5e. PGD Midwifery Exemptions April 2016
5e. PGD Midwifery Exemptions April 2016
5e. PGD Midwifery Exemptions April 2016
• Introduction
• Midwifery exemptions
• PGD’s
• Standards for medicine management (NMC 2007)
• The Code (NMC 2015)
• Standards for competence for registered midwives (NMC
2009)
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.
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
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.
Lidocaine 1% 10mg in 1ml injection 10- Prior to performing an episiotomy & perineal
20mls repair.
REVERSAL AGENTS
OXYTOCICS
I.V. FLUIDS
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
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
Hepatitis B Immunoglobulin Neonate only IM injection For use in protection against Hepatitis B
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)
(GSL)
(GSL)
ANTACIDS
Peppermint water 10-15mls orally 2-3 times daily mixed with 20mls of warm
water
PN & AN women
(P)
Entonox Patient controlled - inhalation Inhalation analgesic for pain in labour or repair
of perineal trauma
(P)
APERIENTS
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)
AD HOC
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)
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)
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
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)
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.
ANTI-EMETICS
(POM)
AD HOC
Lorazepam 4mg I.V. adult dose Management of patients presenting with status
epilepticus and are fitting
(POM)
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
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
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
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.
Standard 1: Methods
Registrants must only supply and administer medicinal products in accordance with one or
more of the following processes:
Standing order
Standard 2: Checking
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
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.
Registrants may use patients’ own medicines in accordance with the guidance in this booklet
Standards for medicines management.
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).
Standard 8: Administration
• you must check that the patient is not allergic to the medicine before administering it
• 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.
• These should be administered in line with relevant legislation and local standard
operating procedures.
• 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.
• 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.
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.
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.
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.
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.
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.
Registrants should never administer any medication that has not been prescribed, or that
has been acquired over the internet without a valid prescription.
Registrants must assess the patient’s suitability and understanding of how to use an
appropriate compliance aid safely.
Students must never administer or supply medicinal products without direct supervision
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.
Registrants must have successfully undertaken training and be competent to practise the
administration of complementary and alternative therapies.
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.
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.
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)