Unlicensed medicines: information, assurance, & diligence
Update: 2025-02-26
Description
In this episode John Oliver speaks to expert guests about the information and assurance needed to support the use of unlicensed medicines. We discuss the procurement process in different care settings, and explore considerations for quality assurance, packaging and labelling and formulation. (20m:05s)
Speakers:
John Oliver, Quality Assurance Specialist; NHS SPS
Penny Daynes, Associate Regional Pharmacy Procurement Specialist; NHS SPS, North East and Yorkshire
Sharon Jackson, Quality Assurance Specialist; NHS SPS
Linda Hardy, Regional Quality Assurance Pharmacist, NHS SPS, North East and Yorkshire
Dr. Andrew Lowey, Lead Clinician, Pharmacy Preparative Services Leeds Teaching Hospitals, and chair of the NHS Pharmacy Production Committee
Useful links:
MHRA guidance
https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials (MHRA guidance on unlicensed medicinal products – specials, including Guidance Note 14)
SPS guidance
https://www.sps.nhs.uk/home/guidance/unlicensed-medicines/
https://www.sps.nhs.uk/articles/understanding-excipients-in-medicines/
https://www.sps.nhs.uk/articles/searching-for-presence-or-absence-of-an-excipient-in-medicines/
https://www.sps.nhs.uk/articles/navigating-a-potential-supply-issue/ (SPS log-in required)
https://www.sps.nhs.uk/articles/managing-complexities-of-medication-use-across-care-boundaries/ (Medication Safety across the System providing resources that include valuable real-world examples of safely managing unlicensed liquid medicines)
Speakers:
John Oliver, Quality Assurance Specialist; NHS SPS
Penny Daynes, Associate Regional Pharmacy Procurement Specialist; NHS SPS, North East and Yorkshire
Sharon Jackson, Quality Assurance Specialist; NHS SPS
Linda Hardy, Regional Quality Assurance Pharmacist, NHS SPS, North East and Yorkshire
Dr. Andrew Lowey, Lead Clinician, Pharmacy Preparative Services Leeds Teaching Hospitals, and chair of the NHS Pharmacy Production Committee
Useful links:
MHRA guidance
https://www.gov.uk/government/publications/supply-unlicensed-medicinal-products-specials (MHRA guidance on unlicensed medicinal products – specials, including Guidance Note 14)
SPS guidance
https://www.sps.nhs.uk/home/guidance/unlicensed-medicines/
https://www.sps.nhs.uk/articles/understanding-excipients-in-medicines/
https://www.sps.nhs.uk/articles/searching-for-presence-or-absence-of-an-excipient-in-medicines/
https://www.sps.nhs.uk/articles/navigating-a-potential-supply-issue/ (SPS log-in required)
https://www.sps.nhs.uk/articles/managing-complexities-of-medication-use-across-care-boundaries/ (Medication Safety across the System providing resources that include valuable real-world examples of safely managing unlicensed liquid medicines)
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