Sample policy · Dermatology

Dermatology prescribing and drug monitoring policy (dermatology)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The primary clinical sources for this policy are the MHRA isotretinoin safety requirements and Pregnancy Prevention Programme, the British Association of Dermatologists systemic and biologic therapy guidance, the GMC good practice in prescribing and managing medicines guidance, and the Summary of Product Characteristics for each medicine; Regulation 12 is the engaged CQC regulation. · primary source

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

5. Scope

This policy applies to:

6. Roles and responsibilities

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:

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:

10. Monitoring and acting on results: the fail-safe

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:

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:

17. Related policies in this pack

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.

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

Version Date Author Changes
v1.2 2026-07-18 Verivius (sample) Added role ownership, the prescribing-to-monitoring workflow, evidence fields, related policies and the current MHRA source.
v1.1 2026-07-11 Verivius (sample) Added treatment-monitoring intent section, policy differentiation and internal links.
v1 2026-06-10 Verivius (sample) Initial sample template, conformed to the Verivius policy standard.

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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

The two harms this policy exists to prevent are irreversible and largely silent until it is too late: a pregnancy exposed to isotretinoin, which can cause severe birth defects, and an abnormal blood result on an immunosuppressant or biologic that is taken but never reviewed. Neither announces itself. A birth defect is set in train weeks before anyone would know a pregnancy had begun, and a rising liver enzyme or a falling blood count does nothing the patient can feel until organ or marrow damage is done. That is why the safety here cannot rest on the prescriber's judgement in the room. It rests on a system that screens before it starts, tests on schedule, notices when a test is missing, carries every result to a clinician who acts on it, and refuses the next prescription when the checks are not current. The person on these medicines is trusting the service to catch the thing they cannot see, so the monitoring trail is not administration. It is the fail-safe standing between them and a harm that cannot be undone, and the record is what shows the fail-safe was actually working on the day it mattered, not just described in a policy.

  1. For every patient who can become pregnant, isotretinoin runs inside the Pregnancy Prevention Programme as the current requirements set it, with the teratogenic risk explained and understood and effective contraception and pregnancy testing in place, so a prescription cannot continue without a required negative test. The record shows the current MHRA isotretinoin risk-minimisation materials were used, including the current Acknowledgement of Risk Form and an assessment of the relevant mental-health and sexual-function risks.

    Strong evidence: The isotretinoin patient record showing each stage of the Pregnancy Prevention Programme completed against current Medicines and Healthcare products Regulatory Agency (MHRA) requirements and the Summary of Product Characteristics: the risk acknowledgement, contraception confirmed, a negative pregnancy test recorded in the window the programme sets before each relevant prescription, and prescription dates that respect the programme's dispensing limits.

    Weak evidence: A signed risk-acknowledgement form on file with nothing behind it: no evidence the pregnancy tests were done and negative before each prescription, a prescription issued after the required test window had lapsed, or a patient who can become pregnant recorded as counselled with no contraception method confirmed. Also weak: the service still working to a superseded version of the programme after MHRA changed the requirements.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  2. A high-risk dermatology medicine is started only once its required baseline checks are complete and clear, so a biologic or an immunosuppressant does not begin over an undetected infection or an abnormal baseline. The screening the medicine's own source requires is seen and reviewed by the prescriber before the first dose, not booked to catch up afterwards.

    Strong evidence: The pre-treatment record listing the baseline blood tests and infection screening the current Summary of Product Characteristics and British Association of Dermatologists guidance require for that medicine, including screening for tuberculosis and hepatitis B and C before a biologic or immunosuppressant where the source requires it, with each result seen and signed off by the prescriber before treatment starts.

    Weak evidence: A start date that predates the baseline results, screening requested but never chased to a result, or a generic baseline panel that omits the infection screening a specific biologic requires. Also weak: the baselines on file but no record that a clinician reviewed and accepted them before the first prescription.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  3. Every monitoring result reaches a competent clinician's recorded decision, and an abnormal result triggers prompt action rather than sitting unread in an inbox. The staff who book and chase tests never close a result as done without that clinical decision, because the harm this guards against is an abnormal blood result that is filed and forgotten.

    Strong evidence: The monitoring log showing each result linked to a named reviewing clinician and the decision taken (continue, change, pause, stop or investigate), with abnormal results showing the action and when it happened, and the coordinator's role limited to arranging, tracking and escalating rather than interpreting results.

    Weak evidence: Results marked seen or filed with no clinical decision recorded, an abnormal result with no documented action, a decision reached in conversation and never written into the record, or an administrator marking results complete or interpreting them outside their competence instead of escalating.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  4. A repeat prescription is not issued while the required monitoring is overdue, so a medicine is never continued on the strength of a test that was never done. The service tracks the monitoring itself and pauses at the point of issue when a check is outstanding, rather than relying on the patient to remember or on the next result turning up in time (Reg 12(2)(g)).

    Strong evidence: The repeat-prescribing check that gates each issue on current monitoring, clinical review and, for isotretinoin, the current pregnancy-prevention steps, with a recorded pause and referral back to the prescriber whenever a requirement is overdue, unclear or unsafe.

    Weak evidence: Repeats issued on a rolling basis with no check that monitoring is current, an override applied with no recorded clinical reason, or a run of issues to a patient whose monitoring log shows the relevant test was overdue at the time. Safe management of medicines is the statutory duty; the exact monitoring intervals come from the Summary of Product Characteristics and specialty guidance, not from this check.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

  5. Where prescribing or monitoring is shared with another clinician, usually the patient's GP, who owns each task is agreed and written down, and neither side assumes the other is doing it, so a monitoring blood test does not fall into the gap between two services, and responsibility is treated as transferred only once the receiving clinician has accepted it (Reg 12(2)(i)). A single-handed service also arranges cover so monitoring continues while the prescriber is away, so continuity of safe monitoring does not depend on one person being present.

    Strong evidence: The shared-care record showing the request, the receiving clinician's explicit acceptance, the split of prescribing and monitoring responsibilities, the information exchanged and any unresolved task carried on a list, plus the cover arrangement for a single-handed prescriber.

    Weak evidence: A shared-care request sent with no evidence it was accepted, monitoring assumed to be the GP's job with nothing confirming they agreed, or a patient whose monitoring stopped while the prescriber was on leave because no cover was arranged. Also weak: a transfer treated as complete the day the letter was sent, before anyone accepted the person's care.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, reg 12(2)(i) (working with other providers on shared or transferred responsibility for care and treatment).

  6. A pregnancy exposed to isotretinoin, a missed abnormal result or a medicine continued without monitoring is treated as a serious patient-safety incident, and each separate duty it triggers is discharged in its own right. The incident is logged and investigated, the Regulation 20 duty of candour, which is owed to the person themselves and is not a notification, is opened where the harm threshold that applies to the service is met, a suspected serious adverse drug reaction is reported to the MHRA about the product through the Yellow Card scheme, and a CQC statutory notification or a safeguarding referral is made where each of those thresholds is separately met, because none of these discharges another.

    Strong evidence: The incident record linked to its investigation and learning, with the duty-of-candour decision recorded as opened or reasoned out, the Yellow Card report reference where a serious adverse reaction is suspected, and the statutory notification or safeguarding referral logged separately where its own threshold is reached.

    Weak evidence: A serious exposure or missed result logged as a routine note with no investigation, a Yellow Card report treated as if it also satisfies the duty of candour to the person, or a candour conversation recorded as done but with no evidence the person was actually told and given an apology. Also weak: an incident closed with no change to the monitoring system that let it happen.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

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Last verified 23 July 2026

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Last reviewed 10 June 2026