Dermatology prescribing and drug monitoring policy (dermatology)

Who this dermatology treatment monitoring policy is for

This template is for dermatology services that need a treatment monitoring policy for isotretinoin, methotrexate, azathioprine, ciclosporin, biologics and other high-risk skin treatments. It is most useful where the inspection risk is not only "was the medicine prescribed safely?", but "did the service keep the baseline checks, blood tests, pregnancy-prevention checks, abnormal-result reviews and repeat-prescription stop rules under control throughout treatment?"

Use this as the dermatology-specific page for treatment monitoring. Use the cross-sector CQC medication policy template for whole-service medicines handling, the GP high-risk drug monitoring policy for primary-care prescribing systems, and the private-clinic aesthetic procedure safety policy for procedure consent, aftercare and complication escalation.

For CQC, the useful evidence is a live monitoring trail: the medicine started only after required checks, monitoring was booked and chased, results were reviewed by a competent clinician, and treatment paused where monitoring was overdue or unsafe. Link this policy from the dermatology medicines register, clinical-audit schedule, prescribing incident review and private-clinic governance pack where systemic dermatology treatment is offered.

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

where responsibility for the care and treatment of service users is shared with, or transferred to, other persons, working with such other persons, service users and other appropriate persons to ensure that timely care planning takes place to ensure the health, safety and welfare of the service users. (Reg 12(2)(i) (shared / transferred responsibility))

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. 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.

4. Sources to verify before adoption

• MHRA, current isotretinoin prescribing guidance and risk-minimisation measures: https://www.gov.uk/drug-safety-update/isotretinoin-changes-to-prescribing-guidance-and-additional-risk-minimisation-measures
• 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

5. 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

6. Roles and responsibilities

• Registered Manager: owns the governance system, confirms the service has safe staffing and cover, and reviews incidents, complaints, audits and overdue improvement actions.
• Clinical lead: approves the medicines and conditions within service scope, keeps the monitoring protocols and stop rules current, and reviews exceptions and audit findings.
• Prescriber: confirms indication and eligibility, completes the baseline assessment, obtains informed agreement, issues prescriptions only when required checks are satisfactory and documents each decision.
• Monitoring coordinator or delegated administrator: books and tracks required tests and reviews, chases missing results and appointments, and escalates anything overdue without interpreting clinical results.
• Reviewing clinician: reviews each result and reported side effect, records the clinical decision and makes sure the patient and relevant shared-care professional receive the agreed plan.
• Dispensing and support staff: follow the current prescription and patient-safety materials, work within role and escalate discrepancies rather than resolving them informally.

7. Step-by-step prescribing and monitoring procedure

1. Confirm scope and current protocol. Check that the medicine, condition and patient group sit within the Service's approved scope and that the current product information and national safety material have been adopted locally.
2. Complete the baseline assessment. Record indication, alternatives, relevant history, contraindications, interactions, baseline tests, pregnancy-prevention requirements where applicable and the patient's questions.
3. Make and record the prescribing decision. A competent prescriber confirms that required results are satisfactory, explains benefits and material risks, provides the current safety materials and records informed agreement.
4. Build the monitoring plan. Record each required test or review, its due window, who will arrange it, who will review it and the action if it is missed or abnormal.
5. Track every result to a clinical decision. The coordinator chases missing information. A clinician reviews the result, records the decision and communicates any action. Administrative staff do not mark a result complete without that decision.
6. Control repeat prescribing. Before each issue, check that monitoring, clinical review and risk-minimisation steps are current. Pause and refer to the prescriber when a requirement is overdue, unclear or unsafe.
7. Manage change, shared care and transfer. Confirm who owns prescribing and monitoring, communicate changes and do not assume responsibility has transferred until the receiving clinician has accepted it.
8. Close treatment safely. Record the reason for stopping, final monitoring or counselling, ongoing risks, follow-up and information sent to the patient and other clinicians.

8. 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.

9. 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

10. 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

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. Records and evidence fields

The prescribing and monitoring record should include:

• indication, medicine, dose, start date, prescriber and approved protocol version
• baseline assessment, contraindication and interaction checks, and required test results
• patient information supplied, questions answered, agreement and current risk-minimisation materials used
• monitoring plan, due windows, appointments, results and named reviewer
• the clinical decision for every result, including continue, change, pause, stop or investigate
• repeat-prescription checks and the reason for any override or exceptional decision
• shared-care request, acceptance, responsibilities, information exchanged and unresolved task
• side effects, safety concerns, pregnancy concern, missed monitoring, incident and follow-up
• treatment closure, final advice and ongoing monitoring owner

17. Related policies in this pack

• Medicines management policy
• Consent policy
• Incident reporting, investigation and learning policy
• Risk management and risk register policy
• Training, competency and mandatory training policy

18. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• MHRA current isotretinoin prescribing guidance, risk-minimisation measures and Pregnancy Prevention Programme
• NICE CKS (acne and high-risk prescribing)
• GMC good practice in prescribing and managing medicines and devices
• British Association of Dermatologists systemic and biologic therapy guidance
• The Summary of Product Characteristics for each high-risk medicine
• Shared-care protocols where prescribing or monitoring is shared with another clinician
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

19. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

20. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.