Controlled drugs in care homes: the register, the witness and the audit

Controlled drugs in care homes are governed by the Misuse of Drugs Regulations 2001 and the safe custody rules that sit alongside them, with NICE guideline SC1 and CQC guidance setting out what good practice looks like. In practice that means a locked CD cabinet, a bound CD register with a running balance, a second person witnessing every administration, regular balance checks, and a clear route for reporting anything that does not add up. None of it is complicated. All of it has to be done every time.

The short answer

A controlled drug is a medicine listed in the schedules to the regulations because of its potential for misuse. In a care home the ones you will meet are mostly opioid painkillers such as morphine, oxycodone and fentanyl, and some sedatives such as temazepam and midazolam. The home must store them in a cabinet that meets the safe custody standard, record every receipt, dose and disposal in a register with a running balance, have a second trained person witness and countersign each administration, check the balance against the register regularly, and investigate and report any discrepancy. The witness is not strictly required by law in every setting but it is expected by NICE and CQC and no sensible manager runs without it. The rest of this guide goes through each of those steps as a manager would.

What counts as a controlled drug

The regulations sort controlled drugs into five schedules. Schedule 1 covers drugs with no medical use and will not appear in a care home. Schedule 2 is the group that carries the full set of requirements: morphine, diamorphine, oxycodone, fentanyl, methadone, methylphenidate and others. Schedule 3 includes temazepam, buprenorphine, midazolam, tramadol, gabapentin and pregabalin, with lighter requirements and some variation about which need safe custody. Schedule 4 covers most benzodiazepines such as diazepam and lorazepam, and the z-drugs. Schedule 5 covers low-strength preparations such as codeine linctus and co-codamol.

The practical point for a manager is that the strict rules about the register, the cabinet and the witness apply to Schedule 2 and to those Schedule 3 medicines that the regulations bring within safe custody, such as temazepam and buprenorphine. For the rest of Schedule 3 and for Schedules 4 and 5, the law is lighter, but many homes choose to apply the same controls to some of them, particularly where there is a risk of diversion. Your pharmacist can confirm the schedule of any medicine, and your medicines policy should list which ones your home treats as controlled.

At a glance: schedules and what applies in a care home

The table is a guide, not a substitute for checking. Schedules change, and the regulations have been amended several times in the last decade. When a new medicine arrives, ask the pharmacy which schedule it is in and record the answer.

The law: what the Misuse of Drugs Regulations actually require

The Misuse of Drugs Regulations 2001 set out who may possess, supply and administer controlled drugs and what records must be kept. The Misuse of Drugs (Safe Custody) Regulations 1973 set the standard for the cabinet. Together they are the legal floor. For a care home the main obligations are that Schedule 2 and safe-custody Schedule 3 medicines are kept in a cabinet that meets the standard, that they are only administered by or under the direction of a registered practitioner in line with the prescription, and that records of receipt and administration are kept.

Whether the register is a strict legal requirement depends on the type of service and how the medicines are held. In a nursing home the person in charge holds controlled drugs under the regulations and is required to keep a register. In a residential home the medicines are the resident's own and the position is less clear cut. That distinction is not worth relying on. NICE SC1 and CQC both expect every care home to keep a CD register for Schedule 2 medicines, and most expect it for safe-custody Schedule 3 medicines too. Treat the register as required and you will never be caught out.

The regulations also cover destruction. A care home may not simply throw controlled drugs away. They are either returned to the pharmacy or denatured using an approved kit, and either way the disposal is recorded in the register and witnessed.

What NICE SC1 and the CQC medication administration guidelines say

NICE SC1, the guideline on managing medicines in care homes, is the document inspectors use to judge medicines practice. On controlled drugs it says the home should have a process for receiving, storing, administering, recording and disposing of them, that records should be kept in a CD register, and that a second member of staff should witness administration and countersign. It also expects regular balance checks and a clear procedure for discrepancies.

CQC's own guidance on medicines in adult social care follows NICE and adds the inspection angle. Inspectors will look at the cabinet, open the register, pick a medicine and count it against the running balance, check that the witness signatures are real people who were on shift, and ask what happened the last time a balance was wrong. They will also ask how the home reports concerns to the Controlled Drugs Accountable Officer.

Neither document is long. Every registered manager should have read both and should be able to point to where the home's policy reflects them. If your policy was written before 2014 and has not been reviewed against SC1, it is out of date.

The CD register

The register is a bound book with numbered pages. Loose-leaf folders and spreadsheets are not acceptable because pages can be removed or edited without trace. Each controlled drug for each resident has its own page, and where a resident has the same medicine in two strengths or two forms, each has its own page.

Every entry records the date and time, what happened (received, administered, returned, destroyed), the quantity, the resident's name, the running balance after the transaction, and the signatures of the person making the entry and the witness. Entries are made in ink, at the time, in chronological order. Mistakes are not crossed out or corrected with fluid; they are bracketed, marked as an error, signed and dated, and the correct entry made underneath.

When a page is full, the balance is carried forward to a new page and both pages cross-reference each other. When a resident leaves or dies, the balance is returned or destroyed and the page is closed with the final entry showing zero. Registers are kept for two years from the last entry, and in practice most homes keep them longer.

Storage: the CD cabinet

The cabinet must meet the safe custody standard: metal, fixed to a solid wall or floor, with a lock that meets the specification, and no visible signage that advertises what it holds. A cabinet inside a locked medicines room is normal, but the room lock is not enough on its own. The cabinet holds only controlled drugs, not other medicines, not keys, not cash.

Key security is the point most often found wanting. The keys are held by the person in charge of medicines on that shift, on their person, not in a drawer or on a hook. There is a record of who holds them at handover. A lost key is a security incident, not an inconvenience, and the lock is changed.

Controlled drugs needing refrigeration, which is rare in a care home, go in a locked fridge with the same key control. Controlled drugs sent out with a resident on leave are recorded out of the register and back in on return, with the quantities checked both ways.

Receiving controlled drugs into the home

A delivery of controlled drugs is checked on arrival by two people. They compare the medicine, strength, form and quantity against the delivery note and the prescription, enter the receipt in the register with the running balance, and both sign. The delivery note is kept with the medicines records. Any discrepancy between what was ordered, what the note says and what is in the bag is raised with the pharmacy immediately and recorded.

Receipt is where a surprising number of balance problems begin. The pharmacy sends thirty, the note says twenty-eight, the worker signs for thirty, and six weeks later the count is two short and nobody knows why. Two people counting on the day prevents that.

Administering a controlled drug: the procedure

This is the sequence for a single dose. It takes a minute or two once staff are used to it.

1. Check the MAR chart or eMAR for the dose due, the prescription, and any PRN protocol or parameters.
2. Both the administering worker and the witness go to the cabinet together. Neither handles the medicine alone.
3. Open the register to the resident's page for that medicine and check the running balance against the stock in the cabinet before removing anything.
4. Remove the dose. Check the label, the strength, the form and the expiry against the prescription.
5. Both count the remaining stock and confirm it matches the new balance.
6. Make the register entry: date, time, resident, quantity given, new balance, both signatures.
7. Lock the cabinet, return the keys to the key holder.
8. Administer the dose to the resident, with the witness watching it being taken.
9. Record the administration on the MAR chart or eMAR, with both signatures where the system requires it.
10. If any part of the dose is not taken, record it as refused or destroyed in the register and on the MAR, and dispose of it with the witness.

The register entry is made before the dose is given, not after, so the running balance is never out of step with the cabinet. Some homes record the MAR at the same time; either way both records are made within the same few minutes.

The witness: who and why

The witness is a second person who watches the whole process and countersigns. Their job is to check the count, check the dose against the prescription, and see it given. They are not a signature collected afterwards. The witness must be trained and competent in medicines administration. In a nursing home they are usually another nurse or a senior carer; in a residential or learning disability home they are another trained medicines worker. A cleaner, a visitor or a resident cannot witness.

The witness protects everyone. It makes an honest error much less likely to reach the resident, because two people are checking. It makes diversion much harder, because two people have to collude. And it protects the worker, because a balance that is wrong at the next check can be traced to an entry that two people signed.

On a night shift with one trained worker the home has a problem, and the honest answer is to plan the rota so it does not happen. If it cannot be avoided, the policy must say what the single worker does, and the audit must show how often it happened. An eMAR that requires a second login to witness a controlled drug makes the countersign part of the process rather than something remembered later; Kiwi handles it that way, and so do most good systems.

Recording on the MAR chart and the eMAR

The register records the stock. The MAR chart records the administration. Both are needed, and they must agree. A dose in the register with no MAR entry, or a MAR entry with no register entry, is a discrepancy, and the monthly audit should look for both.

On paper the MAR box carries the administering worker's initials, and many homes add the witness initials alongside. On an eMAR the system records the administering user and the witnessing user with the time, and can carry a running balance that should match the register. Where they differ, the register is the legal record and the eMAR is the evidence of what happened, and the difference must be investigated rather than adjusted. The guide to MAR chart codes explains how refusals and destroyed doses are coded so the two records line up.

Balance checks and how often to do them

NICE expects regular balance checks. Regular is not defined, and what is right depends on the home. In a nursing home with a large stock of opioids, a check at every handover is normal and is what I would expect to see. In a residential home with two residents on temazepam, a weekly check may be enough. The policy sets the frequency and the audit shows it was kept.

A balance check means two people count the physical stock of every controlled drug and compare each count with the running balance in the register, then sign and date the check in the register or in a separate balance check book. Every discrepancy, however small, is recorded and investigated the same day. Do not adjust the register to match the count. Investigate, find the cause, record it, and then correct the register with a signed, dated, explained entry.

Liquids are the exception that needs judgement. Measured volumes drift because of residue in the bottle and the measuring device. A small, consistent shortfall on a liquid is usually explained by that and should be recorded as such, but a shortfall that grows or appears suddenly is not.

When the balance is wrong

The first thing is to stop and think, not to panic and not to cover. Recount with a different second person. Check the register for arithmetic errors, which cause most discrepancies. Check the MAR for a dose given and not entered in the register. Check whether a dose was returned, sent on leave, or destroyed without an entry. Check the delivery note against the receipt entry.

If the cause is found, record it in full: what the discrepancy was, what caused it, who investigated, what was done. Make the correcting entry. Review whether the process needs to change. If the cause is not found, the discrepancy is unexplained and must be reported: to the registered manager and the provider, to the Controlled Drugs Accountable Officer for your region, to CQC by notification if the threshold is met, and to the police if theft is suspected. Safeguarding may also need to be involved if a resident may have been affected.

An unexplained loss that is reported promptly and investigated properly is a serious event handled well. An unexplained loss that is discovered by an inspector is a different matter. The guide to medication errors in care homes covers the investigation process in more detail.

Refused, dropped and part doses

A controlled drug that leaves the cabinet and does not go into the resident still has to be accounted for. If the resident refuses, the dose is destroyed in the presence of the witness, using a denaturing kit or in line with the policy, and the register shows the dose removed, the reason and the destruction with two signatures. The MAR shows the refusal code. The dose is not put back in the pack or the bottle.

A dropped tablet is treated the same way. A part dose, for example half a tablet where the prescription is for half, means the other half is either kept for the next dose in a labelled container, if the policy allows, or destroyed. Either way it is recorded. A liquid dose drawn up and not used is destroyed and recorded.

These events are where balances go wrong most often, because the worker is dealing with a distressed resident and the paperwork feels secondary. Build them into training with worked examples.

Returns and disposal

Controlled drugs that are no longer needed, because the prescription changed or the resident left or died, are removed from the register and either returned to the pharmacy or destroyed in the home. Residential homes generally return them; the pharmacy signs for them and the register records the return with both signatures and the balance going to zero. Nursing homes may denature them in the home using an approved kit, with a witness, and record the destruction.

When a resident dies, their controlled drugs are kept for seven days in case the coroner needs them, and then returned or destroyed. The register entry records the date of death and the disposal.

Expired controlled drugs are disposed of the same way. They are never left in the cabinet, because they inflate the stock and confuse the count.

Patches, liquids and other forms

Fentanyl and buprenorphine patches are controlled drugs and need the same register and witness. Because the patch stays on the resident for days, the record must also show where it was applied, when it was removed, and that the removed patch was folded and destroyed with a witness. A body map in the daily log is the sensible way to record the site and rotation, and a used patch that cannot be found is a discrepancy.

Oral liquids such as morphine sulfate solution are measured with an oral syringe, never a spoon, and the register records the volume in millilitres. Small shortfalls are normal and should be explained in the balance check. Injectable controlled drugs, mostly in nursing homes for end-of-life care, are recorded by ampoule, and a part ampoule is destroyed and recorded.

Residents' own controlled drugs and self-administration

Some residents, particularly in mental health and learning disability services, manage some of their own medicines. That can include a controlled drug where the risk assessment supports it, but it is unusual and the assessment must be specific to that medicine. The home still needs to know what the resident holds, where it is kept, and how the resident's stock is reconciled.

Where the home is holding a resident's own controlled drug, for example one brought in on admission, it is entered in the register on receipt like any other, and the resident's consent to the home holding it is recorded in the care plan.

Social leave and hospital

When a resident goes out for the weekend and takes a controlled drug with them, the quantity sent is entered out of the register with a witness, and the quantity returned is entered back in, with any difference explained by the doses given while away. The family or carer signs for what they took. When a resident goes into hospital, their controlled drugs usually go with them, and the same process applies; anything not returned is chased with the ward and recorded.

These transactions are where the register and the eMAR most often fall out of step, because the leave is arranged in a hurry. A short procedure and a checklist at the door prevent it.

Controlled drugs in learning disability and mental health services

In these services the controlled drugs are more often sedatives than opioids, some of them PRN, some of them part of a positive behaviour support plan for use in crisis. The same register, cabinet and witness rules apply, and the additional discipline is in the PRN protocol: when the medicine may be used, what must be tried first, the maximum in twenty-four hours, and how the outcome is recorded. Every PRN dose of a controlled drug should be reviewable against the protocol, and a pattern of increasing use is a clinical question for the prescriber, not an operational one for the home.

Capacity and consent matter here too. A resident who refuses a controlled drug may be exercising a choice or may lack capacity for that decision, and the care plan must say which and what follows. Restraint to administer a controlled drug is a serious step that needs a lawful basis and is never a routine matter.

The controlled drugs audit

The monthly medicines audit should include a controlled drugs section, and a fuller controlled drugs audit should be done quarterly. Work through this list.

• The cabinet meets the safe custody standard and is locked, and the keys are held by the named person.
• Every controlled drug in the cabinet has a page in the register and every page has a matching item in the cabinet.
• A full count of every item matches the running balance, and the check is signed by two people.
• Every register entry has two signatures from people who were on shift at that time.
• Every administration in the register has a matching MAR or eMAR entry, and vice versa.
• Every refusal, dropped dose and part dose has a destruction entry with a witness.
• Every receipt matches a delivery note and every return matches a pharmacy signature.
• Balance checks have been done at the frequency the policy sets.
• Every discrepancy in the period was recorded, investigated, and where needed reported.
• Staff who administer and witness have current training and competency records.

Record the findings and the actions. The audit trail matters as much as the count. A good audit and evidence system keeps the audits, the actions and the incident records together so the story can be told on the day. The wider medicines audit is covered in the medication audit checklist for managers.

Reporting: CQC, the accountable officer and safeguarding

Every region in England has a Controlled Drugs Accountable Officer, based in NHS England, whose role includes receiving concerns and incident reports from care homes. Unexplained losses, suspected diversion and serious errors go to them, usually through an online form. The home should know who its CDAO is and how to reach them before it needs to.

CQC must be notified of incidents that meet the thresholds in the registration regulations, which includes events that cause harm and events involving the police. A serious controlled drugs incident is usually notifiable. Safeguarding referrals to the local authority follow where a resident may have been harmed. The provider's own incident process runs alongside all of this, and the record should show every report made, with dates.

Training and competency

Every worker who administers or witnesses controlled drugs needs training that covers the schedules, the register, the cabinet, the procedure, the discrepancy process and the reporting route, followed by a competency assessment that includes a real or simulated administration with witness. The record of that training and assessment is kept, reviewed annually, and shown to inspectors.

Agency and bank staff are the weak point. A home that lets an agency nurse administer controlled drugs on their first shift without checking their competency is taking a risk it does not need to take. The induction for any temporary worker includes the CD process, and the home's own staff witness until competency is confirmed.

Common mistakes

• Adjusting the register to match the count. The discrepancy disappears and so does the chance to find out why it happened.
• Witness signing afterwards. The second signature is collected at the end of the round, so nobody actually watched.
• Keys in a drawer. Anyone in the medicines room can open the cabinet.
• Register entries made after the dose. The balance is wrong between the dose and the entry, and interruptions mean some entries are never made.
• Refused doses put back in the pack. The balance is right but the dose has been handled and is no longer fit to give.
• Expired stock left in the cabinet. It inflates the count and confuses every check.
• Patches not tracked. Nobody knows where the last one was or whether it was removed.
• No CDAO contact. The home has an unexplained loss and does not know who to tell.

What good looks like on inspection day

The inspector asks to see the controlled drugs. The nurse in charge and a second worker take them to the cabinet, which is locked, fixed, and unmarked. The keys come from the nurse's pocket. The register is bound, current, and the last balance check was this morning with two signatures. The inspector picks morphine sulfate solution for one resident and asks for a count. Two workers count it and the volume matches the balance within the small tolerance the policy allows for liquids, and the policy is shown.

The inspector picks a register entry from last week and asks to see the MAR entry. It is there, with the same time, the same two names, and both were on the rota. They ask about the last discrepancy. The manager shows the record: a receipt entered as thirty when the note said twenty-eight, found at the next balance check, investigated the same day, corrected with an explained entry, and the receipt process changed so that two people now count on delivery. They ask who the CDAO is and the manager names them and shows the last report made.

That is what inspection-ready evidence looks like for controlled drugs. Not a perfect record, but a complete one, with two names on every line and an honest account of what went wrong and what changed.

Final conclusion

Controlled drugs are a small part of the medicines a care home manages and a large part of the risk. The legal floor is the safe custody cabinet, the register and lawful administration. The practice standard, set by NICE SC1 and expected by CQC, adds the witness, the regular balance check, the discrepancy investigation and the reporting route. Do those things every time, train every person who touches the cabinet, audit the register against the MAR every month, and report what you cannot explain. That is the whole discipline, and it is what keeps residents, staff and the home safe.

Frequently asked

Do care homes legally have to keep a controlled drugs register?

In a nursing home the person in charge holds controlled drugs under the Misuse of Drugs Regulations 2001 and must keep a register. In a residential home the medicines belong to the resident and the legal position is less direct, but NICE SC1 and CQC both expect a CD register for Schedule 2 medicines in every care home. Treat it as required.

Does a controlled drug have to be witnessed in a care home?

The regulations do not require a witness in every setting, but NICE SC1 recommends a second trained member of staff witnesses and countersigns each administration, and CQC inspectors expect to see it. A home that administers controlled drugs without a witness needs a very good reason and a policy that explains it.

How often should controlled drugs be counted in a care home?

NICE expects regular balance checks and leaves the frequency to the home. In nursing homes with a large opioid stock a check at every handover is normal. In residential homes with a small stock, weekly is common. The policy sets the frequency, two people do the count, and the audit shows it was kept.

What should I do if the controlled drugs balance is wrong?

Recount with a different second person, check the register arithmetic, check the MAR for an unrecorded dose, and check receipts, returns and leave. If the cause is found, record it and make a signed, dated correcting entry. If it is not, report it to the manager, the Controlled Drugs Accountable Officer and, where the threshold is met, CQC and the police. Never adjust the register to match the count.

Which medicines are controlled drugs in a care home?

Most commonly opioids such as morphine, oxycodone and fentanyl (Schedule 2), and sedatives such as temazepam and buprenorphine (Schedule 3 with safe custody). Tramadol, gabapentin, pregabalin and midazolam are Schedule 3 without safe custody, and diazepam and lorazepam are Schedule 4. Ask your pharmacist to confirm the schedule of any new medicine.

How are controlled drugs disposed of in a care home?

They are either returned to the pharmacy, which signs for them, or denatured in the home using an approved kit with a witness. Either way the register records the disposal with two signatures and the balance going to zero. After a death, controlled drugs are kept for seven days in case the coroner needs them, then disposed of.

Can a care home keep the controlled drugs register electronically?

The register must be a record that cannot be altered without trace, and most homes keep a bound paper book. Some eMAR systems offer an electronic register and can require a second user to witness. Check with your pharmacist and your inspector before relying on an electronic register alone, and keep the MAR and the register reconciled either way.

Sources

• Misuse of Drugs Regulations 2001
• Misuse of Drugs (Safe Custody) Regulations 1973
• NICE guideline SC1 Managing medicines in care homes
• CQC: medicines guidance for adult social care, including controlled drugs
• Royal Pharmaceutical Society: Safe and secure handling of medicines
• NHS England: Controlled Drugs Accountable Officers and reporting of controlled drug incidents
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12