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Controlled drugs in care homes
The Misuse of Drugs Act 1971 places controls on certain medicines. We call these 'controlled drugs'.
The Misuse of Drugs Regulations 2001 split controlled drugs into five schedules. The schedules correspond to therapeutic usefulness and misuse potential. 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 in your controlled drugs register. Common examples include morphine, diamorphine, methadone, fentanyl, alfentanil, oxycodone, methylphenidate, dexamphetamine, ketamine and tapentadol.
Some services may choose to store controlled drugs in other schedules in the controlled drugs cupboard and record them in the controlled drugs register. You should always follow your service medicines policy.
You do not need to record schedule 3 drugs in the controlled drugs register. You must store certain schedule 3 drugs in the controlled drugs cupboard. This includes, for example, buprenorphine and temazepam.
There are other schedule 3 drugs that you do not need to store in the controlled drugs cupboard. Common examples include midazolam, pregabalin, gabapentin, tramadol and barbiturates (phenobarbitone).
You do not need to store schedule 4 and 5 medicines in the controlled drugs cupboard. You do not need to record them in your controlled drugs register. Examples include morphine sulfate solution (Oramorph®) 10mg/5mL, zopiclone, codeine and benzodiazepines.
Policies and procedures
You must have a policy or standard operating procedure which details how you manage controlled drugs within your service. This should cover the ordering, storing, administering, recording and disposal of controlled drugs. It should include what to do if there's a discrepancy and 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. We publish a register of their contact details. 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 must:
- be bound (this may be in the form of a separate bound booklet for each preparation)
- have separate sections for each class of controlled drugs - within this each formulation and strength should be recorded on a separate page
- have the name, form and strength of the drug specified at the top of each page.
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 end of life care. 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 stocks of 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.
For good practice, two staff members should witness and sign when:
- receiving controlled drugs stock
- checking stock balances
- administering controlled drugs disposing of controlled drugs.
Both staff members involved in the process should be trained and competent to do so.
Keep detailed records when administering topical controlled drugs, for example, 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 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
For safe practice, use a dedicated cupboard to store controlled drugs. Do not use the controlled drugs cupboard for other drugs.
If an individual is self-administering controlled drugs, a risk assessment should consider where the controlled drugs will be stored.
If you store controlled drugs in a safe, store them in a separate container within the safe. You must also show how the safe complies with the safe custody regulations.
Controlled drugs cupboard
The cupboard must meet British Standard BS2881:1989 security level 1. The Safe Custody Regulations specify the quality, construction, method of fixing, and lock and key for the cupboard.
The controlled drugs cupboard must be:
- secured to a wall and fixed with bolts that are not accessible from outside the cupboard
- fitted with a robust lock
- made of metal with strong hinges.
Location of the controlled drugs cupboard
The cupboard should be in a suitable location.
The walls of the room should be of a suitable thickness and made of a suitable material, for example bricks. This means that the cupboard must be securely fixed to a wall. You can fix the cupboard to an internal wall as long as it is secure.
You do not need to store the controlled d cupboard within another cupboard.
Restricting access to the controlled drugs cupboard
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.
Refrigerating controlled drugs
If a controlled drug has safe custody requirements and requires refrigeration, then 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 meeting the safe custody requirements that require refrigeration need to be stored in a standard medicines’ fridge.
You can store other medicines in the same medicines’ 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. Store them in line with your policy.
Care homes without nursing
In care homes without nursing, controlled drugs should be promptly returned to a community pharmacy. Maintain appropriate records.
Care homes with nursing (patient’s own controlled drugs)
In care homes with nursing, patients' own individually labelled controlled drugs in schedules 2, 3 and 4 (Part I) must be denatured before handing to the waste disposal company. Good practice involves two staff members - one to denature and one to witness. The Environment Agency classes this as processing waste. The nursing home will need to apply for a T28 waste exemption. This is free of charge.
Care homes with nursing (stock)
When the Home Office grants a licence for a Care home with nursing to hold a stock of 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 controlled drugs accountable officer of NHS England 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 their own risk assessment.
The coronavirus pandemic and end of life care
During the coronavirus pandemic, there have been calls for care homes to be able to keep anticipatory medicines for end of life care. These would be intended for use when a normal supply might not be possible. For example, this could be out of hours or at the weekend. The decision to place medicines in care homes as anticipatory stock needs to be balanced with the impact of increased demand on the medicines supply chain.
NHS England advise that care homes should not routinely hold anticipatory medicines stock. And supplies should be centralised as much as possible. Some Clinical Commissioning Groups (CCGs) have already established local hubs to ensure safe, legal and rapid access to anticipatory medicines. These hubs could be a community pharmacy, GP practice, hospital or other settings.
The CCG medicines optimisation teams are central to this action. CCGs should work with providers and healthcare partners to ensure rapid access to end of life medicines for people in care homes.
NHS England publishes a regular bulletin. It provides updates for teams across general practice, dentistry, community pharmacy and optometry.
Find out more in COVID-19: Primary Care Bulletin - 9 April 2020.
- Last updated:
- 01 April 2021