FOR HEALTHCARE PROFESSIONAL USE ONLY
Pharmacist Checklist
Guidance for Dispensing Oral Isotretinoin ▼
Isotretinoin belongs to the retinoid class of drugs that cause severe birth defects. Foetal exposure
to isotretinoin, even for short periods of time, presents a high risk of congenital malformations and
miscarriage.
Therefore, isotretinoin is strictly contraindicated during pregnancy.
People with childbearing potential must fulfil the conditions of the isotretinoin Pregnancy Prevention Programme
(PPP). Contraception is required unless the prescriber and patient agree they expect no risk of pregnancy during
treatment and 1 month after treatment.
A person has childbearing potential if they have a uterus and at least one ovary unless they:
a) Have undergone surgical sterilisation (tubal ligation), confirmed by a healthcare professional.
b) Are post-menopausal, confirmed by a healthcare professional.
All patients with childbearing potential (anyone who may be able to get pregnant) must be entered into the Pregnancy
Prevention Programme.
A person with childbearing potential requires contraception 4 weeks before treatment, during treatment and 1 month after,
UNLESS the prescriber and patient agree that, during treatment and for 1 month after treatment, there is no expected risk
of pregnancy due to:
a) O nly having sex/sexual intercourse with a person who has no potential to make them pregnant. This must be
for the duration of isotretinoin treatment and for 1 month after stopping isotretinoin treatment. Examples
include sex with a:
- Person of the same-sex
- Person who has had a vasectomy with two confirmed tests of being sperm-free
- Transgender man
b) Long-term sexual abstinence (no sexual activity) for the duration of isotretinoin and for 1 month after
stopping isotretinoin treatment.
Applicability of the Pregnancy Prevention Programme to the patient’s circumstances should be confirmed at each clinic
visit by the healthcare professional and should be recorded on the prescription as one of the following:
PPP not applicable - no childbearing No requirement for pregnancy testing. Prescription may be extended for longer
potential than 30 days (up to 12 weeks if no other side effect monitoring required) once
patient is stable on treatment.
PPP group A - no expected risk of Pregnancy testing not mandated. Prescription may be extended for longer than
pregnancy (see above) 30 days (up to 12 weeks if no other side effect monitoring required) once patient
is stable on treatment.
PPP Group B - on highly effective Pregnancy testing will be done at clinic appointments and patients are advised
contraception (IUD, IUS or implant) for they may wish to do monthly pregnancy tests at home because no contraceptive
at least 4 weeks is 100% effective. Prescription may be extended for longer than 30 days (up to
12 weeks if no other side effect monitoring required) once patient is stable on
treatment.
PPP Group C - on effective Pregnancy testing is mandated monthly prior to issue of prescription.
contraception (a hormonal Prescription will be limited to 30 days and will need to be picked up within 7 days
contraceptive pill or hormonal of the pregnancy test and prescription being issued.
injection PLUS a barrier method i.e.
condom, female condom or vaginal
cap) for at least 4 weeks
If you are aware that a pregnancy has occurred in a patient treated with isotretinoin or within 1 month of stopping
isotretinoin, treatment should be stopped immediately, and the patient should be referred promptly to the prescribing
healthcare professional.
M-GB-00014452 October 2023 Ver: 2.1 MHRA Approval Date: October 2023
FOR HEALTHCARE PROFESSIONAL USE ONLY
As a pharmacist, you should only dispense isotretinoin AFTER checking the following information:
For patients of childbearing potential:
Has the PPP status of the patient been recorded on the prescription?
What is the prescription length?
Is there a confirmed pregnancy test result, if applicable?
All patients should be instructed:
Never to give their isotretinoin to another person.
To return any unused capsules to their pharmacist at the end of treatment.
Not to donate blood during isotretinoin therapy and for 1 month after discontinuation due to the potential
risks to the foetus of a pregnant transfusion recipient.
To talk to their dermatology team or GP about their treatment if they have any concerns. To stop taking
isotretinoin and contact their dermatology team or GP for further advice if they have serious concerns about
their mental health or thoughts of harming themselves or other serious side effects.
They can also call the NHS on 111 or local mental health crisis team, for support out of hours. Alternatively,
they can call the Samaritans to talk about anything that is upsetting them, 24 hours a day, 365 days a year.
They can call 116 123 (free from any phone).
If they have seriously harmed themselves or feel that they may be about to harm themselves, call 999 for an
ambulance or go straight to A&E.
You must check the patient has been given a Patient Reminder Card. Please encourage them to read this,
and the package information leaflet thoroughly before and during treatment with isotretinoin.
▼This medicinal product is subject to additional monitoring.
Pregnancies occurring during treatment and within 1 month following discontinuation of treatment should be
reported to the MHRA and the company listed in the patient’s package information leaflet, who will follow up with
you to record the pregnancy outcome.
Healthcare professionals are asked to report any suspected adverse reactions.
Adverse events should be reported to the MHRA, and the company listed in the patient’s package information
leaflet. Reporting forms and information can be found at:
[Link]/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
To order further hard copies of the Oral Isotretinoin PPP materials
please email: oralisotretinoinppp@[Link] or call: 0370 703 0602
Electronic copies are available at: [Link]/emc
M-GB-00014452 October 2023 Ver: 2.1 MHRA Approval Date: October 2023
