National Patient Safety Alert: Shortage of methylphenidate prolonged-release capsules and tablets, lisdexamfetamine capsules, and guanfacine prolonged-release tablets.

National Patient Safety Alert: Shortage of methylphenidate prolonged-release capsules and tablets, lisdexamfetamine capsules, and guanfacine prolonged-release tablets.

National Patient Safety Alert Reference Number: NatPSA/2023/011/DHSC

Date issued: 27th September 2023

Brief description of the problem

There are supply disruptions affecting various strengths of the following medications which are licensed for the treatment of attention deficit hyperactivity disorder (ADHD):

• Methylphenidate:
  • Equasym XL® 10, 20 and 30 mg capsules
  • Xaggitin XL® 18 and 36 mg prolonged-release tablets
  • Concerta XL® 54 mg prolonged-release tablets
  • Xenidate XL® 27 mg prolonged-release tablets
• Lisdexamfetamine:
  • Elvanse® 20, 30, 40, 50, 60 and 70 mg capsules
  • Elvanse® Adult 30, 50, and 70 mg capsules
• Guanfacine:
  • Intuniv® 1, 2, 3 and 4 mg prolonged-release tablets

The supply disruption of these products is caused by a combination of manufacturing issues and an increased global demand.

Other ADHD products remain available but cannot meet excessive increases in demand.

At present, the supply disruptions are expected to resolve at various dates between October and December 2023.

Actions required

Actions to be completed by 11/10/2023

Prescribers should:

• Not initiate new patients on products affected by this shortage until the supply issues resolve.

Healthcare professionals in primary care (and secondary care if appropriate) should:

• Identify all patients currently prescribed these products, and
• make early contact with patients to establish how much supply they have remaining

Where patients have insufficient supplies to last until the re-supply date*, contact:

• Community pharmacies, hospital pharmacy departments, or other dispensing pharmacy services, to establish availability of supply; and
• patient’s specialist team for advice on management options if the product cannot be sourced.

Specialist teams should:

• Support primary care teams seeking advice for patients currently prescribed the affected products,
• provide individualised management plans, where required; and recommend alternatives in line with NICE guidance, where appropriate.

Supply information:

Unlicensed imports of lisdexamfetamine (Vyvanse®) capsules and guanfacine (Intuniv®) prolonged-release tablets have been sourced. Lead times vary.

Limited parallel imports of methylphenidate (Equasym XL®) modified release capsules remain available but cannot support an uplift in demand.

The Department of Health and Social Care (DHSC) issued a Medicine Supply Notification in August 2023 for the shortage of atomoxetine capsules. The supply issue with atomoxetine is set to resolve in October 2023.

* Further information on product availability and anticipated resupply dates can be found on the Specialist Pharmacy Service (SPS) Prescribing available medicine to treat ADHD page

Please see full guidance in the alert.