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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 13 - Skin 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
Links:
British Association of Dermatology (BAD) recommended list of ’specials’ 2018
13.06.02 Oral preparations for acne
13.06.02 Oral antibiotics for acne
13.06.02 Hormone treatment for acne
13.06.02 Oral retinoid for acne

Isotretinoin

RED
Formulary

5mg, 10mg & 20mg Capsules

For use by the Dermatology specialists only

 

Red Triangle Not suitable for peanut allergic patients (contains soy bean oil)

 

Isotretinoin is teratogenic and must not be given to women of child-bearing age unless they practice effective contraception (oral progestogen-only contraceptives not considered effective) and then only after detailed assessment and explanation by the physician.

In patients under 18 years of age two independent prescribers must agree that there is no other appropriate effective treatment before initiation of isotretinoin therapy 

Women must also be registered with a pregnancy prevention programme.

Pregnancy must be excluded before starting isotretinoin (perform pregnancy test 2–3 days before expected menstruation, start treatment on day 2 or 3 of menstrual cycle) — women must practice effective contraception at least 1 month before, during, and for at least 1 month after treatment

Prescribed in accordance to the following Isotretinoin (Alliance) Pregnancy Prevention Programme: Isotretinoin 10 mg soft capsules - Risk Management Materials - (emc) (medicines.org.uk)

 

Entry reviewed: November 2023

BNF BNFc SPC
MHRA DSU Oct 2023 Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of age DSU Oct 2017: Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libido MHRA Drug Safety Update (December 2014) - Isotretinoin (Roaccutane): reminder of possible risk of psychiatric disorders MHRA Drug Safety Update (September 2010) - Isotretinoin: risk of serious skin reactions MHRA Drug Safety Update: Isotretinoin (Roaccutane¥): reminder of important risks and precautions (August 2020) MHRA DSU April 2023 - Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 years
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.