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 and Schedule 223.

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 nearly every situation the pack to be supplied under an exemption will need to be labelled to reflect the dosage details exactly as stated in the PGD or exemptions protocol 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.

Exceptions to comprehensive labelling requirements

The SPS PGD Advisory Service Reference Group are aware of a limited number of exceptions to the requirement for comprehensive labelling.

For example, where the directions for use are complex and do not fit on a standard label, for example podophyllotoxin or imiquimod, they are usually labelled as “To be used as directed” with dosage directions instead included in the Patient Information Leaflet (PIL) or pre-printed onto the outer box at the time of manufacture.

This example is given so that organisations can see that the exceptions to comprehensive labelling should be used in limited circumstances and not used to avoid obtaining over labelled packs.

Any decision to supply a pack that is not over labelled must be carefully considered and risk assessed. Discussion with the relevant professionals or organisations (e.g. Quality Assurance specialist teams/pharmacy teams/the MHRA) should inform a local risk assessment and consider any mitigation actions.

Labelling in limited exceptional cases

If the directions supplied with the medication are the same as those stated in the PGD or exemptions protocol, 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. This label must include the individual’s name, the date supplied and the address of the supplying clinic.

The individual must 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 must ensure the label does not obscure other information on the POM pack.

When a professional working under an exemption adds an address label onto a single box of a POM at the point of supply to an individual under their care, this is not considered “manufacturing” or “assembly” as defined by the Medicines Act or Human Medicines Regulations 2012.

Off label use

Exemptions may be used to supply medicines which are to be used off label and as a result the administration instructions within a PGD or exemptions protocol and those pre-printed on the packaging/within the supplied PIL may not exactly match. If they do not match exactly, including in any exceptional cases, over-labelling by a licensed manufacturing unit 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 and supporting protocols should always identify any other relevant information or advice to be given to the individual, including providing the statutory manufacturer’s PIL. They 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 (e.g. a nasal ‘flu vaccine).

This also applies to parenteral medicines administered under an exemption by the same healthcare professional (e.g. an IM ‘flu vaccination).

Pharmacy Medicines (P)

Labelling of P medicines

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

However, the SPS 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 obtained from a licensed manufacturing unit to ensure consistency of dosage instructions.

Further information

For information relating to the supply of P and GSL medicines refer to the SPS advice P and GSL medicines with PGDs.

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