1. 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: misoprostol dosing errors can cause haemorrhage; under-dosing can cause incomplete termination requiring surgical intervention; over-dosing can cause severe systemic effects. This policy commits the Service to the consistent practice that reduces those risks.
2. Sources to verify before adoption
- 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
- 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)
3. 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 kept on site: adrenaline (anaphylaxis), oxytocin / ergometrine (post-partum haemorrhage), tranexamic acid (haemorrhage), atropine (vasovagal collapse), naloxone (opioid reversal), oxygen.
- All clinicians prescribing, dispensing, administering, or monitoring these medicines.
4. Prescribing
4.1 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.
Independent prescribing by nurses or pharmacists is not enabled for mifepristone or misoprostol at the Service unless the prescriber is on a specific extended-prescribing scheme verified by the clinical lead.
4.2 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.
4.3 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).
5. Storage
5.1 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.
5.2 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).
5.3 Emergency medicines
Stored in a clearly-labelled emergency medicines kit on every clinical floor. Checked daily for expiry, integrity, and completeness. Daily check signed by the clinician completing it; the daily check log is auditable.
The Resuscitation Council UK Quality Standards for Primary Care set the minimum emergency medicines list; the Service's kit is built against that list + any sector-specific additions clinically indicated.
6. Dispensing and administration
6.1 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.
6.2 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.
6.3 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.
7. Adverse drug reactions
7.1 Yellow Card reporting
All suspected adverse drug reactions are reported to the MHRA via the Yellow Card scheme. This includes:
- All reactions to mifepristone or misoprostol.
- Reactions to anaesthetic agents.
- Reactions to emergency medicines administered.
Yellow Card submissions are made by the clinician who identified the reaction, with the clinical lead notified. Submissions are logged in the Service's incidents register under [medication_error_mifepristone_misoprostol] (for the relevant medicines) so the report is visible in the clinical-governance cycle.
7.2 Immediate clinical management
For any adverse reaction, the clinician follows the Service's emergency-response algorithm:
- Anaphylaxis: adrenaline IM per Resuscitation Council UK guidelines, then call 999.
- Haemorrhage: oxytocin / ergometrine / tranexamic acid per protocol, IV fluids, transfer to acute setting if not controlled.
- Vasovagal collapse: positioning, atropine if indicated, IV fluids.
- Other systemic reaction: clinical judgment + transfer to acute setting if escalating.
8. 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 Service's incidents register on the day of identification. Errors causing or potentially causing moderate harm or above trigger:
- Duty of Candour notification to the patient.
- CQC notification under Regulation 17 where the threshold is met.
- Clinical-governance review at the next meeting or sooner if serious.
- A root-cause review for serious errors.
9. Controlled drugs
Where any medicine in the Service's formulary is a controlled drug under the Misuse of Drugs Regulations 2001 + the Controlled Drugs (Supervision of Management and Use) Regulations 2013, the Service applies the additional controlled-drugs procedures:
- Storage in a secure, alarmed cabinet meeting BS 2881 specification (verify current standard).
- A controlled-drugs register maintained per CDR 2001.
- Two-person witness on receipt, dispensing, and destruction.
- The Service's controlled-drugs accountable officer is named in the staff handbook + has a current role.
10. 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.
11. 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. 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.