B. Collaboration with WHO Demonstration Project - India
This section reports on the Center's activities in India in collaboration with the WHO Demonstration Project in Calicut, an Indian non-governmental organization, and several agencies of the Central Government of India as well as several state government Ministries of Health.
Objective:
To overcome regulatory barriers and to improve availability and access to opioid analgesics for patients
with cancer and pain.
Situation:
It is estimated that more than one million people a year in India suffer from pain due to cancer. Cancer is
usually diagnosed when the disease is late-stage which is when pain is severe and sometimes
excruciating. Despite India's heavy cancer burden, the country uses little morphine -- an essential drug
for cancer pain management.7 From 1986 to 1998, the consumption of morphine for medical purposes
decreased by more than 90%, due in part to a plethora of state excise requirements and to a tough anti-narcotics law adopted in 1985. Ironically, this decrease occurred while there were increasing efforts to
improve awareness of pain management and palliative care and to educate and train health-care
professionals according to the WHO Three-Step Analgesic Ladder. Although these educational efforts
have enhanced the willingness of physicians to use opioids for pain relief, the reality is that many
hospitals and palliative care programs have great difficulty obtaining a continuous supply of these drugs.
Method:
The Center developed a method to identify the barriers to morphine availability, devised a plan for policy
and systems change, developed collaboration with governmental and non-governmental organizations;
and, with leadership from the WHO Demonstration Project in Calicut, is implementing a plan to simplify
regulation of morphine in India.
Cooperation:
The Center has collaborated 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 of WHO. The Center also worked closely with the Indian
Association for Palliative Care (IAPC), which appointed a Committee on Morphine Availability and
Control to work with us.
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 period 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 that included (1) development of guidelines for obtaining morphine,
(2) preparation of a plan for simplifying regulations over morphine, and (3) 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 the 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 that became part of the National Cancer Control Program
(NCCP). In addition, the
Center designated a WHO Demonstration Project (WHODP) 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. The PPCS was already a WHO Demonstration Project for
providing cost-effective community-based home care for late-stage cancer patients. The PPCS is directed
by Dr. M.R. Rajagopal, professor of anesthesiology at the Medical College,
Calicut.
Outcomes:
In February 2000, the Center and PPCS sponsored two more morphine availability workshops in the
state of Gujarat (February 21) and in the state of Madhya Pradesh (February 23) to stimulate these state
governments to consider adopting the model regulation to simplify the morphine regulatory system.
These workshops were organized by the IAPC (Dr. Rajagopal) in cooperation with the Center and
palliative care physicians in these states. In addition, a national workshop on morphine availability was
held in New Delhi (February 24) with the Government of India Department of Revenue and Health,
palliative care professionals, and representatives of state governments, WHO-India, and the U.N.
International Drug Control Program. The primary message from this workshop was that palliative care
and morphine availability should become a priority of the Health Ministry.
In addition, the Center presented at the 7th International and National Conference of the Indian Association of Palliative Care in Bangalore,2 and participated in the annual meeting of the IAPC Committee on Morphine Availability. A decision was made to dissolve the current morphine committee and create a new committee for the implementation of adopted rules in each state (the "IAPC Committee on Opioid Availability and Control"). The Committee was reconstituted to reflect movement toward the medical use of opioid analgesics in general rather than morphine specifically. A plan of action was prepared for the new committee that called for additional workshops to encourage the adoption and implementation of the simplified rules, to develop training materials about opioid availability, and to create a state-by-state directory of pain and palliative care programs that have obtained a morphine license.
In September 2000, the Center sponsored two more morphine availability workshops in the state of Andhra Pradesh (September 23) and the state of Madhya Pradesh (September 27). Although Madhya Pradesh was one of the first few states to simplify the morphine requirements (in 1999), it was evident that this change in the narcotics regulation produced only a slightly perceptible improvement in morphine availability. Implementation of the amended regulation was lacking and was strongly encouraged. The meeting participants agreed to develop a system to implement the new morphine rules, based on the procedure used in Kerala. Following the trip, a trip report was sent to various WHO representatives outlining the Center's recommendations for continued progress in India.8
Evaluation:
In 1999 (the most recent year for which information has been reported to the
INCB), morphine
consumption in India was at its highest level in more than a decade (see Figure 1). The decreasing
consumption trend has finally reversed as a direct result of these efforts.
Throughout 2000, the WHODP in Calicut has achieved success in obtaining an adequate and continuous supply of morphine; the morphine has been distributed to more than one thousand patients in a year to relieve their pain and to improve their quality of life (see Figure 2). The WHODP collected data on the use (see Figure 3) and control of morphine as an integral part of providing sustainable low cost community-based pain relief to more than a thousand patients who live in their own homes, annually. This increase in morphine use has been accomplished without evidence of diversion or misuse.9 The WHODP continues to excel 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 to relieve pain in patients at home, and without misuse or diversion. The WHODP has published several articles about the program, and several more are planned in cooperation with the Center.
Our evaluation of the use of the specialized workshops demonstrates the importance of bringing together senior officials from the concerned government departments with doctors to facilitate changes in opioid policy and system administration. Physicians gained valuable information about the morphine licensing and control system, which will enable them to work more effectively with government in the future. The government officials learned about palliative care and the need for opioids.
The workshops also make it clear that simple adoption of a revised regulation is not enough to promote actual improvements in morphine availability. For example, our previous efforts to make morphine available in a district hospital in Madhya Pradesh were unsuccessful for a number of reasons, including (1) cancer and palliative care, while a part of the NCCP, was not a priority for district hospitals, and (2) the unresolved complexity of morphine regulation in that state prevented availability. Consequently, a workshop was required in Madhya Pradesh to address these issues. To increase the availability of opioid analgesics for medical purposes, the state governments of India need to develop a procedure that has heretofore not existed: to identify the medical institutions in the states that need morphine, to establish minimum requirements of accountability for such institutions, and to train doctors about use of morphine. Workshops, coupled with adoption of the simplified rules and physician training in pain management and palliative care, will create a new drug distribution infrastructure that will enhance the availability of morphine for pain relief.