The British Oncology Pharmacy Association’s annual symposium was held in Solihull from September 29 to October 1. Over 120 participants attended the meeting reflecting a growth in specialist pharmacy services and an expansion in the use of drugs to treat cancer. Max Summerhayes reports
This year’s annual British Oncology Pharmacy Association (BOPA) meeting programme contained a diverse mixture of technical, managerial and clinical topics. Several sessions were loosely connected by the theme of risk management.
Capacity planning
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| Graham Sewell: pharmacists are “overwhelmingly in favour” of dose banding |
Among the risk management sessions was a presentation on capacity planning
by Mr MIKE LILLYWHITE (pharmacy department, St Bartholomew’s hospital,
London). He said that two to three years ago it became clear that the workload
in some hospital aseptic units had risen to unacceptable levels for the resources
available. This posed a risk to the safety and quality of the products the unit
produced. The problem had been recognised by the Medicines Control Agency (MCA),
which now required units to carry out capacity planning exercises to ensure
that the safe maximum level of production in each unit was defined and not exceeded,
and that capacity was increased in step with rising demand.
Mr Lillywhite discussed the process of capacity planning and some of the problems
associated with it. He explained that several forecasting methods could be used
to predict future workload. These could be broadly divided into projective (based
on historical workload trends), causal (based on an analysis of factors influencing
demand) or judgmental (based on expert opinion) approaches. He said that a combination
of these methods was usually needed because factors influencing hospital pharmacy
workload were complex. In the case of a chemotherapy compounding unit, these
factors included the number of patients to be treated, the number of medical
consultants in post, the outcome of significant clinical trials, recommendations
from the National Institute for Clinical Excellence (NICE), the availability
of beds and nurses for administration of chemotherapy and the proportion of
chemotherapy being given on an outpatient or inpatient basis (which dictated
the urgency of requests for treatment preparation).
Even when an accurate forecast could be made of future demand, the difficult
problem of how to determine the maximum safe output of the facilities available
remained, said Mr Lillywhite. He added that this could be as difficult as predicting
future workload and pointed out several pitfalls for those involved, explaining
that there was a need to take account of the complexity of work as well as the
volume. One approach was to undertake time and motion studies to assess the
preparative time associated with different products. However, the results of
such studies should be interpreted with caution because they did not generally
take account of non-productive time (staff absences for sickness, annual leave
or meal breaks) or time spent on indirect activities such as unit cleaning,
environmental monitoring, restocking shelves and paperwork. Additionally, he
reminded the audience that it was no use basing output calculations on what
could be achieved by the most efficient, fully trained staff on a good day when,
in reality, not all staff were as productive as others, there were usually some
still in training and not every day was a good day.
Mr Lillywhite concluded that, despite the problems inherent in this area, a
permanent capacity plan, subject to regular review, was now a vital part of
the quality assurance system. The quality of the plan itself should be reviewed
periodically using performance indicators such as overtime levels, unit response
time, error rates, procedural deviations and staff sickness and turnover.
Dose banding
The rising chemotherapy workload has been, in part, responsible for arousing
interest in capacity planning, and has led some pharmacists to seek ways of
streamlining the dispensing process.
Professor GRAHAM SEWELL (department of pharmacy, University of Bath) described
a project that he had recently undertaken with an Australian colleague —
Mr Richard Plumridge (Freemantle, Eastern Australia) — to investigate dose
banding.
Dose banding was first described a few years ago by Jim Baker and his team from
the Queen Elizabeth hospital in Birmingham. It involved the preparation of a
stock of syringes prefilled with a range of standard doses of cytotoxic drugs.
These were then used to fill prescriptions for chemotherapy, instead of each
dose being prepared on a bespoke basis once a prescription was received. As
originally described, the range of syringe sizes was chosen so that, by using
a combination of no more than three or four syringes, a dose could be delivered
which was within 5 per cent of that calculated from the patient’s body
surface area (BSA).
Professor Sewell said that he had been interested to find out how widely used
dose banding had become, what barriers existed to its introduction and the perceived
advantages and drawbacks of this approach.
He said that a literature search had been unhelpful and uncovered only two references
to the topic. However, it had revealed several papers casting doubts on the
values of dosages based on BSA which suggested that BSA was often incorrectly
calculated and also because, when tested, it did not seem to correlate with
the toxicity or efficacy of a given dose of drug. These doubts suggested to
him that the modest approximation of doses inherent in dose banding was of little
clinical significance and should not, in itself, be a barrier to the introduction
of such a system.
Professor Sewell said that Mr Plumridge had also carried out structured interviews
at 15 sites in the United Kingdom and the Republic of Ireland, followed by a
round table meeting to investigate attitudes towards dose banding. This had
revealed that although few treatment centres were currently using this approach,
many were considering it as a way of keeping patient chemotherapy waiting times
down and
reducing stress on staff at times of peak demand. Pharmacists had been overwhelmingly
in favour of the concept, although about one-third of nurses and doctors had
had reservations, which suggested that departments implementing this approach
would need to accompany its introduction with an appropriate explanation of
its safety and benefits.
Several other points had emerged from Mr Plumridge’s investigations. First
was the enthusiasm of pharmacists for industrial involvement in dose banding
through the provision of pre-filled syringes with long shelf-lives which could
be purchased in bulk, thus removing preparative work from their units completely.
Secondly, there was a belief that whatever their presentation or source, cytotoxic
drugs represented a “special case” and should always be issued to
treatment areas in response to a specific prescription, rather than as a bulk
stock.
Finally, the one impediment to full implementation of dose banding was the unwillingness
of clinicians and pharmacists to make the requisite dose approximations for
patients in clinical trials.
Professor Sewell said that although dosing clearly had to be absolutely precise
in pharmacokinetic trials, he could see no reason why dose banding should not
be a feature of other trials provided that allowance was made for it at the
time of protocol preparation.
Risk and unlicensed drugs
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| Participants at the symposium |
Another aspect of risk management was considered by Ms LIBBY HARDY (pharmacy
department, Royal Devon and Exeter hospitals NHS trust) who discussed the unlicensed
use of medicines at a session on palliative care. She explained that this was
an important issue in palliative care: two large surveys had shown that around
15 per cent of prescriptions involved the use of products which either lacked
marketing authorisation or were being used for a purpose different from that
intended by the manufacturer.
Ms Hardy said that although most pharmacists, and many prescribers, were aware
of the need for informed consent from patients receiving unlicensed drugs, many
were less clear on how to deal with established products being used outside
their licensed indications. She gave several examples of drugs routinely used
for purposes not included in their marketing authorisation. These included dexamethasone,
which was regularly used on oncology wards for the treatment of anorexia, dysphagia,
dyspnoea, intestinal obstruction and pain relief, none of which were approved
indications. Ms Hardy said that she doubted that many professionals knew what
the licensed indications for dexamethasonewere were, much less that they sought
informed consent prior to using it for the indications she had described.
She explained that this lack of consent would not necessarily constitute negligence
in any subsequent legal action and that, in court, such use would be subjected
to the Bolham test. This was a legal precedent which stated that if there was
a body of competent professional opinion that supported a defendant’s actions,
a claim of negligence should fail. Ms Hardy said that although this might provide
some comfort to medical professionals, they should be aware that case law had
also established that lack of resources was not an acceptable defence for failure
to provide correct standard of care. She believed that this was particularly
pertinent to the growing use of thalidomide by oncologists and haematologists.
Even with this most notorious of drugs, many clinicians were less diligent than
published guidelines suggested they should be in obtaining and documenting informed
consent and in taking steps to ensure that it was never given to patients who
were or might become pregnant.
New ideas in palliative care
Physicians working in palliative medicine were adept at finding new uses for
old drugs, said Dr CHRIS FARNHAM (specialist registrar in palliative care, Camden
and Islington health authority, London) who spoke about new developments in
palliative care. Alternative drug uses that he described included the use of
beclomethasone inhalers to pretreat an application site for transdermal fentanyl
patches — the dry powder output apparently reduced skin reactions without
interfering with patch adherence. He also suggested that if patients were having
trouble with non-adherent patches, they could apply them to the sole of the
foot, where constant pressure would help to keep them in place.
For those patients receiving their opiates via a syringe driver and with a neuropathic
element to their pain, Dr Farnham said that he had usefully substituted 10ml
of 2 per cent lignocaine for water or saline as the drug diluent. This appeared
to have a favourable impact on pain, although the mechanism was unclear. He
added that although neuropathic pain remained a challenge to those working in
palliative care, there were now a number of approaches to controlling it. His
personal view was that gabapentin should be the first-line therapy for this
problem. Indeed, so convinced was he of its benefits that he suggested it should
be “added to the water supply”!
However, he acknowledged that even gabapentin was not a panacea and said that
a whole range of other agents was being investigated in the management of neuropathic
pain including high-dose (500-1,000mg) parenteral magnesium and the novel antidepressant
mirtazapine, which appeared to be of similar efficacy to tricyclics but with
a better side effect profile.
Dr Summerhayes is principal oncology pharmacist, Guy’s and St Thomas’s hospital, London, and chairman, British Oncology Pharmacy Association