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- - IMPROVING ACCESS TO ANALGESIC DRUGS FOR PATIENTS WITH CANCER IN SUB-SAHARAN AFRICA

Monday, 8th of April 2013

•  IMPROVING ACCESS TO ANALGESIC DRUGS FOR PATIENTS WITH CANCER IN SUB-SAHARAN AFRICA

The Lancet Oncology, Volume 14, Issue 4, Pages e176 - e182, April 2013

Best viewed at http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70343-1/fulltext

This article can be found in the following collections: Global Health; Oncology (Cancer supportive care)

Original Text

Dr Megan O'Brien PhD a   , Faith Mwangi-Powell PhD b, Prof Isaac F Adewole FAS c d, Prof Olaitan Soyannwo FWACS e, Jacinto Amandua MMed f, Elizabeth Ogaja MSc g, Mary Okpeseyi BPharm h, Zipporah Ali MPH i, Rose Kiwanuka BScN j, Prof Anne Merriman FRCP k 

WHO expects the burden of cancer in sub-Saharan Africa to grow rapidly in coming years and for incidence to exceed 1 million per year by 2030. As a result of late presentation to health facilities and little access to diagnostic technology, roughly 80% of cases are in terminal stages at the time of diagnosis, and a large proportion of patients have moderate to severe pain that needs treatment with opioid analgesics. However, consumption of opioid analgesics in the region is low and data suggest that at least 88% of cancer deaths with moderate to severe pain are untreated. Access to essential drugs for pain relief is limited by legal and regulatory restrictions, cultural misperceptions about pain, inadequate training of health-care providers, procurement difficulties, weak health systems, and concerns about diversion, addiction, and misuse. However, recent initiatives characterised by cooperation between national governments and local and international non-governmental organisations are improving access to pain relief. Efforts underway in Uganda, Kenya, and Nigeria provide examples of challenges faced and innovative approaches adopted and form the basis of a proposed framework to improve access to pain relief for patients with cancer across the region.

This is the fifth in a Series of seven papers about cancer control in Africa

WHO has estimated that worldwide cancer incidence will increase from 12 million new cases in 2008 to 26 million per year by 2030.1 Cancer burden in developing countries is growing rapidly2 and incidence in sub-Saharan Africa is expected to exceed 1 million by 2030.1 Roughly 80% of cancer cases in developing countries are in advanced stages at the time of diagnosis because of late presentation to health facilities and poor access to diagnostic technology.2 Despite documented successes in cancer treatment and control programmes globally,3, 4 large differences in mortality persist, with survival rates in developing countries often less than half those of developed countries.5 The need for improved access to effective cancer pain treatment will become increasingly acute in coming years.

WHO recommends opioid analgesics for the treatment of moderate to severe pain,6 such as that of patients with advanced cancer, and regards morphine as an essential drug (figure 1).7 According to WHO data,8, 9 about 552 100 people died of cancer in sub-Saharan Africa in 2009 and studies have shown that roughly 80% of deaths from cancer need pain treatment.10 Opioid analgesics are also used for pain in AIDS patients: 1·84 million people died from HIV/AIDS in the region in 20098, 9 and pain treatment is needed for roughly 50% of deaths from HIV/AIDS.10 Based on these numbers, in sub-Saharan Africa in 2009 pain treatment was needed by about 441 682 people who died of cancer and about 921 800 people who died of HIV/AIDS.

  

  

Figure 1 Full-size image (134K) Hospice Africa Uganda 

A Hospice Africa Uganda nurse measures a patient's oral morphine dose with a bottle cap and syringe

Governments in sub-Saharan Africa reported an overall annual consumption of 720 kg of opioids per year across the whole region for the years from 2007 to 2009 (with consumption of different opioids standardised, by potency, to morphine-equivalent volumes for summation).11 Based on the estimation that, on average, patients who need pain treatment at the end of life consume 67·5 mg of morphine daily for 3 months,10 720 kg is enough to provide treatment for about 116 600 people (ie, about 8·6% of the total number of painful deaths from cancer or HIV/AIDS). However, South Africa (an upper-middle-income country) consumed 71% of the opioids in the region.11 Therefore, only 205 kg of opioids were consumed per year by the remaining countries—enough to treat about 33 000 people (ie, about 2·8% of the estimated 1·17 million annual painful deaths from cancer or HIV/AIDS).

Since opioids are also used to treat pain in patients with other indications for which data are not routinely collected across countries (eg, diseases other than HIV/AIDS or cancer, traumatic injuries, addiction disorders, surgeries, and non-fatal cancer or HIV/AIDS), estimation of how many cancer patients in pain were treated is difficult. However, if all opioids in each country were used to treat only painful cancer deaths (excluding the relative excess consumed in South Africa and Mauritius for patients with other indications), 54 768 people would have been treated, leaving 386 914 (88%) patients with untreated cancer pain. In view of the conservative nature of these calculations, the true proportion of cancer patients with untreated pain is probably much higher.

Several initiatives have been created across Africa for the provision of palliative care, but scale-up has been limited by lack of access to affordable, effective, pain-relieving drugs. In countries where palliative care initiatives have become established, providers have noted that the most affordable opioid is oral morphine that is reconstituted locally with imported morphine powder, water, preservative, and a food dye to show the strength of the formulation.12

Before 1990 there were only two countries in Africa (South Africa and Zimbabwe) in which cancer patients had access to oral morphine tablets. In that year the morphine reconstitution formula was introduced to Africa through Nairobi Hospice in Kenya—one of the first palliative care service in the continent. In 1993, Hospice Africa was founded to support palliative care throughout Africa, and Hospice Africa Uganda was established as a model for hospice services that could be adapted for other countries. The hospice provided holistic care that included pain control with oral morphine. In total, 12 African countries have adopted the morphine reconstitution formula, and 17 countries have access to some type of oral morphine (figure 2). As the map shows, access is especially poor among the Francophone and north African countries.

  

  

Figure 2 Full-size image (102K) Download to PowerPoint

Countries in Africa with access to oral morphine in 2012

Access to opioids for pain relief across Africa is limited by several factors: legal and regulatory restrictions, cultural misperceptions about pain, inadequate training of health-care providers, procurement challenges, weak health systems, and concerns about diversion, addiction, and misuse.13, 14 Some of the barriers that limit cancer patients' access to pain relief are unique to opioid analgesics, but many are general barriers that also limit access to other essential drugs and basic health care. Concrete evidence exists that opioids are safe and effective for the treatment of moderate or severe pain in people with cancer.6, 13 WHO has clearly stated that opioids are essential drugs for pain relief,7, 13, 15 and international drug control treaties require governments to make opioids available for medical use.16, 17 However, clinicians, patients, and policy makers regularly overestimate the risks of opioids, believing them to be more addictive, prone to misuse, and likely to cause side-effects than is suggested by the evidence.14

In many countries, the potential profits for low-volume, inexpensive drugs are lower than the cost to a supplier of registration of the products for sale in those countries. Thus there are some countries in which there are no suppliers willing to register and sell essential drugs, including morphine.

With the exception of Uganda, which allows opioid prescription by nurses trained in clinical palliative care, all countries in Africa require opioid analgesics to be prescribed by a physician. But of the 41 countries in sub-Saharan Africa for which data are available, 24 have fewer than one doctor per 10 000 people.18 Pain relief, like much of cancer care, is inaccessible to patients when access is controlled by very few clinicians.

In 2006 the African Palliative Care Association undertook an assessment of barriers to opioid use across 12 African countries.19 A key finding of the assessment was that the barriers can be classified into three categories: political, clinical, and facility-specific (panel 1).

Panel 1

Barriers to access to opioids in sub-Saharan Africa

Political

• Little political will within health ministries
• Outdated policies and legislation
• Dysfunctional national and international bureaucracies

Clinical

• Little knowledge of pain assessment and management
• Fear of opioids
• Poor training
• Little interest in palliative care
• No reimbursement for palliative care services by insurance schemes

Facilities

• Absence of secure storage capability
• Inadequate connection to drug distribution system
• Absence of skilled professionals

The past 8 years have seen an expansion throughout Africa of efforts to improve access to pain relief for cancer patients. These efforts have been led by ministries of health and health-care workers and supported by national palliative care associations, regional networks such as Hospice Africa and the African Palliative Care Association, and international supporters such as the Worldwide Palliative Care Alliance, the Foundation for Hospices in Sub-Saharan Africa, and the Open Society Foundations. More recently, these initiatives have received technical assistance from international non-governmental organisations such as the Global Access to Pain Relief Initiative, clinical education programmes such as those offered by the Pain & Policy Studies Group and the San Diego Hospice, and international advocacy support such as that undertaken by Human Rights Watch. Based on these initiatives, we have compiled a general outline, called the MORPHINE framework (panel 2), intended to guide the design of national efforts to improve access to essential pain drugs. Although conditions in each country are unique, this framework can provide a useful way to group and order advocacy, education, and technical assistance in a way that fosters leadership by ministries of health and creates sustainable improvements in care for cancer patients in pain. The table provides an example, for Nigeria, of a stepwise process map based on consultation with key stakeholders, and shows some possible barriers to access and some suggested solutions.

Panel 2

MORPHINE framework for improving access to pain relief in sub-Saharan Africa

Mindset

Ensure that government policy makers are familiar with the issues and prepared to take a lead role in improvement of access to pain relief

• Pain relief often falls between several divisions in government ministries or departments, including pharmacy, cancer, HIV/AIDS, and law enforcement departments, and is usually not a priority in any department
• Start with a clear, concise statement of the situation—including numbers of patients, consumption of pain relief drugs, and unmet need—and communicate with all relevant government divisions
• Make clear that morphine is on the WHO list of essential drugs, and note if it is on the equivalent national list (country factsheets with this information are available from the Global Access to Pain Relief Initiative website)

Organise

Consult key stakeholders and partners and identify main barriers to access to pain relief and solutions to address them

• Useful for identification of interventions that have the best chance of improving access

Regulations

Review national quotas from the UN International Narcotics Control Board and national importation, storage, and prescription regulations to ensure that they are up-to-date or identify needed changes

• Can be time-consuming, so start early to update regulations as needed
• The UN Office on Drugs and Crime is expected to produce new model law recommendations, and the African Palliative Care Association has produced regulation guidelines20

Procurement

Establish budget for drug purchase, storage, and distribution; estimate quantities by product and formulation, identify suppliers, secure product registrations, develop tenders, place and pay for orders, and receive and distribute to regional medical stores

• Establishment of supply is a necessary, but not sufficient, condition for any other interventions to work
• Many national procurement departments struggle with unresponsive suppliers and little experience with non-standard drugs
• Distribution of drugs to health facilities can be challenging, especially for sites that are a great distance from central medical stores
• Poor capacity and breakdowns of communication can hamper stock tracking, order fulfilment, and timely reordering

Health workers

Organise awareness-raising activities for health workers and administrators, in-service training, and continuing medical education; develop reference materials and guidelines

• Very important, but expensive, difficult, and time-consuming
• Integration with existing programmes and structures is advisable when possible
• Scope for innovation

Initiation

Establish pain treatment by trained clinicians, usually at large clinical centres or specialised clinical units (eg, cancer centres)

• Early initiators become champions for change in clinical practice
• Early programmes offer opportunities to generate local data for potential effects and to refine systems and approaches

Nationalisation

Scale up by integration of pain treatment into service delivery at regional and district hospitals and ensure adequate geographical coverage to make pain relief accessible to all who need it across the country

• Multiyear step that requires substantial effort and investment
• Standalone systems seldom last and integration into existing training, procurement, and data-management systems and clinical guidelines is crucial for widespread effectiveness

Empowerment

Create a sustainable stakeholder base

• Interventions must focus on nurturing national palliative care associations, health ministry staff, patient advocacy groups, and clinical experts to continue to develop and support high-quality, evidence-based pain treatment
• Support for these groups must be consistent, preferably through government funding mechanisms
• Access is not achieved until this step is realised

TableTable image

Stepwise process map for improvement of access to opioid analgesics (example for Nigeria)

Uganda

Uganda has a population of 33 million,8 with 87% living in rural areas.21 It has one physician for every 8547 people and the per head gross national annual income is US$420.18, 21 About 16 200 deaths from cancer and 109 700 from HIV/AIDS occurred in 2009.8, 9 The average annual morphine-equivalent opioid analgesic consumption from 2007 to 2009 was 27·8 kg,11 which is enough to treat about 7% of the roughly 68 000 deaths in pain from cancer or HIV/AIDS.

Morphine is controlled under the National Drug Policy and Authority Statute (1993).22 Nurses and clinical officers with training in palliative care are allowed to prescribe oral morphine under Statutory Instrument No 13 (2004).23 Palliative care for non-communicable diseases is included in the mission of the Ministry of Health, the National Health Policy,24 and the Health Sector Strategic and Investment Plan.25 The Government of Uganda is committed to providing free morphine to all patients who need it. However, only 7% of patients who need morphine can access it,26 and non-communicable diseases are increasing in the country.

Since the foundation of Hospice Africa Uganda in 1993, there has been substantial improvement in the availability of opioids for patients with life-limiting illnesses27 and Uganda has become a model country from which many others have learned and adopted strategies for palliative care. Uganda has effectively implemented the WHO foundation measures for a public health approach to palliative care. These are drug availability (especially opioid analgesics), education of health workers and the public, and integration into health-system policies.28 Uganda is approaching integration of palliative care into its national health system,29 which is having a substantial effect on the quality of life of patients with life-limiting illnesses and their families.

In 1993, Hospice Africa Uganda began to reconstitute affordable oral morphine solution from raw powder, mostly for cancer patients. In 2005, Joint Medical Stores, a private drug distributor that serves non-governmental facilities, began to reconstitute morphine. In 2007, Joint Medical Stores phased out its manufacturing section and Mulago National Hospital took over morphine reconstitution for the country. The Department of Clinical Services created an expenditure item for morphine, and districts and health facilities provided some funds to allow the transportation of morphine to user facilities. The system worked well until October, 2009, when procurement issues disrupted morphine supply. The reasons for the disruption were complex procurement procedures, transfer of drug funds out of the Ministry of Health, logistical issues in the Mulago Hospital manufacturing unit, and increasing demand for morphine. These issues resulted in severe shortages of morphine for a year, and by late 2010 the public sector ran out of morphine, although Hospice Africa Uganda was still providing the drug to its own patients and to some public facilities.

After consultations between the Ministry of Health, National Medical Stores (a public drug procurement agency), and the Palliative Care Association of Uganda (with technical assistance from the Global Access to Pain Relief Initiative and the African Palliative Care Association), it was agreed that National Medical Stores would take over distribution of morphine to all health facilities in Uganda and that Hospice Africa Uganda would procure morphine powder from Joint Medical Stores, upgrade its facilities to be certified as a drug manufacturer, and reconstitute morphine powder on contract for the procurement agency. The liquid morphine is delivered by National Medical Stores to public health facilities and to Joint Medical Stores for distribution to non-governmental health units. This arrangement has greatly increased the availability of morphine and reduced the cost for the government by 40%.

Kenya

Kenya has a population of 40 million people, with 78% living in rural areas.8, 21 It has one physician for every 7143 people and the per head gross national annual income is $730.18, 21 About 19 300 deaths from cancer and 149 200 from HIV/AIDS occurred in 2009.8, 9 The average annual morphine-equivalent opioid analgesic consumption from 2007 to 2009 was 16·1 kg,11 which is enough to treat about 3% of the roughly 90 000 deaths in pain from cancer or HIV/AIDS.

The government has recognised that patients with painful diseases such as HIV/AIDS, cancer, and other non-communicable diseases have had difficulties accessing services that would improve the quality of their lives, and so has introduced several initiatives to improve the situation. In August, 2010, Kenya approved a new constitution that for the first time recognised health as a human right.30

From independence in 1963 until now, the main focus of the Ministries of Health (Ministry of Medical Services and Ministry of Public Health and Sanitation) has been on infectious diseases. Most palliative care has been provided by non-governmental organisations such as hospices and faith-based organisations. After the enactment of the new constitution, the Ministries restated their commitment to the rights of patients with painful diseases who need analgesics such as morphine. A directive from the Director of Medical Services resulted in the establishment of palliative care centres in 11 regional hospitals. Additional policy actions by the Ministries of Health have included the launch, in 2010, of the National Cancer Control Strategy,31 which comprehensively addressed issues of palliative care, and the continuing effort to develop national guidelines for palliative care.

Before the enactment of the new constitution, under the Health Sector Reform Agenda, the Ministries of Health supported the development of the Kenya National Pharmaceutical Policy, which is awaiting cabinet approval before being debated in parliament. Although not yet approved, some aspects of the policy were deemed important enough to be implemented ahead of time. These were the publication of the revised Standard Clinical Guidelines (2009)32 and the Kenya Essential Medicines List (2010)33 by the National Medicines and Therapeutics Committee. With these key documents, a framework for rational use of essential pain drugs is in place.

The government, through the Ministries of Health, has established a partnership with the Kenya Hospices and Palliative Care Association, a non-governmental, national palliative care organisation committed to the promotion of palliative care in Kenya. The association has lent support to the palliative care centres in the 11 regional hospitals in upgrading their facilities, training clinical staff, and providing morphine powder.

The Government of Kenya has not been able to procure morphine powder over the past 3 years and has faced challenges caused by taxation of morphine powder that increased the price (though the Kenya Revenue Authority has recently removed the tax at the request of the Ministries of Health), difficulty in forecasting demand, and administrative bottlenecks. The procurement process is protracted and remedial action after unsuccessful tendering is slow. Additionally, funding for essential drugs in general has been scarce.

The Ministries of Health intend to expand the number of palliative care centres and improve the referral system in the 47 counties to increase access. Plans are underway to procure roughly 10 kg of morphine powder with government funds for the 2011—12 financial year.

Nigeria

Nigeria has a population of about 155 million people, with 52% living in rural areas.8, 21 It has one physician for every 2532 people and the per head annual income is $1170.18, 21 About 104 400 deaths from cancer and 187 700 from HIV/AIDS occurred in 2009.8, 9 The average annual morphine-equivalent opioid analgesic consumption from 2007 to 2009 was 1·3 kg,11 which is enough to treat less than 1% of the roughly 177 000 deaths in pain from cancer or HIV/AIDS.

Untreated patients face moderate to severe pain associated with cancer, HIV/AIDS, sickle-cell anaemia, trauma, orthopaedics, surgery, and even in childbirth. Of particular importance is the high prevalence of sickle-cell anaemia, which occurs in about 20 per 1000 births.34

Pain is one of the most common physical complaints of a person admitted to a health-care facility, and moderate to severe pain is frequently reported throughout hospital admission, treatment, and even after discharge. The Federal Ministry of Health is the only legal source for controlled drugs for both public and private health facilities. This restriction, in place to prevent misuse and diversion, is recommended by the international drug control treaties to which Nigeria is a party (the 1961 Single Convention on Narcotic Drugs and the 1972 Protocol of Amendment).16 Stocking and supply of these drugs on a sustainable basis by government and their distribution to facilities where they are needed have been erratic over the past 5 years because of poor funding and some logistic issues.

Access to opioid analgesics in Nigeria has been limited by the lack of accurate data for the number of people with moderate to severe pain and inadequate funding for procurement of the drugs, which has resulted in an irregular supply. No comprehensive policy has been created to address the barriers that impede patient access to pain management, particularly inadequate knowledge among health-care professionals about the complex features of pain, patient comorbidities, analgesic pharmacology in general, and safe use of opioids in particular.

The Federal Ministry of Health is taking several steps to improve access to pain relief. The National Agency for Food and Drug Administration and Control in 2010 established a standing committee on the availability of opioid analgesics. In early 2012, the Ministry initiated an emergency procurement of opioid analgesics as a stopgap to address low availability and initiated a collaboration with the Global Access to Pain Relief Initiative to improve access to drugs for pain, which resulted in the hiring of a full-time staff member within the Ministry to focus on pain relief. The Ministry is also moving to establish the manufacture of oral morphine at the Federal Pharmaceutical Manufacturing Laboratory at Yaba, Lagos—a manufacturing facility owned by the federal government.

Access to pain drugs remains a challenge in Nigeria as in other developing countries. The government should intensify its efforts to improve access to these drugs by creating and implementing appropriate policies and increasing funding for procurement of opioid analgesics and training of health professionals in multidisciplinary pain management.

Millions of people in low-income and middle-income countries do not benefit from the advances in cancer treatment achieved in high-income countries over the past few decades. The substantial disparity in cancer outcomes between high-income and lower-income countries has been called the cancer divide.35 Improving timely diagnoses and increasing the availability of expensive radiotherapy machines and chemotherapy drugs in sub-Saharan Africa will need substantial external funding and a long time to implement. Poor access to modern methods of pain relief, however, is an aspect of the cancer divide that can be bridged with existing funding and technical resources. For example, in Uganda provision of 3 months of pain relief with oral morphine solution costs only $23 per person. Replicating the Ugandan approach, the total cost of oral morphine to treat the estimated 400 000 annual cancer deaths with untreated pain in the region would be only $9·2 million.

We have proposed a framework for addressing the different barriers to access to pain relief and for ordering activities to engage the relevant national actors in a comprehensive response. The country-specific examples describe the difficult situations that health ministries face and the different strategies used to address untreated pain. In each case, these strategies include partnering with local and international non-governmental organisations that contribute technical resources, which a ministry of health can use to enhance government initiatives. Governments in Africa should see access to pain relief as a rights issue and every effort should be made to improve the health and wellbeing of their citizens. To ensure improved access can be sustained long term, efforts should be made to introduce pain relief into the curriculum of nursing and medical schools, with emphasis on procurement, storage, distribution, and administration of opioids.

Low patient access to opioids, which are inexpensive, safe, effective, and plentiful on the international market, is caused in large part by the absence of pain relief in the specific mandate of a department within national ministries of health and the low priority given to pain relief within the oncology and general medical communities. Too often, oncologists view their role in cancer care as ending when cure cannot be achieved, but this approach leaves most cancer patients in resource-limited countries with no care at all.

Scaling up initial efforts will require African ministries of health to integrate pain relief and palliative care into existing structures, expansion of capacity in technical non-governmental organisations, and leadership in the oncology community to place pain relief and palliative care squarely within cancer control programmes.

We searched PubMed using the terms “pain”, “cancer”, and “Africa”. We included relevant articles published in English from 1980 to July, 2012.

Contributors

Each author drafted sections of the manuscript and provided comments on other sections. FM-P, MO'B, and AM drafted the introduction. FM-P and MO'B drafted the section on the framework for improvement of access to pain relief. AM and JA drafted the section on Uganda. MO and OS drafted the section on Nigeria. EO and ZA drafted the section on Kenya. MO'B drafted the conclusions section. All authors reviewed the manuscript in its entirety.

Conflicts of interest

IFA has received honoraria from GlaxoSmithKline for participation in various speaker forums, and for serving on the independent data safety monitoring committee for a multinational study. The other authors declare that they have no conflicts of interest.

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a Global Access to Pain Relief Initiative, Union for International Cancer Control and American Cancer Society, Washington, DC, USA

b African Palliative Care Association, Kampala, Uganda

c Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan, Ibadan, Nigeria

d African Organisation for Research and Training in Cancer, Cape Town, South Africa

e Hospice and Palliative Care Unit, University College Hospital, Ibadan, Nigeria

f Ministry of Health, Kampala, Uganda

g Ministry of Medical Services, Nairobi, Kenya

h Federal Ministry of Health, Abuja, Nigeria

i Kenya Hospices and Palliative Care Association, Nairobi, Kenya

j Palliative Care Association of Uganda, Kampala, Uganda

k Hospice Africa Uganda, Kampala, Uganda

Correspondence to: Dr Megan O'Brien, Global Access to Pain Relief Initiative, Suite 300, 555 11th Street, Washington, DC 20004, USA