Labelling medicines

Medicines supplied to a patient by a dental team member must be labelled as directed by the Human Medicines Regulations 2012 (HMR 2012). Provisions are detailed in Regulation 258, Schedule 25 and Schedule 26.

The legal mechanism used, team member involved and legal category of the medicine determines how it should be labelled. Supplying medicines and medical devices: advice for dental teams details the legal categories of medicines.

Medicines supplied against a prescription, patient specific direction (PSD) or patient group direction (PGD) must be labelled before being given to a patient. Labelling is required for prescription only medicines (POMs) and some other medicines supplied under a Schedule 17 exemption.

The following must be included on the label: 

• the name of the person to whom the medicine is to be administered 
• the name and address of the supplying dentist 
• the date on which the medicine is sold or supplied 

When prescribed by a dentist, additional information may be needed on the label if not on the manufacturer’s packaging, or the medicine is repacked. The dentist should add the following information, if considered appropriate:  

• the name of the product or its common name 
• directions for use 
• precautions relating to use of the medicine 

Prescription only medicines (POMs)

All POMs must be labelled before being given to a patient.

Prescribed and supplied by a dentist

All POMs supplied from a dental practice at the direction of a dentist must be labelled to comply with HMR 2012 Schedule 26. This applies whether the supply is to a private or NHS patient, and whether the supply is against a prescription or PSD.

Supplied under a schedule 17 exemption or PGD

POMs supplied under a PGD or Schedule 17 exemption should also be labelled as if the medicine had been dispensed against a prescription as described above. However, HMR 2012 Schedule 26 does not list dental hygienists or dental therapists as professions allowed to label medicines.  

To comply with the law, the medicine must therefore be purchased from a licensed manufacturing unit with the label already applied (“over-labelled”). The label must have a space for: 

• the patient’s name 
• date of supply 
• address of the dental service if not pre-printed 
• if applicable, any variable dosing or course length details 

Any spaces (for example, for the patient’s name and the date) must be filled in at the time of supply. 

Note that dentists can only label medicines for patients under their direct care. They cannot label medicines on behalf of another member of the dental team.

NHS England and DHSC are considering how to manage remuneration for NHS dental contractors where appropriate. Until resolved, patients receiving NHS treatment from dental hygienist or therapist, and requiring a POM, should be issued with a prescription written by a dentist. 

Pharmacy medicines (P)

P medicines do not require labelling if they are supplied in an unopened manufacturer’s original pack which complies with HMR 2012 Schedule 24:

• by a dentist under a PSD (private patients)
• by a dental hygienist or dental therapist working under a Schedule 17 exemption
• by a dental hygienist or dental therapist working under a PGD when the dose directions given to the patient match those printed on the pack

Although not legally required, it is good practice to add a label to a P medicine, at the time of supply. This should include the patient’s name/date supplied and address of the dental practice. The label should be added in such a way that it does not obscure the manufacturer’s information on the pack.

However, if the dosage instructions on the pack do not reflect the intended directions:

• the prescribing dentist must add a label with full details (as above)
• the dental hygienist or therapist working under a PGD or Schedule 17 exemption must supply a fully completed over-labelled pack

Note that dentists can only label medicines for patients under their direct care. They cannot label medicines on behalf of another member of the dental team.

General Sales List (GSL) medicines

GSL medicines do not require labelling if they are sold or supplied:

• in an unopened manufacturer’s original pack which complies with HMR 2012 Schedule 24
• the dosage instructions on the GSL pack reflect the dose to be administered

Although not essential, it is good practice to add a label to any GSL medicine supplied, at the time of supply. This should include the patient’s name/date supplied and address of the dental practice. The label should be added in such a way that it does not obscure the manufacturer’s information on the pack.

Note that dentists can only label medicines for patients under their direct care. They cannot label medicines on behalf of another member of the dental team.

Packaging of medicines

HMR 2012 advises that all medicines must be supplied in a reclosable child-resistant container or pack, for example blister packaging, unless an exemption applies. Dentists, but not other members of the dental team, may supply medicines in alternative packaging if the original packaging is unsuitable for the patient.

Child-resistant packaging is not suitable for all medicines or all patients. Consider if:

• the medicine is in an original pack or patient pack such as to make this inadvisable
• the patient will have difficulty opening a child-resistant container
• a specific request is made that the product not be dispensed in a child-resistant container
• no suitable child-resistant container exists for a particular liquid preparation

Removing doses from original packs

Medicines should be supplied in a manufacturer’s original pack. However, when an original pack contains more doses than prescribed the excess doses should be removed from the pack. For example, supplying the exact number of doses required to complete a course of antibiotics is important to ensure good antimicrobial stewardship. After removing surplus doses:

• dispose of them in the pharmaceutical waste container
• the pack must be labelled to reflect the amended quantity
• the process must be fully documented

This process can only be undertaken by a dentist to comply with a prescription or PSD they have written.

Repacking medicines

Medicines must not be repackaged or a manufacturer’s pack re-labelled in advance of the patient appointment and the prescription or PSD being written. For example, a batch of antibiotic packs with additional doses removed cannot be prepared, labelled and stored for future use.

Advance repackaging and pre-labelling of medicines is considered ‘manufacturing’ and is prohibited by HMR 2012 unless a license is held.

Patient Information Leaflets (PILs)

In addition to packaging and labelling requirements, the HMR 2012 states that all medicines supplied to patients must be accompanied by a Patient Information Leaflet (PIL). The PIL must include information detailed in HMR 2012 Schedule 27. All manufacturer’s original packs contain a PIL.

PILs can be obtained for patients who are visually impaired via X-PIL. X-PIL can be contacted via their freephone number for PILs:

• in large print
• in Braille
• on audio CD