June 2, 2011

IV. The Americas

Regional Overview

"Cancer is killing us. Pain is killing me because for several days I have been unable to find injectable morphine in any place. Please, Mr.  Secretary of Health, do not make us suffer any more."
– A classified ad placed in El País newspaper in Cali, Colombia, on September 12, 2008, by the mother of a woman with cervical cancer.
"[In the United States there is a] widely publicized chilling effect of physician prosecution on physicians concerned with legal scrutiny over prescribing opioids…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.”
– Goldenbaum et al., "Physicians Charged with Opioid Analgesic-Prescribing Offenses," Pain Medicine, vol. 9, no. 6, 2008.

Consumption of opioid analgesics varies greatly in the Americas from some of the highest levels in the world in the United States and Canada to very low levels in Central America and the Caribbean. At least 100,000 terminal cancer and HIV/AIDS patients die without adequate pain treatment in the Americas each year, although the real number is probably much higher.

In Central America and the Caribbean, about half of the countries consume so few opioid medications that even if all were used exclusively to treat patients with terminal cancer and HIV for pain, less than a third of them could receive adequate treatment (Belize, El Salvador, Honduras, Nicaragua, Saint Kitts and Nevis, Trinidad and Tobago, Jamaica, Dominican Republic, and Haiti). Bolivia, Antigua and Barbuda, and Honduras reported no consumption of opioids for 2006 to 2008, and Haiti could treat pain in less than 1 percent of its terminal cancer and HIV/AIDS patients.

In South America, consumption levels are generally significantly higher than in Central America and the Caribbean countries, but still far lower than in North America or Western Europe. Several South American countries, such as Bolivia, Ecuador, Peru, and Suriname, significantly lag behind their neighbors. In these countries, even if all opioid medications were used exclusively to treat chronic pain, fewer than 40 percent of patients could be treated adequately.

Policy

As Table 7 shows, policy support for palliative care is very limited in the countries surveyed in the Americas. Five of eight countries do not have national palliative care policies; survey participants in two countries that do have such policies, Argentina and Brazil, said that they are not implemented in practice. [92] A positive exception is Mexico, which recently adopted a policy on management of terminal patients. None of the countries surveyed have HIV policies that refer to palliative care and only two countries, Brazil and Colombia, address pain management in their national cancer control policies. More positively, oral morphine is a registered medicine in all countries surveyed, and most have it on their essential medicines lists.

Education

Availability of undergraduate education in pain management and palliative care is very scarce in the countries surveyed in the Americas. In two countries, Mexico and El Salvador, instruction on palliative care is altogether unavailable in undergraduate programs, while in most other countries it is available only in a few or some such programs. Instruction on palliative care is compulsory only in some undergraduate medical programs in the United States and in a few in Guatemala. All of the region’s larger countries have opportunities for post-graduate medical education in pain treatment or palliative care, but these are lacking in the less-populous countries, such as Guatemala and possibly El Salvador.

Drug Availability

Supply and Distribution

The United States, the country with by far the highest opioid consumption of countries surveyed, has the greatest availability of morphine across clinical settings, followed by Brazil. Guatemala had the poorest, with morphine available in only some pharmacies and tertiary hospitals. Throughout Latin America, only some pharmacies stock oral morphine. Its availability in health centers and HIV/AIDS clinics is even poorer. Survey respondents in all countries said that it is harder to access opioids outside major cities.

Drug Regulations

All countries surveyed in the Americas require special prescription forms and four require physicians to obtain a special license to be allowed to prescribe opioid medications. Guatemala, the country with the lowest opioid consumption of those surveyed, also imposed the most types of restrictive regulation, including dose limits. Most of the American countries surveyed, with the exception of the United States and El Salvador, also impose a limit on the number of days that a morphine prescription can cover. Five countries have a relatively generous 30-day limit. In Argentina, however, a prescription can cover just 10 days.

In El Salvador, all doctors can prescribe a limited, one-time dose of opioids to treat acute pain, but a different prescription form is needed to prescribe opioids for chronic pain, and those prescriptions must be authorized by the secretary of the health facility and the chief of the narcotics control agency. Survey respondents from all countries except Colombia said that healthcare workers fear legal sanction for mishandling opioids and that this was a deterrent to prescribing them. None of the Latin American countries surveyed allows nurse-prescribing. In most US states, some types of nurses can prescribe morphine. In a few states physician assistants or pharmacists can also prescribe but others impose dose limits.

Table 11: Restrictive Regulation of Morphine Prescribing in the Americas

Cost

Key informants in four countries—Argentina, Brazil, Colombia, and Mexico—said that the government subsidizes the cost of morphine in some circumstances. In Colombia, inexpensive oral liquid morphine is available, but in most countries surveyed in South America, most available morphine formulations are much more expensive, priced up to several dollars for a daily dose. In Ecuador, El Salvador, and Guatemala, the three countries with the lowest opioid consumption of those surveyed, inexpensive immediate release oral morphine is unavailable although costly sustained release tablets are, making the price of morphine unnecessarily high.

Best Practice and Reform Efforts: Colombia

In Colombia, intensive engagement between the government, NGOs, and academics has led to recent progress in improving access to palliative care and pain management services. In the last five years, the government has undertaken significant regulatory reforms to remove unnecessary barriers to accessing pain treatment and improve access to opioid medicines. In 2006 the government increased the maximum number of days allowed for the prescription of opioids from 10 to 30 days,[93] easing access for patients who need opioid therapy for extended periods of time. Revised regulation for regional drug procurement has also been put in place with the aim of improving opioid availability. The new regulation mandates all 32 Colombian states to have at least one place where opioids are guaranteed to be in stock at all times.[94] Morphine consumption has increased following these efforts to improve availability. Between 2006 and 2009, the government reported a 42 percent increase in units of morphine sold.[95]

Modest gains have also been made in the field of education. The country’s first mandatory course in palliative care for undergraduate medical students was implemented at the Universidad de la Sabana in Bogota and could serve as a model for other universities.[96] Continuing education for primary health workers in palliative care is also available to a limited extent.[97]

Columbia’s progress has resulted from several years of close engagement between the government and national and international NGOs and academic institutions. In 2006 members of the Universidad de la Sabana, the International Association for Hospice and Palliative Care, the Pain and Policy Study Group, and the University of Wisconsin developed an action plan for improving access to palliative care and pain management services in Colombia and later organized a workshop with members of the governments and the private health sector to identify barriers to accessing palliative care and solutions to these barriers.[98] These efforts have largely guided Columbia’s reform efforts.

Though Colombia still has far to go in guaranteeing access to pain treatment and palliative care for all who need it, greater progress may be on the horizon. The inclusion of three new opioid formulations in the country’s essential medicines list is being debated by the Regulatory Commission of Health.[99] In addition, a proposed law that would seek to improve access to controlled medicines, quality of palliative care services, and education for healthcare workers was drafted by two senators with input from several Colombian palliative care experts and organizations.[100] At time of writing, the senate had discussed the Bill but not yet voted on it.[101]

[92]Human Rights Watch email correspondence with Dr Roberto Wenk, Argentina, October 18, 2010; Human Rights Watch email correspondence with Dr Roberto Bettega, Brazil, December 10, 2010.

[93]Colombian Minister of Health 001478 Resolution of 2006, https://www.alcaldiabogota.gov.co/sisjur/normas/normal.jsp.old (accessed January 27, 2011).

[94] Leon, Marta et al. “Integrating palliative care in public health: The Colombian experience following an International Pain Policy Fellowship” http://www.painpolicy.wisc.edu/publicat/11pallmed/LeonIPPF2011.pdf (accessed April 24, 2011).

[95] Ibid.

[96] Ibid.

[97] Ibid.

[98] Leon, Marta Ximena et al. Improving Availability of and Access to Opioids in Colombia: Description and Preliminary Results of an Action Plan for the Country.

[99] Ibid.

[100] Ibid.

[101] Congresso Visible, http://www.congresovisible.org/proyectos-de-ley/mediante-la-cual-se-regulan/1080/ (accessed April 1, 2011).