Plain-English explanations of the technical terms and legislation used in this document.
- Batch number
- A code on a medicine pack that identifies the production run it came from, so a specific group of products can be traced and recalled if needed.
- Care Quality Commission (CQC)
- The independent regulator of health and social care services in England.
- Cold chain
- The unbroken system of refrigerated storage, monitoring and transport that keeps a medicine within its safe temperature range, usually 2 to 8 degrees Celsius, all the way from the supplier to the patient.
- Cold-chain excursion
- Any time a refrigerated medicine goes outside its allowed temperature range, or stays out of the fridge for longer than permitted, whether in storage or in transit.
- Conditioned coolant
- Ice or gel packs that have been brought to the correct temperature before packing, so they keep a parcel cool without freezing the medicine.
- Contemporaneous record
- A note written at the time an action is carried out, rather than from memory later, so the record is accurate and reliable.
- Controlled drug
- A medicine whose supply, storage and records are tightly restricted by law because of its potential for misuse.
- Decontamination
- The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
- Dispensing
- Preparing and supplying a medicine to a named patient against a valid prescription.
- General Pharmaceutical Council (GPhC)
- The body that registers and regulates pharmacists, pharmacy technicians and pharmacies in Great Britain.
- GLP-1 receptor agonist
- A type of injectable weight-management medicine (glucagon-like peptide-1 receptor agonist) that is usually supplied refrigerated and can only stay out of the fridge for a limited time.
- Good Distribution Practice
- The agreed standards for storing, transporting and handling medicines so their quality is protected from the manufacturer to the patient.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
- The regulations setting the fundamental standards that providers of regulated health and care must meet, including Regulation 12 on safe care and treatment.
- Human Medicines Regulations 2012
- The main United Kingdom law governing how medicines for people are licensed, supplied, sold and labelled.
- In-use stability window
- The limited period a medicine may safely be kept out of the fridge once it has been removed, as set out in its Summary of Product Characteristics.
- Infection prevention and control (IPC)
- The measures used to stop infection spreading between patients, staff and visitors.
- Licensed wholesaler
- A company that holds an official authorisation (a wholesale dealer's licence) allowing it to buy and supply medicines in bulk in the United Kingdom.
- Maximum and minimum thermometer
- A thermometer that records the highest and lowest temperatures reached since it was last reset, used to confirm a fridge stayed within range overnight.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- The United Kingdom body responsible for regulating medicines and medical devices, including storage and temperature guidance, recalls and safety alerts.
- Near miss
- An event that could have caused harm but did not, by chance or because it was caught in time.
- Patient information leaflet
- The printed leaflet supplied with a medicine that explains how to use and store it safely and what side effects to watch for.
- Prescriber
- A health professional legally allowed to authorise a medicine for a patient, such as a doctor, or a nurse or pharmacist with prescribing qualifications.
- Prescription-only medicine (POM)
- A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
- Quarantine
- Keeping suspect, recalled, expired or returned stock clearly separated so it cannot be supplied until a decision is made about it.
- Reconciliation
- Checking that the amount of stock recorded matches the amount physically present, and investigating any difference.
- Registered manager
- The person registered with the regulator as responsible for the day-to-day running of a service.
- Registered pharmacy
- A pharmacy registered with the General Pharmaceutical Council and supervised by a responsible pharmacist.
- Responsible pharmacist
- The pharmacist legally in charge of the safe and effective running of a pharmacy at a given time.
- Risk assessment
- A structured check identifying what could cause harm and what is being done to prevent it.
- Sharps
- Needles, blades and other items that can cut or puncture the skin.
- Sharps bin
- A puncture-proof container for safely throwing away used needles and other sharp items.
- Standard Operating Procedure (SOP)
- A written, step-by-step instruction describing how a particular task is to be carried out consistently and safely.
- Stock rotation
- Arranging and using stock so that items closest to their expiry date are supplied first.
- Summary of Product Characteristics (SmPC)
- The official document for each licensed medicine that sets out, among other things, its approved use, dosing, storage conditions and shelf life.
- Titration
- Gradually adjusting the dose of a medicine, usually building it up in steps, to reach the right level for a patient.
- Validated cold-chain packaging
- Insulated packaging with coolant that has been tested to keep its contents within 2 to 8 degrees Celsius for a set time and conditions, used for posting refrigerated medicines.
- Wholesale dealer's authorisation
- The official licence a company must hold to lawfully buy, store and supply medicines wholesale in the United Kingdom.