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5e. PGD Midwifery Exemptions April 2016

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Midwifery Exemptions &

Patient Group Directions


(PGD’s) for Midwives

PGD’s & Midwifery Exemptions April 2016 Page 1


INDEX

• Introduction
• Midwifery exemptions
• PGD’s
• Standards for medicine management (NMC 2007)
• The Code (NMC 2015)
• Standards for competence for registered midwives (NMC
2009)

PGD’s & Midwifery Exemptions April 2016 Page 2


DIRECTORATE OF WOMENS HEALTH

MIDWIFERY EXEMPTIONS - INTRODUCTION

Medicines Act exemptions, allows qualified Midwives to sell, supply and administer
particular medicines directly to patients or clients. Provided the requirements of any
conditions attached to those exemptions are met, a patient group direction is not required
(Standards for Medicine Management NMC 2008).

Within the NMC document, section 17 outlines Medicines Act Exemptions, it states
that:

Provided the requirements of any conditions attached to those exemptions are met, a
PGD is not required.

Registrants must work to locally agreed written protocols and procedures, and
maintain auditable records.

Registrants may only supply and administer under an exemption order where the
order pertains to them.

Definitions of drugs ie P, GSL & CD’s refer to their legal status

Pharmacy only medicines (P). These can only be purchased from a registered pharmacy.
The sale must be by or under the supervision of a pharmacist.

General sales list medicines (GSL) These need neither a prescription nor the supervision
of a pharmacist and can be obtained from retail outlets.

Controlled drugs (CDs) The management of controlled drugs is governed by the Misuse of
Drugs Act 1971 and its associated regulations.

Patient Group Directions (PGDs) are documents permitting the supply of prescription-only
medicines (POMs) to groups of patients, without individual prescriptions. Midwives using
PGDs should be sufficiently trained to be able to supply and administer POMs

Student Midwives:

Standard 17 of the Standards for pre-registration midwifery education (NMC 2009) states
that student midwives must be able at the point of registration to select acquire and
administer safely a range of permitted drugs consistent with legislation, knowledge and

PGD’s & Midwifery Exemptions April 2016 Page 3


skills. For student midwives, their involvement in the checking and administration of
medicines, with the exception of controlled drugs, must always be under the direct
supervision of a “sign off” mentor. Direct supervision means in direct visual contact during
which time the midwife observes the act of administration of medicines by the student
midwife.

Student midwives may not administer controlled drugs but may participate in the checking
and preparation of controlled drugs for the administration on the midwives exemption list
under the direct supervision of a registered midwife.

PGD’s & Midwifery Exemptions April 2016 Page 4


Please familiarise yourself with this list

DRUG DOSAGE MAY BE GIVEN AS FOLLOWS

Midwifery Exempt - Prescription Only Medicines (POMS)


ANALGESICS

Diclofenac sodium 25-75mg orally PN patients 8 hourly. Do not exceed 150mg in


24 hours. DO NOT GIVE to asthmatic
patients or those with an ALLERGY TO
ASPIRIN or history of G.I. ULCERATION.
Caution with patients with P.E.T. ,
Hypertension & oedema

Diclofenac suppository 25 – 100mg rectally Following perineal trauma

ONCE ONLY – CAUTION AS ABOVE

Lidocaine 1% 10mg in 1ml injection 10- Prior to performing an episiotomy & perineal
20mls repair.

Dosages required for perineal repair must be


given as per Trust guidance for perineal repair

Diamorphine Patients in established labour

May not be given by a student midwife see


front sheet

Morphine Patients in established labour

May not be given by a student midwife see


front sheet

Pethidine Up to 200mg IM in divided Patients in established labour. No more than


doses at midwifes’ discretion 100mg in 4 hours

May not be given by a student midwife see


front sheet

REVERSAL AGENTS

Naloxone Hydrochloride IM injection only 0.4-2mg; if Reversal of respiratory depression resulting


no response, repeat at from opioid administration
ADULT intervals of 2-3 minutes to a
max dose of 10mg

Naloxone Hydrochloride IM injection only Reversal of respiratory depression resulting


from opioid administration
NEONATE 10 micrograms per kilo

PGD’s & Midwifery Exemptions April 2016 Page 5


ANTI-EMETICS

Cyclizine Lactate 50mg IM injection For management of actual or potential nausea


and vomiting.
PGD available for reference
only Maximum 3 doses of 50mg in 24hrs

Prochlorperazine (Stemetil) IM injection 12.5mg/ml For management of actual or potential nausea


and vomiting.

OXYTOCICS

Syntocinon Follow Trust guidelines: For augmentation of labour or treatment of


post-partum haemorrhage
Induction & augmentation
of labour Women to be reviewed and all syntocinon for
augmentation to be prescribed by a SENIOR
Postpartum haemorrhage - obstetrician
PPH

Third stage labour including


management of retained
placenta

Syntometrine 1ml ampoule IM Active management of the third stage of labour

Ergometrine Maleate 500 micrograms IM/IV For treatment of post-partum haemorrhage –


AVOID USE IF HYPERTENSION OR PET

Carboprost (Hemabate) 0.25mg deep IM or 0.50mg For treatment of post-partum haemorrhage


intramyometrially every 15
minutes to a maximum dose
of 2mg

Refer to Trust guideline Post-


Partum Haemorrhage

I.V. FLUIDS

Gelofusine IV use only For maternal resuscitation

Hartmanns solution IV use only

Sodium chloride 0.9% IV use only

PGD’s & Midwifery Exemptions April 2016 Page 6


AD HOC

Adrenaline 1:1000 Once only IM injection For anaphylaxis only

Anti-D See Trust guideline Adult only – for antenatal & postnatal use to
protect against haemolytic disease of the
Anti-D administration newborn
1500iu IM injection at 28
weeks gestation, dose as
directed by blood transfusion
at any other gestation in
pregnancy

Postnatal dose as directed by


blood transfusion

Miconazole (Daktarin) Oral gel 5-10mls Prevention & treatment of oral & intestinal
fungal infections. To be taken in the mouth
(adults only) after food 4 times daily. Treatment should be
continued for 48hrs after lesions have healed

Nystatin Oral suspension 100 000 Treatment of oral thrush. To be taken in the
units via pipette mouth 4 times daily after food
(neonates only)

VACCINES

Hepatitis B Vaccine Neonate only IM injection For use in protection against Hepatitis B

3 divided doses of 10 Refer to most recent BNF for current


micrograms instructions

1st dose at one month of age

2nd dose one month later

3rd dose two months after 1st


dose

4th dose 12 months after 1st


dose

Hepatitis B Immunoglobulin Neonate only IM injection For use in protection against Hepatitis B

Can be given at same time as Hepatitis


Vaccine, but at different sites. Available from
Health Protection Agency

PGD’s & Midwifery Exemptions April 2016 Page 7


DRUG DOSAGE MAY BE GIVEN AS FOLLOWS

Commonly used pharmacy only medicines (P) and general sales list medicines (GSL)- this
is not a full list and not all drugs may be included

ANALGESICS

Co-codamol 8/500 8mg Codeine with 500mg PN patients ONLY when paracetamol alone is
Paracetamol in each tablet ineffective
(1-2 tablets) orally
(may be given to Breast feeding mothers) Max
8 tabs in 24 hours
(P)

Ibuprofen 400mg orally PN patients 6-8 hourly.

DO NOT GIVE to patients who are


ASTHMATIC or with an ALLERGY TO
ASPIRIN or history of G.I. ULCERATION.
Caution with patients with P.E.T.

(GSL)

Paracetamol 500mg – 1G (1-2 tablets) AN & PN patients 4-6 hourly. Maximum 8


orally tablets (4G) in 24 hours

(GSL)

ANTACIDS

Gaviscon Suspension 5-10mls orally After meals and at bedtime

(GSL) PN & AN women

Magnesium Trisillicate Suspension 10-20mls orally In water three times daily

(GSL) PN & AN women

Peptac Liquid Suspension 10-20mls orally After meals and at bedtime

(GSL) PN & AN women

Peppermint water 10-15mls orally 2-3 times daily mixed with 20mls of warm
water

PN & AN women
(P)

PGD’s & Midwifery Exemptions April 2016 Page 8


GASES

Oxygen 40%-60% at flow of 4-10 To treat hypoxia / hypoxemia


litres per minute (depending
on type of mask) to maintain
(MEDICAL GAS/GSL) O2

Entonox Patient controlled - inhalation Inhalation analgesic for pain in labour or repair
of perineal trauma
(P)

APERIENTS

Glycerol suppository 4g per rectum For patients unable to have a bowel


movement. Not to be given to women with a
known allergy, A.P.H. or pre-term labour. Can
(GSL) cause stomach cramps and / or diarrhoea

Senna 2-4 tablets orally at night Commence with a smaller dose and increase
to maximum if required. Use as a laxative for
10-20mls syrup orally at night postnatal women.
(GSL)

Lactulose 15mls orally Given as an aperient and following major


perineal trauma. Not to be given to women with
a known allergy, A.P.H. or pre-term labour.
May take up to 48 hours to be effective

(GSL) Can cause stomach cramps and / or diarrhoea

AD HOC

T.E.N.S. Lower back - topical Patients in labour EXCLUDING those with


known heart disease or pacemaker
(no pharmaceutical
definition, but training
required for correct
application)

Ferrous sulphate 200mg orally twice a day Any obstetric inpatient A/N or P/N with a
reported Hb between 9.5g/dl & 10.5g/dl. Taken
with orange juice can increase absorbency
(GSL)

KY Jelly For use in vaginal examinations and


administering Prostin Gel
(GSL)

PGD’s & Midwifery Exemptions April 2016 Page 9


Hibitane Cream For use in vaginal examinations except when
administering Prostin Gel
(GSL)

Anusol cream Topical Morning & night and after each bowel
movement for treatment of haemorrhoids –
(Hydrocortisone acetate) advise women with perineal sutures to avoid
putting on suture line

(GSL)

Konakion / Phytomenadione 1mg IM once at birth Newborn infants only

Vitamin K If given orally refer to local


guideline -Vitamin K

Clotrimazole (Canesten) Cream – topical Use in treatment of vaginal Candidiasis

(GSL) Pessary – 500mg

Simple linctus 5mls suspension orally (can 3-4 times daily for treatment of persistent dry
be added to 20mls warm irritating cough. Max dose 20mls in 24 hours. If
water) cough persists for referral to and treatment by
(GSL) a doctor

Glucose 10-20g oral Management of conscious patients with


hypoglycaemia – BM reading of less than
4mmols and associated history of diabetes.
Patient compromised but able to swallow and
tolerate oral glucose. DO NOT GIVE TO
UNCONSCIOUS PATIENTS

Can be given TWICE only per hypoglycaemic


attack

If declined inform medical staff immediately.


(GSL) Refer low BM readings for medical review

Ametop Topical – 1.5g tube under an Patients requiring surface anaesthesia prior to
occlusive dressing cannulation or venepuncture (Excludes infants
(TETRACAINE 4% gel) under 1 month old)

Apply contents of tube to site of venopuncture


or venous cannulation and cover with occlusive
dressing, remove gel & dressing after 30
(P) minutes for venopuncture and 45 minutes for
PGD available for reference venous cannulation

PGD’s & Midwifery Exemptions April 2016 Page 10


PATIENT GROUP DIRECTIONS-

Patient group directions (PGDs) are specific written instructions for the supply or
administration of a licensed named medicine including vaccines to specific groups of
patients who may not be individually identified before presenting for treatment. Guidance on
the use of PGDs is contained within Health Service Circular (HSC) 2000/026.

PGDs should only be used once the registrant has been assessed as competent and whose
name is identified within each document. The administration of drugs via a PGD may not be
delegated. Students cannot supply or administer under a PGD but would be expected to
understand the principles and be involved in the process. Where medication is already
subject to exemption order legislation there is no requirement for a PGD.

PGD’s & Midwifery Exemptions April 2016 Page 11


PGD’s FOR MIDWIVES (12 ONLY REQUIRED)

DRUG DOSAGE MAY BE GIVEN AS FOLLOWS

ANALGESICS Refer to PGD guidance for full directions

Codeine Phosphate 30 – 60mg orally Post-operative pain 4-6 hourly.

Max of 8 tabs / 240mgs in 24 hours

(POM) (caution in breast feeding – risk of overdose in


babies)

Cocodamol 30/500 1 – 2 tablets Post-operative pain 4-6 hourly – maximum


dose of 8 tablets in 24 hours

(caution in breast feeding – risk of overdose in


(POM) babies)

Oromorph 10mgs in 5ml solution Management of severe postnatal pain

10-20mgs up to two doses in 4 hours


(maximum total of 20mgs)

(caution in renal impairment)


(POM)

ANTI-EMETICS

Promethazine (phenergan) 25 – 50mg IM ONCE ONLY – used in conjunction with


pethidine
(POM)

Metoclopramide 10mg IM Every 8 hours – maximum three 10mg doses


hydrochloride (Maxalon) in 24 hours

(POM)

Ranitidine 150mg orally 6 hourly until delivery

50mg in 20mls normal saline Given prior to emergency operative procedures


IV to be given over at least 2 or during labour if there are risks of emergency
minutes prior to operative operative procedures NOT required if oral
(POM) procedure doses have been given throughout labour

PGD’s & Midwifery Exemptions April 2016 Page 12


Sodium Citrate 30mls orally Once only immediately prior to emergency
operative procedure
(POM)

AD HOC

Rubella (MMR) IM injection Post natal women who are non-immune to


Rubella – to attend GP for repeat dose after 1
month to maximise uptake of vaccine

Lorazepam 4mg I.V. adult dose Management of patients presenting with status
epilepticus and are fitting
(POM)

Instillagel 11mls syringe Patients requiring catheterisation

(lidocaine hydrochloride 2% 6mls to be inserted in vicinity of urethra prior to


/ chlorhexidine gluconate catheterisation and apply to tip of catheter
0.25% in a sterile lubricant) using sterile technique described in guidelines.
Avoid insertion into urethra
(POM)
CAUTION with known lidocaine, chlorhexidine
or hydroxybenzoates allergies

Naseptin Cream Topical – pea size amount Management of MRSA positive patients
applied to the inner surface of
(POM) each nostril QDS See PGD for reference

CAUTION WITH PEANUT ALLERGIES

Octenisan Antimicrobial Topical to wet skin Management of MRSA positive patients


Wash Lotion
See PGD for reference
(POM)

Prostaglandins are not covered by PGD’s or maternity exemptions and must be prescribed
by a doctor at the present time

Midwives must sign the appropriate PGD as competent to give the drug concerned.
The above is only a brief guidance – refer to the PGD for full directions

PGD’s & Midwifery Exemptions April 2016 Page 13


EXCERPT FROM ‘THE CODE’ (NMC 2015) RELATING TO DRUG
ADMINISTRATION
The Code contains the professional standards that registered nurses and midwives must
uphold. UK nurses and midwives must act in line with the Code, whether they are
providing direct care to individuals, groups or communities or bringing their professional
knowledge to bear on nursing and midwifery practice in other roles, such as leadership,
education or research. While you can interpret the values and principles set out in the
Code in a range of different practice settings, they are not negotiable or discretionary.

SECTION 18

Advise on, prescribe, supply, dispense or administer medicines within the limits of your
training and competence, the law, our guidance and other relevant policies, guidance
and regulations

To achieve this, you must:


18.1 prescribe, give advice on, or provide medicines or treatment, including repeat
prescriptions (only if you are suitably qualified) if you have enough knowledge of
that person’s health and are satisfied that the medicines or treatment serve that
person’s health needs
18.2 keep to appropriate guidelines when giving advice on using controlled drugs and
recording the prescribing, supply, dispensing or administration of controlled
drugs
18.3 make sure that the care or treatment you advise on, prescribe, supply, dispense
or administer for each person is compatible with any other care or treatment they
are receiving, including (where possible) over-the-counter medicines
18.4 take all steps to keep medicines stored securely, and
18.5 wherever possible, avoid prescribing for yourself or for anyone with whom you
have a close personal relationship.

PGD’s & Midwifery Exemptions April 2016 Page 14


For more information, please visit: www.nmc-uk.org/s

The following summary is taken from the current


Standards for Medicine Management (NMC 2008) and is directly relevant to midwifery
practice. HOWEVER all midwives have a responsibility to familiarise themselves with this
document as all information is relevant, do not rely on these excerpts.

Standards for medicine management replace the Guidelines for the administration of
medicines 2004, although many of its principles remain relevant today, for example:
“The administration of medicines is an important aspect of the professional practice of
persons whose names are on the Council’s register. It is not solely a mechanistic task to be
performed in strict compliance with the written prescription of a medical practitioner (can now
also be an independent and supplementary prescriber). It requires thought and the exercise
of professional judgement...

Summary of standards

This section provides a summary of the standards for easy reference. For further detail you
should read, follow and adhere to the standards as detailed later in the document. It is
essential that you read the full guidance.

Section 1 : Methods of supplying and/or administration of medicines

Standard 1: Methods

Registrants must only supply and administer medicinal products in accordance with one or
more of the following processes:

Patient specific direction (PSD)

Patient medicines administration chart (may be called medicines administration


record MAR)

Patient group direction (PGD)

Medicines Act exemption

Standing order

Homely remedy protocol

PGD’s & Midwifery Exemptions April 2016 Page 15


Prescription forms

Standard 2: Checking

Registrants must check any direction to administer a medicinal product.

Standard 3: Transcribing

As a registrant you may transcribe medication from one ‘direction to supply or administer’ to
another form of ‘direction to supply or administer’.

Section 2: Dispensing

Standard 4: Prescription medicines

Registrants may in exceptional circumstances label from stock and supply a clinically
appropriate medicine to a patient, against a written prescription (not PGD), for self-
administration or administration by another professional, and to advise on its safe and
effective use.

Standard 5: Patients’ own medicines

Registrants may use patients’ own medicines in accordance with the guidance in this booklet
Standards for medicines management.

Section 3: Storage and transportation

Standard 6: Storage

Registrants must ensure all medicinal products are stored in accordance with the patient
information leaflet, summary of product characteristics document found in dispensed UK-
licensed medication, and in accordance with any instruction on the label.

Standard 7: Transportation

Registrants may transport medication to patients including controlled drugs, where patients,
their carers or representatives are unable to collect them, provided the registrant is
conveying the medication to a patient for whom the medicinal product has been prescribed,
(for example, from a pharmacy to the patient’s home).

Section 4: Standards for practice of administration of medicines

Standard 8: Administration

As a registrant, in exercising your professional accountability in the best interests of your


patients:
• you must be certain of the identity of the patient to whom the medicine is to be
administered

• you must check that the patient is not allergic to the medicine before administering it

PGD’s & Midwifery Exemptions April 2016 Page 16


• you must know the therapeutic uses of the medicine to be administered, its normal
dosage, side effects, precautions and contra-indications

• you must be aware of the patient’s plan of care (care plan or pathway)

• you must check that the prescription or the label on medicine dispensed is clearly
written and unambiguous

• you must check the expiry date (where it exists) of the medicine to be administered

• you must have considered the dosage, weight where appropriate, method of
administration, route and timing

• you must administer or withhold in the context of the patient’s condition, (for example,
Digoxin not usually to be given if pulse below 60) and co-existing therapies, for
example, physiotherapy
• you must contact the prescriber or another authorised prescriber without delay where
contra-indications to the prescribed medicine are discovered, where the patient
develops a reaction to the medicine, or where assessment of the patient indicates
that the medicine is no longer suitable (see Standard 25).

• you must make a clear, accurate and immediate record of all medicine administered,
intentionally withheld or refused by the patient, ensuring the signature is clear and
legible. It is also your responsibility to ensure that a record is made when delegating
the task of administering medicine.

In addition:

• Where medication is not given, the reason for not doing so must be recorded.

• You may administer with a single signature any prescription only medicine (POM),
general sales list (GSL) or pharmacy (P) medication.

In respect of controlled drugs:

• These should be administered in line with relevant legislation and local standard
operating procedures.

• It is recommended that for the administration of controlled drugs a secondary


signatory is required within secondary care and similar healthcare settings.

• In a patient’s home, where a registrant is administering a controlled drug that has


already been prescribed and dispensed to that patient, obtaining a secondary
signatory should be based on local risk assessment.

• Although normally the second signatory should be another registered health care
professional (for example doctor, pharmacist, dentist) or student nurse or midwife, in
the interest of patient care, where this is not possible, a second suitable person who
has been assessed as competent may sign. It is good practice that the second
signatory witnesses the whole administration process. For guidance, go to
www.dh.gov.uk and search for safer management of controlled drugs: guidance on
standard operating procedures.

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• In cases of direct patient administration of oral medication from stock in a substance
misuse clinic, it must be a registered nurse who administers, signed by a second
signatory (assessed as competent), who is then supervised by the registrant as the
patient receives and consumes the medication.

• You must clearly countersign the signature of the student when supervising a student
in the administration of medicines.

Standard 9: Assessment

As a registrant, you are responsible for the initial and continued assessment of patients who
are self-administering and have continuing responsibility for recognising and acting upon
changes in a patient’s condition with regards to safety of the patient and others.

Standard 10: Self-administration – children and young people

In the case of children, when arrangements have been made for parents or carers or
patients to administer their own medicinal products prior to discharge or rehabilitation, the
registrant should ascertain that the medicinal product has been taken as prescribed.

Standard 11: Remote prescription or direction to administer

In exceptional circumstances, where medication has been previously prescribed and the
prescriber is unable to issue a new prescription, but where changes to the dose are
considered necessary, the use of information technology (such as fax, text message or
email) may be used but must confirm any change to the original prescription.

Standard 12: Text messaging

As a registrant, you must ensure that there are protocols in place to ensure patient
confidentiality and documentation of any text received including: complete text message,
telephone number (it was sent from), the time sent, any response given, and the signature
and date when received by the registrant.

Standard 13: Titration

Where medication has been prescribed within a range of dosages, it is acceptable for
registrants to titrate dosages according to patient response and symptom control and to
administer within the prescribed range.

Standard 14: Preparing medication in advance

Registrants must not prepare substances for injection in advance of their immediate use or
administer medication drawn into a syringe or container by another practitioner when not in
their presence.

Standard 15: Medication acquired over the internet

Registrants should never administer any medication that has not been prescribed, or that
has been acquired over the internet without a valid prescription.

Standard 16: Aids to support compliance

Registrants must assess the patient’s suitability and understanding of how to use an
appropriate compliance aid safely.

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Section 5: Delegation

Standard 17: Delegation

A registrant is responsible for the delegation of any aspects of the administration of


medicinal products and they are accountable to ensure that the patient, carer or care
assistant is competent to carry out the task.

Standard 18: Nursing and Midwifery students

Students must never administer or supply medicinal products without direct supervision

Standard 19: Unregistered practitioners

In delegating the administration of medicinal products to unregistered practitioners, it is the


registrant who must apply the principles of administration of medicinal products as listed
above. They may then delegate an unregistered practitioner to assist the patient in the
ingestion or application of the medicinal product.

Standard 20: Intravenous medication

Wherever possible, two registrants should check medication to be administered


intravenously, one of whom should also be the registrant who then administers the
intravenous (IV) medication.

Section 6: Disposal of medicinal products

Standard 21: Disposal

A registrant must dispose of medicinal products in accordance with legislation.

Section 7: Unlicensed medicines

Standard 22: Unlicensed medicines

A registrant may administer an unlicensed medicinal product with the patient’s informed
consent against a patient-specific direction but NOT against a patient group direction.

Section 8: Complementary and alternative therapies

Standard 23: Complementary and alternative therapies

Registrants must have successfully undertaken training and be competent to practise the
administration of complementary and alternative therapies.

Section 9: Management of adverse events (errors or incidents) in the administration of


medicines

Standard 24: Management of adverse effects

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As a registrant, if you make an error you must take any action to prevent any potential harm
to the patient and report as soon as possible to the prescriber, your line manager or
employer (according to local policy) and document your actions. Midwives should also inform
their named supervisor of midwives.

Standard 25: Reporting adverse reactions

As a registrant, if a patient experiences an adverse drug reaction to a medication, you must


take any action to remedy harm caused by the reaction. You must record this in the patient’s
notes, notify the prescriber (if you did not prescribe the drug) and notify via the Yellow Card
Scheme immediately. http://yellowcard.mhra.gov.uk

Section 10: Controlled drugs

Standard 26: Controlled drugs

Registrants should ensure that patients prescribed controlled drugs are administered these
in a timely fashion in line with the standards for administering medication to patients.
Registrants should comply with and follow the legal requirements and approved local
standard operating procedures for controlled drugs that are appropriate for their area of
work.

PGD’s & Midwifery Exemptions April 2016 Page 20


Annexe 1
Legislation
There are a number of pieces of legislation that relate to the prescribing, supply, storage
and administration of medicines. It is essential that you comply with them. The following
is a summary of those that are of particular relevance.
Medicines Act 1968

This was the first comprehensive legislation on medicines in the UK. The combination of
this primary legislation and the various statutory instruments (secondary legislation) on
medicines produced since 1968 provides the legal framework for the manufacture,
licensing, prescribing, supply and administration of medicines. Among recent statutory
instruments of particular relevance to registered nurses, midwives and specialist
community public health nurses is The Prescription Only Medicines (Human Use) Order
1997, SI No1830. This consolidates all previous secondary legislation on prescription
only medicines and lists all of the medicines in this category. It also sets out who may
prescribe them. The sections on exemptions are of particular relevance to midwives,
including those in independent practice, and to nurses working in occupational health
settings. The Medicines Act 1968 classifies medicines into the following categories:
Prescription only medicines (POMs)

These are medicinal products that may only be sold or supplied to a patient on the
instruction of an appropriate practitioner. An appropriate practitioner is a doctor, dentist,
supplementary prescriber, or nurse or pharmacist independent prescriber. For more
information on the appropriate use of medicines and the relevant legislation, it is
advisable to consult with a pharmacist. The Royal Pharmaceutical Society of Great
Britain (RPSGB) can also provide more detailed information on medicines legislation.
Pharmacy only medicines (Ps)

These can only be purchased from a registered pharmacy. The sale must be by or under
the supervision of a pharmacist.
General sales list medicines (GSLs)

These need neither a prescription nor the supervision of a pharmacist and can be
obtained from retail outlets.
Controlled drugs (CDs)

The management of controlled drugs is governed by the Misuse of Drugs Act 1971 and
its associated regulations.

PGD’s & Midwifery Exemptions April 2016 Page 21


Introduction
We publish the Standards for pre-registration midwifery education (2009) which includes
standards for competence that clearly state what midwives must achieve before being
registered with us. This is achieved by undertaking an NMC-approved three-year
midwifery degree programme, which includes learning taking place in the university as
well as at least half of the programme being based in clinical practice with direct contact
with women, their babies and families. This can include in the home, the community and
hospitals, and in other maternity services such as midwife-led units and birth centres.
Registered midwives will be expected to understand, promote and facilitate normal
childbirth and identify complications that may arise in women and babies. They will know
when to call for assistance and implement emergency measures, often in conjunction
with other health professionals. It is important for midwives to promote health and
wellbeing and to provide unbiased information and communicate effectively with a range
of women and their families. They must also meet our requirements of good health and
good character.
Midwives must maintain these standards for competence throughout their careers to
remain on our register. Midwives must also practise in line with the most recent version
of The Code: Standards of conduct, performance and ethics for nurses and midwives
(NMC, 2008). We are currently reviewing the Code and a revised version will be
launched in December 2014.
Failing to consistently meet our standards can result in us investigating a midwife’s
fitness to practise and whether they are suitable to remain on our register.
We are now making the standards for competence its own document. We are doing this
to make these standards more accessible to the public and midwives to make it clear
that these are the standards that midwives must meet when they qualify. This will also
reinforce that all midwives must maintain these standards by keeping their knowledge
and skills up to date as long as they are on our register.
Publishing this document meets our commitments in response to the Francis report and
other recent reports on healthcare issues that focus on patient safety and improving
communication with patients and the public. It also comes as a result of ongoing contact
with our key stakeholders representing patients and the public across the four countries
to improve access to information on the standards for competence expected of
midwives.
It is important to note that the standards for competence have not changed and remain
exactly the same as those outlined in Standards for pre-registration midwifery education
(NMC, 2009).

PGD’s & Midwifery Exemptions April 2016 Page 22


Standards for competence that apply to all
midwives
All midwives must demonstrate competencies across the four areas: effective midwifery
practice; professional and ethical practice; developing the individual midwife and others;
and achieving quality care through evaluation and research. All areas are explained fully
for clarity. The examples used are not an exhaustive list. Each category under these
headings should be read in conjunction with the relevant Essential Skills Clusters
(ESCs), as listed fully in the Standards for pre-registration midwifery education (NMC,
2009).

Select, acquire and administer safely a range of


permitted drugs consistent with legislation,
applying knowledge and skills to the situation
which pertains at the time.
Methods of administration will include:
• oral
• intravenous
• intramuscular
• topical
• inhalation.

Complete, store and retain records of practice which:


• are accurate, legible and continuous;
• detail the reasoning behind any actions taken; and
• contain the information necessary for the record’s purpose.

Records will include:


• biographical details of women and babies;
• assessments made, outcomes of assessments and action taken as a result;
• outcomes of discussions with women and advice offered;
• any drugs administered; and
• action plans and commentary on their evaluation.

PGD’s & Midwifery Exemptions April 2016 Page 23


Essential Skills Clusters (ESCs)
ESCs support the achievement of the standards for competence. There are five ESCs:
• Communication
• Initial consultation between the woman and the midwife
• Normal labour and birth
• Initiation and continuance of breastfeeding
• Medicines management

Each essential skill cluster provides further detail to assist the development of the
midwifery degree programme and further details can be found at essential skills clusters
in the Standards for pre-registration midwifery education (NMC, 2009)

PGD’s & Midwifery Exemptions April 2016 Page 24

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