How should medication/drugs be stored correctly in a Care Home?

Controlled Drugs (CDs) in care homes require the strictest standards of management due to their potential for misuse and dependence, and the need to comply with the Misuse of Drugs Regulations 2001 and related legislation.

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.

Not adhering to medication storage guidelines, particularly for Controlled Drugs, presents several serious risks:

Risk of Theft, Misuse, or Diversion: The primary danger with CDs is the risk of them being stolen for illegal use or to feed an addiction. This compromises the safety of both the residents and the staff, and constitutes a criminal offense.

Resident Harm from Medication Errors: Improper storage can lead to medication errors, such as:

• Giving the Wrong Medication or Dose: If drugs are mixed up, poorly organised, or mislabelled due to incorrect storage.
• Reduced Effectiveness (Compromised Efficacy): Medicines that require specific storage conditions (e.g., refrigeration, protection from light, or temperature control) may degrade or lose their potency if stored incorrectly.

Accidental Overdose or Toxicity: Unsecured access could allow a resident to self-administer excessive amounts, leading to severe illness, overdose, or death.

Legal and Regulatory Non-Compliance: Failure to comply with the Misuse of Drugs Regulations and CQC requirements can lead to:

• CQC Enforcement Action: This can range from warnings and conditions to suspension or cancellation of the care home's registration.
• Criminal Prosecution: For staff or the registered person involved in a serious breach of CD laws.
• Reputational Damage: Significant negative publicity and loss of public trust.

References:

https://www.nice.org.uk/guidance/ng46/resources/controlled-drugs-safe-use-and-management-pdf-1837456188613 (April 2016)

The process for receiving and storing Controlled Drugs (CDs), particularly those that require secure custody, involves stringent protocols, often requiring two trained and competent members of staff to witness and sign for each step for verification.

Receiving the Controlled Drug
1. Check Delivery and Documentation:

• Ensure the medication packaging is intact and the tamper-evident seals (if present) are unbroken
• Verify the medicine against the accompanying documentation (e.g., the prescription and/or dispensing label). Check the resident's name, the name of the drug, the form, the strength, and the quantity.

2. Count the Quantity Received:

• Count the exact quantity of the CD (e.g., tablets, capsules, ampoules) received.

3. Registering Drugs Received:

• Immediately enter the receipt details into the Controlled Drug Register (which must be a dedicated, bound book with numbered pages).
• The entry must include the date of receipt, the resident's name, the quantity received, and the supplier's name (usually the pharmacy).
• Two staff members must check the physical stock and the register entry, and both must sign to confirm accuracy.

Storing the Controlled Drug

1. Secure Storage:

• Immediately place the CD into the Controlled Drug Cabinet/Safe.
• The CD Cabinet must be a fixed, double-locked metal cupboard that complies with the Safe Custody Regulations.

 
2. Separate Storage for Individual Residents:

• CDs prescribed for individual residents should be stored separately from those belonging to other residents.

3. Key Control:

• Ensure the CD cabinet is securely locked.
• The keys must be kept secure, usually on a separate holder from other keys, and under the control of a designated, authorised person (e.g., the Nurse in Charge). Access must be restricted to authorised personnel only.

4. Refrigeration Requirements:

• If the CD requires refrigeration (e.g., certain injections or liquids), it must be stored in a locked refrigerator or in a lockable container within a dedicated locked medicines refrigerator.

Stock Checks and Audits
 

1. Regular Balance Checks:

• Check the physical stock balance of the CD against the running balance recorded in the CD Register every time the drug is administered (Schedule 2).
• Two members of staff should perform this check and record it on the Medication Administration Record (MAR) Chart and in the CD Register.

This is the critical step to prevent or quickly identify any discrepancies or loss.

2. Periodic Audits:

• Conduct regular (e.g., weekly, monthly, or at shift changes, as per policy) full audits or stock checks of all CDs.
• Any discrepancies, losses, or errors must be investigated, recorded, and reported immediately to the manager, the prescriber, the police (if loss or theft is suspected), and the NHS Controlled Drugs Accountable Officer (CDAO).

Sources: 

https://www.cqc.org.uk/guidance-regulation/controlled-drugs/controlled-drug-accountable-officers (September 2025)

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/214915/15-02-2013-controlled-drugs-regulation-information.pdf (February 2013)

Which Controlled Drugs need to be Refrigerated?
 

Not all Controlled Drugs require refrigeration; only those whose manufacturer's instructions or Summary of Product Characteristics (SPC) specify storage at a lower temperature (typically 2∘C to 8∘C) need to be kept in a fridge.

Do Schedule 3 Drugs need to be recorded in the CD Register?
 

Legally, no, most Schedule 3 Controlled Drugs are exempt from the requirement to be recorded in the CD Register. However, best practice/good practice guidance strongly recommends that all Schedule 3 CDs (e.g., Tramadol, Midazolam, Gabapentin, Pregabalin) are recorded in the CD Register to maintain a robust audit trail, improve accountability, and reduce the risk of misuse, theft, or diversion.
 

What should happen if a discrepancy in the CD count is found?

If a discrepancy (a difference between the physical stock count and the CD Register balance) is found, the following steps should be taken immediately:

1. Do Not Amend the Register: Do not make any changes to the running balance in the CD Register until the investigation is complete.
2. Re-count and Verify: The two staff members should immediately re-count the CD stock and carefully re-check all previous entries and calculations in the CD Register.
3. Investigate: The discrepancy must be investigated promptly to determine the cause (e.g., miscalculation, incorrect administration recording, or potential diversion/theft).
4. Report: The discrepancy must be reported immediately to the Care Home Manager and the NHS Controlled Drugs Accountable Officer (CDAO). If theft or significant loss is suspected, the Police must also be informed without delay.
5. Document: All details of the discrepancy, the investigation, the outcome, and the reporting process must be thoroughly documented in an incident report and cross-referenced in the CD Register.

References:
https://www.cqc.org.uk/guidance-providers/adult-social-care/controlled-drugs-care-homes#:~:text=You%20should%20separate%20unwanted%20or,in%20the%20controlled%20drugs%20register (January 2025)

The stringent control of drugs, especially Controlled Drugs (CDs), in care homes is paramount for three main reasons: resident safety, legal compliance, and maintaining public trust. Strict storage rules (such as double-locked cabinets) and meticulous record-keeping (like the CD Register, requiring two-person checks) prevent dangerous errors, stop theft or diversion of potent medications, and ensure residents receive the correct treatment safely. Failure to adhere to these robust regulations can lead to serious harm, regulatory enforcement action by the CQC, and potential criminal charges, all of which severely erode the integrity of the care provided.