Prof Dr Christoph Ostgathe, Dr Sébastien Moine, Dr Julie Ling (European Association for Palliative Care) and Prof Lukas Radbruch (International Association for Hospice & Palliative Care).
The USA ‘opioid crisis’ is a well-documented public health disaster and a human tragedy, (0) with complex causes and dramatic consequences on population health, both in terms of morbidity and mortality. A recent report by two members of the US Congress (1) may unexpectedly have contributed to worsen another (global) crisis, as the World Health Organization (WHO) has withdrawn two guidelines on the prescription of opioids for people with severe illnesses and palliative care needs. This may result in many patients in dire need of opioids for pain relief no longer being able to access these medications.
In 2005, the World Health Assembly instructed the WHO Secretariat to work on better access to opioid analgesics through resolution WHA 58.22 on Cancer prevention and control. Around the same time, the UN Economic and Social Council made a similar request to WHO (Resolution ECOSOC 2005/25 on Treatment of pain using opioid analgesics). The WHO responded with the establishment of the Access to Controlled Medications Programme. Part of the programme’s activities aimed to provide guidance for better public-health policies and better pain treatment.
The need for the programme arose from the vast suffering among patients in many countries resulting from the limited access to opioids for the treatment of moderate and severe pain, and controlled medicines more generally required for conditions ranging from opioid dependence to epilepsy. Most countries have a much lower per capita consumption of opioids than the United States of America. In some, it is as much as 30.000 times lower.(2) In such countries the suffering associated with HIV/AIDS, cancer or other severe illnesses is often excruciating. Even in many European countries people still need to fight for adequate access to pain management.
On 22 May 2019, Katherine Clark and Hal Rogers, members of the US Congress, published a report on the development of WHO guidelines on policies and treatment in relation to controlled medicines and pain. (1) The report suggests that these guidelines are “marketing materials” for the pharmaceutical industry. This influence was, according to the report, achieved through named organisations and individuals, serving the interests of a pharmaceutical company, Purdue Pharma, the maker of OxyContin, a commercial brand of oxycodone.
On 20 June 2019, this led to the discontinuation of the guidelines Ensuring Balance in National Policies on Controlled Substances (3) and Who Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses (4) by the WHO. Additionally, the WHO stated that the guidelines have to be seen in light of new evidence on pain management. The WHO policy guidelines Ensuring Balance in National Policies on Controlled Substances (3) were part of an EU 7th Framework Programme Project. These guidelines were primarily developed for policy makers and clinicians. Ensuring Balanceprovides guidance on how to adopt balanced policies to ensure availability to, and rational use of all controlled medicines for legitimate medical needs, and not just opioids. (3) The WHO paediatric pain guidelines were an important step towards better treatment of persistent pain in children. (4)
We support the WHO in their endeavours to secure best possible evidence, and to safeguard guidelines from any possible conflict of interest. However, to discontinue the guidelines based on misleading information without current replacement will have a negative impact on patients in palliative care worldwide requiring opioids for symptom control. We recognise that non-medical use of prescription opioids, or opioid use disorder, (5) may happen in any country and thus underscore the importance of implementing basic mandatory training for all healthcare personnel for safe management and evidence-based prescribing of opioid analgesics. Indeed, the Ensuring Balance guidelines emphasise the importance of providing relevant healthcare staff with the knowledge and skills for using these medicines appropriately when introducing policies on accessibility and availability of controlled medicines.
Regarding the current US context, only focussing on prescription (by restricting the supply of prescription opioids analgesics) in order to tackle the opioid crisis presents a double risk: such a strategy may not be sufficient to lower opioid overdose deaths, since more people use illicit and synthetic opioids (such as heroin and fentanyl) and start opioid use with them. (6) In reality, these drugs are responsible for an increasing number of deaths, despite a decrease in opioid prescriptions. (7) This is one of the reasons why a public health approach with combined interventions, including harm reduction programmes and medication-assisted treatments (MATs), is urgently needed. (7, 8)
Furthermore, rules and regulations aiming to indistinctly restrict access to prescription opioid analgesics would have detrimental effects for the vast majority of patients with severe illnesses with legitimate palliative care needs, especially those living in low- and middle-income countries. For these patients, access to treatment for moderate and severe pain remains a major challenge. (9) The Lancet Commission on Palliative Care and Pain Relief estimated that less than 2 per cent of the opioids needed for palliative care patients are provided in low-income countries. (2) A lack of availability of such treatment is unethical and results in a global inequity and injustice.
As a reaction to these two crises, a Joint Position Statement on the Decision by WHO to Withdraw Guidance Documents has been published by the International Association for Hospice & Palliative Care (IAHPC), the International Children’s Palliative Care Network (ICPCN) and the European Association for Palliative Care (EAPC).
Within a few days of publishing, this statement has been endorsed by more than 100 associations worldwide. The WHO is urged to “revise and update the guidelines they have withdrawn with all deliberate speed, and until this task has been completed, to reinstate both the Ensuring Balance in National Policies on Controlled Substances and Guidelines on the Pharmacological Treatment of Persisting Pain in Children with Medical Illnesses to fill the normative and technical vacuum left by their withdrawal.”
We ask and advise all of our member associations to support this statement. We have to continue to advocate, educate and raise awareness, so that the needless pain and suffering of millions of adult patients and children with palliative care needs is relieved to the best extent possible in accordance with evidence-based quality and safety standards.
0. Lopez G, Frostenson S. How the opioid epidemic became America’s worst drug crisis ever, in 15 maps and charts. Vox2017 (https://www.vox.com/science-and-health/2017/3/23/14987892/opioid-heroin-epidemic-charts, accessed 17 July 2019).
- Clark, K and Rogers H. Corrupting Influence – Purdue & the WHO. 22 May 2019.
- Knaul, FM et al. Alleviating the access abyss in palliative care and pain relief—an imperative of universal health coverage: the Lancet Commission report, The Lancet, Volume 391, Issue 10128, 2018
- World Health Organization. Ensuring balance in national policies on controlled substances, guidance for availability and accessibility of controlled medicines [Internet]. Geneva: World Health Organization; 2010. 78 p. Available from: http://whqlibdoc.who.int/publications/2011/9789241564175_eng.pdf?ua=1
- World Health Organization. WHO Guidelines on the pharmocological treatment of persisting pain in children with medical illnesses [Internet]. Geneva: World Health Organization; 2012. 166 p. Available from: http://whqlibdoc.who.int/publications/2012/9789241548120_Guidelines.pdf
- 5. American Psychiatric Association (APA). Opioid Use Disorder. APA website, November 2018 (https://www.psychiatry.org/patients-families/addiction/opioid-use-disorder/opioid-use-disorder, accessed 17 July 2019)
- Chen Q, Larochelle MR, Weaver DT, et al. Prevention of Prescription Opioid Misuse and Projected Overdose Deaths in the United States. JAMA Netw Open 2019; 2: e187621
- American Medical Association [AMA]. The AMA Urges Removing All Barriers to Treatment for Substance Use Disorder. Chicago: AMA, 2019
- Csete J, Kamarulzaman A, Kazatchkine M, et al. Public health and international drug policy. Lancet 2016; 387: 1427–1480
- Cicero TJ. Is a Reduction in Access to Prescription Opioids the Cure for the Current Opioid Crisis? Am J Public Health 2018; 108: 1322–1323.