Special Event: Taking Action to Increase Access to Controlled Drugs for Medical Purposes While Preventing Diversion and Misuse

Dr Lisa Studdert, Australia’s Head of Delegation

Australia is deeply concern on the global disparity on global access to essential medicines. We need to work together. Adequate provision must be made to ensure access. It’s very important that the conventions do no restrict access. We need to reduce the risks of diversion for illicit use. We recognise barriers include social and cultural barriers. We need to think how programs at local level can work with civil society. Australia has assisted countries implement national strategies on this topic. Pilot programs have been successful in Ghana and East Timor.

This discussion is important through the world. We thank you for all of the states supporting this event

Elisabeth Mettfield, UNODC

We want to acknowledge the importance of member states and civil society involved today.

Kurt Doms, Head Drug Unit, Ministry of Health Belgium

The Universal Declaration of Human Rights includes the right to medical care and essential services – this is also core to the international drug conventions. Providing access to essential medicines is one of the sustainable development goals. Treatment of pain is for children inadequate and under researched. The global pain divide. The outcome doc sets framework of our policies. Urgent action is needed and all tools to take action are available from outcome doc:

  • Review domestic legislation and mechanisms
  • Importance of strengthening capacity of appropriate national organisations
  • Recommends to take measures for capacity building an training for health and medical professionals

We are very pleased to see access to essential medicines in the MOU between UNODC and WHO. We commend the UNODC on the coordination of a meeting on this topic in Sept last year. Policy makers, scientific community, civil society, patients and their families predominantly are key in solving this issue. Ensuring access also means addressing their diversion. The 3 drugs conventions, outcome doc and technical advice from member states and UN agencies can provide a balanced discussion on this issue.

H.E. Mr Aurimeas Taurantas, Ambassador, Permanent Representative of the Republic of Lithuania to the international organisations in Vienna

Close cooperation of all countries concerned here are very important. The video message from WHO director mentioned that many people to do not appropriate access to pain treatment – we think that human rights is central in this issue. For the first time in EU history the Lithuanian President put together guidelines on this issue. Principle of proportionality is key in the outcome document and is interesting to us today.

Mr Alexy Alekhin, Director of the Department on the Development of Pharmaceutical and Medical Industry, Ministry of Industry and Trade of the Russian Federation

The federal law in the Russian Federation fixes the right of the patient for pain relief. In accordance with federal law on narcotics, one of the principles in this strategy is availability of narcotics and psychotropic substances for the civilians who need that. The Russian government has adopted a roadmap on increasing availability of medicines for medical purposes. We group of patients that need pain relief include narcology and terminal stages of HIV and other diseases. These medicines are used for surgeries and to treat acute pain. We have 6 patented names – solutions for injection – narcotic medicines. For all narcotic medicines the factory uses local and imported substances. While executing the roadmap of increasing availability we are running work on local manufacturing of a wide range of narcotic substances – included morphine hydrochloride coated tables – for children from the age of 2. Prolonged medicine will also be available. We are on the R&D for buprenorphine oxycodone hydromorphine, fentanyl film and ketamine for ingestion. All medicines are under strict distribution control. The measures undertaken have led to positive results. The required volume of non-injectables has increased since 2014. Rate of anaesthesia has increased. Despite the fact we monitor this situation in terms of satisfaction of people in need, we realise we have a lot of room for development. During our further work aimed at increasing availability, we will take in other countries negative experience in illegal use to these medicines. The legislation of Russia on drugs allows us to provide strict control on restrictions of narcotics.

Dr Gilles Forte, Coordinator, Officer of Director, Essential Medicines and Health Products (EMP), Medicines, Vaccines and Pharmaceuticals Cluster (MVP), World Health Organisation

Access to controlled medicines is very high on the WHO agenda. It’s a regular agenda item at the WHA. WHO has been instructed to develop a roadmap on justifying this access. WHO is concerned on the global lack of access to controlled medicine, mostly in low-income countries. 3% of world morphine is distributed to low-income countries. Everyone should be able to access medicines in order to live a productive life. Access to controlled medicines is necessary for cancer pain, addiction and other health issues. We have a complex contradiction with the overuse of these substances and overdose and lack of access in other regions. WHO approach is to strive for policies and program to create access and reduce diversion. WHO regularly reviews best available evidence. The WHO of essential meds is regularly updated. WHO has already developed guidelines of pain in children and pharmacological issues. Maintaining price and affordability is central to WHO. There are enough tools that have been developed and tested – they now need to be used in countries to identify gaps in access and strengthen supply chain and capacity build with health professionals. We need to work with specific countries we need to collaborate with civil society and other member states. WHO works with regional partners to ensure this access if improved.

Hanifa Rebbani, Chief Psychotropic Control Section, International Narcotic Control Board Secretariat (INCB)

Being a pharmacist by profession, I could speak for hours on this topic. My 3 main points:

  • Ensuring access is one of the main objectives of the international framework. There is much discrepancy between high middle and low-income countries.
  • The international community has remobilised to have open discussions on the availability to these medicines. UN agencies and civil societies work together on this issue
  • Any result achieved should be measured on the basis of reliable data

In order to monitor and seriously assess availability, we need available data. We are ready to assist governments on this.

Jim Cleary, Director, Pain and Policy Study Group, University of Wisconsin, WHO Collaborating Center, and UICC member

As an oncologist and palliative care specialist I will focus on people who are dying from cancer with no access to pain relief. The WHO recommends a basic pall care package, but how far have we really progressed? Many countries no have a cancer control plan – but many are weak on ensure access to opioid based medicines.

Timor Leste situation – they use 44g of morphine a year in a population of 1 million people. We need to be able to respond to countries that need assistance to improve palliative care.

Dr Viktoriia Tymoshevska, International Renaissance Foundation, speaking on behalf of VNGOC/NYNGOC

I am also a trained physician in palliative care – I want to share real life stories. I had a late Friday afternoon call from someone wanted pain relief for her dying father and they were refusing prescription as they weren’t the family physician. It took her 3 days to get the prescription to her father; he got it 6 hours before he died. There is a huge gap here that we need to address. We work with other countries in our region (Ukraine). We are now able to allow family physicians to prescribe morphine. Geographical prescription now allows better access to controlled medicines. Continued awareness raising by family members and providers lead to the registration of oral morphine in my country. However there are still many gaps in the system. In Georgia you must go to a police station to get your morphine. The opioid overdose crisis in the US has fuelled much misinformation on pain relief medications. We need to strengthen the roles of civil society reps – pharmacists – in joining the conversation. Now people can talk publicly on opioids without fear of legal ramifications.   I call on you to include public health experts in your delegations to ensure health-based policies that reduce harm.

Elisabeth Mettfield, UNODC

We are launching a document today – in hard copy and electronic format. ‘Technical Guidance: increasing access and availability of controlled medicines.

Building a foundation in strong National Policy and Guidelines: Nigeria’s Journey EU funded 

Unoma Asomugha, Assistant Director, Narcotics and Controlled Substances Directorate, NAFDAC, and Akanbi Rafiu Folahan, Head, Narcotics and Drug Abuse Programme

 Assessment report in Nigeria identifies barriers to access:

  • Laws and policies are focused on controls with no attention on access for medical purpose
  • Limited quantification of annual requirements
  • Inadequate and irregular release of funds
  • (….)

 New national policies and guidelines (NCPM, 2017) ensure availability while minimising chance for diversion for illicit use.

Goals:

  1. Ensure uninterrupted supply of controlled meds
  2. Ensure availability
  3. Improve capacity of health care
  4. Promote rational prescribing
  5. Appropriate legislation

There are also key strategies for implementing the NPCM. Guidelines have also been developed in 2017 aiming to standardise the quantification practices and establish estimation practice to ensure adequate availability. Launch of 4 documents – policy, guidelines and minimum standard for drug dependence treatment.

Results and challenges on 2017 national survey

We wanted to conduct a formal piloting of these new documents before they were introduced. Initial pilot phase in 6 centres, now been scaled up. All 36 states visited for data collection. We have more than 150 languages in Nigeria data collected with specialist instruments. We wanted reliable data – and did not want to outsource it. We wanted people trained locally for sustainability. We went to public, private primary health services, and pharmacies.

Findings – smuggling of narcotics a reality, need for Narcotic analgesics very high. Dihydrocodeine found in facility nation wide but permit issuance very low (1kg vs 200kg). This provided a god snapshot of controlled produced available nationwide.

We have a National Drug Control Master Plan. INCB estimates and our on the ground estimates were very similar for codeine; but methadone different. Many challenges/limitations identified. Many facilities don’t maintain adequate documentation.

Priority activities for 2018

Develop regulations for controlled medicines

  1. Decentralise warehousing of narcotics warehouse
  2. Local manufacture of narcotic medicines
  3. Revise curriculum of medical pharmacy and nursing schools to incorporate rational use of controlled medicines
  4. Present final draft of pain management guidelines to the national council on health for approval
  5. Review of inventory and record keeping tools

Nigeria is taking lead in Africa in laying a strong foundation to improvise availability and accessibility. Strong demonstration of government implementing UNGASS outcome document

Using Technology to Increases Access to Controlled Medicines: Mexico’s System

Dr Mario Alanis Garza, Director General for International Affairs of the Federal Commission for the Protection against Sanitary Risk of the Government of Mexico

This is a very important issue for Mexico.

Objectives of regulating the whole supple chain of narcotics and psychotropic substances

  1. Allow and promote use for therapeutic and scientific purpose
  2. Minimise risk of abuse
  3. Reduce the growing trend of their illicit production

Limited availability of narcotics and psychotropic substances for medical ad scientific purposes – Mexico has a much lower per capita consumption of morphine than other Latin America countries. It might be due to availability and regulations. We decided in 2014 to take some actions – created an ‘inter-institutional group’ – multi stakeholder group of national health council, pharmaceutical industry, medicine distributors, pharmacists, hospitals NGOS and the supreme court.

Objective of groups was to develop a national strategy for pain control and palliative care, ensuring adequate supply of morphine in Mexico

It became mandatory for all health institutions to have operational and overall policy schemes for palliative care. We still have big challenges, but a lot has been advanced already. A lot of resources ere developed. We have had excellent results so far with electronic prescription books that have a strict and detailed control of prescriptions issues in each pharmacy.

We have the medicines, but they are not getting the right channels to get the where they needs to be. We are working on statistical analysis, as is Nigeria. We are a big country, so this issue is a big challenge. At the same time we are working with the national hospitals and pharmacists. All pharmacists can consult with our resources to feel more confident with prescribing. Technology has really helped Mexico deal with this issue.

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