Introduction to Controlled Drugs

• Controlled Drugs (CD)

  Drugs that are controlled by legislation due to their potential for abuse or misuse
• Controlled Drug Legislation

  • Misuse of Drugs Act 1971
  • Misuse of Drugs Regulations 2001
  • Misuse of Drugs (safe custody) Regulations 1973
  • Health Act 2006
  • Controlled Drugs (supervision of management and use) Regulations 2013
  • Responsible Pharmacist Regulations 2008
• Purpose of Misuse Drugs Act

  • To control dangerous or otherwise harmful drugs, prevents their misuse and prohibits all activities associated with the drugs controlled under the Act, except were permitted in the regulations
• Prohibited activities with Controlled Drugs

  • Import and export (unless licensed)
  • Producing a CD
  • Supply or offer to supply a CD to another person
  • Possessing a CD
  • Cultivating any plant of the genus cannabis
• Possession of Controlled Drugs

  Unlawful unless: Person holds an appropriate Home Office License, Person is a member of a class specified in the Regulations and is acting in their capacity as a member of that class, The Regulations state that the possession of the drug is not unlawful
• Controlled Drug Requisition Forms

  • FP10CDF (England)
  • CDRF or GP10A (Scotland)
  • WP10CDF (Wales)
• Legal requirements for a CD requisition

  1. Signature of recipient

  2. Name of recipient

  3. Address of recipient

  4. Profession or occupation

  5. Total quantity of drug

  6. Purpose of requisition
• When a requisition of a schedule 1,2 or 3 CD is received

  1. Mark the requisition with the supplier's name and address

  2. Send the original requisition to the relevant NHS agency

  3. Retain copies of the requisitions 2 years from the date of supply
• Correcting errors in CD register entries

  1. Make dated footnotes and mark to indicate who the amendments are attributed to (name, initials, signature and GPhC No.)

  2. Crossing out is not permitted
• Controlled Drug Registers

  • Must be kept 2 years from the date of the last entry
  • Must be kept on the premises
  • Entered chronologically
  • Entered promptly – on the day of the transaction or on the following day (legal requirement)
  • In ink, indelible or computerised
  • Must be unaltered
• Information recorded for RECEIPT of CD in register

  • Date supply received
  • Quantity received
  • Name and address from whom received
• Information recorded for SUPPLY of CD in register

  • Date supplied
  • Quantity supplied
  • Name and address of recipient
  • Details of authority to possess – prescriber or license holder's details
  • Detail of person collecting the schedule 2 CD (Patient/representative or Healthcare professional name and address)
  • Whether proof of Identity was requested
  • Whether Proof of identity was provided
  • Amount of CD supplied
• Stock checks of CDs in registers

  1. Normally done once a week, can be more or less frequent

  2. Recorded in the register – signed and dated by the Healthcare Professional and usually carried out by two people
• Controlled Drugs Storage


  • Must be stored in a locked, safe place (cupboard or room) which stops unauthorised access to the drugs
  • Access to CDs should be documented in a policy to prevent unauthorised access and be able to audit who has had access to CDs
  • Schedule 1, 2 and 3 drugs are stored apart from a few exemptions
• Schedule 3 includes cannabis-based products for medicinal use in humans, which are prescription only medicine (POM).
• Schedule 3 includes cannabis-based products for medicinal use in humans, except Sativex®.
• Schedule 2 lists controlled drugs, including opioids such as morphine, diamorphine, codeine, tramadol, fentanyl, oxycodone, buprenorphine, methadone, pethidine, dextromoramide, pentazocine, nalbuphine, butorphanol, and propoxyphene.
• Schedule 2 lists controlled drugs, including opioids such as morphine, diamorphine, codeine, tramadol, fentanyl, pethidine, methadone, buprenorphine, oxycodone, tapentadol, dextromoramide, pentazocine, nalbuphine, butorphanol, and propoxyphene.
• The Misuse of Drugs Act (1971) is the main legislation that controls drugs.
• CDs must not be left unattended when being transported.
• Sativex® is a Schedule 4 drug because it contains both THC and CBD.
• Theft of controlled drugs is an offence under Section 5(3)(b) Misuse of Drugs Act 1971.
• If a patient requests their own medication outside normal hours, it may be possible if they have been prescribed them regularly and there is no reason to suspect abuse.
• The storage location must have adequate security measures such as locks on doors and windows, alarms, CCTV cameras, etc.
• CDs should not be kept with other medications unless they are securely locked away.
• Schedule 4 contains benzodiazepines like diazepam, temazepam, lorazepam, clonazepam, flunitrazepam, midazolam, zopiclone, and zolpidem.
• Schedule 5 is used for substances with low abuse potential, such as cough suppressants containing codeine.
• CDs can only be prescribed by doctors on the General Medical Council's register or dentists registered with the General Dental Council.
• Prescriptions for CDs cannot be issued more than one month ahead of time.
• Drugs are classified into five schedules based on their potential for abuse or dependence.
• Schedule 4 lists controlled drugs, including benzodiazepines like diazepam, temazepam, lorazepam, clonazepam, midazolam, zopiclone, zolpidem, flunitrazepam, nitrazepam, oxazepam, and triazolam.
• CDs can only be prescribed by doctors registered with the General Medical Council (GMC), dentists registered with the GDC, or veterinary surgeons registered with the RCVS.
• Schedule 5 lists controlled drugs, including preparations containing small amounts of certain substances that have low potential for abuse.
• A doctor can only issue prescriptions for CDs on Form FP10 or private prescription forms.
• Schedule 5 CDs include preparations containing small amounts of certain substances, such as cough mixtures with less than 0.2% dihydrocodeine per unit dose.
• Section 6(1) of the Misuse of Drugs Act 1971 states that no person shall have any CD in their possession unless they are authorized by law or exempt from control.
• Prescriptions for CDs cannot be issued electronically unless they have been authorized by the Home Office.
• Prescribers are responsible for ensuring that patients receive appropriate treatment with CDs.
• Possession without authority can result in imprisonment up to seven years and/or fine.
• Controlled drugs are stored separately from other medicines and kept out of sight.