Oral retinoids must not be used during pregnancy. They have a high risk of causing severe birth defects and miscarriage.

What the PPP is

The pregnancy protection programme (PPP) protects people of childbearing potential (anyone who may be able to get pregnant) using oral retinoids (used to treat severe skin conditions) by minimising the risk of becoming pregnant.

What and who the PPP applies to

The PPP applies to:

• Oral acitretin, alitretinoin and isotretinoin – all people of childbearing potential on these retinoids must be entered into the PPP. Each retinoid has its own PPP and must not be taken by people of childbearing potential unless the conditions of the PPP are met. See each individual summary of product characteristics (SPCs) on the electronic medicines compendium (emc) website, for risk minimisation materials, including prescriber checklists and contraceptive and pregnancy testing requirements.
• Some people are not at risk of pregnancy (no expected risk of pregnancy). However, they should still be supported under the PPP and must have their pregnancy risk reviewed at every follow-up visit unless the prescriber agrees there are compelling reasons to indicate that there is no risk of pregnancy – document discussions on the patient’s records. No expected risk of pregnancy may include:
  • If they are not sexually active (and there is certainty that sexual activity will not start during the period of teratogenic risk). For example, long-term sexual abstinence, no sexual activity (note – for isotretinoin, this must be for the duration of isotretinoin treatment and for one month after stopping treatment, confirmed at each clinic visit).
  • Only having sexual intercourse with a person who has no potential to make them pregnant (e.g. people of the same sex, people who have had a vasectomy with two confirmed tests of being sperm-free).

The PPP does not apply to:

• Oral tretinoin and oral bexarotene – do not have a PPP due to their oncology indication and specialist care setting. However, they are still extremely teratogenic and must not be used during pregnancy. See individual SPCs for contraceptive and pregnancy testing requirements for these retinoids.
• Topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin) – do not have PPPs. However, risk cannot be excluded. As a precaution, they must not be used during pregnancy or if planning a pregnancy. See individual SPCs for contraceptive requirements for these retinoids.
• Where there is no childbearing potential (no risk of pregnancy) – neither contraception nor pregnancy testing is required:
  • For example, medically unable to become pregnant due to a hysterectomy, no uterus, oophorectomy, post-sterilisation (tubal ligation), post-menopausal (etc.). 

What the PPP involves

The PPP includes:

• Pregnancy testing requirements.
• Contraception requirements.
• Distribution control (prescribing and dispensing).
• Education for healthcare professionals (HCPs) and people taking oral retinoids to understand teratogenic risk.

Pregnancy testing requirements

Pregnancy testing is required:

• Before treatment – pregnancy should be excluded before starting treatment
• During treatment – ideally monthly, depending on method of contraception and pregnancy risk
  • Repeated medically supervised pregnancy tests should be determined by local practice, considering the person’s sexual activity and recent menstrual history (e.g. abnormal menses, missed periods or amenorrhea).
• After stopping treatment – for one month (alitretinoin) or for three years (acitretin with one to three monthly intervals recommended) after stopping.

For isotretinoin, pregnancy testing requirements depend on the PPP status category:

• PPP not applicable – no childbearing potential, therefore not under the PPP and no requirement for pregnancy testing.
• PPP Group A – no expected risk of pregnancy, so pregnancy testing is not mandated as long as their situation remains unchanged. However, pregnancy testing may be done at the discretion of the patient or prescriber.
• PPP Group B – pregnancy testing done at clinic appointments and optional monthly pregnancy tests at home. 
• PPP Group C – monthly pregnancy testing is mandated before issuing a prescription.

Dates and results of pregnancy tests should be documented in the patient’s notes.

Ideally, pregnancy testing should occur on the same day as issuing and dispensing the prescription.

For isotretinoin, remote pregnancy testing may be regarded as a medically supervised test with appropriate guidance and oversight to ensure tests are performed correctly and safely. See the Medicines and Healthcare products Regulatory Agency (MHRA) website for the Drug Safety Update – Isotretinoin – updates to prescribing guidance and survey of services (2025).

Contraception requirements

Advise people of childbearing potential under the PPP to consistently and correctly use:

• One highly effective user-independent method (e.g. intrauterine device (IUD) or implant) or;
• Two user-dependent forms (e.g. oral contraceptive and barrier method).

Alitretinoin and acitretin

Start contraception one month before treatment and continue during treatment and after stopping for at least:

• One month after stopping alitretinoin.
• Three years after stopping acitretin.

Isotretinoin 

Contraception requirements depend on the PPP status category: 

• PPP not applicable – no childbearing potential (see the section on who the PPP applies to), therefore not under the PPP and no requirement for contraception.
• PPP Group A – no expected risk of pregnancy during treatment and for one month after treatment, so not required to be on contraception.
• PPP Group B – using a non-user dependent, highly effective contraception (IUD, intrauterine system or implant) for at least four weeks.
• PPP Group C – must be advised to use effective contraception (a hormonal contraceptive pill or hormonal injection plus a barrier method, i.e. condom, female condom or vaginal cap) for at least four weeks.

Education for HCPs and people taking oral retinoids 

Risk minimisation materials available for oral retinoids under the PPP include:

• Prescriber checklist – to be used by the prescriber (e.g. lead prescriber, dermatologists, GPs with an extended role in dermatology or specialist dermatology nurses) to record risk discussions with the person needing the medicine and check they comply with, understand and acknowledge the reasons for the PPP and agree to monthly follow-ups, contraceptive precautions, pregnancy testing and other possible risks and precautions. 
• Isotretinoin Acknowledgement of Risk Form (updated January 2026, there are risk forms for alitretinoin and acitretin also, see the emc for more information) – the lead prescriber (prescriber initiating isotretinoin treatment) must complete the Acknowledgement of Risk Form for all patients treated with isotretinoin. The form covers possible side effects, including risks to mental health, sexual function and the PPP. All people (and a parent or guardian if the person is under 18 years old) must sign the form. A signed copy should be provided to the person needing the medicine. Hard copies will be available to order from the marketing authorisation holders.
• Patient reminder card – should be given by the prescriber.
• Pharmacist checklist – used when dispensing oral acitretin, alitretinoin and isotretinoin.
• Patient information video – HCPs should advise patients to watch the video on isotretinoin before starting treatment. Produced by the British Association of Dermatologists (BAD), the MHRA and Commission on Human Medicines (CHM), it explains the risks associated with isotretinoin treatment. Patients will need to confirm they are aware of the video on the isotretinoin Acknowledgement of Risk Form.

These compulsory regulatory risk minimisation materials can be found in individual SPCs on the emc website.

Prescribing under the PPP

Who can prescribe

All oral retinoids must be prescribed within a team, led by a consultant dermatologist, that has a full understanding of the risks of systemic retinoid therapy and monitoring requirements (see the MHRA’s Drug Safety Update – Oral retinoids: pregnancy prevention – reminder of measures to minimise teratogenic risk), with additional guidance below for isotretinoin.

For isotretinoin, HCPs involved in prescribing are:

• A lead prescriber who initiates isotretinoin treatment – HCP who makes the decision to initiate isotretinoin treatment – see the MHRA Report of the CHM Isotretinoin Implementation Advisory Expert Working Group (IIAEWG) (updated January 2026) for the list of HCPs.
• A follow-up prescriber responsible for continuation of treatment and monitoring – for example, lead prescriber, specialist dermatology nurse or pharmacist prescriber with appropriate dermatology expertise, experience, skills and training in prescribing isotretinoin, working within a consultant dermatologist- or GP-with-an-extended-role- (GPwER) agreed pathway.

Prescribing considerations 

Prescriber checklists are available to support the PPP in people of childbearing potential taking oral acitretin, alitretinoin and isotretinoin.

Considerations:

• Oral retinoids should only be initiated by or under the supervision of a consultant dermatologist-led team under the conditions of the PPP.
  • The prescriber must:
    • Complete the relevant prescriber checklist.
    • Complete the relevant Acknowledgement of Risk Form.
    • Provide the relevant patient reminder card.
    • Check that the person complies with, understands and acknowledges the reasons for pregnancy prevention and agrees to monthly follow-ups, contraceptive precautions and pregnancy testing, monthly prescriptions and other risks and precautions using the relevant regulatory risk minimisation materials.
• Validity of prescriptions:
  • For oral acitretin and alitretinoin – valid for seven days. 
  • For isotretinoin – depends on the PPP status category:
    • Group C – valid for seven days and will need to be picked up within seven days of the pregnancy test and prescription being issued.
• Duration of treatment:
  • For oral acitretin and alitretinoin – ideally should be limited to 30 days.
  • For isotretinoin – depends on the PPP status category:
    • Group A, B and PPP not applicable – prescription may be extended for longer than 30 days (up to 12 weeks if no other side-effect monitoring is required) once the person is stable on treatment.
    • Group C – prescription limited to 30 days.
• Advise all people on retinoids about the possible risk of neuropsychiatric reactions. If they experience changes in their mood or behaviour, they should speak to their doctor and inform their family and friends to look out for these changes – see the MHRA’s Drug Safety Update – Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women (2019).

Further requirements before prescribing isotretinoin:

• The lead prescriber needs to assess and document the PPP status of the person on the isotretinoin Acknowledgement of Risk Form – people can only be assigned one of four PPP status categories:
  • PPP not applicable.
  • PPP Group A.
  • PPP Group B.
  • PPP Group C.
• The PPP status of the person must be recorded on the prescription.
• Assess the person’s mental health and sexual function, including personal and family history.
• Inform all people on the benefits and risks of treatment and the possible mental health and sexual function side effects – give the person sufficient time to consider, reflect, ask questions and decide whether it is the right treatment for them.
• Review in-person approximately one month after initiating treatment.

Information on the roles and responsibilities of HCPs involved in the treatment of people with acne, including the referrer (e.g. GP or primary care HCP), lead prescriber and follow-up prescriber, can be found in the MHRA Report of the CHM IIAEWG above.

Consultations, including follow-ups

The initial consultation should be in-person, face-to-face. 

Isotretinoin consultations

The initial consultation should also be in-person, face-to-face. 

Follow-up consultations do not necessarily need to be in-person and could be remote if appropriate. This should be discussed and agreed with the patient, considering the clinical assessment, the patient’s needs and preferences and safeguarding. The prescriber should consider standards and best-practice guidance set by their regulatory and professional bodies on consultations (including remote). 

Patients should continue to be asked about sexual function at follow-up appointments, although by the third appointment, this may be brief.

See the MHRA’s updates to prescribing guidance and survey of services for isotretinoin (2025).

Monitoring

All oral retinoids require monitoring for:

• People at risk of pregnancy – they should receive regular follow-up and pregnancy testing, depending on the method of contraception and pregnancy risk.
• People with signs of depression and suicidal ideation – they should be referred, if necessary, including people with a history of depression.
• For isotretinoin, check mental health and sexual function side effects at follow-up appointments, although by the third appointment, this may be brief.
  • For information on initial and follow-up isotretinoin consultations, see the section above on consultations, including follow-ups.

Further details on monitoring and adverse/side effects of oral retinoids can be found in the British National Formulary (BNF) and individual product SPCs (via the emc).

Dispensing retinoids under the PPP

Considerations for pharmacists and their teams dispensing oral acitretin, alitretinoin and isotretinoin under the PPP:

• Use the pharmacist checklist – available under risk materials in the individual SPCs on the emc website.
• Clinically check the prescription – you may find our clinical checks guide helpful.
• Check the validity of the prescription:
  • For acitretin, alitretinoin and isotretinoin Group C – the prescription must be dispensed within seven days and ideally on the date the prescription is written.
    • Consider prescriptions presented after seven days expired – use your professional judgment on a case-by-case basis and refer the person back to the prescriber, as they may need to have another pregnancy test before getting a new prescription. 
  • For male patients, the validity of seven days doesn’t apply.
• Check the duration of treatment:
  • Oral acitretin and alitretinoin ideally should be limited to 30 days of treatment:
    • A quantity for more than 30 days can only be dispensed if the person is confirmed by the prescriber as not being under the PPP.
    • In exceptional circumstances, where a person under the PPP requires a quantity of more than 30 days (e.g. going on holiday) then these should be dealt with on a case-by-case basis and documented in the patient notes.
  • For isotretinoin, the duration of treatment depends on the PPP status category:
    • Group A, B and PPP not applicable – the prescription may be extended for longer than 30 days (up to 12 weeks if no other side effect monitoring is required) once stable on treatment.
    • Group C – the prescription is limited to 30 days.
  • For male patients, prescriptions do not have a limit on the duration of treatment.
• Check if there is a confirmed pregnancy test result (if applicable) – ideally, pregnancy testing, issuing the prescription, and dispensing should all occur on the same day.
• A telephone request should only be accepted if this is an emergency supply at the request of a PPP specialist prescriber, together with confirmation of a negative pregnancy test within the last seven days to exclude pregnancy (if applicable).

Counselling for those on oral retinoids

Advise all people on oral retinoids to read the patient information leaflet (PIL) and packaging as a reminder of key safety messages. 

Discuss the following:

• The medicine – what it is, how it works and how to use it (importance of adherence).
• The benefits and risks of treatment.
• Side/adverse effects – make sure the person is aware of what signs and symptoms to look out for, what to do if they occur and when to seek medical attention and advice:
  • Retinoids can cause dryness and thinning of the skin – advise people to use sun cream, lip balm and emollients during therapy and avoid exposure to UV light (including sunlight). 
  • For isotretinoin, inform people of the possible sexual function side effects and ask if they have any sexual function concerns.
  • The risk of neuropsychiatric reactions associated with all oral retinoids – advise people to read the PIL for possible risks and what to do. Monitor and ask about any changes in mood. Warn them to speak to their HCP if they recognise signs and symptoms of depression, anxiety and suicidal thoughts, especially if there is a personal or family history of mental health issues. Encourage people to share information with family and friends so they can also look out for any changes in mood.
    • Systemic absorption is negligible for topical retinoids and unlikely to result in neuropsychiatric reactions.
  • The risk of teratogenicity associated with all oral retinoids in people of childbearing potential – oral retinoids are strictly contraindicated during pregnancy. Advise people to read the PIL for possible risks and what to do if they become pregnant or think they might be pregnant.
  • Report side effects associated with oral acitretin, alitretinoin and isotretinoin to the MHRA via the Yellow Card scheme and relevant clinical IT systems (e.g. EMIS, SystmOnline, VISION, MiDatabank and Ulysses). Remember to provide as much information as possible, including medical history, concomitant medication, onset timing and treatment date.
• Contraception – check and counsel on correct contraception use if under the PPP.
• Patient reminder card – check the person has a patient reminder card if they are under the PPP – ask them to read it and keep it safe, as it contains important safety information to be aware of before and during treatment.
• Acknowledgement of Risk Form – check that the person has a copy of the relevant risk acknowledgement form.
• Patient information video – HCPs should advise patients to watch the video before starting treatment. Patients will need to confirm they are aware of the video.
• Referrals – make sure the person is aware when to see a prescriber (see the section on when to refer).
• Blood donation – advise people not to donate blood during treatment, and for one month (alitretinoin and isotretinoin) or three years (acitretin) after stopping, due to the potential risks to the foetus of a pregnant transfusion recipient.
• Laser, waxing and dermabrasion – advise people to avoid laser skin treatment, waxing and dermabrasion during treatment and for six months after treatment (isotretinoin).
• Sharing medicines – advise people never to share their medicines with another person.
• Interactions – make sure the person is aware to check interactions with a pharmacist before starting any new medicines.
• Storage and disposal – advise all people on how to correctly store and return any unused medicines to a pharmacy for disposal when treatment finishes.
• Health promotion – provide general lifestyle and wellbeing advice where appropriate, including diet, exercise, smoking cessation, and weight and blood pressure management.

You may also find our pharmacy guide on counselling people on the use of medicines useful.

When to refer

Refer if:

• Pregnancy occurs during treatment or within one month (alitretinoin and isotretinoin (PPP Group A only)) or three years (acitretin) after stopping – advise to discontinue treatment and immediately refer to the prescribing HCP.
• There are signs and symptoms of depression or worsening of symptoms – refer for appropriate medical treatment.
• There are visual difficulties – expert referral needed.

Audits

Isotretinoin audit

A regular clinical audit of risk minimisation measures for isotretinoin will be developed and implemented by the BAD. Information will be gathered and submitted to the CHM for review. If there is evidence risk minimisation measures are not being followed by services, further regulatory measures will need to be considered.

Audits will continue on a regular basis.

HCPs are expected to fully engage in the clinical audit, which will be initiated later in 2026 when the BAD determines what the audit will involve and what data will be required from services.

Further reading

• BNF.
• emc – includes PILs and SPCs.
• BAD.
• European Medicines Agency: Retinoid-containing medicinal products – referral – data on safety and efficacy for all retinoid medicines, and Pharmacovigilance Risk Assessment Committee Retinoid Article 31 report (European Commission final decision).
• MHRA:
  • MHRA – Isotretinoin – changes to prescribing guidance and additional risk minimisation measures.
  • MHRA – Medicines with teratogenic potential: what is effective contraception and how often is pregnancy testing needed?
  • Report of the CHM IIAEWG.
  • MHRA – Oral retinoid medicines▼: revised and simplified pregnancy prevention educational materials for healthcare professionals and women.
  • MHRA – Isotretinoin – updates to prescribing guidance and survey of services.
  • MHRA – Oral retinoids: pregnancy prevention – reminder of measures to minimise teratogenic risk.
  • MHRA – Acknowledgment of Risk Form (for isotretinoin).
  • MHRA – Yellow Card scheme.
  • MHRA – Isotretinoin (Roaccutane▼) – introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age.