Risk assessment

Medicines Storage Risk Assessment

Safe storage, security, temperature control and handling of medicines across all clinical and storage areas

For Private Healthcare ClinicRef BS-PH-RA-004See a sample (PDF) →
£44.99
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  • Instant download after checkout
  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This risk assessment is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Scope and purpose
  • 2. Legal and regulatory framework
  • 3. Risk assessment methodology
  • 4. Hazards, controls and risk rating
  • 5. Action plan
  • 6. Monitoring and review
  • 7. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - in particular Regulation 12 (Safe care and treatment) and Regulation 17 (Good governance)
  • Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations 2001 (as amended)
  • Misuse of Drugs (Safe Custody) Regulations 1973 (as amended)
  • The Human Medicines Regulations 2012 (as amended)
  • The Controlled Drugs (Supervision of Management and Use) Regulations 2013
  • Health and Safety at Work etc. Act 1974 and the Management of Health and Safety at Work Regulations 1999
  • Control of Substances Hazardous to Health Regulations 2002 (COSHH)
  • National Institute for Health and Care Excellence (NICE) guideline NG5 (Medicines optimisation) and guideline SC1 (Managing medicines in care homes)

Who it applies to

All registered managers, nurses, prescribers, healthcare assistants, pharmacy leads, facilities and housekeeping staff, and any worker involved in the ordering, receipt, storage, transport, administration or disposal of medicines at [Organisation Name].

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Accountable Officer (Controlled Drugs)
The senior person responsible for the safe, appropriate and lawful management of Controlled Drugs within an organisation.
Anticoagulant
A medicine that thins the blood and reduces clotting, which carries a high risk of harm if it is given incorrectly.
Biologic
A medicine made from living cells or organisms that often needs careful temperature-controlled storage.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Controlled Drug (CD)
A medicine whose supply, storage and records are tightly restricted by law because of its potential for misuse.
Controlled Drugs Local Intelligence Network (CDLIN)
A local network that shares information and concerns about the safe management of Controlled Drugs between organisations.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Cytotoxic medicine
A medicine, often used in cancer treatment, that is toxic to cells and requires special handling to protect staff.
Diversion
The theft or redirection of medicines, especially Controlled Drugs, away from their proper and lawful use.
First-expiry-first-out (FEFO)
A stock rotation method that uses the items with the earliest expiry date first to reduce waste and avoid using out-of-date stock.
General sales list medicine
A medicine that can be sold to the public without a prescription or pharmacist supervision.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations that set the fundamental standards providers of regulated care must meet, enforced by the Care Quality Commission.
High-risk medicine
A medicine that is more likely to cause serious harm if it is used in error, so it needs extra storage and handling safeguards.
Human Medicines Regulations 2012
The main law governing the sale, supply, labelling and handling of medicines for human use in the UK.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Likelihood
How probable it is that a hazard will actually cause harm, scored as part of a risk rating.
Look-alike / sound-alike (LASA)
Medicines whose names or packaging are similar enough to be confused with one another, increasing the risk of selection errors.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates medicines and medical devices and issues safety alerts about them.
Misuse of Drugs Act 1971
The law that classifies dangerous or harmful drugs and controls their possession, supply and production.
Misuse of Drugs Regulations 2001
The regulations that set out how Controlled Drugs may be lawfully possessed, stored, supplied and recorded, grouped into schedules.
Misuse of Drugs (Safe Custody) Regulations 1973
The law that sets the security and storage standards, such as cabinet construction, for certain Controlled Drugs.
National Institute for Health and Care Excellence (NICE)
The body that produces evidence-based guidance and standards for health and care in England.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Pharmacy medicine
A medicine that can be sold without a prescription but only under the supervision of a pharmacist.
Potassium chloride concentrate
A strong electrolyte solution that can be fatal if given undiluted, so its storage is tightly restricted.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Quarantine (stock)
Setting aside expired, recalled or damaged stock in a separate area so it cannot be used by mistake.
RCD-protected socket
An electrical socket fitted with a residual current device that cuts the power quickly if a fault is detected, reducing the risk of electric shock or fire.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Registered Provider
The organisation or person legally registered with the regulator to carry out a regulated activity.
Regulation 12 (Safe care and treatment)
The regulation requiring care and treatment, including medicines management, to be provided in a safe way for the people using the service.
Regulation 17 (Good governance)
The regulation requiring providers to have effective systems to assess, monitor and improve the quality and safety of their services.
Residual risk
The level of risk that remains after the existing controls have been put in place.
Risk assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Schedules 2 to 5 (Controlled Drugs)
The legal categories that group Controlled Drugs by how strictly their storage, supply and record-keeping are regulated.
Patient
A person who receives care or treatment from the service; also referred to in legislation as a service user.
Severity
How serious the harm would be if a hazard caused an injury or loss, scored as part of a risk rating.
Single assessment framework
The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
Standard operating procedure (SOP)
A written, step-by-step instruction that staff follow to carry out a task safely and consistently.
Tall-man lettering
Writing part of a medicine name in capital letters to highlight the differences between look-alike or sound-alike names and reduce errors.
Yellow Card scheme
The UK system for reporting suspected side effects of medicines and problems with medical devices to the Medicines and Healthcare products Regulatory Agency.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

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