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Published on 6 June 2008

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Congress covers cutting-edge topics with focus on pharmacists’ added value

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Cutting-edge topics featured strongly at the EAHP Congress, held in Maastricht, Netherlands, on 27-29 February 2008. The theme was how hospital pharmacists add value to healthcare

Laurence A Goldberg
FRPharmS

Editorial Consultant
HPE

How can you afford not to employ a full-time pharmacist? That was the question asked by Lars Heslet (director, intensive care department, National University Hospital of Copenhagen). The ICU accounts for some 5% of hospital admissions and 15-20% of the overall hospital budget. About 14% of this expenditure is attributed to pharmacy charges (drugs). The ICU is thus an ideal setting to promote cost savings by the clinical pharmacist, he continued. One full-time pharmacist is employed in his department. The pharmacist is able to help reduce costs in several ways, he explained. These have included changing the standard drug list, particularly focusing on high-cost products, optimising mixing protocols and reducing length of treatment. Before these measures were introduced, expenditure on drugs was $127,000 a month, and afterwards it fell to $110,000 – an annual saving of $200,000.

Another important role is teaching pharmacology to doctors and nurses. Now that less pharmacology is taught in medical school it makes good sense to use the pharmacist for this, he commented.

The pharmacist also functions as a “gatekeeper” for safe, effective treatment – by checking doses, routes of administration and preparation procedures and then, after administration of a drug, checking that the expected effects are achieved.

Moreover, pharmacy services such as centralised preparation of injections ensure that nurses have more time to spend at the bedside and spend less time in medicines preparation. In Professor Heslet’s department about 25,000 premixed injections are used each year. This accounts for 95% of all injectable doses, he said.

It is important to have the clinical pharmacist at the bedside where problems can be identified and solved, said Professor Heslet. Although there is some overlap between the expertise of doctors, pharmacists and nurses, they each have their own “platforms” of expertise. One obvious area to tackle is medication errors. One study conducted in an emergency department (ED) had shown that interventions by a pharmacist had reduced medication errors by 67%. Prescribing errors vary greatly between different intensive care units and there is considerable room for improvement, said Professor Heslet.

The clinical pharmacist also had a major influence on good clinical practice. One study had examined the influence of a clinical pharmacist on sedation and mechanical ventilation. The more sedation a patient receives, the slower the weaning process and the greater the risk of pneumonia. Thus, if sedation is not reduced according to the protocol, mortality increases, Professor Heslet explained. A total of 156 mechanically ventilated patients prescribed a continuous infusion of sedative medication while in the medical intensive care unit were included. A pharmacist evaluated all the patients daily and made recommendations to adhere to the institution’s previously approved sedation guidelines. A retrospective control group was used. The results showed that the intervention group was ventilated for about seven days, compared with 14 days for the control group. “It seems that someone has to tell you to adhere to your own protocol,” Professor Heslet said. More importantly, the results show that a clinical pharmacist can reduce morbidity in the ICU. That is why we want a clinical pharmacist, he added.

Future scenarios for hospital pharmacy could see new roles emerging, said Bert Leufkens (Utrecht Institute for Pharmaceutical Sciences, Netherlands). The pharmacist could become a “molecular systems pharmacist”, strongly focused on high-tech products, a “care manager”, focused on direct patient care activities, or a “clerk”. The first two would provide the pharmacist with high professional autonomy, whereas the “clerk” role would have low professional autonomy.

Pharmacists should be inspired by these possible scenarios and work out how they wish to work in the future, he suggested. They will need to take account of the major trends in the changing healthcare environment. Biological drugs will be important cost drivers for hospital pharmacy – at present they are growing at the rate of 18-22% annually. There will be increasing demands to show a clinical return on investment, so outcomes research will become more important. Advanced therapies such as those involving gene, cell and tissue technologies will need appropriate skills, knowledge and a high-quality, best-practice environment.

Risks of unlicensed medicines
Unlicensed medicines account for about 3% of the medicines held in the pharmacy, said Martin Hug (clinical pharmacist, University of Freiburg Hospital, Germany), at a satellite symposium sponsored by IDIS. Such medicines are required when a particular drug is not approved, when there is a shortage of an approved drug, when the dosage form is not available or when the approved product is not in a form suitable for the intended use.

Dr Hug had been under the impression that imported drugs were safe until an incident in his hospital underlined the risks. An intravenous drug was ordered but the oral form – also packed in ampoules, containing sugar and a preservative – was sent. This was not noticed and the drug was sent to the operating theatre. At the point of use a nurse who could read French – the language of the label – realised that it was an oral product and prevented it from being administered intravenously.

When using imported products the design, content and language of the prescribing information could give cause for concern. Pharmacological and therapeutic details for all drugs approved in Germany are listed in the Red List compendium (Der rote Liste – German physician’s desk reference), but there is no such document for unlicensed products.

He said what pharmacists need is fast, reliable information in the language or languages of their own countries and rapid feedback on availability. At present we are walking on thin ice when we deal with unlicensed products, he concluded.

Commenting on the UK perspective, Ian Bourns (director of medicines management and pharmacy, Eastbourne District General Hospital, UK) pointed out that in 2005 only 36% of UK hospitals were routinely risk-assessing unlicensed medicines. Since then, risk assessment has been carried out more frequently, a databank has been developed and the standards and quality of producers have been examined. Other steps have included a protocol for action to take if something goes wrong.

The most useful measures are sharing of information about policies and risks and training and development of staff, he said.

Biosimilars
Biosimilars are here to stay and are tomorrow’s generic products, according to Allan Karr (UK pharmacy business services manager, University College London Hospitals NHS Trust, UK), who was speaking at a Teva satellite symposium. At present suppliers of biosimilars face a number of problems, he explained. There is as yet no clear global regulatory framework. Biopharmaceuticals are defined by their production process and so it has become critically important to understand the possible impacts of changes to the process.

In the UK the value of the biosimilars market is growing rapidly. In order to make savings on the scale of those made with traditional “blockbuster” drugs it will be necessary to look at this market very carefully, he predicted.

The normal period of patent protection may not be long enough for biologicals – development could take longer than 20 years because of delays in licensing. Normally the expiry of a product patent releases funds for new medicines, but if patent life is extended then this opportunity is lost.

Tackling the question of why biosimilars are not used more widely, Mr Karr said that the necessary infrastructures were not yet in place in pharmaceutical companies or in the UK’s NHS. At present there is no mechanism for drugs and therapeutics committees to consider biosimilar products. There is also debate about product definitions and international nonproprietary names (INNs), and questions about whether indications or formulations should be licensed. There are problems with pricing – there is little room for discounts because competition has already eroded prices.

There can be delays in bringing new products to the market because the originator companies will always argue about clinical trials and manufacturing processes. Finally, for hospital trusts the switching process may be complex – achieving consensus between all the doctors involved could be time-consuming.

EU guidelines for biosimilar products are already in place, Mr Karr noted. We need to sort out clear guidelines for managing this new market – just licensing is not enough, he concluded.

Two biosimilar products – Realdiron® (interferon alpha 2b) and Grasalva® (filgrastim) – have been in use for many years in Lithuania, Dainius Characiejus (deputy director of research, Institute of Oncology, University of Vilnius, Lithuania) told the audience.

About one-third of all cancer patients in Lithuania are treated in the Institute of Oncology. Realdiron has been in routine use since 1993 and has been used to treat more than 300 patients with renal cell carcinoma and more than 100 patients with melanoma. In some patients treatment has continued for up to five years and so far no serious side-effects have been observed.

It is used as an adjuvant in treating melanoma – it is often difficult to decide when to stop treatment, Dr Characiejus commented.

The side-effects of Realdiron are the same as those listed on the summary of product characteristics (SPC) of the originator product. “No new side-effects have been observed,” Dr Characiejus said.

Concerning efficacy, studies in Lithuania have shown that survival is improved for both metastatic renal cell carcinoma and for melanoma treated with Realdiron.

It was important to find markers to identify the patients who would benefit from Realdirontreatment, and unrestricted use of the drug provided the patient numbers to make this possible, Dr Characiejus said.

Grasalva was registered in Lithuania just before the country’s accession to the EU. It was registered on condition that a trial to evaluate safety and tolerability was undertaken. Patients with breast cancer who were candidates for treatment with docetaxel and doxorubicin were recruited.

The secondary endpoints were incidence of febrile neutropenia, delay in subsequent chemotherapy cycles and reduced chemotherapy doses due to adverse reactions.

One group received docetaxel and doxorubicin and the other group received docetaxel alone.  Grasalva treatment was started on day two and given daily until the absolute neutrophil count (ANC) was at least 1.5 x 109/l.

Side-effects related to filgrastim amounted to 9% of the total reported. No unanticipated serious adverse effects were related to Grasalva. One episode of bone pain was observed with the biosimilar Grasalva but this is also a documented side-effect of the innovator filgrastim product Neupogen®. There was no evidence of antibody formation.

Concerning efficacy, febrile neutropenia occurred in 14% of patients who received the combination treatment. In the absence of filgrastim febrile neutropenia occurs in 33-48% of patients – clearly demonstrating that filgrastim prevents it in many cases, Dr Characiejus pointed out. There was no need to reduce doses of chemotherapy because of adverse drug events and the researchers concluded that Grasalva was safe and tolerable.

“There was no evidence from our experience that the biogenerics are unsafe or ineffective,” Dr Characiejus said. “We could not have done all of this work if generics had not been available in Lithuania,” he added. â–



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