Dear Member,

The MHRA has released a significant update regarding the prescribing and dispensing of Isotretinoin (Roaccutane, Reticutan), effective immediately. These changes follow a review of the risk minimisation measures introduced in 2023.

Please ensure your pharmacists and dispensing teams are briefed on these changes to avoid disrupting patient care.

Key Change: Second Prescriber No Longer Required

The requirement for a second prescriber to agree to treatment initiation for patients under 18 years of age has been removed.

Impact on Community Pharmacy:

• Dispensing Checks: When dispensing for patients under 18, you no longer need to verify that a second prescriber has approved the treatment.
• Action: Inform your teams (including locums) immediately to ensure valid prescriptions for under-18s are not refused or queried unnecessarily on these grounds.

New Risk Minimisation Measures

While the second prescriber rule is gone, new measures have been introduced to ensure safety:

1. New "Acknowledgement of Risk" Form:
   • A streamlined 2-page form is replacing the previous version.
   • Prescribers must now confirm on the form that there is no other appropriate effective treatment.
   • Pharmacy Action: Be prepared to see this new form. (Digital versions are live now; hard copies will follow).
2. Patient Information Video:
   • Patients must now confirm on the Risk Form that they have been advised to watch a new safety video produced by the British Association of Dermatologists (BAD).
   • Pharmacy Action: As part of your counseling, you can verify the patient has watched this video or signpost them to it if they are unsure.

What Has NOT Changed (Critical Reminders)

To ensure patient safety, the following strict controls remain in place and must be adhered to:

• The Pharmacist Checklist: You must continue to use the MHRA Pharmacist Checklist for every dispensing event.
• Pregnancy Prevention Programme (PPP): Strict rules for patients of child-bearing potential remain:
  • Prescriptions are valid for 7 days only from the date of the pregnancy test (date of script).
  • Maximum 30 days’ supply.
• Counseling: Continue to check that patients are aware of potential mental health and sexual function side effects and have their Patient Reminder Card.

Recommended Actions for Pharmacy Owners

1. Update SOPs: Review your Isotretinoin SOPs to remove the check for a "second prescriber" for under-18s.
2. Team Training: Ensure all staff are aware that the absence of a second signature for under-18s is no longer a reason to withhold supply, provided the other PPP checks are met.
3. Transition Period: Note that while the changes are immediate, there may be a transition period where you see a mix of old and new forms. Both should be handled with the usual clinical diligence.

You can read the full MHRA Drug Safety Update here: https://www.gov.uk/drug-safety-update/isotretinoin-changes-to-prescribing-guidance-and-additional-risk-minimisation-measures 

Regards,

PharmaPlus

Disclaimer: This communication is provided for general information purposes only and does not constitute legal or clinical advice. While every effort has been made to ensure the accuracy of the information summarized above, Pharmaplus (PPL) accepts no liability for any errors, omissions, or consequences arising from the use of this information. It is the sole responsibility of the pharmacy contractor and the Responsible Pharmacist to read the full MHRA guidance, verify the current regulations, and ensure full compliance within their practice.