The new WHO guideline on balanced national policies for controlled medicines to ensure medical access and safety were launched on Friday 23rd May at the Palais des Nations, Geneva during the 78th World Health Assembly.
Sadly, we all know of places where people who need access to medicines do not have it, whether this is for pain, palliative care, mental health disorders, anaesthetics, epilepsy etc. We know that there is great inequity in access, highlighted by the Lancet Commission report on alleviating the access abyss in palliative care and pain relief – an imperative of universal health coverage.
This report states that “the lack of global access to pain relief and palliative care throughout the life cycle constitutes a global crises, and action to close this divide between rich and poor is a moral, health and ethical imperative. The need for palliative care and pain relief has been largely ignored. Yet, palliative care and pain relief are essential elements of universal health coverage.”
Since the publication of the Lancet commission report, in 2019 the WHO withdrew their guidelines on ensuring balance in national policies on controlled substance and work began on developing new guidelines. The withdrawal of these guidelines left a big gap in global policy for access to medicines, and at the time the palliative care community released a joint position statement on the decision by WHO to withdraw their guidance documents.
In their 2022 annual report the International Narcotics Control Board highlighted that “Despite the prominence given to the issue [of ensuring the availability of controlled substances for medical use] …. achieving adequate and affordable access to controlled medicines for the treatment of health conditions remains a distant goal in many countries, where people still suffer or die in pain or do not have access to the medications they need.
At the same time as there is a lack of access to controlled medicines in many countries, other regions have experienced the negative health and social consequences of the non-rational prescription of controlled substances, resulting in an epidemic of opioid dependence and related overdose deaths.” The following year that reiterated that “the Board emphasizes the importance of ensuring sufficient availability at the global level and calls upon countries with greater availability of and access to opiate raw materials and opiates to assist those countries with limited access and availability in their efforts to increase access to and availability of such substances and raw materials”.
There are many reasons for the inequity seen around the world with regards to both access and safe use of controlled medicines. Inequity in access results in a lack of sustainable controlled medicines in many low-and-middle income countries, across a wide range of conditions, and not limited to palliative care. These include anaesthesia, pre and post surgical care, analgesics, medicines needed for mental health disorders, opioid agonist therapies, neurological disorders including epilepsy and severe spasticity as well as a range of other conditions. Another challenge is often the lack of appropriate formulations and dosages for children, the elderly etc.
The WHO recommends that essential medicines, including those that are controlled, be available to all patients at all times at a price that the individual and the community can afford. In line with their obligations under the United Nation’s drug treaties, governments and health systems must ensure that people who need controlled medicines for medical and scientific purposes can access them and also ensure that these medicines are used safely and appropriately. Policies should seek to maximize access to essential and beneficial controlled medicines for all people who need them, while effectively restricting non-medical use, which poses serious risks to safety and has harmful consequences for individuals and societies.
Thus, the purpose of these new guidelines is to assist WHO Member States and their partners in developing and implementing national policies on controlled medicines to ensure their accessibility, availability and affordability for medical and scientific uses and to minimize the risk of harm arising from non-medical use.
The guideline addresses policies for groups (of all ages, from neonates to older people) affected by conditions in which the use of controlled medicines is deemed to be medically appropriate according to evidence-based clinical practice guidelines. The guidelines are intended to cover all types of controlled medicines with authorised medical or scientific purposes. Importantly these guidelines address policy rather than clinical practice and therefore do not provide advice on the clinical use of controlled medicines, although they do stress the importance of their uses being based on clinical need, e.g. is it the right medication for an individuals specific type of pain?
The report recommends that controlled medicines, be available to all patients in need at all times, including in humanitarian emergencies, at a price that the individual and the community can afford. In line with their obligations under the United Nation’s drug treaties, governments and health systems must ensure that people who need controlled medicines for medical and scientific purposes can access them and also ensure that these medicines are used safely and appropriately. Policies should seek to maximise access to essential and beneficial controlled medicines for all people who need them, while effectively restricting non-medical use, which poses serious risks to safety and has harmful consequences for individuals and societies.
Last week a rapid communication outlining the guidelines recommendations was published, with the full report being published in the next few months. Key to the guidelines are the guiding principles that underpin and apply to all national policies pertaining to controlled medicines. The guidelines also draw upon existing WHO guidance where it exists. The guidelines cover the following domains:
- Development of a national controlled medicines policy
- Pricing and financing of controlled medicines and related health-care services
- Medicines selection
- Procurement and supply chain management
- Medicines, regulation and control
- Prescribing, dispensing and administration
- Education, knowledge and attitudes.
As the Co-Chair of the Guidelines Development Committee, it has been both an honour and a big responsibility to develop these new WHO guidelines. Many governments and policy makers have been waiting for these guidelines to be released and it is essential that these policy guidelines are utilised, thus within the full guidelines there is information about implementation, how we use these guidelines, and research gaps.
These guidelines must be utilised, they must make a difference and not just sit on the shelf gathering dust. For those of us who have been involved in their development, despite the journey to get to where we are, this is also just the beginning, as these guidelines are launched, the recommendations are translated into action, and we begin to see the reduction in the inequity of access to medicines, around the world, and get medicines to the people who need them, in the dose and formulations that they need them, in the place that they need them and in a timely manner.
I would like to thank Dr Afarin Rahimi-Movagher for co-chairing these guidelines with me, and also all of the members of the Guidelines Development Group, the systematic review teams, the reviewers, the team at the WHO and everyone involved in the development of these guidelines. I would also like to remember two champions for access and the safe use of controlled medicines who have died in the past few weeks:
- Dr Anne Merriman – palliative care pioneer who campaigned to make affordable oral morphine available throughout Africa
- Ms Naomi Burke-Shyne, a visionary leader in harm reduction and human rights who was a member of the guidelines development group.
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