Sample policy · Termination of pregnancy

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

Statutory anchor: Regulation 12 (safe care and treatment), in particular the proper and safe management of medicines, Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). This policy also engages the Care Quality Commission (Registration) Regulations 2009, Regulation 20 (requirements relating to termination of pregnancies), and Regulation 17 (good governance). The medicines themselves are governed by the Human Medicines Regulations 2012, the BNF monographs, the manufacturer Summary of Product Characteristics and MHRA guidance. Providers must check the live source before adopting specific clinical steps, medicine lists, dose schedules, forms or reporting processes. · primary source

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:

4.1 Roles and responsibilities

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:

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:

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:

7.3 Patient self-administration (medical termination at home)

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

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:

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

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 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:

Training records are kept in the Verivius training matrix.

12. Audit

The Service audits medication safety on the following schedule:

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

12.1 Related policies and 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:

Verivius source pack:

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

Version Date Author Changes
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 (and Registration Reg 20) text, plain-English summary, source pack and document control. All original operational sections and sources preserved.
v1.1 2026-07-19 Verivius (sample) Added role ownership and a medicines workflow, corrected notification and candour wording, and made controlled-drug and emergency controls service specific.

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.

Termination medicines are unusual in this library because the highest-risk dose is often the one the clinician never watches being taken. Misoprostol is increasingly given for the person to use at home, sometimes with no further contact, so the safety net is not a second nurse at the bedside but everything set before they leave the clinic: the right gestational-age regimen chosen from a current protocol, a prescription tied to that person and not to a blank script, written instructions they can follow alone, and a clear route back to advice out of hours if bleeding or pain is not going to plan. A wrong dose, a wrong gestational band, or a complication that nobody flagged a way back from can cause serious avoidable harm or a failed termination, and the service will often not see it happen. That is why the evidence trail carries more weight here than almost anywhere else: the prescribing record, the protocol version, the two-person check on what is given in the clinic, and the reporting web that runs when something goes wrong, including the written notification to CQC of a death that may be associated with the termination, stand in for the bedside observation the clinician cannot do. These are the highest-stakes medicines in the set, so the technical detail lives in the protocol and its named sources, and the governance that proves the service followed them lives here.

  1. Every dose of mifepristone, misoprostol or an injectable anaesthetic agent is checked by two clinicians at the moment it is given and written up as it happens, not reconstructed after the list has finished. The check confirms the person's identity, their allergy status, the medicine, its dose, its route and the timing the current protocol sets, and it still happens even when the prescriber is one of the two people.

    Strong evidence: The completed administration records for a sample of episodes, each showing the administering clinician, the second checking clinician, and the medicine, dose, route and time entered at the point of administration, held against the two-check rule (Section 7.1) and the contemporaneous-documentation standard (Section 7.2).

    Weak evidence: Administration entries filled in as a block once the clinic has closed, so the recorded times cluster together and cannot show the real sequence. A second-checker column left blank, initialled by someone who was not present, or signed by the prescriber alone on the basis that a prescriber needs no checking. The independent double-check for injectables is established professional practice rather than a numbered statutory rule, but the record made at the time is the accurate, contemporaneous record required by Regulation 17(2)(c).

    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. The dose and regimen for mifepristone and misoprostol follow one current, clinician-approved written protocol keyed to gestational age, and staff work to that protocol rather than to habit or memory. The protocol names its sources, is verified against current Royal College of Obstetricians and Gynaecologists (RCOG) best practice and the manufacturer's Summary of Product Characteristics (SPC), is version-controlled, and is re-checked whenever those sources change and at the annual review the service commits to.

    Strong evidence: The approved dosing protocol carrying its version number, approval date and named clinical approver, showing the gestational-age structure and the RCOG and SPC sources it was verified against, held against the dose-and-gestational-age-dependency section (Section 5.3).

    Weak evidence: Two versions of the regimen circulating in different rooms, or a protocol with no version number, no approval date and no named approver, so nobody can say which one is live. A dosing sheet lifted from an old course handout with no trace of when it was last checked against current RCOG guidance or the manufacturer's SPC. The actual doses and gestational bands belong in the protocol and its named sources, never in a note taped to the fridge.

    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. The person who prescribes mifepristone and misoprostol is legally authorised to do so and is prescribing for a named patient, so proper and safe management of medicines starts at the prescription rather than at the point someone tries to give the dose (Reg 12(2)(g)). Each prescription identifies the patient, the medicine, dose, route and frequency, the prescriber and the date, and the patient identifiers are completed by the prescriber at the point of prescribing, not pre-printed onto blank scripts.

    Strong evidence: A sample of prescriptions showing patient identifiers, medicine, dose, route, frequency, prescriber identification and date completed at the point of prescribing, held against the prescribing-discipline section (Section 5.2) and the record of which clinicians sit on the service's prescribing list with their registration confirmed.

    Weak evidence: Pre-printed or part-completed prescriptions waiting for a patient name to be added later, which severs the prescription from the decision to prescribe for that person. A prescriber on the list whose registration was taken on trust rather than confirmed against the live register, or an assumption that a non-medical prescribing qualification alone is authority to prescribe abortion medicines when the service has taken no specialist advice on that model.

    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)(g)

  4. Mifepristone, misoprostol and the anaesthetic agents are stored in the conditions the manufacturer's Summary of Product Characteristics (SPC) sets, in a secure area, with stock rotated by expiry, tamper-evident packaging kept intact until the medicine is dispensed or given, and any cold-chain requirement maintained and logged. Stock is counted and reconciled on the service's stated cadence, and out-of-date or excursion-affected stock is quarantined rather than left on the shelf.

    Strong evidence: The storage and stock records at Section 6: the storage location and its security, the stock-check and full-audit cadence the policy commits to, the expiry and stock-rotation record, and any temperature or excursion log showing the action taken when a reading fell outside the SPC range.

    Weak evidence: A storage log signed in a suspiciously even rhythm with no entry showing what was done when a reading or an excursion fell out of range, so the log proves attendance rather than control. Tamper-evident packaging already opened on the shelf, expired stock mixed in with in-date, or a stock count that has never been reconciled against what is physically present. The actual storage temperature range lives in the manufacturer's SPC, not in this check.

    The instructions from the maker of a product, device, or medicine. Following them is how the item is used safely, and for medical devices it is effectively expected.

  5. Where any anaesthetic or other medicine the service holds is a controlled drug, it is handled under the controlled-drugs regime and not the ordinary medicines process. The register and running-balance record-keeping follow the controlled-drugs record-keeping and register duties (regs 19 and 20), reconciled to the physical stock, while the medicines lead maps each drug's schedule to the storage, witnessing and destruction requirements that actually apply and works to a named accountable-officer arrangement. The service does not assume that every controlled drug carries the same cabinet, register or witnessing rules.

    Strong evidence: The controlled-drugs procedure and records at Section 10: the schedule mapping for each controlled drug the service holds, the statutory register where one is required with its running balance reconciled to physical stock, the witnessed-destruction record, and the accountable-officer arrangement, or the route to the NHS England controlled-drugs accountable officer where the provider has none of its own.

    Weak evidence: A single controlled-drugs cabinet and register assumed to cover every agent, with no analysis of which schedule each medicine sits in. A register whose running balance has never been counted against the physical stock, corrections written over the original entry, or destruction recorded with no authorised witness. An accountable-officer arrangement that nobody in the service can name when asked. The register and record-keeping duty sits in the Misuse of Drugs Regulations 2001 (regs 19 and 20); safe custody, witnessed destruction and the accountable officer sit in other instruments, so the service confirms which apply to the agents it actually holds.

    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.

    Misuse of Drugs Regulations 2001, regs 19 and 20

  6. Where a person dies within 12 months in circumstances that may be associated with the termination, the registered person gives notice in writing to the Care Quality Commission (CQC). This statutory notification is a duty in its own right: a local incident entry, a Yellow Card, or a duty-of-candour conversation does not discharge it, and it is separate from the notification the Abortion Act pathway makes to the Chief Medical Officer.

    Strong evidence: The notification record showing written notice given to CQC. Regulation 20(10) of the Care Quality Commission (Registration) Regulations 2009 requires that 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, held against the verbatim Regulation 20(10) duty (Section 1) and the CQC route in the error response (Section 9).

    Weak evidence: A death that may be associated with the termination treated as an internal matter, with no written notification to CQC, or the notification assumed covered by the incident log. A notice given late, with nothing to show when the information was first received, so the fourteen-day period cannot be evidenced.

    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.

    Care Quality Commission (Registration) Regulations 2009, reg 20(10)

  7. When a medication error or a suspected adverse drug reaction happens, the person's immediate clinical care comes first, and then the external channels are each weighed on their own footing and none stands in for another: a Yellow Card report to the Medicines and Healthcare products Regulatory Agency (MHRA) where a reaction or product defect is suspected, and the duty of candour owed to the person under Regulation 20 of the Regulated Activities Regulations where the harm threshold is met. A local incident entry discharges none of these, and where a death has occurred the separate written notification to CQC is also owed.

    Strong evidence: A sampled incident or reaction record showing the immediate clinical response first, then a considered decision on each channel: the Yellow Card submission reference where indicated and the duty-of-candour conversation and written follow-up where the threshold is met, held against the adverse-drug-reaction and error sections (Sections 8 and 9). The Yellow Card decision goes to the MHRA about the product; the duty of candour is owed to the person and is not a notification, so neither one discharges the other.

    Weak evidence: A local incident form closed as though it were the whole response, with the Yellow Card and the candour decision left blank or assumed covered by the incident log. A candour conversation recorded as a bare 'family informed' with no trace of the apology, the account given or the written follow-up. Potential harm alone logged as crossing the statutory candour threshold, or serious harm recorded with the threshold never opened at all.

    Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.

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Last verified 23 July 2026

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Last reviewed 19 July 2026