Notes on medicines legislation in midwifery practice.
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 produsts on a General Sale List
All P medicines
Prescription only medicines containing any of the following:
Chloral hydrate Ergometrine maleate Pentazocine hydrochloride Phytomenadione Triclofos sodium
|
The sale or supply of the prescription only medicines listed opposite shall be only in the course of their professional practice and in the case of ergometrine maleate only when contained in a medicinal product which is not for parenteral administration |
Exemptions from the restrictions on administration:
| Prescription only medicines to which the exemption applies |
Conditions |
|
Prescription only medicines for parenteral administration containing any of the following substances specified in column 1 of Schedule 1 to this Order:
Diamorphine Ergometrine maleate Lignocaine Lignocaine hydrochloride Morphine Naloxone hydrochloride Oxytocins, natural and synthetic Pentazocine lactate Pethidine hydrochloride Phytomenadione Promazine hydrochloride
|
The administration shall be only in the course of their professional practice and in the case of promazine hydrochloride, lignocaine and lignocaine hydrochloride shall be only while attending on a woman in childbirth |
Contact for further information
For further information on this part of our site, please contact our Sale and Supply section, MHRA, 16-142, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 2392, fax 020 7084 2121 or e-mail info@mhra.gsi.gov.uk