Willem Scholten

A First Comparison Between the Consumption of and the Need for Opioid Analgesics at Country, Regional, and Global Levels

ABSTRACT The objective of this study was to propose a rough but simple method for estimating the total population need for opioids for treating all various types of moderate and severe pain at the country, regional, and global levels. We determined per capita need of strong opioids for pain related to three important pain causes for 188 countries. These needs were extrapolated to the needs for all the various types of pain by using an adequacy level derived from the top 20 countries in the Human Development Index. By comparing with the actual consumption levels for relevant strong opioid analgesics, we were able to estimate the level of adequacy of opioid consumption for each country. Good access to pain management is rather the exception than the rule: 5.5 billion people (83% of the worlds population) live in countries with low to nonexistent access, 250 million (4%) have moderate access, and only 460 million people (7%) have adequate access. Insufficient data are available for 430 million (7%). The consumption of opioid analgesics is inadequate to provide sufficient pain relief around the world. Only the populations of some industrialized countries have good access. Policies should seek a balance between maximizing access for medical use and minimizing abuse and dependence. Countries should aim to increase the medical consumption to the magnitude needed to address the totality of moderate and severe pain.

Formulary availability and regulatory barriers to accessibility of opioids for cancer pain in the Middle East: a report from the Global Opioid Policy Initiative (GOPI)

The Middle East is a heterogeneous region with substantial variability in social development, wealth and palliative care development. The region has few democracies, strong but diverse religious affiliations, and many of the regions counties are involved in political upheavals or regional conflicts. While the global consumption of opioids has increased throughout the last 30 years, there has been little increase in opioid consumption in the Middle East. This is the first comprehensive study of opioid availability and accessibility of opioids in the Middle East. Data are reported on the availability and accessibility of opioids for the management of cancer pain in 16 of 24 countries. The data are relevant to 329 million of the regions 403 million people (82%). The survey found that with the exception of Israel, opioid availability continues to be low throughout most of the Middle East. Formulary deficiencies are severe in several countries in particular Afghanistan, Iraq, Lebanon, Libya, Palestine and Tunisia. Even when opioids are on formulary, they are often unavailable, particularly in these same countries. Access is also significantly impaired by widespread over-regulation that is pervasive across the region.

Opioid Inaccessibility and Its Human Consequences: Reports From the Field

ABSTRACT Strong opioids such as morphine are rarely accessible in low- and middle-income countries, even for patients with the most severe pain. The three cases reported here from three diverse countries provide examples of the terrible and unnecessary suffering that occurs everyday when this essential, inexpensive, and safe medication is not adequately accessible by patients in pain. The reasons for this lack of accessibility are explored, and ways to resolve the problem are proposed.

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

ABSTRACT 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.

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.

Legal Barriers in Accessing Opioid Medicines: Results of the ATOME Quick Scan of National Legislation of Eastern European Countries

CONTEXT Overregulation of controlled medicines is one of the factors contributing to limited access to opioid medicines. OBJECTIVES The purpose of this study was to identify legal barriers to access to opioid medicines in 12 Eastern European countries participating in the Access to Opioid Medication in Europa project, using a quick scan method. METHODS A quick scan method to identify legal barriers was developed focusing on eight different categories of barriers. Key experts in 12 European countries were requested to send relevant legislation. Legislation was quick scanned using World Health Organization guidelines. Overly restrictive provisions and provisions that contain stigmatizing language and incorrect definitions were identified. The selected provisions were scored into two categories: 1) barrier and 2) uncertain, and reviewed by two authors. A barrier was recorded if both authors agreed the selected provision to be a barrier (Category 1). RESULTS National legislation was obtained from 11 of 12 countries. All 11 countries showed legal barriers in the areas of prescribing (most frequently observed barrier). Ten countries showed barriers in the areas of dispensing and showed stigmatizing language and incorrect use of definitions in their legislation. Most barriers were identified in the legislation of Bulgaria, Greece, Lithuania, Serbia, and Slovenia. The Cypriot legislation showed the fewest total number of barriers. CONCLUSION The selected countries have in common as main barriers prescribing and dispensing restrictions, the use of stigmatizing language, and incorrect use of definitions. The practical impact of these barriers identified using a quick scan method needs to be validated by other means.

Providing paediatric palliative care in Kenya

Your Sept 11 Editorial (p 846) discusses the excellent Human Rights Watch report, Needless Pain: Government Failure to Provide Palliative Care for Children in Kenya, which provides one example of how poor access to pain management aff ects children around the world. The report correctly informs on WHO’s work and we welcome its recom mendation to complete the ongoing treatment guidelines on chronic pain for children. However, your Editorial labels these WHO guidelines as “long overdue”, which is not entirely fair. WHO established thorough procedures for guideline development, consistent with best practices, including appropriate use of evidence. We fi nalised a scoping document in October, 2008, and donors enabled us to work on guidelines from early 2009. In 2 years, we went through the intensive steps of retrieval and appraisal of evidence and formulation of recommendations. Those draft recommendations are currently subject to a fi nal expert review. After clearance and editing, they will be published in the coming months. The Editorial highlights the fact that Human Rights Watch criticises health donors for overlooking pain treatment and palliative care. We agree with this assertion. Updated evidence-based 2 Lönnroth K, Castro K, Chakaya JM, et al. Tuberculosis control and elimination 2010–50: cure, care, and social development. Lancet 2010; 375: 1814–29. 3 WHO, International Union against Tuberculosis and Lung Disease. A WHO/the Union monograph on TB and tobacco control. WHO/ TB/2007.390. Geneva, Switzerland: World Health Organization, 2008. 4 Ottmani SE, Murray MB, Jeon CY, et al. Consultation meeting on tuberculosis and diabetes mellitus: meeting summary and recommendations. Int J Tuberc Lung Dis 2010; 14: 1513–17. 5 Harries AD, Murray MB, Jeon CY, et al. Defi ning the research agenda to reduce the joint burden of disease from diabetes mellitus and tuberculosis. Trop Med Int Health 2010; 15: 659–63. includes estimates of their related population-attributable fractions. Bailey and Godfrey-Faussett rightly point to the importance of these links for policy development and implementation. As discussed in our paper, the links between tuberculosis and non-communicable diseases have major potential policy implications. To improve early diagnosis of all people with tuberculosis, intensifi ed case detection is necessary in specifi c high-risk groups. This could include, for example, regular tuberculosis screening of people with diabetes in settings where tuberculosis prevalence is high. To further improve health outcomes in tuberculosis patients, comorbidities need to be optimally managed. Such management requires early diagnosis and good management of diabetes and undernutrition, as well as eff orts to minimise the harmful use of alcohol and tobacco in people diagnosed with tuberculosis. Such eff orts would also help to strengthen general care for non-communicable diseases. To prevent tuberculosis more eff ectively, the prevalence of noncommunicable diseases and their risk factors need to be reduced at population level. This requires broad public health eff orts, including regu latory approaches and actions to address social and economic determinants of ill health. WHO and the International Union Against Tuberculosis and Lung Disease have already developed a framework for tuberculosis and tobacco, and are in the process of developing a similar framework for tuberculosis and diabetes. We are also pursuing work to improve the evidence base on tuberculosis and nutrition, alcohol misuse, and mental health.

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.

Response to Kolodny: Negative Outcomes of Unbalanced Opioid Policy Supported by Clinicians, Politicians, and the Media

Dr. Kolodny missed our point that a good analysis of a situation is needed in order to design an effective policy that solves any occurring problems. The core of our message is that, in contrast to casual observations, there is little evidence that pain patients to whom opioids have been prescribed legitimately have accounted for the considerable escalation in overdose deaths that involved licensed manufactured medications. Unfortunately, blunt instrument efforts to reduce opioid prescribing are clearly causing hardship in pain patients who may face increasing hassle and stigmatization in efforts to obtain effective pain medications and may be denied effective medications altogether. This apparently is even occurring in Veterans Administration hospitals that are practicing blunt approaches to reduce their rates of opioid prescribing. We support careful and appropriate prescribing and individualized comprehensive pain management.1,2 That may lead to reduced opioid prescribing in some populations, and may also lead to increased opioid prescribing in populations that are often without adequate access to appropriate medications, including ethnic minorities and socioeconomic vulnerable groups in the United States. They often suffer the brunt of blunt instrument approaches to reduce opioid prescribing in particular and to reduce health care costs in general.3,4 In fact, the very real problem is that disparities in pain management among vulnerable groups should be addressed with the same compassion as are efforts to reduce nonmedical and harmful use of opioids and overdose, but they may actually be worsened by efforts such as many of those suggested by Dr. Kolodny. Dr. Kolodny is not afraid of distorting the facts. We mentioned this already in our original article when