Midwives exemptions circular 21 may 2010

Category Midwifery
Status Action
Changes to Midwives Exemptions
• The Nursing and Midwifery Council exists to safeguard the health and well being of the public. We do this by maintaining a register of nurses and midwives and by setting standards for education and practice. • On 1 June 2010, amending legislation will come into force which expands and updates the range of prescription only medicines that may be sold, supplied or administered by registered midwives in the course of their professional practice. • This circular takes place with effect from 1 June 2010 and replaces NMC Circular • This document should be read in conjunction with the NMC documents: • The code: Standards of conduct, performance and ethics for nurses and • Midwives rules and standards (NMC, 2004) • Standards for medicines management (NMC, 2007).
Background

Under the Medicines Act 1968, medicines classified as pharmacy (P) medicines may
be sold or supplied only through registered pharmacies by or under the supervision of a
pharmacist (section 52).
Prescription only medicines (POM) are subject to an additional requirement: they may only be sold or supplied through pharmacies against a prescription from an appropriate practitioner (section 58). 1 The Medicines for Human Use (Miscellaneous Amendments) Order 2010. SI 2010/1136. 2 For more information contact: Claire Homeyard Midwifery Adviser 020 7333 6695 email: [email protected] Mandy Forrester Midwifery Adviser 020 7333 6694 Email: [email protected] General Sale List (GSL) medicines may be sold through retail outlets other than pharmacies as they do not need to be sold or supplied under the supervision of a pharmacist (sections 51 and 53). Exemptions from the general rules are permitted for midwives. These are provided for in the Prescription Only Medicines (Human Use) Order 1997 (SI 1997/1830 the 'POM Order') the Medicines (Pharmacy and General Sale- Exemption) Order 1980 (SI 1980/1924), the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 (SI 1980/1923). Registered midwives may supply and administer, on their own initiative, any of the substances that are specified in medicines legislation under midwives exemptions, provided it is in the course of their professional midwifery practice. They may do so without the need for a prescription or patient-specific direction (PSD) from a medical practitioner. Provided the requirements of any conditions attached to those exemptions are met, a patient group direction (PGD) is not required. If a medicine is not included in the midwives exemptions then a PGD, or a prescription, or a patient-specific written direction will be required. There is no legal definition for standing orders and they do not exist under any medicines legislation (Standards for medicines management, 2007). We recommend that the term standing orders is no longer used and is replaced with the term midwives exemptions. Registered midwives must only supply and administer those medicines, including analgesics, in which they have received the appropriate training as to therapeutic use, dosage, side effects, precautions, contra-indications and methods of administration (Midwives rules and standards, 2004). On 1 June 2010 medicines legislation will be amended to expand and update the range of prescription only medicines that may be sold, supplied or administered by a registered midwife. Article 3 substitutes the list of substances in Parts 1 and 3 of Schedule 5 to the POM Order in order to expand and update the range of prescription only medicines that may be sold, supplied or administered by registered midwives. No changes were made to legislation that affects pharmacy medicines or general sales list medicines used in the course of a midwife’s professional practice. Amendment of the POM Order
The following is an extract from the Amendments Order 20101:

3.
—(1) The POM Order is amended as follows.
(3) in schedule 5 (exemption for certain persons from section 58(2) of the Act): (a) in Part 1 (exemption from restrictions on sale or supply), in column 2, for “4 Prescription only medicines containing any of the following substances— Diclofenac Ergometrine maleate Hydrocortizone acetate Lidocaine Lidocaine hydrochloride Miconazole Nystatin Phytomenadione.” (b) in Part 3 (exemptions from restriction on administration), in column 2, for the substances listed in item 2 substitute—
“Adrenaline
Anti-D immunoglobulin
Carboprost
Cyclizine hydrochloride
Diamorphine
Ergometrine maleate
Gelofusine
Haemaccel
Hartmann’s solution
Hepatitis B vaccine
Hepatitis immunoglobulin
Lidocaine
Lidocaine hydrochloride
Morphine
Naloxone hydrochloride
Oxytocins, natural and synthetic
Pethidine hydrochloride
Phytomenadione
Prochloperazine
Sodium chloride 0.9%.”

The above list will be reviewed on an annual basis. Please note the following will be
removed or amended at a future date:
• Oral ergometrine is no longer available in the British National Formulary (will be • Lidocaine and lidocaine hydrochloride for topical use are pharmacy drugs (will • Cyclizine hydrochloride is licensed for oral use only and cannot be used for IM
Further information and advice

When supplying or administering medicines under midwives exemptions, midwives must ensure their practice is evidence based. Midwives must be familiar with current guidance published in the British National Formulary and British National Formulary for Children, including the use, side effects and contra-indications of the medicines. Some medicinal products supplied and administered by midwives under midwives exemptions are used outside of their license. Using a medicine in this way is known as 'off-label' use. Midwives may use ‘off label’ the medical products listed in the midwives exemptions list provided there is: • no appropriately licensed alternative • there is a sufficient evidence base and/or experience of using the medicine to • midwives should explain to women and their families, in broad terms, the reasons why the medicine is not licensed for the proposed use. The midwives exemptions list and advice on use and administration is attached at annexe 1 and 2. This circular may be reproduced by all to whom it is addressed. This circular has been issued by Professor Dickon Weir-Hughes Chief Executive and Registrar Nursing and Midwifery Council
Annexe 1: Midwives can supply and administer for non-parenteral use prescription only
medicines containing any of the following:

Midwives exemptions list
Drug name
NMC advice for professional practice


Diclofenac
for postpartum pain relief up to 48 hours after birth for the treatment of haemorrhoids in the antenatal and postnatal period Drug name
NMC advice for professional practice


Nystatin
prophylactic use to prevent vitamin k deficiency bleeding (haemorrhagic
Annexe 2: Midwives can administer for parenteral use prescription only medicines
containing any of the following substances:

Midwives exemptions list
Drug name
NMC advice for professional practice

Adrenaline 1:1000
for antenatal and postnatal use to protect against haemolytic disease of no particular uterotonic drug can be recommended over another for the treatment of postpartum haemorrhage. Treatment combinations for postpartum haemorrhage might include repeat bolus of oxytocin (intravenous), ergometrine (intramuscular, or cautiously intravenously), intramuscular oxytocin with ergometrine (Syntometrine), oxytocin infusion (Syntocinon) or carboprost (intramuscular). Diamorphine hydrochloride for pain relief in labour IV use with caution – risk of hypertension 1 Taken from the National Collaborating Centre for Women’s and Children’s Health document Intrapartum care: care of healthy women and their babies during childbirth. Commissioned by the National Institute for Health and Clinical Excellence (NICE 2007, updated 2008). Drug name
NMC advice for professional practice

Gelofusine
Morphine sulphate for pain relief in labour for reversal of respiratory depression resulting from opioid administration no particular uterotonic drug can be recommended over another for the Treatment combinations for postpartum haemorrhage might include repeat bolus of oxytocin (intravenous), ergometrine (intramuscular, or cautiously intravenously), intramuscular oxytocin with ergometrine (Syntometrine), oxytocin infusion (Syntocinon) or carboprost (intramuscular). 1 Taken from the National Collaborating Centre for Women’s and Children’s Health document Intrapartum care: care of healthy women and their babies during childbirth. Commissioned by the National Institute for Health and Clinical Excellence (NICE 2007, updated 2008). Drug name
NMC advice for professional practice


Pethidine
for management of actual or potential nausea and vomiting Drug name
NMC advice for professional practice


Hepatitis B
for use in protection against Hepatitis B for use in protection against Hepatitis B for reversal of respiratory depression resulting from opioid administration prophylactic use to prevent vitamin k deficiency bleeding (haemorrhagic

Source: http://www.nmc-uk.org/Documents/Circulars/2010circulars/NMCcircular06_2010.pdf

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