This page provides notes on medicines legislation in midwifery practice.

Two babies

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 (POM) medicines are subject to an additional requirement: they may only be sold or supplied through pharmacies against a prescription from an appropriate practitioner (section 58). General Sale List (GSL) medicines may be sold more widely through other retail outlets (sections 51 and 53).

Exemptions from the general rules are permitted for midwives. These are provided for in the Prescription Only Medicine (Human Use Order) 1997 SI No 1830 (the 'POM Order') the Medicines (Pharmacy and General Sale- Exemption) Order 1980 SI No 1924 and the Medicines (Sale or Supply) (Miscellaneous Provisions) Regulations 1980 SI No 1923.

A Patient Group Direction is not necessary for midwives to be able to supply and/or administer any of those substances that are specified in medicines legislation under the 'midwives exemptions'.

Some maternity service providers have produced local guidelines, often referred to as 'standing orders', to supplement the legislation on the medicines that practising midwives may supply and/or administer. Such guidelines, whilst they may be appropriate locally, are not a prerequisite under any medicines legislation. In fact there is no legal definition for medicine 'standing orders' and this terminology does not exist in any medicines legislation.

Provided it is in the course of their professional practice, midwives have the following exemptions under medicines legislation:

Medicines to which the exemption applies Conditions

All medicinal products on a General Sale List
All P medicines
Prescription Only Medicines containing any of the following:

Diclofenac
Hydrocortizone acetate
Miconazole
Nystatin
Phytomenadione

The sale or supply of the Prescription Only Medicines listed opposite shall be only in the course of their professional practice.


Prescription Only Medicines to which the exemption applies Conditions

Prescription Only Medicines for parenteral administration containing any of the following substances:

Adrenaline
Anti-D immunoglobulin
Carboprost
Cyclizine lactate
Diamorphine
Ergometrine maleate
Gelofusine
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 administration shall be only in the course of their professional practice and in the case of lidocaine and lidocaine hydrochloride shall be only while attending on a woman in childbirth.
Student midwives
With the exception of controlled drugs, student midwives can administer any of the parenteral medicines on the midwives’ list under the direct supervision of a registered midwife.

Notes:
Further changes to the list are proposed to take account of the following:

  1. Oral ergometrine and Haemaccel are no longer commercially available.
  2. Lidocaine and lidocaine hydrochloride for topical use are pharmacy drugs and do not, therefore need to be on the list.
  3. Cyclizine hydrochloride is licensed for oral use only and cannot be used for IM or IV use. The reference to hydrochloride was an error.


Contact for further information
For further information on this part of our site, please contact our Sale and Supply section, 020 3080 6392 or email info@mhra.gsi.gov.uk


Page last modified: 12 July 2011