Standard operating procedure

Controlled Drug (Stimulant) Prescribing Procedure

How [Organisation Name] prescribes controlled-drug stimulants for attention deficit hyperactivity disorder (ADHD) safely and lawfully, writes valid controlled-drug prescriptions, manages private controlled-drug prescriptions and prescription stationery, guards against diversion and misuse, and audits its controlled-drug prescribing.

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Procedure
  • 6. Records
  • 7. Related documents
  • 8. Review and version control
  • 9. Disclaimer

Legislation & standards it maps to

  • Misuse of Drugs Act 1971
  • The Misuse of Drugs Regulations 2001 (SI 2001/3998, as amended) - classification of controlled drugs into Schedules and requirements for prescriptions, records and safe custody
  • The Misuse of Drugs (Safe Custody) Regulations 1973 (SI 1973/798, as amended)
  • The Controlled Drugs (Supervision of Management and Use) Regulations 2013 (SI 2013/373) - the Accountable Officer and local intelligence network arrangements
  • The Human Medicines Regulations 2012 (SI 2012/1916, as amended) - prescribing and supply of prescription-only medicines, including private prescription requirements
  • National Institute for Health and Care Excellence, Attention deficit hyperactivity disorder: diagnosis and management, NICE guideline NG87 (2018, updated 2019)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 12 (Safe care and treatment) and Regulation 17 (Good governance)
  • General Medical Council, Good practice in prescribing and managing medicines and devices (2021)
  • Data Protection Act 2018 and the UK General Data Protection Regulation

Who it applies to

All prescribers at [Organisation Name] who are qualified, registered and authorised to prescribe controlled drugs for ADHD - including specialist doctors (consultant and specialty psychiatrists and paediatricians), and non-medical prescribers (nurse and pharmacist independent prescribers) working within their competence - together with the Controlled Drugs Accountable Officer, clinical pharmacists, prescription-stationery custodians, and the administrative and clinical staff who support prescribing, dispensing liaison and audit.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

ADHD (attention deficit hyperactivity disorder)
A condition affecting attention, activity levels and impulse control, sometimes treated with stimulant medicines.
Annotated independent-prescriber qualification
A formal note on a nurse's or pharmacist's professional register confirming they are trained and authorised to prescribe medicines in their own right.
Atomoxetine
A non-stimulant medicine used to treat ADHD; it is not a controlled drug.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Caldicott Guardian
The senior person responsible for protecting the confidentiality of people's health and care information.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Contemporaneous record
A record written at the time of, or immediately after, the event it describes, so it is accurate and reliable.
Controlled drug (CD)
A medicine whose supply, storage and records are tightly restricted by law because of its potential for misuse.
Controlled Drugs Accountable Officer (CDAO)
The named senior person responsible for the safe and effective management and use of controlled drugs in an organisation.
Controlled-drug register
The legally required book or electronic record showing every controlled drug received, supplied, used and destroyed, with running balances.
Cross-border dispensing
A pharmacy in one nation of the United Kingdom dispensing a prescription written under the rules of another, which is not always permitted.
Data Protection Act 2018
The UK law that sets the rules for how organisations collect, store and use people's personal information.
Dexamfetamine
A stimulant medicine licensed to treat ADHD; it is a Schedule 2 controlled drug.
Diamorphine
A strong opioid painkiller (medical heroin) and a Schedule 2 controlled drug, mentioned here only as an example.
Diversion
When a prescribed controlled drug is redirected away from the patient it was meant for, towards illegal use or supply.
Dosage unit
A single countable amount of a medicine, such as one tablet or one capsule.
FP10PCD
The standardised, individually numbered form used in England to write a private prescription for a Schedule 2 or 3 controlled drug.
General Medical Council (GMC)
The body that registers and sets standards for doctors in the United Kingdom.
General practitioner (GP)
A family doctor who provides general medical care in the community.
Guanfacine
A non-stimulant medicine used to treat ADHD; it is not a controlled drug.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards that registered health and care providers in England must meet.
Home Office licence
Permission from the government department responsible for drugs policy, needed to possess the most tightly controlled drugs.
Human Medicines Regulations 2012
The main UK law governing how medicines are licensed, prescribed and supplied.
Immediate-release
A medicine formulation that releases its full dose quickly after it is taken.
Indelible ink
Permanent ink that cannot easily be erased or altered, required for signing controlled-drug prescriptions.
Independent prescriber
A registered professional authorised to assess patients and prescribe medicines on their own responsibility.
Lisdexamfetamine
A stimulant medicine licensed to treat ADHD; it is a Schedule 2 controlled drug and is turned into dexamfetamine by the body.
Local intelligence network
An arrangement through which organisations and regulators share information about concerns relating to controlled drugs.
Mandatory particulars
The details the law requires on a controlled-drug prescription before it is valid and can be dispensed.
Methylphenidate
A stimulant medicine licensed to treat ADHD; it is a Schedule 2 controlled drug.
Misuse of Drugs Act 1971
The main UK law that controls dangerous or harmful drugs and classifies them by their potential for misuse.
Misuse of Drugs Regulations 2001
The regulations that sort controlled drugs into Schedules and set the rules for prescribing, recording and storing them.
Misuse of Drugs (Safe Custody) Regulations 1973
The law setting out how certain controlled drugs must be securely stored, for example in an approved locked cabinet.
Modified-release
A medicine formulation designed to release its dose slowly over time, so it works for longer.
National Institute for Health and Care Excellence (NICE)
The independent body that produces evidence-based guidance on treatments and care for use across the United Kingdom.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
NICE guideline NG87
The National Institute for Health and Care Excellence guideline on diagnosing and managing attention deficit hyperactivity disorder.
Non-medical prescriber
A trained professional who is not a doctor, such as a nurse or pharmacist, authorised to prescribe medicines.
Patient Group Direction (PGD)
A written instruction letting named staff supply or give a medicine without an individual prescription; it cannot be used for ADHD stimulants.
Prescription stationery
The blank prescription forms and related printing materials used to issue prescriptions, which must be kept secure.
Private prescriber identification number
A unique number a prescriber must hold and put on private controlled-drug prescriptions; it is different from their professional registration number.
Prodrug
A medicine that is inactive when taken and is converted by the body into the active drug.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulation 12 (Safe care and treatment)
The fundamental standard requiring care and treatment to be provided safely, including the safe management of medicines.
Regulation 17 (Good governance)
The fundamental standard requiring providers to have effective systems to monitor, assess and improve the quality and safety of care.
Safe custody
The legal requirement to store certain controlled drugs securely so they cannot be lost, stolen or misused.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Schedule (controlled drugs)
One of five legal categories (1 to 5) that set how tightly a controlled drug is regulated, based on its medicinal use and misuse risk.
Shared care
An arrangement where responsibility for a patient's treatment is formally divided between two providers, such as a specialist and a family doctor.
Smartcard
A secure personal card used to log in to clinical systems and confirm a user's identity.
Standard operating procedure (SOP)
A written step-by-step instruction setting out how a task should be carried out consistently and safely.
Stimulant
A type of medicine that increases certain brain activity and is used to treat ADHD; the ones used are controlled drugs.
Titrate
To adjust the dose of a medicine gradually until the right balance of benefit and side effects is reached.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.

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