Developing outcome centric, territory-specific access protocols for the provision of niche product - John Bardsley (2021 Conference) (LDN, low dose naltrexone)

Developing outcome centric, territory-specific access protocols for the provision of niche product - John Bardsley (2021 Conference) (LDN, low dose naltrexone)

John Bardsley is managing director of Thistle Pharma Ltd. LDN is an unlicensed medicine. Much of what he is talking about pertains specifically to the UK sector, and may apply to your own territories as well.

Unlicensed medicines typically are not subjected to any degree of scrutiny by oversight authorities, thus lack marketing authorizations which are normally a consequence of a close scrutiny of the efficacy and safety data. He discusses what is needed to try to ensure compliance when we're working within this segment. He identifies the key areas to be managed: prescribing, the product, dispensing, procurement, and supply chain behaviours.

In the UK, prescribers are able to write for unlicensed medicines for patients where they have a clearly identified unmet need that can’t, or hasn't been satisfied by the licensed alternatives available. He discusses the related guidance from the UK regulator, the GMC, and applies it to the key areas, including compounding pharmacies and the hierarchy of product risks. He cautions that patients should avoid any websites offering prescription-only medicines without requiring prescription.

He advocates for more sharing about patient outcomes, and multidisciplinary territory managed Access Solutions, in the way successful in the UK.

KEYWORDS: low dose naltrexone (LDN), compounding pharmacy, compounding, outcomes

This is a summary of the presentation. Click on the video for full information.