Legislation

Under the Human Medicines Regulations 2012 Regulation 223 registered midwives can administer or supply any Pharmacy Only (P) or General Sales List (GSL) medicines as part of their professional practice.

Prescription Only Medicines (POMs) require a prescription or Patient Group Direction for administration or supply. The only exceptions are those medicines listed in the Schedule 17 of the HMR 2012 exemptions which permit registered midwives to administer/supply the listed POMs as part of their professional practice.

Note under Schedule 17 of the HMR 2012 exemptions Part 3 (2) student midwives may also administer the listed parenteral medicines when under the direct supervision of a registered midwife (not including diamorphine, morphine or pethidine).

Legal status of medicines

The legal status of medicinal products depends on the:

• licenced indication for use
• formulation
• strength
• pack size

Off label use

Registered midwives may supply or administer GSL/P preparations for off-label use when such use is clearly justified and supported by best clinical practice, such as national guidance.

Off-label uses would include dosage or dosage regime or indication outside the product licence.

Where such practice is undertaken midwives should consider informing individuals about the licence for their medicines, in line with prescribing guidance published by the General Medical Council (2013).

Off–label use should be noted in any supporting local protocol.

Applying this advice in practice

We have used omeprazole to illustrate this advice in practice.

Omeprazole for use within antenatal and maternity services has template protocols that can be locally adapted for use.

Legal status of omeprazole

Omeprazole 10mg and 20mg tablets are available as GSL medicines for the short-term relief of reflux-like symptoms in adults over 18 years, at a maximum daily dose of 20mg, to be taken for maximum of 4 weeks and a maximum pack size of 28 tablets (10mg) and 14 tablets (20mg).

All other formulations, preparation, strength and pack sizes are POMs.

Administration of omeprazole

A registered midwife may administer any GSL medicine to an individual under their professional care without the need for a prescription or PGD.

Whilst not a legal requirement it would be good practice to have a local protocol or similar in place to support this practice.

There is no set layout or content requirements for protocols but it would be advised that they include the clinical indication for administration, inclusion/exclusion criteria, dose to be given, maximum number of doses that can be given under the protocol and any off-label use.

P and GSL medicines with PGDs contains further details.

Single doses for administration

The MHRA have advised that administration of single doses of a medicine which is classified as a GSL as well as a POM (classification based on its pack size/licenced indication) can be made from a POM or GSL pack, which has been legally obtained by the organisation without the need for a prescription or PGD.

‘Single dose’ means that one dose can be supplied and/or administered at a time. Therefore, repeated doses are permitted but must be supplied/administered each time a dose is due. Organisations must ensure that only those POM products/formulations which are also classified as GSL medicines are administered in this way. In the case of omeprazole, this would be limited to POM packs of 10mg and 20mg tablets only.

Supply of omeprazole

A registered midwife may supply an original, unopened GSL pack of omeprazole tablets to an individual under their professional care without the need for a prescription or PGD.

If the product to be supplied is classified as a POM then a prescription or PGD will be required for a legal supply to be made.

It would be good practice to have a local protocol or similar in place to support the practice of supplying GSL medicines.

P and GSL medicines with PGDs contains further details.

Labelling requirements

If the dosage instructions on the GSL pack reflect the dose required to be taken, then over-labelling with dosage instructions is not required.

It would be good practice to add the individual’s name and the date supplied and address of the supplying unit to any medicine supplied. This information can be as a pre-printed label to which the individual’s name and date of supply is added at the time of supply.  Any label added to the original pack should be added in such a way that it does not obscure any required information printed on the box.

If the instructions of the GSL pack do not match those to be followed the product can either be over-labelled with the correct instructions or a locally produced information leaflet detailing the dosage to be taken can be supplied alongside appropriate counselling.

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