This is the second instalment of a two-part feature on the issue of internationally controlled essential medicines used in palliative care. We talked to:
Part 1, in the November 2018 Newsletter, contains an overview titled ‘The Essentials: Palliative care, pain, and symptom relief’ plus an outline of ‘Concrete Steps to Improve Access to Opioids.’
‘We don’t need more tools; the tools exist,’ says WHO’s Gilles Bernard Forte, when asked what could be done to further pain relief in low- and middle-income countries. ‘We need to ask for political support from our member states. We need to acknowledge the problem of availability and access to drugs for palliative care.’
This feature introduces some of those tools to help initiate, expand, and entrench use of controlled medicines essential to palliative care and pain relief.
The WHO and INCB agree that they need to increase capacity and expertise to cope with rising interest and demand from members. Heloisa Broggiato emphasized the need for education of medical professionals. ‘It’s the number one barrier’ to addressing pain in palliative care in Brazil, she states. ‘I think that 100% of physicians told me they don’t learn properly how to treat severe pain.’
This unit ‘combines efforts with public, private, and NGO stakeholders to increase procurement and access to priority medicines at the country level; facilitates strategies to promote rational use; and, ultimately, establishes mechanisms for drug pricing policies and monitoring.’ It also works to further the National Medicines Policy of member states.
‘We try to take an approach that will strengthen the whole system,’ says Forte of WHO’s involvement. ‘We promote procurement and supply chain people at the country and the regional level. We have a set of tools promoting good procurement practices, and good supply chain practices.’
Studies, statistics, and resolutions are building upon each other.
A few years ago, the INCB submitted a questionnaire to governments worldwide, asking what problems they were encountering with improving availability of controlled medicines. The resulting report included concrete recommendations, many of which were incorporated into a resolution by the subsequent United Nations General Assembly Special Session on Drugs (UNGASS). This resolution put 100 detailed recommendations on paper.
The INCB has followed up with a second questionnaire, to evaluate progress. The data has been collected and is expected to be released in early 2019.
Recognizing that sudden catastrophe can strike at any time, driving need beyond actual availability on the ground, the INCB has developed a process to deliver controlled medicines quickly. ‘For emergency situations, there is a provision to allow importation of medicines without certifications,’ says INCB’s Stefano Berterame. He adds that even a request to respond to increased need unrelated to an emergency can be fulfilled fast — within five working days.
Published every two years, the Access to Medicine Foundation Index ‘holds the world’s 20 leading research-based pharmaceutical companies accountable for making their products more accessible in low- and middle-income countries.’ The list is capable of exposing misconduct and charting improvements in industry behavior.
The IAHPC website includes Opioid Price Watch, a project to monitor and report the dispensing price of opioids around the world, where the information is available. The current data, published in 2016, is in the form of a map; click on a region to find a price, then click on ‘See the availability and prices of other opioids’ for more details.
Launched in West Africa in 2013, this is a rapid-report system to identify ‘medicines’ of unacceptably low quality or that are outright shams. More than 400 personnel from 126 countries have been trained to use the system; their reports are uploaded to a secure WHO database that compares it to other reports. If adverse reactions are found, the originating country is informed within 24 hours. Member states can request technical support, such as laboratory analysis or, in complex cases, the deployment of experts.
INCB’s International Import Export System (I2ES) is an online platform developed in 2015 to facilitate and speed up the process of issuing import and export authorizations for narcotic drugs and psychotropic substances. It is currently being used by about 53 countries.
The INCB Operational Partnerships to Interdict Opioids' Illicit Distribution & Sales (OPIOIDS) Project supports national authorities and international organizations' efforts in preventing access to nonmedical synthetic opioids and fentanyl-related substances. It does this by offering technical assistance and training to nurture industry partnerships, by sharing information, and by increasing awareness.
Uganda’s Tactic Thwarts Diversion
In Uganda, morphine powder is heavily diluted before it is distributed in pint bottles. Even if a whole bottle is consumed, the dose would not get the person ‘high,’ it would simply make them sleepy. It would take an enormous amount of time and effort for anyone to distill an amount of interest to the illicit market. And, given the shortage of doctors, Ugandan law permits nurses with specialized training to prescribe it.
This program was introduced in 2001, when generic, low-cost treatments for HIV, tuberculosis, and malaria were flooding India without stringent regulatory controls. Experts were sent to inspect manufacturing facilities and test to ensure that the quality and efficacy of the products matched the patented originals.
Since then, it has extended to include prequalification of active pharmaceutical ingredients and drug-testing labs. A WHO ‘prequalified’ stamp of approval means that the medicines are safe, effective, and high quality.
IAHPC has implemented 13 workshops in 27 countries on the Availability and Rational Use of Opioids for pain treatment and palliative care. The workshops help providers and regulators to identify and eliminate a country’s barriers to access.
The WHO holds regular workshops at both the regional and national level. The workshops ‘promote the WHO tools for better selection, use, and quantification of medicines,’ says Forte.
Aside from offering day-to-day help to ensure that countries are accurately assessing their needs, the INCB launched the INCB Learning project, a series of seminars. ‘We’re training the authorities of various countries in fulfilling their data reporting obligations,’ says Berterame, ‘focusing on regions where there were problems with compliance.’
Additionally, the INCB website contains online training materials on how to use INCB’s three reporting forms (in Arabic, Chinese, English, French, Russian, Spanish) along with the forms themselves.
The WHO convened a Fair Pricing Forum in 2017, cohosted with The Netherlands, where experts discussed the pricing of pharmaceutical products and ‘alternative approaches to R&D, business models for innovation, facilitating collaboration among payers, increasing exchange of information (such as assessing the value of new products), and profit margins.’
‘We’re looking at affordability and pricing of medicines,’ says WHO’s Forte. ‘We have done some measurements of market prices, in countries where we are actively engaged.’
In May 2018, the INCB held a Civil Society Hearing, inviting about a dozen non-government organizations to discuss one topic: the medical and nonmedical use of cannabis. ‘The reasoning is that the board wanted to have a better understanding of the issues and the situations,’ says Berterame. It was part of INCB’s effort to collect information for its upcoming annual report; Chapter 1 is on cannabis. There may be more hearings in store. ‘I would like to see one on the importance and availability of opioid analgesics, which is probably an area of interest for the board.’
3 Steps to Overall Improvement
Researcher Heloísa Broggiato suggests three key actions suitable to any government:
One problem she identified is lack of transparency. ‘In Brazil, research concluded in 2016 includes data consumption but it is embargoed. No one outside of government knows the results.’
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