18 October 2016
International Drug Control Conventions Single Convention on Narcotic Drugs of 1961 as amended by the 1972 Protocol Convention on Psychotropic Substances of 1971 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 2
Definitions Controlled medicines Controlled substances are the substances listed in the international drug control conventions: - List of Narcotic Drugs under International Control https://www.incb.org/incb/en/narcotic-drugs/yellowlist_forms/yellow-list.html - List of Psychotropic Substances under International Control https://www.incb.org/documents/psychotropics/greenlist/2016/v1604744_eng.pdf - List of Chemicals frequently used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances under International Control https://www.incb.org/documents/precursors/red_list/redlist2015_e_14hed.pdf Controlled medicines are medicines containing controlled substances 3
International Drug Control Conventions The preamble of both 1961 and 1971 Conventions refer to their scope and impact on health: The parties, Concerned with the health and welfare of mankind (1961) 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 (1961) Being concerned with the health and welfare of mankind (1971) Recognizing that the use of psychotropic substances for medical and scientific purposes is indispensable and that their availability for such purposes should not be unduly restricted (1971) 4
WHO Mandate within World Health Assembly Resolutions 2005 WHA58.22: Cancer Prevention and Control: treating pain with opioid analgesics; 2014 WHA67.19: Strengthening of palliative care as a component of comprehensive care throughout the life course: improving access to controlled medicines for pain and palliative care, including for children; 2015 WHA68.15: Strengthening emergency and essential surgical care and anaesthesia as a component of universal health coverage: improving access to essential medicines for anaesthesia and essential surgery; 2015 WHA68.20: Global burden of epilepsy and the need for coordinated action at the country level to address its health, social and public knowledge implications; 5
19th WHO Model List of Essential Medicines (April 2015) 6
Essential palliative care medicines in primary care Percentage of Member States reporting that oral morphine is available in >50% pharmacies, by WHO Region Source: WHO NCD Country Capacity Survey 2015. 7
Controlled substances (1961, 1971, 1988) - medicines WHO Model List of Essential Medicines Medicines for pain and palliative care Opioid analgesics codeine; morphine (granules, injection, oral liquid, tablet (slow release and immediate release)); alternatives limited to hydromorphone and oxycodone Anticonvulsants/antiepileptics - diazepam, lorazepam, phenobarbital, midazolam Local anaesthetics ephedrine (for use in spinal anaesthesia during delivery, to prevent hypotension) Medicines for disorders due to psychoactive substance use - methadone, buprenorphine Preoperative medication and sedation for short-term procedures midazolam Palliative care diazepam, midazolam Oxytocics - ergometrine 8
INCB report 2015 9
Trend in the consumption of opioid analgesics 10
Mean availability of opioids for pain management (2011-13) (2001-03) Source: INCB and Berterame et al. 2016 11
INCB report 2015 - Impediments 12
WHO guidelines WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses http://www.who.int/medicines/areas/quality_safety/guide_perspainchild/en/ WHO Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence http://www.who.int/hiv/pub/idu/opioid/en/ Other WHO pain guidelines to follow: WHO is currently developing a new Guideline on Management of Cancer Pain in Adults 13
Ensuring balance in national policies on controlled substances Guidance for availability and accessibility of controlled medicines while preventing misuse and diversion Activities carried out in countries: Analysis of country-specific barriers to opioid accessibility; Revision of national drug control legislation and policy; Adequate estimates and statistics for medical purposes; Training and awareness raising; Development of national strategic action plan; National consensus workshop on recommendations. Project Access to Opioid Medications in Europe (ATOME) was carried out in 12 European countries 14
21 guidelines for working on the improvement They relate to seven aspects of policy and legislation: - content of drug control legislation and policy (Guidelines 1 and 2); - authorities and their role in the system (Guidelines 3 to 6); - policy planning for availability and accessibility (Guidelines 7 to 10); - healthcare professionals (Guidelines 11 to 14); - estimates and statistics (Guidelines 15 to 17); - procurement (Guidelines 18 to 20); - other (Guideline 21). 15
Guideline 5 Authorities and their role in the system Governments should ensure that there is a forum where drug control authorities and public health authorities cooperate and meet as necessary with health professional organizations and other stakeholders for the promotion of the availability and accessibility of controlled medicines for medical and scientific purposes, as well as the prevention of abuse, dependence syndrome and diversion Guideline 6 All government agencies, depending on their roles and obligations, should ensure that in the fulfilment of their duties, they do not impede health policies and access to legitimate treatment with controlled medicines. Health authorities should provide relevant information on treatment principles to drug law enforcement and other relevant agencies 16
Healthcare professionals Guideline 11 Appropriately trained and qualified physicians, and, if applicable, nurses and other health professionals, at all levels of health care should be allowed to prescribe and administer controlled medicines, based on their general professional license, current medical knowledge and good practice without any further license requirements Guideline 12 Appropriately trained and qualified pharmacists at all levels of health care should be allowed to dispense controlled medicines, based on their general professional license, current medical knowledge and good practice without any further license requirements 17
Healthcare professionals Guideline 13 Governments should promote that medical, pharmaceutical and nursing schools teach the knowledge and skills for the treatment of pain, substance use disorders in the context of medical use of controlled medicines, and other health conditions that need treatment with controlled medicines Guideline 14 In countries where controlled medicines become available and accessible for the first time, governments should organize education initiatives for healthcare professionals to ensure their rational use 18
Estimates and statistics Guideline 15 Governments should develop a practical method to estimate realistically the medical and scientific requirements for controlled substances, using all relevant information Guideline 16 Governments should furnish to the INCB estimates (annually for narcotic drugs) and assessments (at least every three years for psychotropic substances) of the quantities of controlled substances required for legitimate medical and scientific purposes and supplementary estimates or modified assessments to the INCB if it appears that the availability of controlled substances for legitimate purposes will fall short because of initial underestimation of regular demand, emergencies or exceptional demand 19
Procurement Guideline 18 Governments should ensure, in cooperation with companies and agencies managing distribution, that the procurement, manufacture, and distribution of controlled medicines are accomplished in a timely manner with good geographical coverage so that there are no shortages of supply, and that such medicines are always available when they are needed while maintaining adequate controls to prevent diversion, abuse, or dependence syndrome Guideline 19 Governments should minimize the negative impact of control and safety measures on the affordability and availability of controlled medicines. 20
UNGASS 2016 21
UNGASS 2016 - Operational recommendations on ensuring the availability of and access to controlled substances Consider reviewing domestic legislation and regulatory and administrative mechanisms, as well as procedures including domestic distribution channels, with the aim of simplifying and streamlining those processes and removing unduly restrictive regulations and impediments identify, analyse and remove impediments to the availability and accessibility of controlled substances for medical and scientific purposes provide capacity-building and training on adequate access to and use of controlled substances expanding the national coverage of distribution networks to rural areas consider the development and wider implementation of relevant clinical guidelines on the rational use of controlled medicines allowing appropriately trained and qualified professionals to prescribe, dispense and administer controlled medicines based on their general professional license adequately estimate and assess the need for controlled substances and paying special attention to essential medicines review national lists of controlled substances and national lists of essential medicines 22
Collaboration with partners for improving access to controlled medicines The Access to Opioid Medication in Europe (ATOME) programme improving access to opioids for pain management, palliative care and the treatment of opioid dependence in 12 European countries; The Joint Global Program to improve access to controlled medicines for pain and palliative care WHO, UNODC and UICC Ghana; Timor-Leste; INCB Learing Project regional training for East Africa, national awareness raising workshop for Kenya; regional training for South and East Asia and the Pacific; national awareness raising workshop for Thailand; UNODC HONLEA Africa, Working Group on best practices in promoting measures to ensure the availability and accessibility of internationally controlled drugs for medical and scientific purposes, Addis Ababa, Ethiopia. 23
Together towards improvement 24