Manage medicines and controlled drugs safely

Medicines law decides who may direct a medicine, who may supply and give it, and how controlled drugs are held and recorded. A provider that stocks or gives medicines has to meet those rules. A registered provider also answers to its regulator for managing medicines safely.

Decide who can direct each medicine

A prescription only medicine can be sold or supplied only on a prescription from an appropriate practitioner: a doctor, a dentist, a supplementary prescriber, a nurse independent prescriber or a pharmacist independent prescriber. Other independent prescribers have narrower rights. Nobody may give a prescription only medicine by injection or another parenteral route, other than to themselves, unless they are an appropriate practitioner or acting on the directions of one.

Use a patient group direction only where the law allows

A patient group direction must be signed by a doctor or dentist and a pharmacist, and by or on behalf of the provider that authorises it. Only a medicine with a UK marketing authorisation can go in one.

Only some providers can use PGDs. They are NHS bodies and people supplying under an arrangement with them, independent hospitals, clinics and medical agencies registered for treatment, surgery, diagnostic, maternity or family planning activities, and some dental practices. Only certain registered professionals can supply under one, such as nurses, midwives, pharmacists, paramedics, physiotherapists and radiographers, and the provider must designate each in writing. NICE says to give most care on an individual basis, keep PGDs for limited situations where they benefit patients, and not use them for long-term conditions such as hypertension or diabetes.

Keep controlled drugs within the Misuse of Drugs rules

A nurse or other member of staff who is not a doctor or dentist can administer a Schedule 2, 3 or 4 drug only on the directions of a doctor or dentist, or on the authority of a PGD or an independent or supplementary prescriber who may prescribe it.

Check, audit and destroy

The Regulations set no frequency for stock checks, but NICE guidance says most organisations should check the balance in the register against stock at least once a week, record the check, and have two people do it where possible, with a written procedure for audits and for reporting discrepancies.

If you must keep records of a controlled drug in Schedule 1 to 4, you may destroy it only in the presence of, and following the directions of, a person authorised by the Secretary of State or by an accountable officer. The register entry must give the date and quantity and be signed by that person.

Check whether you need a Home Office licence

The person in charge of a hospital or care home can hold and supply Schedule 3 and 4 stock under the Regulations whoever funds it. Someone holding a medicine dispensed for a named resident can keep and give it in line with the prescriber's directions without a licence.

Offences and penalties

Prescription only medicines. Under the Human Medicines Regulations 2012, selling or supplying a prescription only medicine other than in accordance with a prescription from an appropriate practitioner breaches regulation 214(1), unless one of the exemptions in the Regulations applies, such as a pharmacist's emergency supply. That breach, and possessing a prescription only medicine intending to supply it in that way, are offences under regulation 255. They can be tried either way. On indictment the maximum is an unlimited fine, 2 years in prison, or both; on summary conviction it is a fine up to the statutory maximum (unlimited in England and Wales, £10,000 in Scotland, £5,000 in Northern Ireland). In Great Britain the General Pharmaceutical Council enforces regulation 214 alongside the Secretary of State.

Controlled drugs you are authorised to handle. Practitioners and pharmacists possess and supply controlled drugs lawfully under regulations made under the Misuse of Drugs Act 1971, such as the Misuse of Drugs Regulations 2001. Breaching those regulations, or the terms of a licence or other authority issued under them, is an offence under section 18, with a maximum on indictment of 2 years in prison, a fine, or both.

Unlawful supply of controlled drugs. Supplying or offering to supply a controlled drug without that authority is an offence under section 4(3). On indictment the maximum is life imprisonment for a Class A drug and 14 years for a Class B or Class C drug, with a fine in each case. Possessing a Class A drug without authority carries up to 7 years on indictment.