Plain-English explanations of the technical terms and legislation used in this document.
- Accredited service
- A service provider that has been formally approved to a recognised standard to carry out work such as servicing or calibration.
- Adjunct
- An additional medicine or product used to support a main treatment.
- Adverse incident
- Any unexpected or unwanted event linked to care or treatment that harms, or could harm, a patient.
- Batch number
- A code identifying the specific production run of a medicine, used to trace and recall stock if needed.
- Botulinum toxin
- A prescription-only injectable medicine, used in aesthetic and clinical treatments, that must be kept refrigerated to remain safe and effective.
- Calibration
- Checking and adjusting a measuring device, such as a thermometer, against a known standard so its readings can be trusted.
- Cold chain
- The unbroken run of refrigerated storage and handling that keeps a product within its safe temperature range from manufacture through delivery to use.
- Contemporaneous
- Recorded at the time the event happened, or as soon as possible afterwards, so the record is accurate and reliable.
- Data logger
- An electronic device that records temperature continuously over time and can raise an alarm if readings go out of range.
- Decontamination
- The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
- Efficacy / effectiveness
- How well a medicine produces the intended result when used correctly.
- Falsified medicine
- A medicine that has been deliberately and fraudulently misrepresented, for example a fake product or one with a false source or contents.
- Formulation
- The particular form a medicine comes in, such as a solution, powder or pre-filled syringe.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
- The regulations setting the fundamental standards that providers of regulated care must meet, enforced by the Care Quality Commission.
- Human Medicines Regulations 2012
- The main United Kingdom law governing the licensing, supply, storage and handling of medicines for human use.
- Maximum/minimum thermometer
- A calibrated thermometer that shows the highest and lowest temperatures reached since it was last reset, as well as the current temperature.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- The United Kingdom body that regulates medicines and medical devices and issues guidance on their safe handling and storage.
- Near miss
- An event that could have caused harm but did not, by chance or because it was caught in time.
- Pharmaceutical / clinical waste
- Waste from medicines and healthcare activities that must be segregated and disposed of safely under waste-handling rules.
- Prescription-only medicine (POM)
- A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
- Quarantine
- Setting affected stock aside and clearly marking it so it cannot be used until a decision on its safety has been made.
- Regulated activity
- A type of care or treatment the law requires a provider to register with the regulator to deliver.
- Regulation 12 (Safe care and treatment)
- The part of the regulated-activities regulations requiring care and treatment to be provided in a safe way, including the safe management of medicines.
- Registered Manager
- The person registered with the regulator as responsible for the day-to-day running of a service.
- Standard Operating Procedure (SOP)
- A written set of step-by-step instructions that staff must follow to carry out a task safely and consistently.
- Stock rotation (first-to-expire, first-out)
- Arranging stock so the items with the nearest expiry date are used first, reducing waste and the risk of using expired products.
- Summary of Product Characteristics (SmPC)
- The manufacturer's licensed information for a medicine, including how it must be stored and used.
- Temperature excursion
- Any recorded temperature outside the required 2 to 8 degrees Celsius range, or any reading suggesting the range may have been breached.
- Thermostat
- The control that sets and maintains the target temperature inside a refrigerator.
- Validated alternative store
- A backup storage method, such as a cool box with conditioned ice packs, that has been checked to keep stock within the required temperature range.
- Wholesaler
- A licensed business that supplies medicines in bulk to pharmacies and healthcare providers.