Chapter 23: Administration of systemic anticancer therapies
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Legal and professional issues
Chemotherapy administered using this route has the potential to cause great harm (Sewell et al. [230]) and has been associated with the deaths of at least 13 patients since 1985. The risks of intrathecal chemotherapy have been well documented in An Organization with a Memory (DH [43]) and the government set a target to eliminate incidents of patients dying or being paralyzed by maladministered intrathecal injections by the end of 2001 (DH [43]). Two reports on injection errors (Toft [244]) gave rise to the publication of the national guidance for the safe administration of intrathecal chemotherapy.
Following the publication of the guidance, all UK trusts that undertake to administer intrathecal cytotoxic chemotherapy (ITC) must ensure safe practice guidelines have been introduced and that they are fully compliant with the Updated National Guidance on the Safe Administration of Intrathecal Chemotherapy (DH [47]). The key requirements of the guidance are noted in Box 23.13.
The chief executive must identify a ‘designated lead’ who in turn must ensure the appropriate induction, training and continuing professional development of designated personnel authorized to administer intrathecal chemotherapy. A register of these personnel must be kept along with details of certain competency‐based tasks such as prescribing, dispensing, issuing, checking and administration. It is important to keep up to date with relevant safety alerts concerning intrathecal chemotherapy which may be issued by the Department of Health agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA) or National Patient Safety Agency (NPSA). Such reports have highlighted concerns over the risk of neurological injury due to implantable drug pumps for intrathecal therapy (MHRA [155]) and the storage of vinca alkaloid minibags (NPSA [168]).
Box 23.13
Summary – requirements of intrathecal guidance
- Only trained, designated personnel whose names are recorded on the appropriate intrathecal register are authorized to prescribe, dispense, check or administer intrathecal chemotherapy.
- All staff involved in the intrathecal chemotherapy process must undertake a formal competency‐based induction programme that is appropriate to their role, and annual training must be provided for all professional staff to remain on the register.
- Staff involved with intrathecal chemotherapy must use this policy in conjunction with the national guidance HSC 2008/001 and the Rapid Response Report NPSA/2008/RRR004 relating to intravenous vinca alkaloid administration.
- Staff are given an annual date‐expiring certificate on satisfactory completion of their training.
- Intrathecal chemotherapy must be prescribed by a consultant, associate specialist, specialist registrar, staff grade or ST3 grade doctor only and they must be on the register.
- Intrathecal chemotherapy drugs must be issued and received by designated staff only. Any such products not used must be returned to the pharmacy at the end of the intrathecal chemotherapy session.
- In adults, intravenous drugs must be administered before intrathecal drugs are issued (or once intravenous continuous infusions have been started).
- Children receiving intrathecal therapy under general anaesthetic will have their intrathecal treatment first in theatre. Intravenous drugs (excluding vinca alkaloids) may be given later in day care or on the ward, but never in theatre.
- Intrathecal chemotherapy should always be administered in a designated area, within normal working hours; out‐of‐hours administration must only occur in exceptional circumstances.
- Checks must be made by medical, nursing and pharmacy staff at relevant stages throughout the prescribing, preparation and administration process.
- This guidance predominantly relates to treatment given intrathecally, by lumbar puncture (i.e. via spinal injection) but is also relevant to intraventricular chemotherapy (i.e. via injection into the ventricles of the brain).