Scope

Where the term exemption is used in this article, this refers to patient group directions (PGDs) and other exemptions listed in the Human Medicines Regulations 2012, such as those in Schedule 17.

Prescription Only Medicine (POM)

Legislation

Schedule 25 of the Human Medicines Regulations 2012 sets out provisions for labelling of medicines supplied by a prescription. It does not specifically mention prescription only medicines supplied under an exemption. However, the SPS PGD Advisory Service Reference Group considers that it is appropriate for medicines supplied under an exemption to require the same labelling and other information as if the medicine had been dispensed against a prescription.

Labelling requirements of POMs supplied under exemptions

In most cases the pack to be supplied under an exemption will need to be labelled to reflect the dose exactly as stated in the PGD or, for exemptions a locally developed supporting protocol or SOP, in the same way as if it were being dispensed against a prescription. In practice the medicine will usually require over-labelling by a licensed unit leaving a space for the individual’s name, date of supply, address of the service and, if applicable, any variable dosing or course length details to be added at the time of supply.

Dosage instructions

The SPS PGD Advisory Service Reference Group are aware of some exceptions to the requirement for comprehensive labelling. For example, contraceptives intended for self-administration are often prescribed and labelled “To be taken as directed” or “To be administered as directed”. Dosage directions are instead included in the Patient Information Leaflet (PIL) or pre-printed onto the outer box at the time of manufacture. This non-specific labelling may also apply to other POMs where the directions for use are complex and do not fit on a label, for example podophyllotoxin or imiquimod.

Labelling

In these exceptional cases, and as long as the directions supplied with the medication are the same as those stated in the PGD or supporting protocol or SOP, it is acceptable for the healthcare professional operating under the exemption to attach a label with no dosage instructions to the product at the time of supply (see also Considerations when labelling contraceptives below). This label must include the individual’s name, the date supplied and the address of the supplying clinic. The individual needs to be fully counselled on the dosage instructions at the time of supply and must be shown where these instructions are located for reference. The supplying healthcare professional should ensure the label does not obscure other information on the POM pack.

The practice of adding an address label onto a single box of a POM by the professional working under the exemption at the point of supply to an individual under their care, is not considered “manufacturing” or “assembly” as defined by the Medicines Act.

MHRA requirements

It is the view of the SPS PGD Advisory Service Reference Group that if the advice under Dosage instructions and Labelling above is complied with, the requirement of the MHRA (that the information the individual receives is the same whether the medicine is prescribed or supplied under an exemption) has been met.

Considerations when labelling contraceptives

Faculty of Sexual and Reproductive Health (FSRH) guidance may recommend dosage regimes for some contraceptives which differ from the licensed dosage regimes. As a result, caution needs to be taken in ensuring the administration instructions within a PGD matches exactly those pre-printed on the packaging/within the supplied PIL. If they do not match exactly, over-labelling with the intended dosing instructions will be required.

The issuing healthcare professional will also need to ensure the recipient is made aware that the packaging instructions/PIL are different from those on the label and ensure they are aware of the correct dosage regime to follow.

Other relevant patient information

PGDs, supporting protocols or SOPs should always identify any other relevant information or advice to be given to the individual, including providing the statutory manufacturer’s PIL. It should also refer to any other checks that practitioners must carry out to ensure that they and the individual/their carer fully understand how to take or use the supplied medicine.

Labelling of single dose POMs for immediate administration

The MHRA has advised that single dose medicines which are non-parenteral and which are supplied by a healthcare professional under an exemption and then immediately self-administered or administered by another person, such as a carer or healthcare worker, in the same room or clinic do not require labelling.

This also applies to parenteral medicines supplied and administered under an exemption by the same healthcare professional.

Pharmacy Medicines (P)

Over-labelling of P medicines

If the dosage instructions on the P pack reflect the dose required to be administered under the exemption, then over-labelling is not required.

However the PGD Advisory Service Reference Group have advised that it is good practice to add a label stating the individual’s name, date supplied and address of the supplying clinic. Staff need to do this at the time of making the supply and in such a way that they do not obscure the manufacturer’s dosage information on the pack.

Pre-printed dosage instructions on P medicine packaging

Practitioners and organisations need to be aware that, in some circumstances, doses on some P packs vary. For example, different brands of ibuprofen liquid have been known to have different dosage schedules and there could be circumstances where a service has more than one brand in stock.

Local governance measures may be required to manage any potential risk to ensure that anyone supplied with a P medication under an exemption has the intended dosage instructions. It may be that where this risk is identified, over-labelled stock is purchased to ensure consistency of dosage instructions.

Further information

For information relating to the supply of P and GSL medicines see P and GSL medicines with PGDs.

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