Proposals to include Schedules 2 and 3 Controlled Drugs within the scope of the Electronic Prescription Service

Executive summary

• The NHS Electronic Prescription Service (EPS) enables prescribers such as general practitioners (GPs) and practice nurses to send prescriptions electronically to a dispenser (such as a pharmacy) of the patient’s choice. This makes the prescribing and dispensing process more efficient and convenient for patients.
• Controlled drugs (CDs) are a group of medicines that have the potential to be abused, but are essential to modern clinical care. The Misuse of Drugs Regulations 2001 divides CDs into five “schedules” according to the level of regulation required. Schedule 1 CDs have no proven therapeutic value and have potential for misuse and are therefore heavily regulated, whereas Schedule 5 CDs present little or no risk and are lightly regulated.
• Previous changes to the Misuse of Drugs Regulations in 2005 already allow for the electronic transmission of prescriptions for Schedules 4 and 5 CDs, but Schedules 2 and 3 CDs are currently out of scope.
• The main aim of this consultation and proposed changes to legislation is to enable the electronic prescribing of NHS prescriptions for Schedules 2 and 3 CDs. However, the Misuse of Drugs Regulations and medicines legislation cover both NHS and private prescriptions. These are prescribed in private care (non-NHS settings, such as private clinics), although some may be issued by a GP in an NHS consultation.
• This consultation document is structured as a two-part consultation:

1. Do we enable NHS prescribed Schedules 2 and 3 CDs to be prescribed electronically (for England, this would be via EPS)?
2. Do we enable privately prescribed Schedules 2 and 3 CDs to be prescribed electronically? If yes, with

• an Advanced Electronic Signature (AES) alone; or
•  additional security (in England this would be via EPS)?
• • Within the NHS in England, electronic prescriptions are sent by EPS, which has an AES (a unique electronic signature linked to the data being signed and the identity of the signer) and has multiple layers providing security. The other three countries in the UK, known as the Devolved Administrations (DAs) have yet to develop an NHS electronic system that utilises the AES provisions. The Department of Health is therefore working with colleagues to make sure the proposals are compatible with any developments they may pursue.

• The legislation that would need to be amended in England would be:
• the Misuse of Drugs Regulations 2001;
• the Human Medicines Regulations 2012;
• the NHS (General Medical Services Contract) Regulations 2004 as amended;
• the NHS (Personal Medical Services Agreement) Regulations 2004 as amended; and
• the NHS (Pharmaceutical Services and Local Pharmaceutical Services) Regulations 2013.

Corresponding changes will be applied to arrangements for the provision of primary medical services under Alternative Provider Medical Services contracts.

• The Misuse of Drugs Regulations 2001 requires that prescriptions for Schedules 2 and 3 CDs must express the total quantity of the drug prescribed in words and figures. It is thought that this requirement was introduced to make it harder for prescriptions to be tampered with, in particular, to have the quantity changed prior to presentation for dispensing and to make instructions of the prescriber clear to the pharmacist. If we enable Schedules 2 and 3 CDs to be prescribed electronically, we are also asking you whether we should continue to require the total quantity of the prescribed medicine to be written in words and figures or whether you wish us to remove this requirement for electronic prescriptions only (all paper prescriptions will still need to comply with this requirement).