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Manufacturing issues behind ‘safety critical’ ADHD drug shortage, DH warns

A Department of Health and Social Care (DH) patient safety alert has warned pharmacies that “safety critical” shortages of a plethora of ADHD drugs could last months.

The national patient safety alert sent to community pharmacies yesterday (September 27) said that there are “supply disruptions affecting various strengths” of certain medications for attention deficit hyperactivity disorder (ADHD).

This has been caused by “a combination of manufacturing issues and an increased global demand”, it said.

Read more: Suspended sentence for illegal POM dealers found with 1.3m pills

It added that while other ADHD products “remain available”, they “cannot meet excessive increases in demand” and the disruption is “expected to resolve at various dates between October and December 2023”.

The DH said that the alert was both “safety critical and complex”, adding that its implementation should be supported by “clinical leaders” in community pharmacy and other relevant healthcare organisations.


Which drugs are affected?


The “shortage” affects methylphenidate prolonged-release capsules and tablets, lisdexamfetamine capsules and guanfacine prolonged-release tablets, it added.

This includes:

  • Methylphenidate Equasym XL® 10mg, 20mg and 30mg capsules

  • Methylphenidate Xaggitin XL® 18mg and 36mg prolonged-release tablets

  • Methylphenidate Concerta XL® 54mg prolonged-release tablets

  • Methylphenidate Xenidate XL® 27mg prolonged-release tablets

  • Lisdexamfetamine Elvanse® 20mg, 30mg, 40mg, 50mg, 60mg and 70mg capsules

  • Lisdexamfetamine Elvanse® Adult 30mg, 50mg, and 70mg capsules

  • Guanfacine Intuniv® 1mg, 2mg, 3mg and 4mg prolonged-release tablets


Two weeks to take action

The DH alert said that healthcare professionals should start taking action by tomorrow (September 29) , with actions to be completed by October 11.

Community Pharmacy England (CPE) yesterday set out that prescribers should not initiate new patients on the affected medicines until the shortages resolve.

It added that “healthcare professionals in primary care” should identify all patients currently prescribed them and make “early contact” to “establish how much supply they have remaining”.

Read more: What can community pharmacists do to help their patients with ADHD?

And it said that they should contact community pharmacies and other dispensing services to establish availability of supply where patients have “insufficient supplies to last until the re-supply date”.

If necessary, specialist teams should provide advice on alternative management options, it added.

What alternatives are available?

According to CPE, unlicensed imports of lisdexamfetamine (Vyvanse®) capsules and guanfacine (Intuniv®) prolonged-release tablets “have been sourced” but lead times “vary”.

And it said that while “limited” parallel imports of methylphenidate (Equasym XL®) modified release capsules “remain available”, these “cannot support an uplift in demand”.

Meanwhile, supply issues with atomoxetine capsules are ongoing but “set to resolve” next month, it added.

Read more: Antidepressant items rocket to 85.5m in 2022/23, new data shows

It comes after health minister Will Quince last week (September 21) said that the DH was “aware of intermittent supply disruptions affecting Elvanse lisdexamfetamine capsules”.

Responding to a written parliamentary question, he said that the government was working with the manufacturer to ensure that “continuous supply is resumed quickly”.


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