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A WHO guide for planners, implementers and managers
Ensuring access to essential controlled 
medicines
Strong opioids such as morphine are essential for the treatment of pain due to cancer, HIV/AIDS and 
other serious illnesses, or due to traumatic injuries, burns and surgery. Yet despite being included on 
the WHO Model List of Essential Medicines, morphine has not been accessible at all times in adequate 
amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price 
the individual and the community can afford 
(43). Of the world’s population, 75% lacks access to morphine 
or another strong opioid when clinically indicated to treat pain. WHO estimates that 5.5 million terminal 
cancer patients and 1 million end-stage HIV/AIDS patients worldwide suffer each year without adequate 
treatment for moderate to severe pain. 
International drug regulatory bodies, such as the INCB, have acknowledged that their emphasis historically 
has been on restricting opioid misuse and abuse, rather than on ensuring the medical availability of opioids 
(86). Yet the United Nations Single Convention on Narcotic Drugs, which virtually all nations have signed, 
states that nations must both minimize the risk of abuse and diversion of opioids and ensure their availability 
for medical and scientific purposes. This dual obligation of governments is called the principle of balance, 
a principle that has been affirmed by WHO 
(43,87,88), the United Nations Commission on Narcotic Drugs 
and the United Nations General Assembly. Governments should ensure that all physicians involved in 
patient care are both legally permitted and institutionally authorized to prescribe and administer strong 
opioids such as morphine according to the medical needs of patients. Governments also should ensure 
that a sufficient supply of morphine is available to meet all medical needs. While misuse of controlled 
substances poses a risk to society, the system of control is not intended to be a barrier to their availability 
for medical and scientific purposes, nor interfere in their legitimate medical use for patient care.
To fulfil the requirements of the Single Convention and of acceptable medical practice, every effort should 
be made to identify the barriers to opioid availability within each country. Typically, these barriers include:
n
overly restrictive regulations on opioid prescribing and dispensing;
n
inadequate education of doctors, nurses and pharmacists in pain control and the appropriate use of 
opioids; and 
n
lack of understanding of the appropriate use of opioids among drug regulators who often focused 
only on reducing the risk of misuse and abuse and not at all on making these medicines available. 
Examples of overly restrictive regulations include 
(44):
n
a requirement that physicians purchase special opioid prescription pads;
n
a requirement that all opioid prescriptions for outpatients be signed not only by the prescribing 
physician, but also by a supervisor or an anaesthesiologist;
n
permitting only specifically designated physicians to prescribe opioids;
n
permitting only specialist physicians to prescribe opioids and not general practitioners or family 
doctors;
n
setting a low maximum daily dose of opioid that may be prescribed and a low maximum amount that 
may be prescribed and dispensed; and
n
restricting opioids to patients who are receiving hospice services.

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Integrating palliative care and symptom relief into primary health care
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All health systems should establish a system to monitor the flow of opioids from import or manufacture to 
use by the patient 
(89). In the inpatient setting, there should be verification of opioids taken by the patient. 
In the outpatient setting, there should be verification of opioids handed over by a pharmacist or clinician 
to the patient or to a family member on behalf of the patient, minus any amount returned to the pharmacy 
or clinician by the patient or family. Such a system should not interfere with access to opioids for medical 
uses, but rather ensure continued availability of these medicines. So-called stockouts and other supply 
chain failures result in patients suffering both from opioid withdrawal symptoms and from pain, and can 
increase risk of illicit opioid use and suicide 
(90).
The Single Convention requires all countries to report annual opioid consumption to the INCB. Together 
with other health statistics, this reporting is crucial for estimating a country’s expected opioid need in the 
next year and for the INCB to officially allocate the amount needed 
(91). The INCB has defined various 
methods for countries to calculate their expected need. Increases in allocation from one year to the next 
can be requested based on, for example, expected improvements in health care services or on revised 
estimates of disease prevalence. The INCB uses the pooled estimates from all countries to ensure that the 
appropriate quantity of opioids is available globally.

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A WHO guide for planners, implementers and managers

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