The second residential symposium of the British Oncology Pharmacy Association was held at the Royal Court Hotel, Kersley, Coventry, from September 24-26, and was attended by around 130 people. The symposium included a full programme of lectures and around 25 poster presentations. Dr Max Summerhayes (principal oncology pharmacist, Guy's and St Thomas's hospitals, London) reports
As someone whose first experience of an oncology pharmacy conference was a meeting on the safe handling of cytotoxic drugs held in Hanover a decade ago and who, until recently, thought that the last word had been said on the subject, it is interesting to see what a hot topic it has become once again.
This renewed interest was reflected by the excellent attendance at a satellite meeting on cytotoxic hazards sponsored by Faulding Pharmaceuticals.
Recently, attention has focussed on possible deficiencies in the recirculating biological safety cabinets used in North America, and elsewhere, to protect pharmacy staff reconstituting cytotoxic drugs. It was interesting to hear Dr Mark van Robays (Faulding Pharmaceuticals, Brussels, Belgium) talk about another, unexpected source of occupational exposure to chemotherapeutic drugs - vials whose external surfaces are contaminated at the point of manufacture.
Dr van Robays described work done in the University of Liege in which samples of ready-to-use 5-fluorouracil (5-FU) solutions from three different commercial suppliers were subjected to a standardised swabbing procedure and the swabs analysed for 5-FU residues. Of 90 vials tested (10 from each of three separate batches from each manufacturer), 27 (4, 13 and 10 from each of the three manufacturers) had detectable levels of surface contamination by 5-FU and three (all from the same manufacturer) had quantifiable (4.8-18.1mg/vial) surface levels of 5-FU.
Dr van Robays said that the most likely source of contamination of primary packaging was splashing and foaming during the filling process, though subsequent contact with packaging equipment soiled by prior contact with broken or contaminated vials could also be to blame.
He added that while all manufacturers were aware of this problem - which has been reported with other cytotoxic drugs - the measures they took to avoid it, such as post-fill vial washing, appeared to vary in their efficiency, with none being entirely effective.
External contamination of drug vials is a potential risk that is probably overlooked by many pharmacists and could, potentially, pose a hazard to staff engaged in activities thought to pose no exposure risk (except when breakages occur), such as shelf-filling or assembling materials for subsequent manipulation.
Therefore, it was timely to hear Professor Graham Sewell (University of Bath) announce the launch of the MARC (Management and Awareness of the Risks of Cytotoxics) programme which he is co-ordinating with funding from Faulding Pharmaceuticals. The aim of MARC is to develop evidence-based guidelines on safe handling procedures for all those working with cytotoxic drugs.
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Graham Sewell announces the launch of the Management and Awareness of the Risks of Cytotoxics (MARC) programme |
First, there was a lack of national guidelines designed to cover all staff groups which could be used to inform and support local initiatives. Secondly, guidelines were often introduced in the absence of an educational programme to ensure that the appropriate staff were aware of them and, finally, audit to ensure that guidance was being followed was often lacking.
Professor Sewell explained that, when he began work on this project, he looked at documentation from a variety of sources to ensure that he was not reinventing the wheel. Of these, the most current and widely disseminated are, probably, the Royal College of Nursing (RCN) guidelines. Although these are extensive, Professor Sewell - and several members of his audience - considered them to be less than ideal. Inevitably, they are nurse-centred and, according to the speaker, they lacked the technical depth required to give them credibility. They also avoided some difficult, but important, areas, such as the handling of anti-neoplastics by pregnant staff.
Having satisfied himself that better guidance was needed, Professor Sewell has assembled a multidisciplinary team, including representation from the Health and Safety Executive, with the remit of producing comprehensive guidelines for the handing of cytotoxic materials by the entire range of health care staff (from stores staff to laundry workers). It is intended that these guidelines should be practical, user friendly and backed by an educational programme and an audit tool.
The audit is to be based on a document originally formulated by Professor Sewell's team at Derriford hospital and refined by Tim Root and Alison Conway at the Royal Marsden hospital. It allows those working in hospitals to assess the risk awareness of personnel, the availability of suitable protocols for safe working and staff compliance with them.
Professor Sewell explained that, ultimately, it was intended that it would be possible to return completed audit documents to a central office for assessment, with performance scores entered into a database which would allow all users of the audit to compare their department's performance with that of others. He hoped that this would provide an incentive for those with low scores to raise their standard of practice to that of the best.
The safe handling of cytotoxic drugs is, of course, only an issue if hospitals can afford to purchase them in the first place, and there are few cancer centres in the UK which would not admit to financial restraints on their use of oncology drugs.
According to Mr David Campbell-Morrison, from the Campaign for Effective and Rational Treatment (CERT), speaking during a session on the problems of funding new cancer treatments, this was unsurprising since the UK spent 95p per head of population on anticancer drugs each year compared with £3.81 in Italy, £6.24 in Germany and £7.76 in the US. This equated to around £127m spent in the UK, each year, on chemotherapeutic drugs, hormonal agents and immunomodulators, and less than half of the £300m that CERT considered should be spent.
Mr Campbell-Morrison explained that CERT began as a patient-centred, privately funded lobby group, set up to campaign for the adequate funding of new treatments for HIV infection and AIDS. It had later attracted some "arms-length" funding from the pharmaceutical industry for specific projects and had come to the attention of various oncologists, who suggested that CERT look at the problems of funding for new anticancer drugs, too.
With the help of clinical experts, CERT had compiled a list of expensive, recently introduced, cytotoxic treatments and calculated, on the basis of epidemiological data, the cost of applying these treatments to the UK cancer patient population.
Mr Campbell-Morrison said that CERT estimated that an extra £170m per annum was required if these new therapies were to be made freely available.
He added that, overall, expenditure on cancer treatment needed to rise by significantly more than that since the projected increase took no account of the increasing number of cancer patients presenting as the population aged, the greater employment of older drugs as the role of chemotherapy expanded, the administration costs associated with chemotherapy, the cost of support drugs such as antiemetics and analgesics (which would be the subject of a separate CERT report) plus, of course, the costs associated with new developments in the non-drug treatment of cancer.
Although the gulf between current expenditure and projected need is depressingly large, Mr Campbell-Morrison said that he believed that improved cancer services were high on the government's agenda and he was confident that substantial new spending in this area would be announced this autumn.
However, he warned that, if adequate funding was to be secured, continuing pressure had to be applied. He believed that the CERT report was a valuable lever for the application of such pressure and that it would be even more potent if professional groups lent it their support.
He expressed a degree of frustration that the British Oncological Association and the Association of Cancer Physicians had been ambivalent towards the document, apparently because of CERT's industrial sponsors, and said he hoped that BOPA would want to lend its support to the document and, perhaps, help CERT identify "patient advocates" willing to talk about their cancer treatment. Such advocates had been a particularly powerful element in the campaign to attract adequate funding for anti-HIV treatments. Mr Campbell-Morrison suggested that the power of patient advocacy was not the only lesson to be learned from the campaign to improve HIV treatment. Pharmacists also needed to be alert to the need to monitor the distribution of any new funds, since it had been calculated that 20 per cent of the money centrally allocated to the treatment of HIV disease had been diverted to other therapeutic areas.
Like most people at the meeting, Professor Mike Richards (clinical director of oncology, Guy's and St Thomas's hospitals) would doubtless be pleased to see an increase in the sum of money allocated to cancer treatment. However, as he acknowledged in his address - delivered during the same conference session as Mr Campbell Morrison's - the NHS was always likely to be short of resources, with allocation of funds to one area drawing money from another. For this reason, any arguments for increased resources to pay for new anticancer drugs needed to be very persuasive.
He went on to explain the approach used to manage the introduction of new and expensive cytotoxic drugs in South East London. He said that this approach acknowledged the complexity of the issues involved, the various stakeholders involved and the gaps in the clinical data which usually existed at the time a new treatment was launched. It did this by involving clinicians and managers, trusts and health authorities, evidence-based reviews of the treatments and consensus meetings, assessments of clinical effectiveness and strength of evidence and impact on quality of life and survival.
He believed that marrying clinical effectiveness and strength of evidence was vital because it was what clinicians did in their everyday dealings with patients - clinical decisions had to be informed by a good knowledge base but would, inevitably, and properly, be coloured by clinical experience and the needs of the individual patient.
Professor Richards said that it became clear, during 1997, that a wave of new cytotoxic treatments was about to become available whose costs could not be absorbed into normal budgets and that there was a need to discuss this issue with purchasers.
To facilitate this, the senior oncology pharmacist within his cancer centre, working with clinicians, compiled a series of one to two page briefing documents for each of the new treatments.
Each document incorporated an assessment of the likely benefits of treatment on a scale from D (more convenient and/or possibly less toxic than existing therapy) to A (prolongs survival by nine months or more) and of strength of evidence from g (single phase II study) to a+ (two or more high quality randomised controlled trials) and cost to the cancer centre (based on current referral patterns) and to the South East London health authorities (based on epidemiological data).
These briefing documents formed the basis of consensus meetings attended by representatives of the local health authorities and clinicians from the cancer centre, expanded the following year to include representatives of other cancer centres within the catchment area.
Professor Richards said that this approach had not only been a useful aid to rational debate and increased the understanding by purchasers and providers of each other's problems, but had also led to significantly increased funding for cancer treatment within the South East London area such that those treatments ranked as having the highest levels of clinical effectiveness were freely available within his centre and those considered less effective were available, subject to his approval, for use in exceptional circumstances.
One of the mechanisms used by hospitals and health care purchasers to restrict spending on expensive new drugs is to refuse to sanction their use outside of their licensed indications. The inconsistency with which this policy is applied was suggested by a poster presentation from Fiona Crosse and Geoff Saunders (Christie hospital, Manchester) who found that, on the oncology ward which they surveyed, 21.25 per cent of medications were being used "off-label" and a further 0.13 per cent were unlicensed products. For chemotherapeutic drugs, 56 per cent were being used outside of the conditions specified in their product licence.
Declaration Dr Summerhayes's attendance at this meeting was self-funded. He has previously received payment for attendance at a MARC advisory board meeting.