The Access to Opioid Medication in

ATOME training of lawyers and national counterparts workshop: a report Europe an outlook In February 2011, stakeholders from Central and Eastern Europe took part in a workshop funded by the Access to Opioid Medication in Europe (ATOME) project. Tom Lynch, Sheila Payne, Willem Scholten, Saskia Jünger and Lukas Radbruch report The Access to Opioid Medication in Europe (ATOME) project commenced in December 2009, funded over five years by the European Commission. 1 Its objective is to improve patients access to opioids in 12 European countries where there is statistical evidence of very low per capita morphine consumption: Bulgaria, Cyprus, Estonia, Greece, Latvia, Lithuania, Poland, Slovakia, Hungary, Slovenia, Serbia and Turkey. ATOME is led by a consortium of ten partners from the fields of palliative care and pain management, treatment of opioid dependence, public health and legal affairs (see Box 1). 2 The consortium works with national teams comprising government officials and public health experts to review legislation and policy. The outcomes of these reviews will lead to recommendations that will hopefully improve access for all patients who require medications regulated by the international drug conventions. The key aims are harm reduction and palliative care integration. Exploring values and attitudes A two-day workshop on the training of lawyers and national counterparts, funded by the ATOME project, took place in February 2011 in Bucharest, Romania. The workshop, hosted by the Romanian National Anti-Drug Agency and organised by Hospice Casa Sperantei, consisted of a number of presentations and group (question and answer) sessions. The aim was to invite participants to reflect on their beliefs and concerns about controlled medicines used for pain and symptom management, and discuss their experiences. All the ATOME countries were represented, along with Romania. Mr. Mohamed Ramzy Ismail from Egypt represented the WHO Regional Office for the Eastern Mediterranean (EMRO). Many participants were from their countries health ministries and/or narcotic drugs agency. The workshop was led by ATOME consortium members and guest experts from the USA and Spain. In total, 35 people attended the event. A questionnaire was handed out to at the beginning and end of the workshop. In both, participants were asked to what extent they agreed or disagreed with seven statements regarding access to controlled medicines in their respective countries. The participants responses are shown in Figures 1 7. In both the pre- and post-workshop questionnaires, participants were asked to list three barriers hindering access to controlled medicines; their responses are shown in Figure 8. Participants were also asked to list three opportunities to improve access to controlled medicines (see Figures 9a and 9b). Key points The Access to Opioid Medication in Europe (ATOME) project aims to improve patients access to opioids in 12 Central- and Eastern-European countries where there is statistical evidence of very low per capita morphine consumption. In February 2011, delegates from the ATOME countries took part in a workshop in Bucharest, reflected on their beliefs and concerns about controlled medicines used for pain and symptom management, and discussed their experiences. In the autumn of 2011, two further workshops will be held in Bucharest. Eventually, a report on the findings in each country will be presented by the ATOME project team to the respective countries health ministries. EUROPEAN JOURNAL OF PALLIATIVE CARE, 2011; 18(6) 293

Getting involved On the first day, participants and experts started by describing their work and its relevance to the workshop. Among others, Bogdan Iasnic, Chief Director of the Romanian National Anti-Drugs Agency, spoke about the work of the agency; Irina Gresaru, Consultant for European Affairs at the Romanian Ministry of Health, spoke about opioid legislation in her country; and Dr Victor Olsavsky from the WHO spoke about the work of his organisation in Romania and other countries. A detailed presentation of the ATOME project by Lukas Radbruch was followed by a short group session. Then Willem Scholten delivered a presentation entitled No access to controlled medicines: who does not suffer from unaccessibility?, which was followed by another group session. At this stage, participants appeared rather reluctant to get involved although this may have been partly due to the fact that English was not their first language. After a documentary on The Two Faces of Opium and a presentation on the legitimacy of access to controlled medicines for medical purposes by Asra Husain (University of Wisconsin, USA), participants were asked to describe their Box 1. The ten partners of the ATOME* project Department of Palliative Medicine, RWTH Aachen University, Germany Hospice Casa Sperantei, Brasov, Romania Help the Hospices, London, UK International Observatory on End of Life Care, Lancaster University, UK European Association for Palliative Care, Milan, Italy World Health Organization, Geneva, Switzerland Utrecht University, Utrecht, the Netherlands Eurasian Harm Reduction Network, Vilnius, Lithuania National Anti-Drug Agency, Bucharest, Romania Harm Reduction International (formerly known as the International Harm Reduction Association), London, UK *ATOME = Access to Opioid Medication in Europe personal experiences. This greatly improved the group dynamics. Participants spoke at length about issues such as International Narcotics Control Board estimates and additional supplementation; balance, prevention and diversion of controlled medicines; and the relevance of international opioid legislation to their respective countries. Figure 1. Patients with moderate-to-severe pain have proper access to controlled medicines (n=18) Figure 2. Patients with drug dependence have proper access to opioid substitution therapy (n=18) Figure 3. Access to controlled medicines is a fundamental human right (n=18) Figure 4. Access to controlled medicines is a fundamental legal right (n=18) 294 EUROPEAN JOURNAL OF PALLIATIVE CARE, 2011; 18(6)

First feedback After a presentation by Professor Snezana Bosnjak (Serbian Institute of Oncology and Radiology) on the key role of opioids in pain management, a wide range of issues were discussed, including pseudo-dependence; barriers to opioid availability and accessibility; political issues surrounding drugs such as tramadol; lack of consumption data; and WHO guidelines on the treatment of pain, including changes to the WHO three-step analgesic ladder. 4 The participants explained their interest in ATOME and gave feedback on the workshop. Among others, the participant from Greece said they were particularly interested in legal issues and the lack of data on pain relief in their country; the participants from Latvia, Estonia and Lithuania expressed interest in the issues surrounding opioids their manufacturing, prescription, distribution and marketing and how to overcome restrictions; the Slovenian participant was interested in pain treatment as a human right, suggesting that, although there was no restriction on opioid prescribing and dispensing in Slovenia, consumption was heavily monitored; the participant from Hungary stated that balance was still necessary and that there was a need for tramadol consumption data; the Serbian Figure 5. Regulatory government systems are barriers to the accessibility of controlled medicines (n=18) Figure 6. Excessive organisational bureaucracy is a barrier to the accessibility of controlled medicines (n=18) Figure 7. Negative social and cultural stereotypes relating to opioid addiction are a barrier to the accessibility of controlled medicines (n=18) Figure 8. Barriers hindering access to controlled medicines Pre-workshop barriers to access to controlled medicines (n=10) Post-workshop barriers to access to controlled medicines (n=13) Figure 9a. Pre-workshop opportunities to improve accessibility to controlled medicines (n=11) Figure 9b. Post-workshop opportunities to improve accessibility to controlled medicines (n=12) EUROPEAN JOURNAL OF PALLIATIVE CARE, 2011; 18(6) 295

It was argued that regulations should be adapted to each country s sociocultural context participant explained that Serbia was in the process of preparing regulations for symptom management; the Polish participant said they were very interested in pain management, suggesting that opioid availability in their country was affected by a lack of knowledge among physicians; and the participant from Cyprus spoke of concerns over dependence, drug control policies and the need for more research evidence on opioid use. Comparing experiences In his presentation on the role of opioids in the treatment of dependence, Romanian psychiatrist and psychotherapist Dr Gabriel Cicu gave an overview of national strategy in Romania, but stressed the difficulties in obtaining data for the whole country. In the following group session, participants discussed issues surrounding substitution therapy, injectable drug use in prisons and availability of opioids. The participants from Romania, Poland and Serbia suggested that their national drug dependence strategies were based on cost rather than need. Presentations by Willem Scholten ( Role of other controlled medicines in medical practice ) and Asra Husain ( Prevention of abuse and diversion ) stimulated many comments and questions relating to diversion, the principle of balance in drug control policy and the effectiveness of drug control treaties. It was argued that regulations should be adapted to each country s sociocultural context, and concerns were raised that overly strict legislation may actually have the opposite effect to that intended. Prescribing laws in Poland provided a telling illustration of this. The participant from Serbia reported a lack of morphine due to overly restrictive control measures. The participant from Slovenia explained that, in their country, although legislation relating to prescribing and dispensing opioids was strict, there was still good accessibility because the regulations were accepted by both healthcare professionals and patients and families. The participants from Serbia and Romania both argued that decisions about the maximum dose given to a patient should be made by the patient s physician, not the legislator. Discussing and debating Dr Daniela Mosoiu (Hospice Casa Sperantei) delivered a presentation entitled The Romanian experience: changing from restrictive to balanced legislation, which stimulated much debate on ongoing evaluation and the way in which progress has been measured in that country; on the effectiveness of training and education initiatives; and on diversion, prescribing and monitoring. Participants also commented on bureaucracy, in particular the need to complete special prescription forms (although these were described as less complicated than before), and on the cost of opioids. The topic of the next presentation, delivered by Willem Scholten, was Ensuring balance in national policies on controlled substances: guidance for accessibility and availability of controlled medicines. In the ensuing group session, the participant from Slovenia described a strict system of monitoring opioids in their country, in particular with regard to dispensing, suggesting that new legislation was needed to advise doctors accordingly. The participant from Serbia suggested that improved training of doctors in this area was required so that they could negotiate with drug regulators. The different prescribing legislations were discussed, as well as issues surrounding cost, dosage and quantity of opioids. Dr Martha Maurer (University of Wisconsin, USA) delivered Methodology of legislation review: experience with the PPSG US Domestic Program. This prompted the participants to compare the approaches adopted by their respective countries regarding the reporting of a person abusing opioids. Social and cultural connotations were discussed, as well as medical and legal aspects. Numerous other topics were debated and areas explored during the workshop, including: examples of relevant opioid policies; defining the need for increased morphine consumption; policy relating to patient care; barriers to access identified in previous studies; barriers to access due to excessive bureaucracy and how these can potentially be overcome (for example, by using electronic systems to reduce the need for special prescription forms); border issues and opioid tourism (people moving from one country to another to avoid restrictive legislation); the domestic manufacture of opioids to improve affordability and availability; and the workability of opioid legislation. 296 EUROPEAN JOURNAL OF PALLIATIVE CARE, 2011; 18(6)

Achievements The workshop achieved its main goal to prompt participants to reflect on their beliefs and concerns about controlled medicines, and discuss their experiences. The questionnaires enabled the ATOME team to assess the effect of the workshop on participants values and attitudes. The workshop gave participants an opportunity to collaborate with each other and compare their experiences; this in turn enabled them to reflect on the current situation in their own country. The workshop also provided a good opportunity for discussion and debate; plans for future collaboration between participants were formulated. At the end of the workshop, Lukas Radbruch invited participants to share their overall impressions with the group (see Box 2). He concluded by stressing that, although the ATOME project would provide support and assistance wherever possible, there was also a need for countries to change themselves. What s next? The next step in the ATOME project was that Utrecht University in the Netherlands (one of the ten consortium partners) would study each country s opioid legislation from a legal point of view. This would be followed by a more comprehensive review of nine of the 12 countries at this stage. The results of these reviews would then be discussed at the two sixcountry workshops to be held in Bucharest in the autumn, 4 where the formulation of action plans and the sharing of experiences and ideas could be further developed. Country group number one comprises Estonia, Hungary, Latvia, Lithuania, Poland and Slovakia; country group number two is made up of Bulgaria, Cyprus, Greece, Serbia, Slovenia and Turkey. 4 Willem Scholten detailed the process of publication of the WHO guidelines; 5 within two weeks of the workshop, translations of the guidelines would be made available to participants. The WHO country checklist 6 would also be made available. Each national team would then be able to draft an analysis of their country s situation before the six-country workshops in the autumn. Eventually, a report on the findings in each country will be presented by the ATOME project team to the respective countries health ministries. This paper was prepared on behalf of the ATOME consortium. The full workshop report, including the list of attendees, is available on the ATOME website. 7 Box 2. Some of the participants feedback The participant from Greece felt that the ATOME project would be beneficial as their country was currently in the process of changing its opioid legislation The participants from Cyprus and Bulgaria felt that the ATOME project and the workshop provided a great opportunity to improve opioid availability in their respective countries The participant from Poland had gained a tremendous amount of information and their awareness had been raised by the workshop The participant from Hungary found that the workshop had made them reflect on their country s current situation, and were looking forward to the forthcoming six-country workshop The participant from Slovakia felt that closer contact with other countries and the sharing of experience and ideas would be of particular benefit The participant from Serbia stressed the importance of improving legislation in symptom management The participant from Turkey suggested that participating in the ATOME project would result in improved training and education opportunities The participant from Lithuania felt that the workshop would be useful in improving legislation The participant from Latvia said the workshop would open great possibilities for enabling healthcare professionals to discuss issues around controlled medicines with government officials The participant from Estonia stated that it was good to meet with neighbouring countries and that this would assist with the process of legislative change The participant from Slovenia stressed the importance of improving legislation through collaboration Declaration of interest The authors declare that there is no conflict of interest. References 1. www.atome-project.eu/index.php (last accessed 25/08/2011) 2. www.atome-project.eu/about.php (last accessed 25/08/2011) 3. www.who.int/cancer/palliative/painladder/en/ (last accessed 26/08/2011) 4. www.atome-project.eu/events.php (last accessed 25/08/2011) 5. www.who.int/medicines/areas/quality_safety/guide_nocp_ sanend/en/index.html (last accessed 06/10/2011) 6. www.who.int/medicines/areas/quality_safety/gls_ens_balance\ _NOCP_Col_EN_sanend.pdf (last accessed 06/10/2011) 7. www.atome-project.eu/documents/atome_report_lawyers_ Training.pdf (last accessed 26/08/2011) Tom Lynch, ATOME Project Evaluator, International Observatory on End of Life Care, Lancaster University, Lancaster, UK; Sheila Payne, President, European Association for Palliative Care (EAPC); and Director, International Observatory on End of Life Care, Lancaster University, Lancaster, UK; Willem Scholten, Team Leader, Access to Controlled Medicines, Department of Essential Medicines and Pharmaceutical Policies, WHO, Switzerland; Saskia Jünger, Health Scientist, Department of Palliative Medicine, University Hospital Bonn, Germany; Lukas Radbruch, Chair of Palliative Medicine, University of Bonn, Director, Palliative Medicine Department, University Hospital Bonn, and Director, Palliative Care Centre, Malteser Hospital Bonn/Rhein-Sieg, Germany EUROPEAN JOURNAL OF PALLIATIVE CARE, 2011; 18(6) 297