Isotretinoin - Dispensing under the MHRA Pregnancy Prevention Programme
Oral retinoid medicines are associated with a high risk of severe congenital malformations and miscarriage following foetal exposure. To minimise this risk, the MHRA requires strict implementation of the Pregnancy Prevention Programme (PPP) for any patient with childbearing potential.
New guidance has been issued for both NHS and private prescribing and dispensing of isotretinoin.
Pregnancy Prevention Programme (PPP)
All patients of child-bearing potential (people who may be able to get pregnant) must be enrolled on to the Pregnancy Prevention Programme.
The prescriber must record the PPP status on the prescription at every clinic review.
There are four possible PPP status categories and patients can only be assigned one category:
Not applicable
Those with no child-bearing potential and therefore are not part of the Pregnancy Prevention Programme. These are patients who are medically unable to become pregnant (no uterus/ hysterectomy/ oophorectomy/ sterilisation (tubal ligation)/ postmenopausal). Neither contraception nor pregnancy testing are required.
PPP Group A
The patient and the prescriber agree that there is no expected risk of pregnancy during treatment and for one month after treatment and the patient is therefore not required to be on contraception.
They will still be enrolled on the PPP to have their pregnancy risk reviewed at every follow-up visit. They are not required to have pregnancy tests as long as the situation remains unchanged. However pregnancy testing may be done at the discretion of the patient or prescriber.
Expectation of no risk of pregnancy could include patients in any of the following circumstances:
- only 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 persons of the same-sex, persons who have had a vasectomy with two confirmed tests of being sperm-free, or transgender men.
- long-term sexual abstinence (no sexual activity) for the duration of isotretinoin treatment and for 1 month after stopping isotretinoin treatment.
PPP Group B
The patient has been using a non-user dependant, highly effective method of contraception for at least 4 weeks (IUD, IUS or implant). They do not require pregnancy testing every month but must have pregnancy testing at follow up appointments. Patients should be informed that they may choose to do pregnancy tests monthly at home as no contraceptive is 100% effective.
PPP Group C
All other patients of childbearing potential who are prescribed isotretinoin. These patients must be advised to use a hormonal contraceptive pill or contraceptive injection plus a barrier method (in other words, a condom, female condom, vaginal cap). Monthly pregnancy testing is required. The prescription may only be for 30 days and must be dispensed within 7 days.
For all patients in groups A,B and C, contraception must be used for four weeks before treatment, during treatment and one month after.
| PPP category | Prescription durations |
| Not Applicable | No requirement for pregnancy testing. 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 A | Pregnancy testing not mandated. 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 B | Pregnancy testing will be done at clinic appointments and patients are advised they may wish to do monthly pregnancy tests at home because no contraceptive 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 | Pregnancy testing is mandated monthly prior to issue of prescription. Prescription will be limited to 30 days and will need to be picked up within 7 days of the pregnancy test and prescription being issued |
Advice for Pharmacy Teams:
- Before dispensing a prescription for isotretinoin, pharmacists must ensure that:
- PPP status is clearly recorded on the prescription for patients of child-bearing potential (A,B or C)
- The prescription duration complies with the PPP category- see table above
- Pregnancy test results are confirmed and valid, if required
- All patients should be counselled on:
- Never sharing isotretinoin with another person
- Returning unused capsules to the pharmacy
- Not donating blood during treatment and for one month afterwards
- The importance of reading the Patient Reminder Card and PIL
- Seeking urgent medical advice and stopping treatment if experiencing either worsening mental health or suicidal thoughts or serious side effects
- Pregnancies occurring during treatment and within one 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 to record the pregnancy outcome.
Other Oral Retinoids – Acitretin and Alitretinoin
Risk minimisation materials and further information on the PPP including a Pharmacist Checklist can be found under each drug monograph on the emc.
There is no change at present to the restrictions on supply and all prescriptions issued to a patient under the PPP must be dispensed within seven days of a valid negative pregnancy test, ideally on the date the prescription is written and they should be limited to 30 days’ treatment.