What are the legal requirements for labelling a Prescription Only Medicine (POM) issued via a PGD before supply to the patient?

· NHS PGD Website

The MHRA have advised that medicines supplied under a PGD would usually be considered to be “dispensed medicines” but that the definition in the legislation [Schedule 5 of The Medicines (Marketing Authorisations etc) Regulations 1994 number 3144] does not specifically mention PGDs.

It is therefore considered appropriate for such medicines to be supplied to patients with the same labelling and other information which they would otherwise receive if the medicine had been supplied against a prescription.

In the majority of cases the pack to be issued under a PGD will need to be labelled to reflect the dose exactly as authorised in the PGD as if it were being dispensed against a prescription. In practice the medicine will usually have been over-labelled by a licensed unit leaving a space for the patient’s name, date of dispensing, address of the service and, if applicable, any variable dosing or course length details to be added at the time of supply.

The SPS PGD Service Advisory Board are aware of some exceptions to the requirement for comprehensive labelling. Oral contraception and injectable contraceptives intended for self-administration are often prescribed and labelled “To be taken as directed” or “To be administered as directed” – dosage directions are included in the Patient Information Leaflet (PIL) or are pre-printed on to the outer box at time of manufacturer. This non-specific labelling may also apply to other POMs where the directions for use are complex and do not fit on a label e.g. podophyllotoxin or imiquimod.

In such exceptional cases, and as long as the directions supplied with the medication are the same as those stated in the PGD*, then it is acceptable for the healthcare professional operating under the PGD to attach to the product at the time of supply a label including the patient’s name, the date supplied and the address of the clinic from which it was supplied but including no dosage instructions. The patient 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 that they add the label in such a way that it does not obscure other information on the POM pack.  The practice of adding an address label onto the box of a POM by a clinic nurse at the point of supply to a patient under their care, is not considered “manufacturing” or “assembly” as defined by the Medicines Act.

The PGD should also identify any other relevant information or advice to be given to the patient, including providing the statutory manufacturer’s Patient Information Leaflet. It should also refer to any other checks that practitioners must carry out to ensure that they and the patient/carer fully understand how to take or use their medicine.

It is the view of the SPS PGD Advisory Board that if all the above advice is complied with, the requirement of the MHRA that the information the patient receives is the same whether the medicine is prescribed or supplied under PGD has been met.

*Recent changes in the national guidance on dosage regimes for some oral contraceptives has resulted in variance between the licensed dosage regimes and those advised within the guidance.  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 PIL.  If they do not match exactly over-labelling with the intended dosing instructions will be required.  Also the issuing healthcare professional will need to ensure that the recipient is made aware that the packaging instructions/PIL are different from those on the label and ensure they are aware of the dosage regime to follow.

Labelling of single dose POMs for immediate administration

The MHRA has confirmed that single dose medicines which are non-parenteral and which are supplied by a healthcare professional under PGD 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 injectable medicines supplied and administered under a PGD by a healthcare professional.

Medicines supplied and taken away by the patient for self-administration or administration by a carer/ another healthcare worker at a later time must be labelled.