Retinoid Medicines – Safe Prescribing and Supply Guideline – NHS Borders

Warning

Objectives

To ensure that the prescribing and supply of retinoid medicines to patients in NHS Borders meets the MHRA mandated risk minimisation measures (2023 – 2026).

Scope

This guideline is intended to support clinical and pharmacy staff to provide retinoid medicines in line with the: 

  • MHRA risk minimisation measures. 
  • The acknowledgement of risk form.  
  • The Pregnancy Prevention Programme (PPP). 
  • The MHRA pharmacist checklist.

Audience

All prescribers, pharmacists, nursing and support staff involved in the prescribing, supply and monitoring of retinoid medicines

The MHRA has mandated several requirements for the prescribing and supply of isotretinoin for 3 main reasons:

  • Severe teratogenicity.

  • Potential mental health side effects (depression and suicidal ideation).

  • Potential sexual dysfunction

Prescribing requirements:

Prescribers must confirm that isotretinoin is clinically indicated and that no other effective treatment options remain. On the East Region Formulary, it is indicated for severe acne that is resistant to adequate courses of standard therapy with systemic antibiotics and topical therapy. It must be prescribed under specialist supervision.

Risk Acknowledgement Form and Prescription Requirements

Before issuing a prescription for isotretinoin/retinoid medication the prescriber must:

  1. Complete the risk acknowledgement form and ensure it is signed by the patient.

  2. Confirm understanding of risks, monitoring, contraception requirements and treatment indication.

  3. Determine the appropriate pregnancy prevention group and prescribe an appropriate length of isotretinoin (as per Table 1).

  4. For all individuals of childbearing potential, a copy of the risk acknowledgement form should be attached to the prescription.

  5. On the prescription indicate the length of treatment and the pregnancy prevention group of the patient (as per Table 1).

  6. The nurse undertaking the pregnancy test must indicate the result and date of the test on the prescription.

Table 1: Pregnancy prevention groups: required for all patients with childbearing potential (defined as anyone with a uterus and at least one ovary unless post-menopausal or surgically sterilised).

Group

Description

Pregnancy testing

Max prescription length

PPP not required

No childbearing potential, people without a womb

Not required

Up to 12 weeks

A

No pregnancy risk (same sex partner, vasectomised partner or abstinent)

Not mandated

Up to 12 weeks

B

Highly effective contraception (IUD/IUS/implant > 4 weeks)

Follow up appointments mandated.  Monthly recommended

Up to 12 weeks

C

Combined methods (injections +/- barrier +/- contraceptive pill )

Monthly Mandated

30 days, must collect within 7 days

Sample Prescription

Sample prescription for Isotretinoid with dummy details

 

Clinical Review Requirements

  1. At each clinical review assess the patient for adverse effects using PROMs such as HADS, PHQ-9 and GAD-7.

  2. Patients should be asked about side effects, or requested to complete the side effect questionnaire Isotretinoin-side-effects-patient-questionnaire-OCT-2025.pdf. 

  3. Patients should be requested to watch the BAD patient video on the benefits, risks and requirements of isotretinoin treatment Isotretinoin Acne Treatment Information Video on Vimeo.

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Dispensing requirements

At the professional check stage of the pharmacy process the pharmacist must:

  1. Check the PPP group is recorded on the prescription for individuals of childbearing potential.

  2. Check the result of a valid pregnancy test on the prescription if appropriate (for individuals of childbearing potential as per the PPP group – see Table 1).

  3. For group C: prescription is valid for 7 days after pregnancy test.

  4. For the first dispensing: check that the acknowledgment of risk form has been completed (a copy of Page 2 - Pregnancy Prevention Programme should be attached to the prescription for individuals of childbearing potential for the first dispensing). If this is not attached to the prescription request it from the clinical team.

  5. If it is the first dispensing of isotretinoin, access the patients TRAK record and insert a pharmacy note indicating that an acknowledgement of risk form has been completed and reviewed by a pharmacist. For subsequent dispensing, check the patient’s TRAK record for this pharmacy note – this is sufficient to allow dispensing.

  6. Check the quantity to dispense does not exceed the recommendations in Table 1 above (as per PPP group).

The patient should be counselled on:

  1. Never share isotretinoin.

  2. Return unused capsules to the pharmacy for destruction.

  3. For individuals of childbearing potential to avoid pregnancy for at least 1 month after stopping.

  4. Report mood or sexual function changes immediately

Check that the patient has been provided with the British Association of Dermatologists’ Isotretinoin PIL (patient information leaflet) or the Patient Reminder Card (Patient_Reminder_Card.pdf)

APPENDIX 1 - MHRA Checklist

APPENDIX 2 - MHRA Acknowledgement of Risk Form

Editorial Information

Last reviewed: 31/05/2026

Next review date: 31/05/2029

Author(s): Harvey, K.

Version: 1.0

Co-Author(s): Holme, A.

Approved By: NHS Borders Area Drug & Therapeutics Committee

Reviewer name(s): Harvey, K.