B. Establish WHO Demonstration Projects

The following section reports on the Center's activities in India in collaboration with the WHO Demonstration Project in Calicut, an Indian non-governmental organization, and a number of agencies within the Central Government of India as well as several state governments.

India:

Objective:
To improve availability and access to opioid analgesics for patients with cancer and pain.

Situation:
Cancer pain relief and palliative care are relatively new developments in India. There have been major efforts to improve awareness and to educate and train health professionals according to the WHO analgesic ladder, including many sponsored by WHO and by the Oxford WHO Collaborating Center. These efforts have led to decreased reluctance to use opioids for pain relief; however, relief from cancer pain cannot be achieved unless drugs like morphine are actually available. It has been impossible for many hospitals and palliative care programs to obtain morphine, the only "third step" opioid recommended by WHO which is legally obtainable in the country (although pethidine [meperidine, in some countries] is available, it too is in short supply and in any event is not recommended for chronic pain). Ironically, regional cancer centers have received morphine donated by the WHO but many do not use it. Consumption of morphine for medical purposes decreased by more than 90% from 1986 to 1996 due in part to adoption of a new national anti-narcotics law in 1985. This decreasing availability of medical morphine in India is particularly ironic because India produces much of the opium and narcotic raw material which is exported to manufacture morphine and other opioid analgesics for the rest of the world.

Method:
The Center developed a method to identify the reasons for morphine unavailability, devised a plan for policy and systems change, developed collaboration with government and non-governmental organizations, and is helping to implement an action plan to simplify regulation of morphine.

Cooperation:
The Center developed cooperation with the Narcotics Commissioner of India, and through him with the Secretary of the Department of Revenue of the Government of India, as well as with the WHO Office-India and the South East Asian Regional Office (SEARO) of WHO. The Center worked closely with the Indian Association for Palliative Care (IAPC), which appointed a Committee on Morphine Availability and Control to work with the Center.

Problem identification:
In 1995 and 1996, members of the Center visited India several times to participate in meetings and workshops with government officials to study the policies that govern the availability and use of opioid analgesics as well as relevant systems for delivery of health care and distribution of drugs. We gained a thorough understanding of the requirements for obtaining morphine by conducting an evaluation of the India Narcotic Drugs and Psychotropic Substances Act, including the regulations of each state. This review showed that the licensing of morphine for medical purposes was principally a state rather than a central government function, that the states required as many as five licenses for each medical institution wanting morphine, and that these must often be obtained from more than one branch of state government. The periods of validity for some licenses was so short that they would likely expire before all necessary licenses could be obtained.

Action plan:
The Center prepared an action plan included development of guidelines for obtaining morphine, preparation of a plan for simplifying regulations over morphine, and sponsorship of workshops on morphine availability with state governments. The WHO Cancer and Palliative Care Unit in Geneva had also designated a Demonstration Project to make morphine available at District Hospital level in the state of Madhya Pradesh (in cooperation with the Regional Cancer Center in Gwalior). This was the only part of the action plan which was included in the National Cancer Control Program (NCCP). In addition, the Center designated a Demonstration Project to be a source of national expertise and leadership in opioid availability (at the Pain and Palliative Care Society [PPCS], Calicut, in the state of Kerala) on the use and control of morphine. PPCS was already a WHO Demonstration Project for providing cost-effective community-based home care for late-stage cancer patients. PPCS is directed by Dr. M.R. Rajagopal, professor of anesthesiology at the Medical College, Calicut. The WHO Demonstration Project is collecting data on the use and control of morphine as an integral part of providing sustainable low cost community-based pain relief to patients who live in their own homes. PPCS is also working with the State of Kerala to simplify the morphine rules, because the main barrier to availability of cancer pain relief is restrictive state narcotic regulations.

Outcomes:
In 1996, in cooperation with the IAPC and the PPCS, the Center drafted "Guidelines: how to obtain morphine for cancer pain relief and palliative care in India." ⁷ These guidelines, which also explained the India narcotics law requirements for obtaining morphine, were published in the Indian Journal of Palliative Care in 1998.

In 1997, in cooperation with the IAPC and the PPCS, the Center drafted a proposal to simplify India's regulations for licensing of opioid analgesics and submitted it (February 9, 1997) to the Revenue Secretary and to the Narcotics Commissioner of India. This proposal was published in the Indian Journal of Palliative Care in 1998.⁸ In 1997, the Government of India accepted the proposal in principle and in 1998, assigned a government lawyer, Mr. M.C. Mehanathan, to prepare a model state regulation. The Revenue Secretary sent the model regulation, which was narrowed to pertain only to morphine, the only strong opioid analgesic recommended and available at that time, to all state and territorial governments with instructions to adopt a new state regulation to simplify licensing and access to morphine for pain relief.

In 1998, the Center and PPCS sponsored a workshop in Trivandrum (capital of Kerala) to encourage formal consideration of the regulation. The workshop convened key individuals from the primary state government and non-government systems involved in morphine licensing and production as well as from cancer control, palliative care and medical education. Following the workshop, the Kerala Health Secretary, Mr. Vijayachandran, appointed a task force of the Drugs Controller and Excise Commissioner to undertake the necessary formalities to simplify the Kerala narcotic rules. The simplified rule was adopted in November 1999. The new rule reduced the number of licenses needed by medical institutions from five to two, simplified the licensing procedure, linked licensing to physician training, and increased the period of validity for the required licenses.

In 1998, at the request of the Center, the WHO Programme on Cancer Control amended ⁹ the terms of reference for the WHO Demonstration Project at the PPCS, Calicut. This letter reaffirmed the previous term of reference (to demonstrate how to provide pain and palliative care coverage for cancer patients using home care and a community-based approach), and added a new term of reference: to demonstrate how to ensure that opioids are continuously available to patients in the community while preventing misuse and diversion. In 1998 and 1999, the Center provided technical assistance to this Demonstration Project, as well as a stipend to cover costs of the additional work involved. An article reporting the results is being prepared.

In 1999, in cooperation with state governments and the Department of Revenue (Narcotics Division), the Center and the IAPC sponsored three more workshops to stimulate state governments to consider adopting the new model regulation to simplify the morphine regulatory system. The Center obtained a grant for workshop costs from the United States Cancer Pain Relief Committee, a private non-profit educational, scientific and charitable organization. These workshops were organized by the IAPC (Dr. Rajagopal) in cooperation with the Center and palliative care physicians in the states. They were held in Cuttack on October 8, 1999 for the state of Orissa; in Mumbai on October 4, 1999 for the state of Maharashtra; and in Bangalore on February 26, 1999 for the state of Karnataka. The Center was an active participant and co-chaired the sessions with the senior government official. Each workshop also benefitted from the invaluable assistance of M.C. Mehanathan, Deputy Legal Counsel of the Division of Narcotic Drugs, whose time and expenses for all three workshops was contributed by the Department of Revenue. As a result of these workshops, steps are being taken in these states to adopt the rule to simplify morphine licensing. The states that adopted the simplified rule by the end of 1999 are: Sikkim (1998), Kerala (1999), Madhya Pradesh (1999), Orissa (1999) and Tripura (1999).

In 1999, following a meeting with the national Health Secretary, the Center, PPCS, and the IAPC prepared and submitted a proposal to the Ministry of Health, Government of India, for the next steps to simplify state regulations, organize workshops, train professionals, and monitor and develop the opioid distribution system. The Center also recommended to the Health Secretary that a representative of the PPCS be considered for membership on the committee to revise the national cancer control plan. Finally, the Center and IAPC requested the WHO Office-India and SEARO to provide support for the workshop initiative.

Each year, in 1997, 1998 and 1999, the Center presented a progress report to the IAPC membership on the steps being taken to improve availability of morphine. The Center participated in a panel discussion on opioid availability with the Drugs Controller from Mumbai in the state of Maharashtra during the 1998 Conference. In 1999, the Center sponsored the participation of Professor June L. Dahl from the WHO Demonstration Project in Wisconsin, USA; she gave a presentation to the IAPC conference on the principles and actions necessary to make pain relief an institutional priority. In 1997, 1998, and 1999, the Center met with the IAPC Committee on Morphine Availability and Control during the IAPC annual conference to review progress and decide on the next steps to improve availability of opioids in the country.

Evaluation:
The Demonstration Project is excelling at fulfilling its terms of reference by 1) providing cost-effective home care to more than a thousand terminally ill patients annually, and 2) showing how morphine can be used by trained health professionals with the assistance of volunteers to relieve pain in numerous patients who live at home, without misuse or diversion. The PPCS has published several articles on the program in international journals, and several more are planned in cooperation with the Center.

Progress is being made to implement the action plan to improve opioid availability and cancer pain relief. The Revenue Department has endorsed simplification of the rules and is supporting the workshops, through the contribution of the travel time and expenses, expertise and leadership of key officials; the workshops are resulting in changing the rules and improving communication.

The workshop experience made it apparent that bringing together senior officials from the concerned government departments with doctors could facilitate changes in opioid policy and system administration. Doctors gained valuable information about the morphine licensing and control system, which will enable them to work more effectively with government in the future. The workshop also made it clear that a revised regulation in itself was not enough: the state government needed to develop a procedure which heretofore had not existed, to identify the medical institutions in the state that need morphine, to establish minimum requirements for such institutions, and to train doctors about use of morphine. Indeed, a new drug distribution infrastructure for pain relief and palliative care is being created. Reports of progress are being made to IAPC meetings and in the PPCS and IAPC newsletter.

This progress, in contrast with past years of frustration, is producing enthusiasm and hope that Indian palliative care workers may finally be able to have morphine to relieve pain in the one million cancer patients with unrelieved pain.

The effort to make morphine available from the District Hospitals to patients in the community in the state of Madhya Pradesh was not successful for systemic reasons: a) cancer pain relief, while a part of the National Cancer Control Program, is not a priority for the delivery of primary health care, which is a responsibility of state government, and b) the unresolved complexity of morphine regulation in that state. It should be noted that all the physicians and administrators we worked with were very cooperative.

In the past, there were efforts to address morphine unavailability by distributing it free to regional cancer centers. While of laudable intent, this approach had a low potential for sustainable benefit to patients because 1) it was limited only to regional cancer centers, not all of which provided pain relief, 2) it postponed the time when institutions must make their own arrangements to obtain a continuous supply, and 3) it appears that some of the morphine provided to regional centers was not used before the expiration date and had to be disposed, adding to the frustration that already existed among programs that wanted morphine and could not obtain it.

Over the last ten years, substantial resources have been devoted to many training seminars on pain relief and palliative care throughout India.

The consumption of morphine (an indicator of progress to improve cancer pain relief used by WHO) decreased through 1996. However, with the simplification of the state rules and the expansion of palliative care especially in Kerala, the Center fully expects that this trend will finally reverse and begin to increase in 1998 or 1999 (however, there will be a delay in verifying any increase due to the lag in statistical reporting and also questions about the accuracy of reporting).

It should be noted that many training sessions which have been sponsored in India by various groups are traditional lecture format and are better described as awareness sessions, and as such have little potential to change practice and therefore improve pain relief and palliative care that is so urgently needed.

Financial support for this project in India is likely to decrease because current funds from the US Cancer Pain Relief Committee will be expended in 2000. More support will be necessary to sustain the momentum. This support should come from the Government of India Health Department, SEARO, WHO-India, and other sources. Resources are needed for workshops to simplify the opioid rules in all the states, to develop infrastructure for licensing of medical institutions, determine annual estimates of need for opioids, produce and distribute opioids, and train health professionals.

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