The politics of painBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c3800 (Published 11 August 2010) Cite this as: BMJ 2010;341:c3800
Dozens of recycled plastic mineral water bottles are filled with brightly coloured solutions. The bottles are full of oral morphine, colour coded for different strengths—green for the weakest, then pink, and blue for the strongest. Every day, teams of nurses take them to paediatric and cancer wards and patients living at home near Kampala, Uganda.
In a country where fewer than 5% of cancer patients ever receive radiotherapy or chemotherapy, and with a high HIV/AIDS prevalence, the need for pain relief is crucial, says Anne Merriman, an Irish palliative care specialist who set up Hospice Africa there in 1993.
She agreed to establish the service on condition the government changed its rules on morphine provision. Previously only doctors, dentists, and vets were allowed to prescribe opioids—although midwives could prescribe pethidine. In the early 1990s oral morphine was used only rarely, and with a shortage of doctors, few patients ever met a health worker allowed to prescribe it. In 1992 the government agreed to allow nurses and clinical officers trained in palliative care at Hospice Uganda to prescribe oral morphine. “The government had seen so much suffering with the AIDS epidemic. Everyone had a family member who had died in agony,” says Dr Merriman.
Lack of oral morphine
Today, despite Hospice Africa’s attempts to export the model, widely available oral morphine remains an exception rather than the rule. In about 150 countries,1 including Indonesia and India, severe restrictions on the use of morphine for pain relief means patients are still living and dying in severe pain.
Although WHO guidelines for the treatment of moderate to severe pain in cancer state there can be no substitute for [strong] opioid analgesics such as morphine,2 weaker drugs are often used to treat pain in people with terminal cancer and HIV/AIDs patients. Gabriel Madiye, executive director of the Shepherd’s Hospice in Sierra Leone says: “We have tried codeine [a weak opioid], diclofenac, and paracetamol. They are not enough.”
Recently WHO estimated that 5.5 million people with terminal cancer, a million late stage HIV/AIDS patients, and 800 000 patients with unintentional injuries or injuries caused by violence are not receiving the pain relief they need. Also, many patients with conditions, such as sickle cell anaemia, those recovering from surgery, and HIV/AIDs patients on antiretrovirals, require relief but do not get it. Controlled drugs that are used to treat drug addiction or obstetric complications, such as ergometrine, are severely restricted too.3
Most countries do not have bans on opioids for medical use, but their policies and rules are so onerous the result is lack of access for patients. In some countries only oncologists and palliative care specialists are allowed to prescribe opioids, or they can only prescribe extremely limited amounts. Some formulations, such as oral morphine, are not allowed (see box 1). Indian pharmacies require so many licences to stock controlled drugs that many do not bother (see box 2). Nigeria and Cameroon each have just one government pharmacy stocking oral morphine, says Faith Mwangi-Powell, executive director of the African Palliative Care Association, which is studying the African opioid supply chain.
Injectable morphine is not an option—too many safety problems are associated with it because it needs to be administered in controlled conditions. The same issues apply to controlled release forms of morphine.
Even countries that have embarked on strategies to change laws and increase palliative care provision, such as Malaysia, have run into problems. Too few doctors are trained to prescribe morphine says Ednin Hamzah, chief executive officer of Hospis Malaysia. “We organise many workshops and have started to get some palliative care content into undergraduate education, but it is very little.”
Artificially low demand
With so few people prescribing it, the perceived demand for morphine is artificially low. A report by Human Rights Watch last year found that in 2008 Egypt ordered enough morphine for just 3% of those who are estimated to need it, Philippines 8%, and Senegal 0.6%.4
The situation is, to a large extent, the result of 100 years of international treaties, stigma, and fear. It means that Australia, Canada, New Zealand, the United States, and European Union countries in 2008 consumed more than 90% of the world’s legal morphine, and 96% of all fentanyl, a synthetic opiate.
At a time when Britain dominated the opium trade, an International Opium Commission met in Shanghai in 1909 to curb it for the first time. Faced with an opium addiction crisis, the international community—albeit only the 13 nations that attended the meeting—agreed that some drugs, including opium and derivatives, morphine, and heroin, represented a grave danger, and called for regulation and even prohibition.
That agreement laid the foundations for a series of legally binding conventions on drug control. The 1961 Single Convention, for instance, strictly controls the manufacture, trade, and distribution of narcotics, including opioids.5
National policies and controlled drugs
But although the convention allows countries to use controlled drugs for medical and scientific purposes—it even enables countries to estimate how much they might need annually to match with opium poppy growing quotas—many nations do not.
“Most of their governments’ efforts are focused on preventing abuse. It’s all about control,” says Karen Ryan, a senior policy fellow at the Pain and Policy Studies Group (PPSG) based at the University of Wisconsin, which works with WHO and assists countries from Philippines to Guatemala to remove barriers to using pain killing drugs.6
The problem is that policymakers believe morphine will cause addiction, or will be diverted into an illicit trade. That’s a mistake, says Ryan. Physical dependence on a drug, which is easily managed with good medical practice, is not the same as psychological addiction. But such misconceptions are still reflected in national rules. “These policies date back decades, to when it was thought that even a single exposure to this medication could create addiction,” she says. The evidence points to very low rates of addiction, and there is little evidence of diversion either, she adds.7 8 9
Such misconceptions have permeated through to the medical profession, and patients. Several generations of Indian doctors have been taught that morphine is bad says M R Rajagopal, an Indian palliative care specialist. “For half a century doctors [in India] have not seen oral morphine or how it is used,” he says. “Even if the regulatory barriers were removed tomorrow, we would have tens of thousands of doctors who have no idea how to use oral morphine.”
How much low opioid consumption for medical uses is down to cultural reasons is unclear say many palliative care specialists. Help the Hospices, a UK non-governmental organisation, has collected anecdotal evidence that some cultures view pain and suffering as a test of faith, may be fatalistic about pain, which they feel they cannot control, or value stoicism and may not disclose their pain.
International involvement to improve access to opioids
That national policies persist, however, can be also attributed to an absence of international involvement, say activists.
The feeling is that UN international drugs control agencies, for instance, have not done enough to promote medical uses because they have spent 50 years focusing on the war on drugs and are often dominated by representatives from ministries of justice and law enforcement who do not traditionally take a health perspective.
Diederik Lohman, senior researcher at Human Rights Watch, says the International Narcotics Control Board (INCB), a United Nations body set up to police adherence to the single convention and other drugs treaties, pays scant attention to medical uses in its annual report,10 compared with pages of text on illicit drug controls. He reckons it is also impossible to determine how strongly INCB impresses the importance of medical issues on individual governments compared with controls, whether it seeks specific commitments and checks that promises are kept. “INCB is much less transparent than other UN agencies. We don’t know anything about what they discuss,” he says.
For its part, INCB disagrees about the level of attention paid to medical uses. Pavel Pachta, deputy secretary of the board and chief of the INCB secretariat’s Narcotics Control and Estimates Section, says, “I think INCB is doing a lot in this area. It is a matter of opinion whether it is enough or not but definitely INCB is very much putting emphasis on dialogue with governments.” INCB insists it constantly negotiates with countries, has been behind a host of resolutions and speeches aimed at promoting change, and has set up an “access to controlled medications” unit with WHO, which is working on a number of projects, including guidelines to help countries improve their morphine demand estimates.
Action and support from the global health community that usually champions drug access, is curiously absent too.
The Bill & Melinda Gates Foundation, the Global Fund to fight AIDS, Tuberculosis and Malaria, Médecins Sans Frontières, and Oxfam do not have specific initiatives to improve access to opioids for medical use—although the Global Fund has placed a strong focus on opioid access for the treatment of addiction because, for example, in Russia methadone is still illegal.
It may be that agendas are already stuffed, but some believe that because opioid access is about making people comfortable, it doesn’t have the same value to donors as interventions that save lives. Promoting palliative care for people with HIV/AIDS might also be interpreted as a signal that activists are giving up on the fight for universal access to lifesaving antiretrovirals.
International action to help countries change policies is lacking; from up to date evidence based guidelines for treating acute pain and chronic pain in children and adults to model laws that help countries amend national legislation to more accurately reflect a balance between medical use and control of opioids; controlled medicine policy recommendations are years old and focus on cancer. That said, Willem Scholten, head of the access to controlled medications programme at WHO, is completing guidelines for children and updating policy recommendations. But low funding means work on chronic pain in adults and acute pain has been delayed.
Not all bad news
That’s not to say there has been no progress. INCB says opioid consumption has increased globally by a factor of 2.5 over the past 20 years as countries from Serbia to Vietnam have begun to change polices and increase training. Colombia has tripled the number of days a patient can be prescribed morphine to 30, and the Philippines has removed the confusion between psychological and physical dependence within its laws. The African Palliative Care Association says attitudes in Africa are changing too. Several pharmacies will now stock morphine in Tanzania; Zambia and Sierra Leone are embarking on oral morphine pilots at hospices.
And international approaches are developing too. Personnel changes at the rather conservative INCB are expected to improve approaches. And unexpectedly, another UN drugs body, the Commission for Narcotic Drugs in March this year passed a groundbreaking resolution instructing governments to do more to make opioids available for medical uses, and for the INCB to report them.11 A lot of good could come out of it, says Alison Crocket, a senior adviser at the UK’s Department for International Development, who witnessed the resolution. “It was a fairly unusual thing to happen and quite a coup,” she says.
Box 1 Armenia
Hrant Karapetyan and colleagues have set up Armenia’s first dedicated pain control and palliative care centre, but face many restrictions.
Most physicians cannot prescribe opioids, for example. “It’s a crazy situation,” says Dr Karapetyan. “I give lectures for oncologists in pain management. My student oncologists have permission to prescribe morphine, I have not.”
The only morphine available is an injectable form that can be prescribed for 10 days—although outpatient prescriptions are often limited to three days at a time. Very ill patients living in rural areas are forced to travel to municipalities each time they want another supply, says the Open Society Institute, which has studied Armenian palliative care. More worryingly, oncologists rarely prescribe more than 10 mg per day. “It is a very low dose and does not give adequate analgesia,” Dr Karapetyan says.
Things are improving gradually. Oral morphine may reach Armenia later this year, and palliative care training courses are planned. Finances remain a problem, however. Dr Karapetyan has been paying for the centre from his own pocket and staff work without pay. “The situation is very bad,” he says.
Box 2 India
India may be one of the world’s largest legitimate opium growers, but only about 0.4% of the population in need of opioids for pain relief get them, according to figures from 2007.12
Restrictions result from an attempt to tackle the growing drugs trade. In 1985 the government passed a law that required pharmacies to have multiple licences from different agencies before they could stock and dispense morphine. The drug then disappeared from the shelves and doctors stopped prescribing it.
Realising the inadvertent consequences of its law, the government then allowed India’s states to amend rules to allow hospices to stock and dispense morphine without complex licensing.
The problem is, only a few states have chosen to do so. And the new rules do not affect the onerous pharmacy licensing system, which still applies. M R Rajagopal, director of the Trivandrum Institute of Palliative Sciences says access to morphine is limited, even in Kerala, a state that has more palliative care centres than the rest of India put together. “Pharmacies still do not stock morphine.” He says. “Most hospitals even in Kerala do not practise any kind of pain relief. Most do not have morphine.”
That’s why Dr Rajagopal plans to represent fellow palliative care specialists at India’s Supreme Court in a few months with a legal case aimed at trying to change the rules.
Cite this as: BMJ 2010;341:c3800
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Provenance and peer review: Commissioned; not externally peer reviewed.