Medication safety policy (mifepristone, misoprostol, anaesthesia) (termination of pregnancy)

1. What the regulation says

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

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

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))

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

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

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))

Where a service user dies within 12 months in circumstances that may be associated with a termination, the Care Quality Commission (Registration) Regulations 2009, Regulation 20 requires:

the registered person must give notice in writing to the Commission of that information, within the period of 14 days beginning on the day on which the information is received. (Reg 20(10))

The full text of Regulation 12 is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12 and the Registration Regulations are at https://www.legislation.gov.uk/uksi/2009/3112. 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. For a termination service this means the medicines used to end a pregnancy and the medicines kept for clinical complications must be prescribed, stored, dispensed, administered and monitored to a consistent standard, by competent people, with errors caught and learned from.

3. Purpose

This policy sets out how the Service prescribes, stores, dispenses, administers, and monitors the medicines used in termination of pregnancy: mifepristone and misoprostol for medical termination, local and general anaesthetic agents for surgical termination, and the emergency medicines kept for clinical complications.

Medication safety in termination care is high stakes. An error in patient, medicine, dose, route, timing, storage, supply or follow-up can cause avoidable harm or treatment failure. This policy sets the controls that prevent, detect and respond to those errors.

4. Scope

This policy applies to:

• Mifepristone and misoprostol prescribing, supply, dispensing, and administration.
• Local anaesthetic agents used in surgical termination (lidocaine, prilocaine, bupivacaine, etc.): verify against the Service's actual formulary.
• General anaesthetic agents (where the Service performs procedures under GA).
• Emergency medicines and equipment kept on site as specified in the Service's current, clinician-approved emergency protocol (covering anaphylaxis, haemorrhage, vasovagal collapse, opioid reversal and oxygen), verified against RCOG/NICE, BNF/SPC and resuscitation guidance.
• All clinicians prescribing, dispensing, administering, or monitoring these medicines.

4.1 Roles and responsibilities

• Registered Manager: owns the medicines-governance system, ensures audits and incidents are reviewed and makes sure actions close.
• Medical Director or Lead Clinician: approves the formulary and clinical protocols, verifies current BNF, SPC, RCOG, NICE, MHRA and resuscitation sources and decides any restriction after an incident.
• Prescriber: confirms the legal and clinical pathway, patient-specific prescription, allergies, gestation-dependent protocol and information needed for safe use.
• Supplying or administering clinician: checks the prescription and patient, works within competence, records the supply or administration contemporaneously and escalates any mismatch before proceeding.
• Medicines or pharmacy lead: controls ordering, receipt, storage, stock reconciliation, expiry, cold-chain requirements where applicable, disposal and controlled-drug arrangements.
• All staff: report suspected reactions, errors, near misses, missing stock, storage excursions or record discrepancies immediately.

5. Prescribing

5.1 Who can prescribe

Mifepristone and misoprostol are prescription-only medicines under the Human Medicines Regulations 2012. They are prescribed by registered medical practitioners on the Service's prescribing list, with the GMC in good standing, in line with the Abortion Act pathway.

Current DHSC guidance allows trained nurses or midwives to participate in the termination and administer medicines under agreed protocols once a doctor has prescribed them and remains responsible for the process. A non-medical prescribing qualification alone must not be treated as authority to prescribe abortion medicines. The Service obtains specialist advice before adopting any different model.

5.2 Prescription discipline

Every prescription identifies:

• The patient (name + clinical record number).
• The medicine, dose, route, and frequency.
• The prescribing clinician's GMC number.
• The date.
• The indication (medical termination, gestational age band).

Prescriptions are not pre-printed with patient identifiers absent. The prescribing clinician completes the patient identifiers at the point of prescribing.

5.3 Dose and gestational-age dependency

Dosing for mifepristone and misoprostol is gestational-age dependent. The Service's clinical protocol specifies the dosing regimen by gestational age band; the protocol is verified against current RCOG best practice and the manufacturer SPC at adoption + annually thereafter.

Off-label use (where applicable per current regulatory status) is consented to by the patient as part of the standard consent conversation (see consent policy).

6. Storage

6.1 Mifepristone and misoprostol

Stored at room temperature per manufacturer SPC, in a secure pharmacy area accessible only to clinical staff. Stock-rotation by expiry date. Twice-weekly stock check by named staff member; monthly full audit.

Tamper-evident packaging is preserved until the medicine is dispensed to the patient or administered.

6.2 Anaesthetic agents

Stored per manufacturer SPC. Where any anaesthetic agent is a controlled drug under the Misuse of Drugs Regulations 2001, the Service applies the controlled drugs storage, register, witness, and destruction requirements separately (see Service controlled-drugs policy).

6.3 Emergency medicines

Emergency medicines are stored in a clearly labelled, tamper-evident kit in each clinical area identified by the risk assessment. The Service sets a checking frequency based on when the area is used and the current approved protocol. Each check records expiry, integrity, completeness, checker and action taken.

The Service uses relevant Resuscitation Council UK quality standards as a reference point and verifies the final list against its procedures, patient group, RCOG or NICE guidance, BNF or SPC information and transfer arrangements. A primary-care list is not treated as a universal minimum for every termination service.

7. Dispensing and administration workflow

For each medicine supply or administration, staff use this workflow:

1. Confirm the pathway: match the patient, gestation, procedure and location to the current clinician-approved protocol.
2. Validate the prescription: check medicine, formulation, dose, route, timing, allergy status, prescriber authority and any relevant previous dose.
3. Select and inspect stock: verify pack, batch, expiry, integrity and storage history, including any excursion or recall status.
4. Complete the independent check: apply the Service's two-check control and resolve every discrepancy before supply or administration.
5. Supply or administer safely: give the required explanation, written information, aftercare and urgent-contact route.
6. Record contemporaneously: document the people checking and administering, medicine details, timing, route, batch where required and patient response.
7. Reconcile and escalate: update stock, report any omission, mismatch, suspected reaction or error and make sure immediate clinical care comes first.

7.1 The two-check rule

Every dose of mifepristone, misoprostol, or an injectable anaesthetic agent is checked by two clinicians at the point of dispensing or administration. The check covers:

• Patient identity (against wristband / record).
• Medicine name, dose, route, expiry.
• Allergy status.
• Time of last dose where this is a subsequent dose.

The two-check rule applies even where one clinician is the prescriber.

7.2 Documentation

Every administration is documented in the patient record at the time of administration, not later. The record includes:

• Medicine, dose, route, time.
• The administering clinician.
• The checking clinician.
• The patient's response (where the medicine is administered to clinical effect).
• Any adverse reaction observed.

7.3 Patient self-administration (medical termination at home)

Where the patient self-administers misoprostol at home as part of a medical termination pathway:

• The patient is given clear written + verbal instructions on dose, timing, and what to do if something doesn't go to plan.
• The patient is given a clear pathway to contact the Service for advice, including out of hours.
• The administration is recorded in the patient record on the patient's report at the next contact; where there is no follow-up contact, the pathway treats the administration as completed at the timing the patient was instructed to take it.

8. Adverse drug reactions

8.1 Yellow Card reporting

The clinician assesses suspected adverse drug reactions, product defects and device incidents against the live MHRA Yellow Card guidance and reports through the appropriate route. The record states the suspected product, reaction or incident, seriousness, action taken, reporter, submission reference and follow-up. A local incident record does not replace a Yellow Card where reporting is indicated, and a Yellow Card does not replace the Service's incident review.

8.2 Immediate clinical management

For any adverse reaction, staff stop the medicine where clinically appropriate, assess and protect the patient, call for emergency help at the threshold in the current local protocol and work within role and competence. Medicines, doses and transfer decisions come from the current clinician-approved emergency or complication pathway, not from this sample policy. Staff preserve the medicine and packaging where relevant, record care and advice, and begin the incident and pharmacovigilance process after immediate safety is managed.

9. Errors

A medication error is any deviation from the prescribed regimen that reached the patient or could have reached the patient. Categories:

• Wrong medicine.
• Wrong dose.
• Wrong route.
• Wrong patient.
• Wrong time.
• Omitted dose.
• Patient with documented allergy received the medicine.
• Storage / dispensing breach (e.g. expired medicine dispensed).

Every error is logged in the incident register on the day of identification. The Clinical Lead records and acts on:

• immediate patient assessment, treatment and monitoring
• actual harm and the statutory duty-of-candour threshold, noting that potential harm alone does not trigger the statutory threshold
• the applicable CQC, commissioner, MHRA, controlled-drug, safeguarding or professional-regulator route, where any threshold is met
• stock quarantine, staff restriction or service pause needed to prevent recurrence
• the proportionate learning response and whether urgent governance review is required

Regulation 17 is the governance duty to identify, assess and improve risk. It is not a generic CQC notification route.

10. Controlled drugs

Where any medicine is a controlled drug, the medicines lead maps its schedule, activity and provider status to the exact legal and local requirements before use. The controlled-drugs procedure records:

• the storage standard that applies to that medicine and premises
• whether a statutory controlled-drugs register is required and how entries and corrections are made
• receipt, supply, administration, balance checks, discrepancy response, returns and disposal
• when an authorised witness is required for destruction
• the provider's accountable-officer arrangement, or the NHS England controlled-drugs accountable officer route where the provider does not have its own
• incident and occurrence-reporting routes and retained evidence

The Service must not assume that every controlled drug has the same cabinet, register or witnessing requirements.

11. Training

All clinicians involved in prescribing, dispensing, administering, or monitoring termination medicines complete:

• Induction training on the Service's medication protocols.
• Annual update on mifepristone + misoprostol prescribing.
• Annual update on anaesthetic-agent safety and complications response.
• Annual update on Yellow Card reporting.
• Resuscitation training at the level commensurate with role (BLS, ILS, or ALS).

Training records are kept in the Verivius training matrix.

12. Audit

The Service audits medication safety on the following schedule:

• Daily emergency medicines check (every floor).
• Twice-weekly mifepristone + misoprostol stock check.
• Monthly comprehensive medicines audit.
• Quarterly medication-error rate audit.
• Annual prescribing-pattern audit.

Audit findings feed the quarterly clinical-governance meeting and the annual CQC self-assessment.

12.1 Related policies and records

• Termination consent and reflection policy
• Termination statutory notification policy
• Termination clinical governance and complications policy
• Termination patient confidentiality and data protection policy
• Medicines management policy
• Incident reporting, investigation and learning policy
• Medical emergencies and deteriorating patient policy
• Duty of candour policy
• Formulary, protocol approval, stock, administration, training, incident and audit records

13. Review

This policy is reviewed at least annually and whenever the BNF monographs, manufacturer SPCs, MHRA Yellow Card guidance, or the Human Medicines Regulations 2012 materially change.

14. 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.

Original sources carried forward from this policy:

• Human Medicines Regulations 2012 (SI 2012/1916): https://www.legislation.gov.uk/uksi/2012/1916
• Misuse of Drugs Regulations 2001 (SI 2001/3998): where applicable to anaesthetic agents: https://www.legislation.gov.uk/uksi/2001/3998
• Controlled Drugs (Supervision of Management and Use) Regulations 2013 (SI 2013/373): https://www.legislation.gov.uk/uksi/2013/373
• BNF mifepristone monograph: https://bnf.nice.org.uk/drugs/mifepristone/
• BNF misoprostol monograph: https://bnf.nice.org.uk/drugs/misoprostol/
• MHRA Yellow Card scheme: https://yellowcard.mhra.gov.uk
• MHRA Yellow Card guidance: https://www.gov.uk/guidance/the-yellow-card-scheme-guidance-for-healthcare-professionals-patients-and-the-public
• Royal College of Obstetricians and Gynaecologists, Best practice in abortion care: https://www.rcog.org.uk/guidance/browse-all-guidance/other-guidelines-and-reports/best-practice-in-abortion-care/
• Resuscitation Council UK, Quality Standards: Primary care (anaphylaxis response): https://www.resus.org.uk/library/quality-standards-cpr/primary-care
• Manufacturer Summary of Product Characteristics for each prescribed medicine (verify at https://www.medicines.org.uk/emc before adoption)

Verivius source pack:

• CQC medicines-management supporting-document guidance, updated February 2026: https://www.cqc.org.uk/guidance-regulation/registration/supporting-documents-provider/document/medicines-management
• CQC Regulation 17: Good governance
• Care Quality Commission (Registration) Regulations 2009, Regulation 20 (requirements relating to termination of pregnancies); CQC statutory notifications guidance
• Abortion Act 1967; Abortion Regulations 1991; DHSC HSA forms guidance
• Recent changes to the criminal law on ending one's own pregnancy in England and Wales (verify against current primary legislation before publishing patient-facing wording; provider obligations under the Abortion Act 1967, the Abortion Regulations 1991, HSA1/HSA4 and the CQC Registration Regulations are unchanged unless primary legislation says otherwise)
• RCOG and NICE abortion care guidance; CQC Reg 12/17/20

15. 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.

16. 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.