Using articles in this series
When dealing with controlled drugs an understanding of legal requirements and national guidance is essential. This article is the first in a series designed to help dental teams understand how to manage controlled drugs safely and within the law.
Identifying and classifying CDs
CDs are drugs considered dangerous or harmful that have the potential to be abused; they are subject to strict controls.
CDs are divided into five Schedules, each with different requirements governing their handling and use.
The BNF gives the schedule each CD belongs to in the ‘medicinal forms’ section of monographs.
The BNF section on Controlled drugs and drug dependence provides lists of CDs in each Schedule and advice on prescribing.
The Patient UK website provides further information on handling CDs.
Schedule 1
Not usually used therapeutically. A Home Office licence is required to possess or supply them. These will not be considered further.
Schedule 2
Examples include:
- fentanyl
- morphine (except low-dose liquids)
Schedule 2 CDs are subject to additional requirements relating to prescription-writing, safe custody, and keeping registers.
Schedule 3
Examples include:
- midazolam
- temazepam
Schedule 3 CDs are subject to additional requirements relating to prescription-writing and safe custody (midazolam is exempt). A register need not be kept, but invoices must be retained for two years.
Schedule 4
Examples include:
- diazepam
Schedule 4 CDs are not subject to additional prescription-writing or safe custody requirements, or the need to keep a register.
Schedule 5
Examples include:
- dihydrocodeine
- nitrous oxide
Schedule 5 CDs are subject to few additional controls other than the requirement to keep invoices for 2 years.
CD governance
The Care Quality Commission (CQC) is responsible for ensuring service providers, including dental teams, manage and use CDs safely.
Large organisations must have a Controlled Drug Accountable Officer (CDAO) responsible for managing all aspects of the use and handling of CDs. Smaller organisations do not need a CDAO, but NICE guidance on Controlled drugs: safe use and management advises appointing a named CD lead.
All organisations must have a comprehensive suite of standard operating procedures covering all aspects of CD handling.
For further information, see our article Controlled drugs governance for dental teams (SPS page).
Possessing CDs
It is unlawful for any person to possess a CD unless the Misuse of Drugs Regulations 2001 permit it. The Regulations allow specified healthcare professionals, acting in their professional capacity, to possess, administer, and supply CDs.
Dentists may possess, administer, and supply CDs in Schedules 2 to 5 for use on their patients.
Dental hygienists, dental therapists and dental nurses may not possess, administer or supply CDs unless in accordance with the written direction of a dentist.
Managing stock CDs
The Care Quality Commission (CQC) advises that stock CDs are those a service holds that have not already been prescribed, administered, or supplied to a patient. Midazolam in an emergency kit is a stock CD.
Obtaining stock CDs
All requisitions for schedule 2 and 3 CDs must be made on the official form FP10CDF.
Necessity for a Home Office licence
A Home Office licence may be required by a practice keeping stock CDs.
Using midazolam in an emergency
Stock midazolam may only be administered by a dentist or against a patient specific direction in the patient’s record.
A patient’s own buccal midazolam may be administered to them by practice staff who are trained and competent to do so.
For further details, see our article Managing controlled drugs held as stock for dental teams (SPS page).
Prescribing CDs
Prescriptions for NHS patients are limited to medicines listed in the Dental Practitioners Formulary and must be written on form FP10D.
Prescriptions for private patients for Schedule 2 or 3 CDs must be written on form FP10PCD. Dentists can prescribe any CD appropriate for the patient’s dental needs for private patients.
All prescriptions for Schedule 2 or 3 CDs must be written in a specific format.
For further advice, see our article Prescribing controlled drugs for dental teams (SPS page).
Storing and recording CDs
Requirements for storing and recording transactions involving CDs differs between Schedules.
Storing CDs
All medicines should be stored safely. However, Schedule 2 and 3 CDs are subject to extra safe custody requirements, unless exempt.
Recording CD transactions
Transactions involving Schedule 2 CDs must be recorded in a CD register. Registers must be kept for two years after the date of the last entry.
Transactions involving Schedule 3, 4, and 5 CDs do not need to be recorded in a CD register. However, records are essential to ensure an audit trail of supply, administration and disposal.
Our article Storing and recording controlled drugs for dental teams (SPS page) gives further information.
Managing CD waste
CDs in Schedules 2, 3, and 4(1) should be denatured before disposal. After being denatured, they should be disposed of as pharmaceutical waste.
Destruction of stock Schedule 2 CDs must be witnessed by an authorised person.
It is good practice for the destruction of other CDs to be witnessed by a member of staff familiar with CDs.
For further information, see our article Managing controlled drugs waste for dental teams (SPS page).
CD legislation
CDs are defined and controlled by several Acts of Parliament and Regulations working together.
Important legislation governing CDs
The Human Medicines Regulations 2012 is the main piece of legislation regulating the management of all medicines.
The Misuse of Drugs Act 1971 regulates production, supply, possession, and exportation of specified ‘controlled’ drugs considered to be dangerous or harmful.
The Misuse of Drugs Regulations 2001 define who may possess and supply CDs and classify them into five schedules.
The Misuse of Drugs (Safe Custody) Regulations 1973 require some CDs to be kept in a locked cabinet or room. The regulations specify the type of cabinet or room required.
The Controlled Drugs (Supervision of Management and Use) Regulations 2006 introduced the requirement for organisations to appoint a Controlled Drugs Accountable Officer. The Controlled Drugs (Supervision of Management and Use) Regulations 2013 replaced the 2006 regulations to reflect NHS reorganisation.
Timeline of relevant changes to controlled drug legislation
2023: the Misuse of Drugs (England and Wales and Scotland) (Amendment) Regulations 2023 made nitrous oxide a Schedule 5 CD. However, it is exempted from many of the requirements of Schedule 5.
2015: the Misuse of Drugs (Amendment) (No. 2) (England, Wales and Scotland) Regulations 2015 introduced the requirement to use an official CD requisition form.
2008: the Misuse of Drugs and Misuse of Drugs (Safe Custody) (Amendment) Regulations 2007 moved midazolam from Schedule 4 to Schedule 3.
2006: the Misuse of Drugs (Amendment No. 2) Regulations 2006 introduced the private CD form FP10PCD for all private CD prescriptions.