Secondary Logo

Journal Logo

Opioids for Cancer Pain: Availability, Accessibility, and Regulatory Barriers in Turkey and Pallia-Turk Project

Ozgul, Nejat MD*; Koc, Orhan MD; Gultekin, Murat MD*; Goksel, Fatih MD; Kerman, Saim MD; Tanyeri, Pelin MD; Ekinci, Halil MD§; Tuncer, Murat A. MD*; Sencan, Irfan MD

Journal of Pediatric Hematology/Oncology: April 2011 - Volume 33 - Issue - p S29–S32
doi: 10.1097/MPH.0b013e3182121bd9
Supplements
Free

Palliative care is an emerging topic in Turkey within recent years. Currently, there are only few number of palliative care services across the country and majority of the centers are pain control units. Morphine consumption rate per capita is low, accessibility and availibility of morphine products are also limited. One of the main headings of Turkish Cancer Control Programme 2009–2015 is palliative care and a serial palliative care unit implementation with continuous training programmes is planned to be finalized untill 2015. This article reviews the current palliative care situation in Turkey, opioid availibility in Turkey and also briefly summarizes Pallia-Turk Project which is unique with respect to many different aspects for implementation, and can be a good model for many other countries that still did not have such an implemented palliative care program.

*Cancer Control Department

General Directorate of Curative Services

General Directorate of Phameceuticals and Pharmacy

§General Directorate of Primary Health Care Services, Turkish Ministry of Health, Turkey

Reprints: Murat Gultekin, MD, Cancer Control Department, Turkish Ministry of Health, Turkey (e-mail: mrtgultekin@yahoo.com).

Received January 12, 2011

Accepted January 24, 2011

The Turkish Ministry of Health has launched a national cancer control program for the next 5 years in 2009. The program includes 5 main headings: Registry, Prevention, Screening and Early Diagnosis, Treatment, and finally Palliative Care. Among these, palliative care was the weakest part of current cancer control activities in Turkey. The main reason for this playing down palliative care was the traditional Turkish family structure. Turkish families are so crowded that one gets in trouble if all family members come together around this person; therefore, Turkish families had an intrinsic palliative and home care services. A second reason for ignoring palliative care is the absence of such a medical discipline in the medical education programs.

Currently, there are few palliative care centers across the country. Majority of the centers are pain units (Table 1). In addition, despite the fact that >90% of the raw material of opioids are produced in Turkey, our country was lacking behind many countries with respect to morphine consumption per capita. In contrast, not only the consumption rates but the available morphine products within Turkish market were also lacking. Many opioid types were absent in our market such as sublingual opioid tablet or immediate release morphines (Table 2).

TABLE 1

TABLE 1

TABLE 2

TABLE 2

Another big concern was the current legislation about opioid prescription. General practitioners and family physicians are not permitted to prescribe morphine. Only few specialists have the right to prescribe opioids using the red prescription papers. In addition, each physician and prescript is closely followed by the local health governors and also narcotic divisions of the police departments. These, of course, inevitably force the physicians to avoid morphine prescription.

Another concern is the training of the medical staff for morphine consumption. Majority of the clinicians do not know appropriate algorithms for main management. In addition, they do not have much experience with the use of morphine and to manage its related side effects.

In Turkey, pharmaceutical products indicated for use in cancer therapy are available to patient access through licensing, off-label use, and the compassionate use program. When a medicinal product is yet nonlicensed and there exists no alternative satisfactory treatment; if it is necessary for the patient's survival and his/her quality of life, the Ministry of Health follows its legislation for providing to patients either through the compassionate use program or through off-label use.

Legal trade (ie, import, export, production, consumption, procurement, and stock status control) of psychotropic substances used in cancer therapy is under the responsibility of the Ministry of Health. According to the World Health Organization (WHO) and International Narcotics Control Body data, Turkey is categorized along with countries that are not able to provide sufficient amounts of opioid products.

With all these realities, Turkish Ministry of Health, Cancer Control Department has launched a Project so called Pallia-Turk to be implemented in 2011. The Project can be summarized in 4 main headings:

  1. Increase of morphine availability in the markets
  2. New legislations for morphine prescription
  3. Training of medical staff against opiophobia
  4. Implementation of a community-based family physician-based palliative care model

Back to Top | Article Outline

INCREASE OF MORPHINE AVAILABILITY IN THE MARKETS

The ministry has invited all local companies to import new morphine types to the country. Some encouraging policies were announced from the ministry as facilitating the licensing and reimbursements. However, as morphine tablets were so cheap, neither of the companies has presented an interest on importation. With this reality, Turkish Council of Ministers have launched a new law and gave the opportunity to the Cancer Control Department to import new morphine tablets itself, as a governmental agency. With this new legislation, Turkish Ministry of Health, Cancer Control Department has now the chance to import new morphines into the market and distribute these drugs free of charge to all citizens who are in need. Cancer control department now searches for international drug companies who may get interest in this importation and will invite these companies for the tender to be held in early 2011.

Back to Top | Article Outline

NEW LEGISLATIONS FOR MORPHINE PRESCRIPTION

Another big concern was about the prescription legislation of morphines. Currently, as mentioned before, only few specialists have the right to prescribe morphine and all prescriptions are closely followed by local health governors. With the new legislation planned to be published by 2011, all family physicians will have the right to prescribe opioids. As all morphines will be imported by the Ministry, the distribution of drugs to the patients will be done through Ministerial Cancer Early Diagnosis, Screening and Education Centers (KETEM) centers. Such an approach will avoid abusement of morphine prescriptions, as the patients will receive their tablets through hospitals but not through private pharmacies. This will decrease the pressure over the family physicians and will encourage them to prescribe morphine.

Back to Top | Article Outline

TRAINING OF MEDICAL STAFF AGAINST OPIOPHOBIA

A third problem is the training process of family physicians with respect to the pain management algorithms, use of morphines, and to manage morphine-related side effects. Turkey has around 20,700 family physicians and each needs to be trained for these topics. Cancer Control Department is now in close collaboration with some Professional national (Turkish Society of Palliative Care, Turkish Society of Medical Oncology, and Turkish Society of Oncology Nursing) and international societies (MECC, WHO The Catalan Institute of Oncology Center) to implement nationwide training modules to all family physicians and their nurses. A core group of 40 people is planned to be trained as trainers who will cover the whole country for training, which is planned to take 2 years to be finalized.

Back to Top | Article Outline

IMPLEMENTATION OF A COMMUNITY-BASED FAMILY PHYSICIAN-BASED PALLIATIVE CARE MODEL

The so-called Pallia-Turk Project is unique with respect to many different aspects for implementation, and in case of success, can be a good model for many other countries that still did not have such an implemented palliative care program. The unique properties of the project are

  • A community-based system based on family physicians and their nurses, so that every citizen will have the chance to receive basic palliative care services through their family physicians at the primary level health care.
  • There is so-called integration of nongovernmental organizations (NGOs) and local governors (municipals) to cover the social, economic and physiologic, and religious needs of patients
  • There is no hospice system at the start point

The basic structure of the system can be summarized as follows:

Pallia-Turk Project has 3 levels of organizations: primary, secondary, and tertiary palliative care centers (Fig. 1):

  • (1) Primary Level: Primary level organization includes family physicians, home care teams, KETEMs, NGOs, and local governors. Patients who cannot be managed at this level are referred to secondary level centers.
  • (a) Home Care Team: Each hospital will have a home care team by the end of 2011 according to national plans of general directorate of curative services. A total 0f 500 teams is planned to be implemented until the end of 2011. All government hospitals (class A, B, and C according to Ministerial Guidelines) and some subspecialty hospitals (chest diseases, physiotherapy and rehabilitation, maternity hospitals for in-home phototherapy) will have home care teams. Each team is consisted of 1 general practitioner, 2 nurses, 1 driver, 1 secretary, and 1 car, minimally. Depending on the hospital facilities, if available, each team also may contain 1 physiotherapist, 1 dietician, 1 physiologist, and a social worker. Any patient who is in need of home care can directly admit to these teams, or if any family physician or any specialist doctor (such as general surgeon, internal medicine etc) needs home care for their patients, they can get in touch and direct the team for their patients. Home care teams will be responsible for simple acute measures such as pain relief, constipation, wound dressing, and parenteral drug administration. They will take care for the patients who are not mobile sufficiently. Each home care team can also support patients economically in case of need, which will be covered by the hospital circulating capital. They take for not only oncology patients, but also for other diseases (such as asthma, chronic obstructive lung disease, neuromuscular diseases, bed ridden patients with diabetes, hypertension etc and also infants for phototherapy). The teams may do in-home physical examination, all in-home nursing (injection, intravenous infusion, etc), blood analysis, drug prescriptions, bringing of the drugs to the patients, transport to hospital if needed, all rehabilitive and basic palliative care, training, and supportive efforts. All these cares are totally free of charge and every patient can easily reach to the home care by a private telephone line
  • (b) Family Physicians: Currently, Turkey has 20,700 family physicians. Each Turkish citizen has 1 family physician that will take care of him or her. However, currently, neither of the family physicians is trained for basic palliative care. They do not have any knowledge about how to manage pain in their patients, how to deal with basic symptoms of palliative care, how to support these patients and their families physco-socially, and how to teach them the ways to deal with mourning periods. Terminal patients frequently admit to emergency departments, and majority of these admissions are unnecessary. Furthermore, these frequent but unnecessary admissions have a large economic impact on the health budget of governments. If family physicians were to train the patients and their relatives, they could have handled the upcoming fear and anxiety due to disease-related symptoms and could avoid frequent hospital admissions.
  • (c) KETEMs: KETEMs are the key points of the project between the primary and secondary levels. There is at least 1 KETEM in each province of Turkey. Each KETEM is integrated to one of the government hospitals in these provinces where there are many experts in different medical specialties. Each KETEM also works in close collaboration with the local governors and NGOs. Two beds will be reallocated for palliative care patients in each hospital and KETEM physicians will have the responsibility of these 2 beds. The role of KETEMs in this project is:
  • (i) To evaluate the patients who could not be managed by family physicians and therefore admitted to a hospital. KETEM physicians will examine the patients and may decide on necessary consultations within the integrated hospital (eg, chest diseases physicians, cardiologist, psychologist etc). Depending on the consultations and patients' status, they may decide to admit the patients to palliative care beds (2 to 3 beds) of the hospital they are integrated (so-called secondary level centers).
  • (ii) To work in close collaboration with local governors and NGOs to increase the awareness of the population for palliative care services and to do fund raising activities to use in needs of these patients.
  • (iii) Majority of the palliative care patients can be handled by simple measures. But sometimes you may need a multidisciplinary approach in a hospital (some complex cases particularly). KETEMs are the link between hospitals (secondary level) and family physicians.
  • (d) NGOs and Local Governors: For a successful and satisfactory palliation, support and close collaboration between Pallia-Turk staff and NGOs and local governors is a must, as palliative care is a multidimensional topic. The expected inputs of these NGOs can be summarized as follows:
  • (i) Training: All basic trainings will be organized by
  • (1) National Professional NGOs:
  • (a) Turkish Society of Palliative Care,
  • (b) Turkish Society of Medical Oncology
  • (c) Turkish Society of Oncologic Nursing.
  • (2) International Collaborators:
  • (d) WHO Collaborating Center, Barcelona, Spain
  • (e) European Association for Palliative Care
  • (f) Middle East Cancer Consortium
  • (ii) Awareness: All societies will increase the awareness of the public and Turkish Medical Staff for Pallia-Turk through different scientific and public meetings. Local governors are also of high importance for awareness activities.
  • (iii) Fund Raising: All NGOs working for cancer patients and their relatives will work for fund raising activities that can be used for the needs of the patients.
  • (2) Secondary Level Centers: These are located in KETEM hospitals, and are responsible to take care of patients with symptoms of moderate severity and for patients who are in need of acute-subacute and chronic palliation that cannot be managed by family physicians. These centers will be under the responsibility of an internal medicine expert. Each center will be consisted of 2 to 3 beds with vital monitors. KETEM physician and nurses will be responsible to allocate such patients and to follow them up with their family physicians. Appropriate consultations will be decided by the internal medicine expert who works with consultant physiotherapists, psychologists, social workers, religious man, and other medical experts of the hospital.
  • (3) Tertiary Level Centers: These centers are the centers of excellence. They take care of complex patients who cannot be managed at the primary or secondary levels. These centers work in a multidisciplinary approach. Teams include physicians (internal medicine, medical oncology, cardiology, thoracic diseases, anesthesiology or algology, and general practitioners), experienced oncology nurses (1 for 2 patients), social workers, physiotherapists, nutrition expert, psychologist, and religious man. These centers will also plan research activities within time.
FIGURE 1

FIGURE 1

Back to Top | Article Outline

THE ROLE OF TURKISH MINISTRY OF HEALTH IN PALLIA-TURK

  • (a) Cancer Control Department:
  • (1) Primary responsible body of the project.
  • (2) Will organize all ministerial activities in collaboration with KETEMs and NGOs.
  • (3) Primarily responsible for population-based palliative care system and training of medical staff.
  • (4) Importation of new morphine drugs to Turkey
  • (b) General Directorate of Curative Services: Are responsible for
  • (1) Implementation of home care teams
  • (2) Reallocation of beds for secondary level palliative care centers.
  • (3) Implementation of tertiary palliative care services within future
  • (c) General Directorate of Primary Health Care Services: Are responsible for incorporation of family physicians in to the population-based palliative care system and their organization
  • (d) General Directorate of Pharmacy and Pharmaceuticals: Are responsible for import of new morphine drugs and their legislations, follow-up system
Keywords:

cancer pain; opioids; availability; Turkey

Copyright © 2011 Wolters Kluwer Health, Inc. All rights reserved.