Cross-border recognition of medicines prescriptions: results from a mystery shopping experiment

Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.19 | No.4 | 2013 12 3 Hesselink G, Vernooij-Dassen M, Pijnenborg L, et al. Organizational culture: an important context for addressing and improving hospital to community patient discharge. Medical Care 2013; 51: 90 – 8. 4 Hesselink G, Flink M, Olsson M, et al. Are patients discharged with care? A qualitative study of perceptions and experiences of patients, family members and care providers. BMJ Quality & Safety 2012; 21: 39 – 49. 5 Groene O, Poletti P, Vallejo P, et al. Quality requirements for Cross-Border Care in Europe: a qualitative study of patients’, professionals’ and healthcare financiers’ views. Quality & safety in Health Care 2009; 18: 15 – 21. 6 Glonti K, Hawkesworth S, Doupi P, et al. An exploratory analysis of hospital discharge summaries across Europe. Journal of Health Services Research and Policy (submitted mimeo). CROSS-BORDER RECOGNITION OF MEDICINES PRESCRIPTIONS: RESULTS FROM A MYSTERY SHOPPING EXPERIMENT By: Rita Baeten and Lorena San Miguel Summary: According to the Directive on the application of patients’ rights in cross-border health care, medicines legally prescribed in a Member State should be dispensed by pharmacists in other Member States in which the medicinal product is authorised. We explored potential challenges from a public health perspective, which could arise when this provision is implemented. Our research included a mystery shopping experiment in which we presented prescriptions prescribed in other European Union countries in pharmacies. We conclude that, overall, the provisions on mutual recognition of medical prescriptions in the Directive do safeguard patient safety. Yet, clear information and guidelines for pharmacists and prescribers on the legal framework are indispensable to ensure effective implementation. Keywords: Cross-Border Care, Medical Prescriptions, Mutual Recognition, Directive on Patients’ Rights Rita Baeten is Senior Policy Analyst at the European Social Observatory (OSE), Brussels, Belgium and Lorena San Miguel is an Expert in Economic Analysis at the Belgian Health Care Knowledge Centre (KCE) and former Researcher at the OSE. Email: baeten@ose.be Mutual recognition of prescriptions The European Union (EU) Directive on the application of patients’ rights in cross-border health care, 1 provides that medicinal products legally prescribed in a Member State should be dispensed by pharmacists in other Member States in which the medicinal product is authorised (Article 11). (See also the article on ‘Cross-border Health care: common rules on medical prescriptions when travelling to another EU country’ in this issue). Restrictions on the recognition of individual prescriptions are prohibited unless limited to what is necessary to Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.19 | No.4 | 2013 13 safeguard human health or based on legitimate and justified doubts about the authenticity, content or comprehensibility of an individual prescription. Medicinal products containing narcotic and psychotropic substances and products likely, if incorrectly used, to present a substantial risk of medicinal abuse, to lead to addiction or be misused for illegal purposes, are excluded from this mutual recognition. 2 In an implementing act, the Commission ruled that Member States have to ensure that prescriptions which are issued upon the request of a patient who intends to use them in another Member State, should contain a minimum set of elements, including professional qualifications and contact details of the prescriber. Additionally, aside from some exceptions, these types of prescriptions should be written using international non- proprietary names (INN). 3 The Directive had to be transposed into national law by 25 October 2013. Our research aimed to identify potential challenges from a public health perspective that could arise when this provision is implemented; in particular, a prescribed product may not be dispensed to a patient who needs it; an inappropriate product could be dispensed or inappropriate instructions may be given at the time of dispensing and finally, a product may be dispensed and further consumed or sold based on a false prescription. The methodology used included a review of national legislation regarding prescribing and dispensing, stakeholder interviews and a mystery shopping experiment to capture pharmacists’ reactions when confronted with cross- border prescriptions. Ensuring cross border access to medicinal products Between October 2011 and February 2012, 192 Belgian or Finnish prescriptions were presented in pharmacies in five other Member States (Belgium, Finland, Germany, Spain and the United Kingdom) in order to assess whether pharmacists would dispense the prescribed product and to identify factors that influence such decisions. 4 Over half of pharmacists were willing to dispense, yet willingness varied greatly depending on the country where prescriptions were presented, with pharmacists in Finland (33% of the prescriptions) and the United Kingdom (29%) being less willing to dispense than in Belgium (67%), Germany (79%), and Spain (67%). The main reasons given by pharmacists in Finland and the United Kingdom not to dispense was a belief that their national laws barred them from dispensing foreign prescriptions. However, there is no such legal restriction in the United Kingdom, while Finnish prescribers in 2012 were constrained in relation to non-Nordic prescriptions.* This finding suggests that having an enforceable law in place is not sufficient to change dispensers’ behaviour; clear guidelines on how pharmacists should respond to EU prescriptions are necessary. Reasons for not dispensing in the remaining countries were primarily linked to the impossibility of identifying the correct product when pharmacists were presented with prescriptions using country-specific brand names. This obstacle appears to be key to dispensing. In most countries, prescribing by brand is still common practice. Furthermore, generic substitution is forbidden for private prescriptions in three of the five countries analysed (Belgium, Germany and the United Kingdom), which makes the dispensation of an equivalent product illegal. Our legal analysis revealed that there are differences in the information requested for a prescription to be valid in the different countries. As a result, pharmacists may consider prescriptions coming from another Member State to be ‘incomplete’. Our interviews revealed that pharmacists are more likely to dispense against an incomplete prescription in emergency cases or if the product was for the treatment of a chronic condition and presented no potential risks for the health of the patient. 5 This reflects the findings of the experiment, where no prescription was refused due to a lack of information that was legally required in the country of dispensing. Nevertheless, having a minimum list of elements included in cross-border prescriptions (as defined by * At the time of the research (2012) Finland had not yet transposed the Directive into national legislation. the Commission) would avoid refusals to dispense on the grounds of insufficient information. Avoiding confusion Although in our experiment the right molecule was dispensed in all cases (brands and pack sizes sometimes differed from the prescribed ones), the potential for dispensing the wrong product, primarily due to pharmacists’ inability to recognise its commercial name, or to read and understand the instructions on the prescription form, should be taken seriously. The Commission’s decision to limit the mutual recognition of prescriptions as a general rule to products that have been prescribed by their INN, should enable pharmacists to recognise the right product. Avoiding fraud or abuse Products that could reasonably lead to inappropriate, illegal or commercial use are excluded from the mutual recognition of prescriptions. This limits the risk of dispensing against a false prescription. To reduce the risk of fraud further it is necessary to facilitate the authentication of both the prescriber and the prescription. Although during the experiment, the verification of the authenticity of the prescription or the prescriber did not appear to play an important role in the decision on whether or not to dispense a product; we should recognise that our scenarios were for common conditions with few risks. Thus, our results should not be generalised to more complex cases in which the safety of the patient could be put at risk. Tools used nationally/locally to this end, such as prescriber codes, stamps and signatures would not help in the validation of foreign prescriptions, since codes are only valid within the specific national territories. The obligation in the Commission’s implementing act to insert contact details, in particular a phone number of the prescriber in EU-wide prescriptions, could enable pharmacists to both verify the authenticity of the prescriber, and ask for further information in case of doubt. Eurohealth OBSERVER Eurohealth incorporating Euro Observer — Vol.19 | No.4 | 2013 14 Conclusion Overall, the provisions on medical prescriptions in the Directive do safeguard patient safety. Yet, clear information and guidelines for pharmacists and prescribers on the legal framework are indispensable to ensure effective implementation. References 1 Directive 2011/24/EU of the European Parliament and the Council 9 March 2011 on the application of patients’ rights in cross-border healthcare. Official Journal of the European Union, L 88/45 – 65. 2 European Parliament and Council. Article 71(2) of Directive 2001/83/EC of 6 November 2001. 3 European Commission. Implementing Directive 2012/52/EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescriptions issued in another Member State. Official Journal of the European Union, L 356/68 – 70, 22 December 2012. 4 San Miguel L, Baeten R, Remmen R, et al. Obstacles to the recognition of medical prescriptions issued in one EU country and presented in another: An observational study. European Journal of Public Health 2013. doi: 10.1093/eurpub/ckt071. 5 San Miguel L, Augustin U, Busse R, et al. EU wide recognition of pharmaceutical prescriptions: A comparison of legislation and practices in 5 Member States. Health Policy. Available at: http://dx.doi.org/10.1016/j.healthpol.2013.11.003. WHAT INFORMATION DO PATIENTS WANT WHEN CHOOSING A HOSPITAL AT HOME OR ABROAD? A CASE STUDY FROM GERMANY By: Michela Tinelli, Zlatko Nikoloski and Dimitra Panteli Summary: The European Union (EU) is keen to promote patients’ rights, and to ensure that an informed choice is pursued when seeking health care in EU Member States. The 2011 Directive on the application of patients’ rights in cross-border health care is aimed at supporting the achievement of these goals. This article investigates German patients’ experience regarding their access and use of quality information when choosing hospital care in their own country and abroad. The findings could be used to inform the implementation of the Directive and the provision of quality information to patients, via the establishment of National Contact Points. Keywords: Cross-Border Care, Patients’ Rights, Patients’ Choice, Hospital Care, Quality Information Michela Tinelli is Research Fellow and Zlatko Nikoloski is Research Officer at LSE Health and Social Care, The London School of Economics and Political Science, London, United Kingdom. Dimitra Panteli is Research Fellow at the Department of Health Care Management, Berlin University of Technology, Germany. Email: m.tinelli@lse.ac.uk Introduction Ensuring patients have access to quality information is crucial to help them make informed choices, not only when they are in their home country, but also before going abroad for health care. One of the key objectives of the European Union's (EU) 2011 Directive on the application of patients’ rights in cross-border healthcare is to make sure that people have clear information on their rights to Cross- Border Care and relevant knowledge on quality and safety standards enforced in the country of interest, as well as specific medical, organisational and financial aspects of the health care services and the treatment options on offer. 1 Such information should be provided by so- called National Contact Points (NCPs) which are to be established in all Member States (MS). This case study investigated what type of information German patients accessed and what source they used when choosing a hospital for their care. Two scenarios were compared, one examining patients seeking care in their own country