2023-07-09 13:26:26
The Department of Health and Social Care has now published in draft the Human Medicines (Amendment Relating to Original Pack Dispensing (England and Wales and Scotland) Regulations 2023.
Permission to supply in original packs – up to 10% variation
When these Regulations come into force, they will amend the Human Medicines Regulations so that the sale or supply of an original pack will be treated as being in accordance with a prescription even if the quantity is different to the quantity specified on the prescription unless:
(a) the difference between the quantity prescribed and the quantity supplied is not more than 10%; or
(b) the pharmacist who makes or supervises the sale or supply considers, in the exercise of their professional skill and judgement, that the sale or supply of a different quantity to that ordered on the prescription may mean that the patient does not, or is not able to, follow the medication regimen as intended by the prescriber.
The 10% maximum variation and the exception for cases where the pharmacist exercises professional skill and judgment will not apply to cases where.
(a) The medicine is in a form that makes it impracticable to dispense the exact quantity ordered;
(b) The medicine is in a container that has an integral means of application, or from which it is not practicable to dispense an exact quantity;
(c) The medicine cannot be dispensed in the quantity ordered without adversely affecting the medicine.
Subject to amendment of NHS terms of service
The new regulatory permission to sell or supply an original pack with a different quantity will not apply to NHS prescriptions, unless the relevant NHS terms of service expressly apply the amendments to the Human Medicines Regulations.
Original packs mandatory for valproate prescriptions
To ensure that medicines containing sodium valproate, valproic acid and valproate semisodium are sold or supplied with a package leaflet that contains warnings about the risk of birth defects when taken by any woman or girl able to have children, these medicines must be sold or supplied:
(a) in a manufacturer’s original outer packaging;
(b) if the quantity sold or supplied is different to the quantity ordered on the prescription, the quantity sold or supplied is as close as possible to the quantity prescribed.
The requirement to sell or supply in a manufacturer’s original pack will not apply where:
(a) the sale or supply is by or under the supervision of a pharmacist; and
(b) the pharmacist is satisfied that –
(i) a risk assessment is in place that refers to the need for the patient to receive the medicine in different packaging from the manufacturer’s original pack (eg in a monitored dosage system);
(ii)processes are in place to ensure the patient receives a package leaflet, unless the medicine does not have a marketing authorisation (otherwise than because it has been repackaged).
Coming into force
Once the draft Regulations have been approved by both Houses of Parliament, they will come into force 28 days later.