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Pharmaceutical care models and therapeutic innovations in Europe


The European Society of Clinical Pharmacy Autumn symposium, held in Dubrovnik on 21-24 October 2008, was attended by more than 800 pharmacists from 40 countries

Laurence A Goldberg
Editorial Consultant

The benefits of pharmacy practice are said to include rational drug selection, prevention of adverse drug events and unnecessary hospitalisation, and improvement in patient outcomes. It is important to be able to provide evidence for these assertions, and economic evaluations can help to do this, according to Steven Simoens (professor of pharmacoeconomics, Catholic University of Leuven, Belgium).

Economic evaluation
Economic evaluation involves linking effectiveness and costs. Economic evaluation can assess efficiency of pharmacy practice by linking the clinical and humanistic impact to resource requirements. As such, the results of economic evaluation allow pharmacists to speak to managers and persuade them to invest in services.

Turning to the detail of economic evaluation, Professor Simoens explained that the process always involves a comparison of at least two interventions that are assessed in terms of both costs and consequences. In general it is better to examine specific
interventions rather than a mixture of activities.

Many studies have shown positive benefits of pharmacy services due to direct savings or estimated cost avoidance arising from reduced adverse drug events (ADEs) or decreased length of stay in hospital. Greater savings can be made for specific interventions such as preventing ADEs, switching therapy or in high-cost areas such as intensive care units.

When planning a clinical pharmacy service, “think of areas where a big impact can be made such as neonatal care-saving one patient here could mean a gain of many years of life,” advised Professor Simoens. It is also important to focus on areas where the pharmacist can add value, he added.

When calculating costs it is important to look at net costs. In practical terms this means the difference between the saving made by the intervention and the cost of providing the service (ie, the pharmacist’s salary). Many studies overlook this element, said Professor Simoens.

Clinical pharmacy involves a process of care that has multiple consequences.

Cost-effectiveness analysis, which focuses on a single consequence, does not lend itself readily to this situation and can only give a partial picture of efficiency.

Cost-utility analysis, which measures benefits as quality of life or life expectancy, and cost-benefit analysis (CBA), which puts monetary value on benefits, are both more suitable for  evaluation of pharmacy services. However, CBAs often only focus on costs and exclude health benefits. As a result, the economic value of pharmacy practice is underestimated.

Professor Simoens concluded that pharmacoeconomics is a suitable tool to evaluate pharmacy practice and to present information about efficient pharmacy practice to policymakers. However, it requires methodologically sound assessments of the practice and must take account of the decision-making context
facing policymakers.

Diffusion of innovations
There is a gap between the efficacy of many drugs, which is demonstrated in clinical trials, and the effectiveness when the drug is used in day-to-day practice. Published evidence suggests that 65% of patients with hypertension receive the recommended treatment. For those with atrial fibrillation the proportion receiving recommended treatment is only 25%.

This situation provides pharmacists with a tremendous opportunity to improve the quality of care, according to Philip Schneider (clinical professor and associate dean for academic and professional affairs, University of Arizona College of Pharmacy, Phoenix).

The adoption of changes in healthcare can be painfully slow, explained Professor Schneider. For example, over a four-year period during the 1990s there were only modest improvements in adherence to guidelines for treatment of acute myocardial infarction. Pharmacists should take responsibility for adherence to best practice with medicines, he suggested.

At present in the USA, 19.7% of patients with left ventricular systolic dysfunction (LVSD) receive angiotensin-converting enzyme inhibitors, whereas the goal is 90%. Similarly, smoking cessation counselling is currently offered to eligible patients by 34% of hospital pharmacies but the target is 80%.

Some people are more likely to adopt new ideas than others. “Innovators” and “early adopters” will always be the first, most people will follow as middle or late adopters and a few laggards will always be the last. “Do not waste time working on the late adopters and the laggards,” advised Professor Schneider.

It is a mistake to imagine that innovations will sell themselves. By way of example Professor Schneider pointed out that a cure for scurvy, the disease that killed more sailors than all other causes, was discovered by James Lancaster in 1601 but was not adopted by the British Navy until 1797. Similarly, the QWERTY keyboard that was originally introduced to slow typing speed and avoid key jams is still universally used in spite of the development of the more efficient Dvorak keyboard.

The diffusion of innovation can be helped by a number of critical measures. When a sound innovation is identified, innovators and early adopters should be cultivated. Early adopter activity should be made visible and room should be created for change. Above all, managers should lead by example, he concluded.

Clinical evidence Evidence-based medicine (EBM) allows access to research and permits comparison of treatments. It also helps healthcare professionals to identify effective treatments and discontinue ineffective treatments, Mark Stuart (deputy editor of BMJ Best Practice, London, UK) told the audience. EBM is concerned with the application of filtered, contextualised information. EBM does not tell prescribers what to do, but it identifies options and provides the supporting information in
defined populations, he explained.

It is important for evidence to be contextualised, otherwise there is a danger of information overload. Pharmacists need to take into account patients’ conditions, values and circumstances.

Sources of EBM information can be categorised according to a pyramidal model with systems such as computerised decision support at the top and original studies at the bottom. In between, in descending order, are summaries (eg, BMJ Clinical Evidence), synopses (eg, evidence-based journal articles) and syntheses (eg, Cochrane reviews). The higher the information source in the pyramid, the more useful it is to guide practice.

Translating trials into practice
Randomised controlled trials will remain the basis of EBM for the foreseeable future, but they must be interpreted with care, said Marcel Bouvy (SIR Institute for Pharmacy Practice and Policy, Leiden, and Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Netherlands).

There are many points at which the interpretation of a clinical trial can be affected – for example, the design can be faulty, reviewers may be insufficiently experienced and editors can be biased. Further on, practitioners can be biased or influenced by advertising, the public can have a limited understanding and other investigators can overinterpret the results. The situation is further complicated by the use of the drug in a wider population in real life than in the original clinical trials.

A subtle problem that can arise is inadequate follow-up, explained Dr Bouvy. For example, early trials of rofecoxib failed to identify cardiovascular problems because they do not occur in the first 18 months of treatment and trials ended before the effects became obvious.

A different type of problem arose with mibefradil, a calcium channel blocker that inhibits CYP3A4. In trials it was not a problem because patients were carefully selected, but in normal use it caused numerous troublesome drug interactions.

Trials for many new drugs lack meaningful clinical outcomes and rely instead on surrogate endpoints such as glycaemic control with oral antidiabetic agents or tumour progression with cytotoxic agents.

Another important aspect is the context of a study. For example, an early study had shown promising results when spironolactone was added to other treatment for severe heart failure. In the subsequent multicentre RALES study only 4% of the treatment group was able to tolerate spironolactone to the study end. Dr Bouvy concluded by advising pharmacists to examine the quality of a study and interpret the results in the context of day-to-day practice.

Patients usually minimise their drug adherence problems, said Marie-Paule Schneider (ambulatory care pharmacist, University Hospital, Lausanne, Switzerland). Describing the drug adherence programme in the University Hospital of Lausanne, she explained that physicians referred patients with chronic diseases who had problems with adherence.

The majority of the patients in the programme are HIV-positive and they attend the clinic every two months.

Adherence is modified through a combination of motivational interviewing and use of Micro-Electro-Mechanical System (MEMS) containers that record each opening of the container by means of a microprocessor in the cap.

Seven pharmacists and three technicians are involved in the programme, and they spend 30 – 35 minutes in total on each patient at each consultation. Technicians handle the supply functions, and the pharmacists are responsible for interviewing the patients. A study is currently underway to evaluate the
outcomes of the project, said Dr Schneider.

Nonprescription medicines
Half the medicines purchased every day in European pharmacies are nonprescription medicines, according to Hubertus Cranz (director general, Association of the European Self-Medication Industry (AESGP).

The availability of over-the-counter (OTC) medicines for self-treatment is regarded as desirable, and there is increasing harmonisation of these products throughout Europe, he continued.

Although some national differences persist, the AESGP database shows that numerous important switches to nonprescription status have been made in recent years.[1] For example, loperamide and nicotine patches and gum are available as OTC medicines in five European countries (France, Spain, Germany, Italy and the UK), whereas simvastatin is only available in this way in the UK. Naratriptan can be purchased in Germany but not in the other countries.

It is important to ensure that pharmacists are educated to support and guide patients in the process of self-care, and teaching about nonprescription medicines should be a priority in universities, he emphasised. This should include training in communication and counselling.

The future of self-medication is closely related to the future of pharmacists, he concluded.

Medication risk management
Until the ENEIS study there was a general refusal in France to recognise the occurrence of adverse drug events, Edith Dufay (chief pharmacist, Luneville Hospital, France) told the audience.[2]

After the study, which was similar to the Harvard Medical Practice study, patients were granted defined rights about safety in healthcare and medication risk management became a topic of discussion. Hospitals in France are now required to demonstrate that they have medication risk management measures in place.

The next step will involve certification for hospitals. Patient safety will play a prominent role. One element is called “the therapeutic process” and includes computerised prescribing, review of drug orders by pharmacists, unit-dose distribution and the analyses of medication errors.

The ENEIS study identified 450 serious adverse events in 8,754 hospitalised patients. The results suggest that there are 40,000-60,000 avoidable adverse drug events each year in France. Pharmacists must now build a programme to reduce ADEs, said Ms Dufay.

A handbook is now available that explains the steps involved in REMED (Revue des Erreurs liees aux Medicaments et Dispositifs associes) and provides template documents. It is not easy to persuade people involved in errors to get together, but “it is a real mission for hospital pharmacists”, she said.

One difficulty in France is that there is no protection for healthcare professionals who have been involved in a medication error – they are obliged to hand over documents and could be prosecuted, explained Ms Dufay.

Generic medicines
Aleksander Danilovski (Pliva, Croatia Ltd) described how the world climate for generic medicines is now undergoing rapid changes.

Until recently, the generic market targeted blockbuster drugs, but this is no longer a profitable strategy as too many generic manufacturers enter the market immediately after the patent has expired on a branded medicine. This has the effect of reducing the price dramatically.

Another factor that has changed is the main source of supply of the active pharmaceutical ingredients. In the past they were sourced in Europe, usually from Spain, Italy, Hungary or Germany, but now Chinese and Indian suppliers dominate the market.

Generic manufacturers are now developing new strategies for survival, explained Dr Danilovski. Increasingly they are targeting niche markets and undertaking brand development and licensing of new products to fill gaps in the marketplace.

The ideal position for a generic company is to develop a “supergeneric”, a new product that genuinely adds value following the “better than good” principle – for example, finding a way to improve the safety or tolerability of an established drug.

Another avenue for generic manufacturers is to extend global reach – by 2012, 50% of worldwide demand will come from the emerging economies of Latin America, South Eastern Europe, Asia and Japan, which together currently account for about 30% of demand. Selling into these markets could be very
profitable for generic manufacturers.

1. European Self-Medication Industry (AESGP). OTC
ingredient tables. Available from:
2. ENEIS (Enquête Nationale sur les Evénements
Indésirables Graves liés aux Soins). In French. Available

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