Managing intrathecal chemotherapy risks

The Department of Health’s HSC 2008/001: Updated national guidance on the safe administration of intrathecal chemotherapy outlines the minimum requirements for an NHS Trust providing an intrathecal chemotherapy (ITC) service. The national guidance is currently being updated.

The requirements are summarised below, but all NHS Trusts should be familiar with the full national guidance.

All ITC services

The national guidance applies to all NHS Trusts that provide an ITC service regardless of where the ITC is prepared. ITC may be prepared in a Section 10 aseptic unit, NHS Manufacturer Specials (MS) licensed aseptic unit or purchased from an external MS licensed facility.

The Trust Chief Executive must ensure an annual review of the scale of the ITC service and the associated risks is completed.

Low volume service

A low-volume service is classed as 10 procedures or less each year.

The risk assessment must include risks associated with low numbers and staff involvement for training and ongoing competence.

High volume service

A high-volume service is classed as 500 procedures or more each year.

The annual review must ensure that locally agreed safe working limits are in place and not exceeded.

Responsibilities for intrathecal chemotherapy

The responsibilities for everyone involved in providing ITC are described below.

All individuals on the ITC register

Everyone on the ITC register has a responsibility to ensure:

• any colleagues they involve in any part of the ITC process are on the ITC register for the task in question
• they challenge if ITC protocols are not being adhered to, or if the actions of an individual may cause potential risk to a patient

Trust Chief Executive

The Chief Executive has overall responsibility for ensuring compliance with national guidance on the safe administration of ITC.

Designated Lead

The Chief Executive will identify a designated lead for ITC to oversee compliance.

The designated lead can be a doctor, nurse or pharmacist and has overall responsibility for:

• holding the ITC register, ensuring that it is maintained and kept up to date, delegating day to day responsibility for maintaining individual aspects of the register to other senior staff
• induction, training and continuing professional development related to ITC, delegating training responsibilities to other senior staff identified as lead trainer(s)

Lead Trainer

The lead trainer(s) are accountable to the designated lead for ensuring that:

• a formal induction course is available and attended by staff; the induction should explain the patient risks if medicines that are unsafe for intrathecal administration are accidentally administered via this route
• staff involved in any part of the ITC process have read the national guidance and local protocols
• staff involved must sign a written confirmation that they have read and understood these documents annually
• staff can demonstrate they are competent in their designated task(s); competence is reviewed annually alongside how often staff carry out respective tasks
• staff receive written confirmation that they have completed the training (or annual refresher training) and are competent or remain competent to be included on the ITC register for the designated task(s)

There can be more than one lead trainer, for example medical, nursing and pharmacy.

Managing intrathecal chemotherapy processes

There are several requirements for each ITC process that must be followed, these are summarised below.

Register of designated personnel

An ITC register must be established and maintained of staff who have been trained and authorised in one or more of the designated tasks:

• prescribing ITC
• dispensing ITC (preparing the dose, filling the syringe, packaging for transport)
• issuing ITC from pharmacy
• checking ITC prior to administration
• administering ITC

Training and staff competency

The designated tasks are competency based. The standards for competency should be defined by the local NHS Trust.

Staff must be appropriately trained and deemed competent by the designated lead or delegated lead trainer(s).

An induction programme, annual competence reviews and written confirmation of staff competence are required.

Prescribing

Only staff appropriately trained, deemed competent and on the ITC register for prescribing can prescribe ITC.

ITC must only be prescribed by ST3 level doctors and above.

A purpose-designed ITC prescription or an area dedicated to ITC on a chemotherapy chart must be used.

The medicine and route of administration must be written in full on the prescription.

Dispensing and labelling

Dispensing is the activity of preparing the dose, filling the syringe and placing the syringe in packaging for transport.

Only staff appropriately trained, deemed competent and on the ITC register for dispensing tasks must dispense ITC.

Labels should use positive messaging in the largest practical font size for the route of administration, example, “For intrathecal use only”.

Storage in pharmacy

If storage is required between dispensing and issuing, ITC must be stored in a dedicated locked container or refrigerator in pharmacy.

This dedicated container or refrigerator must never be used to store intravenous medicines.

Checks required before issuing

For a patient prescribed both ITC and intravenous (IV) chemotherapy, the ITC must be issued from pharmacy at a different time from the IV chemotherapy. The IV chemotherapy must be issued and administered first.

ITC should only be issued following written confirmation that the patient’s IV chemotherapy for that day has been administered.

Issuing from pharmacy

ITC can only be issued from pharmacy by one of the following mechanisms:

• collected from pharmacy by the administering doctor
• delivered by pharmacy to the clinical area where it will be administered

In both cases the pharmacy staff handing over or delivering the ITC must be on the ITC register for issuing.

When delivered to the clinical area by pharmacy, the ITC must be either:

• issued directly to the administering doctor
• stored in a dedicated locked container or refrigerator

In all cases, the pharmacy staff must record the name of the administering doctor they are issuing the ITC to, or that the ITC has been locked in the relevant container or refrigerator. The pharmacy staff must sign for issuing the ITC, the documentation records used for this should be defined locally.

Where the administering doctor does not take direct receipt of the ITC, they must check the ITC when collecting it from the dedicated container or refrigerator. The administering doctor must sign for collecting the ITC, the documentation records used for this should be defined locally.

Administration location

ITC must be administered in a designated room where no other chemotherapy medicines are being given or stored.

Chemotherapy medicines for IV use must never be stored in this area, even when the area is not in use.

Checks prior to administration

A member of staff who is on the ITC register for administration must review the patient before the ITC is administered. The patient must be told the nature of the procedure, the route of administration, and the medicine to be administered.

Recorded checks are required to ensure that the right medicine and the right dose is given by the right route to the right patient. These checks must include:

• the administering doctor
• a second member of staff appropriately trained, deemed competent and on the ITC register to carry out this check

The patient may be involved in the checking process if they wish.

Administration

Administration of ITC must only be undertaken by ST3 level doctors and above, who have been appropriately trained, deemed competent and on the ITC register for administration.

Waivers to allow ST1 and ST2 grades to administer ITC are permitted, although not in Trusts that administer a low volume of ITC.

Out-of-hours ITC administration should be in exceptional circumstances only.

Governance principles for an intrathecal chemotherapy service

All NHS Trusts that provide an ITC service must have a formal governance system in place including local protocols, regular audits and reporting arrangements.

Local protocols

The Trust must have current and approved local protocol(s) covering all aspects of the national ITC guidance from prescribing through to administration.

Local information on the following must be included:

• responsibilities and designated tasks
• location of all designated ITC administration and storage areas
• location of key documents such as national guidance, local protocols and the full ITC register

The local protocol(s) must be read by all members of staff directly involved in any aspect of the ITC service.

Regular audits

The Trust must have processes in place to regularly self-audit the ITC service and act on the results. This is to ensure it is compliant with all aspects in the national guidance from prescribing to administration.

Audits may include, but are not limited to, review of:

• effectiveness and adherence of medical, nursing, and pharmacy staff to local policy
• number of adult and paediatric procedures per year
• number of out of hours procedures per year
• designated ITC storage locations and administration areas
• staff training and competency records
• prescribing systems
• incident reports
• patient records

The Pharmacy Intrathecal Chemotherapy Audit Aide Memoire 4th Edition (Yellow Cover) available from SPS supports with audit of pharmacy aspects of the safe administration of ITC.

Reporting arrangements

All ‘near misses’ or incidents relating to ITC should be reported on the Trust’s incident reporting system and reviewed by the designated lead. The Medication Safety Officer and patient safety specialists should also be involved to ensure opportunities for learning and implementation of safer practice are identified.

Reporting arrangements for escalation of any incidents, issues or non-compliances identified via self or external audit should be defined, for example haematology governance meetings.