Making the Palliative Care Law Work

As long as there are no obligations and penalization the law remains nice words. The law is great but it does not oblige anyone to do anything…it is no more than a romantic notion – Dr. Guillermo Aréchiga, November 2011.[214]

The adoption of the 2009 changes to México’s health law was a major step. With it, México clearly determined that palliative care for terminal patients should be an integral part of the country’s healthcare services. But putting the law in place was, in many ways, the easy part. Weaving palliative care into the DNA of México’s healthcare system is a challenge of a different magnitude. To achieve this, strong leadership by the federal and state governments and a comprehensive implementation strategy are essential.

It will require a persistent effort to adapt México’s healthcare system for the delivery of palliative care and to remove the barriers identified in this report that impede its provision. Government agencies, healthcare and health insurance providers, the pharmaceutical industry, civil society, academia and other players will need to work in coordination with each other to implement the systemic change required to make the vision of the law—that no one should have to die in unnecessary suffering—a reality. Without a clear plan of action and a coordinated effort, it is highly likely that palliative care will continue to develop in a haphazard and fragmented manner and that thousands of Mexicans will continue to suffer unnecessarily as a result.

The past year has seen increasingly positive signs that México is ready to embrace this challenge. The years 2013 and 2014 have seen a major increase in attention for palliative care in Mexican society. Several Mexican civil society groups have taken up the issue as a priority while key high level government officials, including the health minister, the head of COFEPRIS and a Supreme Court justice, have all publicly underscored the importance of implementing the law. In October 2013, the Mexican Health Foundation and Tómatelo a Pecho organized an international seminar on palliative care in which key government officials, Mexican civil society leaders and international experts discussed the state of palliative care in the country and actions to be taken. The Mexican Health Foundation and Tómatelo a Pecho, working closely with Harvard University, have since organized several follow-up meetings that included a broad range of actors to discuss specific next steps. At the same time, the National Autonomous University of México has convened a number of meetings, initiated by former health secretary Juan Ramon de la Fuente, to discuss the training of healthcare personnel in palliative care as well as drug regulatory and other barriers to the use of opioid analgesics.

These various initiatives and meetings have yielded some important results. In November 2013, the ministry of health issued an important regulation clarifying a number of important normative issues the 2009 legal changes did not resolve.[215] In March 2014, COFEPRIS announced a decision to introduce an electronic system for licensing physicians to prescribe opioid analgesics, issuing barcoded stickers and keeping records.[216] That same month, Health Minister Mercedes Juan López instructed her ministry to develop a national palliative care strategy, asking Dr. Felicia Knaul of the Mexican Health Foundation to work with the ministry on this process.[217] Furthermore, the National Commission for Social Protection in Health, which administers one of México’s largest health insurers, Seguro Popular, added a number of key palliative care interventions to its package, which previously did not include palliative care for most patients. In mid-2014, the ministry of health tasked the department of quality and education in health with improving the availability of palliative care and hired an experienced palliative care physician to coordinate this work.[218] Following an internal review, the Mexican Social Security Institute recently announced its intention to strengthen availability of palliative care within its system, including psychosocial and spiritual support and access to medicines.[219] The adoption of the official norm on the implementation of the palliative care section of México’s health law is expected in October 2014. Moreover, the Public Health Council (Consejo Nacional de Salubridad) is preparing an agreement between different government agencies on the development of palliative care.

The implementation of the law will require a progression of actions that address several key challenges. First, the normative and conceptual basis for México’s palliative care system needs to be finalized. The law and regulation decide many big picture legal and conceptual questions but do not offer a specific model for the delivery of palliative care and leave a number of legal questions unresolved. Secondly, the healthcare system itself needs to be prepared to support and deliver palliative care services. This means that palliative care needs to be incorporated into insurance packages and financing structures and integrated into educational programs for healthcare workers. Finally, México will need to build the delivery system for palliative care by setting up services, training existing healthcare workers, and creating referral systems.

Finalizing the Normative and Conceptual Base

The chapter in the health law and the 2013 regulations offer a partial normative framework and set out a broad vision of universal palliative care for patients with terminal illness. However, as noted above, the law and regulation also leave a number of major conceptual and normative questions unresolved. It is essential that the government, in cooperation with the national health system, civil society, and other relevant actors, address these conceptual and normative gaps to allow for proper operationalization and implementation of an integrated palliative care system. The official norm will be essential in this respect, as is the national palliative care strategy the health ministry is currently developing.

Choosing Model(s) of Delivery. The law and regulation are not specific on the model of palliative care that should be used, leaving that decision to the ministry of health. The law and regulation do set some parameters that the model must meet including the ability to: grant patients a right to opt to receive palliative care in their homes; determine that all healthcare institutions must offer palliative care; articulate a number of specific obligations for healthcare workers of secondary and tertiary care institutions; and determine that palliative care must be provided by multidisciplinary teams on the basis of a palliative care treatment plan. Different models of palliative care may meet these criteria. The official norm and national strategy should address in particular how home-based palliative care will be delivered, what role primary care providers will play, and lay the groundwork for a functioning referral and counter-referral system.

• Role of primary health providers. The law and regulation make no specific mention of primary health providers or their involvement in the delivery of palliative care. In order to ensure that palliative care is offered as close to the home of the patient as possible, an active role for primary health teams is essential. The government thus has to determine what role these healthcare workers are to play and how they are going to be trained and supported. Effective coordination and cooperation between primary health providers and the multidisciplinary palliative care teams at secondary and tertiary care facilities that are mandated by the law will likely be essential to the successful implementation of a palliative care system.

• Home-based palliative care. The law states that patients with terminal illness have the right to “opt to receive palliative care in a private home” but it offers little guidance on how home-based palliative care is to be delivered apart from instructing healthcare workers to train family members in basic care needs. In order to ensure effective home-based palliative care, home visits by trained healthcare workers for certain groups of patients are essential. The government needs to determine who would conduct such visits, who would be eligible for home care visits, and ensure the regulations permit home-care teams to carry essential palliative care medicines, including opioid analgesics. It will also have to develop a system for round-the-clock support for patients at home and their families, via telephone, text message and/or video link. Health insurance policies should cover these interventions. The national phone number the law envisions is unlikely to work effectively unless patients and families can access on-call healthcare workers who have access to their files and know their specific situations.

• Referral and counter-referral systems. In order to allow patients to receive highest quality palliative care as close to home as possible, it is essential that a strong system of referral and counter-referral be developed. As discussed above, most patients with life-limiting illnesses receive curative treatment at tertiary or secondary care facilities that are far from their homes. A system needs to be put in place that allows patients to be referred between levels of care so that they can receive palliative care close to home while primary care providers can also refer them back to higher level facilities if so required.

• Palliative care for children. The law refers to pediatric palliative care only in passing, making it clear that children with terminal illness have a right to this health service without providing any detailed guidance. The palliative care needs of children differ significantly from those of adults as do the skills required by healthcare workers, making it important to develop specific child-friendly models for them. These models should address the special needs of children, their parents and siblings in terms of communication about the illness, psychosocial needs, assessment of pain, and the place of care.

Mandating Inclusion of Palliative Care in Insurance Packages. While the law and regulation clearly identify palliative care as a right of patients with terminal illness, both are silent on the role of insurance providers. The explicit inclusion of palliative care interventions, medicines and other medical products in insurance packages will be essential to their availability and financial accessibility. The normative framework should clearly require health insurers to cover palliative care and associated institutions to offer it or otherwise facilitate access to it.

Ensuring Inclusion of Patients with Prognosis Exceeding Six Months. The palliative care chapter of the health law explicitly leaves people with life-limiting illnesses who are not terminal unprotected even if they do require palliative care. The WHO definition of palliative care does not contain any reference to life expectancy, instead focusing on patient need, and international human rights law grants people a right to appropriate health services to all. The government will thus need to determine how the healthcare system should address the palliative care needs of these patients.

The limited prognosis requirement of the law is particularly problematic for pediatric palliative care. A life-limiting illness in a child has great impact on parents and siblings, making early initiation of care focused on quality of life care especially important. Furthermore, many children who require palliative care have neurological diseases, genetic conditions, congenital malformations, or degenerative disorders that undermine the quality of life of the child and the whole family over periods of time far beyond six months.

Ensuring Access to Medicines. Changes to the normative base are finally required to ensure that home-based palliative care teams can carry these medicines on visits to patients. The government should use the WHO policy guidelines “Ensuring balance in national policies on controlled substance. Guidance for availability and accessibility of controlled medicines” in making these changes.[223]

Preparing the Healthcare System for the Integration of Palliative Care

As palliative care has traditionally not been part of México’s healthcare system, a series of steps are required to ensure the building blocks for the delivery system are in place. Without adequate human resources, clinical protocols, availability of medicines, and other medical products and coverage by insurance providers, it will be impossible to build an effective and sustainable delivery system for palliative care. Thus, the government needs to prepare the system for the integration of palliative care, working with the healthcare institutions, health insurers, academia and other training institutes for healthcare workers, and civil society groups.

Incorporating Palliative Care into Health Insurance Systems. In addition to introducing normative rules that require health insurers to cover palliative care, steps need to be taken to actually integrate palliative care interventions, and medicines into existing insurance packages and medicines lists. This includes revising Seguro Popular’s list of covered interventions to include palliative care and the medicines lists of Seguro Popular and IMSS. Given their importance in provision of home-based palliative care, all insurance providers should also ensure that home visits and consults by phone or video are adequately covered.

Preparing Human Resources. The single greatest challenge is the preparation of adequate personnel to deliver palliative care. As noted above, very few healthcare workers are currently trained in this area. Most undergraduate training for health providers does not include any palliative care; availability of in-service training is very limited; and there are few continued education programs in palliative care.

Making palliative care an integral part of health services offered in México requires that all healthcare workers have at least basic knowledge of and skills in palliative care. This requires a systematic effort to train existing healthcare workers and to ensure that healthcare workers currently in pre-service training learn about palliative care during academic programs and as part of in-service training.

We recommend that government undertake the following steps:

• Work with associations of medical, nursing, pharmacy, psychology and social work faculties to ensure palliative care training is incorporated into relevant undergraduate curricula as a mandatory subject.

• Work with academic hospitals to ensure that rotations in palliative care units and pain clinics become a standard element of residencies of healthcare workers, including for pediatricians in training.

• Integrate palliative care training into continuing education programs for healthcare workers, including training in children’s palliative care. To allow a major scale-up of palliative care, all current healthcare workers need training in the basics of palliative care. A plan should be drawn up to use continuing education to bring such training to all healthcare workers, including those at children’s hospitals, within the next few years, with a special focus on primary healthcare workers.

• Recognize palliative care as a specialty/subspecialty of medicine. Recognition of palliative care as a (sub)specialty of medicine will accelerate training of healthcare workers and encourage academic research.

• Recognize at least one hospital with a successful palliative care service in each state as a training site and invest in the capacity of these hospitals to conduct training activities.

The primary responsibility for training healthcare staff at the primary level lies with palliative care teams established in secondary level hospitals in each of Panama’s regions through programs of continuing education and hands-on mentorship of primary care givers.

Under the program, a number of modules were developed for basic, intermediate and advanced training of current healthcare workers as well as government officials. Trainings were conducted both in-person and online. In total, more than 1200 people in Panama have received training in palliative care.[225]

Medicines Availability. The government and insurance providers need to ensure that all essential medicines for palliative care for adults and children in all relevant formulations and dosages, as defined by the WHO, are included in the medicines lists of the Public Health Council and insurance providers. All these medicines should be approved for use at all levels of care and covered by insurance plans. The lists should follow the WHO Model List of Essential Medicines in grouping all essential palliative care medicines together in a section on pain and palliative care.

Controlled Medicines. Ensuring availability and accessibility of controlled medicines, especially opioid analgesics, at all levels of care will be essential for the delivery of palliative care. Steps to improve their availability and accessibility should focus on drastically increasing the number of physicians that prescribe these medicines and pharmacies that dispense them and on resolving existing difficulties with prescribing and dispensing them.

The ministry of health and COFEPRIS have already announced the introduction of an electronic system for issuing prescribing licenses and barcoded stickers to physicians, and for keeping records at pharmacies.[226] The planned system has the potential for resolving many of the problems with licensing and barcoded stickers that currently exist.

A digital system could also lead to new barriers to prescribing these medicines, which will need to be avoided or addressed. Some of these are:

• Avoid application fees or requirement to buy specific software or equipment. This would be a deterrent for many physicians and would likely result in limited numbers of prescribers.
• Ensure system functions even in areas with frequent power outages and unstable or slow internet connections. It will be critical that the digital system can function well under varying conditions.
• Address facilities without, or with limited internet access. There are many small health facilities in México that currently do not have internet.

The government has already announced that it would remove the requirement that physicians’ private addresses be included in prescription forms. It should finalize this step as soon as possible. Finally, the government should facilitate an uninterrupted and adequate supply of opioid analgesics, using the International Narcotics Control Board and WHO’s guide on estimates requirements for controlled medicines,[227] and encourage the production of generic opioid analgesics which would both help keep down the cost of these medicines and help prevent stock-outs.

Clinical Guidance. The Centro Nacional de Excelencia Tecnólogica en Salud (CENETEC), in cooperation with IMSS, issued a guide on clinical practice and a quick reference guide on palliative care in 2011.[228] We recommend that the ministry of health and CENETEC ensure wide distribution of this clinical guidance as part of efforts to train healthcare workers and establish palliative care services. They should also convene periodic meetings of palliative care providers, primary care providers, and other relevant parties to review and update this clinical guidance. Clinical guidance needs to be developed for pediatric palliative care, taking into consideration the 2012 WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses.[229]

Paving Way for Home-Based Palliative Care. Once conceptual questions around home-based palliative care have been decided, steps will need to be taken to set up home-based palliative care teams, to ensure they can prescribe all essential palliative care and that home visits and phone or video consults are covered by insurance providers.

Research and Data Collection. An investment should be made in research into the need for palliative care among adults and children and across different illnesses; availability and accessibility of palliative care; the effectiveness and efficiency of available services; and specific models of delivery. Such research will allow the government and health system to assess progress and make adjustments to policy or delivery systems as needed. We recommend, among others, the following steps:

• México should use the consumption of opioid analgesics per cancer death as an indicator to measure progress in the development of palliative care over time, as recommended by the WHO Global Action Plan on the Prevention and Control of NCDs.[230]

• The Asociación Latinoamericana de Cuidados Paliativos has developed a set of indicators for assessing the availability of palliative care that measure progress in policy development, education, and drug availability.[231] Using these indicators, México could set a baseline and measure progress.

• Hospitals should be required to report regularly on the availability of pain clinics and palliative care. These units/services should be included in organograms of hospitals.

Building the Delivery System

Putting in place the delivery system for palliative care will undoubtedly be the most challenging part of implementing the law. As noted above, at present the number of palliative care services in México is very limited and few healthcare workers have any training in the discipline, making it impossible to establish high quality palliative care services throughout the country and at all levels of care overnight. This will have to be a gradual process.

It is, however, critical that the government show a strong commitment and strong leadership to initiate this process and keep it moving. Given the complexity of the task and the number of players involved it is essential that México develop a mandatory implementation plan that assigns clear responsibilities and timelines, and includes accountability mechanisms.

The specifics of such plan will necessarily depend on decisions made regarding the normative and conceptual framework and the model(s) of care México decides to implement. However, we believe that there are a number of key criteria the plan must fulfill in order to be effective. These include the following:

• The national plan should set the overall strategy for the development of the delivery system. Each state should develop a specific state-level strategy that takes into account the specific circumstances of the state. Great variation between circumstances of different states and current development of palliative care services requires that implementation strategies are tailored.

• The national and state plans should clearly identify the responsibilities of different institutions involved, including the state health department, health insurers, healthcare providers, and other relevant institutions.

• The plans should establish specific targets and benchmarks against which progress can be measured. These should include targets and benchmarks for training of healthcare workers, establishment of multidisciplinary teams and palliative services, and on provision of palliative care at primary care level and at home.

• The plans should establish strong accountability mechanisms. The health ministry and state departments of health should have final responsibility for implementation of the strategies and be required to report on a regular basis on progress made. The plans should grant the health ministry and health departments tools to impose sanctions, if needed, on institutions that are not complying with the implementation plan or law. We recommend that at the national and state levels specific officials are put in charge of the implementation plans.

• The plans should make resources available for the implementation process.

• Training of existing healthcare personnel should be one of the central components of the implementation plans. Training programs should, whenever possible, include classroom and bedside teaching; rotations into palliative care services; and mentoring. Training is likely to require the most significant resource investment.

• The implementation strategies should build on existing palliative care services in each state. These services should play a key role in the training of healthcare providers, including through rotations and bedside teaching, setting up palliative care services at secondary and tertiary hospitals, and in putting together multidisciplinary palliative care teams.

• The plans should include a clear strategy for integrating palliative care into primary care. This will require multidisciplinary palliative care teams at secondary level hospitals to support primary care providers, including a mentoring and referral system.