2023-03-21 18:08:25
The Department of Health and Social Care (DHSC) conducted a consultation in late 2021 on a proposal to enable Prescription Only Medicines to be supplied in original packs even if the quantity supplied was more or less than the quantity prescribed. Currently, regulation 214 of the Human Medicines Regulations 2012 prohibits the supply of a POM otherwise than in accordance with a prescription. The DHSC’s proposal was to amend the Human Medicines Regulations so as to permit a supply of up to 10% more or less of the medication prescribed.
A further proposal was made regarding sodium valproate, the continued prescribing of which to women of childbearing age remains a concern (see, for example, https://www.chemistanddruggist.co.uk/CD136123/Clinical-negligence-claims-against-pharmacists-ignoring-sodium-valproate-guidance-cannot-be-ruled-out). In the case of sodium valproate, supplying in an original pack would be mandatory so as to increase patient safety by ensuring that a Patient Information Leaflet is provided to all patients.
DHSC has just published its conclusions after considering the responses to the consultation https://www.gov.uk/government/consultations/original-pack-dispensing-and-supply-of-medicines-containing-sodium-valproate/outcome/original-pack-dispensing-and-medicines-containing-sodium-valproate-consultation-response . These are:
1. The proposed changes to the Human Medicines Regulations will:
- allow pharmacists to have flexibility to dispense up to 10% more or less than the prescribed quantity if that means they can supply a manufacturer’s original pack, except where, in the exercise of clinical judgement, this would negatively affect the patient’s clinical treatment regimen – for example when steroids or antibiotics are prescribed and a decision may need to be made to supply the exact quantity prescribed.
- require sodium valproate to be supplied in an original pack in the nearest quantity to that prescribed (rounding up or down). There will be an exception from this requirement where a risk assessment is in place that refers to the need for different packaging, such as a supply in a monitored dosage system and where processes are in place to ensure the supply of a patient information leaflet.
2. The changes to the Human Medicines Regulations to allow pharmacists to dispense up to 10% more or less than the quantity prescribed will be made using powers in the Medicines and Medical Devices Act. Once those powers have been exercised and the Human Medicines Regulations are amended, they will only have immediate effect in the case of private prescriptions and, in the case of NHS prescriptions, in Scotland.
3. It will be left to NHS England, NHS Wales and the Department of Health in Northern Ireland to decide when and how to allow pharmacists to supply a different quantity than that prescribed on NHS/HSC prescriptions, because decisions will have to be made about what pharmacy owners should be reimbursed for supplying a different quantity to that prescribed. When a decision is made, the amended law can be brought into force and the Drug Tariffs in each country will presumably then be amended.