Special for the Armenian Weekly
Human Rights Watch (HRW) on July 14 released a comprehensive report on the inadequate treatment provided to terminally ill cancer patients in Armenia, where palliative care, which “seeks…to prevent suffering and improve quality of life,” remains largely unavailable. The treatment provided in Armenia diverges greatly from the recommendations of the World Health Organization (WHO), leaving thousands of cancer patients without the proper care. Around 8,000 people die from cancer each year in Armenia, and more than 50 percent of cancer patients receive their diagnoses at a late stage. According to the 86-page report, titled, “‘All I Can Do Is Cry’: Cancer and the Struggle for Palliative Care in Armenia,” “Almost half of Armenia’s cancer patients are at stage 3 or 4 of the disease when they receive their initial diagnosis.” They are left in severe pain, which remains untreated or undertreated for the remainder of their lives. In recent years, Armenia has taken steps to develop palliative care; however, much more remains to be done.
Morphine is used to treat chronic pain in cancer patients, but in Armenia, oral morphine is not a registered medication. The WHO designates morphine as an essential medication that should be made available to all patients who need it; however, morphine is difficult to obtain in Armenia. The standard for palliative care there deviates from the principles and guidelines set by the WHO. The WHO estimates that 80 percent of people with cancer develop moderate to severe pain “and will require morphine for an average period of 90 days before death.” Yet, from 2010-12, Armenia only consumed enough morphine to adequately treat moderate to severe pain in about 3 percent of those who needed such treatment. The HRW traveled to Yerevan and many villages in Armenia to conduct its study on the need for palliative care.
According to the WHO, medication should be given by mouth whenever possible. However, in Armenia, oral morphine remains unavailable. Furthermore, doctors are only able to administer morphine through intramuscular injections. This method can be dangerous for patients who are frail and who have little muscle tissue, and the medication from an injection only lasts up to four hours. Standard care in Armenia is to provide only one to two shots per day, leaving patients in pain for the majority of the day.
One of the WHO’s principles for cancer pain treatment states that medication should be taken “by the clock.” Even when morphine is prescribed in Armenia, it is at painfully conservative doses; there is an unofficial rule that doctors only prescribe one to two ampoules of morphine for a patient. Doctors interviewed by the HRW explained that they will only increase the prescription from one ampoule to two ampoules after two weeks, even if it was clear from the beginning that one was not sufficient.
Sixty one-year-old Lyudmila was diagnosed with breast cancer in 2007 and developed pain starting in 2010. When she was interviewed 2 years after first developing chronic cancer pain in 2012, she was still suffering from severe pain 22 hours of the day. “During the day I endure pain. What else can I do? I have a prescription only for one ampoule. I take it the way it’s prescribed,” she told HRW.
The WHO’s guidelines explain how the prescription for pain medication should be handled. Doctors should operate “by the ladder”: When a non-opioid is not sufficient in strength, an opioid for mild to moderate pain should be prescribed, in addition. If the non-opioid in combination with the stronger medication fail to relieve the pain, an even stronger opioid should be prescribed in place of the other medication.
“We start with one ampoule of morphine and increase later if need be,” one doctor told HRW. “In about 2 weeks or 20 days we usually increase the dosage. This might not be very humane, but that’s how it is. We know that 1 ampoule is enough for 4 to 6 hours, but we always start with 1 ampoule and give other painkillers too. I might not agree with it, but that’s how it is.”
Other doctors justified their actions by explaining that the pain not alleviated by the one ampoule of morphine could be offset with other medications. “One ampoule is not enough, we know. But we combine opioids with other analgesics, like Ketonal, Diclofenac, and others,” said one physician. These other medications, however, are weaker and less effective, sometimes still leaving patients in agonizing pain.
Medication should be administered at regular intervals. According to the WHO, “Most, if not all, pain due to cancer could be relieved if we implemented existing medical knowledge and treatments.” The WHO’s guideline emphasizes that “the use of morphine should be dictated by the intensity of pain, not by life expectancy”; however, in Armenia, morphine is only prescribed to cancer patients within the last month of their illness. As a result, many cancer patients suffer severe chronic pain for weeks, months, or years before they are prescribed the correct medication.
The HRW found that “Armenia’s drug regulations are at the heart of problems with availability and accessibility of palliative care and pain management.” The complex process of prescribing opioids is monitored closely by the police and requires written monthly reports from doctors that include the patient’s name, address, ID number, diagnosis, prescribed dosage, and information on whoever procures the prescription. Pharmacies also give similar reports. This practice violates patients’ right to privacy and confidentiality, which is an essential element of the right to health. Furthermore, the HRW found that police often survey establishments that fill opioid prescriptions and that, according to one pharmacy employee, “police regularly check prescriptions the pharmacy fills.”
Police involvement in the prescription process “generates a sense of trepidation among oncologists and pharmacists. As one former Health Ministry official explained, ‘one of the main problems in our system is that doctors are afraid to prescribe opioids or prescribe [inappropriately] low dosages.’”
Many pharmacies avoid seeking licenses to fill prescriptions for morphine; only a few clinics with pharmacies and one pharmacy in Yerevan have such a license. It is expensive to implement security measures, and the HRW observes that “Scrutiny by police and potential criminal liability may further serve to dissuade pharmacies and clinics from seeking licenses.” One health care personnel who deals with opioids told HRW, “[Y]ou lose one ampoule and prison is waiting for you…”
Regarding the prescription procedure in Armenia, medical personnel explained that “sometimes the procedures are so burdensome and take such a long time that by the time it is all cleared there is no need for it anymore. Needs are great for pain medications like opioids, but the amount of paper-pushing associated with it is not often worth it.”
Several doctors in addition to the oncologist, including the polyclinic’s chief, chief nurse, general practitioner, and at times others, are required to sign off on the decision to prescribe morphine. The HRW says that oncologists “must record each opioid prescription transaction in several different registries, including one that must be kept in a fireproof safe.”
The process for prescribing opioids is long and complicated, and “patients sometimes die in agonizing pain before opioids are prescribed.” The HRW interviewed Anahit Garibyan, whose father, Sergey, died in September 2012, a month after he was diagnosed with a stage four lung tumor. “My father was in agonizing pain,” she said. “He kept screaming for six or eight hours before he died.” She added that when she went to see the oncologist, “he told me that it was not that easy to prescribe opioids, and that a standing commission was to visit [my father] first. When I asked him to initiate the process, he told me that a tramadol injection should be prescribed first, which I got, but it did not help much, and [my father] died in pain.”
Armenia’s restrictive regulation and excessive police involvement “goes against WHO guidance on nationally controlled substance policies, which says that ‘when balancing drug control legislation and policies, it is wise to leave medical decisions up to those who are knowledgeable on medical issues.’”
Cancer patients (or their relatives) must at times travel far to secure their prescription. There are only a select few locations where patients can acquire morphine, and empty ampoules are required to refill the prescription. Oncologists will only prescribe opioids to last for 24 or 48 hours at a time; the prescription sometimes has to be refilled every day.
Doctors are only able to prescribe medication to a patient whose cancer diagnosis has been confirmed through a biopsy. In order to get the diagnosis confirmed, a patient must travel to one of three medical centers. If patients are too weak or cannot afford to travel, they will not be registered as cancer patients and therefore will be denied access to the proper medication. According to HRW, “Of 5,581 patients who died of cancer in 2013, 1,274 were diagnosed post-mortem, according to the data provided by the National Oncology Center. None of these people received a formal confirmed diagnosis yet a large percentage of them are likely to have had serious pain.”
Only about eight percent of cancer patients with chronic pain have access to the appropriate pain medication. Some oncologists interviewed by the HRW explained that they were fearful of their patients becoming drug-dependent, hence their reluctance to prescribe morphine. The WHO maintains that these fears are scientifically unfounded, and yet oncologists continue to prescribe weaker pills instead of morphine even with the consequence of severe pain for their patients.
In 2014, the World Health Assembly declared the provision of palliative care an “ethical responsibility of health systems.” The WHO recommends that all countries establish a standard for palliative care. In 2009, Armenia recognized palliative care as a medical service; however, oncologists still follow the 1994 directive and not the 2002 law.
Recommendations
The HRW issued a number of recommendations, one of which encourages Armenia to take steps that will lead to the availability of oral painkillers. The HRW recommends that oral opioids be registered to allow physicians—not only oncologists—to prescribe them. The HRW also advocates the abolition of restrictions associated with procuring opioids for late-stage cancer patients, including the requirement for biopsy-confirmed cancer.
The HRW also advises Armenia to cease excessive police involvement in the prescription process, simplify record-keeping, and eliminate the need for multiple doctors’ signatures on a prescription form. Patients should be allowed to collect a supply of opioids lasting 14 days. The HRW urges Armenia to establish a wide range of palliative care as well as a home-based palliative care system.
In developing a national strategy action plan, the HRW recommends reforms that will introduce palliative care as a subject of teaching in medical schools and will inform medical staff on the proper administration. The HRW proposes that Armenia appeal to the World Health Assembly for assistance. The HRW also calls upon several international organizations, including the WHO, the European Union, the Council of Europe, and the International Narcotics Control Board (INCB), to assist Armenia in developing its palliative care system.
Amanda Berger
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Great article Amanda. So proud of you!