1. What the regulation says
Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))
the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))
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))
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
A single-handed independent specialist often prescribes privately, sometimes without the patient's GP knowing, and sometimes remotely. That carries real risks: an interaction the prescriber does not see, a controlled drug misused, or a medicine that needs monitoring no one is doing. This policy sets out how the practice prescribes safely, issues private prescriptions correctly, and keeps the patient's wider care joined up.
The practice must verify this policy against current GMC prescribing guidance and the Human Medicines Regulations 2012 before adoption.
4. Scope
This policy applies to:
- all prescribing by the practice, including private prescriptions, controlled drugs and remote prescribing
- the doctor who prescribes and any staff who support prescribing
- the patients prescribed for
5. Roles and responsibilities
- Doctor / Registered Manager: owns the prescribing system, approves the formulary or treatment list used by the practice, confirms prescribing is within competence, and reviews prescribing incidents, complaints and audit findings.
- Prescriber: makes the prescribing decision, confirms there is enough reliable information, checks allergies, interactions and monitoring needs, records the decision, and does not delegate clinical judgement to administrative staff.
- Administrative or clinical support staff: prepare only the non-clinical parts of a prescription workflow, send approved information to the patient or GP, and escalate missing information, urgent results or patient concerns.
- Governance lead or nominated reviewer: tracks prescribing incidents, controlled-drug concerns, medicine-safety alerts, repeat-prescribing exceptions and improvement actions.
6. Safe prescribing procedure
The practice follows this procedure before issuing any medicine, treatment or device:
- Confirm the prescribing purpose. Record the diagnosis, indication, intended benefit, planned duration, and whether this is a new prescription, repeat, private prescription, remote prescription or controlled drug.
- Check competence and scope. Confirm the prescribing decision is within the doctor's competence and within the practice's declared scope of services.
- Check patient identity and information. Confirm identity, allergies, current medicines, relevant medical history, pregnancy or breastfeeding status where relevant, monitoring results and contraindications.
- Decide whether the consultation mode is safe. Use face-to-face assessment when examination, testing, communication need or medicine type makes remote prescribing unsafe.
- Assess interactions and monitoring. Check interactions, duplicate therapy, high-risk medicine monitoring, controlled-drug risks, dependence risk and any need for follow-up tests.
- Discuss the medicine with the patient. Explain the reason for the prescription, likely benefits, material risks, common side effects, alternatives, what to do if symptoms worsen, and the cost of a private prescription.
- Share information where needed. Ask for consent to inform the GP or usual prescriber where this supports safe care. If the patient refuses and the risk cannot be managed safely, do not prescribe and record why.
- Issue the prescription correctly. Include the legal prescription details, controlled-drug wording where relevant, quantity, dose, route, directions, date and prescriber details.
- Track monitoring and repeats. Do not issue open-ended repeats. Confirm required monitoring is current before continuing a medicine.
- Escalate safety concerns. Open an incident or safeguarding concern where prescribing raises serious harm, diversion, dependence, coercion, falsified information, medicine-safety alert exposure or a patient-safety near miss.
7. Prescribing within competence and on adequate information
- the doctor prescribes only within their competence and for conditions they are managing
- before prescribing, the doctor has enough information about the patient, including their other medicines, allergies and relevant history, to prescribe safely, and checks for interactions and contraindications
- the doctor does not prescribe simply because a patient requests a medicine; the decision is a clinical one
8. Private prescriptions
- private prescriptions are written correctly and legibly with the information the law requires, and dated and signed
- the patient is told what the medicine costs them and where they can have it dispensed
- the practice keeps a record of what was prescribed
9. Controlled drugs
Where the practice prescribes controlled drugs:
- the additional legal requirements for controlled-drug prescriptions are met
- the practice is alert to the risk of dependence, diversion and misuse, and prescribes cautiously, especially for opioids and other drugs of dependence
- the practice records its controlled-drug prescribing and follows the controlled-drug governance that applies to it
10. Keeping care joined up
Because a single-handed specialist may be one of several people prescribing for a patient:
- the practice asks the patient's consent to tell their GP what has been prescribed, and where the patient agrees, does so promptly, so the GP record is complete and interactions can be seen
- where the patient declines, the practice records that and is especially careful, because no one else may know what has been prescribed
- the practice does not assume the GP will take over monitoring it has not agreed with them (see the shared-care arrangements in the scope, indemnity and continuity policy)
11. Remote prescribing
Where the practice prescribes remotely, it does so only where it can make a safe decision without examining the patient, gathers enough information, and does not prescribe medicines (such as some controlled drugs) where remote prescribing is not appropriate. The basis for a remote prescription is recorded.
12. Repeat prescribing and monitoring
A medicine that needs monitoring is prescribed only with the monitoring arranged and tracked, and a repeat is not issued where monitoring is overdue. The practice does not run open-ended repeats without review.
13. Recording
The practice records, for every prescription: the medicine, dose and quantity, the indication, the information the decision was based on, any remote-prescribing basis, and whether the GP was informed. The record shows the prescription was safe and considered.
14. Records and register links
The prescribing record should include:
- patient identity check and relevant clinical information used
- allergies, current medicines, interaction check and contraindication check
- medicine, strength, form, dose, route, quantity and directions
- indication, expected benefit, alternatives discussed and safety-netting advice
- private prescription cost information and dispensing route
- GP or usual-prescriber communication decision, including consent or refusal
- remote-prescribing rationale where relevant
- monitoring requirement, due date, result and repeat-prescribing decision
- controlled-drug legal checks, quantity, dependence or diversion risk assessment, and accountable-officer contact where applicable
- medicine-safety alert action, prescribing incident, complaint, risk entry or improvement action
Prescribing errors, near misses, medicine-safety alerts and controlled-drug concerns are reviewed through the incident register. Repeated prescribing risks, overdue monitoring or shared-care failures are tracked through the risk register and improvement-actions register.
15. Training and competence
The doctor keeps prescribing knowledge current through continuing professional development, appraisal and review of GMC prescribing guidance, medicines alerts, controlled-drug requirements, high-risk medicine monitoring and remote-prescribing safeguards. Any staff who support the prescribing process receive training on prescription handling, confidentiality, urgent escalation, medicine-safety alerts and what they must not do.
Training records are held in the training matrix. Prescribing themes from incidents, complaints, audit and patient feedback are reviewed through governance.
16. Audit cadence
The practice checks, on a stated cadence, that:
- prescribing was within competence and based on adequate information, with interactions checked
- private and controlled-drug prescriptions met the legal requirements
- the GP was informed with consent, and shared monitoring was arranged not assumed
- remote prescriptions were appropriate and recorded, and monitored medicines were not repeated on overdue monitoring
The doctor and the Registered Manager review the results and record the improvement actions that follow.
17. 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.
- GMC, Good practice in prescribing and managing medicines and devices: https://www.gmc-uk.org/professional-standards/professional-standards-for-doctors/good-practice-in-prescribing-and-managing-medicines-and-devices
- The Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916/contents
- The Misuse of Drugs Regulations 2001 and controlled-drug prescription requirements: https://www.legislation.gov.uk/uksi/2001/3998/contents
- MHRA drug safety alerts
- Controlled drugs rules where applicable; NHS England controlled drugs accountable officer guidance where applicable
- NICE medicines guidance; CQC medicines optimisation guidance
- CQC Regulation 12: Safe care and treatment
- 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
18. Related reading
- Related policy: Medicines Management Policy
- Related policy: Consent and shared decision-making policy
- Related policy: Clinical records and information governance policy
- Related policy: Scope of practice, indemnity and continuity policy
- Procedure checklist: Medicines management
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 |
|---|---|---|---|
| v1.1 | 2026-07-12 | Verivius (sample) | Added role ownership, safe-prescribing procedure, evidence fields, register links, training and competence controls, and related reading. |
| v1 | 2026-06-10 | Verivius (sample) | Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 text, plain-English summary, and standard sources, advice and document-control blocks. Existing purpose, scope and operational sections preserved and renumbered. |
This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.