A1 Medicine storage meets national guidance and regulatory requirements. Governance arrangements are established using the four principles (see section 3.3) and audit trails are in place to underpin the storage of medicines.

A2 A risk management approach determines storage systems which reduce the risk of accidental access as well as unauthorised intentional access, whilst balancing the need for urgent or immediate access in clinical emergency situations.

A3 The storage of Schedule 2 controlled drugs (and where appropriate Schedule 3) meets the minimum requirements specified in legislation (where applicable) and prevents unauthorised access.[69]

A4 Cupboards and closed storage units in which medicines are stored and/or the rooms that accommodate these are lockable and locked when not being accessed.

A5 Medicines with differing routes/methods of administration, or which look alike/sound alike[70] are stored separately or segregated to minimise selection errors. Risk assessments consider the latest national[71],[72] and local safety guidance to further segregate medicines at high risk of selection and/or administration error.

Examples include, but are not limited to:

  • potassium chloride concentrate solutions
  • organ perfusion fluids
  • high strength opiates
  • epidurals separately from intravenous infusions.

A6 Medical gases in cylinders are stored safely and securely[73] to mitigate the following health and safety and diversion risks:

  • cylinders are heavy and can cause severe injuries if mishandled
  • cylinders contain compressed gas at high pressure and can cause severe injury or death if damage leads to sudden escape of gas
  • oxygen supports combustion and increases the risk of fire
  • other gases may cause suffocation if used inappropriately or may be subject to theft, diversion and abuse.

A6.1 Small size medical gas cylinders (e.g. size C, CD) are stored horizontally on shelves or in wall-mounted fittings. Larger cylinders are stored in a cage or secured to a fixed structure by a safety chain, at all times. When transported in vehicles such as ambulances, cylinders are secured appropriately so they cannot move in transit.[74]

A7 Areas where oxygen is stored or used display appropriate signage.[75]

A8 All medicines, including intravenous fluids and frequently used small volume injections in ampoules (such as dental cartridges, sodium chloride 0.9% and water for injection) are stored in their original packaging and not loose or decanted. Where this is not possible, risk assessments are undertaken and reviewed regularly.

A9 Non-medicines and chemicals such as disinfectants, diagnostic reagents (including those for urine testing), non-medicated dressings and dietary supplements, that may be accessed by people who would not otherwise have access to medicines are stored separately from medicines.

A10 Cupboards for the storage of medicines comply with the current British Standard 2881.

A10.1 Locks for cupboards (except patients’ medicine cabinets/lockers) comply with the current British Standard as a minimum. The current British Standard is BS 3621.

A11 Bulk flammable solutions are stored in lockable metal cupboards. A risk assessment is undertaken to determine whether a fire-resistant cabinet is required – this may not be required for small quantities in clinical areas.

A12 Access is controlled (by key or other means) to cupboards, trolleys and rooms where medicines are stored.

A12.1 Risk assessments are undertaken to determine the number of key copies and safe custody arrangements for these that are appropriate for the healthcare setting.

A12.2 Electronic locking systems that secure areas used to store medicines may use electronic keys, swipe cards or fingerprint and other technology that open the lock and lock immediately on closing the door. These systems allow cards or keys to be allocated to individual authorised persons, enabling audit of access to take place. Standard keypads where a number is shared with multiple users are not suitable for medicine cupboards.[76] Where key pads are used on entry doors, the codes are changed at appropriate intervals subject to local risk assessment.

A13 Requirements for electronic medicines storage, issuing and locking systems are agreed locally. Issues such as access to power supply, IT connectivity and power failure back-up systems are considered where appropriate.

A14 Medicine trolleys are lockable and secured at an anchor point (i.e. a point at which trolleys can be secured to the floor or wall) when not in use. Alternatively, medicines trolleys may be stored securely in a locked room when not in use if access to the room is restricted to authorised persons.

Storage of patients’ own drugs

A15 All patients’ own medicines are stored securely.

A16 The level of security to be applied in the storage of patients’ own drugs, including controlled drugs, and the way in which this is achieved, is balanced against the need to ensure timely access to medicines when they are required.

A17 Where a personal locker/cabinet is used, a risk assessment determines the number of keys (or key cards/key fobs etc) available and responsibility for the master key.

Storage and access arrangements of medicines for clinical emergency[77]

A18 Storage arrangements allow for immediate access to critical medicines in the event of a clinical emergency, e.g. cardiac arrest or anaphylaxis. For further information on theatre settings see Appendix C: Operating theatres.

A19 These critical medicines are ready to administer preparations wherever possible and are held in containers, e.g. resuscitation boxes or crash carts/trolleys, which are tamper-evident, labelled appropriately, and clearly marked ‘for emergency use’. The locations of containers are clearly signposted.

A20 Unless a risk assessment has defined otherwise (e.g. in mental health units), containers are tamper-evident and are not held in locked cupboards or rooms, but at strategic and accessible sites.

A21 Policies and procedures are in place to ensure that boxes or crash carts/trolleys for clinical emergencies are maintained. This includes replacing used items as soon as possible, checking and replacing expired or damaged items, and defining who is responsible.

A22 Policies and procedures are in place to manage the risks of theft of and tampering with these medicines.

Temperature control

A23 Medicines are stored under conditions that assure their quality until they are used or administered including during transportation.

A24 A risk management approach is taken to determine suitable storage arrangements and monitoring requirements depending on individuals’ needs, the type and range of medicines stored, the length of time that medicines will be stored and local environmental factors including ambient room temperature.

A25 Any decision to store a medicine or use a medicine which has been stored outside the manufacturer’s recommended temperature range is fully risk assessed. Specific guidance is available for vaccines.[78]

A26 There is a policy in place, and procedures that outlines the actions to be taken if there is a temperature excursion outside the range specified for the medicines being stored and assurance that the procedure is followed.

A27 For items that require refrigeration or freezing, the equipment used is designed for the storage of medicines and conforms to current guidance.[79],[80],[81],[82]

A28 The temperature of the refrigerator or freezer is monitored on each working day using a calibrated maximum-minimum thermometer or other approved monitoring device and a recording system is in place. This may be a fully automated system, or a manual reading which is recorded by the person who monitors the temperature.

A29 Staff reading the temperature are trained to ensure correct readings are recorded and that they understand how to reset thermometers where relevant. Where staff reading the temperature find that it is outside the accepted range they are aware of the actions to be taken to report and address this.

A30 Refrigerators and freezers are not overloaded to allow air circulation and medicines are not stored in contact with the sides or bottom of the refrigerator/freezer.

A31 Refrigerators and freezers are locked when not in use.

A32 Steps are taken to ensure that refrigerators and freezers are not accidently switched off.

A33 Refrigerators and freezers used for the storage of medicines are not used to store any other items.

[81] Medicines and Healthcare products Regulatory Agency. (2017). Rules and Guidance for Pharmaceutical Distributors.

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