Steiner Collet N. - ACCESS TO PAIN MANAGEMENT (Hospice, Palliative Care & Pain Control - WCD - 04_Feb)
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ДОСТУПНОСТЬ ОБЕЗБОЛИВАНИЯ: СИТУАЦИЯ В МИРЕ И РЕКОМЕНДАЦИИ. Натали ШТЕЙНЕР КОЛЛЕТ, Консультант по паллиативной помощи, Женева, Швейцария От имени Вильям ШОЛТЕН, PharmD, Консультант по лекарственным и регламентированным средствам. Ниан, Швейцария (В прошлом эксперт и Советник ВОЗ) - - - ACCESS TO PAIN MANAGEMENT: GLOBAL SITUATION AND GUIDELINES. Nathalie STEINER COLLET, Consultant Palliative Care, Geneva, Switzerland on behalf of Willem SCHOLTEN, PharmD, M.P.A., Consultant - Medicines and Controlled Substances, Nyon, Switzerland. Former Team Leader, WHO Access to Controlled Medicines, Geneva
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Steiner Collet N. - ACCESS TO PAIN MANAGEMENT (Hospice, Palliative Care & Pain Control - WCD - 04_Feb)
- 1. Access to Pain Management: Global Situation and Guidelines Dr Nathalie Steiner – Collet Consultant Palliative Care , Geneva, Switzerland on behalf of Willem Scholten, PharmD, M.P.A. Consultant – Medicines and Controlled Substances, Nyon, Switzerland Former Team Leader, WHO Access to Controlled World Cancer Day Medicines, Geneva Hospice, Palliative Care & Pain Civic Chamber Moscow February, 4, 2013
- 2. Inequality • 93.8% of all (licit) morphine consumption by 21.8% of the world population (INCB 2010, Data for 2009) • 4.7 billion people live in countries where medical opioid consumption is near to zero (on a total world population of 6.5 billion) (Seya et al. 2011, Data for 2006) Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 2 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 3. Adequacy Consumption of Opioid Analgesics (2007) from: Seya MJ et al, J Pain & Pall Care Pharmacother 2011;25:6-18 Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 3 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 4. Preamble Single Convention Single Convention on Narcotic Drugs (1961; as amended in 1972) Recognizing that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes … Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 4 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 5. Categories of barriers • Overly restrictive laws and regulations – Rules often not preventing abuse, dependence and diversion – Rules often creating a barrier for medical access • Medical education • Attitudes – Excessive fear for dependence – Excessive fear for diversion – Problems related to assessment of medical needs • Economic – However, opioid analgesics should not be expensive Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 5 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 6. How to improve access? • Full analysis of national legislation and policies • Identify areas that need improvement • Policy planning – Measures to take – Priority setting • Implementation • Evaluate, set new priorities and adjust policy plan, etc… WHO Guidelines can be helpful (Policy, Treatment) Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 6 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 7. WHO Tools • WHO Policy guidelines (2011) • WHO Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illness (2012) To follow: guidelines on – Persisting Pain in Adults – Acute Pain Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 7 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 8. WHO Policy Guidelines Ensuring Balance in National Policies on Controlled Substances, Guidance for accessibility and availability of controlled medicines (Geneva 2011) • Russian version: on-line only; free of charge • In print (English, French and Spanish only): US$ 25 • http://www.who.int/medicines/a reas/quality_safety/guide_nocp_ sanend/en/index.html Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 8 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 9. Based on Principle of Balance Obligation of governments to establish a system of drug control that – ensures the adequate availability of controlled substances for medical and scientific purposes – while simultaneously preventing abuse, diversion and trafficking • 21 Guidelines • Provides many examples • Country Check List Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 9 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 10. 21 Guidelines Topics: • Content of drug control legislation and policy (2 GLs) • Authorities and their role in the system (4 GLs) • Policy planning for availability and accessibility (4 GLs) • Healthcare professionals (4 GLs) • Estimates and statistics (3 GLs) • Procurement (3 GLs) • Other (1 GL) Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 10 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 11. Examples of changes Roumania Kerala (India) Uganda Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 11 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 12. Persisting Pain in Children Package http://www.who.int/medicin es/areas/quality_safety/guide _perspainchild/en/index.html Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 12 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
- 13. Access to Pain Management: Global Situation and Guidelines Dr Nathalie Steiner - Collet Willem Scholten, PharmD, M.P.A. Consultant, Palliative Care, Geneva, Switzerland Consultant – Medicines and Controlled Substances, Nyon, Member of the Swiss Association for Palliative Medicine, Care and Support And of EAPC (European Association of Palliative Care) Switzerland Former Team Leader, WHO Access to Controlled Medicines, Geneva. T +41 22 340 04 75 M +41 79 691 53 19 E nathsteiner@hin.ch M +41 79 449 57 59 Skype nathsteinercollet E wk.scholten@bluewin.ch Skype wimscholten Willem Scholten PharmD MPA Consultant – Medicines and Controlled Substances 13 Access to Global Pain Management | Hospice, Palliative Care & Pain – February 4, 2013
Editor's Notes
- Willem Scholten used to be the Team Leader, Access to Controlled Medicines in Headquarters, World Health Organization
- There is a world wide problem with access to opioid analgesics like morphine Only a few industrialized countries use sufficient opioid analgesics; in many countries it is not available. It is estimated that these countries with bad access constitute 75% of the world population
- - A study by Seya et al. compared the level of access to opioid analgesics in the 20 most developed countries with all other countries. They defined the average consumption of the top 20 of the Human Development Index as adequate. For all countries they calculated how much opioids were used in comparison to that level of adequacy. This is shown in this world map. Countries in dark red have a consumption lower than 3% of the adequate level. As you can see, the Russian Federation is one of these countries with very low access. Only if there is discussion about the validity of the figures , make the following comments: - The authors put emphasis on the fact that the adequate level is approximate It cannot be used to have an exact prognosis of the amount of opioids Russian Federation needs However, it shows that the opioid consumption in all countries colored in brown is extremely low and needs improvement Only if there is debate on the freshness of the figur es (they are for 2006): Currently an update with figures based on the most recent statistics (consumption figures for 2010) is on its way
- Medicines for opioid analgesia, such as morphine, are subject to the Single Convention on Narcotic Drugs. This Convention has been signed by 97 countries, amongst which the Russian Federation. Therefore it obligated to do what has been agreed in this convention. One of the things to ensure is mentioned in the Convention’s Preamble (introductory paragraphs): adequate provision must be made to ensure the availability of these medicines. The convention also recognizes that these medicines are indispensable for the relief of pain and suffering. Countries who signed the drug convention obligated themselves to work on achieving these objectives. For the Russian translation of the convention: please see www.incb.org -------------------------------------------------------------------------------------------- Additional personal notes: “ The adoption of this Convention is regarded as a milestone in the history of international drug control. The Single Convention codified all existing multilateral treaties on drug control . The principal objectives of the Convention are to limit the possession, use, trade in, distribution, import, export, manufacture and production of drugs exclusively to medical and scientific purposes and to address drug trafficking through international cooperation to deter and discourage drug traffickers”. The Convention also established the International Narcotics Control Board . The first consideration of the Preamble of the Single Convention reads: “The Parties (to this Convention), Concerned with the health and welfare of mankind”.
- One may wonder why there are so many countries that have bad access to controlled medicines. One reason is that during a century of drug control, the focus has been on the prevention of substance misuse. Many countries have stricter rules than required by the international drug control conventions, sometimes not contributing to the prevention of substance misuse, but creating a barrier for patient access. (Then present the text from the slide) ------------------------------- Additional notes: A systematic review of research papers concerning patients treated with opioids for non cancer pain for at least 6 months concludes that only 0.43% patients with no previous history of substance abuse treated with opioid analgesics to relieve pain abused their medication and only 0.05% developed dependence syndrome. (Noble MN et al. JPSM 2008, cited in Ensuring balance in national policies on controlled substances) «A study by De Lima et al, found that the average retail cost of a monthly morphine supply in 2003 ranged from USD 10 in India to USD 254 in Argentina. The study found that median cost of a month’s supply of morphine was more than twice as high in low and middle income countries (USD 112) as in industrialized countries (USD 53). «Basic oral morphine should be very cheap. Cipla in India makes 10 mg morphine tablets that sells at US 0.017 cents each. K Foley estimates that generic morphine should not cost more than UDS 0.01 per mg. An average month’s supply of morphine would cost USD 9 to 22.5 per patient. De Lima et al. J of Pain and Palliative care Pharmacotherapy 2004 Potent Analgesics Are More Expensive for Patients in Developing Countries. A Comparative Study http://informahealthcare.com/doi/abs/10.1080/J354v18n01_05
- For improving the situation, the approach is as for all policies: first make an analysis of the situation, then make a plan for change, implement it, and after some time evaluate the achievements, adjust the plans if necessary and then continue implementing. In the case of access to controlled medicines, the WHO guidelines on policies and on treatment will show to be helpful. ---------------------------------------------------------------------------------------- Additional notes: Ref also: Joranson DE, Ryan KM. Ensuring opioid availability: Methods and resources. J Pain Symptom Manage. 2007; 33(5):527-532. Countries who wish to work on formulating new policy or improving existing policies and legislation may want to work with WHO’s Access to Controlled Medications Programme (ACMP). Also, the WHO Collaborating Center for Pain Policy and Palliative Care (University of Wisconsin) can assist in various aspects and makes different resources available on its website”
- Currently, WHO has policy guidelines (ensuring balance in national policies on controlled substances) and treatment guidelines for persisting pain in children. More treatment guidelines are in the planning stage. Additional notes: Current best practices should be derived from WHO treatment guidelines and other international and national evidence-based guidelines for the various diseases that need treatment with controlled medicines
- The WHO policy guidelines are entitled Ensuring Balance in National Policies on Controlled Substances, Guidance for accessibility and availability of controlled medicines. They will be extremely useful for the analysis and planning. A Russian version if free of charge downloadable from the web. If you want to know more of the this subject, please download this very important document to read.
- The basis principle of these guidelines comes directly from the international drug control treaties. It is called the principle of balance (READ OUT) The idea behind it, is that public health is best served if access to medicines is maximized and substance misuse is minimized at the same time. This requires that we need to re-think the design of our drug control measures, both in the form of rules or in the form of policies: Any measures should not blindly block access to medicines, but at the same time, should also not stimulate substance misuse. For achieving the best public health outcome, there is an optimum somewhere in the middle. The guidelines document has 21 recommendations, but also a check list to check what the topics are to work on. -------------------------------------------------- Additional note: The Country Assessment Checklist is a tool for the analysis of national drug control policies and legislation, identify barriers at different levels, in order to gradually improve access and availability of controlled medicines and work towards an optimal balance. Its allows to check the extent to which the guidelines are adhered to in a given country.
- The are the topics (READ OUT). For each subject, there are a number of practical recommendations that will help to improve the drug control system to arrive at the best public health outcome. There are examples, and the legal aspects in international law are discussed.
- Additional notes (not to be mentionned in detail at the conference) Cf.: www.painpolicy.wisc.edu/sites/www.painpolicy.wisc.edu/files/Joranson_2010_Bonica%20Chapter%2016.pdf Roumania (Global State of pain treatment. Human Rights Watch 2011) : Picture of the 2002 Regional Workshop regional workshop in Budapest, Hungary entitled “ Assuring Availability of Opioid Analgesics for Palliative Care”. Workshop attended by teams of health are professionals and drug regulators from Bulgaria, Croatia, Hungary, Lithuania, Poland, and Roumania. 2002: Romania’s participation in a 2002 workshop convened by OSI and WHO. Romanian Ministry of Health appointed a commission of specialists to provide reform recommendations 2006: New legislation and new regulations: it is the sole responsibility of the doctor to determine the appropriate opioid dose and allow doctors to prescribe opioids to patients in severe pain regardless of the underlying disease. New regulations also provide for the improvement of Romanian health workers’ education in palliative care (over 4,000 doctors have since completed this Ministry of Health-approved course). Romanian Ministry of Health had identified palliative care as a “medical sub-specialty” in 2000 Despite the impressive progress that has been made, substantial challenges remain in providing palliative care in Romania. Kerala, India In 1999, a task force appointed by the Kerala Health Secretary was successful in simplifying the state morphine rules, and a national policy was changed. The number of palliative care clinics in Kerala increased from 21 in 2000 to 68 in 2006. Uganda In 1998, the Ugandan Ministry of Health invited staff from Hospice Africa Uganda, to be technical experts in a pilot study looking at the viability and safety of using morphine to treat chronic pain at the community level. Development of a strategic plan to address barriers to opioid availability, after having made an analysis of the situation and identified them.
- WHO also developed the WHO guidelines in the pharmacological treatment of persisting pain in children with medical illnesses. They may be too technical for those of you who do not have medical training. However, there is a brochure for policy makers for quick reference. It contains those issues you should know. It is only 28 pages long and, like the guidelines itself, it can be downloaded free of charge from the WHO website. Other brochures for quick reference are for physicians and nurses and for pharmacists.