Obstacles to Provision of Pain Treatment and Palliative Care

There is no lack of information about the reasons why so many people who suffer from severe pain cannot get access to adequate pain treatment. In dozens of publications spanning several decades, the World Health Organization, the International Narcotics Control Board, healthcare providers, academics and others have chronicled the barriers in great detail.[65] A common theme of many of these publications is the failure of many governments around the world to take reasonable steps to improve access to pain treatment and palliative care services and to strike the right balance between ensuring availability of controlled medications for legitimate purposes and preventing their abuse.

In its 2007 Annual Report, the INCB repeated its previous calls for improvement:

The low levels of consumption of opioid analgesics for the treatment of pain in many countries…continue to be a matter of serious concern to the Board. The Board again urges all Governments concerned to identify the impediments in their countries to adequate use of opioid analgesics for the treatment of pain and to take steps to improve the availability of those narcotic drugs for medical purposes...[66]

To date, these calls have largely fallen on deaf ears. Because of countries' failure to act on the recommendations of WHO and INCB, many of the same obstacles that the organizations identified two decades ago remain today.

These barriers include the failure of many governments to put in place functioning drug supply systems; the failure to enact policies on pain treatment and palliative care; the existence of unnecessarily restrictive drug control regulations and practices; fear among healthcare workers of legal sanctions for legitimate medical practice; poor training of healthcare workers; and the unnecessarily high cost of pain treatment.

While there is no doubt that it will not be easy to overcome some of these barriers and implement comprehensive pain treatment and palliative care services, particularly for countries with limited resources, much progress could be made if governments took the action required of them by international human rights standards and the UN drug conventions. Indeed, the governments of countries like Romania, Uganda and Vietnam-each of which have adopted comprehensive approaches to improving availability of pain treatment-have shown that much can be done to comply with the basic standards required, even by countries with limited resources. While each of these countries still has much to do to make pain treatment and palliative care fully available they are all moving in the right direction.

Failure to Ensure Functioning and Effective Supply System

Opioid analgesics are controlled medicines. As such, their manufacture, distribution and prescription are strictly regulated; these medications cannot be traded freely on the market. The 1961 Single Convention on Narcotic Drugs has created a system to regulate supply and demand. Every year, countries submit estimates of their need for morphine and other controlled medications to INCB, which then approves a quota for countries and authorizes producing countries to grow a specified amount of raw material. Once INCB has approved their quota, countries may then purchase morphine up to the approved amount. Each individual transaction across international borders must be authorized and registered by INCB. On a national level, special drug control agencies are responsible for communicating with INCB about the need for morphine, imports and exports, and for regulating and overseeing all domestic transactions involving controlled medications.

Under the UN drug conventions, countries have an obligation to ensure a functioning and effective supply system for controlled medications. The INCB has held that

…an efficient national drug control regime must involve not only a programme to prevent illicit trafficking and diversion but also a programme to ensure the adequate availability of narcotic drugs for medical and scientific purposes.[67]

Such drug availability programs must be capable of ensuring that adequate amounts of morphine and other controlled medicines are available in the country at any given time, that an effective system of distribution is in place to provide healthcare providers and pharmacies with a continuous and adequate supply of the medications, and that a sufficient number of pharmacies and health facilities stock them so that healthcare providers and patients around the country can reasonably gain access to them at need. As the World Health Organization has noted, good communication between health workers and drug regulators is crucial to meet these goals.[68]

Because the production, distribution and dispensing of controlled medicines is under exclusive government control, governments have a particularly strong responsibility to ensure their availability and accessibility. With medications that are not controlled, private actors, including healthcare providers, pharmaceutical companies and nongovernmental organizations, can produce or import medications themselves without limited or no government facilitation. That is not the case with controlled medications–if a government does nothing to ensure an adequate supply and a functioning distribution system, they will simply not be legally available.

Yet, many governments, particularly in low and middle income countries, have failed to put in place functioning and effective supply systems for controlled medicines. Indeed, judging by the fact that in dozens of countries almost no morphine is used, it appears that many do not have a functioning supply system at all. In 1999, the INCB noted that this is not just the result of resource limitations but also of "a lack of determination on the part of Governments and their services."[69]

Research that the African Palliative Care Association (APCA) conducted in 2006 illustrates the lack of commitment of some African countries to ensuring availability of controlled medicines. The organization tried to conduct a survey among palliative care providers and drug control authorities in twelve African countries to identify challenges in implementation of palliative care and pain treatment services. The organization succeeded in securing the participation of drug control agencies in five of the twelve target countries in the survey.

The survey findings suggest a considerable disconnect between drug control authorities and the healthcare system. Three of the five drug control agencies-from Kenya, Tanzania and Ethiopia-stated that they believed the regulatory system worked well, even though morphine consumption in each of these countries is far below estimated need and the palliative care providers surveyed identified myriad problems with the regulatory system.[70]

Furthermore, the survey suggested that drug control agencies in each of the five countries listed controlled medicines as available in healthcare settings when none of the palliative care providers actually had access to them. In its report, APCA wrote:

In every country without exception INCB competent authorities cited specific opioids that they believed to be available in-country that were never cited by any [palliative care] service within that country.[71]

Estimating National Need

Many countries do not submit estimates for their need for controlled substances based upon careful assessment of population needs to the INCB, as required by the UN drug conventions. Some countries submit no estimate or estimates that are only symbolic in nature. For example, the West African nation of Burkina Faso estimated that it will need 49 grams of morphine in 2009.[72] Using Foley's estimate that the average terminal cancer or AIDS patient who suffers from severe pain will need 60 to 75mg of morphine per day for an average of about 90 days, this amount would suffice for about 8 patients. As a result, countries like Burkina Faso receive quotas from INCB for morphine that are so low that they cannot possibly ensure adequate availability of morphine for pain treatment in the country.[73]

Many other countries submit estimates that vastly understate the actual medical need for morphine. Often, these estimates are not based on actual need but on morphine consumption during the previous year. Some countries appear to simply reproduce the same estimate each year, regardless of demographic changes or true estimates of need.[74]

Figure 1. Morphine Estimates, Mortality, and Pain Treatment Need *

* The purpose of this figure is to illustrate the gross inadequacy of estimates for medical need submitted to INCB by many countries. The projection for the numbers of people requiring pain treatment does not include persons with pain related to non-terminal cancer or HIV, acute pain, or chronic pain not associated with cancer or HIV. The true number of people who require pain treatment is much greater. The table only calculates morphine estimates. Some countries also use methadone or pethidine for pain control. The table is based on an estimate by Foley and others that 80% of terminal cancer patients and 50% of terminal AIDS patients will require an average of 90 days of pain treatment with 60 to 75 mg of morphine per day. [75] Country estimates were obtained from INCB website; [76] projections for annual cancer and AIDS deaths are based on the most recent cancer and AIDS mortality figures reported by WHO. [77] As the Pain & Policies Studies Group has pointed out, a population-based method for estimating the need for controlled medications "will likely overestimate the quantities that would be consumed when a country lacks the infrastructure and resources to distribute large quantities of medications." [78] Without such infrastructure and resources, there is a very real potential that drugs could be wasted if large quantities are purchased and ultimately not consumed. Additionally, a potential for diversion exists if large amounts of drugs are held, unused, in stocks.

INCB has repeatedly reminded countries of their obligation to submit estimates based upon population need and has encouraged all countries to review their methods for preparing estimates so as to ensure that they actually reflect the need for controlled medications.[79]

Ensuring Effective Distribution

Without an effective distribution system, accessibility of morphine to those who need it cannot be assured. As controlled medications may only be transferred between parties that have been authorized under national law, governments play a key role in putting in place such a distribution system. They must ensure that a sufficient number of pharmacies are licensed to handle morphine. They must also ensure that procedures for procuring, stocking and dispensing it are workable; in other words, they must strike the appropriate balance between ensuring pharmacies can obtain it without unnecessarily cumbersome or expensive procedures and preventing abuse.

Yet, in many countries few hospitals or pharmacies actually stock morphine. In some cases, this is due to government regulations that allow only specific institutions to stock the medication. The APCA study, for example, found that in Zambia only hospitals can stock morphine and that in Nigeria oral morphine is available only from one pharmacy, the National Drug Store.[80] Similarly, in Cameroon only one pharmacy prepares oral morphine.[81]

In some countries, excessively burdensome procedures for procurement, dispensing and accounting discourage health institutions from procuring morphine.  In India, Human Rights Watch found that many hospitals do not stock oral morphine because they must obtain a number of different licenses for each order of morphine that is procured and these licenses are often very difficult to obtain. In Mexico City, a city of 18 million people, only nine hospitals and pharmacies stock morphine, apparently due to regulatory requirements around controlled medications.[82] Restrictions on licenses or cumbersome handling procedures that are not necessary for preventing abuse of these medications violate the right to health, and should be reformed. As countries are under the obligation to ensure adequate availability of opioid analgesics, they must take steps to ensure that a sufficient number of pharmacies or hospitals stock them. Recognizing this obligation, Vietnam adopted a new opioid prescription regulation in February 2008 which obliges district hospitals to stock opioids if no pharmacies in the district do.[83]

Where hospitals and pharmacies do stock morphine, problems with inefficient distribution systems are common. In India, for example, Human Rights Watch found that the excessively burdensome procurement procedures in many states can lead to stock-outs and delays in dispensing.[84] In Colombia, morphine has regularly been out of stock in the province of Valle del Cauca over the last several years, resulting in numerous patients being unable to obtain morphine to treat their pain. By contrast, other prescription medications have been widely available.[85] APCA's survey of palliative care providers in twelve African countries found "massive delays between scripts [physician prescription] and dispensing" due to problems with supply and distribution systems.[86]

Failure to Enact Palliative Care and Pain Treatment Policies

A core obligation under the right to health holds that countries must "adopt and implement a national public health strategy and plan of action, on the basis of epidemiological evidence, addressing the health concerns of the whole population." As part of this obligation, countries must develop a strategy and plan of action for the implementation of palliative care and pain treatment services. While these do not have to provide for the immediate implementation of the full range of services, they must set out a road map for their progressive implementation. There will be a strong presumption that any cost neutral steps will have to be taken immediately.[87]

In 1996, WHO identified the absence of national policies on cancer relief pain and palliative care as one of the reasons why cancer pain is so often not adequately treated.[88] In 2000, the organization noted that pain treatment continued to be a "low priority" in healthcare systems. In its 2002 book on cancer control programs, WHO noted that although governments around the world have endorsed the integration of palliative care principles into public health and disease control programs, "a yawning gap is evident between rhetoric and realization."[89] Two leading experts on palliative care stress the importance of having a comprehensive strategy, pointing out that some policies have failed because they omitted community involvement in the provision of palliative care services.[90]

Yet, as these experts have observed, most countries do not have palliative care and pain treatment policies, whether as stand-alone policies or as part of cancer or HIV/AIDS control efforts.[91] In a 2007 report on palliative care and HIV/AIDS, the UK government's Department for International Development found that palliative care was often not "integrated into health sector policies and National AIDS Frameworks."[92]

Many countries have even failed to take relatively cost-neutral steps that are crucial to improving access to pain treatment and palliative care, such as adding oral morphine and other opioid-based medicines to their list of essential medicines or issuing guidelines on pain management for healthcare workers. For example, respondents to APCA's 2007 survey of palliative care providers from four countries-Kenya, Namibia, Nigeria and Rwanda-reported that oral morphine was not on their country's list of essential medicines.[93] According to Anne Merriman, a leading palliative care advocate in Africa, only fourteen African nations have oral morphine-all others only have injectable morphine, which is primarily used to treat acute pain in hospital settings.[94]

INCB has recommended that national drug control laws must recognize the indispensible nature of narcotic drugs for the relief of pain and suffering as well as the obligation to ensure their availability for medical purposes. Its 1995 survey found that the laws of 48 percent of responding governments contained the former and of 63 percent the latter.[95] Although it is not known exactly how many countries still do not have the relevant language in their legislation, it is telling that the model laws and regulations on drug control that the UN Office on Drugs and Crime has developed for the use of countries in developing national drug control laws and regulations themselves do not contain these provisions.[96] A new draft drug control law that is currently under consideration in Cambodia makes no reference to the fact that controlled medications are indispensible for the relief of pain and suffering or of the obligation to ensure their availability.[97]

Lack of Training for Healthcare Workers

One of the biggest obstacles to provision of good palliative and pain treatment services in many countries around the world is a lack of training for healthcare workers. As Brennan and others put it, "for too long, pain and its management have been prisoners of myth, irrationality, and cultural bias."[98] While misinformation about oral morphine remains extremely common among healthcare workers, knowledge about how to assess and treat pain is often absent or deeply inadequate. The combination of ignorance among healthcare workers with myths about opioids results in failure to treat patients, who are suffering from severe pain, with opioid analgesics.

Some of the most common myths hold that treatment with opioids leads to addiction-the most frequently cited impediment to the medical use of opioids in INCB 1995 study;[99] that pain is necessary; that it is essential for diagnosis; that it is unavoidable; and that it has negligible consequences. Each of these myths is inaccurate.[100] Numerous studies have shown that treatment of pain with opioids very rarely leads to addiction;[101] most pain can be treated well;[102] pain is not necessary for diagnosis;[103] and pain has considerable social, economic and psychological consequences as it keeps people who suffer from pain and often their caregivers out of productive life.[104]

Ignorance about the use of opioid medications is the result of a failure, across much of the world including in some industrialized countries, to provide healthcare workers with adequate instruction on palliative care and pain management. A survey by the Worldwide Palliative Care Alliance among healthcare workers in 69 countries in Africa, Asia and Latin America found that 82 percent of healthcare workers in Latin America and 71 percent in Asia had not received any instruction on pain or opioids in undergraduate medical studies. In Africa, the figure was 39 percent.[105] In a 2007 African Palliative Care Association survey, 33 out of 56 participating healthcare providers felt that there were insufficient training opportunities on palliative care and pain treatment. Twenty-one of the twenty-three providers that said that there was adequate opportunity for training were based in South Africa and Uganda, two countries where considerable training is available.[106]

Even in industrialized countries instruction on palliative care and pain treatment remains a considerable challenge. A 1999 review of literature regarding barriers to effective cancer pain management in industrialized nations found, for example, that considerable numbers of healthcare workers surveyed had insufficient factual knowledge about pain management.[107]

Under the right to health, governments must take reasonable steps to ensure healthcare workers have appropriate training on palliative care and pain management. As an integral part of care and treatment for cancer and HIV, two key diseases around the world, countries need to ensure that basic instruction on palliative and pain management is part of undergraduate medical studies, nursing school, and continuing medical education. Specialized instruction should be available for healthcare workers who pursue a specialization in oncology, HIV and AIDS and other disciplines where knowledge of pain management and palliative care is an integral part of care.

Excessively Restrictive Drug Control Regulations or Enforcement Practices

The 1961 Single Convention on Narcotic Drugs lays out three minimum criteria that countries must observe in developing national regulations regarding the handling of opioids:

·Individuals must be authorized to dispense opioids by their professional license to practice, or be specially licensed to do so;

·Movement of opioids may occur only between institutions or individuals so authorized under national law;

·A medical prescription is required before opioids may be dispensed to a patient.

Governments may, under the Convention, impose additional requirements if deemed necessary, such as requiring that all prescription be written on official forms provided by the government or authorized professional associations.[108]

However, as WHO has observed, "this right must be continually balanced against the responsibility to ensure opioid availability for medical purposes."[109] Therefore, any regulations that unnecessarily impede access to controlled medications will be inconsistent with both the UN drug conventions and the right to health, which requires countries find a similar balance between ensuring availability for legitimate medical use and preventing abuse.  WHO has developed guidelines for the regulation of health professionals who handle controlled medications that government can use to develop what WHO has called a "practical system."[110]

Yet, many countries have regulations that are unnecessarily strict, creating complex procedures for procurement, stocking and dispensing of controlled medications. In some cases, drug control authorities or health systems go even beyond the strictures of regulations in their implementation and which limit access to those who need them. The effect of these unnecessarily strict regulations or implementation practices is that pharmacies and health facilities do not procure and stock opioids, that doctors do not prescribe them because of the hassle or fear of criminal sanction, and that prescription is so impractical that many patients cannot realistically obtain them on an ongoing basis.

One explanation for the existence of excessively strict regulations is the fact that many of these regulations were put in place before 1986, when WHO first recommended the use of oral morphine for long-term pain management.[111] Before that, most countries used only injectable morphine to treat acute pain, which is mostly used in hospital settings over short periods of time. As WHO has noted, "The science and best practices of opioids have progressed more rapidly than the legal structures governing them, leaving many antiquated and overly restrictive legal policies."[112]

Since the 1980s, WHO and INCB have repeatedly called on countries to review their drug control regulations and implementation practices, and make sure they do not unnecessarily impede the use of oral morphine. While INCB has repeatedly reminded states that they must continue to take steps to prevent diversion[113]-controlled medications being diverted for illicit use-it has also noted that:

Diversion of narcotic drugs from the licit trade into illicit channels remains relatively rare and the quantities involved are small in comparison to the large volume of transactions. That holds true for drugs in the international trade as well as in domestic wholesale circuits.[114]

Some countries have taken important steps in this regard. Uganda, for example, has approved nurse-based prescribing of oral morphine. Several countries have lifted restrictions on the amount of oral morphine that can be prescribed. Yet, in many countries problematic regulations continue to be in place. A number of common problems in these regulations include:

Overly Restrictive Licensing of Healthcare Institutions

Some countries impose licensing procedures for pharmacies and healthcare providers that make it impossible or overly complicated for them to procure and dispense opioids. Palliative care providers that do not have inpatient facilities but offer home-based care services often have a particular difficulty getting licenses to dispense morphine, even though this is vital to their mission and they can provide a low-cost way of reaching large numbers of people in need of pain treatment. In its 2007 report, the African Palliative Care Association observed for example that:

Although in theory many countries permit importation and distribution of the drugs, it can be impossible in practice to obtain the necessary authority from regulation bodies to prescribe the drugs.[115]

Palliative care providers in Kenya surveyed by APCA noted, for example, that oral morphine is "mostly dispensed in hospitals and hospices so many patients [who are not in such institutions] do not get access."[116] A 2007 report by the Worldwide Palliative Care Alliance quotes a healthcare worker as saying that

Palliative care doctors have a right to prescribe morphine but cannot obtain it if they work in a hospice which is not registered in the Ministry of Health as a medical organization.[117]

In India, regulations in some states make it practically impossible for palliative care providers to obtain a license to prescribe oral morphine, while in other states regulations establish a straight- forward procedure that has allowed palliative care providers to play a key role in making pain treatment available at the community level.[118]

Some countries allow only certain types of medical institutions to prescribe opioids. For example, in China, only hospitals above Level 2-hospitals in China are ranked from Level 1 to 3 depending on the jurisdiction they fall under-have the right to prescribe opioids, which means that hospitals in many cities and towns cannot dispense opioids and people may have to travel long distances in order to be able to obtain oral morphine.[119]

These licensing requirements significantly impede access to oral morphine. Countries need to ensure that all healthcare providers and pharmacies are either automatically licensed to procure, stock, and dispense by virtue of their registration as a healthcare institution, or have access to a rational and transparent procedure for obtaining a special license. There is no rational reason for denying palliative care programs that provide mostly home-based care services the right to prescribe and dispense oral morphine.

Licensing of Health Workers

Many countries require special licenses for healthcare workers who want to prescribe opioids, and these licenses are often difficult to obtain. For example, the Worldwide Palliative Care Alliance reported in its 2007 report that in Mongolia, Peru, Honduras, Kyrgyzstan and a state in India only palliative care specialists and oncologists are authorized to prescribe oral morphine; that in the Philippines doctors must obtain two special licenses to be able to prescribe; and found that seventeen percent of locations (countries and sub-national regions) covered by the survey required special licenses that were hard to obtain.[120] At the 2008 Eastern European and Central Asian AIDS Conference, a Russian AIDS doctor told conference delegates that he could not treat a patient who suffered from severe pain because he was not licensed to prescribe morphine and that oncologists, who are, would not be able to provide her with morphine because she was not a cancer patient.[121]

While medical doctors in many countries can prescribe morphine by virtue of their professional license, this is not the case for nurses. This is a considerable problem in many middle and low income countries around the world where there are few medical doctors. For example, in Malawi there is only one doctor per 100,000 people.[122] In 2004, Uganda introduced nurse-based prescribing of oral morphine. According to its amended regulations nurses with a certificate in specialized palliative care are permitted to prescribe and supply certain types of opioid analgesics, including oral morphine.[123] Prior to 2004, many people in rural Uganda-where there is one physician per 50,000 people-did not have realistic access to medications for moderate to severe pain. INCB praised Uganda for this important step.[124]

Under the 1961 Single Convention on Narcotic Drugs, states do not have to require that healthcare workers obtain a special license to handle opioids. WHO has recommended that "physicians, nurses and pharmacists should be legally empowered to prescribe, dispense and administer opioids to patients in accordance with local needs."[125] As special licensing procedures impede accessibility of opioids for patients who need them, countries should strive as much as possible to allow healthcare workers to handle opioids by virtue of their professional license or establish rapid rational and transparent procedures for obtaining special licenses.

Burdensome Prescription Procedures

Some countries have established special prescription procedures for opioids that are cumbersome and discourage healthcare workers from prescribing them. A common example is the requirement to use special prescription forms and to keep multiple copies of the prescription. The WHO Expert Committee on Cancer Pain Relief and Active Support Care has observed that special multiple-copy prescription requirements "typically…reduce prescribing of covered drugs by 50 percent or more."[126] Yet, countries ranging from Cote d'Ivoire to Ukraine require such special prescription forms.[127] In 1995, INCB found that 65 percent of countries that participated in its survey had special prescription procedures.[128]

Another common problem is that prescriptions by healthcare workers must be approved by their colleagues or superiors or that dispensing must be witnessed by multiple healthcare workers. In Ukraine, for example, decisions to prescribe morphine have to be made by a group of at least three doctors, one of whom must be an oncologist.[129] In South Africa, two nurses must observe the dispensing of opioids.[130] In Guatemala, every prescription must be authorized through an ink seal and a signature that are only issued in the central office of the Narcotic Control Agency.[131] In Colombia, the National Fund follows up every prescription with phone calls to the prescribing doctor.[132] In Vietnam, some hospitals mandate that all doctors and nurses return empty morphine ampoules to the chief pharmacist or otherwise be investigated for opioid diversion, even though Vietnam's drug control regulations do not so require.[133]

Many of these special prescription procedures go well beyond what is required by the 1961 Single Convention and are unlikely to be necessary for preventing diversion. WHO has recommended that "if physicians are required to keep records other than those associated with good medical practice, the extra work incurred should be practicable and should not impede medical activities."[134] Requirements that do not need meet those criteria will violate the right to health.

Prescription Limitations

Regulations in some countries impose limitations on the dose of oral morphine that can be prescribed per day or unnecessarily restrict the number of days that it can be prescribed and dispensed for at once. These restrictions impede access to adequate pain management. WHO has recommended that "decisions concerning the type of drug to be used, the amount of the prescription and the duration of therapy are best made by medical professionals on the basis of the individual needs of each patient, not by regulation."[135]

The 1995 INCB survey found that 40 percent of countries participating set a maximum amount of morphine that could be prescribed at one time to a hospitalized patient, and 50 percent did so for patients who lived at home.[136] INCB noted that some governments had set the maximum amount "as low as 30 milligrams" – or approximately half the average daily dose in low and middle income countries.[137] WPCA reported in 2007 that Israel limits morphine prescription to 60 milligrams per day for non-cancer patients.[138] It is unclear how many other countries maintain dosage limitations today. Dosage limitations make no medical sense as patient need varies considerably from person to person, and some people require very large doses to achieve adequate pain control. They are therefore not consistent with the right to health.

The 1995 INCB report found that 20 percent of countries participating in the survey imposed a maximum length of time that a hospitalized patient could receive morphine, and 28 percent of governments had such restrictions for patients at home. In some cases, patients could only receive morphine for three to seven days at once and sometimes that was not renewable.[139] Although no comprehensive overview of countries that impose these kinds of limitations today is available, they continue to be widespread. WPCA reported in 2007 that Honduras and Malawi do not allow morphine to be dispensed for more than three days at a time.[140] In China, prescriptions can only be given for seven days at a time.[141] In Israel, prescriptions can only be given for ten days at a time unless the doctor confirms that the patient lives far away from a pharmacy.[142]

While there are good reasons, including preventing diversion, for certain limitations on the length of time medications can be dispensed, the kinds of restrictions mentioned above make it impractical or impossible for many patients to have continuous access to them. Many patients live far away from pharmacies or healthcare centers and repeated travel is a considerable burden because of expense and difficulty of travel for people who are ill. It also puts a drain on healthcare workers who are already overworked in many parts of the world. Any limitations on the amount of time morphine can be described or dispensed for should be reasonable-the limitations should be necessary for preventing abuse and not result in the medication becoming practically inaccessible for people who need them-otherwise they will violate the right to health. In recent years, an increasing number of countries have relaxed the length of time for which oral morphine can be prescribed at once, with many settling on about a month. These countries include Romania (from 3 to 30 days), France (from 7 to 28 days), Mexico (from 5 to 30 days), Peru (from 1 to 14 days), and Colombia (from 10 to 30 days).[143]

Fears of Legal Sanction

In some countries, a key reason for the low consumption of opioid medications is fear among healthcare workers that they may face legal sanctions for prescribing them. INCB has recommended that

health professionals…should be able to…[provide opiates]…without unnecessary fear of sanctions for unintended violations [including]…legal action for technical violations of the law…[that]…may tend to inhibit prescribing or dispensing of opiates.[144]

Almost fifty percent of countries participating in the 1995 INCB survey cited such fear as an impediment to medical use of opioids.[145] In APCA's survey of national drug control authorities, four out of five cited fears among healthcare professionals as one of the key reasons for low use of opioid medications. The drug control authority in Kenya stated that "due to the punitive nature of the 1994 Act, most providers have shied away from selling opioids."[146]

Ambiguity in regulations, poor communication by drug regulators to healthcare workers about the rules for handling opioids, the existence of harsh sanctions are some of the reasons for this persistent fear among medical professionals, and, in some countries, actual prosecutions of healthcare workers for unintentional mishandling of opioids. In China, for example, regulations that were adopted in 2005-and have significantly improved accessibility of opioids-hold that healthcare workers can prescribe opioids for "reasonable need" but the rules do not clearly define reasonable.[147] In INCB's 1995 survey some countries reported that failure to comply with laws and regulations governing opiate prescribing could result in a 22-year prison sentence. Almost fifty percent of participating countries reported mandatory minimum sentences, some as high as 10 years in prison.[148] In some cases, these are sentences for unintentional mistakes in handling opioids, not for drug dealing.

In the United States, many physicians are reported to fear unjustified prosecution or sanctioning for prescribing opioids for pain and, consequently, tend to under-prescribe.[149] While a recent survey of criminal and administrative cases between 1998 and 2006 found that the number cases had grown from 17 in 1998 to 147 in 2006, the study also concluded that "the widely publicized chilling effect of physician prosecution on physicians concerned with legal scrutiny over prescribing opioids appears disproportionate to the relatively few cases in which convictions and regulatory actions have occurred."[150] The authors suggested that

[I]t seems likely that physicians react to frightening or inconsistent public policy statements. Likewise, they are sensitive to experience with, or lore about, investigations that were ultimately dismissed but which disrupted a medical practice and produced fear and possibly panic. Thus, the chilling effect may be, in part, related to public relations and communications problems on the part of regulators as well as to how law enforcement handles the full number of its investigations, not just those that lead to conviction or discipline. Thus, these data may be extrapolated to suggest that regulators and law enforcement may do well to improve how they craft their public messages to physicians and how they handle routine investigations of medical practice. These phenomena deserve greater study.[151]

Unfortunately, the U.S. Drug Enforcement Administration's public message to physicians who prescribe opioids has been ambiguous. After initially supporting a series of Frequently Asked Questions (FAQ) for physicians about the use of pain management medications that had been developed by a panel of clinicians and regulators, including DEA officials, it abruptly pulled the FAQ from its website in August 2004, creating confusion over what acceptable prescribing practices are.[152] It has not been re-posted since.

While countries have a right-and an obligation under the drug conventions-to take legal action against medical professionals who dispense opioids for non-medical uses, criminalizing unintentional mistakes in opioid prescription is not consistent with the right to health. Furthermore, countries must ensure that regulations are unambiguous and that complete information about them is readily available for healthcare providers.

Cost

Cost is a frequently cited impediment to improving access to pain treatment and palliative care services, particularly for low and middle income countries. Under the right to health, governments do not have to offer medications such as oral morphine free of charge. However, they must strive to ensure that they are "affordable to all." In some countries and for certain sections of countries' populations that will mean that it must be provided at no or very little charge. In any case, governments must take all reasonable efforts to ensure that medications are available at a reasonable price that is affordable for patients.

Basic oral morphine should be very cheap. Cipla in India makes 10 mg morphine tablets that sell at US$0.017 cents each.[153] Foley and others estimate that generic morphine should not cost more than US$0.01 per milligram.[154] An average month's supply of morphine would cost US$9 to 22.5 per month per patient.[155]

In reality, however, morphine is often much more expensive. A study by De Lima and others found that the average retail cost of a monthly morphine supply in 2003 ranged from US$10 in India to US$254 in Argentina. The study found that median cost of a month's supply of morphine was more than twice as high in low and middle income countries (US$112) as in industrialized countries (US$53).[156] The study suggested that a number of factors might explain the discrepancy: the fact that most industrialized countries subsidized medications while low and middle income countries did not; that several industrialized governments regulated the price of opioids; taxes, licenses and other costs related to import of finished product; large overhead of local production; poorly developed distribution systems; low demand; and regulatory requirements that drive up cost.[157]

A 2007 report of the W0rldwide Palliative Care Alliance also found that the promotion of non-generic-and costly-forms of opioid analgesics has made pain treatment medications unaffordable in some areas. It stated that "when expensive formulations of opioids appear on the market, inexpensive immediate-release morphine often becomes unavailable" as pharmaceutical companies withdraw basic oral morphine from the market. It cited India as an example of a country where in some places hospitals have costly sustained release morphine or transdermal fentanyl but no immediate release morphine, even though the regulatory barriers are the same for both.[158]

Governments have an obligation to explore ways to ensure that basic morphine is available at low cost to people who are in need of pain treatment. A number of countries have successfully sought ways to create capacity for local production of basic oral morphine, in tablet or liquid form, at low cost. For example, in the state of Kerala in India, a small manufacturing unit has been set up at a hospital that produces low cost immediate release morphine tablets from morphine powder that is purchased from a factory at Ghazipur.[159] In Uganda, the ministry of health commissioned charitable procurement and manufacturing facility to produce morphine solution which could be distributed to hospitals, health centers and palliative care providers. Before deciding on this option, the ministry of health had approached commercial manufacturers but these were not interested in producing morphine solution due to lack of profitability.[160] In Vietnam, a new opioid prescription regulation allows the ministry of health to mandate state and para-state pharmaceutical companies to produce oral and injectible opioids.[161]