Featured Article

2018; Volume 19, No 11, November

Featured Article

This is the first instalment of a two-part feature on the issue of internationally controlled essential medicines used in palliative care. We talked to:

  1. Gilles Bertrand Forte, Coordinator, Office of the Assistant Director General, Cluster for Access to Medicines, Vaccines and Pharmaceuticals, World Health Organization (WHO)
  2. Stefano Berterame, Chief, Narcotic Control and Estimates, International Narcotics Control Board Secretariat (INCB)
  3. Heloisa Broggiato, researcher and journalist

Part 1 is an overview; Part 2, to appear in the December issue, lists useful tools.

The Essentials: Palliative care, pain, and symptom relief

In the last few years, the issue of pain relief — and access to internationally controlled medicines (narcotic drugs, e.g., opioids) needed to alleviate severe pain and symptoms, such as dyspnea — has moved into the spotlight.

Advocacy groups demanding change are more numerous and vocal, high-level resolutions devoted specifically to the cause have passed, supply-management tools have been refined, and our three interviewees agree that there is clear evidence that the political will to end serious health-related suffering has gained strength globally.

Integrating the issue into daily work
Dr. Gilles Forte

At the World Health Organization (WHO), increasing interest and demand for information from Member States has stretched its resources.

‘We are trying to integrate more and more the specificities of medicines for pain and palliative care into the mainstream of our work,’ says Gilles Bertrand Forte. ‘It has become an integral part of our program, which was not the case a few years ago.’

Of the 500 medicines on WHO’s Model List of Essential Medicines, reviewed once every two years, 17 are specified for pain and palliative care. The list now includes the fentanyl patch (for cancer pain, with methadone as a complementary choice), and five formulations of morphine. ‘The concept of the list is to provide a selection of medicines considered essential, and which should be available at all levels of health care at all times,’ says Forte. ‘It is meant to help prescribers and people who procure the medicines at the country level make the right decisions,’ and to select medicines proven to be both safe and effective.

‘More than 100 countries have adopted the concept of the Essential Medicines list, and they have developed their own national lists, especially in low- and middle-income countries,’ says Forte. ‘We realize that the list is used as a guide for their own policies, for prescribing, for making public health decisions, or decisions about expensive medicines.’

In many low- and middle-income countries, however, the primary pain relief opiate — morphine — is unavailable or inaccessible. Its use is considered taboo, even with a doctor’s prescription; it is in limited supply; or it costs too much in those few urban areas where it is available.

But our three interviewees concur that a swell of political will to improve the situation is growing.

Fear fostered neglect
Heloísa Broggiato

‘Decision-makers have not paid enough attention to medications for pain, such as morphine, because of fear of prescribing, of abuse,’ says Forte. ‘This fear has led to neglecting education and awareness-raising, putting us in a situation where we have huge gaps of access to these medicines.’

People often point to abuse problems in the United States when the topic of opioids arises, says Heloísa Broggiato, who is writing her PhD on access to opioids as a human right at the Global Drug Policy Observatory, Swansea University, UK. ‘It’s very important to explain that the U.S. problem is mostly due to illicit opioids. It’s a problem of policy, education, and proper control. If we keep terrorizing people about opioids, we’re going nowhere.’

From concept to concrete action

An important part of the International Narcotics Control Board (INCB) mandate is to provide a global import-export system to track internationally controlled essential medicines.

‘The system we put in place is very effective,’ explains INCB’s Stefano Berterame. ‘We have 187 countries that ratified the 1961 Convention [Single Convention on Narcotic Drugs] and 184 countries that ratified the 1971 Convention [on Psychotropic Substances], and even those who did not ratify it need to be part of the system in order to procure the substances they need.’

The key to good control
Dr. Stefano Berterame

The key to a country maintaining good local control of these medicines is to correctly measure the health needs of its citizens, he adds. ‘If you have an excessive amount, the risk of diversion [from the medical supply chain] increases.’ Before a new year starts, the INCB asks each country to provide an estimate of need, submitted online or on paper. After the year concludes, it seeks a consolidated report on the precise amounts used; quarterly reports may also be necessary.

‘The control requirements aren’t onerous,’ says Berterame, but adds that overworked employees given this additional task may feel overloaded. Also, ‘some countries have created regulations to avoid diversion that have turned into bureaucratic impediments.’

‘There are idiosyncracies to each country to overcome,’ says Broggiato. ‘But they are not necessarily complicated barriers that need a lot of money to resolve. What I hear from people is that you need to go to those responsible, who may not understand the need of collecting data and providing estimates of the necessary amount of medicines, and say, “You have to do the paperwork. People in pain need this medicine.”’

Production & pricing

Morphine Shortage Measured

The lack of painkillers is a major contributor to serious health-related suffering. Some examples:

(Source: 2017 Lancet Commission report, Alleviating the Access Abyss)

The lack of morphine in many health care systems cannot be attributed to low global production. Berterame notes that 88% of morphine available worldwide is transformed into codeine for use in cough syrups. Furthermore, the 2017 Lancet Commission report, Alleviating the access abyss in palliative care and pain relief, revealed that 90% of the morphine to treat pain is consumed by high-income countries, while low- and middle-income countries consume just 10%. An insufficient sliver of that is used to relieve pain associated with end-of-life care.

Even when pain relief medicine is available, ‘we found that many countries had difficulty procuring it at a reasonable price,’ says Berterame. [Note: IAHPC maintains an Opioid Price Watch.]

Some countries have responded by producing their own supply. Others turn to the WHO for help. ‘We have a set of tools promoting good procurement practices and good supply chain practices, and for assessing the quality of medicines and the price,’ says Forte.

Growing grassroots awareness and demand is fueling palliative care organizations that help raise the issue of pain relief and palliative care. Both the WHO and INCB representatives credit a surge of support by civil society for the improving international framework obliging UN member states to make these essential medicines available to their populations in need.

‘This [interest in palliative and pain relief] did not happen in a vacuum,’ says Berterame. ‘A number of issues brought it to the forefront. One of the most important was civil society organizations representing health professionals and patients, which was essential.’

‘They work at a global level, in big fora, and are raising the issue at every opportunity,’ says Forte. ‘They are very vocal, and we appreciate and depend on their work.’

The next phase

When asked what the next phase will be, Berterame replies, ‘We cannot back off, because ensuring the availability for medicinal purposes was one of our main goals, and until the work is done, it would be irresponsible to forego. The job is not complete.’

Broggiato notes that the debate is turning from drug control to health as a human right. In the past few years, the United Nations Human Rights Council has adopted resolutions reaffirming the importance of access to medicines as a right, to give people relief from pain and suffering, and improve enjoyment of life. The flip side? ‘There’s a lot of resistance in countries that are not interested in human rights,’ she says.

What is on WHO’s horizon? The organization is tackling the issue of pricing, and ‘there is a lot to be done in measuring the impact of essential medicines on people,’ says Forte, ‘and it is even more important for those medicines that alleviate pain. We’re paying more attention to measuring, to having baselines.’

Much has been accomplished, but sustained efforts are crucial.

Concrete Steps to Improve Access to Opioids

In March, the United Nations Office on Drugs and Crime released a draft of Technical Guidance: Increasing access and availability of controlled medicines. It provides concrete, interlinked actions that Member States can take to combat ‘the enormous burden of untreated pain,’ as part of a comprehensive approach to quality health care.

Three core areas wereidentified. Here are a few of the suggestions for each:

  1. Systems Strengthening and Integration
    • Appoint a lead agency and focal person.
    • Convene regularly scheduled meetings.
    • Map the overlap of ministries.
    • Create a data collection hub.
  2. Education and Awareness
    • Create basic training for medical staff on the science behind use of controlled drugs.
    • Ensure incoming workforce is trained in treating pain.
    • Enact annual mandatory continuing education.
    • Develop training materials to make community aware of pain treatment.
  3. Supply Chain Management
    • Include all stakeholders in developing a national policy.
    • Map the supply chain and its management.
    • Analyze procurement benefits/challenges.
    • Encourage use of INCB/UNODC import/export system.

Five themes emerged: Economic Structure, Consistent Messaging, Patient-Centered Care, Prevention of Diversion and Non-medical Use, and Data and Research.

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