11.2 Core Midwifery Medicines Administration & Controlled Drugs Storage/Recording

Core Midwifery Medicines Administration & Controlled Drugs Storage/Recording

Safe and proficient medicines management is a foundational pillar of modern professional midwifery. Midwives bear personal professional accountability for every medication they prepare, dispense, administer, or withhold. In the maternity setting, where pharmacotherapy impacts both the mother and the developing fetus or newborn infant, strict compliance with the NMC Code (2015, updated 2018), the Misuse of Drugs Act 1971, and the Misuse of Drugs Regulations 2001 is paramount to prevent adverse drug events, uphold statutory law, and preserve public safety.

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The NMC Professional Standards & The "6 Rights" of Administration

The Nursing and Midwifery Council sets explicit expectations regarding registrant accountability in medicines management. The Code emphasizes that registered midwives must:

• Work within their sphere of clinical competence, recognizing when to seek expert guidance.
• Maintain clear, contemporaneous, and legible documentation of all pharmacological interventions.
• Ensure informed consent is obtained prior to administering any medicinal substance.
• Assess the therapeutic response and promptly report any unexpected adverse reactions or errors.

The Core "6 Rights" of Medication Administration

To eliminate preventable administration errors, midwives must systematically execute the 6 Rights prior to administering any substance:

1. Right Woman or Baby: Positively verify the identity of the recipient using two unique identifiers: full legal name, date of birth, and unique hospital/NHS number. In hospital settings, cross-check the patient's identity wristband against the prescription chart. In community settings, verbally confirm identity details with the woman. When administering medicines to a neonate, verify the baby's identity band attached to the limb against maternal records.
2. Right Medicine: Read the prescription order carefully. Cross-check the generic name, trade name, and formulation on the drug packaging against the prescription chart on three separate occasions: when removing the medicine from storage, during preparation/drawing up, and immediately prior to administration at the bedside. Verify that the medication is not expired.
3. Right Dose: Independently perform all dosage calculations. Confirm that the prescribed dose aligns with standard British National Formulary (BNF) or BNF for Children recommendations, maternal weight, gestational age, and renal/hepatic parameters. Inspect the volume and concentration to ensure accurate measurement.
4. Right Route: Administer the medication strictly via the authorized anatomical route (e.g., oral, sublingual, subcutaneous, intramuscular, intravenous infusion, or rectal). Confirm that the formulation is specifically manufactured and licensed for that designated route (e.g., ensuring an intramuscular formulation is never injected intravenously).
5. Right Time: Verify the prescribed administration time, dosing interval, and clinical timing relative to physiological events (e.g., administering prophylactic oxytocin immediately following the delivery of the anterior shoulder or full birth of the infant during the third stage of labour).
6. Right Documentation: Document the administration immediately after the drug is given, never beforehand. Record the exact date, time, dosage, route, site of injection, batch number, expiry date, and the legible signature or electronic credential of the administering practitioner.

Essential Expanded Rights in Midwifery Practice

Beyond the traditional six rights, contemporary clinical governance encompasses critical supplementary dimensions:

• Right to Refuse: Midwives must respect maternal autonomy. A competent pregnant or postnatal woman has the absolute legal and ethical right to decline any medication after being fully informed of the risks and benefits. When a woman refuses, the midwife must explore her concerns, document the refusal comprehensively in the maternal records, notify the multidisciplinary team, and institute alternative care plans.
• Right Reason / Indication: The midwife must understand the explicit clinical rationale for the medication and confirm that the drug is clinically appropriate for the woman's current clinical status.
• Right Response / Evaluation: The midwife must continuously evaluate the woman and fetus for desired therapeutic effects and monitor for recognized adverse reactions (e.g., monitoring maternal blood pressure after labetalol or fetal heart rate following opioid analgesia).

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Controlled Drugs (CDs) Governance in Maternity Care

Controlled Drugs are substances subject to high levels of regulation due to their potential for misuse, dependence, and diversion. In the UK, their management is governed by the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 (as amended).

Classification and Schedules

The 2001 Regulations divide Controlled Drugs into five distinct schedules based on their therapeutic utility and risk of harm. Maternity care primarily utilizes:

• Schedule 2 Controlled Drugs: High therapeutic utility but significant abuse potential. Includes potent opioids: Diamorphine, Morphine, Pethidine, and Fentanyl. Subject to the strictest statutory storage, register-recording, dual-checking, and destruction mandates.
• Schedule 3 Controlled Drugs: Includes barbiturates and certain intermediate-acting substances (e.g., Midazolam, Temazepam). Subject to safe custody storage requirements, but exempt from formal bound CD register entries in standard ward administration (though local hospital policies often mandate registration).
• Schedule 4 & 5 Controlled Drugs: Benzodiazepines (Schedule 4 Part 1) and dilute preparations of opioids such as low-strength codeine (Schedule 5); subject to standard prescription-only medicine storage.

Safe Storage & Physical Security

Under the Misuse of Drugs (Safe Custody) Regulations 1973, Schedule 2 Controlled Drugs must be stored securely to prevent unauthorized access:

• Dedicated Steel Cupboard: Must be constructed of heavy-gauge sheet steel, securely bolted to a solid brick or concrete wall, or secured to a solid floor with heavy-duty rag bolts.
• Double-Lock System: The CD cupboard must feature a robust double-lock mechanism. In traditional settings, this requires two distinct physical keys held on a designated key ring. In modern facilities, electronic biometric or electronic key-fob systems provide an automated electronic audit trail.
• Key Custody: The keys to the Controlled Drugs cupboard must be retained in the personal custody of a designated Registered Midwife or Nurse (the 'Nurse-in-Charge' or designated delivery suite coordinator). The keys must never be left unattended, placed in open drawers, or handed to student midwives or unregistered personnel.
• Exclusive Storage: The CD cupboard must contain only Controlled Drugs. Non-controlled pharmaceuticals, patient valuables, cash, or routine ward items must never be stored inside.

The Controlled Drugs Register (CDR)

Every clinical ward, birth centre, or delivery suite holding Schedule 2 drugs must maintain a formal Controlled Drugs Register (CDR) in accordance with Regulation 19 of the Misuse of Drugs Regulations 2001:

• Bound Book with Numbered Pages: The physical register must be a permanently bound volume with pre-printed, sequential page numbering to prevent page removal. Alternatively, the Misuse of Drugs Regulations allow computerised registers, provided entries are attributable to the person making them, cannot be altered without an audit trail, and can be produced for inspection.
• Separate Folios: A dedicated, separate page or section must be allocated for each drug, each pharmaceutical formulation, and each specific strength (e.g., separate folios for Diamorphine 5 mg ampoules and Diamorphine 10 mg ampoules).
• Strict Legibility & Prohibited Erasures: All entries must be written in indelible ink. The use of correction fluid (Tipp-Ex), erasures, scraping, or overwriting is strictly illegal. If an error is made, the midwife must draw a single neat line through the erroneous entry, write the correction clearly in the margin, and initial and date the alteration.
• Required Entry Fields: Every transaction (receipt from pharmacy, administration to a patient, or return) must be logged chronologically and include:
  1. Date and exact time of transaction.
  2. Full name of the woman to whom the drug was administered.
  3. Hospital number or unique patient identifier.
  4. Exact dose administered.
  5. Name, designation, and signature of the administering Registered Midwife.
  6. Name, designation, and signature of the witnessing practitioner.
  7. Resulting running balance of physical stock remaining in the cupboard.

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Dual-Practitioner Independent Checking & Waste Disposal

To ensure absolute safety, the administration of Schedule 2 Controlled Drugs requires two-practitioner independent checking at every stage of the process:

┌─────────────────────────────────────────────────────────────────┐
│                     INDEPENDENT CHECKING STEP 1                 │
│ Midwife 1 & Midwife 2 independently verify prescription chart:  │
│       Patient Name, Drug, Dose, Route, Time, Frequency          │
└────────────────────────────────┬────────────────────────────────┘
                                 │
                                 ▼
┌─────────────────────────────────────────────────────────────────┐
│                     INDEPENDENT CHECKING STEP 2                 │
│ At CD Cupboard: Verify physical ampoules, concentration,        │
│ expiry date, calculate volume, and physically count balance     │
└────────────────────────────────┬────────────────────────────────┘
                                 │
                                 ▼
┌─────────────────────────────────────────────────────────────────┐
│                     INDEPENDENT CHECKING STEP 3                 │
│ Prepare and draw up drug in presence of witness. Sign register: │
│   Administering Midwife + Witnessing Professional sign entry    │
└────────────────────────────────┬────────────────────────────────┘
                                 │
                                 ▼
┌─────────────────────────────────────────────────────────────────┐
│                     INDEPENDENT CHECKING STEP 4                 │
│ At Bedside: Check maternal identity wristband, allergy band,    │
│ witness physical administration, discard waste, document chart  │
└─────────────────────────────────────────────────────────────────┘

Destruction and Disposal of Controlled Drug Waste

In clinical maternity practice, a woman may require only a fraction of an ampoule (for example, administering 5 mg of diamorphine prepared from a 10 mg ampoule). Under the Misuse of Drugs Regulations 2001:

• Immediate Destruction: The remaining surplus drug (5 mg) must be destroyed immediately at the time of preparation and rendered completely irretrievable.
• Denaturing Protocol: The surplus liquid must be expelled into an approved pharmaceutical waste absorption bin or a dedicated Controlled Drugs denaturing kit (containing absorbent granules), never squirted onto cotton wool or poured directly into clinical sinks.
• Witnessed Disposal: The destruction of residual waste must be directly witnessed by the second practitioner.
• Register Recording: The CDR entry must explicitly record the total amount taken from stock (10 mg), the dose administered (5 mg), and the quantity destroyed/wasted (5 mg), witnessed and countersigned by both practitioners.

Discrepancy Escalation & The Controlled Drugs Accountable Officer (CDAO)

A physical stock count of every Controlled Drug must be performed at least once every 24 hours (and typically at every change of nursing/midwifery shift) by two registered practitioners.

If the physical count does not match the running balance in the CDR:

1. Immediate Audit: Re-check all recent arithmetic calculations, examine all administration entries over the preceding 24–48 hours, and inspect the CD cupboard to ensure no ampoules have rolled behind shelving.
2. Immediate Local Escalation: If the discrepancy remains unresolved, notify the Delivery Suite Coordinator, Ward Manager, and Lead Clinical Pharmacist immediately.
3. Formal Statutory Reporting: The unresolved discrepancy must be formally escalated to the Controlled Drugs Accountable Officer (CDAO) of the healthcare organization. Under the Health Act 2006 (Controlled Drugs (Supervision of Management and Use) Regulations 2013), every NHS Trust and healthcare organization must appoint a CDAO with statutory responsibility for overseeing the safe custody, investigating thefts or losses, and liaising with the police and regulatory authorities where criminal diversion is suspected.

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Pharmacology in Pregnancy, Birth and Breastfeeding

The Future Midwife standards (3.18) expect midwives to understand pharmacology and to recognise the positive and adverse effects of medicines across the continuum of care, including allergies, sensitivities, side effects, contraindications, incompatibilities, adverse reactions, prescribing errors, polypharmacy and over-the-counter medicines.

How Pregnancy Changes Drug Handling

• Absorption: Nausea, vomiting and slower gastric emptying in pregnancy and labour can delay or reduce absorption of oral medicines (opioids slow gastric emptying further).
• Distribution: Plasma volume rises by about 40% to 50% and albumin falls, so water-soluble drugs are diluted and more of a highly protein-bound drug may be unbound.
• Metabolism: Hepatic enzyme activity changes; for example, oestrogen increases glucuronidation, which lowers lamotrigine levels.
• Excretion: Renal blood flow and glomerular filtration rise by about 50%, increasing clearance of renally excreted drugs such as lithium and some antibiotics.
• Placental Transfer: Small, lipid-soluble, unionised and non-protein-bound drugs cross the placenta most readily. Opioids cross easily, which is why neonatal respiratory depression can follow pethidine or diamorphine given close to birth.
• Breastfeeding: Most medicines are compatible with breastfeeding. Transfer into milk depends on the drug's protein binding, lipid solubility and half-life, and the baby's age and maturity. Midwives check resources such as the BNF and specialist breastfeeding drug information services, and avoid advising women to stop breastfeeding without good reason.

Adverse Drug Reactions, Allergies and Contraindications

• Allergy Checks: Confirm the woman's allergy status and the nature of any previous reaction before every first dose. A true allergy (for example, anaphylaxis to penicillin) differs from a side effect (for example, nausea).
• Side Effects and Adverse Reactions: Examples include hypotension with rapid IV oxytocin, vomiting and hypertension with ergometrine, bronchospasm with carboprost, and respiratory depression with opioids.
• Contraindications and Cautions: Ergometrine is contraindicated in hypertension and pre-eclampsia; NSAIDs such as diclofenac are avoided in severe pre-eclampsia, renal impairment, asthma sensitive to NSAIDs and significant haemorrhage.
• Incompatibilities: Some drugs must not be mixed in the same line or syringe; check the product information and local IV guidance before giving drugs together.
• Reporting: Suspected adverse drug reactions are reported through the MHRA Yellow Card scheme. Reporting is especially valuable in pregnancy and breastfeeding, where trial data are limited.

Polypharmacy, Over-the-Counter Medicines and Errors

• Polypharmacy: Women with long-term conditions may take several medicines (for example, antiepileptics, antihypertensives, antidepressants and anticoagulants). Each new medicine increases the risk of interactions, so a full medicines reconciliation is completed at booking, admission and transfer.
• Over-the-Counter and Herbal Products: Ask specifically about non-prescription medicines, herbal remedies and supplements. For example, high-dose vitamin A (retinol) supplements and fish liver oil are avoided in pregnancy, and some herbal products interact with prescribed medicines.
• Prescribing and Administration Errors: If a prescription is unclear, illegible or appears wrong, the midwife must not administer it and must contact the prescriber. Any error or near miss is reported through local incident systems, and the duty of candour applies if harm results.

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Medication Error Reporting & The Statutory Duty of Candour

When a medicines administration error occurs (e.g., incorrect dose administered, omitted dose, or wrong patient), the midwife must act immediately with professional integrity and transparency.

Immediate Clinical Actions

1. Patient Safety Assessment: Immediately assess the maternal and fetal/neonatal clinical condition. Obtain vital signs and initiate supportive care or specific reversal agents (such as naloxone) if toxicity is present.
2. Medical Escalation: Inform the attending obstetrician and neonatal team immediately.
3. Clinical Incident Logging: Submit an electronic incident report via the organization's risk management system (e.g., Datix, Ulysses, or the national Learn from Patient Safety Events [LFPSE] service) within 24 hours.

The Duty of Candour

Under Regulation 20 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 and the NMC Code, midwives have a legal and professional Duty of Candour:

• When an unintended or unexpected incident occurs that results in moderate harm, severe harm, or psychological distress, the midwife and healthcare team must inform the woman and her family promptly.
• Provide an open, honest, and compassionate verbal explanation of what occurred.
• Offer a sincere, formal apology on behalf of the healthcare team.
• Document the discussion in the healthcare records and provide written follow-up outlining the investigation findings and measures instituted to prevent recurrence.

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Cold Chain Integrity & Storage of Thermosensitive Medicines

Many essential maternity medications are highly sensitive to thermal degradation. Maintaining an uninterrupted cold chain between 2°C and 8°C is essential to ensure that pharmaceuticals retain their potency and clinical efficacy.

Daily Monitoring & Protocol for Cold Chain Breaches

• Daily Logging: Refrigerator temperatures must be monitored using calibrated digital minimum/maximum thermometers. Registrants must record the current, minimum, and maximum temperatures daily, subsequently resetting the thermometer.
• Action in Breaches: If temperatures fall below 2°C or rise above 8°C, the midwife must immediately:
  1. Quarantine all affected stock within the refrigerator and affix a prominent label: "DO NOT USE – QUARANTINED STOCK DUE TO TEMPERATURE EXCURSION".
  2. Log the exact temperature range and estimated duration of the breach.
  3. Contact the hospital pharmacy department to obtain stability data or arrange replacement stock.
  4. Never administer potentially compromised medicines to women or neonates.