GP safe prescribing and high-risk medicines policy template

1. What the regulation says

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

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

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

This policy sets out how the Practice prescribes safely, monitors high-risk medicines, reviews repeat prescribing and responds to prescribing errors or controlled-drug discrepancies.

It applies to private GP and NHS-contracted prescribing activity.

This is the GP and primary-care policy page for prescribing and monitoring. For a broader cross-sector starting point, use the CQC medication policy template. For the 2025 CQC controlled-drugs report angle, read CQC controlled drugs 2025: evidence for providers. For the matching audit tool, use the primary care prescribing and medicines audit checklist.

4. Sources to verify before adoption

• Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916/contents
• Misuse of Drugs Regulations 2001: https://www.legislation.gov.uk/uksi/2001/3998/contents
• Controlled Drugs (Supervision of Management and Use) Regulations 2013: https://www.legislation.gov.uk/uksi/2013/373/contents
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12: https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17: https://www.legislation.gov.uk/uksi/2014/2936/regulation/17
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: https://www.legislation.gov.uk/uksi/2014/2936/regulation/20
• 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
• NHS England, Controlled Drugs Accountable Officer alerts and reporting: https://www.england.nhs.uk/contact-us/privacy-notice/how-we-use-your-information/safety-and-quality/controlled-drugs-accountable-officer-alerts-etc/
• GOV.UK, controlled drugs licences, fees and returns: https://www.gov.uk/guidance/controlled-drugs-licences-fees-and-returns
• CQC GP mythbuster 11, Electronic prescribing: https://www.cqc.org.uk/guidance-providers/gps/gp-mythbusters/gp-mythbuster-11-electronic-prescribing

5. Scope

This policy applies to:

• acute prescribing
• repeat prescribing
• high-risk drug monitoring
• prescribing errors and near misses
• contraindicated prescribing
• allergy, interaction and pregnancy checks
• controlled-drug prescribing discrepancies
• prescribing by GP partners, salaried GPs, locum GPs, pharmacist prescribers and other authorised prescribers
• medicines requests handled by reception or administration staff

The Practice verifies each prescriber's professional scope and system access before they prescribe.

Before adoption, the Practice names its medicines lead, high-risk medicine list, monitoring protocols, urgent clinical route, shared-care acceptance route, prescribing systems, external reporting contacts and records locations. It records who may authorise, change and remove each level of prescribing-system access.

6. Prescribing process

The Practice follows a documented prescribing process for every prescription.

6.1 Patient and medicine check

Before issuing a prescription, the prescriber checks:

• patient identity
• allergy status
• diagnosis or clinical reason
• current medicines
• relevant test results
• contraindications
• interactions
• pregnancy or breastfeeding status where relevant
• previous adverse reactions
• whether review or monitoring is overdue
• whether the request is acute, repeat or urgent

The prescriber records the clinical reason where the record does not already make it clear.

6.2 Repeat prescribing

The Practice keeps a repeat-prescribing protocol.

The protocol covers:

• which medicines can be issued as repeats
• who can authorise repeats
• maximum number of issues before review
• review date handling
• overdue review escalation
• medicine synchronisation where appropriate
• patient request routes
• rejected request handling
• communication with community pharmacy

Staff do not issue a repeat prescription where the review status, monitoring status or prescriber instruction makes it unsafe to do so.

6.3 Acute and urgent prescribing

The prescriber records why acute or urgent prescribing is needed.

Where prescribing happens without full routine information, the prescriber records:

• what information was available
• what risk was accepted
• what safety-netting was given
• when follow-up or review is needed

The Practice does not use urgent prescribing to bypass monitoring requirements for convenience.

6.4 Prescribing error response

Where staff identify wrong drug, wrong dose, contraindicated drug, allergy conflict or repeat prescription issued without review, staff:

• make the patient safe
• seek clinical advice immediately where needed
• contact the patient or pharmacy where appropriate
• record the event as an incident
• preserve prescribing and communication records
• inform the Clinical Lead
• consider duty of candour
• consider external reporting where current source material requires it
• assign corrective action

The Practice reviews prescribing errors through the SEA process.

7. High-risk drug monitoring

The Practice keeps a high-risk drug register.

The register includes medicines or medicine groups that need defined monitoring, such as:

• methotrexate
• lithium
• warfarin
• disease-modifying anti-rheumatic drugs
• amiodarone
• any other medicine identified by the Practice, prescriber or shared-care protocol

For each medicine group, the local protocol records:

• monitoring test required
• source of the monitoring requirement
• staff role responsible for checking status
• prescribing stop or escalation rule where monitoring is missing
• communication route with specialist, pharmacy or patient
• review owner

The Practice sets exact monitoring schedules from current prescribing guidance, shared-care agreements, specialist advice and GMC source material. This template does not restate medicine-specific monitoring intervals.

8. Controlled drugs and prescribing review

The Practice treats controlled-drug prescribing discrepancies as high-risk incidents.

Where staff identify a discrepancy, the Clinical Lead:

• checks the prescribing record
• checks stock or issue records where relevant
• confirms whether the discrepancy is clerical, clinical, diversion-related or unexplained
• makes the patient safe
• informs the Registered Manager
• considers NHS England CDAO notification where the Practice is NHS-contracted
• considers Home Office or police routes where current source material or CDAO advice requires it
• records the decision and action taken

The Practice reviews prescribing data at least quarterly as a Verivius default from the GP sector pack. The review covers controlled drugs, antibiotics, opioids, high-risk medicines and repeat prescribing without review.

9. Responsibilities

• Registered Manager: owns this policy, ensures governance oversight and signs off annual review.
• Clinical Lead: owns day-to-day prescribing safety, prescribing incident review and high-risk drug monitoring governance.
• Lead GP or GP Partner: reviews doctor-only prescribing decisions, shared-care concerns and complex clinical risk.
• Prescribers: prescribe within competence, check monitoring and record clinical decisions.
• Practice pharmacist or medicines lead: supports prescribing data review, high-risk register checks and medicine-safety actions where the Practice has this role.
• Reception and administration staff: process requests only within the Practice protocol and escalate clinical concerns.

10. Training, competence and system access

• Prescribers hold current professional registration, any required prescribing annotation, suitable indemnity and evidence of competence for the medicines and patient groups within their scope.
• The Clinical Lead verifies a new or locum prescriber's identity, registration, scope, local induction and system competence before approving access.
• Prescribers receive local induction on repeat prescribing, high-risk monitoring, shared care, controlled drugs, clinical decision support, incidents, recalls and MHRA Yellow Card reporting.
• Reception and administration staff are trained only for the request-processing tasks assigned to them. They do not make clinical decisions and use a named escalation route.
• System access follows least privilege, is reviewed at the provider's stated cadence, and is removed promptly when a person's role changes or ends.
• Competence is reassessed after a prescribing incident, significant protocol change, extended absence or concern about practice. Restrictions and supervision are recorded until competence is restored.

Training, registration, scope, access approval, review and reassessment must be recorded in the training matrix and staff access-control record.

11. Records and evidence fields

For each prescription or high-risk monitoring decision, the clinical or governance record includes, as applicable:

• patient identifiers and medicine, strength, form, dose, route, quantity and directions
• prescriber identity, date and time, indication and material clinical rationale
• allergy, interaction, contraindication, pregnancy and relevant clinical checks
• monitoring required, result source and date, status, next review and person responsible
• repeat-authorisation limit, review outcome, stop or escalation decision and patient communication
• shared-care proposal, the information received, explicit acceptance or refusal of responsibility, agreed monitoring and communication with the other prescriber and patient
• prescribing error, near miss or controlled-drug discrepancy, immediate safety action and linked incident
• adverse-reaction, MHRA Yellow Card, CDAO or other external-reporting decision and reference
• follow-up owner, due date and completion

The high-risk drug register, prescribing-review minutes, staff competence and access records, audit findings and improvement actions form the wider evidence set. Records are cross-linked rather than copied where possible and are retained under the Practice's records-management procedure.

12. Audit cadence

The Practice uses the following Verivius default audit rhythm unless current source material requires more frequent review:

• Monthly: the medicines lead or Clinical Lead checks overdue high-risk monitoring and urgent prescribing actions.
• Quarterly: the Practice reviews prescribing data, controlled drugs, antibiotics, opioids, high-risk medicines and repeat prescribing without review.
• Annually: the Registered Manager audits prescribing governance, staff access, incident learning and policy compliance.

Audit findings are recorded as improvement actions with an owner and review date.

13. Version control and review date

The Practice keeps a controlled copy of this policy. The footer or document-control table records:

• policy owner
• version number
• date approved
• next review date
• changes made since the last version
• source material checked during the review

14. Related records

• Incident register
• SEA meeting minutes
• High-risk drug register
• Repeat-prescribing protocol
• Controlled-drug discrepancy log
• Duty of candour policy
• Patient data and information governance policy
• Staff access-control record
• Improvement action register

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

15. Related reading

• Cross-sector policy: CQC medication policy template
• Audit checklist: Primary care prescribing and medicines audit checklist
• Sector hub: GP and primary care guide

16. 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
• CQC Regulation 17: Good governance
• CQC Regulation 20: Duty of candour
• CQC medicines optimisation guidance
• NICE medicines guidance and NICE CKS
• MHRA safety alerts
• Controlled Drugs Regulations (Misuse of Drugs Regulations 2001; Controlled Drugs (Supervision of Management and Use) Regulations 2013)
• NHS England controlled drugs accountable officer guidance where applicable
• GMC prescribing guidance (Good practice in prescribing and managing medicines and devices)
• Shared-care protocols
• Human Medicines Regulations 2012
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)

17. 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.

18. 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.