Working draft — Scientific review: pending | Regulatory review: pending | Not for external clinical or promotional use without independent verification

Governance Framework

The MDT, peer-review, shared-care and audit framework for cannabinoid Specials prescribing — sourced from UK regulatory primaries only.

Why Governance Matters for Specials

Unlicensed Specials prescribing carries higher GMC and CQC expectations than licensed prescribing. Documented governance protects the prescriber, the patient and the service. This framework is anchored to MHRA Specials Note 14 [60], GMC Decision Making and Consent [61], and CQC provider standards [66].

Initiating Specialist vs Follow-Up Prescriber

Initiating SpecialistFollow-Up Prescriber (Shared Care)
Confirms diagnosis + Specials justification (per [60])Continues prescribing in line with shared-care plan
Documents informed consent (per [62]) — see Patient LeafletMonitors per agreed schedule
Sets dose, monitoring schedule, stop criteriaEscalates to specialist if stop criteria triggered
Reviews at 2–4 wk, 8–12 wk, then 3-monthlyMay not change dose without specialist approval

NHS England guidance is that GPs are not expected to initiate cannabinoid Specials prescribing without specialist MDT involvement. Refer to the relevant NHS England circulars. The underlying regulatory event is the Home Office 2018 rescheduling [65].

MDT / Peer-Review Trigger Thresholds

The thresholds below are derived from RCT safety-monitoring board protocols [6], [8], [84], [85] and from GMC [61] and CQC [66] expectations for unlicensed prescribing. They are recommended starting thresholds — local services should adopt thresholds appropriate to case mix.

  • 1Any new Specials prescription — per GMC unlicensed-prescribing standard [61]
  • 2Indication outside the standard list — see Conditions A–Z
  • 3Dose escalation beyond the indication's published RCT range — see Dosing
  • 4Patient with a relative contraindication — see Contraindications
  • 5Concomitant high-risk DDI — see Interactions
  • 6Treatment-resistant case (≥ 2 prior failures)
  • 7Patient under 18 outside Epidyolex / Sativex licensing
  • 8Suspected misuse, diversion, or non-adherence
  • 9Unexpected serious AE (alongside Yellow Card) — per [60]

Audit and Outcome Capture

  • Annual case-note audit per CQC [66]
  • Outcome data captured on validated instruments (outcome measures tools planned for Phase 2)
  • Adverse events reviewed at MDT
  • Yellow Card reports to MHRA [60]

Documentation Requirements

Anchored to GMC [61] and GMC consent [62].

  • Specials justification statement (why no licensed alternative)
  • Informed consent record per [62] (use Patient Leaflet template)
  • Dose, frequency, monitoring schedule
  • Outcome measures at each visit
  • Yellow Card reports per [60]
  • Discontinuation criteria documented at start (see Discontinuation & Tolerance)

Regulatory Overlap

CQC [66] provider expectations require documented governance for any service prescribing unlicensed medicines. GPhC standards [117] require pharmacies to support patient choice and maintain professional accountability. The MHRA Specials manufacturer licensing chain [60]ensures product quality from manufacture through to dispensing.

Related Pages

ContraindicationsDiscontinuation & TolerancePrescription MechanicsDosingDrug InteractionsConditions A–Z

Last reviewed: 2026-04-30 · Reviewer: Grace Blest-Hopley PhD · Next review: 2026-10-30