Prescription Only Medicines (POM)
Schedule 25 of the Human Medicines Regulations 2012 sets out provisions for labelling of medicines on prescription. It does not specifically mention prescription only medicines supplied under a PGD. However the SPS PGD Service Advisory Board considers that it is appropriate for medicines supplied under a PGD to require the same labelling and other information which would be required if the medicine had been dispensed against a prescription.
Labelling requirements of POMs supplied under a PGD
In the majority of cases the pack to be supplied under a PGD will need to be labelled to reflect the dose exactly as authorised in the PGD 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.
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” with dosage directions are included in the Patient Information Leaflet (PIL) or are pre-printed on to the outer box at 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 with products such as 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 individual’s name, the date supplied and the address of the clinic from which it was supplied but including no dosage instructions. 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 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 a single box of a POM by the professional working under the PGD at the point of supply to an individual under their care, is not considered “manufacturing” or “assembly” as defined by the Medicines Act.
In such circumstances PGDs should also 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.
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 individual receives is the same whether the medicine is prescribed or supplied under PGD has been met.
*It is specifically noted that the nationally recognised Faculty of Sexual and Reproductive Health (FSRH) guidance recommends dosage regimes for some oral 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 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 parenteral medicines supplied and administered under a PGD by the same healthcare professional.
Pharmacy Medicines (P)
Overlabelling of P medicines
If the dosage instructions on the P pack reflect the dose required to be administered under the PGD, then over-labelling is not required.
However the PGD Service Advisory Board have advised that it is good practice to add a label stating the individual’s name, date supplied and address of the supplying unit. 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 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 a PGD 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 is assured.