The Pharmaceutical Journal Vol 267 No 7174 p707
17 November 2001

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Compulsory guidelines aim to stop intrathecal chemotherapy disasters

Since 1985 inadvertent intrathecal administration of vincristine has left at least 13 patients dead or paralysed. Following two investigations into intrathecal medical errors, the Department of Health has launched compulsory guidelines intended to eliminate such errors completely. Michael Thompson looks at what they say

National Health Service trusts have been given just three weeks to check that they comply with new compulsory guidelines on the safe administration of intrathecal chemotherapy and a further month to implement the guidelines in any areas where they fall short.

The seriousness with which the Department of Health is taking the guidelines is evident from the fact that a clinical governance checklist designed to highlight any areas of shortfall has to be signed by each trust's chief executive, medical and nursing director and chief pharmacist. The only area in which non-compliance with the guidelines will be tolerated is the administration of intrathecal chemotherapy by doctors below registrar grade if there are "compelling" reasons to do so. All four officers, plus the clinical director of cancer services, have to sign before this exemption will be accepted.

The core of the new guidelines is a register of staff who have been trained and certified as competent to prescribe, dispense, check or administer intrathecal chemotherapy.

To be registered, individuals will have to show that they are competent for their designated roles and to have been certified as such. Professionals who move hospitals will be able to take their certification with them, but will have to demonstrate their competence again in order to be registered.

Preparing and dispensing drugs for intrathecal administration and vinca alkaloids is to be restricted to pharmacy staff who have been so registered. Minimum training must cover all potential clinical hazards and formal assessment will be required. Once dispensed, intrathecal and intravenous drugs will have to be stored, issued and transported separately. Drugs for intrathecal administration are only to be issued directly to doctors who are to administer them or placed by authorised pharmacy staff into refrigerators reserved for them. Whatever happens, a signed paper trail has to be created.

Labels will have to include the intended route of administration, printed in a large bold typeface. Negative labelling, such as "Not for intrathecal use", will not be permitted. Instead, products, such as vincristine, will have to be labelled "For intravenous use only — fatal if given by other routes". Minimum dilutions will also be required, so that vincristine is never administered in more concentrated form than 0.1mg per ml and is always dispensed in syringes of at least 10ml capacity. Only patients under 10 years old will be allowed to be given 1mg per ml vincristine in order to keep injection volumes within reason.

Prescribing is to be restricted to consultants and registrars, as is administration. In exceptional circumstances other career grade doctors are to be allowed to administer intravenous chemotherapy, but not to prescribe it. Senior house officers will only be allowed to administer treatment in centres where the caseload means that they have plenty of experience, and then only after training and certification. They will not be allowed to prescribe it. Prescribing will have to be on special intrathecal prescribing charts, and not on general prescription charts and provision will have to be made for the charts to be signed by the people responsible for prescribing, dispensing, collecting and administering the treatment.

If patients are to receive both intravenous and intrathecal treatment, the intravenous drugs have to be injected first and intrathecal drugs are not even to be issued until there is written proof that the intravenous treatment has been completed. The only permitted exception to this rule is where treatment is to be given to children under general anaesthetic.

Before administration of intrathecal chemotherapy, medical staff are required to follow formal checking procedures involving trained nurses and patients and their relatives. Patients will have to be explicitly told what is to be done to them and the drug they are to be given. Records of this will have to be kept.

The guidelines were drawn up by a working party which included Tim Root, chief pharmacist at the Royal Marsden Hospital, Dr Max Summerhayes, principal oncology pharmacist at Guy's Hospital and the Department of Health's chief pharmaceutical officer, Dr Jim Smith.

Chemotherapy has been recognised as a high risk area for many years and oncology pharmacists have been increasingly involved in reducing clinical risk. This means that many treatment centres already have procedures that comply with parts of the new guidelines and will only need to fill in the more demanding gaps.

Mary Maclean, principal oncology pharmacist, St Bartholomew's Hospital, London, said: "It is going to be an onerous task, but it is essential to take these guidelines on board and implement them.

Some of the expectations will be harder to satisfy than others. For example, the requirement for written evidence that IV treatment has been administered before intrathecal injections can even be issued. The involvement of patients in the final check of intrathecal treatment may also raise issues that are difficult to resolve.

Hospitals will need to make their own arrangements for suitable training for the time being, but help may be on the way.

Mr Root said: "There will be work nationally on training for all staff." He expects specific postgraduate training, plus improved undergraduate teaching in relevant areas.

Region-wide training is already available in London as a result of steps taken to address problems experineced at Great Ormond Street Hospital for Children some years ago.

The full guidance can be found on the internet.