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Electronic prescribing has grown strongly in the US but its future as a European-wide approach in healthcare has been uncertain; new regulatory interest could change the playing field.
With underlying technologies advancing, there has been a drive in recent years to introduce electronic prescriptions. Although electronic prescribing has gained popularity in the US and been explored by a few countries in the EU, such as Sweden, Denmark and the Netherlands, it's widespread acceptance in Europe is still pending, particularly as official backing has been unclear.
This situation looks likely to change. The EMA's Unit for Information and Communications Technology recently issued a request for expressions of interest from softwaredevelopment companies to participate in a workshop, scheduled to be held at the beginning of October, on the future of electronic prescribing in the EU (1). The outcome, once published, will provide important insight into how the agency will regulate the area of electronic prescribing. As any changes in the way prescriptions are handled will impact all stakeholders within healthcare, the EMA also extended its workshop invitation to physicians, pharmaceutical purchasers, patient representatives, health-technology-assessment bodies, specialists in the safety of medicines, experts in quality monitoring of healthcare, regulators and representatives of the pharmaceutical industry. Members of the EMA's electronic summary of product characteristics (e-SPC) project will be the main representatives from the agency's side. The e-SPC project has been examining how the information regarding authorised medicines that appears in summaries of product characteristics can be structured to better relate to available and emerging electronic media. The hope is that by understanding prescribers' information needs and providing a means to supply it electronically, the prescribing process can be better customised for individual patient needs, while also improving safety and effectiveness.
Much attention in the area of electronic prescribing inevitably centres on technologies emerging in daily life, such as faster internet connections, iPads and voice-activated control systems, that might be harnessed for the purposes of heathcare. However, focus also needs to be broader for electronic prescribing to stand any chance of success. Technology cannot just be looked at in isolation and needs to be customised to suit the situation and the people who will be using it. You can't just throw a gadget at something and hope that it solves all your problems! Thus, electronic prescribing cannot just be a simple tool that delivers prescriptions in an electronic format; it must integrate into the existing healthcare system, making it more secure and reliable as a result of the electronic decision-making database systems employed.
Electronic prescribing has several potential advantages; for example, it could provide a means to crosscheck on double medication, contra-indications and dosage at the moment of prescribing. In particular, much has been made of the potential an electronic approach offers in reducing the number of medical accidents due to prescribing errors. In a litigious country such as the US, this potential benefit is a highly topical subject and has contributed towards greater acceptance of the electronic prescribing concept. For example, one US legal firm cites figures stating that 7000 people lose their lives due to prescription mistakes annually and that more than 100000 people are affected by prescription mistakes each year (2). A 2007 report by CNN also stated that an estimated 30 million dispensing errors out of 3 billion prescriptions annually occur at outpatient pharmacies in the US (3). There is also a concern that prescription errors are increasing. This is partly due to the wide array of drugs now on the market, some of which have similar names, and a greater reliance on healthcare services taking place outside the hospital.
In Europe, it is much harder to get a picture of how widespread this problem is, but some information is available for individual countries. In the UK, a 2009 report commissioned by the General Medical Council (GMC) suggested that almost 1 in 10 prescribed items in hospitals had errors associated with them (4). The study involved hospital pharmacists in 19 hospitals in North West England. Out of 124260 medication orders checked by pharmacists within the study hospitals over a predefined period, 11077 errors were detected (6). Of these, 2% were classified as potentially lethal (4). Worryingly, errors were made by all grades of doctors, including consultants. Nearly all these errors were reportedly intercepted by pharmacists before the patients received the medicines prescribed. In a separate part of the study that examined qualitative factors in prescribing, many doctors stated that they relied heavily on pharmacists and nurses to identify and correct prescribing errors. In effect, they believed that pharmacists provided an important safety net to prevent patients receiving the wrong medication. For example, if a system links up to a patient database, it may be able to provide details about medicines that specific patients need to avoid because of interactions with other drugs. In addition, if a doctor mistakenly prescribes a medicine that could potentially interact with another, the electronic system could immediately flag up a warning.
The European leaders in electronic prescribing are Sweden and Denmark, but the concept is gaining momentum in the Netherlands. In 2002 the Dutch government established the National IT Institute for Healthcare (Nictiz) to introduce IT solutions into the field of healthcare. Nictiz initially focused on gathering the medication history of patients based on dispensing information retrieved from community pharmacies. It has now implemented solutions for electronic prescribing, but has acknowledged difficulties in convincing all physicians of the benefits of the system.
Despite this, most general practitioners in the Netherlands now register their prescriptions electronically. Patients tend to first be treated by a GP before being referred to specialists, and Nictiz has noted that it is the specialists giving the consultation who often still seem reluctant to use electronic devices to enter patient data. There could be several reasons for this. Doctors may feel as if they are losing control by handing everything over to an electronic system, or they could be way about the promises of electronic systems, which largely remain untested on a wide scale.
In the Netherlands, electronic prescriptions will be equipped with an electronic signature from the prescriber, which will make the paper version obsolete. European legislation requires a signature to be on a prescription, but Dutch law has been amended to accept an electronic signature as valid from a recognised prescriber. As well as improving the acceptance of electronic prescriptions, it is necessary to have adequate intervention systems in place. Although the telephone still acts as an emergency option, the hope is to have electronic intervention systems that can automatically flag anomalies. The speed of such systems is critical. For example, when patients have been discharged from the hospital, it will be important that medication instructions do not get overlooked as their care is transferred to others outside the hospital.
Other countries in the EU are only cautiously exploring electronic prescribing. For example, an electronic prescriptions project was launched in April 2011 by the Czech State Institute of Drug Control, but the system seems only electronic in name as each prescription tends to be accompanied by a paper version. Czech health insurance funds do have no access to the electronic prescription system, which means they are unable to check that a particular prescription was actually filled by a doctor. Consequently, this affects reimbursement decisions for the medicine, but Czech health insurance law is currently being amended to close this gap. To date, the electronic prescription system has only been used by eight doctors and eight pharmacies, with 512 electronic prescriptions issued, but the entire project has cost more than €6.99 million (5). The Czech situation illustrates the need for an approach to electronic prescribing that takes into account all stakeholders in healthcare, which is why the EMA has made efforts to include a wide range of participants in their workshop.
Electronic prescribing has important implications for the pharmaceutical industry because it will represent a change in physician behaviour. Pharma companies will need to determine how this trend will affect the prescribing of their products and ensure they provide physicians with adequate support (9). To maintain relationships with physicians, companies will need to be seen as experts in the electronic prescribing field themselves. In the US market, pharmaceutical companies have had to adapt very quickly to changes in physician attitudes and assess the strategy of their sales representatives who interact with physicians. In 2007, only 6% of physicians were prescribing electronically, but by 2010 this had jumped to over 30% (6)—and financial incentives from the US government to drive uptake mean that this trend will increase.
In Europe, although there has been discussion of the issues around electronic prescribing, there are few obvious signs that the pharma industry is preparing for large-scale uptake. It is inevitable that it will be eventually adopted, but no timeline can be predicted at the moment. The EMA's workshop will provide important direction to those interested in the concept and provide an official framework for the field to develop. Based on these outcomes, the European pharmaceutical industry will need to rapidly adapt to the changing prescribing environment. However, its knowledge of markets where electronic prescribing has proved a success should provide suitable experience to deal with changes in the European healthcare environment.
1. EMA, "Software development companies invited to express interest in workshop on electronic prescribing", News Release (UK, 2011).
2. Whitener Law Firm, P.A, "Prescription mistakes" (US, 2011). www.whitenerlawfirm.com, accessed 9 Sept. 2011.
3. E. Cohen, "Don't be a victim of pharmacy errors", CNN (2007). http://edition.cnn.com, accessed 9 Sept. 2011.
4. Guild of Healthcare Pharmacists, "Pharmacists EQUIP doctors with safety net when it comes to prescribing in hospital" (2009). www.ghp.org.uk, accessed 9 Sept. 2011.
5. PMR, "Czech e-prescription system paperless only in name" (2011). www.ceepharma.com, accessed 9 Sept. 2011.
6. E. John. "Pharma must prepare for e-prescribing closeup", Medical, Marketing & media (2011). www.mmm-online.com, accessed 9 Sept. 2011.