Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Neuroprotective agents

Restrictions on Epidyolex prescribing reduced, as it is rescheduled

The UK government has reclassified cannabidiol as being under Schedule 5 of the Misuse of Drugs Act, reducing the number of restrictions around prescribing and dispensing the medicine.

epidiolex cannabidiol cbd bottle and packaging

Source: GW Pharma

Epidyolex has been moved to Schedule 5 of the Misuse of Drugs Act

The cannabis-based medicine Epidyolex (cannabidiol; GW Pharma) will be easier to prescribe and dispense, following its move from Schedule 2 to Schedule 5 under the Misuse of Drugs Act, Gino Martini, chief scientist at the Royal Pharmaceutical Society (RPS) has said.

On 24 June 2020 the Home Office announced that it had reclassified the drug with immediate effect across the UK, following a recommendation from the Advisory Council on the Misuse of Drugs’s (ACMD’s) Technical Committee on 29 January 2020. In its recommendation, the committee said that the low levels of tetrahydrocannabinol in Epidyolex — “present only as an impurity and … specified within the product’s approved marketing authorisation to be limited to <0.10% w/w” — meant that the drug presents “a low risk of abuse potential, low risk of dependency and low risk of diversion”.

The ACMD said that the amendment to the Misuse of Drugs Regulations 2001 should not refer to the proprietary name “Epidyolex”, and should instead include a “suitable description of the relevant component(s)” of the medicine.

On 18 December 2018 the National Institute for Health and Care Excellence recommended that the medicine, which is used alongside clobazam, should be provided by the NHS as an adjunct therapy for two severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome.

The RPS was asked by the Home Office for its views on rescheduling the drug. Martini said that the Society supported the move, which would “be beneficial to patients and will provide more flexibility in prescribing and dispensing of this medicine.

He added that “rescheduling Epidyolex would assist in the emergency supply of this medicine as and when the need arises, which is an important factor when considering [its] indications.”

Chris Tovey, chief operating officer at GW Pharma, said that the move “is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole — reducing costs and ensuring the medicine can be dispensed more easily”.

In a statement, the company said that the decision meant patients would have “greater flexibility on the quantity of medicine they can receive and be able to benefit from repeat prescriptions, thereby potentially reducing travel to hospital pharmacies, while healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2”.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2020.20208105

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 1 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £138.50Buy now
  • BNF and BNF for Children

    BNF and BNF for Children

    Now available as a 2 year print subscription to both the BNF and BNFC, ensuring you have the latest medicines information as it publishes and at a greatly reduced price.

    £262.50Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Sport and Exercise Medicine for Pharmacists

    Sport and Exercise Medicine for Pharmacists

    All the information you need to provide patients with evidence-based advice on sports and exercise related health matters.

    £27.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.