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Drug safety: paediatrics, stem cells and ethics


Becki Davies
Editor, HPE

The general theme of the EAHP conference and one of the principal aims of the association is drug safety, through improved monitoring and prevention of adverse effects. A  number of seminars were held dealing with a range of practical and scientific issues associated with medication safety, including:

  • Provision of drug information.
  • The pharmacist’s role in patient education.
  • Automated dispensing systems.
  • Drug interactions with herbal medicines and nutritional supplements.
  • Quality assurance of pharmacy services.
  • Licensing medicines for use in children.
  • The role of the computer in drug safety.
  • Safe medicines administration.
  • Managing drug budgets.
  • Leadership and the pharmacy team.

In addition to these seminars, three keynote presentations were given by speakers from outside the hospital pharmacy field, on subjects of growing importance and relevance to pharmacy practice.

Paediatric drug safety
In the first of these, Gregory Kearns, Chair in Paediatric Pharmacology, and Professor of Paediatrics and Pharmacology at the University of Missouri, and Chief of the Division of Paediatric Pharmacology and Medical Toxicology, Children’s Mercy Hospitals and Clinics, Kansas City, Missouri, USA, highlighted the role of the hospital pharmacist in paediatric drug safety.
Adverse drug reactions (ADRs) are a significant problem in hospitalised paediatric patients, and one of the major causes of preventable ADRs is incorrect dosage. Dramatic changes in the way the body absorbs and metabolises drugs occur throughout childhood, so calculating the correct dosage to give can be a complicated procedure. This is complicated still further by interpopulation differences in metabolising enzymes, which have been found to affect drug metabolism in adults. This is an area where the involvement of hospital pharmacists, with their knowledge of drug pharmacokinetics and pharmacodynamics, could make a crucial difference to medication safety. Currently, very few clinical trials of new drugs involve children, partly because of the high interindividual variability, and partly for the obvious ethical reasons; however, this is something that Gregory Kearns is keen to see changed.

Stem cell research
The principles behind stem cell research, and its potential applications in the field of medicine, were explained by Professor Nicholas Anagnou, from the University of Athens School of Medicine in Greece.
He spoke of the different capabilities of embryonic and adult stem cells to divide while remaining undifferentiated in vitro, and to develop into different tissue types when introduced to the body, a process that is still not well understood, but that it is hoped can be exploited to treat a range of medical conditions. Undifferentiated stem cells introduced to damaged heart tissue in patients following myocardial infarction replaced damaged heart tissue, and research into the use of stem cells in the pancreas of patients with diabetes, and in the brains of those with degenerative brain disorders such as Parkinson’s disease, although in the initial stages, offer hope for the future.

Perception, ethics, power
The role of ethics in the way we make decisions was explored by Max Baumann, from Kussnacht in Switzerland. Hospital pharmacists work within a complex network of relationships – with colleagues, the institution they work for, other hospital staff and GPs, the pharmaceutical industry, professional associations, patients and the general public. The hospital pharmacist has negotiating power, whether as an individual or as part of their professional association, and responsibility to all, and in all relationships. However, Mr Baumann believes that, despite this, hospital pharmacists tend towards severe understatement and underestimation of their powers.

Hospital pharmacists are required to make ethical decisions as part of their job, and the important thing to remember when confronted with a problem is that it is not necessarily important to find the “right” solution (there may be many possible solutions, with none being clearly right or wrong), but to make defensible solutions. To achieve that he described a simple schematic: seven steps to ethical decision-making. His choice of ethical quandary proved to be a slightly controversial one in the light of recent EC legislation on the provision of patient packs: the provision of appropriate pack sizes. He said that inappropriate packaging sizes have a number of potentially negative effects on health, the economy and the environment, although they might also have positive effects, such as purchasing discounts for the hospital, and greater economic benefits for industry. Hospital pharmacists should establish the alternative actions that could be used to counter this problem, eg, find out whether smaller packs are available, negotiate with the suppliers, perhaps via the professional association, to produce smaller pack sizes, use an alternative drug if it is available in a better pack size, or split packs (which would mean that standard patient packs carrying patient information couldn’t be used). A pharmacist in the audience pointed out afterwards that the real answer to this problem is to provide appropriate pharmaceutical care to ensure that the patient understands how they should be taking their medicine – a concept that should be familiar to all those involved in clinical pharmacy.
Although this example may not necessarily have been the most suitable in the circumstances, it illustrated the point that problems should be viewed from the perspective of their effect on the health system as a whole, not just the potential impact on the individual institution, and that pharmacists’ principal loyalty should lie with the patient, not the industry. There are many areas where hospital pharmacists could use their powers more effectively, and following a structured approach to problem solving offers a way of reaching an appropriate, and defensible, solution.

Closed-loop computerised medication administration
One of several satellite symposia introducing new advances in therapeutics and technology was a presentation of preliminary data from a study at the Haim Sheba Medical Centre in Israel, chaired by Laurence Goldberg, UK-based  Consultant Pharmacist. The trial is monitoring the introduction of an automated medication administration system designed to provide seamless patient care. Haim Sheba is a 2,000-bed hospital – the largest in the Middle East – but has only 30 pharmacists and technicians, a poor reporting rate for adverse events (170 reported drug-related events in 2002), and medicolegal costs of $5m. The MDG Medical Serve Rx system introduced to the hospital comprises four main elements:

  • A computerised medication-dispensing cabinet.
  • A mobile computerised cart.
  • Ward-based workstation software.
  • Computerised Physician Order Entry on handheld computer.

It has initially been introduced to a geriatric rehabilitation ward, with another geriatric ward acting as a control. So far the automated ward has shown a reduction in medication errors. It is also hoped that the system will free up pharmacist time as nurses take on significant involvement in the process, filling the medication carts from the cabinet and administering them to patients in a step-bystep process controlled by a barcode system. The system has been evaluated against a range of outcome measures over a 50-day period, and the results are still being analysed.
One of the advantages of the system is its flexibility. A new pilot site in a surgical ward at Hammersmith Hospital in London, UK, will test the system using patient packs, and it is possible to use the system in conjunction with whatever commercial  drug software packages are routinely used in a particular country. It also has the capability to be linked to laboratory results.

The first results from the Hammersmith pilot site are expected in six to nine months time, and will be covered in Hospital Pharmacy Europe later this year. 

Next year’s EAHP meeting

9th Congress of the European Association of Hospital Pharmacists Palacio de Exposiciones y Congresos Sevilla, Spain 17–19 March 2004 

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