About the podcast series
We have recorded a series of podcasts about unlicensed medicines. We welcome a range of expert guests who explain why we need unlicensed medicines, the information and assurance required for their use, and good practice principles for managing them.
Unlicensed medicines: why we need them
In this episode John Oliver speaks to expert guests who define unlicensed medicines and explain why we need them. We discuss the shared responsibility for their use and the role of the pharmacy team in managing them safely.
Speakers:
- John Oliver, Quality Assurance Specialist, NHS SPS
- Emma Kirk, Medication Safety Officer Network Lead, and Medicines Use and Safety Pharmacist NHS SPS
- Linda Hardy, Regional Quality Assurance Specialist Pharmacist, NHS SPS, North East and Yorkshire
- Nicola Husain, Education and Training Lead for the Neonatal and Paediatric Pharmacy Group
- Tim Root, Specialist Pharmacist NHS SPS and a former Chief Pharmacist
Unlicensed medicines: information, assurance and diligence
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, labelling and formulation.
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 Specialist 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
Unlicensed medicines: good practice principles
In this episode John Oliver speaks to expert guests about evaluating the suitability of unlicensed medicines for the patient. We discuss practical considerations for managing them in dispensaries, performing a quality assessment and good governance frameworks.
Speakers:
- John Oliver, Quality Assurance Specialist, NHS SPS
- Dr. Andrew Lowey, Lead Clinician, Pharmacy Preparative Services Leeds Teaching Hospitals, and chair of the NHS Pharmacy Production Committee
- Penny Daynes, Associate Regional Pharmacy Procurement Specialist, NHS SPS, North East and Yorkshire
- Katherine Cullen, Divisional Director Clinical Support Services, Chief Pharmacist, Tameside and Glossop Integrated Care NHS Foundation Trust
- Lynn Morrison, Regional Quality Assurance Specialist Pharmacist, NHS Scotland
- Amanda Cooper, Assistant Head of NHS SPS
Further information
MHRA guidance
The MHRA guidance on supply unlicensed medicinal products (specials) provides guidance including Guidance Note 14.
SPS guidance
Further useful SPS resources are found here:
- SPS resource on unlicensed medicines
- SPS resource on understanding excipients in medicines
- SPS resource on searching for presence or absence of an excipient in medicines
- SPS resource on navigating a potential supply issue procurement guidance (SPS website log-in required))
- The SPS event on managing complexities of medication use across care boundaries is a Medicines Safety Across the System (MSATS) webinar that includes valuable real-world examples of safely managing unlicensed medicines