Patient harm

Adrenal insufficiency can lead to adrenal crisis if not identified and treated. Adrenal crisis is a medical emergency. Individuals at risk of suspected adrenal crisis should be treated immediately. Delayed treatment with hydrocortisone can result in harm including coma, permanent disability and death.

Reports of harm have occurred where individuals in adrenal crisis experienced a delay in treatment with injectable hydrocortisone. Reasons for delay include unavailability of the hydrocortisone injection or components required for injection, poor communication and a lack of guidance.

Clinical use

Adrenal crisis emergency management kits, also known as ‘adrenal crisis kits’, are supplied to individuals at risk of adrenal crisis. They contain hydrocortisone to be administered via intramuscular injection by the individual, their carer or a person with them.

The NICE guideline ‘Adrenal insufficiency: identification and management’ (2024) outlines who the kits should be supplied to, and the quantity for supply.

Several organisations provide useful guidance and resources:

• the Addison’s Disease Self-Help Group has guidance for GPs to support the care of people with Addison’s disease, and resources including videos on emergency injections for the treatment of adrenal crisis
• the Living with CAH and The Pituitary Foundation websites have helpful resources, including videos, about the emergency treatment of adrenal crisis

Individuals with emergency management kits are encouraged to register with their local ambulance service so they can be recorded as potentially needing emergency hydrocortisone.

Management across care boundaries

Healthcare professionals (HCPs) in all care settings need to be involved in providing emergency management kits. Initial supply is often from specialists in secondary care. Follow up is shared between primary and secondary care. Use is predominately outside healthcare settings. Strategies to improve the safe use of emergency management kits require a system wide approach.

Without a national consensus about responsibilities for supply, there are variations and inconsistencies in practice, including within organisations and at transitions of care.

Addison’s Disease Self-Help Group suggests GPs and/or specialist teams may support with prescribing/supplying kit components.

Supply

Practice varies for how organisations pre-prepare and supply emergency management kits/components.

Some organisations purchase kits from external NHS manufacturing units, others make up kits in-house or may supply separate components to individuals.

While some organisations have procedures for the supply of hydrocortisone injections, processes for supply of consumables are less well defined. Some kit components may not be reimbursed when prescribed on FP10s, contributing to the variation in practice.

Risk

Delayed treatment of adrenal crisis, due to unavailability of a kit and/or components, may result from:

• failure to clearly document and communicate the clinical need, and supply arrangements, for emergency management kits at transfers of care
• lack of agreed processes between primary and secondary care regarding supply continuation of emergency management kits and kit components

Poor patient experience may occur if individuals struggle to obtain replacement components for their kit.

Kit components

Previously, there was a lack of clarity and consensus as to what emergency management kits should include.

NICE provides some clarity regarding the contents of emergency management kits. It recommends including:

• intramuscular hydrocortisone injection
• blue (intramuscular) needles x 2
• 2mL syringes x 2
• written instructions on preparation, administration and safe disposal of syringes and needles
• steroid emergency cards
• glucose gel (only for people under 16 years old)
• an orange needle and a 1mL syringe (only for babies under 1 year old)

Intramuscular hydrocortisone

There are two different formulations of hydrocortisone used in emergency management kits:

• hydrocortisone sodium phosphate 100mg/1mL (ready to use), or
• hydrocortisone sodium succinate 100mg powder for solution for injection (requires reconstitution prior to administration)

Water for injection is required for reconstitution if hydrocortisone sodium succinate powder is supplied. Reconstitution adds an additional step for the user.

Some formulations of hydrocortisone sodium succinate include the diluent in the pack, others require the additional supply of diluent.

Consumables

Timely administration of hydrocortisone is dependent on the availability of all consumables necessary. They need to be appropriate for the formulation of hydrocortisone, safe for the individual, and in date.

The size of intramuscular needles provided should be appropriate for the individual.

A sharps disposal box, ‘Amp Snaps’ (for opening glass vials), sterile skin wipes and cotton wool may support safe administration and disposal.

Written instructions

The Addison’s Disease Self-Help Group include example leaflets on their website.

Expiry date

The components, including consumables, of emergency management kits have a range of expiry dates. The individual should have all components of the kit in-date at the point of use.

Risk

There may be delays to timely treatment, and harms, as a result of:

• the inadvertent supply of an incorrect formulation of hydrocortisone, resulting in required diluent/consumables not being available at the point of use
• failure to adapt kit components (including diluents and consumables) following an intentional change in hydrocortisone formulation (for example due to supply disruption)
• failure to provide all required kit components in sufficient quantities
• failures to provide kits with sufficiently long expiry dates, or to replace expired kit components, leading to an in-date kit not being available when needed
• failure to communicate key information following an intentional change in hydrocortisone formulation, leading to confusion at the point of administration
• failure to supply written instructions for the safe and timely preparation/administration of the hydrocortisone formulation supplied

Failure to supply sharps disposal bins may increase the potential for inappropriate disposal and needle stick injuries.

Counselling

Individuals should be able to recognise the symptoms of adrenal crisis and know how they/others should use the emergency management kit. Initial training may come from the individual’s specialist team.

Individuals with adrenal insufficiency will interact with HCPs in all care settings. Where appropriate, HCPs should check individuals and/or their carers are aware of, and able to:

• use their emergency management kit
• check the expiry dates of kit components
• order replacements kits/kit components

Risk

There may be delays to timely treatment as a result of:

• failure to provide appropriate preparation and administration guidance to the individual and/or carer
• failure to provide sufficient guidance on when to order, and how to obtain, replacement emergency management kits/kit components
• failure to communicate intended changes to kit components

Mitigation

Ongoing work is needed to standardise practice nationally. Locally, there are opportunities to minimise potential harm where emergency management kits are required.

Standardise practice

Practice related to the prescribing and supply of emergency management kits should be reviewed and actions taken to ensure:

• the contents of kits are standardised across systems
• the contents are listed within clinical guidelines/protocols, formularies and prescribing systems to limit the risk of confusion
• supply quantities are sufficient to facilitate emergency administration, with consideration given to the potential for accidents and breakages
• kits are supplied with sufficient expiry dates (kits should be clearly labelled with the expiry date of the shortest dated component)
• there are agreed system wide governance arrangements outlining responsibility for the initial prescribing and supply, and continuation of emergency management kits and components
• agreed mechanisms exist for the documentation and communication, between care settings, regarding emergency management kit need and provision
• agreed governance arrangements exist for situations where a change to the content of emergency management kits is required, such as due to supply disruptions
• there is a robust process for the supply of sharps bins, and individuals are counselled on how to dispose of these
• there is a robust process for training and counselling individuals about how and when to use emergency management kits (this should include checking expiry dates, and how/when to obtain replacement kits/kit components)

Awareness and knowledge

Ensure guidance is comprehensive, consistent and readily available to all HCPs responsible for prescribing or supplying emergency management kits.

Ensure adequate guidance is provided to individuals at risk of adrenal crisis on:

• the importance of carrying a kit
• how and when to use the kit
• the importance of checking expiry dates
• how and where to obtain replacement kits/kit components
• how to safely dispose of used or expired kit components
• how intended changes to kit components impact the use of the kit

Promote clear documentation in medical notes and transfer of care documentation when counselling has been undertaken.