Agonist Treatment for Opioid Dependence Syndrome: The Impact of Current Understanding upon Recommendations for Policy Initiatives.

The provision of opioid agonist treatments (OATs), as a standard approach towards opioid dependence syndrome, differs widely between countries. In response to access disparities, in 2014, the Council of Europe's Pompidou Group first brought together an expert group on framework conditions for the treatment of opioid dependence. The group used a Delphi approach to structure their discussions and develop guiding principles for the modernisation of OAT regulations and legislation. The expert group identified some 60 guiding principles, which were then the subject of wide public consultation. Endorsed by Pompidou Group member states, the final report identified four key recommendations: (1) Prescription and delivery without prior authorisation schemes; (2) Effective removal of financial barriers to access to care; (3) Coordination and follow-up by a national consultative body; and (4) Neutral, precise and respectful terminology. During meetings, the expert group hypothesised that inequalities in OAT access are likely to be linked to underlying rationales which in theory are contradictory, but in practice co-exist within the different political frameworks. The present article considers the perceived influence upon different regulatory frameworks. Discussion is centred around the potential impact of underlying rationales upon the effective implementation of a modernised framework.

Developing a new national MDMA policy: Results of a multi-decision multi-criterion decision analysis.

BACKGROUND: Ecstasy (3,4-methylenedioxymethamphetamine (MDMA)) has a relatively low harm and low dependence liability but is scheduled on List I of the Dutch Opium Act ('hard drugs'). Concerns surrounding increasing MDMA-related criminality coupled with the possibly inappropriate scheduling of MDMA initiated a debate to revise the current Dutch ecstasy policy. METHODS: An interdisciplinary group of 18 experts on health, social harms and drug criminality and law enforcement reformulated the science-based Dutch MDMA policy using multi-decision multi-criterion decision analysis (MD-MCDA). The experts collectively formulated policy instruments and rated their effects on 25 outcome criteria, including health, criminality, law enforcement and financial issues, thematically grouped in six clusters. RESULTS: The experts scored the effect of 22 policy instruments, each with between two and seven different mutually exclusive options, on 25 outcome criteria. The optimal policy model was defined by the set of 22 policy instrument options which gave the highest overall score on the 25 outcome criteria. Implementation of the optimal policy model, including regulated MDMA sales, decreases health harms, MDMA-related organised crime and environmental damage, as well as increases state revenues and quality of MDMA products and user information. This model was slightly modified to increase its political feasibility. Sensitivity analyses showed that the outcomes of the current MD-MCDA are robust and independent of variability in weight values. CONCLUSION: The present results provide a feasible and realistic set of policy instrument options to revise the legislation towards a rational MDMA policy that is likely to reduce both adverse (public) health risks and MDMA-related criminal burden.

Epidural anesthesia is no longer the standard of care in abdominal surgery with ERAS. What are the alternatives?

Epidural anesthesia has been considered the gold standard for perioperative analgesia, but the implementation of enhanced recovery after surgery (ERAS) protocols and a shift from open to laparoscopic surgery have diminished the advantage of epidural anesthesia. The authors summarize data from two newer meta-analyses and discuss the consequences for the role of epidural anesthesia (EA) in the perioperative setting. These meta-analyses enabled to distinguish between pre- and post-ERAS outcomes. Endpoints related to open and laparoscopic abdominal surgery were retrieved. General data, also applicable on abdominal surgery, were included. Data on other types of surgery were ignored. Two meta-analyses met the subject and inclusion criteria of the search. They demonstrate no difference between epidural analgesia and the control for most investigated endpoints. Analgesia employing epidural techniques is often not clinically superior to its alternatives; is associated with a small but relevant number of serious complications; and has a relatively high failure rate. Data show that the distinction between pre-ERAS and ERAS is essential for understanding the role of EA in intestinal surgery. Since ERAS was introduced, the advantages of epidural anesthesia vanished while the incidence of serious neurological complications is higher than previously thought. The authors conclude that epidural anesthesia in abdominal surgery has become less preferred and is limited to patients and types of surgery known to be accompanied with difficult pain management. This requires the use of other methods for analgesia, such as intravenous ketamine, peripheral nerve blocks, continuous wound infiltration, intrathecal morphine, and intravenous, and non-invasive PCA.

Analyzing and Benchmarking Global Consumption Statistics for Opioid Analgesics 2015: Inequality Continues to Increase.

Many countries around the world have a very low per capita consumption of opioid analgesics, which is probably related to absence or inadequate management of moderate and severe pain for large parts of their populations. We conducted a longitudinal observational study with opioid analgesic consumption data for all countries from 2000-2015, to assess 2015 per capita consumption data for strong opioid analgesics and to investigate the hypothesis that inequality decreased over the years 2000-2015. We based our study on the official statistics kept by the International Narcotics Control Board, built on data submitted by governments annually. Adequate consumption was defined as the average 2015 opioid analgesic consumption of the 20 most-developed countries, or above. In addition, we defined categories of moderate, low, very low and extremely low consumption, each category differing 0.5 on a logarithmic scale. Consumption was expressed as the AOC Index. The direction of inequality in consumption between different countries' development levels through the years 2000-2015 was assessed using a mixed effects model. We found that the average consumption of the 20 most-developed countries was 256 ± 208 mg per capita (range 5.9-778) in 2015. In all, 119 countries did not have a moderate or adequate consumption of opioid analgesics. Inequality of adequacy of consumption between low- and highly-developed countries increased from 2000 to 2015. The world needs 1867 tonnes ME for treating pain with opioids analgesics at an adequate level (actual use: 365 tonnes or 19.5% of the global need). We concluded that in 2015, almost 6.5 billion people lived in countries where opioid analgesic consumption was low, very low, or extremely low.

The perception of barriers concerning opioid medicines: A survey examining differences between policy makers, healthcare professionals and other stakeholders.

BACKGROUND: In many countries, the consumption of opioid medicines is too low to meet population needs. Discussions within the Access To Opioid Medication in Europe project indicated that there may be significant differences in the perception of barriers for their adequate use, depending on the stakeholders. AIM: The aim of this study was to examine the perception of barriers and their impact concerning opioid medicines, comparing policy makers, healthcare professionals working in the field of pain management, palliative care or harm reduction and other stakeholders. DESIGN: Data were collected using a questionnaire partially constructed from existing surveys, reviewed for content validity by four experts and pilot-tested in Latvia. SETTING/PARTICIPANTS: Participants of the Access to Opioid Medication in Europe national conferences were invited to complete the questionnaire. Stakeholder groups were compared using non-parametric rank-sum tests. RESULTS: In total, 199 participants (54%) in seven countries completed the questionnaire. Most frequently rated major barriers included lack of financial resources and inadequate knowledge, skills and training among policy makers (55%-66%). Overall, policy makers perceived issues less often as major barriers or having major impact (29% barrier, 32% impact) compared to other stakeholders (36%-42% barrier, 39%-51% impact). Significant differences were seen on several aspects. For example, excessive regulation or bureaucracy for prescribing was rated as having major impact by 55%-57% of healthcare professionals in contrast to only 20% of the policy makers (p = 0.002). CONCLUSION: Multiple barriers may play an important role, partly depending on the perspective of the stakeholder involved. Hence, when addressing perceived barriers, it is important to include all relevant stakeholder groups. Only then, effective and widely supported solutions can be implemented.

Quantifying the Adequacy of Opioid Analgesic Consumption Globally: An Updated Method and Early Findings.

Opioid analgesics are the mainstay for treatment of moderate and severe pain but, in many countries, the consumption of these medicines is inadequate. Over time, various groups have published opioid analgesic metrics, including authors from the World Health Organization. They linked consumption to a level considered adequate based on the actual consumption in developed countries. In this study, we present our current results on the adequacy of opioid analgesic consumption. We included statistics for 18 controlled opioid medicines that are primarily used as analgesics, and we developed the Adequacy of Opioid Consumption (AOC) Index. The average of the 20 most developed countries for 2015 is set as equal to an AOC Index of 100. An AOC Index of 100 or higher is considered adequate consumption. The average opioid analgesic consumption of the top-20 countries of the Human Development Index increased from 84 morphine milligram equivalents per capita (2000) to 256 morphine milligram equivalents per capita (2015). The extremes we found for 2015 were Germany (AOC Index: 304) and Nigeria (AOC Index: 0.0069). These extremes differ by 44 000 times. Adequacy of opioid analgesic consumption continues to be problematic around the world.

Words matter: a call for humanizing and respectful language to describe people who experience incarceration.

BACKGROUND: Words matter when describing people involved in the criminal justice system because language can have a significant impact upon health, wellbeing, and access to health information and services. However, terminology used in policies, programs, and research publications is often derogatory, stigmatizing, and dehumanizing. DISCUSSION: In response, health experts from Europe, the United States, and Australia recommend that healthcare professionals, researchers, and policy makers working with people in detention follow key principles that foster constructive and humanizing language. These principles include: engage people and respect their preferences; use stigma-free and accurate language; prioritize individuals over their characteristics; and cultivate self-awareness. The article offers examples of problematic terms to be avoided because they do not convey respect for incarcerated people and propose preferred wording which requires contextualization to local language, culture, and environment. CONCLUSION: The use of respectful and appropriate language is a cornerstone of reducing harm and suffering when working with people involved in the criminal justice system; the use of stigmatizing and dehumanizing language must therefore come to an end.

[Modernising the framework conditions for medicine treatments in opioid dependence syndrome]. / Moderniser les conditions-cadres des traitements médicamenteuxdu syndrome de dépendance aux opioïdes.

Opioid medicines prescribed on a long-term basis for opioid dependence syndrome have historically been deemed « substitution treatments ¼ and misunderstood as involving the "replacement of an illicit drug by a legal drug". Prior authorisation schemes, in addition to ordinary procedures for authorising medicines and supervising professionals, interfere with access to treatment. In order to guide the countries in their efforts to modernise their regulations, the Pompidou Group mandated a group of health and legal experts, who identified 62 guiding principles and developed four strategic recommendations : 1) the removal of prior authorisation schemes, 2) the removal of financial barriers, 3) supervision by a national consultative body and 4) The adoption of neutral, precise and respectful terminology.

Les médicaments opioïdes prescrits à long terme dans le cadre du syndrome de dépendance aux opioïdes ont longtemps été qualifiés de « traitements de substitution ¼ et compris à tort comme « remplacement d'une drogue de rue par une drogue d'Etat ¼. Des régimes spéciaux d'autorisation en sus des procédures ordinaires d'homologation du médicament et de supervision des professionnels entravent l'accès au traitement. Afin de guider les pays dans leurs efforts de modernisation de leur réglementation y relative, le Groupe Pompidou a mandaté un groupe d'experts de la santé et du droit qui ont défini 62 principes directeurs et avancé quatre recommandations stratégiques, à savoir : 1) la suppression des régimes d'autorisation, 2) la suppression des barrières financières, 3) le suivi par une instance nationale consultative et 4) l'adoption d'une terminologie neutre, précise et respectueuse.

Access to Strong Opioid Analgesics in the Context of Legal and Regulatory Barriers in Eleven Central and Eastern European Countries.

BACKGROUND: In 2011-2013, >95% of the global opioid analgesics consumption occurred in three regions, accounting for 15% of the world population. Despite abundant literature on barriers to access, little is known on the correlation between actual access to opioid analgesics and barriers to access, including legal and regulatory barriers. OBJECTIVE: This study aimed to evaluate the correlation between access to strong opioid analgesics and barriers to access in national legislation and regulations in 11 central and eastern European countries that participated in the Access to Opioid Medication in Europe (ATOME) project. DESIGN: Two variables were contrasted to assess their correlation: the country level of access to strong opioid analgesics indicated by the Adequacy of Consumption Measure (ACM) and the number of potential legal and regulatory barriers identified by an external review of legislation and regulations. MEASUREMENTS: A linear correlation was evaluated using a squared linear correlation coefficient. RESULTS: Evaluation of the correlation between the ACM and the number of potential barriers produces an R2 value of 0.023 and a correlation plot trend line gradient of -0.075, indicating no correlation between access to strong opioid analgesics and the number of potential barriers in national legislation and regulations in the countries studied. CONCLUSIONS: No correlation was found, which indicates that other factors besides potential legal and regulatory barriers play a critical role in withholding prescribers and patients essential pain medication in the studied countries. More research is needed toward better understanding of the complex interplay of factors that determine access to strong opioid analgesics.

Barriers to access to opioid medicines for patients with opioid dependence: a review of legislation and regulations in eleven central and eastern European countries.

BACKGROUND AND AIMS: Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify specific access barriers for patients with opioid dependence in legislation and regulations of 11 central and eastern European countries. METHODS: This study builds on a previous analysis of legislation and regulations as part of the EU 7th Framework Access To Opioid Medication in Europe (ATOME) project. An in-depth analysis was undertaken to determine specific barriers for patients with opioid dependence in need of opioid analgesics or opioid agonist therapy (OAT). For each country, the number and nature of specific potential barriers for these patients were assessed according to eight categories: prescribing; dispensing; manufacturing; usage; trade and distribution; affordability; penalties; and other. An additional keyword search was conducted to minimize the omission of barriers. Barriers in an additional category, language, were recorded qualitatively. Countries included Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia and Turkey. RESULTS: Ten of the 11 countries (all except Estonia) showed specific potential barriers in their legislation and regulations. The total number of barriers varied from two (Slovenia) to 46 (Lithuania); the number of categories varied from one (Slovenia) to five (Lithuania). Most specific potential barriers were shown in the categories 'prescribing', 'usage' and 'other'. The total number in a single category varied from one to 18 (Lithuania, prescribing). Individual differences between countries in the same specific potential barrier were shown; for example, variation in minimum age criteria for admission to OAT ranging from 15 (Lithuania, in special cases) to 20 years (Greece). All countries had stigmatizing language in their legislation. CONCLUSIONS: Patients with opioid dependence are likely to experience specific barriers to accessing opioids in addition to those experienced by other non-dependent patients.

A Multifaceted Approach to Improve the Availability and Accessibility of Opioids for the Treatment of Cancer Pain in Serbia: Results From the International Pain Policy Fellowship (2006-2012) and Recommendations for Action.

Cancer is the second leading cause of death in Serbia, and at least 14,000-16,000 patients experience moderate-to-severe cancer pain every year. Cancer pain relief has been impeded by inadequate availability of opioid analgesics and barriers to their accessibility. In 2006, a Serbian oncologist was selected as an International Pain Policy Fellow. The fellow identified barriers to opioid availability in Serbia and implemented an action plan to address the unavailability of oral morphine, attitudinal and knowledge barriers about opioids, and barriers in the national opioid control policy, in collaboration with the government, local partners, and international experts, including those from the World Health Organization. Collaborative efforts resulted in availability of immediate-release oral morphine, registration of controlled-release hydromorphone, and reimbursement of oral methadone for cancer pain; numerous educational activities aimed at changing inadequate knowledge and negative attitudes toward opioids; recognition of opioids as essential medicines for palliative care in a new National Palliative Care Strategy; and recognition of the medical use of opioids as psychoactive-controlled substances for the relief of pain included in a new national law on psychoactive-controlled substances, and the development of recommendations for updating regulations on prescribing and dispensing opioids. An increase in opioid consumption at the institutional and national levels also was observed. This article outlines a multifaceted approach to improving access to strong opioids for cancer pain management and palliative care in a middle-income country and offers a potential road map to success.

Negative outcomes of unbalanced opioid policy supported by clinicians, politicians, and the media.

Harmful and nonmedical use of prescription opioids has increased precipitously in the United States and some other countries in recent years, but not everywhere around the world. Addressing this problem requires attention to scientific data and to objective and balanced consideration of factors driving the problems. Unfortunately, the situation has been blurred by some politicians, health professionals, and the media by their using inadequate concepts, misrepresenting and exaggerating facts, and demonizing pain patients. In this article, we analyze what has occurred and present what we believe to be a balanced view of the problems. We advocate comprehensive drug control policies implemented in a way to reduce harmful use and diversion problems balancing the public health benefits and risks of opioid medications. We make recommendations for responsible prescribing, including implementing the World Health Organization (WHO) policy guidelines and similar United Nations Office of Drug Control (UNODC), which we believe can contribute measurably to the prevention of diversion of prescription opioids while ensuring patient access to the most appropriate medicines. Measures to reduce the risks of nonmedical use of opioid medicines should be based to the greatest extent possible on accurate evaluation of the mechanisms leading to such use, including diversion activities.

Barriers to access to opioid medicines: a review of national legislation and regulations of 11 central and eastern European countries.

Control measures designed to prevent the misuse of opioid medicines can often unintentionally restrict legitimate medical use, leaving patients with cancer in pain. This study aimed to develop and validate an assessment instrument based on WHO policy guidelines to systematically identify legal and regulatory barriers to opioid access in 11 European countries (Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia, and Turkey) as part of the Access to Opioid Medication in Europe project. Relevant legislation and regulations were independently assessed by three reviewers and potential barriers were identified within nine categories including prescribing, penalties, and others. Potential barriers were identified in all countries, ranging from 22 potential barriers (Cyprus) to 128 potential barriers (Lithuania). The total number of barriers in a single category varied from one (Slovenia, usage category) to 49 (Greece, prescribing category). Differences, such as prescription validity, varied within one category, ranging from 5 days (Hungary) to 13 weeks (Cyprus). The results of this Review should give rise to a national review and revision of provisions that impede access to opioids, disproportionate to their (intended) benefit in preventing misuse, in these 11 European countries.

A Systematic Content Analysis of Policy Barriers Impeding Access to Opioid Medication in Central and Eastern Europe: Results of ATOME.

CONTEXT: Reliable access to opioid medication is critical to delivering effective pain management, adequate treatment of opioid dependence, and quality palliative care. However, more than 80% of the world population is estimated to be inadequately treated for pain because of difficulties in accessing opioids. Although barriers to opioid access are primarily associated with restrictive laws, regulations, and licensing requirements, a key problem that significantly limits opioid access relates to policy constraints. OBJECTIVES: To identify and explore policy barriers to opioid access in 12 Eastern and Central European countries involved in the Access to Opioid Medication in Europe project, funded by the European Community's Seventh Framework (FP7/2007-2013, no. 222994) Programme. METHODS: A systematic content analysis of texts retrieved from documents (e.g., protocols of national problem analyses, strategic planning worksheets, and executive summaries) compiled, reviewed, approved, and submitted by either the Access to Opioid Medication in Europe consortium or the national country teams (comprising experts in pain management, harm reduction, and palliative care) between September 2011 and April 2014 was performed. RESULTS: Twenty-five policy barriers were identified (e.g., economic crisis, bureaucratic issues, lack of training initiatives, stigma, and discrimination), classified under four predetermined categories (financial/economic aspects and governmental support, formularies, education and training, and societal attitudes). Key barriers related to issues of funding allocation, affordability, knowledge, and fears associated with opioids. CONCLUSION: Reducing barriers and improving access to opioids require policy reform at the governmental level with a set of action plans being formulated and concurrently implemented and aimed at different levels of social, education, and economic policy change.

Identification of Challenges to the Availability and Accessibility of Opioids in Twelve European Countries: Conclusions from Two ATOME Six-Country Workshops.

BACKGROUND: Access to many controlled medicines is inadequate in a number of European countries. This leads to deficits in the treatment of moderate to severe pain as well as in opioid agonist therapy. OBJECTIVE: The study objective was to elaborate the reasons for this inadequacy. The work plan of the Access to Opioid Medication in Europe (ATOME) project included two six-country workshops. These workshops comprised a national situational analysis, drafting tailor-made recommendations for improvement and developing action plans for their implementation. METHODS: In total, 84 representatives of the national Ministries of Health, national controlled substances authorities, experts representing regulatory and law enforcement authorities, leading health care professionals, and patient representatives from 13 European countries participated in either one of the workshops. The delegates used breakout sessions to identify key common challenges. Content analysis was used for the evaluation of protocols and field notes. RESULTS: A number of challenges to opioid accessibility in the countries was identified in the domains of knowledge and educational, regulatory, legislative, as well as public awareness and training barriers that limit opioid prescription. In addition, short validity of prescriptions and bureaucratic practices resulting in overregulation impeded availability of some essential medicines. Stigmatization and criminalisation of people who use drugs remained the major impediment to increasing opioid agonist program coverage. CONCLUSIONS: The challenges identified during outcomes of the workshops were used as the basis for subsequent dissemination and implementation activities in the ATOME project, and in some countries the workshop proceedings already served as a stepping-stone for the first changes in regulations and legislation.

The unique role of transdermal buprenorphine in the global chronic pain epidemic.

Pain is a global epidemic, exacerbated by barriers to access of opioid analgesics. Regulations about opioids attempt to protect public health from the risks of harmful use of opioids, diversion, and dependence. Transdermal buprenorphine is an effective opioid analgesic agent with unique properties that may make it particularly well suited for more widespread use. It is a versatile analgesic product with demonstrated safety and effectiveness in cancer and noncancer pain populations. Its pharmacological properties make it a first-line opioid analgesic for geriatric patients and patients with renal dysfunction; no dosing adjustments need to be made. The 7-day transdermal delivery system is convenient for patients and promotes compliance. A low dose of buprenorphine can provide effective and well-tolerated pain relief. Although buprenorphine has been associated with certain opioid-related adverse effects, such as dizziness and nausea, it is associated with a lower rate of constipation than many other opioid analgesics. The potential for nonmedical use of buprenorphine is relatively low compared with other opioid agents. Buprenorphine has a relatively low likeability for nonmedical use and the transdermal matrix patch renders the substance particularly difficult to extract for illicit purposes.

Improving access to adequate pain management in Taiwan.

There is a global crisis in access to pain management in the world. WHO estimates that 4.65 billion people live in countries where medical opioid consumption is near to zero. For 2010, WHO considered a per capita consumption of 216.7 mg morphine equivalents adequate, while Taiwan had a per capita consumption of 0.05 mg morphine equivalents in 2007. In Asia, the use of opioids is sensitive because of the Opium Wars in the 19th century and for this reason, the focus of controlled substances policies has been on the prevention of diversion and dependence. However, an optimal public health outcome requires that also the beneficial aspects of these substances are acknowledged. Therefore, WHO recommends a policy based on the Principle of Balance: ensuring access for medical and scientific purposes while preventing diversion, harmful use and dependence. Furthermore, international law requires that countries ensure access to opioid analgesics for medical and scientific purposes. There is evidence that opioid analgesics for chronic pain are not associated with a major risk for developing dependence. Barriers for access can be classified in the categories of overly restrictive laws and regulations; insufficient medical training on pain management and problems related to assessment of medical needs; attitudes like an excessive fear for dependence or diversion; and economic and logistical problems. The GOPI project found many examples of such barriers in Asia. Access to opioid medicines in Taiwan can be improved by analysing the national situation and drafting a plan. The WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances can be helpful for achieving this purpose, as well as international guidelines for pain treatment.