Pharmacists from over 30 European countries attended a seminar in Strasbourg, France from October 20 to 22 to promote the role of the pharmacist in managing new health risks presented by emerging technology
The main risks of self-medication arose from interactions with foodstuffs or other drugs, contraindications in certain conditions, and adverse events caused by incorrect use of medication, stated Mr THIERRY ROISIN (pharmacy inspector, Belgium). In addition, patients might underestimate the seriousness of their condition and pharmacists might overestimate it. Also, drugs might conceal the symptoms of serious disease, preventing early diagnosis.
At present, self-medication was thought to account for 22 per cent of sales in Belgium and, in France, 80 per cent of the population were thought to self-medicate. The use of self-medication was likely to increase probably because of the change in consumer's attitudes to medicines and the public was increasingly keen to take care of their own health. Also, political authorities were aware that it could lead to significant savings in the health budget.
Pharmacists were seen as guarantors of the products that they sold and were responsible for advising patients on the correct use of medicines. The general public were being inundated with information about medicines and health and it was not an easy task for them to distinguish between information that was objective and that that was promotional. Pharmacists were entitled to refuse to sell medication that they thought to be inappropriate for a particular patient. They should also be aware of their limitations and be prepared to refer patients, if necessary.
Mr Roisin thought that it would be beneficial to allow pharmacists to undertake repeat dispensing of drugs initially prescribed by a doctor, under conditions established in advance concerning the number of repeats allowed. This would be most appropriate in conditions that did not require close medical supervision.
Workshop conclusions
The revolution in DNA-based and related technologies was leading to the development of novel biological medicines and diagnostic tools, said Dr ELWYN GRIFFITHS (department of vaccines and biologicals, World Health Organisation). In addition, there was now the prospect of correcting or replacing defective genes. While the potential benefits of these new technologies were enormous, they generated new safety issues that would have to be considered by the industry and regulatory bodies.
The behaviour of cells post-manipulation was not fully known. There might be a major risk of contamination. In the case of xenotransplantation, a benign animal virus might become pathogenic in humans, leading to infection in the individual and a health risk to society. For gene therapy, perhaps the biggest danger was the potentially pathogenic effects of the virus vector. Viruses that had been engineered not to replicate might, through recombination events, become infectious. Also, the possible integration of vector DNA at sites that disrupted normal cell function and caused cancer had to be considered. The challenge continued to be to ensure the safety of new technology, without inhibiting the development of useful medicinal products. This could be done by predicting and acknowledging potential issues and finding ways around them. There needed to be international collaboration over this, as infection knew no boundaries.
Pharmacists working in industry and regulatory agencies would play an important part in these discussions, in decision making and in managing the risks.
Workshop conclusions
Although it was well known that developing countries suffered from the problem of counterfeit drugs, it was less well known that they also existed in Europe, said Dr DIETRICH SCHNÄDELBACH (former chairman, European Pharmacopoeia Commission, Germany).
Counterfeits that appeared in the legal distribution chain in Germany were usually based on original products that had been repackaged illegally, almost certainly with no use of good manufacturing practice. It was possible that such products would be mislabelled, expired, be deteriorating due to poor storage, or simply be the wrong medicine. Criminals selling drugs on the black market found it easier to sell counterfeits, as they did not then need to circumvent the official distribution chain.
Pharmacists working in wholesalers should only buy stock from reliable sources, as should those working in pharmacies, he said. They should inspect the products that they handled and not dismiss complaints from patients that products tasted, smelt or appeared to be different from usual. This would help to contain the risks that might emerge from counterfeit and other illegal medicinal products.
Workshop conclusions
Pharmacists added value in two basic ways, said Dr MICHAEL ASCIAK (a member of the parliamentary assembly of the Council of Europe). First, as a health worker specialising in pharmacology and, secondly, as a guardian of the ethics and morals of new biotechnology and medicines.
In the first instance, the pharmacist provided patients and colleagues with correct scientific information about drugs. Dr Asciak described a tool, developed by the University of Malta, that monitored the professional services provided by community pharmacists and measured the impact of pharmacists' interventions in patient care. The skills assessed by this tool included dispensing, responding to symptoms, communication with patients and the standard of equipment used. The system was being adopted by the Swiss Pharmaceutical Society, he said. The sale of medicines over the internet allowed patients to obtain medicines directly from the manufacturer, completely by-passing the protective scientific input of the pharmacist. He suggested that legislation be brought in that required all medicines sent through private or state postal services to be released by the post office only after they had been vetted by a pharmacist.
Cloning, genetic engineering, pre-natal diagnosis and experimentation on human embryos presented a challenge to human rights and the Convention of Human Rights and Biomedicine, published by the Council of Europe, could guide well-meaning scientists through the minefield of misguided or misplaced ethics. Pharmacists should care for the lives in their hands and strive to maintain the dignity of patients at all times. The human body should not give rise to financial gain and dignity should not be dispensed at a financial cost, he concluded.
Added value - a health economist's view
The future of pharmacists depended on the extent to which they could achieve added value, both in health insurance schemes and state-run health services, stated Dr WILLY OGGIER (health economist, St Gallen, Switzerland).
Pharmacists would have to cope with increased competition, as drug stores, health food shops and supermarkets would become increasingly active in the over-the-counter (OTC) market. In addition, the mail-order trade, especially in drugs offered on the internet, would gain in importance for both prescription and non-prescription items. If pharmacists did not modify their stance, these players would continue to erode the pharmacist's role and the very existence of pharmacies would be brought up for serious discussion. Three alternative scenarios were suggested by Dr Oggier. These were: that small pharmacies would combine to work with each other at a single location; that pharmacists would become integrated into the health care team and would provide drug and economic information to physicians and nurses; and that they would became a partner of political authorities. In this last scenario, the pharmacist could be deployed to fight against the illegal trade in pharmaceuticals via the internet and other channels, and would have more of a policing role. Pharmacists had to adapt, otherwise they ran the risk of falling behind, especially when compared with general practitioners.
Added value - an insurance company's view
There had been much discussion during the seminar of the value of pharmacists in ensuring quality and safety, and in providing advice. However, little had been said about the cost of this service and whether it was worth the cost, said Dr JOSEPHA HULSHOF (department of curative services, Health Insurance Council, the Netherlands). Was society willing to pay for the future of the profession or would a crisis in professional identity and a reluctance to pay for the expertise of pharmacists slowly but steadily undermine the status of the profession? In the Netherlands, 20 per cent of the total drugs bill was spent on handling, quality control and dispensing. Although pharmacists claimed to have reduced the drugs bill by rationalising prescribing, it was hard to tell what their actual contribution had been. Much was said about pharmacists preventing iatrogenic pathology but they could also cause it if they did not do their job well. Dr Hulshof challenged professional and academic organisations to start research on the added value that the profession actually provided. Only when this information was available could pharmacy liberate itself from the position of underdog.
The internet provided an opportunity for pharmacists to establish themselves as an experienced, knowledgeable "coach" that transformed the infinite amount of data available into useful information for patients. The role of the pharmacist would be determined by trends towards cost containment and evidence-based medicine. Increasingly, treatment could be standardised and one pharmacist would eventually be able to oversee automated prescribing, dispensing and pharmacovigilance. However, not all patients would be suitable for standard treatment and would require the specific knowledge of specialised pharmacists. Furthermore, standardised treatment had to be developed in the first place, which would also require specialist knowledge. One thing was sure: new technology was here to stay and it was better to be prepared than to be taken over by surprise.
Added value - a pharmacist's view
A contrasting opinion was presented by Mr PEDRO CAPILLA (president of the General Council of Pharmacists' Societies, Spain). He said that authorities were now becoming more aware of the cost savings that pharmacists could offer, even just in terms of reducing hospital stay.
A database had been set up by the General Council of Pharmacists' Societies in Spain that gave data on the principal activities of pharmacists. Once a month, prescriptions that had been dispensed were collected and data extracted on many aspects of drug use, including drug interactions, doses and side effects. This information could then be used to analyse expenditure on medicines and to provide data to support the profession. Medicines were not simple, commercial goods and it was important that they be handled by knowledgeable professionals. An ongoing training programme for pharmacists was underway in Spain, as it was felt that life-long learning was vital. Other components that would contribute to the success of the profession were forming networks with other health care professions and increased specialisation among pharmacists.
Improvement of information flow within the health care system was now possible because of advances in electronic data processing, said Dr HAMID FARROUKH (Federal Union of German Associations of Pharmacists).
Currently, doctors used a computer to print out a paper prescription, which was taken to the pharmacist, who then put the details on to their computer. The paper prescription was then sent to the pricing authorities (and insurance companies in some countries) who entered the data on to their computer. All of this could be accomplished more easily if the entire system was computerised and linked. The goal was to create an infrastructure that allowed storage of medical data in a secure and trustworthy form. The Federal Union of German Associations of Pharmacists was working on systems for Germany based on smart cards or networks. The advantage of smart cards was that they were portable, provided security and confidentiality and off-line processing was possible. This would be useful, for example, when doctors made house calls. A card that worked via a network required that the doctor should know to whom the message was to be sent. The problem with this was that patients did not always go to the same pharmacist to have their prescriptions dispensed.
He concluded by saying that a prototype electronic prescription had been completed but had not yet been incorporated into the software of pharmacists and physicians.
Workshop conclusions
Everybody benefited from the speed of the internet and the worldwide availability of expert knowledge. However, the new sales and advertising opportunities it presented might be less beneficial, said Mr LUTZ TISCH (head of legal section, Federal Union of German Associations of Pharmacists, Germany).
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Delegates from 30 countries attended the Council of Europe seminar |
Also of concern, was that sales of this sort could not be regulated using the laws of the country in which the drugs were received, only by using the laws of the country of origin. If European laws were set up that guaranteed the safety of drugs bought over the internet from European countries, that might be seen as an endorsement of this form of supply. The laws of the country of destination should be applied to such sales, rather than those of the country of origin. This would not prevent a company from offering drugs on the internet in countries where it was permitted as they could indicate on their website for which countries the offer was valid. A warning could also be added saying that orders would not be processed from countries that prohibited such sales. Another option would be to prohibit the sale of drugs in this manner but it would be difficult to achieve, as members of the European Union differed strongly as regards drug advertisement and sales.
Getting the most from the internet
The web was the fastest growing communication medium ever. It took two and a half years to reach 10 million users, compared with 35 years for the telephone, 22 years for the fax and five years for the wireless, said Mr JOHAN de GIER (Health Base Foundation, Holland).
Worldwide, 44 per cent of physicians accessed the web and 75 per cent of doctors in the UK, US and Canada used it on a daily or weekly basis. Although figures for pharmacists were not available, Mr de Gier guessed that their usage was probably similar. There were already 30 web pharmacies operating in the US and one of the largest (drugstore.com) was part-owned by amazon.com - a bookseller. Pharmacists could be reactive by providing information to patients on demand or they could be proactive and provide information and education before the patient was even unwell. This would require full partnerships with doctors, other health care providers, and organisations that paid for health service provision. There would be more of a health promotion emphasis, which could begin with consumers of school age. A proactive approach was a "winner's scenario" and would allow pharmacists to become a critical part of the health care landscape.
Is the internet really a problem?
It was easy to forget that 80 per cent of the world's population had never used a telephone, let alone sent an e-mail message, said Mrs KIRSTEN MYHR (Norwegian Board of Health). The typical internet user was male, under 35 years old, with a university degree and a high income - he was urban-based and spoke English. The typical user of health services was female, over 65 years old, with low social status and had hardly seen a computer, let alone used one. So was the internet problem being blown up out of proportion?
Internet sales of drugs did invite irresponsible doctors, pharmacists or, indeed, anybody, to operate with little risk of prosecution. However, it was unlikely that this could be stopped. The question was how to raise consumer awareness of the risks and for the professions to make the best of the situation. The final aim might be harmonisation of international laws and regulations regarding medicines but this had a long way to go until it was achieved. In the US, the National Community Pharmacists Association had provided participating pharmacies with their own websites, which were organised into a nationwide network (cornerdrugstore.com). This was marketed aggressively nationwide as one brand, uniting all independent pharmacies. Also, the National Association of Boards of Pharmacies was offering on-line pharmacies the opportunity to register and be given a seal of approval.
Workshop conclusions
Pharmacists should be included in the developing health care computer networks, stated Mr IAN SHEPHERD (Royal Pharmaceutical Society of Great Britain). They could demonstrate their value both by using the information made available by such networks to enhance patient care, and by providing information for use by other health care professions. The barriers that might prevent pharmacists from having access to information were largely political rather than technical. However, increased access to clinical information also meant that pharmacists must have the knowledge necessary for using it appropriately and reliably. In the United Kingdom, the process of linking community pharmacists into health care networks was currently receiving much attention but was, at present, struggling to provide an adequately attractive case for the financial investment required. An alternative would be for such networking to be driven by pharmaceutical organisations, with funding provided by the pharmacists themselves.
Pharmacists should consider developing systems for confidential recording of everyday tasks such as community pharmacy interventions, counselling and education of patients, compliance monitoring and repeat medication provision. This would provide evidence of the invaluable role they had to play as part of the health care team.
Workshop conclusions
The seminar proceedings are available on http://www.coe.fr/soc-sp/sem.htm, the Council of Europe website. Conclusions of workshops that discussed presentations further are on The Journal website (www.pharmj.com).