The Misuse of Drugs Act 1971 places controls on certain medicines. We call these 'controlled drugs'.
The Misuse of Drugs Regulations 2001 categorise controlled drugs into 5 schedules. The schedules correspond to the level of therapeutic usefulness and the potential for harm from misuse, with lower schedules having higher risk. The Home Office has produced a list of the most commonly prescribed controlled drugs.
You must store schedule 2 drugs in a controlled drugs cupboard. Keep records of these drugs in your controlled drugs register. Examples include:
Some services may choose to store other schedule controlled drugs in the controlled drugs cupboard and record them in the controlled drugs register. You should always follow your service’s medicines policy.
You do not need to record schedule 3 drugs in the controlled drugs register. However, you must store certain Schedule 3 drugs in the controlled drugs cupboard. This includes, for example, buprenorphine and temazepam.
Some other Schedule 3 drugs do not need to be stored in the controlled drugs cupboard. Examples include:
- barbiturates (phenobarbitone).
You do not need to store controlled drugs in Schedules 4 and 5 in the controlled drugs cupboard or record them in your controlled drugs register. However, you must consider where you store these drugs and ensure that they are stored securely. You must keep accurate records of their receipt, administration and disposal to minimise the opportunity for diversion. Examples include:
- morphine sulfate solution (Oramorph®) 10mg/5mL
Policies and procedures
You must have a policy or standard operating procedure that details how you manage controlled drugs in your service. This should cover:
It should include what to do if there's a discrepancy and the contact details of anyone who you need to inform. This should include the regional NHS controlled drugs accountable officer (CDAO) at NHS England or the police, depending on the circumstances. Check the contact details for:
- your local NHS England CDAO on our website: Controlled drug accountable officers
- your local police CD liaison officer: Your nearest CDLO
- you need to inform CQC if the incident meets the criteria of a statutory notification.
Controlled drug registers
You must record any movement of a Schedule 2 controlled drug in a controlled drugs register. The register is a bound book with numbered pages. Electronic registers are permitted as an alternative.
Legislation requires that computerised entries must:
- be attributable to the person who created the record
- be secure
- not be cancelled or altered
- be able to be corrected and dated when the correction is made
- be able to be audited
- comply with best practice
- be accessible from the care home and capable of being printed.
You must use the register to record the receipt, administration, disposal and transfer of controlled drugs held by the care home. The following are important points:
- The entry must be made as soon as possible on the same day.
- Entries must be in chronological order.
- Entries should not be cancelled, altered or crossed out. You should sign and date any corrections in the margin or in footnotes.
- The member of staff making the entry should sign and date it. Whenever possible, all entries should also be witnessed by a suitably trained member of care home staff who should also sign the entry.
- The register should not be used for any other purpose.
- The register must be kept in a secure place when not in use.
Care homes with nursing can hold stocks of controlled drugs. There must be a separate section in the register for different drugs and a separate page for each formulation and strength. Enter the name, form and strength at the top of the page. You need to record the name of the person given the medicine, the dose and time administered.
For controlled drugs prescribed for an individual person, enter their name and the drug’s name, form and strength at the top of the page. Use a separate page for each form and strength of medication.
Holding stocks of controlled drugs
Care homes with nursing can hold stocks of controlled drugs in Schedules 3, 4 and 5 without a Home Office licence. This may be the case if several people are receiving care at the end of life. You need a controlled drugs licence to hold stocks of controlled drugs in Schedule 2 if less than 50% of the care home’s funding comes from public funds or charitable donations.
Care homes without nursing must not hold stocks of controlled drugs. They can only hold controlled drugs prescribed and dispensed for an individual person.
You can ask for advice on Home Office legislation by contacting the Home Office Duty Compliance Officer.
Managing controlled drugs
It is recommended that care homes keep a running balance of the stock levels of each controlled drug preparation. This makes it much easier to spot and track discrepancies.
It is good practice for 2 members of staff to witness and sign when:
- receiving controlled drugs
- checking stock balances
- administering controlled drugs
- disposing of controlled drugs.
Both members of staff involved in the process should be trained and competent to do so.
You need to keep detailed records when administering topical controlled drugs, for example transdermal patches. These records should include the site of application and the frequency of rotation of the site.
Prescriptions for controlled drugs are valid for 28 days after the date on the prescription. The Department of Health and Social Care strongly recommends that the maximum quantity of controlled drugs prescribed should not exceed a period of 30 days.
Emergency supplies are not permitted. There must be a valid controlled drugs prescription to obtain supplies from a pharmacy. Staff must make sure ordering processes are robust enough so that people do not run out of these medicines.
Storing controlled drugs
Controlled drugs cupboards must meet British Standard BS2881:1989 security level 1 and the requirements of. The Misuse of Drugs (Safe Custody) Regulations 1973 (legislation.gov.uk). A label should be fitted to the inside of the door displaying manufacturer name and other specific information.
- You do not need to store the controlled drugs cupboard within another cupboard
- You must not use the controlled drugs cupboard to store other medicines or items such as jewellery or money.
- You must restrict access to the cupboard according to need.
- Store spare keys securely.
- There are no rules about which members of staff can hold controlled drugs keys in a care home. Providers should carry out a risk assessment to decide this. This should also be included in your controlled drugs policy.
- If a person is self-administering controlled drugs, they can keep them in their possession provided the controlled drugs are kept safely. A risk assessment should consider where the controlled drugs will be stored.
Refrigerating controlled drugs
If a controlled drug has safe custody requirements and needs to be kept in a fridge, it will need to be stored in a locked medicines fridge. There are no medicines fridges available that meet the Misuse of Drugs (Safe Custody) Regulations. Therefore, controlled drugs subject to the safe custody requirements that require refrigeration can be stored in a standard locked medicine fridge.
You can store other medicines in the same medicine fridge as controlled drugs, but they must be stored separately. To provide additional security, controlled drugs should be kept in a lockable box within the fridge and access should be restricted.
Disposing of controlled drugs
You should separate unwanted or out-of-date controlled drugs from current stock and store in line with your policy. In care homes without nursing, store them in the controlled drugs cupboard until they are returned to the community pharmacy for destruction.
Make a record in the controlled drugs register. This should be signed by the person making the entry and another suitably trained person as a witness.
Care homes without nursing
All medicines, including controlled drugs, must be promptly returned to a community pharmacy. Pharmacies are contractually obliged to dispose of medicines waste for care homes without nursing and you do not require a T28 waste exemption as the pharmacy will denature the controlled drugs.
Good practice involves one member of staff to make the record of controlled drug destruction in the controlled drugs register and a second member of staff to check and sign the record. This helps to verify that the register is accurate. Make sure to record the new stock balance. Some pharmacists will sign the register to acknowledge receipt. This is not a legal requirement.
Care homes with nursing – people's own controlled drugs
People’s own individually labelled controlled drugs (Schedules 2, 3 and 4 (Part I)) must be denatured before handing to the waste disposal company. The Environment Agency classes this as processing waste. Care homes with nursing will need to apply for a T28 waste exemption. This is free of charge.
Good practice involves one member of staff to make the record of controlled drug destruction in the controlled drugs register and a second member of staff to act as a witness and check and sign the record. Make sure to record the new stock balance.
Care homes with nursing - stock controlled drugs
You must denature out-of-date stocks of controlled drugs in Schedules 2, 3 and 4 (Part I).
You must destroy Schedule 2 stock in the presence of an authorised witness. This includes a police constable or inspectors of the General Pharmaceutical Council. The lead NHS England controlled drugs accountable officer may also appoint authorised witnesses.
You also need to record details of the destruction in your controlled drugs register. It is good practice for another member of staff to witness the denaturing of stock in Schedules 3 and 4 (Part I).
Medicinal and food grade cannabis products
Cannabis-based products for medicinal use (CBPMs) are controlled drugs. This means they can only be prescribed by a specialist doctor. They must have specialist knowledge and expertise and they must be on the specialist register of the General Medical Council.
People can buy food grade cannabis products over the counter (for example cannabidiol, CBD and hemp oil products) as food supplements. These products are not medicines and therefore cannot make health claims. As with other over-the-counter products, care home staff should take medical advice if people want to use food grade cannabis products. This is in case there are any issues, for example, interactions with prescribed medicines. A GP would not usually have to authorise the use of food grade cannabis products. But if a GP is involved, this could reduce any risks to the person concerned.
If people bring in food grade cannabis products for their own (or a relative's) use, the service must do its own risk assessment.
Supply of medicines for end of life care
NHS England advises that care homes should not routinely hold anticipatory medicines stock. Commissioners may make local arrangements for medicines to be readily available when needed. This could be from a community pharmacy, GP practice, hospital or other settings.
NHS England publishes a regular bulletin. It provides updates for teams across general practice, dentistry, community pharmacy and optometry.