1. Purpose
Dermatology prescribes some of the highest-risk medicines in general use: isotretinoin, which causes severe birth defects; immunosuppressants such as methotrexate, azathioprine and ciclosporin, which need regular blood monitoring; and biologic therapies, which need screening before they start. Each is safe only with the right checks before and during treatment. This policy sets out how the Service prescribes and monitors these medicines so that a preventable harm, above all a pregnancy exposed to isotretinoin or a missed abnormal blood result, does not happen.
The Service must verify this policy against current MHRA safety guidance, British Association of Dermatologists guidance and the drug Summaries of Product Characteristics before adoption.
2. Sources to verify before adoption
- MHRA, isotretinoin and the Pregnancy Prevention Programme, and other drug safety guidance: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
- British Association of Dermatologists, guidelines on systemic and biologic therapy and monitoring: https://www.bad.org.uk/
- The Summary of Product Characteristics for each medicine (the required screening and monitoring)
- GMC, Good practice in prescribing and managing medicines and devices: https://www.gmc-uk.org/
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
3. Scope
This policy applies to:
- the prescribing and monitoring of high-risk dermatology medicines, including isotretinoin, oral immunosuppressants and biologics
- the clinicians who prescribe them and the staff who arrange and track monitoring
- patients on these medicines for the duration of treatment
4. The high-risk medicines and their checks
The Service keeps, for each high-risk medicine it uses, a record of the checks needed before starting and the monitoring needed during treatment, taken from the current Summary of Product Characteristics and guidance. These typically include:
- baseline blood tests, and for some medicines screening for infections such as tuberculosis and hepatitis B and C before a biologic or immunosuppressant starts
- a schedule of blood tests during treatment, at the frequency the guidance sets
- pregnancy and contraception checks where the medicine can harm a pregnancy
A medicine is started only when its required baseline checks are complete and clear.
5. Isotretinoin and the Pregnancy Prevention Programme
Because isotretinoin causes severe birth defects, for any patient who can become pregnant the Service follows the Pregnancy Prevention Programme in full:
- the risk is explained and understood, and recorded
- effective contraception is in place as the programme requires, before, during and after treatment
- pregnancy testing is done before starting, at the intervals the programme sets during treatment, and after stopping
- prescriptions are limited and timed as the programme requires, and treatment does not continue without the required tests
- the Service confirms the current requirements against MHRA guidance, including any controls that apply to all patients
6. Monitoring and acting on results: the fail-safe
- monitoring blood tests are arranged on the schedule and tracked, so a missing test is noticed and chased
- results are reviewed by a clinician, acted on and recorded; an abnormal result triggers prompt action, which may mean reducing the dose, stopping the medicine, or further investigation
- a prescription is not continued or repeated where the required monitoring is overdue
- the system does not rely on the patient to remember; the Service tracks the monitoring
7. Patient information and consent
Before starting, the patient is told, in a form they can keep, what the medicine is for, its main risks, the monitoring required, what to watch for, and what to do if they have side effects or, for isotretinoin, if a pregnancy is possible. Their understanding and agreement are recorded.
8. Shared care and continuity
Where monitoring or prescribing is shared with another clinician (for example the patient's GP), the responsibilities are agreed and documented so nothing falls between the two, and neither assumes the other is doing it. Where the Service is single-handed, it arranges cover so monitoring continues if the prescriber is away.
9. When something goes wrong
A pregnancy exposed to isotretinoin, a missed abnormal result, or a medicine continued without monitoring is treated as a serious patient-safety incident: logged, investigated, with the duty of candour opened where the threshold is met, and reported as required.
10. Training
Clinicians prescribing these medicines keep current with their safety requirements, and staff who arrange and track monitoring are trained in the schedules and the fail-safe. The Service records who is competent and the next refresher date.
11. Audit cadence
The Service checks, on a stated cadence, that:
- baseline screening was complete before each high-risk medicine started
- the Pregnancy Prevention Programme was followed in full for every relevant patient on isotretinoin
- monitoring was arranged, tracked, reviewed and acted on, with no prescription continued on overdue monitoring
- shared-care responsibilities were agreed and continuity was maintained
The Registered Manager and the clinical lead review the results and record the improvement actions that follow.